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08/04/2016
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Confidential
Evidence‐based Information on Nutrition 
and Non‐Traditional Therapy
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Confidential
Dominick M. Maino, OD, MEd, 
FAAO, FCOVD‐A
Professor, Illinois College of
Optometry/Illinois Eye Institute
3241 S. Michigan Ave; Chicago, Il 60616
312-949-7282 dmaino@ico.edu
Lyons Family Eye Care
3250 N. Lincoln Ave; Chicago, Il 60657
773-935-2020 LyonsFamilyEyeCare.com
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Confidential
Clinician’s View of Researchers 3
Confidential
Researcher’s View of Clinicians
Inconsistent Patient Populations
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Patients’ View of Clinicians & Researchers 5
Confidential
Do we need evidence for everything?
There is no randomized, controlled trial (RCT)
supporting the contention that evidence-based
medicine is beneficial, and "evidence" is more than
the information that can be obtained from RCTs.
Systematic reviews have severe limitations of
scope and reach, and RCTs can lead to false or
contradictory conclusions. Most controlled studies
enroll only highly selected groups of patients,
specifically excluding those with complicating factors,
yet real patients bring with them an abundance of
messy heterogeneity. Considering this, we should not
withhold potentially beneficial treatment just because
we lack randomized controlled trials. The frequent
lack of solid clinical evidence requires clinicians to
invoke critical thinking, communication, judgment,
and even intuition on behalf of their patients. Medical
training is as much an apprenticeship as it is an
education, and medicine as much a craft as it is
an art.
Hunter DG1Do we need evidence for
everything? Am Orthopt J. 2010;60:59-62.
.
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Do we need evidence for everything?
Attitudes and Barriers to Evidence-Based Practice in
Optometry Educators
A group of optometrists and academics
new to implementing education in EBP
displayed positive attitudes to EBP but
considered that its application and
teaching could be significantly hindered
by a lack of time to access and
appraise the large volume of available
research evidence in the field of eye
care. (Optom Vis Sci 2015;92:514Y523)
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Confidential
Standard of Care May
be Changing:
Malpractice
Dr. XYZ , in breach of the standard
of care … failed to: perform
DFE/Cyclo, failed to properly
treat the amblyopia, failed to
determine proper Rx, failed to
monitor, failed to patch, failed to
properly instruct parents about
condition….
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Confidential
Do we need evidence for everything?
Standard of Care is Changing in What We Do
Treatment of Amblyopia (** supported by clinical trials)
1.) Rx spectacles, follow up 2-3 months **
2.) Continue to monitor until no further improvement, change Rx as needed, start patching
or atropine **
3.) Continue to monitor (taper patching over time if VA improves to target level)
3.) Continue to monitor until no improvement, start HVT
4.) Continue to monitor until no improvement, start OVT
Start Binocular Therapy SOONER rather than later.
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The Power of a Pair of Spectacles
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The Cochrane Database of
Systematic Reviews (CDSR) is the
leading resource for systematic
reviews in health care.
The CDSR includes Cochrane
Reviews (the systematic reviews) and
protocols for Cochrane Reviews as
well as editorials. The CDSR also has
occasional supplements. The CDSR is
updated regularly as Cochrane
Reviews are published ‘when ready’
and form monthly issues
http://www.cochranelibrary.com/
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Levels of Scientific Evidence
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Levels of Scientific Evidence
Level 5
1. Case report (a report of a single case)
2. Expert opinion
3. Personal observation
Susan A. Cotter,* Lynn A.
Cyert,† Joseph M.
Miller,‡ and Graham E. Quinn§, for
the National Expert Panel to the
National Center for Children’s
Vision and Eye Healtha.
Vision Screening for Children 36 to
<72 Months: Recommended
Practices. Optom Vis Sci. 2015
Jan; 92(1): 6–16.
Maino D. Ophthalmology
Causes Myopia! J Optom Vis
Dev 2004;35 (2):67-69.
Maino D, Schlange D,
Maino J, Caden B. Ocular
anomalies in fragile X
syndrome. J Am Optom
Assoc 1990;61:316-23
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Levels of Scientific Evidence
Level 4
1. Case report/series
A single subject study or a report of
multiple patients with the same treatment,
but no control group or comparison group
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Levels of Scientific Evidence
Level 3
1. Retrospective cohort study
a study in which patient groups are
separated non-randomly by exposure or
treatment, with exposure occurring before
the initiation of the study
2. Case-control study
a study in which patient groups are
separated by the current presence or
absence of disease and examined for the
prior exposure of interest
3. Meta-analysis of Level 3 studies
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Levels of Scientific Evidence
Level 2
1. Prospective comparative study
(therapeutic)
a study in which patient groups are
separated non-randomly by exposure or
treatment, with exposure occurring after
the initiation of the study
2. Meta-analysis of Level 2 studies or
Level 1 studies with inconsistent
results
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Levels of Scientific Evidence
Level 1
1. Randomized controlled trial (RCT)
a study in which patients are randomly
assigned to the treatment or control
group and are followed prospectively
2. Meta-analysis of randomized trials with
homogeneous results
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Levels of Scientific Evidence
Ia Scientific evidence obtained from meta-analyses of randomized clinical
trials.
Ib Scientific evidence obtained from at least one randomized clinical trial
IIa Scientific evidence obtained from at least one well-designed, non-
randomized controlled prospective study
IIb Scientific evidence obtained from at least one well-designed,
quasiexperimental study
III Scientific evidence obtained from well-designed observational studies,
such as comparative studies, correlation study or case-control studies.
IV Scientific evidence obtained from documents or opinions of experts
committees and/or clinical experiences of renowned opinion leaders.
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Clinical Trial Information
ClinicalTrials.gov: ClinicalTrials.gov is a registry and results database of
publicly and privately supported clinical studies of human participants
conducted around the world.
ClinicalResearchTrials.NIH.gov: Gives basic information about clinical trials
for the public
FoxTrialFinder.MichaelJFox.org: Fox Trial Finder was created by the Michael
J. Fox Foundation to help increase the flow of willing participants — both
people with Parkinson’s and control participants who do not have Parkinson’s
— into the clinical trials that need them, accelerating the Parkinson’s drug
development process.
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Confidential
MyClinicalTrialLocator.com: Helps you find a clinical trial
TrialReach.com: the world’s first online distribution network dedicated solely
to clinical trials and patients, joining forces with dozens of communities,
advocacy groups, patient portals, blogs, and charities, to reach a combined
audience of 100+ million patients per month, we bring the best and latest
clinical trial information directly to patients.
RareDiseasesNetwork.org is made up of 22 distinctive consortia and a Data
Management and Coordinating Center that are working in concert to improve
availability of rare disease information, treatment, clinical studies, and general
awareness for both patients and the medical community. The RDCRN also
aims to provide up-to-date information for patients and to assist in connecting
patients with advocacy groups, expert doctors, and clinical research
opportunities.
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Confidential
www.Apple.com/researchkit/:
With ResearchKit,
researchers can easily create
apps that take advantage of
iPhone features to gather
new types of data on a scale
never available before
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Confidential
Offit PA. Do you believe in Magic: The sense and nonsense of alternative
medicine. Harper Collins, NY, NY;2013
Steve McQueen (The Great Escape, Thomas Crown Affair, Bullit)
Mesothelioma.
Laetrile: is another name for amygdalin.
Amygdalin is found in the pits of many fruits, raw nuts, and Laetrile has shown
little anticancer effect in laboratory studies, animal studies, or human studies.
The side effects of laetrile are like the symptoms of cyanide poisoning
Laetrile is not approved by the U.S. FDA.
McQueen paid $80,000/month. Suffered. Died.
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Confidential
Offit PA. Do you believe in Magic: The sense and nonsense of alternative
medicine. Harper Collins, NY, NY;2013
Steve Jobs
Pancreatic Cancer. Treatable with surgery. Good success rate.
He treated himself with acupuncture, herbal remedies, bowel cleansings, and a
cancer diet of carrot and fruit juices for 9 months. Now it was too late.
He died.
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Research Gone Wrong
Hubel & Wiesel: Amblyopia
• Deprivational not functional amblyopia
• Critical vs sensitive periods
• Cats are not human
• OMD/scientist misinterpretation of the data: Deliberate?
Political?
• Decades of children and adults suffered
• Ignored clinical experience
• Perceptual Learning vs Optometric Vision Therapy
• Amblyopia can be treated at any age!
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Confidential
Do we need evidence for everything?
There is no randomized, controlled trial (RCT) supporting the
contention that evidence-based medicine is beneficial
….and yet!
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Confidential
Vaccines
You are just about to examine a 4 y/o, when you notice these red blotches
on his skin. It looks like measles, but you know there is an effective
vaccine for this disease. You ask mom if the child has had his shots. She
says no because they cause autism. What’s your response?
The Huffington Post has a story about your university closing down
because of the number of students with measles. What is your response?
USA Today has a story that in 2014, 1100 individuals came down with
mumps. What is your response?
In the 1920’s, my dad’s youngest sister died from measles. Have we
returned to those times?
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Vaccines
Vaccines for preventing smallpox: Fairly effective. Several adverse side
effects
Vaccines for preventing rotavirus diarrhea: Efficacy is lower in high-
mortality countries, but absolute benefit higher
Vaccines for preventing the common cold in healthy people: Not effective
Can nicotine vaccines help people stop smoking or help stop recent
quitters from relapsing? Currently no evidence that nicotine vaccines
enhance long-term smoking cessation.
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Using the combined vaccine for
protection of children against measles,
mumps and rubella:
…at least one dose of MMR
vaccine was 98% effective in
preventing laboratory-
confirmed measles cases;
one or two MMR doses were
respectively 92% and 95%
effective in preventing
secondary measles cases.
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Vaccines and Autism
…No significant association
between MMR immunization and
the following conditions: autism,
asthma, leukemia, hay fever, type
1 diabetes, gait disturbance,
Crohn's disease, demyelinating
diseases, or bacterial or viral
infections …
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Total Load Theory
According to the total load theory, at some point, which
varies widely between individuals, the body can no
longer handle the “load” of stressors such as nutritional
deficiencies and aggressive use of
medications/vaccines, and begins to show signs of that
burden. The signs of overload are the characteristic
symptoms of attention deficiencies and developmental
delays.
No support for this theory at this time.
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Nutrition/Supplements/Probiotics
How many of your patients have adopted various nutritional
regimens?
How many take supplements to improve health and well being or
to fight a current disease?
How many use probiotics?
How many of you use also participate in the use of diet
interventions, supplements and probiotics?
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Nutrition
Mediterranean diet
**…promising dietary tool for the primary prevention
of diabetes
**….fruits, nuts and vegetables reduce cancer risk
**A dietary pattern characterized by high fruit,
vegetable, legume, whole grain, nut, berry, seed, and
fish intakes, and possibly by intakes of dairy, coffee,
tea, chocolate, and alcohol (not in excess), but low
meat and detrimentally processed foods is associated
with reduced incidence of cardiovascular disease
and rates of noncardiovascular, noncancer
chronic inflammatory-related mortality.
**…red wine and extra virgin olive oil may
decrease risk of Alzheimer's disease.
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Vegetarian diet
**…vegetarian diets reduces mean body weight
**…, improving the plasma lipid profile and in decreasing
the incidence of high arterial blood pressure,
cardiovascular disease, stroke, metabolic syndrome and
arteriosclerosis. In addition, improved insulin sensitivity
together with lower rates of diabetes and cancer has been
observed.
**…Mortality from all-causes, ischemic heart disease, and
circulatory and cerebrovascular diseases was significantly
lower in vegetarians
… Adverse effects may include hyperhomocysteinaemia,
protein deficiency, anaemia, decreased creatinine content
in muscles and menstrual disruption in women who
undertake increased physical activity. Reduced Vit B12
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References
Diabetes Metab Res Rev. 2015 Jun 24. doi: 10.1002/dmrr.2672. [Epub ahead of print] Adherence to Mediterranean diet and 10-year
incidence (2012-2014) of diabetes; the mediating effect of inflammatory and oxidative stress biomarkers: results from ATTICA
cohort study. Koloverou E1, Panagiotakos DB1, Pitsavos C2, Chrysohoou C2, Georgousopoulou EN1, Grekas A1, Christou
A1, Chatzigeorgiou M1, Skoumas I2, Tousoulis D2,Stefanadis C2; ATTICA Study group.
Br J Nutr. 2015 Apr;113 Suppl 2:S102-10. doi: 10.1017/S0007114515000148. Fruit and vegetables and cancer risk: a review of
southern European studies. Turati F1, Rossi M1, Pelucchi C1, Levi F2, La Vecchia C3.
Curr Opin Lipidol. 2015 Jun 22. [Epub ahead of print] What an anticardiovascular diet should be in 2015. Jacobs DR Jr1, Tapsell LC
Adv Exp Med Biol. 2015;863:1-20. doi: 10.1007/978-3-319-18365-7_1. Olive Oil Phenols as Promising Multi-targeting Agents Against
Alzheimer's Disease. Rigacci S1.
J Acad Nutr Diet. 2015 Jun;115(6):954-69. doi: 10.1016/j.jand.2014.11.016. Epub 2015 Jan 22. A systematic review and meta-analysis
of changes in body weight in clinical trials of vegetarian diets. Barnard ND, Levin SM, Yokoyama Y.
Rocz Panstw Zakl Hig. 2014;65(1):9-14. Health benefits and risk associated with adopting a vegetarian diet. Pilis W, Stec K, Zych
M, Pilis A.
J Sci Food Agric. 2014 Jan 30;94(2):169-73. doi: 10.1002/jsfa.6362. Epub 2013 Oct 2. Effect of the vegetarian diet on non-
communicable diseases. Li D1.
.
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Vitamins
**…Vit B Mood/cognitive improvement with seniors with
normal Vit B levels.
When used to treat peripheral neuropathy, it is not clear if it
helps
… Not enough evidence to determine if giving women vitamin
C/E during pregnancy helps prevent babies dying, being born
too soon or being born small.
…No evidence that folic acid, thiamine, vitamin D or vitamin
E improve seizure control or prevent side effects for people
with epilepsy
…Vit C Trials of high doses of vitamin C administered
therapeutically, starting after the onset of symptoms, showed
no consistent effect on the duration or severity of common
cold symptoms
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Nutrition/Supplements/Probiotics
Vitamins
…Due to the small number of studies, the methodological quality of studies,
and small sample sizes, no recommendation can be advanced regarding the
use of B6-Mg as a treatment for autism.
…Quinine low quality evidence that quinine significantly reduces cramp
number and cramp days and moderate quality evidence that quinine reduces
cramp intensity
**…Folate may have a potential role as a supplement to other treatments for
depression
…Beta-carotene and vitamin E seem to increase mortality, and so may higher
doses of vitamin A (Sao Paulo Med J. 2015 Mar-Apr;133(2):164-5. doi: 10.1590/1516-3180.20151332T1. Epub
2015 Apr 1. Antioxidant supplements for prevention of mortality in healthy participants and patients with various
diseases. Bjelakovic G, Nikolova D, Gluud LL, Simonetti RG, Gluud C.)
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Nutrition/Supplements/Probiotics
Vitamins
The bottom line appears to be to obtain your
vitamin needs mostly through the food you eat
and not out of a bottle!
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Nutrition/Supplements/Probiotics
Sugar
…statistically significant associations between both sugar and artificially
sweetened soda consumption and HTN
Surprisingly few reviews noted in PubMed!
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Chocolate
**…evidence suggests that higher chocolate intake is
associated with a lower risk of future cardiovascular events
(Heart. 2015 Jun 15. pii: heartjnl-2014-307050. doi: 10.1136/heartjnl-2014-307050. [Epub ahead of print]
Habitual chocolate consumption and risk of cardiovascular disease among healthy men and women.
Kwok CS1, Boekholdt SM2, Lentjes MA3, Loke YK4, Luben RN3, Yeong JK5, Wareham NJ6, Myint PK7, Khaw
KT3.)
**… an inverse relation of chocolate intake with incident DM
(Am J Clin Nutr. 2015 Feb;101(2):362-7. doi: 10.3945/ajcn.114.092221. Epub 2014 Nov 26. Chocolate
consumption and risk of diabetes mellitus in the Physicians' Health Study. Matsumoto C1, Petrone
AB1, Sesso HD1, Gaziano JM1, Djoussé L1)
**… improvements in various contributors to cardiovascular
disease (CVD) including hypertension, platelet aggregation
and adhesion, insulin resistance, and hypercholesterolemia
(J Clin Hypertens (Greenwich). 2014 Feb;16(2):101-6.Chocolate--guilty pleasure or healthy
supplement? Latham LS, Hensen ZK, Minor DS.)
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Coffee
**…light to moderate coffee intake is associated with a
reduced risk of death from all causes, particularly in
women (Public Health Nutr. 2015 May;18(7):1282-91. doi:
10.1017/S1368980014001438. Epub 2014 Aug 4.Association of coffee drinking with all-
cause mortality: a systematic review and meta-analysis. Zhao Y1, Wu K1, Zheng J1, Zuo
R1, Li D1)
**… coffee consumption may reduce the risk of urologic
cancer (Int Urol Nephrol. 2014 Aug;46(8):1481-93. doi: 10.1007/s11255-014-0699-9.
Epub 2014 Mar 28. Coffee consumption and urologic cancer risk: a meta-analysis of
cohort studies. Huang TB1, Guo ZF, Zhang XL, Zhang XP, Liu H, Geng J, Yao XD, Zheng
JH)
**…coffee consumption is associated with a reduced
risk of total mortality (Br J Nutr. 2014 Apr 14;111(7):1162-73. doi:
10.1017/S0007114513003814. Epub 2013 Nov 27.Coffee consumption and total
mortality: a meta-analysis of twenty prospective cohort studies.
Je Y1, Giovannucci E2)
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Nutrition/Supplements/Probiotics
Omega-3
**Positive benefits for Bipolar Disorder (depressive)
**…decreases central arterial stiffness in older, but not young healthy adults
**…may play an important role in the maintenance of cardiovascular health
and disease prevention.
**… beneficial effects: cardio-protective effects, reduce ischemic stroke
risk in both men and women and total stroke risk in women, increase insulin
sensitivity in Asians, decrease risk of breast cancer and colorectal cancer
in men.
**….reduces inflammation
**…. supplementing some dyslexics' diets with fish oils (DHA) can …improve
their magnocellular (where) function and reading.
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Nutrition/Supplements/Probiotics
Omega-3
**…..positive effects on inflammation, hyperlipidemia, platelet
aggregation, and hypertension
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Nutrition/Supplements/Probiotics
Omega-3
…unfavourable effects on type 2 diabetes in Caucasians
Dementia/Cognitive function: No evidence to support use
AMD: No evidence to support use
Learning Disorders: Insufficiency evidence
Cognition: marginal positive evidence, no evidence of an effect in the general
population or those with neurodevelopmental disorders.
Academic Performance: not supported
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Ginkgo biloba
Cochrane Review:
The evidence that Ginkgo biloba has predictable and clinically significant
benefit for people with dementia or cognitive impairment is
inconsistent and unreliable
Gingo biloba and AMD questionable
**…improved inattention symptoms but has no significant effects on
hyperactivity-impulsivity symptoms.
**…increased the clinical treatment response rate of methylphenidate
by 35%.
Ginkgo biloba in the treatment of attention-deficit/hyperactivity disorder in
children and adolescents. A randomized, placebo-controlled, trial
(http://www.ctcpjournal.com/article/S1744-3881(15)00029-8/abstract?rss=yes)
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Diseases & CAM
Hypertension: Dietary supplements such as
garlic, cocoa, vitamin C, coenzyme Q10, omega-
3 fatty acids, and magnesium have been
suggested for lowering blood pressure, but
evidence is lacking.
Asthma/Allergies:…little evidence to support
with vitamins (A, C, and E), folate, and omega-
3 and omega-6
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Diseases & CAM
Low back pain… the strongest evidence supports
exercise therapy with supervised physical therapy,
multidisciplinary biopsychosocial rehabilitation, and
acupuncture. Therapies with fair evidence include
yoga, back schools, thermal modalities, acupressure,
and cognitive-behavioral therapy. Poor or little
evidence include manipulation, transcutaneous electrical
nerve stimulation, low-level laser therapy, reflexology,
biofeedback, progressive relaxation, hypnosis, and
aromatherapy.(Neuromodulation. 2014 Oct;17 Suppl 2:24-30. doi: 10.1111/ner.12078.Noninvasive and alternative
management of chronic low back pain (efficacy and outcomes).Wellington J1.)
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Nutrition/Supplements/Probiotics
Probiotics (live bacteria and yeasts)
Ecezema: Not enough evidence
** Probiotics were found to be better than placebo in reducing the number of
participants experiencing episodes of acute URTI by about 47% and the
duration of an episode of acute URTI by about 1.89 days.
**Probiotics may slightly reduce antibiotic use and cold-related school
absence.
**One trial has shown a reduction in the rate of Gestational Diabetes
Mellitus
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Herbal and Plant Therapy
**…in ulcerative colitis, aloe vera gel, triticum aestivum, andrographis
paniculata extract and topical Xilei-san were superior to placebo in
inducing remission or clinical response, and curcumin was superior to
placebo in maintaining remission; boswellia serrata gum resin
and plantago ovata seeds were as effective as mesalazine….In Crohn's
disease, mastic gum, Artemisia absinthium, andTripterygium wilfordii were
superior to placebo in inducing remission and preventing clinical
postoperative recurrence
Herbal therapies exert their therapeutic benefit by different mechanisms
including immune regulation, antioxidant activity, inhibition of leukotriene
B4 and nuclear factor-kappa B, and antiplatelet activity.
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Acupuncture
**Amblyopia: positive outcomes noted
**Fibromyalgia: acupuncture is probably better than non-acupuncture
treatment in reducing pain and stiffness and improving overall well-being and
fatigue
**Shoulder pain: improvement noted
**Neck pain: moderate evidence to support use
**Schizophrenia: May have positive result
**Dermatitis, chloasma, pruritus, urticaria, hyperhidrosis, and facial
elasticity: improved outcomes
**Neurological Recovery in Spinal Cord Injury: some support noted
Depression/Epilepsy/Stroke Rehab/Acute stroke: Insufficient evidence, no
clear evidence
Children with Asthma: unclear
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Acupuncture
** Osteoarthritis: Support for its use
** Elbow Pain: Some support for its use
Myopia, Bell’s Palsy, Restless Leg Syndrome,
Tension Headache: little/inconsistent support for
its use
Glaucoma: Unknown
Autism: No support
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Chiropractic
* Lowback pain: slight improvement (?)
*Weak evidence to support the use of
hypnosis, psychotherapy,
acupuncture, chiropractic and
medicinal herbs but it was provided in
each case by single small trials
**…Interventions commonly used
in chiropractic care improve outcomes
for the treatment of acute and chronic
neck pain (J Manipulative Physiol Ther. 2014 Jan;37(1):42-63.
doi: 10.1016/j.jmpt.2013.08.010. Epub 2013 Nov 19.Evidence-based
guidelines for the chiropractic treatment of adults with neck
pain.Bryans R1, Decina P2, Descarreaux M3, Duranleau M4, Marcoux
H5, Potter B6, Ruegg RP7, Shaw L8, Watkin R9, White E10.)
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Homeopathy
Homeopathy is a complementary healing
system based on "curing like with like". It
involves greatly diluting substances in
order to strengthen the body's own
healing response to a problem.
Chronic Asthma, Dementia, ADHD:
No/absence of evidence
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Craniosacral therapy
CranioSacral Therapy (CST) is a gentle, hands-on approach that releases
tensions deep in the body to relieve pain and dysfunction and improve
whole-body health and performance. It was pioneered and developed by
Osteopathic Physician John E. Upledger after years of clinical testing and
research at Michigan State University where he served as professor of
biomechanics.
No to little support for
its use
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Detoxification
Detoxification is one of the more widely
used treatments and concepts in
alternative medicine.
It is based on the principle
that illnesses can be caused by the
accumulation of toxic substances (toxins) in
the body. Eliminating existing toxins and
avoiding new toxins are essential parts of th
e healing process. Detoxification utilizes a
variety of tests and techniques.
No to little evidence to support it use
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Son–Rise therapy
Son-Rise is a home-based program for children with autism spectrum
disorders and other developmental disabilities, which was developed by Barry Neil
Kaufman and Samahria Lyte Kaufman for their autistic son, who is claimed to have
fully recovered from his condition
**…intensive intervention focused on fostering child-initiated interaction increases
social-communicative behaviors in children with autism.
Very limited evidence to support this. Only 4 studies found in PubMed
In general, information found from 33 Autism interventions on websites, only
three have strong empirical support.
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Developmental Individual Relationship-based (DIR) Model
D (Developmental) part of the Model describes the building blocks of this
foundation. Understanding where the child is developmentally is critical to planning a treatment
program
I (Individual differences) part of the Model describes the unique biologically-
based ways each child takes in, regulates, responds to, and comprehends sensations such as
sound, touch, and the planning and sequencing of actions and ideas.
R (Relationship-based) part of the Model describes the learning relationships with
caregivers, educators, therapists, peers, and others who tailor their affect based interactions to
the child’s individual differences and developmental capacities to enable progress in mastering
the essential foundations.
Several pilot studies support this approach
**… DIR™ can be considered as a possibility for evidence-based
practice (EBP), but not as an evidence-based treatment (EBT).
(http://rsw.sagepub.com/content/early/2015/04/22/1049731515583062.abstract)
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EBP means integrating individual clinical
expertise with the best available external
clinical evidence from systematic research.”
(Sackett D, 1996) EBP is the integration of
clinical expertise, patient values, and the best
research evidence into the decision making
process for patient care.
EBT refers to empirically developed specific
interventions that are based upon randomized
control trials (RCTs) using a control group and
an experimental group to prove their validity,
reliability, and effectiveness (generalizability).
Confidential
Massage Therapy
**…Massage appears to be beneficial for patients
with low-back pain (Int J Nurs Pract. 2015 May;21 Suppl 2:32-7. doi:
10.1111/ijn.12299. Back massage intervention for relieving lower back pain in
puerperal women: A randomized control trial study. Lee HJ1, Ko YL2).
**… Massage therapy reduces pain and improves
function compared to no treatment in some
musculoskeletal conditions. (J Physiother. 2015 Jul;61(3):106-16.
doi: 10.1016/j.jphys.2015.05.018. Epub 2015 Jun 17. Massage therapy has short-term
benefits for people with common musculoskeletal disorders compared to no
treatment: a systematic review. Bervoets DC1, Luijsterburg PA1, Alessie JJ2, Buijs
MJ2, Verhagen AP1)
Facial paralysis: Low quality evidence to support
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Aroma Therapy
… limited evidence suggesting that aroma inhalation may be
effective in controlling stress (Maturitas. 2014 Dec;79(4):362-9. doi:
10.1016/j.maturitas.2014.08.006. Epub 2014 Aug 21.Aromatherapy for stress reduction in healthy adults: a
systematic review and meta-analysis of randomized clinical trials. Hur MH1, Song JA1, Lee J2, Lee MS3).
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Syntonics/Phototherapy
The use of light as therapy. No
evidence for amblyopia, reading
problems, etc. (Wallace LB. The theory and practice of
syntonic phototherapy: a review. Optom Vis Dev 2009;40(2):73-81)
**SAD: fairly effective
Ulcers: uncertain
**Preterm, low birth weight neonatal
jaundice: Support for its use
**Nonseasonal depression: Modest
antidepressive affect
Psoriasis: Inconclusive
Sleep blue light therapy: Inconclusive
Dementia: No support
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Essential Oils
Eczema: no evidence
**…antimicrobial activity
**…suggested a positive effect
of essential oils on sleep
**…Efficacy studies of lavender,
orange and peppermint essential
oils to treat anxiety and nausea have
shown positive results.
For pain control uncertain results. (Evid
Based Complement Alternat Med. 2014;2014:726341. doi: 10.1155/2014/726341. Epub 2014 Feb
24.
Essential oils for complementary treatment of surgical patients: state of the art.
Stea S1, Beraudi A2, De Pasquale D2.)
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Music Therapy (http://www.musictherapy.org/research/factsheets/)
Autism: Promising results are reported for music therapy,
sensory integration therapy, acupuncture, and massage.(Evid Based
Complement Alternat Med. 2015;2015:258589. doi: 10.1155/2015/258589. Epub 2015 May 7.Complementary and
Alternative Therapies for Autism Spectrum Disorder.Brondino N1, Fusar-Poli L1, Rocchetti M1, Provenzani U1, Barale
F1, Politi P1.)
**…improves behavior disorders, anxiety and agitation in
subjects diagnosed with dementia (Neurologia. 2014 Dec 29. pii: S0213-4853(14)00248-5.
doi: 10.1016/j.nrl.2014.11.001. [Epub ahead of print]Benefits of music therapy on behaviour disorders in subjects
diagnosed with dementia: a systematic review.Gómez-Romero M1, Jiménez-Palomares M2, Rodríguez-Mansilla
J3, Flores-Nieto A4, Garrido-Ardila EM2, González-LópezArza MV2.)
**… improves global and social functioning in schizophrenia
and/or serious mental disorders, gait and related activities in
Parkinson's disease, depressive symptoms, and sleep quality.
(Patient Prefer Adherence. 2014 May 16;8:727-54. doi: 10.2147/PPA.S61340. eCollection 2014.
Effectiveness of music therapy: a summary of systematic reviews based on randomized controlled trials of
music interventions.
Kamioka H1, Tsutani K2, Yamada M3, Park H4, Okuizumi H5, Tsuruoka K6, Honda T7, Okada S8, Park SJ8, Kitayuguchi
J9, Abe T9, Handa S5, Oshio T10, Mutoh Y11.)
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Occupational therapy
From Cochrane Reviews:
**…less likely to deteriorate and are more likely to
be independent in their ability to perform personal
activities of daily living
**…positive effect on functional ability in patients
with rheumatoid arthritis.
…..no conclusions can be stated whether or not
occupational therapy improves outcomes in MS
patients
…insufficient evidence to support or refute the
view that perceptual interventions are effective
…..OT intervention for CP inconclusive
(http://cre.sagepub.com/content/18/1/1.short)
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Physical therapy
Cochrane Reviews: Little to no evidence in many
areas
**…some positive evidence for upper extremity
training (http://www.biomedcentral.com/1471-2431/8/14)
**…positive outcomes for task specific activities
(http://cre.sagepub.com/content/18/8/833.short)
**… evidence that aerobic and strength exercises and
yoga reduce psychiatric symptoms, state anxiety,
and psychological distress and improve health-
related quality of life, that aerobic exercise improves
short-term memory, and that progressive muscle
relaxation reduces state anxiety and psychological
distress.
(http://ptjournal.apta.org/content/92/1/11.short)
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Speech therapy
Cochrane Reviews
…insufficient evidence to conclusively
support or refute the efficacy of SLT for
speech problems in Parkinson's disease.
…Firm evidence of the positive effects of
SLT for children with cerebral palsy has not
been demonstrated
**… positive effect of speech and language
therapy interventions for children with
expressive phonological and expressive
vocabulary difficulties
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Dyslexia
From Cochrane Reviews
**… Phonics training appears to be effective
for improving some reading skills.
Little to no additional clinical trials on
treatment of reading disabilities
National Institutes of Health Clinical Trials
Interventions for Children With Attention and Reading Disorders (ICARD)
Started in 2010 no results published
Comprehensive Program to Improve Reading and Writing Skills in At-
Risk and Dyslexic Children: completed 2006/no study results posted
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Dyslexia
CITT-ART
http://citt-art.com/
https://clinicaltrials.gov/ct2/show/NCT02207517
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Strabismus
Cochrane Reviews
The majority of published literature on the use of botulinum toxin in the
treatment of strabismus consists of retrospective studies, cohort studies or case
reviews. Although these provide useful descriptive information, clarification is
required as to the effective use of botulinum toxin as an independent treatment
modality. Four RCTs on the therapeutic use of botulinum toxin in strabismus have
shown varying responses ranging from a lack of evidence for prophylactic
effect of botulinum toxin in acute sixth nerve palsy, to poor response in patients
with horizontal strabismus without binocular vision, to no difference in response in
patients that required retreatment for acquired esotropia or infantile esotropia. It was
not possible to establish dose effect information. Complication rates for
use of Botox™ or Dysport™ ranged from 24% to 55.54%.
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Strabismus
Cochrane Reviews
Adjustable or non-adjustable sutures: No reliable conclusions could
be reached regarding which technique
Clinical management of intermittent exotropia: difficult to reliably
interpret the results
Interventions for infantile esotropia: No reliable conclusions
[So insurance doesn’t pay for vision therapy….but does pay for these
“proven” interventions? ]
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Vision therapy: Little to no information in Cochrane Reviews
Convergence Insufficiency, Convergence excess
Divergence insufficiency, Divergence excess
Accommodative Disorders, Oculomotor disorders
**Vision Therapy/Orthoptics: Current research suggests
that outpatient vision therapy/orthoptics is more effective than
home-based convergence exercises or home-based computer
vision therapy/orthoptics for children. In adult population,
evidence of the effectiveness of various non-surgical
interventions is less consistent.
Research on Vision Therapy Available From COVD at:
http://www.covd.org/?page=Research
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Pansell T1, Hellgren K, Jacobson L, Brautaset R, Tedroff K. The accommodative process in children with cerebral palsy: different strategies to
obtain clear vision at short distance. Dev Med Child Neurol. 2014 Feb;56(2):171-7. doi: 10.1111/dmcn.12266. Epub 2013 Sep 4.
Children with CP exhibit problems in generating an appropriate accommodative response. This can affect everyday living
and reading skills.
McClelland JF1, Parkes J, Hill N, Jackson AJ, Saunders KJ. Accommodative dysfunction in children with cerebral palsy: a population-based
study. Invest Ophthalmol Vis Sci. 2006 May;47(5):1824-30.
significantly reduced accommodative responses
J Am Optom Assoc. 1984 Apr;55(4):281-3. Accommodation in cerebral palsy: function and remediation.
Duckman RH.
Accommodation dysfunction in CP can be improved
Oculomotor, accommodative, vergence dysfunctions. High incidence of
strabismus. Rx Bifocals
Cochrane Reviews:
Little to no information in terms of clinical trials and reviews of these trials
Cerebral Palsy 71
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Down Syndrome
Woodhouse M. Maino D. Down Syndrome. In Taub
M, Bartuccio M, Maino D. (Eds) Visual Diagnosis
and Care of the Patient with Special Needs;
Lippincott Williams & Wilkins. New York,
NY;2012:31-40.
Strabismus: functional in nature (accommodative
ET)
Accommodative “weakness” (insufficiency):
Bifocals both compensating and therapeutic
Little to nothing in Cochrane Reviews
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TBI/Concussion
Effect of binasal occlusion (BNO) on the
visual-evoked potential (VEP) in mild
traumatic brain injury (mTBI) 2013, Vol. 27,
No. 1 ,41-47 Kenneth J. Ciuffreda, Naveen K.
Yadav, and Diana P. Ludlam
…. individuals with mTBI habitually attempt to
suppress visual information in the near retinal
periphery to reduce their abnormal visual
motion sensitivity , with addition of the BNO
negating the suppressive influence and thus
producing a widespread disinhibition effect and
resultant increase in VEP amplitude…
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TBI/Concussion
Vision Diagnoses Are Common After
Concussion in Adolescents. Christina L.
Master, et al.
(http://cpj.sagepub.com/content/early/2015/0
7/07/0009922815594367.abstract)
…100 adolescents were examined, with a
mean age of 14.5 years. Overall, 69% had one
or more of the following vision diagnoses:
accommodative disorders (51%), convergence
insufficiency (49%), and saccadic dysfunction
(29%). In all, 46% of patients had more than
one vision diagnosis. …
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TBI/Concussion
Effect of oculomotor rehabilitation on vergence
responsivity in mild traumatic brain injury. JRRD
Preethi Thiagarajan,et al.
(http://www.rehab.research.va.gov/jour/2013/50
9/jrrd-2012-12-0235.html
…The significant improvement in most
aspects of vergence eye movements following
oculomotor training demonstrates considerable
residual brain plasticity via oculomotor learning.
The improved vergence affected positively
on nearwork-related symptoms and visual
attention….
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TBI/Concussion: Post Trauma Vision
Syndrome
Blurred vision
Sensitivity to light, glare sensitivity
Reading difficulties; words appear to move
Comprehension difficulty
Attention and concentration difficulty
Memory difficulty
Double vision
Aching eyes
Headaches with visual tasks
Inability to maintain visual contact
Reduction or loss of visual field
Difficulties with eye movements
Perceptual Midline Shift
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Brief Review of Various Disabilities
Fragile X syndrome: Strabismus
Berrry-Kravis E, Maino D. Fragile X Syndrome. In Taub M, Bartuccio M, Maino D. (Eds) Visual
Diagnosis and Care of the Patient with Special Needs; Lippincott Williams & Wilkins. New York,
NY;2012:41-48.
Autism: Strabismus, Perceptual Dysfunction, Oculomotor
Pediatric Cortical Visual
Impairment:
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Summary
Do we need evidence for everything?
Yes and No.
Use your clinical experience and judgement, AOA Clinical Guidelines,
and research to determine the best approach for each patient, who unlike
subjects in a clinical trial, tend to be heterogeneous, idiosyncratic, and
unique.
Taylor your approach to the individual patient.
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Additional References
Lipids Health Dis. 2015 Jun 6;14(1):53. doi: 10.1186/s12944-015-0049-7. A review of the effect of omega-3 polyunsaturated fatty acids on blood
triacylglycerol levels in normolipidemic and borderline hyperlipidemic individuals. Leslie MA1, Cohen DJ2, Liddle DM3, Robinson LE4, Ma DW5.
Am Fam Physician. 2015 Jun 1;91(11):772-6. Nonpharmacologic management of hypertension: what works? Oza R1, Garcellano M1.
Asia Pac J Clin Nutr. 2015;24(1):10-5. doi: 10.6133/apjcn.2015.24.1.21. Omega-3 polyunsaturated fatty acids and non-communicable diseases:
meta-analysis based systematic review. Li D1,2,3.
Curr Opin Allergy Clin Immunol. 2015 Aug;15(4):369-74. Diet and asthma: an update. Han YY1, Forno E, Holguin F, Celedón JC.
J Psychopharmacol. 2015 Jul;29(7):753-763. Epub 2015 Jun 3.Omega-3 polyunsaturated fatty acid supplementation and cognition: A
systematic review and meta-analysis. Cooper RE1, Tye C2, Kuntsi J2, Vassos E2, Asherson P2.
Omega 3 fatty acids for preventing or slowing the progression of age-related macular degeneration. Cochrane Database Syst Rev. 2015 Apr
9;4:CD010015 Lawrenson JG, Evans JR.
Ann Gastroenterol. 2015 Apr-Jun;28(2):210-220. Herbal and plant therapy in patients with inflammatory bowel disease.
Triantafyllidi A1, Xanthos T1, Papalois A2, Triantafillidis JK3.
Inflammopharmacology. 2015 Jun;23(2-3):79-89. doi: 10.1007/s10787-015-0228-1. Epub 2015 Feb 14. Role of fish oil in human health and possible
mechanism to reduce the inflammation. Ellulu MS1, Khaza'ai H, Abed Y, Rahmat A, Ismail P, Ranneh Y.
Nutrients. 2014 Oct 3;6(10):4058-73. doi: 10.3390/nu6104058. The role for dietary omega-3 fatty acids supplementation in older adults. Molfino
A1, Gioia G2, Rossi Fanelli F3, Muscaritoli M4.
Eur J Clin Nutr. 2015 Apr;69(4):419-24. doi: 10.1038/ejcn.2014.155. Epub 2014 Aug 13. Omega-3 supplementation during the first 5 years of life and
later academic performance: a randomised controlled trial. Brew BK1, Toelle BG2, Webb KL3, Almqvist C4, Marks GB1; CAPS investigators.
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References
J Altern Complement Med. 2015 Jun 26. [Epub ahead of print] Acupuncture as a Treatment Modality in Dermatology: A Systematic Review.
Ma C1, Sivamani RK1.
J Neurotrauma. 2015 Jun 16. [Epub ahead of print] The Impact of Acupuncture on Neurological Recovery in Spinal Cord Injury:A
Systematic Review and Meta-analysis. Ma R1,2, Liu X3,4,5, Clark J6, Williams GM7, Doi SA8.
Evid Based Complement Alternat Med. 2013;2013:648054. doi: 10.1155/2013/648054. Epub 2013 Apr 30.A meta-analysis of randomized controlled
trials on acupuncture for amblyopia. Yan X1, Zhu T, Ma C, Liu A, Dong L, Wang J.
J Commun Disord. 2013 Sep-Dec;46(5-6):495-506. doi: 10.1016/j.jcomdis.2013.09.004. Epub 2013 Oct 10. Promoting child-initiated social-
communication in children with autism: Son-Rise Program intervention effects. Houghton K1, Schuchard J, Lewis C, Thompson CK.
80
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Dominick M. Maino, OD, MEd, 
FAAO, FCOVD‐A
Professor, Illinois College of
Optometry/Illinois Eye Institute
3241 S. Michigan Ave; Chicago, Il 60616
312-949-7282 dmaino@ico.edu
Lyons Family Eye Care
3250 N. Lincoln Ave; Chicago, Il 60657
773-935-2020 LyonsFamilyEyeCare.com
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Supplemental Information
Amblyopia
82
Sutured Protective Occluder for Severe
Amblyopia
Ten children completed this protocol from December 1999 through January 2002. All tolerated
the occluder for 12 to 36 days. The resultant skin scars were acceptable to parents,
patients, and investigators.
There was no damage to the sound (occluded) eye.
http://archopht.jamanetwork.com/article.aspx?articleid=420619
Cost of this was estimated to be $3300.
What’s wrong with this? Ethics? Child abuse?
Research gone bad!
Confidential
Amblyopia
Cochrane Reviews
Vision screening: The lack
of data from randomized
controlled trials makes it
difficult to analyze the impact of
existing screening programs on
the prevalence of amblyopia.
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84
Many studies…..!
And…the bottom line is:
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The Power of a Pair of Spectacles
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Amblyopia
Cochrane Reviews
**… Occlusion appears to be more effective than refractive correction alone in
the treatment of strabismic amblyopia. The benefit of combining near activities
with occlusion is unproven. No RCTs were found that assessed the role of either
partial occlusion or optical penalization to refractive correction for strabismic
amblyopia.
…Stimulus deprivation amblyopia: no clinical trials
**…Both conventional occlusion and atropine penalization produce visual
acuity improvement in the amblyopic eye. Atropine penalization appears to be
as effective as conventional occlusion, although the magnitude of improvement
differed among the three trials. Atropine penalization can be used as first line
treatment for amblyopia.
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Amblyopia
Treatment of Amblyopia (** supported by clinical trials)
1.) Rx spectacles, follow up 2-3 months **
2.) Continue to monitor until no further improvement, change Rx as needed, start
patching or atropine **
3.) Continue to monitor (taper patching over time)
3.) Continue to monitor until no improvement, start HVT
4.) Continue to monitor until no improvement, start OVT
Start binocular vision therapy sooner rather than later
Vision Res. 2015 Apr 20. pii: S0042-6989(15)00052-8. doi: 10.1016/j.visres.2015.02.009. [Epub ahead of
print]Amblyopia and the binocular approach to its therapy.Hess RF1, Thompson B2.
Eye (Lond). 2014 Oct;28(10):1246-53. doi: 10.1038/eye.2014.165. Epub 2014 Jul 25.
A binocular iPad treatment for amblyopic children. Li SL1, Jost RM1, Morale SE1, Stager DR2, Dao L3, Stager D3, Birch
EE4.
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Amblyopia
Treatment of Amblyopia
Start binocular vision therapy sooner rather than later
Clin Exp Optom. 2014 Sep;97(5):389-98. doi: 10.1111/cxo.12192. Epub 2014 Aug 18. The iPod binocular home-based
treatment for amblyopia in adults: efficacy and compliance. Hess RF1, Babu RJ, Clavagnier S, Black J, Bobier
W, Thompson B.
Strabismus. 2014 Mar;22(1):1-6. doi: 10.3109/09273972.2013.877945. Binocular training reduces amblyopic visual
acuity impairment. Mansouri B1, Singh P, Globa A, Pearson P.
Invest Ophthalmol Vis Sci. 2014 Apr 15;55(4):2384-91. doi: 10.1167/iovs.13-12627.Perceptual learning improves
stereoacuity in amblyopia.Xi J1, Jia WL, Feng LX, Lu ZL, Huang CB.
Amblyopia can be treated at any age. The younger the patient
the better the outcome. All deserve an opportunity to improve
vision function.
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Yet another reason to
treat amblyopia:
Malpractice
Dr. XYZ , in breach of the standard
of care … failed to: perform
DFE/Cyclo, failed to properly
treat the amblyopia, failed to
determine proper Rx, failed to
monitor, failed to patch, failed to
properly instruct parents about
condition….
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Yet another reason to
treat amblyopia:
Malpractice
06-17-1999 Age 6
+4.00 OU (Rx varied over time,
variable responses from child)
Supposedly told mom nothing
could be done after age 5yrs
Mom looked it up on the Internet
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91Pedig Amblyopia Studies Bottom-line:
Spectacles: Spectacles alone improves bilateral amblyopia (3-10 y/0);
improves strabismic amblyopia
Patching: 2 hrs often shows marked improvement in VA. Then consider 6
hrs. Use 6 hrs for severe amblyopia
Atropine: Equal to patching; can improve severe amblyopia
Bangerter filters: Use them. Fairly equal to patching. Maybe more readily
acceptable to patient (Moderate amblyopia 20/40-20/80 VA)
Eye alignment: Amblyopia therapy (patching/atropine) may improve
alignment
Confidential
Amblyopia
Cochrane Reviews
**… unilateral refractive amblyopia: treatment benefit from refractive
correction alone. Where amblyopia persists there is evidence that adding
occlusion further improves vision
Is it better to do strabismus (squint) surgery before or after completing amblyopia
(lazy eye) treatment? No RCTs available
>>>>Hyperopia and strabismus/amblyopia: Although children who were allocated
to the spectacle group were less likely to develop strabismus and less likely
to have visual acuity worse than 20/30 children allocated to no spectacles, these
effects may have been chance findings, or due to bias. Due to the
high risk of bias and poor reporting of included trials, the true effect of spectacle
correction for hyperopia on strabismus is still uncertain ********* ????????
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93Pedig Amblyopia Studies Bottom-line:
Age: Under age 7 better results, some remarkable improvement up to age
12. Older children (17) also show improvement in VA
Non-PEDIG studies suggests improvement at any age
Recurrence: High rate of recurrence after treatment stops (risk of recurrence is
greater when patching is stopped abruptly rather than when it is reduced)
Reading: Monocular oral reading ability was slightly worse when reading
with previously treated amblyopic eyes in terms of rate, accuracy and
fluency, but reading comprehension testing was similar. (Current PEDIG
studies do not use binocular vision therapy to treat amblyopia. Could this
account for the decreased reading ability?)
Patching with near activities: Patching with/without similar results (crafts,
reading, writing, and computer or video games)
Confidential
Adult Treatment of Amblyopia
Levi DM. 2005. Perceptual learning in adults with amblyopia: A reevaluation of critical periods
in human vision. Developmental Psychobiology 46: 222-232.
Improving vision in adult amblyopia by perceptual learning. Uri Polat, Tova Ma-Naim, Michael
Belkin, Dov Sagi (http://www.pnas.org/content/101/17/6692.full.pdf)
Adult amblyopia reversed by contralateral cataract formation. ME Wilson - Journal of
pediatric ophthalmology and strabismus, 1991 (Why did this take so many decades)
Dichoptic training enables the adult amblyopic brain to learn. Jinrong Li, et al.
(http://www.sciencedirect.com/science/article/pii/S0960982213000948)
….and finally…
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Adult Treatment of Amblyopia
The Effect of Video Game Training on the Vision of Adults with Bilateral
Deprivation Amblyopia. Seong Taek Jeon, et al. Seeing and Perceiving
25 (2012) 493–520
… there is enough residual plasticity in the adult visual system to
effect improvements, even in cases of deep amblyopia caused by
early bilateral deprivation…The game may be effective because it
contains the components of perceptual learning
(stimulus/response/feedback) based simultaneously on many
aspects of vision presented in a visually complex and challenging
environment in an immersive, engaging, and adaptive way…
Sounds a lot like
optometric vision therapy!
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96Pedig Amblyopia Studies
Quinn GE, Beck RW, Holmes JM, Repka MX, Pediatric Eye Disease
Investigator Group. Recent advances in the treatment of
amblyopia. Pediatrics 2004;133(6):1800-2
Pediatric Eye Disease Investigator Group. A randomized pilot study of
near activities versus non-near activities during patching therapy for
amblyopia. J AAPOS 2005;9(2):129-36
Holmes JM, Lazar EL, Melia BM, Astle WF, Dagi LR, Donahue SP, Frazier
MG, Hertle RW, Repka MX, Quinn GE, Weise KK, for the Pediatric Eye
Disease Investigator Group. Effect of Age on Response to Amblyopia
Treatment in Children. Arch Ophthalmol. 2011;129(11):1451-7
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97Pedig Amblyopia Studies
Wallace DK, Lazar EL, Melia M, Birch EE, Holmes JM, Hopkins KB, Kraker
RT, Kulp MT, Pang Y, Repka MX, Tamkins SM, Weise KK, on behalf of the
Pediatric Eye Disease Investigator Group. Stereoacuity in Children with
Anisometropic Amblyopia. J AAPOS 2011;15(5):455-61
Pediatric Eye Disease Investigator Group. A randomized trial comparing
Bangerter filters and patching for the treatment of moderate
amblyopia in children. Ophthalmology. 2010 May;117(5):998-1004
Pediatric Eye Disease Investigator Group. A Randomized Trial to
Evaluate Combined Patching and Atropine for Residual
Amblyopia. Arch Ophthalmol 2011;129(7):960-2
Confidential
98Pedig Amblyopia Studies
Lyon DW, Hopkins K, Chu RH, Tamkins SM, Cotter SA, Melia M, Holmes
JM, Repka MX, Wheeler DT, Sala NA, Dumas JD, Silbert DI, on behalf of
Pediatric Eye Disease Investigator Group. Feasibility of a clinical trial of
vision therapy for treatment of amblyopia. Optom Vis Sci
2013;90(5):475-81.
Pediatric Eye Disease Investigator Group. A randomized trial to evaluate
2 hours of daily patching for strabismic and anisometropic amblyopia
in children. Ophthalmology 2006;113(6):904-12
Pediatric Eye Disease Investigator Group. Treatment of anisometropic
amblyopia in children with refractive correction. Ophthalmology
2006;113(6):895-903
Confidential
99Pedig Amblyopia Studies
Pediatric Eye Disease Investigator Group. Treatment of strabismic
amblyopia with refractive correction. Am J Ophthalmol
2007;143(6):1060-3
Pediatric Eye Disease Investigator Group. A randomized trial of near
versus distance activities while patching for amblyopia in children
aged 3 to less than 7 years. Ophthalmology 2008;115(11):2071-8
Pediatric Eye Disease Investigator Group. Treatment of bilateral
refractive amblyopia in children three to less than 10 years of age. Am
J Ophthalmol 2007;144(4):487-96
Confidential
100Pedig Amblyopia Studies
Pediatric Eye Disease Investigator Group. Pharmacologic plus optical
penalization treatment for amblyopia: results of a randomized
trial. Arch Ophthalmol 2009;127(1):22-30
Repka MX, Kraker RT, Beck RW, et al. Treatment of severe amblyopia
with atropine: results from two randomized clinical trials. J AAPOS
2009;13(3):258-63
Pediatric Eye Disease Investigator Group. Patching vs atropine to treat
amblyopia in children aged 7 to 12 years: a randomized trial. Arch
Ophthalmol 2008;126(12):1634-42
Confidential
101Pedig Amblyopia Studies
Pediatric Eye Disease Investigator Group. Pharmacologic plus optical
penalization treatment for amblyopia: results of a randomized
trial. Arch Ophthalmol 2009;127(1):22-30
Repka MX, Kraker RT, Beck RW, et al. Treatment of severe amblyopia
with atropine: results from two randomized clinical trials. J AAPOS
2009;13(3):258-63
Pediatric Eye Disease Investigator Group. Patching vs atropine to treat
amblyopia in children aged 7 to 12 years: a randomized trial. Arch
Ophthalmol 2008;126(12):1634-42
Confidential
102Pedig Amblyopia Studies
Repka MX, Kraker RT, Beck RW, et al. Treatment of severe amblyopia
with atropine: results from two randomized clinical trials. J AAPOS
2009;13(3):258-63
Felius J, Chandler DL, Holmes JM, et al. Pediatric Eye Disease Investigator
Group. Evaluating the Burden of Amblyopia Treatment from the Parent
and Child’s Perspective. J AAPOS. 2010; 14(5):389-95
Pediatric Eye Disease Investigator Group. A randomized trial of atropine
vs. patching for treatment of moderate amblyopia in children. Arch
Ophthalmol 2002;120(3):268-78
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103Pedig Amblyopia Studies
Pediatric Eye Disease Investigator Group. Two-year follow-up of a 6-
month randomized trial of atropine vs patching for treatment of
moderate amblyopia in children. Arch Ophthalmol 2005;123(2):149-57
Repka MX, Holmes JM, Melia BM, et al. The effect of amblyopia therapy
on ocular alignment. J AAPOS 2005;9(6):542-5 (
Repka MX, Melia M, Eibschitz-Tsimhoni M, et al. The effect on refractive
error of unilateral atropine as compared with patching for the
treatment of amblyopia. J AAPOS 2007;11(3):300-2
Holmes JM, Melia M, Bradfield YS, et al. Factors associated with
recurrence of amblyopia on cessation of patching. Ophthalmology
2007;114(8):1427-32
Confidential
104Pedig Amblyopia Studies
Pediatric Eye Disease Investigator Group. A randomized trial of atropine
vs patching for treatment of moderate amblyopia: follow-up at age 10
years. Arch Ophthalmol 2008;126(8):1039-44
Repka MX, Kraker RT, Beck RW, et al. Contrast sensitivity following
amblyopia treatment in children. Arch Ophthalmol 2009;127(9):1225-7
Kulp MT, Foster NC, Holmes JM, et al. Effect of Ocular Alignment on
Emmetropization in Children <10 Years With Amblyopia. Am J
Ophthalmol 2012;154(2): 297-302
Pediatric Eye Disease Investigator Group. Atropine vs patching for
treatment of moderate amblyopia: follow-up at 15 years of age of a
randomized clinical trial. JAMA Opthalmol. Jul 2014;132(7):799-805
Confidential
105Pedig Amblyopia Studies
Pediatric Eye Disease Investigator Group. Optical Treatment of
Strabismic and Combined Strabismic-Anisometropic
Amblyopia. Ophthalmology 2011;119(1):150-8
Repka MX, Kraker RT, Beck RW, et al. Pilot study of levodopa dose as
treatment for residual amblyopia in children aged 8 years to younger
than 18 years. Arch Ophthalmol. 2010 Sep;128(9):1215-7
Pediatric Eye Disease Investigator Group. A randomized trial of
increasing patching for amblyopia. Ophthalmology. 2013
Nov;120(11):2270-7.
Confidential
106Pedig Amblyopia Studies
Pediatric Eye Disease Investigator Group. A randomized trial of adding a
plano lens to atropine for amblyopia. J AAPOS. Feb 2015;19(1):42-48
Pediatric Eye Disease Investigator Group. A randomized trial of levodopa
as treatment for residual amblyopia in older children. Ophthalmology.
May 2015;122(5):874-881
Pediatric Eye Disease Investigator Group. A randomized trial of
prescribed patching regimens for treatment of severe amblyopia in
children. Ophthalmology 2003;110(11):2075-87
Pediatric Eye Disease Investigator Group. A randomized trial of patching
regimens for treatment of moderate amblyopia in children. Arch
Ophthalmol 2003;121(5):603-11
Confidential
107Pedig Amblyopia Studies
Pediatric Eye Disease Investigator Group. A randomized trial of adding a
plano lens to atropine for amblyopia. J AAPOS. Feb 2015;19(1):42-48
Pediatric Eye Disease Investigator Group. A randomized trial of levodopa
as treatment for residual amblyopia in older children. Ophthalmology.
May 2015;122(5):874-881
Pediatric Eye Disease Investigator Group. A randomized trial of
prescribed patching regimens for treatment of severe amblyopia in
children. Ophthalmology 2003;110(11):2075-87
Pediatric Eye Disease Investigator Group. A randomized trial of patching
regimens for treatment of moderate amblyopia in children. Arch
Ophthalmol 2003;121(5):603-11
Confidential
Dominick M. Maino, OD, MEd, 
FAAO, FCOVD‐A
Professor, Illinois College of
Optometry/Illinois Eye Institute
3241 S. Michigan Ave; Chicago, Il 60616
312-949-7282 dmaino@ico.edu
Lyons Family Eye Care
3250 N. Lincoln Ave; Chicago, Il 60657
773-935-2020 LyonsFamilyEyeCare.com
108

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Evidence-based Information on Nutrition and Non-Traditional Therapy

  • 1. 08/04/2016 1 Confidential Evidence‐based Information on Nutrition  and Non‐Traditional Therapy 1 Confidential Dominick M. Maino, OD, MEd,  FAAO, FCOVD‐A Professor, Illinois College of Optometry/Illinois Eye Institute 3241 S. Michigan Ave; Chicago, Il 60616 312-949-7282 dmaino@ico.edu Lyons Family Eye Care 3250 N. Lincoln Ave; Chicago, Il 60657 773-935-2020 LyonsFamilyEyeCare.com 2 Confidential Clinician’s View of Researchers 3 Confidential Researcher’s View of Clinicians Inconsistent Patient Populations 4 Confidential Patients’ View of Clinicians & Researchers 5 Confidential Do we need evidence for everything? There is no randomized, controlled trial (RCT) supporting the contention that evidence-based medicine is beneficial, and "evidence" is more than the information that can be obtained from RCTs. Systematic reviews have severe limitations of scope and reach, and RCTs can lead to false or contradictory conclusions. Most controlled studies enroll only highly selected groups of patients, specifically excluding those with complicating factors, yet real patients bring with them an abundance of messy heterogeneity. Considering this, we should not withhold potentially beneficial treatment just because we lack randomized controlled trials. The frequent lack of solid clinical evidence requires clinicians to invoke critical thinking, communication, judgment, and even intuition on behalf of their patients. Medical training is as much an apprenticeship as it is an education, and medicine as much a craft as it is an art. Hunter DG1Do we need evidence for everything? Am Orthopt J. 2010;60:59-62. . 6
  • 2. 08/04/2016 2 Confidential Do we need evidence for everything? Attitudes and Barriers to Evidence-Based Practice in Optometry Educators A group of optometrists and academics new to implementing education in EBP displayed positive attitudes to EBP but considered that its application and teaching could be significantly hindered by a lack of time to access and appraise the large volume of available research evidence in the field of eye care. (Optom Vis Sci 2015;92:514Y523) 7 Confidential Standard of Care May be Changing: Malpractice Dr. XYZ , in breach of the standard of care … failed to: perform DFE/Cyclo, failed to properly treat the amblyopia, failed to determine proper Rx, failed to monitor, failed to patch, failed to properly instruct parents about condition…. 8 Confidential Do we need evidence for everything? Standard of Care is Changing in What We Do Treatment of Amblyopia (** supported by clinical trials) 1.) Rx spectacles, follow up 2-3 months ** 2.) Continue to monitor until no further improvement, change Rx as needed, start patching or atropine ** 3.) Continue to monitor (taper patching over time if VA improves to target level) 3.) Continue to monitor until no improvement, start HVT 4.) Continue to monitor until no improvement, start OVT Start Binocular Therapy SOONER rather than later. 9 Confidential The Power of a Pair of Spectacles 10 Confidential The Cochrane Database of Systematic Reviews (CDSR) is the leading resource for systematic reviews in health care. The CDSR includes Cochrane Reviews (the systematic reviews) and protocols for Cochrane Reviews as well as editorials. The CDSR also has occasional supplements. The CDSR is updated regularly as Cochrane Reviews are published ‘when ready’ and form monthly issues http://www.cochranelibrary.com/ 11 Confidential Levels of Scientific Evidence 12
  • 3. 08/04/2016 3 Confidential Levels of Scientific Evidence Level 5 1. Case report (a report of a single case) 2. Expert opinion 3. Personal observation Susan A. Cotter,* Lynn A. Cyert,† Joseph M. Miller,‡ and Graham E. Quinn§, for the National Expert Panel to the National Center for Children’s Vision and Eye Healtha. Vision Screening for Children 36 to <72 Months: Recommended Practices. Optom Vis Sci. 2015 Jan; 92(1): 6–16. Maino D. Ophthalmology Causes Myopia! J Optom Vis Dev 2004;35 (2):67-69. Maino D, Schlange D, Maino J, Caden B. Ocular anomalies in fragile X syndrome. J Am Optom Assoc 1990;61:316-23 13 Confidential Levels of Scientific Evidence Level 4 1. Case report/series A single subject study or a report of multiple patients with the same treatment, but no control group or comparison group 14 Confidential Levels of Scientific Evidence Level 3 1. Retrospective cohort study a study in which patient groups are separated non-randomly by exposure or treatment, with exposure occurring before the initiation of the study 2. Case-control study a study in which patient groups are separated by the current presence or absence of disease and examined for the prior exposure of interest 3. Meta-analysis of Level 3 studies 15 Confidential Levels of Scientific Evidence Level 2 1. Prospective comparative study (therapeutic) a study in which patient groups are separated non-randomly by exposure or treatment, with exposure occurring after the initiation of the study 2. Meta-analysis of Level 2 studies or Level 1 studies with inconsistent results 16 Confidential Levels of Scientific Evidence Level 1 1. Randomized controlled trial (RCT) a study in which patients are randomly assigned to the treatment or control group and are followed prospectively 2. Meta-analysis of randomized trials with homogeneous results 17 Confidential Levels of Scientific Evidence Ia Scientific evidence obtained from meta-analyses of randomized clinical trials. Ib Scientific evidence obtained from at least one randomized clinical trial IIa Scientific evidence obtained from at least one well-designed, non- randomized controlled prospective study IIb Scientific evidence obtained from at least one well-designed, quasiexperimental study III Scientific evidence obtained from well-designed observational studies, such as comparative studies, correlation study or case-control studies. IV Scientific evidence obtained from documents or opinions of experts committees and/or clinical experiences of renowned opinion leaders. 18
  • 4. 08/04/2016 4 Confidential Clinical Trial Information ClinicalTrials.gov: ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. ClinicalResearchTrials.NIH.gov: Gives basic information about clinical trials for the public FoxTrialFinder.MichaelJFox.org: Fox Trial Finder was created by the Michael J. Fox Foundation to help increase the flow of willing participants — both people with Parkinson’s and control participants who do not have Parkinson’s — into the clinical trials that need them, accelerating the Parkinson’s drug development process. 19 Confidential MyClinicalTrialLocator.com: Helps you find a clinical trial TrialReach.com: the world’s first online distribution network dedicated solely to clinical trials and patients, joining forces with dozens of communities, advocacy groups, patient portals, blogs, and charities, to reach a combined audience of 100+ million patients per month, we bring the best and latest clinical trial information directly to patients. RareDiseasesNetwork.org is made up of 22 distinctive consortia and a Data Management and Coordinating Center that are working in concert to improve availability of rare disease information, treatment, clinical studies, and general awareness for both patients and the medical community. The RDCRN also aims to provide up-to-date information for patients and to assist in connecting patients with advocacy groups, expert doctors, and clinical research opportunities. 20 Confidential www.Apple.com/researchkit/: With ResearchKit, researchers can easily create apps that take advantage of iPhone features to gather new types of data on a scale never available before 21 Confidential Offit PA. Do you believe in Magic: The sense and nonsense of alternative medicine. Harper Collins, NY, NY;2013 Steve McQueen (The Great Escape, Thomas Crown Affair, Bullit) Mesothelioma. Laetrile: is another name for amygdalin. Amygdalin is found in the pits of many fruits, raw nuts, and Laetrile has shown little anticancer effect in laboratory studies, animal studies, or human studies. The side effects of laetrile are like the symptoms of cyanide poisoning Laetrile is not approved by the U.S. FDA. McQueen paid $80,000/month. Suffered. Died. 22 Confidential Offit PA. Do you believe in Magic: The sense and nonsense of alternative medicine. Harper Collins, NY, NY;2013 Steve Jobs Pancreatic Cancer. Treatable with surgery. Good success rate. He treated himself with acupuncture, herbal remedies, bowel cleansings, and a cancer diet of carrot and fruit juices for 9 months. Now it was too late. He died. 23 Confidential Research Gone Wrong Hubel & Wiesel: Amblyopia • Deprivational not functional amblyopia • Critical vs sensitive periods • Cats are not human • OMD/scientist misinterpretation of the data: Deliberate? Political? • Decades of children and adults suffered • Ignored clinical experience • Perceptual Learning vs Optometric Vision Therapy • Amblyopia can be treated at any age! 24
  • 5. 08/04/2016 5 Confidential Do we need evidence for everything? There is no randomized, controlled trial (RCT) supporting the contention that evidence-based medicine is beneficial ….and yet! 25 Confidential Vaccines You are just about to examine a 4 y/o, when you notice these red blotches on his skin. It looks like measles, but you know there is an effective vaccine for this disease. You ask mom if the child has had his shots. She says no because they cause autism. What’s your response? The Huffington Post has a story about your university closing down because of the number of students with measles. What is your response? USA Today has a story that in 2014, 1100 individuals came down with mumps. What is your response? In the 1920’s, my dad’s youngest sister died from measles. Have we returned to those times? 26 Confidential Vaccines Vaccines for preventing smallpox: Fairly effective. Several adverse side effects Vaccines for preventing rotavirus diarrhea: Efficacy is lower in high- mortality countries, but absolute benefit higher Vaccines for preventing the common cold in healthy people: Not effective Can nicotine vaccines help people stop smoking or help stop recent quitters from relapsing? Currently no evidence that nicotine vaccines enhance long-term smoking cessation. 27 Confidential Using the combined vaccine for protection of children against measles, mumps and rubella: …at least one dose of MMR vaccine was 98% effective in preventing laboratory- confirmed measles cases; one or two MMR doses were respectively 92% and 95% effective in preventing secondary measles cases. 28 Confidential Vaccines and Autism …No significant association between MMR immunization and the following conditions: autism, asthma, leukemia, hay fever, type 1 diabetes, gait disturbance, Crohn's disease, demyelinating diseases, or bacterial or viral infections … 29 Confidential Total Load Theory According to the total load theory, at some point, which varies widely between individuals, the body can no longer handle the “load” of stressors such as nutritional deficiencies and aggressive use of medications/vaccines, and begins to show signs of that burden. The signs of overload are the characteristic symptoms of attention deficiencies and developmental delays. No support for this theory at this time. 30
  • 6. 08/04/2016 6 Confidential Nutrition/Supplements/Probiotics How many of your patients have adopted various nutritional regimens? How many take supplements to improve health and well being or to fight a current disease? How many use probiotics? How many of you use also participate in the use of diet interventions, supplements and probiotics? 31 Confidential Nutrition Mediterranean diet **…promising dietary tool for the primary prevention of diabetes **….fruits, nuts and vegetables reduce cancer risk **A dietary pattern characterized by high fruit, vegetable, legume, whole grain, nut, berry, seed, and fish intakes, and possibly by intakes of dairy, coffee, tea, chocolate, and alcohol (not in excess), but low meat and detrimentally processed foods is associated with reduced incidence of cardiovascular disease and rates of noncardiovascular, noncancer chronic inflammatory-related mortality. **…red wine and extra virgin olive oil may decrease risk of Alzheimer's disease. 32 Confidential Vegetarian diet **…vegetarian diets reduces mean body weight **…, improving the plasma lipid profile and in decreasing the incidence of high arterial blood pressure, cardiovascular disease, stroke, metabolic syndrome and arteriosclerosis. In addition, improved insulin sensitivity together with lower rates of diabetes and cancer has been observed. **…Mortality from all-causes, ischemic heart disease, and circulatory and cerebrovascular diseases was significantly lower in vegetarians … Adverse effects may include hyperhomocysteinaemia, protein deficiency, anaemia, decreased creatinine content in muscles and menstrual disruption in women who undertake increased physical activity. Reduced Vit B12 33 Confidential References Diabetes Metab Res Rev. 2015 Jun 24. doi: 10.1002/dmrr.2672. [Epub ahead of print] Adherence to Mediterranean diet and 10-year incidence (2012-2014) of diabetes; the mediating effect of inflammatory and oxidative stress biomarkers: results from ATTICA cohort study. Koloverou E1, Panagiotakos DB1, Pitsavos C2, Chrysohoou C2, Georgousopoulou EN1, Grekas A1, Christou A1, Chatzigeorgiou M1, Skoumas I2, Tousoulis D2,Stefanadis C2; ATTICA Study group. Br J Nutr. 2015 Apr;113 Suppl 2:S102-10. doi: 10.1017/S0007114515000148. Fruit and vegetables and cancer risk: a review of southern European studies. Turati F1, Rossi M1, Pelucchi C1, Levi F2, La Vecchia C3. Curr Opin Lipidol. 2015 Jun 22. [Epub ahead of print] What an anticardiovascular diet should be in 2015. Jacobs DR Jr1, Tapsell LC Adv Exp Med Biol. 2015;863:1-20. doi: 10.1007/978-3-319-18365-7_1. Olive Oil Phenols as Promising Multi-targeting Agents Against Alzheimer's Disease. Rigacci S1. J Acad Nutr Diet. 2015 Jun;115(6):954-69. doi: 10.1016/j.jand.2014.11.016. Epub 2015 Jan 22. A systematic review and meta-analysis of changes in body weight in clinical trials of vegetarian diets. Barnard ND, Levin SM, Yokoyama Y. Rocz Panstw Zakl Hig. 2014;65(1):9-14. Health benefits and risk associated with adopting a vegetarian diet. Pilis W, Stec K, Zych M, Pilis A. J Sci Food Agric. 2014 Jan 30;94(2):169-73. doi: 10.1002/jsfa.6362. Epub 2013 Oct 2. Effect of the vegetarian diet on non- communicable diseases. Li D1. . 34 Confidential Vitamins **…Vit B Mood/cognitive improvement with seniors with normal Vit B levels. When used to treat peripheral neuropathy, it is not clear if it helps … Not enough evidence to determine if giving women vitamin C/E during pregnancy helps prevent babies dying, being born too soon or being born small. …No evidence that folic acid, thiamine, vitamin D or vitamin E improve seizure control or prevent side effects for people with epilepsy …Vit C Trials of high doses of vitamin C administered therapeutically, starting after the onset of symptoms, showed no consistent effect on the duration or severity of common cold symptoms 35 Confidential Nutrition/Supplements/Probiotics Vitamins …Due to the small number of studies, the methodological quality of studies, and small sample sizes, no recommendation can be advanced regarding the use of B6-Mg as a treatment for autism. …Quinine low quality evidence that quinine significantly reduces cramp number and cramp days and moderate quality evidence that quinine reduces cramp intensity **…Folate may have a potential role as a supplement to other treatments for depression …Beta-carotene and vitamin E seem to increase mortality, and so may higher doses of vitamin A (Sao Paulo Med J. 2015 Mar-Apr;133(2):164-5. doi: 10.1590/1516-3180.20151332T1. Epub 2015 Apr 1. Antioxidant supplements for prevention of mortality in healthy participants and patients with various diseases. Bjelakovic G, Nikolova D, Gluud LL, Simonetti RG, Gluud C.) 36
  • 7. 08/04/2016 7 Confidential Nutrition/Supplements/Probiotics Vitamins The bottom line appears to be to obtain your vitamin needs mostly through the food you eat and not out of a bottle! 37 Confidential Nutrition/Supplements/Probiotics Sugar …statistically significant associations between both sugar and artificially sweetened soda consumption and HTN Surprisingly few reviews noted in PubMed! 38 Confidential Chocolate **…evidence suggests that higher chocolate intake is associated with a lower risk of future cardiovascular events (Heart. 2015 Jun 15. pii: heartjnl-2014-307050. doi: 10.1136/heartjnl-2014-307050. [Epub ahead of print] Habitual chocolate consumption and risk of cardiovascular disease among healthy men and women. Kwok CS1, Boekholdt SM2, Lentjes MA3, Loke YK4, Luben RN3, Yeong JK5, Wareham NJ6, Myint PK7, Khaw KT3.) **… an inverse relation of chocolate intake with incident DM (Am J Clin Nutr. 2015 Feb;101(2):362-7. doi: 10.3945/ajcn.114.092221. Epub 2014 Nov 26. Chocolate consumption and risk of diabetes mellitus in the Physicians' Health Study. Matsumoto C1, Petrone AB1, Sesso HD1, Gaziano JM1, Djoussé L1) **… improvements in various contributors to cardiovascular disease (CVD) including hypertension, platelet aggregation and adhesion, insulin resistance, and hypercholesterolemia (J Clin Hypertens (Greenwich). 2014 Feb;16(2):101-6.Chocolate--guilty pleasure or healthy supplement? Latham LS, Hensen ZK, Minor DS.) 39 Confidential Coffee **…light to moderate coffee intake is associated with a reduced risk of death from all causes, particularly in women (Public Health Nutr. 2015 May;18(7):1282-91. doi: 10.1017/S1368980014001438. Epub 2014 Aug 4.Association of coffee drinking with all- cause mortality: a systematic review and meta-analysis. Zhao Y1, Wu K1, Zheng J1, Zuo R1, Li D1) **… coffee consumption may reduce the risk of urologic cancer (Int Urol Nephrol. 2014 Aug;46(8):1481-93. doi: 10.1007/s11255-014-0699-9. Epub 2014 Mar 28. Coffee consumption and urologic cancer risk: a meta-analysis of cohort studies. Huang TB1, Guo ZF, Zhang XL, Zhang XP, Liu H, Geng J, Yao XD, Zheng JH) **…coffee consumption is associated with a reduced risk of total mortality (Br J Nutr. 2014 Apr 14;111(7):1162-73. doi: 10.1017/S0007114513003814. Epub 2013 Nov 27.Coffee consumption and total mortality: a meta-analysis of twenty prospective cohort studies. Je Y1, Giovannucci E2) 40 Confidential Nutrition/Supplements/Probiotics Omega-3 **Positive benefits for Bipolar Disorder (depressive) **…decreases central arterial stiffness in older, but not young healthy adults **…may play an important role in the maintenance of cardiovascular health and disease prevention. **… beneficial effects: cardio-protective effects, reduce ischemic stroke risk in both men and women and total stroke risk in women, increase insulin sensitivity in Asians, decrease risk of breast cancer and colorectal cancer in men. **….reduces inflammation **…. supplementing some dyslexics' diets with fish oils (DHA) can …improve their magnocellular (where) function and reading. 41 Confidential Nutrition/Supplements/Probiotics Omega-3 **…..positive effects on inflammation, hyperlipidemia, platelet aggregation, and hypertension 42
  • 8. 08/04/2016 8 Confidential Nutrition/Supplements/Probiotics Omega-3 …unfavourable effects on type 2 diabetes in Caucasians Dementia/Cognitive function: No evidence to support use AMD: No evidence to support use Learning Disorders: Insufficiency evidence Cognition: marginal positive evidence, no evidence of an effect in the general population or those with neurodevelopmental disorders. Academic Performance: not supported 43 Confidential Ginkgo biloba Cochrane Review: The evidence that Ginkgo biloba has predictable and clinically significant benefit for people with dementia or cognitive impairment is inconsistent and unreliable Gingo biloba and AMD questionable **…improved inattention symptoms but has no significant effects on hyperactivity-impulsivity symptoms. **…increased the clinical treatment response rate of methylphenidate by 35%. Ginkgo biloba in the treatment of attention-deficit/hyperactivity disorder in children and adolescents. A randomized, placebo-controlled, trial (http://www.ctcpjournal.com/article/S1744-3881(15)00029-8/abstract?rss=yes) 44 Confidential Diseases & CAM Hypertension: Dietary supplements such as garlic, cocoa, vitamin C, coenzyme Q10, omega- 3 fatty acids, and magnesium have been suggested for lowering blood pressure, but evidence is lacking. Asthma/Allergies:…little evidence to support with vitamins (A, C, and E), folate, and omega- 3 and omega-6 45 Confidential Diseases & CAM Low back pain… the strongest evidence supports exercise therapy with supervised physical therapy, multidisciplinary biopsychosocial rehabilitation, and acupuncture. Therapies with fair evidence include yoga, back schools, thermal modalities, acupressure, and cognitive-behavioral therapy. Poor or little evidence include manipulation, transcutaneous electrical nerve stimulation, low-level laser therapy, reflexology, biofeedback, progressive relaxation, hypnosis, and aromatherapy.(Neuromodulation. 2014 Oct;17 Suppl 2:24-30. doi: 10.1111/ner.12078.Noninvasive and alternative management of chronic low back pain (efficacy and outcomes).Wellington J1.) 46 Confidential Nutrition/Supplements/Probiotics Probiotics (live bacteria and yeasts) Ecezema: Not enough evidence ** Probiotics were found to be better than placebo in reducing the number of participants experiencing episodes of acute URTI by about 47% and the duration of an episode of acute URTI by about 1.89 days. **Probiotics may slightly reduce antibiotic use and cold-related school absence. **One trial has shown a reduction in the rate of Gestational Diabetes Mellitus 47 Confidential Herbal and Plant Therapy **…in ulcerative colitis, aloe vera gel, triticum aestivum, andrographis paniculata extract and topical Xilei-san were superior to placebo in inducing remission or clinical response, and curcumin was superior to placebo in maintaining remission; boswellia serrata gum resin and plantago ovata seeds were as effective as mesalazine….In Crohn's disease, mastic gum, Artemisia absinthium, andTripterygium wilfordii were superior to placebo in inducing remission and preventing clinical postoperative recurrence Herbal therapies exert their therapeutic benefit by different mechanisms including immune regulation, antioxidant activity, inhibition of leukotriene B4 and nuclear factor-kappa B, and antiplatelet activity. 48
  • 9. 08/04/2016 9 Confidential Acupuncture **Amblyopia: positive outcomes noted **Fibromyalgia: acupuncture is probably better than non-acupuncture treatment in reducing pain and stiffness and improving overall well-being and fatigue **Shoulder pain: improvement noted **Neck pain: moderate evidence to support use **Schizophrenia: May have positive result **Dermatitis, chloasma, pruritus, urticaria, hyperhidrosis, and facial elasticity: improved outcomes **Neurological Recovery in Spinal Cord Injury: some support noted Depression/Epilepsy/Stroke Rehab/Acute stroke: Insufficient evidence, no clear evidence Children with Asthma: unclear 49 Confidential Acupuncture ** Osteoarthritis: Support for its use ** Elbow Pain: Some support for its use Myopia, Bell’s Palsy, Restless Leg Syndrome, Tension Headache: little/inconsistent support for its use Glaucoma: Unknown Autism: No support 50 Confidential Chiropractic * Lowback pain: slight improvement (?) *Weak evidence to support the use of hypnosis, psychotherapy, acupuncture, chiropractic and medicinal herbs but it was provided in each case by single small trials **…Interventions commonly used in chiropractic care improve outcomes for the treatment of acute and chronic neck pain (J Manipulative Physiol Ther. 2014 Jan;37(1):42-63. doi: 10.1016/j.jmpt.2013.08.010. Epub 2013 Nov 19.Evidence-based guidelines for the chiropractic treatment of adults with neck pain.Bryans R1, Decina P2, Descarreaux M3, Duranleau M4, Marcoux H5, Potter B6, Ruegg RP7, Shaw L8, Watkin R9, White E10.) 51 Confidential Homeopathy Homeopathy is a complementary healing system based on "curing like with like". It involves greatly diluting substances in order to strengthen the body's own healing response to a problem. Chronic Asthma, Dementia, ADHD: No/absence of evidence 52 Confidential Craniosacral therapy CranioSacral Therapy (CST) is a gentle, hands-on approach that releases tensions deep in the body to relieve pain and dysfunction and improve whole-body health and performance. It was pioneered and developed by Osteopathic Physician John E. Upledger after years of clinical testing and research at Michigan State University where he served as professor of biomechanics. No to little support for its use 53 Confidential Detoxification Detoxification is one of the more widely used treatments and concepts in alternative medicine. It is based on the principle that illnesses can be caused by the accumulation of toxic substances (toxins) in the body. Eliminating existing toxins and avoiding new toxins are essential parts of th e healing process. Detoxification utilizes a variety of tests and techniques. No to little evidence to support it use 54
  • 10. 08/04/2016 10 Confidential Son–Rise therapy Son-Rise is a home-based program for children with autism spectrum disorders and other developmental disabilities, which was developed by Barry Neil Kaufman and Samahria Lyte Kaufman for their autistic son, who is claimed to have fully recovered from his condition **…intensive intervention focused on fostering child-initiated interaction increases social-communicative behaviors in children with autism. Very limited evidence to support this. Only 4 studies found in PubMed In general, information found from 33 Autism interventions on websites, only three have strong empirical support. 55 Confidential Developmental Individual Relationship-based (DIR) Model D (Developmental) part of the Model describes the building blocks of this foundation. Understanding where the child is developmentally is critical to planning a treatment program I (Individual differences) part of the Model describes the unique biologically- based ways each child takes in, regulates, responds to, and comprehends sensations such as sound, touch, and the planning and sequencing of actions and ideas. R (Relationship-based) part of the Model describes the learning relationships with caregivers, educators, therapists, peers, and others who tailor their affect based interactions to the child’s individual differences and developmental capacities to enable progress in mastering the essential foundations. Several pilot studies support this approach **… DIR™ can be considered as a possibility for evidence-based practice (EBP), but not as an evidence-based treatment (EBT). (http://rsw.sagepub.com/content/early/2015/04/22/1049731515583062.abstract) 56 Confidential 57 EBP means integrating individual clinical expertise with the best available external clinical evidence from systematic research.” (Sackett D, 1996) EBP is the integration of clinical expertise, patient values, and the best research evidence into the decision making process for patient care. EBT refers to empirically developed specific interventions that are based upon randomized control trials (RCTs) using a control group and an experimental group to prove their validity, reliability, and effectiveness (generalizability). Confidential Massage Therapy **…Massage appears to be beneficial for patients with low-back pain (Int J Nurs Pract. 2015 May;21 Suppl 2:32-7. doi: 10.1111/ijn.12299. Back massage intervention for relieving lower back pain in puerperal women: A randomized control trial study. Lee HJ1, Ko YL2). **… Massage therapy reduces pain and improves function compared to no treatment in some musculoskeletal conditions. (J Physiother. 2015 Jul;61(3):106-16. doi: 10.1016/j.jphys.2015.05.018. Epub 2015 Jun 17. Massage therapy has short-term benefits for people with common musculoskeletal disorders compared to no treatment: a systematic review. Bervoets DC1, Luijsterburg PA1, Alessie JJ2, Buijs MJ2, Verhagen AP1) Facial paralysis: Low quality evidence to support 58 Confidential Aroma Therapy … limited evidence suggesting that aroma inhalation may be effective in controlling stress (Maturitas. 2014 Dec;79(4):362-9. doi: 10.1016/j.maturitas.2014.08.006. Epub 2014 Aug 21.Aromatherapy for stress reduction in healthy adults: a systematic review and meta-analysis of randomized clinical trials. Hur MH1, Song JA1, Lee J2, Lee MS3). 59 Confidential Syntonics/Phototherapy The use of light as therapy. No evidence for amblyopia, reading problems, etc. (Wallace LB. The theory and practice of syntonic phototherapy: a review. Optom Vis Dev 2009;40(2):73-81) **SAD: fairly effective Ulcers: uncertain **Preterm, low birth weight neonatal jaundice: Support for its use **Nonseasonal depression: Modest antidepressive affect Psoriasis: Inconclusive Sleep blue light therapy: Inconclusive Dementia: No support 60
  • 11. 08/04/2016 11 Confidential Essential Oils Eczema: no evidence **…antimicrobial activity **…suggested a positive effect of essential oils on sleep **…Efficacy studies of lavender, orange and peppermint essential oils to treat anxiety and nausea have shown positive results. For pain control uncertain results. (Evid Based Complement Alternat Med. 2014;2014:726341. doi: 10.1155/2014/726341. Epub 2014 Feb 24. Essential oils for complementary treatment of surgical patients: state of the art. Stea S1, Beraudi A2, De Pasquale D2.) 61 Confidential Music Therapy (http://www.musictherapy.org/research/factsheets/) Autism: Promising results are reported for music therapy, sensory integration therapy, acupuncture, and massage.(Evid Based Complement Alternat Med. 2015;2015:258589. doi: 10.1155/2015/258589. Epub 2015 May 7.Complementary and Alternative Therapies for Autism Spectrum Disorder.Brondino N1, Fusar-Poli L1, Rocchetti M1, Provenzani U1, Barale F1, Politi P1.) **…improves behavior disorders, anxiety and agitation in subjects diagnosed with dementia (Neurologia. 2014 Dec 29. pii: S0213-4853(14)00248-5. doi: 10.1016/j.nrl.2014.11.001. [Epub ahead of print]Benefits of music therapy on behaviour disorders in subjects diagnosed with dementia: a systematic review.Gómez-Romero M1, Jiménez-Palomares M2, Rodríguez-Mansilla J3, Flores-Nieto A4, Garrido-Ardila EM2, González-LópezArza MV2.) **… improves global and social functioning in schizophrenia and/or serious mental disorders, gait and related activities in Parkinson's disease, depressive symptoms, and sleep quality. (Patient Prefer Adherence. 2014 May 16;8:727-54. doi: 10.2147/PPA.S61340. eCollection 2014. Effectiveness of music therapy: a summary of systematic reviews based on randomized controlled trials of music interventions. Kamioka H1, Tsutani K2, Yamada M3, Park H4, Okuizumi H5, Tsuruoka K6, Honda T7, Okada S8, Park SJ8, Kitayuguchi J9, Abe T9, Handa S5, Oshio T10, Mutoh Y11.) 62 Confidential Occupational therapy From Cochrane Reviews: **…less likely to deteriorate and are more likely to be independent in their ability to perform personal activities of daily living **…positive effect on functional ability in patients with rheumatoid arthritis. …..no conclusions can be stated whether or not occupational therapy improves outcomes in MS patients …insufficient evidence to support or refute the view that perceptual interventions are effective …..OT intervention for CP inconclusive (http://cre.sagepub.com/content/18/1/1.short) 63 Confidential Physical therapy Cochrane Reviews: Little to no evidence in many areas **…some positive evidence for upper extremity training (http://www.biomedcentral.com/1471-2431/8/14) **…positive outcomes for task specific activities (http://cre.sagepub.com/content/18/8/833.short) **… evidence that aerobic and strength exercises and yoga reduce psychiatric symptoms, state anxiety, and psychological distress and improve health- related quality of life, that aerobic exercise improves short-term memory, and that progressive muscle relaxation reduces state anxiety and psychological distress. (http://ptjournal.apta.org/content/92/1/11.short) 64 Confidential Speech therapy Cochrane Reviews …insufficient evidence to conclusively support or refute the efficacy of SLT for speech problems in Parkinson's disease. …Firm evidence of the positive effects of SLT for children with cerebral palsy has not been demonstrated **… positive effect of speech and language therapy interventions for children with expressive phonological and expressive vocabulary difficulties 65 Confidential Dyslexia From Cochrane Reviews **… Phonics training appears to be effective for improving some reading skills. Little to no additional clinical trials on treatment of reading disabilities National Institutes of Health Clinical Trials Interventions for Children With Attention and Reading Disorders (ICARD) Started in 2010 no results published Comprehensive Program to Improve Reading and Writing Skills in At- Risk and Dyslexic Children: completed 2006/no study results posted 66
  • 12. 08/04/2016 12 Confidential Dyslexia CITT-ART http://citt-art.com/ https://clinicaltrials.gov/ct2/show/NCT02207517 67 Confidential Strabismus Cochrane Reviews The majority of published literature on the use of botulinum toxin in the treatment of strabismus consists of retrospective studies, cohort studies or case reviews. Although these provide useful descriptive information, clarification is required as to the effective use of botulinum toxin as an independent treatment modality. Four RCTs on the therapeutic use of botulinum toxin in strabismus have shown varying responses ranging from a lack of evidence for prophylactic effect of botulinum toxin in acute sixth nerve palsy, to poor response in patients with horizontal strabismus without binocular vision, to no difference in response in patients that required retreatment for acquired esotropia or infantile esotropia. It was not possible to establish dose effect information. Complication rates for use of Botox™ or Dysport™ ranged from 24% to 55.54%. 68 Confidential Strabismus Cochrane Reviews Adjustable or non-adjustable sutures: No reliable conclusions could be reached regarding which technique Clinical management of intermittent exotropia: difficult to reliably interpret the results Interventions for infantile esotropia: No reliable conclusions [So insurance doesn’t pay for vision therapy….but does pay for these “proven” interventions? ] 69 Confidential Vision therapy: Little to no information in Cochrane Reviews Convergence Insufficiency, Convergence excess Divergence insufficiency, Divergence excess Accommodative Disorders, Oculomotor disorders **Vision Therapy/Orthoptics: Current research suggests that outpatient vision therapy/orthoptics is more effective than home-based convergence exercises or home-based computer vision therapy/orthoptics for children. In adult population, evidence of the effectiveness of various non-surgical interventions is less consistent. Research on Vision Therapy Available From COVD at: http://www.covd.org/?page=Research 70 Confidential Pansell T1, Hellgren K, Jacobson L, Brautaset R, Tedroff K. The accommodative process in children with cerebral palsy: different strategies to obtain clear vision at short distance. Dev Med Child Neurol. 2014 Feb;56(2):171-7. doi: 10.1111/dmcn.12266. Epub 2013 Sep 4. Children with CP exhibit problems in generating an appropriate accommodative response. This can affect everyday living and reading skills. McClelland JF1, Parkes J, Hill N, Jackson AJ, Saunders KJ. Accommodative dysfunction in children with cerebral palsy: a population-based study. Invest Ophthalmol Vis Sci. 2006 May;47(5):1824-30. significantly reduced accommodative responses J Am Optom Assoc. 1984 Apr;55(4):281-3. Accommodation in cerebral palsy: function and remediation. Duckman RH. Accommodation dysfunction in CP can be improved Oculomotor, accommodative, vergence dysfunctions. High incidence of strabismus. Rx Bifocals Cochrane Reviews: Little to no information in terms of clinical trials and reviews of these trials Cerebral Palsy 71 Confidential Down Syndrome Woodhouse M. Maino D. Down Syndrome. In Taub M, Bartuccio M, Maino D. (Eds) Visual Diagnosis and Care of the Patient with Special Needs; Lippincott Williams & Wilkins. New York, NY;2012:31-40. Strabismus: functional in nature (accommodative ET) Accommodative “weakness” (insufficiency): Bifocals both compensating and therapeutic Little to nothing in Cochrane Reviews 72
  • 13. 08/04/2016 13 Confidential TBI/Concussion Effect of binasal occlusion (BNO) on the visual-evoked potential (VEP) in mild traumatic brain injury (mTBI) 2013, Vol. 27, No. 1 ,41-47 Kenneth J. Ciuffreda, Naveen K. Yadav, and Diana P. Ludlam …. individuals with mTBI habitually attempt to suppress visual information in the near retinal periphery to reduce their abnormal visual motion sensitivity , with addition of the BNO negating the suppressive influence and thus producing a widespread disinhibition effect and resultant increase in VEP amplitude… 73 Confidential TBI/Concussion Vision Diagnoses Are Common After Concussion in Adolescents. Christina L. Master, et al. (http://cpj.sagepub.com/content/early/2015/0 7/07/0009922815594367.abstract) …100 adolescents were examined, with a mean age of 14.5 years. Overall, 69% had one or more of the following vision diagnoses: accommodative disorders (51%), convergence insufficiency (49%), and saccadic dysfunction (29%). In all, 46% of patients had more than one vision diagnosis. … 74 Confidential TBI/Concussion Effect of oculomotor rehabilitation on vergence responsivity in mild traumatic brain injury. JRRD Preethi Thiagarajan,et al. (http://www.rehab.research.va.gov/jour/2013/50 9/jrrd-2012-12-0235.html …The significant improvement in most aspects of vergence eye movements following oculomotor training demonstrates considerable residual brain plasticity via oculomotor learning. The improved vergence affected positively on nearwork-related symptoms and visual attention…. 75 Confidential TBI/Concussion: Post Trauma Vision Syndrome Blurred vision Sensitivity to light, glare sensitivity Reading difficulties; words appear to move Comprehension difficulty Attention and concentration difficulty Memory difficulty Double vision Aching eyes Headaches with visual tasks Inability to maintain visual contact Reduction or loss of visual field Difficulties with eye movements Perceptual Midline Shift 76 Confidential Brief Review of Various Disabilities Fragile X syndrome: Strabismus Berrry-Kravis E, Maino D. Fragile X Syndrome. In Taub M, Bartuccio M, Maino D. (Eds) Visual Diagnosis and Care of the Patient with Special Needs; Lippincott Williams & Wilkins. New York, NY;2012:41-48. Autism: Strabismus, Perceptual Dysfunction, Oculomotor Pediatric Cortical Visual Impairment: 77 Confidential Summary Do we need evidence for everything? Yes and No. Use your clinical experience and judgement, AOA Clinical Guidelines, and research to determine the best approach for each patient, who unlike subjects in a clinical trial, tend to be heterogeneous, idiosyncratic, and unique. Taylor your approach to the individual patient. 78
  • 14. 08/04/2016 14 Confidential Additional References Lipids Health Dis. 2015 Jun 6;14(1):53. doi: 10.1186/s12944-015-0049-7. A review of the effect of omega-3 polyunsaturated fatty acids on blood triacylglycerol levels in normolipidemic and borderline hyperlipidemic individuals. Leslie MA1, Cohen DJ2, Liddle DM3, Robinson LE4, Ma DW5. Am Fam Physician. 2015 Jun 1;91(11):772-6. Nonpharmacologic management of hypertension: what works? Oza R1, Garcellano M1. Asia Pac J Clin Nutr. 2015;24(1):10-5. doi: 10.6133/apjcn.2015.24.1.21. Omega-3 polyunsaturated fatty acids and non-communicable diseases: meta-analysis based systematic review. Li D1,2,3. Curr Opin Allergy Clin Immunol. 2015 Aug;15(4):369-74. Diet and asthma: an update. Han YY1, Forno E, Holguin F, Celedón JC. J Psychopharmacol. 2015 Jul;29(7):753-763. Epub 2015 Jun 3.Omega-3 polyunsaturated fatty acid supplementation and cognition: A systematic review and meta-analysis. Cooper RE1, Tye C2, Kuntsi J2, Vassos E2, Asherson P2. Omega 3 fatty acids for preventing or slowing the progression of age-related macular degeneration. Cochrane Database Syst Rev. 2015 Apr 9;4:CD010015 Lawrenson JG, Evans JR. Ann Gastroenterol. 2015 Apr-Jun;28(2):210-220. Herbal and plant therapy in patients with inflammatory bowel disease. Triantafyllidi A1, Xanthos T1, Papalois A2, Triantafillidis JK3. Inflammopharmacology. 2015 Jun;23(2-3):79-89. doi: 10.1007/s10787-015-0228-1. Epub 2015 Feb 14. Role of fish oil in human health and possible mechanism to reduce the inflammation. Ellulu MS1, Khaza'ai H, Abed Y, Rahmat A, Ismail P, Ranneh Y. Nutrients. 2014 Oct 3;6(10):4058-73. doi: 10.3390/nu6104058. The role for dietary omega-3 fatty acids supplementation in older adults. Molfino A1, Gioia G2, Rossi Fanelli F3, Muscaritoli M4. Eur J Clin Nutr. 2015 Apr;69(4):419-24. doi: 10.1038/ejcn.2014.155. Epub 2014 Aug 13. Omega-3 supplementation during the first 5 years of life and later academic performance: a randomised controlled trial. Brew BK1, Toelle BG2, Webb KL3, Almqvist C4, Marks GB1; CAPS investigators. 79 Confidential References J Altern Complement Med. 2015 Jun 26. [Epub ahead of print] Acupuncture as a Treatment Modality in Dermatology: A Systematic Review. Ma C1, Sivamani RK1. J Neurotrauma. 2015 Jun 16. [Epub ahead of print] The Impact of Acupuncture on Neurological Recovery in Spinal Cord Injury:A Systematic Review and Meta-analysis. Ma R1,2, Liu X3,4,5, Clark J6, Williams GM7, Doi SA8. Evid Based Complement Alternat Med. 2013;2013:648054. doi: 10.1155/2013/648054. Epub 2013 Apr 30.A meta-analysis of randomized controlled trials on acupuncture for amblyopia. Yan X1, Zhu T, Ma C, Liu A, Dong L, Wang J. J Commun Disord. 2013 Sep-Dec;46(5-6):495-506. doi: 10.1016/j.jcomdis.2013.09.004. Epub 2013 Oct 10. Promoting child-initiated social- communication in children with autism: Son-Rise Program intervention effects. Houghton K1, Schuchard J, Lewis C, Thompson CK. 80 Confidential Dominick M. Maino, OD, MEd,  FAAO, FCOVD‐A Professor, Illinois College of Optometry/Illinois Eye Institute 3241 S. Michigan Ave; Chicago, Il 60616 312-949-7282 dmaino@ico.edu Lyons Family Eye Care 3250 N. Lincoln Ave; Chicago, Il 60657 773-935-2020 LyonsFamilyEyeCare.com 81 Confidential Supplemental Information Amblyopia 82 Sutured Protective Occluder for Severe Amblyopia Ten children completed this protocol from December 1999 through January 2002. All tolerated the occluder for 12 to 36 days. The resultant skin scars were acceptable to parents, patients, and investigators. There was no damage to the sound (occluded) eye. http://archopht.jamanetwork.com/article.aspx?articleid=420619 Cost of this was estimated to be $3300. What’s wrong with this? Ethics? Child abuse? Research gone bad! Confidential Amblyopia Cochrane Reviews Vision screening: The lack of data from randomized controlled trials makes it difficult to analyze the impact of existing screening programs on the prevalence of amblyopia. 83 Confidential 84 Many studies…..! And…the bottom line is:
  • 15. 08/04/2016 15 Confidential The Power of a Pair of Spectacles 85 Confidential Amblyopia Cochrane Reviews **… Occlusion appears to be more effective than refractive correction alone in the treatment of strabismic amblyopia. The benefit of combining near activities with occlusion is unproven. No RCTs were found that assessed the role of either partial occlusion or optical penalization to refractive correction for strabismic amblyopia. …Stimulus deprivation amblyopia: no clinical trials **…Both conventional occlusion and atropine penalization produce visual acuity improvement in the amblyopic eye. Atropine penalization appears to be as effective as conventional occlusion, although the magnitude of improvement differed among the three trials. Atropine penalization can be used as first line treatment for amblyopia. 86 Confidential Amblyopia Treatment of Amblyopia (** supported by clinical trials) 1.) Rx spectacles, follow up 2-3 months ** 2.) Continue to monitor until no further improvement, change Rx as needed, start patching or atropine ** 3.) Continue to monitor (taper patching over time) 3.) Continue to monitor until no improvement, start HVT 4.) Continue to monitor until no improvement, start OVT Start binocular vision therapy sooner rather than later Vision Res. 2015 Apr 20. pii: S0042-6989(15)00052-8. doi: 10.1016/j.visres.2015.02.009. [Epub ahead of print]Amblyopia and the binocular approach to its therapy.Hess RF1, Thompson B2. Eye (Lond). 2014 Oct;28(10):1246-53. doi: 10.1038/eye.2014.165. Epub 2014 Jul 25. A binocular iPad treatment for amblyopic children. Li SL1, Jost RM1, Morale SE1, Stager DR2, Dao L3, Stager D3, Birch EE4. 87 Confidential Amblyopia Treatment of Amblyopia Start binocular vision therapy sooner rather than later Clin Exp Optom. 2014 Sep;97(5):389-98. doi: 10.1111/cxo.12192. Epub 2014 Aug 18. The iPod binocular home-based treatment for amblyopia in adults: efficacy and compliance. Hess RF1, Babu RJ, Clavagnier S, Black J, Bobier W, Thompson B. Strabismus. 2014 Mar;22(1):1-6. doi: 10.3109/09273972.2013.877945. Binocular training reduces amblyopic visual acuity impairment. Mansouri B1, Singh P, Globa A, Pearson P. Invest Ophthalmol Vis Sci. 2014 Apr 15;55(4):2384-91. doi: 10.1167/iovs.13-12627.Perceptual learning improves stereoacuity in amblyopia.Xi J1, Jia WL, Feng LX, Lu ZL, Huang CB. Amblyopia can be treated at any age. The younger the patient the better the outcome. All deserve an opportunity to improve vision function. 88 Confidential Yet another reason to treat amblyopia: Malpractice Dr. XYZ , in breach of the standard of care … failed to: perform DFE/Cyclo, failed to properly treat the amblyopia, failed to determine proper Rx, failed to monitor, failed to patch, failed to properly instruct parents about condition…. 89 Confidential Yet another reason to treat amblyopia: Malpractice 06-17-1999 Age 6 +4.00 OU (Rx varied over time, variable responses from child) Supposedly told mom nothing could be done after age 5yrs Mom looked it up on the Internet 90
  • 16. 08/04/2016 16 Confidential 91Pedig Amblyopia Studies Bottom-line: Spectacles: Spectacles alone improves bilateral amblyopia (3-10 y/0); improves strabismic amblyopia Patching: 2 hrs often shows marked improvement in VA. Then consider 6 hrs. Use 6 hrs for severe amblyopia Atropine: Equal to patching; can improve severe amblyopia Bangerter filters: Use them. Fairly equal to patching. Maybe more readily acceptable to patient (Moderate amblyopia 20/40-20/80 VA) Eye alignment: Amblyopia therapy (patching/atropine) may improve alignment Confidential Amblyopia Cochrane Reviews **… unilateral refractive amblyopia: treatment benefit from refractive correction alone. Where amblyopia persists there is evidence that adding occlusion further improves vision Is it better to do strabismus (squint) surgery before or after completing amblyopia (lazy eye) treatment? No RCTs available >>>>Hyperopia and strabismus/amblyopia: Although children who were allocated to the spectacle group were less likely to develop strabismus and less likely to have visual acuity worse than 20/30 children allocated to no spectacles, these effects may have been chance findings, or due to bias. Due to the high risk of bias and poor reporting of included trials, the true effect of spectacle correction for hyperopia on strabismus is still uncertain ********* ???????? 92 Confidential 93Pedig Amblyopia Studies Bottom-line: Age: Under age 7 better results, some remarkable improvement up to age 12. Older children (17) also show improvement in VA Non-PEDIG studies suggests improvement at any age Recurrence: High rate of recurrence after treatment stops (risk of recurrence is greater when patching is stopped abruptly rather than when it is reduced) Reading: Monocular oral reading ability was slightly worse when reading with previously treated amblyopic eyes in terms of rate, accuracy and fluency, but reading comprehension testing was similar. (Current PEDIG studies do not use binocular vision therapy to treat amblyopia. Could this account for the decreased reading ability?) Patching with near activities: Patching with/without similar results (crafts, reading, writing, and computer or video games) Confidential Adult Treatment of Amblyopia Levi DM. 2005. Perceptual learning in adults with amblyopia: A reevaluation of critical periods in human vision. Developmental Psychobiology 46: 222-232. Improving vision in adult amblyopia by perceptual learning. Uri Polat, Tova Ma-Naim, Michael Belkin, Dov Sagi (http://www.pnas.org/content/101/17/6692.full.pdf) Adult amblyopia reversed by contralateral cataract formation. ME Wilson - Journal of pediatric ophthalmology and strabismus, 1991 (Why did this take so many decades) Dichoptic training enables the adult amblyopic brain to learn. Jinrong Li, et al. (http://www.sciencedirect.com/science/article/pii/S0960982213000948) ….and finally… 94 Confidential Adult Treatment of Amblyopia The Effect of Video Game Training on the Vision of Adults with Bilateral Deprivation Amblyopia. Seong Taek Jeon, et al. Seeing and Perceiving 25 (2012) 493–520 … there is enough residual plasticity in the adult visual system to effect improvements, even in cases of deep amblyopia caused by early bilateral deprivation…The game may be effective because it contains the components of perceptual learning (stimulus/response/feedback) based simultaneously on many aspects of vision presented in a visually complex and challenging environment in an immersive, engaging, and adaptive way… Sounds a lot like optometric vision therapy! 95 Confidential 96Pedig Amblyopia Studies Quinn GE, Beck RW, Holmes JM, Repka MX, Pediatric Eye Disease Investigator Group. Recent advances in the treatment of amblyopia. Pediatrics 2004;133(6):1800-2 Pediatric Eye Disease Investigator Group. A randomized pilot study of near activities versus non-near activities during patching therapy for amblyopia. J AAPOS 2005;9(2):129-36 Holmes JM, Lazar EL, Melia BM, Astle WF, Dagi LR, Donahue SP, Frazier MG, Hertle RW, Repka MX, Quinn GE, Weise KK, for the Pediatric Eye Disease Investigator Group. Effect of Age on Response to Amblyopia Treatment in Children. Arch Ophthalmol. 2011;129(11):1451-7
  • 17. 08/04/2016 17 Confidential 97Pedig Amblyopia Studies Wallace DK, Lazar EL, Melia M, Birch EE, Holmes JM, Hopkins KB, Kraker RT, Kulp MT, Pang Y, Repka MX, Tamkins SM, Weise KK, on behalf of the Pediatric Eye Disease Investigator Group. Stereoacuity in Children with Anisometropic Amblyopia. J AAPOS 2011;15(5):455-61 Pediatric Eye Disease Investigator Group. A randomized trial comparing Bangerter filters and patching for the treatment of moderate amblyopia in children. Ophthalmology. 2010 May;117(5):998-1004 Pediatric Eye Disease Investigator Group. A Randomized Trial to Evaluate Combined Patching and Atropine for Residual Amblyopia. Arch Ophthalmol 2011;129(7):960-2 Confidential 98Pedig Amblyopia Studies Lyon DW, Hopkins K, Chu RH, Tamkins SM, Cotter SA, Melia M, Holmes JM, Repka MX, Wheeler DT, Sala NA, Dumas JD, Silbert DI, on behalf of Pediatric Eye Disease Investigator Group. Feasibility of a clinical trial of vision therapy for treatment of amblyopia. Optom Vis Sci 2013;90(5):475-81. Pediatric Eye Disease Investigator Group. A randomized trial to evaluate 2 hours of daily patching for strabismic and anisometropic amblyopia in children. Ophthalmology 2006;113(6):904-12 Pediatric Eye Disease Investigator Group. Treatment of anisometropic amblyopia in children with refractive correction. Ophthalmology 2006;113(6):895-903 Confidential 99Pedig Amblyopia Studies Pediatric Eye Disease Investigator Group. Treatment of strabismic amblyopia with refractive correction. Am J Ophthalmol 2007;143(6):1060-3 Pediatric Eye Disease Investigator Group. A randomized trial of near versus distance activities while patching for amblyopia in children aged 3 to less than 7 years. Ophthalmology 2008;115(11):2071-8 Pediatric Eye Disease Investigator Group. Treatment of bilateral refractive amblyopia in children three to less than 10 years of age. Am J Ophthalmol 2007;144(4):487-96 Confidential 100Pedig Amblyopia Studies Pediatric Eye Disease Investigator Group. Pharmacologic plus optical penalization treatment for amblyopia: results of a randomized trial. Arch Ophthalmol 2009;127(1):22-30 Repka MX, Kraker RT, Beck RW, et al. Treatment of severe amblyopia with atropine: results from two randomized clinical trials. J AAPOS 2009;13(3):258-63 Pediatric Eye Disease Investigator Group. Patching vs atropine to treat amblyopia in children aged 7 to 12 years: a randomized trial. Arch Ophthalmol 2008;126(12):1634-42 Confidential 101Pedig Amblyopia Studies Pediatric Eye Disease Investigator Group. Pharmacologic plus optical penalization treatment for amblyopia: results of a randomized trial. Arch Ophthalmol 2009;127(1):22-30 Repka MX, Kraker RT, Beck RW, et al. Treatment of severe amblyopia with atropine: results from two randomized clinical trials. J AAPOS 2009;13(3):258-63 Pediatric Eye Disease Investigator Group. Patching vs atropine to treat amblyopia in children aged 7 to 12 years: a randomized trial. Arch Ophthalmol 2008;126(12):1634-42 Confidential 102Pedig Amblyopia Studies Repka MX, Kraker RT, Beck RW, et al. Treatment of severe amblyopia with atropine: results from two randomized clinical trials. J AAPOS 2009;13(3):258-63 Felius J, Chandler DL, Holmes JM, et al. Pediatric Eye Disease Investigator Group. Evaluating the Burden of Amblyopia Treatment from the Parent and Child’s Perspective. J AAPOS. 2010; 14(5):389-95 Pediatric Eye Disease Investigator Group. A randomized trial of atropine vs. patching for treatment of moderate amblyopia in children. Arch Ophthalmol 2002;120(3):268-78
  • 18. 08/04/2016 18 Confidential 103Pedig Amblyopia Studies Pediatric Eye Disease Investigator Group. Two-year follow-up of a 6- month randomized trial of atropine vs patching for treatment of moderate amblyopia in children. Arch Ophthalmol 2005;123(2):149-57 Repka MX, Holmes JM, Melia BM, et al. The effect of amblyopia therapy on ocular alignment. J AAPOS 2005;9(6):542-5 ( Repka MX, Melia M, Eibschitz-Tsimhoni M, et al. The effect on refractive error of unilateral atropine as compared with patching for the treatment of amblyopia. J AAPOS 2007;11(3):300-2 Holmes JM, Melia M, Bradfield YS, et al. Factors associated with recurrence of amblyopia on cessation of patching. Ophthalmology 2007;114(8):1427-32 Confidential 104Pedig Amblyopia Studies Pediatric Eye Disease Investigator Group. A randomized trial of atropine vs patching for treatment of moderate amblyopia: follow-up at age 10 years. Arch Ophthalmol 2008;126(8):1039-44 Repka MX, Kraker RT, Beck RW, et al. Contrast sensitivity following amblyopia treatment in children. Arch Ophthalmol 2009;127(9):1225-7 Kulp MT, Foster NC, Holmes JM, et al. Effect of Ocular Alignment on Emmetropization in Children <10 Years With Amblyopia. Am J Ophthalmol 2012;154(2): 297-302 Pediatric Eye Disease Investigator Group. Atropine vs patching for treatment of moderate amblyopia: follow-up at 15 years of age of a randomized clinical trial. JAMA Opthalmol. Jul 2014;132(7):799-805 Confidential 105Pedig Amblyopia Studies Pediatric Eye Disease Investigator Group. Optical Treatment of Strabismic and Combined Strabismic-Anisometropic Amblyopia. Ophthalmology 2011;119(1):150-8 Repka MX, Kraker RT, Beck RW, et al. Pilot study of levodopa dose as treatment for residual amblyopia in children aged 8 years to younger than 18 years. Arch Ophthalmol. 2010 Sep;128(9):1215-7 Pediatric Eye Disease Investigator Group. A randomized trial of increasing patching for amblyopia. Ophthalmology. 2013 Nov;120(11):2270-7. Confidential 106Pedig Amblyopia Studies Pediatric Eye Disease Investigator Group. A randomized trial of adding a plano lens to atropine for amblyopia. J AAPOS. Feb 2015;19(1):42-48 Pediatric Eye Disease Investigator Group. A randomized trial of levodopa as treatment for residual amblyopia in older children. Ophthalmology. May 2015;122(5):874-881 Pediatric Eye Disease Investigator Group. A randomized trial of prescribed patching regimens for treatment of severe amblyopia in children. Ophthalmology 2003;110(11):2075-87 Pediatric Eye Disease Investigator Group. A randomized trial of patching regimens for treatment of moderate amblyopia in children. Arch Ophthalmol 2003;121(5):603-11 Confidential 107Pedig Amblyopia Studies Pediatric Eye Disease Investigator Group. A randomized trial of adding a plano lens to atropine for amblyopia. J AAPOS. Feb 2015;19(1):42-48 Pediatric Eye Disease Investigator Group. A randomized trial of levodopa as treatment for residual amblyopia in older children. Ophthalmology. May 2015;122(5):874-881 Pediatric Eye Disease Investigator Group. A randomized trial of prescribed patching regimens for treatment of severe amblyopia in children. Ophthalmology 2003;110(11):2075-87 Pediatric Eye Disease Investigator Group. A randomized trial of patching regimens for treatment of moderate amblyopia in children. Arch Ophthalmol 2003;121(5):603-11 Confidential Dominick M. Maino, OD, MEd,  FAAO, FCOVD‐A Professor, Illinois College of Optometry/Illinois Eye Institute 3241 S. Michigan Ave; Chicago, Il 60616 312-949-7282 dmaino@ico.edu Lyons Family Eye Care 3250 N. Lincoln Ave; Chicago, Il 60657 773-935-2020 LyonsFamilyEyeCare.com 108