Given the low number and included trials and the lowmethodological quality, any conclusion based on the resultsof this review have to be regarded as preliminary. However,as single case studies and clinical trials indicate a positiveeffect, homeopathy could be considered a complementarytreatment for patients with fibromyalgia

1. Complementary Therapies in Medicine (2014) 22, 731—742
Available online at www.sciencedirect.com
journal homepage: www.elsevierhealth.com/journals/ctim
Homeopathy in the treatment of
fibromyalgia—–A comprehensive
literature-review and meta-analysis
Katja Boehma
, Christa Raaka,∗
, Holger Cramerb
, Romy Laucheb
,
Thomas Ostermanna,∗
a
Institute for Integrative Medicine, Witten/Herdecke University, Germany
b
Department of Internal and Integrative Medicine, Kliniken-Essen-Mitte, Faculty of Medicine, University of
Duisburg-Essen, Germany
Available online 28 June 2014
KEYWORDS
Fibromyalgia;
Homeopathy;
Review;
Meta-analysis
Summary
Background: Coping with the complex nature of fibromyalgia symptoms (FMS) still remains a
challenge for patients. Taking into account the possible adverse events of pharmacological
treatments patients often seek additional treatments for the management of fibromyalgia and
turn towards complementary and alternative medicine (CAM).
Objective: In this review, we aimed to investigate the current state of literature of homeopathy
in the treatment of FMS.
Methods: We searched Medline, the Cochrane Register of Controlled Trials, Embase, AMED,
PsycInfo and CAMbase for the terms ‘‘fibromyalgia AND homeopath$’’ through February 2013.
In addition we searched Google Scholar, the library of the Carstens Foundation and that of
the Deutsche Homöopathische Union (DHU). Standardized mean differences (SMD) with 95%
confidence intervals (CI) were calculated and meta-analyzed using the generic inverse variance
method.
Results: We found 10 case-reports, 3 observational studies, 1 non-randomized and 4 ran-
domized controlled trials (RCTs) on homeopathy for fibromyalgia. Both case reports and
observational studies are naturally predominated by the use of qualitative and not validated
outcome measures. Meta-analyses of CCTs revealed effects of homeopathy on tender point
count (SMD = −0.42; 95%CI −0.78, −0.05; P = 0.03), pain intensity (SMD = −0.54; 95%CI −0.97,
−0.10; P = 0.02), and fatigue (SMD = −0.47; 95%CI −0.90, −0.05; P = 0.03) compared to placebo.
Conclusion: The results of the studies as well as the case reports define a sufficient basis for dis-
cussing the possible benefits of homeopathy for patients suffering from fibromyalgia syndrome
although any conclusions based on the results of this review have to be regarded as preliminary.
© 2014 Elsevier Ltd. All rights reserved.
∗ Corresponding authors. Tel.: +49 2330623643.
E-mail addresses: christa.raak@uni-wh.de (C. Raak), thomas.ostermann@uni-wh.de (T. Ostermann).
http://dx.doi.org/10.1016/j.ctim.2014.06.005
0965-2299/© 2014 Elsevier Ltd. All rights reserved.

2. 732 K. Boehm et al.
Contents
Introduction.............................................................................................................. 732
Methods.................................................................................................................. 733
Search strategy...................................................................................................... 733
Study selection...................................................................................................... 733
Inclusion/exclusion criteria................................................................................... 733
Selection process............................................................................................. 733
Statistical analysis................................................................................................... 733
Quality assessment.................................................................................................. 733
Results................................................................................................................... 733
Characteristics of included studies .................................................................................. 734
Case reports.................................................................................................. 734
Uncontrolled clinical trials.................................................................................... 734
Controlled clinical trial....................................................................................... 735
Randomized controlled trials ................................................................................. 735
Meta-analysis........................................................................................................ 736
Quality assessment.................................................................................................. 736
Discussion................................................................................................................ 736
Meta-analysis........................................................................................................ 740
Single cases ......................................................................................................... 740
Strengths and limitations............................................................................................ 740
Implications for further research.................................................................................... 741
Conclusions .............................................................................................................. 741
Conflict of interest statement............................................................................................ 741
Funding ................................................................................................................ 741
References ............................................................................................................. 741
Introduction
The fibromyalgia syndrome (FMS) is a condition defined by
chronic widespread pain, fatigue, cognitive disturbances
and sleep disorders.1,2
Patients with FMS also experience
various somatic symptoms and psychological distress.1,2
Fibromyalgia is a frequent comorbidity alongside other
rheumatologic conditions. Thus patients experience sub-
stantial disabilities and often report a negative impact of
fibromyalgia on their quality of life, mood, anxiety, depres-
sion and self-esteem.3
According to a recent epidemiological study of Branco
et al.4
fibromyalgia affects about 1.4—3.7% of adults in
Europe depending on the country. Epidemiological studies
estimated how many people in the general population meet
the FM-criteria at the time and found that with a Euro-
pean point prevalence of 2.9% this leads to a total of about
15 million people in Europe suffering from fibromyalgia.4
With respect to the costs a recent study of Berger et al.5
reports three times higher healthcare costs over 12 months
in fibromyalgia patients compared to a matched patient
sample in the US. These results are comparable with find-
ing of the same research group in German GPs: compared to
other primary care patients, fibromyalgia patients counted
for twice as many GP visits, referrals and sick notes.6
In conventional medical practice, fibromyalgia is treated
by using a wide range of symptom specific pharmacological
therapies, including antidepressants, opioids, non-steroidal
anti-inflammatory drugs, sedatives, muscle relaxants, and
anti-epileptics.33
Non-pharmaceutical treatments include
aerobic exercises, physical therapies, massage, and cogni-
tive behavioural therapy. Evidence-based recommendations
for the management of fibromyalgia syndrome identified
by a team of UK researchers in 2008 included antide-
pressants, analgesics, and ‘‘other pharmacological’’ and
exercise, cognitive behavioural therapy, education, dietary
interventions and ‘‘other non-pharmacological’’.32
Treat-
ment by opioids (except Tramadol) was not recommended
by recent evidence-based guidelines.
However, coping with the complex nature of fibromyal-
gia symptoms still remains a challenge for patients. Taking
into account the possible adverse events of pharmacolog-
ical treatments patients often seek additional treatments
for the management of fibromyalgia and turn towards com-
plementary and alternative medicine (CAM). According to a
survey by Wahner-Roedler et al.7
89% of patients referred
to a fibromyalgia treatment programme at a tertiary care
centre had used at least some type of CAM therapy dur-
ing the previous 6 months including exercise therapy (48%),
spiritual healing and prayers (45%), massage therapy (44%),
chiropractic treatments (37%), or vitamins and minerals
(35—25%). Nevertheless the evidence base for many of those
therapeutic options for fibromyalgia is quite sparse and the
methodological quality of clinical studies often is low.
A recent overview of Terry et al.,8
a meta-analysis of
Langhorst et al.,9
and a qualitative review of Baranowsky
et al.10
not only found positive results for hydrotherapy and
spa therapy but also for homeopathy. According to Perry
et al.8
existing RCTs in homeopathy suggested results in
favour of homeopathy which up to now have not been sum-
marized by means of a meta-analysis. Moreover, results from
observational studies or even case reports have not been
collected to complement these findings.
Thus, in the following review we aimed to compre-
hensively investigate the current state of literature for
homeopathic interventions in the treatment of patients

3. Homeopathy in the treatment of fibromyalgia 733
suffering from fibromyalgia and examine all reports from
single case reports to clinical trials. We were particularly
interested in the reporting of pain intensity and tender mus-
cle points before and after treatment.
Methods
Search strategy
To get a first overview, the following electronical databases
were used to find articles on fibromyalgia and homeopa-
thy: Medline, PubMed, Embase, AMED, CAMbase11
and the
library of the Carstens Foundation. The literature search,
which was constructed around search terms for ‘home-
opathy’ and ‘fibromyalgia syndrome’, was adapted and
translated for each database, if necessary. For example, the
following search strategy was used on the PubMed/MEDLINE
database:
(Hoemopathy [MeSH Terms] OR homeopathy [Title/
Abstract]) AND (fibromyalgia [MeSH Terms] OR fibromyalgia
[Title/Abstract] OR fibrositis [Title/Abstract]).
In addition, an internet search was performed using
Google Scholar adding the search terms ‘‘study’’ and ‘‘case
report’’ to the above search terms. Finally, we also screened
the database ‘‘Erfahrungsschatz Homöopathie’’ (Thieme
Publishers) to find additional material. All articles found this
way were fully read and their reference lists were checked
for further relevant publications. Articles included in this
comprehensive review were classified with respect to year
of publication, research design, homeopathic treatment,
patient demographics, the number of patients involved, and
main outcomes/results. The search was performed between
October 2012 and February 2013.
It should be noted that fibrosis is the formation of excess
fibrous connective tissue in an organ or tissue in a reparative
or reactive process. This can be a reactive, benign, or patho-
logical state. Fibrositis, on the other hand, was historically
used to name what is now labelled fibromyalgia.
Study selection
Inclusion/exclusion criteria
Non-randomized and randomized controlled trials, uncon-
trolled observational trials, case studies, and case series
were eligible when they assessed the effects of a homeo-
pathic intervention on patient-related outcomes in patients
with fibromyalgia. There were no language restrictions.
No restrictions in terms of age were applied (children,
adolescents, adult and elderly were included). Stud-
ies with patients with a serious concomitant medical
illness as an inclusion criterion were excluded. ‘Case
reports’ also included case series of more than one
case.
Selection process
Two review authors independently screened abstracts iden-
tified during literature and read potentially eligible articles
in full to determine whether they met the eligibility
criteria. No other study or report characteristics were pre-
specified other than it having to be a clinical study of FMS
patients who received a homeopathic treatment of some
sort.
Statistical analysis
Meta-analysis on the effects of homeopathic treatment was
carried out according the established guidelines for non-
randomized and randomized controlled trials.12,13
When a
trial was found to be eligible, data were extracted and
entered into a pre-specified data sheet. If the number of
studies included in a meta-analysis is small, random effects
tests are regarded as only approximate and fixed effects
tests are regarded as more precise.41
Thus, a fixed effects
model was used. Standardized mean differences (SMD) with
95%CI were calculated as the difference in means between
groups divided by the pooled standard deviation and meta-
analyzed using the generic inverse variance method with
a fixed effect model.13
Cohen’s d is defined as the differ-
ence between two means divided by a standard deviation
for the data. From this one can calculate the SMD. Effect
sizes can then be interpreted by keeping to pointers such as
0.2 ≡ small, 0.5 ≡ moderate and 0.8 ≡ large.42
Single case reports were exempt from meta-analysis as
no SMD could be calculated.
Heterogeneity between trials was assessed by stan-
dard Chi-Square-tests and the I2
-coefficient measuring the
percentage of total variation across studies due to true het-
erogeneity rather than chance. Overall estimates of the
treatment effect were obtained from fixed effects meta-
analysis. Results were displayed using a forest plot. Due
to the small number of eligible studies further analysis by
means of meta-regression was omitted.
Subgroup analyses were conducted for type of homeo-
pathic treatment (individualized homeopathy; homotoxicol-
ogy; potentized anthroposophic remedies).
Quality assessment
Quality of non-randomized and randomized controlled tri-
als was rated according to the Cochrane Quality Assessment
Tool for Quantitative Studies. Rating included (A) selection
bias, (B) study design, (C) confounders, (D) blinding, (E) data
collection methods, (F) withdrawals and drop outs, (G) inter-
vention integrity, and (H) appropriateness of analysis. Both
data extraction and quality assessment was cross-checked
by an independent rater. In case of disagreement consen-
sus between the raters was obtained by involving a third
reviewer. The reporting of the results follows the established
PRISMA guidelines.30
Results
In total, we retrieved 10 case-reports, 3 uncontrolled obser-
vational trials, 1 non-randomized controlled trial and 4
randomized controlled trials on homeopathy for fibromyal-
gia from the literature search (for flow chart, see Fig. 1).
They are listed chronologically by means of their research
design in Tables 1—3.

4. 734 K. Boehm et al.
Potentially relevant studies addressing
fibromyalgia and homeopathy (n=164)
setacilpud–seidutsdedulcxE
(n=108)
Potentially appropriate studies to be
included (n=56)
Excluded studies (n=48)
Included controlled studies; suitable for data extraction
(n=8)
Randomized and
single-blinded
(n=6)
Non-randomized
(n=2)
Included in meta-analysis
(n=6)
Fig. 1 Flow chart of study inclusion.
Characteristics of included studies
Case reports
Ten case reports focussing the use of homeopathy for
patients suffering on fibromyalgia were found (Table 1).
Gemmell et al.14
reported the outcomes of three patients
treated with Rhus toxicodendron 6 times for at least 21 days.
No patient, however, showed sustained improvement after
30 days.
Klein15
reported on the work with a male patient, age 54
and suffering from FMS with fatigue and pain. He received
Loxosceles reclusa (spider) 30c. After taking the first dose
his back symptoms were increasingly worse for 7 days, then
better but still problematic for 3 weeks. A more dramatic
improvement was observed after this point. The symptoms
of fibromyalgia, pain and depression all improved remark-
ably. The 30c dosage was repeated once.
Fleisher16
reported on a 56 year old business woman
with severe chronic fatigue and fibromyalgia. After intensive
repertorising she was prescribed a single dose of Crotalus
cascavella 1 M. Three months later, she reported that fatigue
and muscle pain were reduced by more than 80%. She also
felt more relaxed.
Jones and Whitmarsh17
reported two cases of 64 and 45
year old females. While the first one received Rhus toxico-
dendron 6c three times daily followed by Lachesis 200c and
LM1, the second one received Calcium carbonicum 200c fol-
lowed by LM1 and LM2. The first patient reported less muscle
pain as well as uplifted mood and a better ability to cope
with problems. The second patient also reported decreased
pain and increased calmness. She also felt strong enough to
deal with her marital problems, which had been present for
a long time.
Saltzman18
prescribed Papaver somniferum 30c to a
female patient with fibromyalgia and gastroparesis, the
physical and mental complaints disappeared and the patient
showed very positive personal and spiritual development.
Walters et al.19
also reported two cases out of a study of
56 patients who had received individualized homeopathic
remedies. One female patient reported no improvement of
physical complaints, but she felt more positive and fulfilled.
The other female patient showed improved general health,
but increased shoulder pain, which homeopathy could not
help with.
Uncontrolled clinical trials
Three observational studies were included in this review
(Table 2).
One Dutch trial20
included 42 patients attending their
general practitioner for FMS complaints. Patients were asked
to complete the Fibromyalgia Impact Questionnaire (FIQ) at
baseline, after five and ten weeks of treatment. Treatment
consisted of Hepar Magnesium D10 intravenously adminis-
tered weekly for 10 weeks. After five weeks, the rating of
nine out of ten FIQ items demonstrated a statistically sig-
nificant improvement. After ten weeks the rating of seven
FIQ items demonstrated a statistically significant improve-
ment. The results show that a large subgroup demonstrates

5. Homeopathy in the treatment of fibromyalgia 735
Table 1 Study characteristics: case reports.
Reference Patients (N, age,
diagnosis)
Homeopathic remedy Results
Gemmell et al.,
1991
69 year old female Rhus toxicodendron 6x, three
times daily for at least 21
days + spinal manipulations
Homeopathic remedy failed to improve
pain.
48 year old female Rhus toxicodendron 6x, three
times daily for at least 21 days
Homeopathic remedy failed to improve
pain.
46 year old female Rhus toxicodendron 6x, three
times daily for at least 21 days
Short term improvement of pain on a
numerical rating scale was observed,
afterwards return to baseline pain
Klein, 2001 54 year old male Loxosceles reclusa (spider) 30c Back pain worsened for 7 days following
the first dose, and then improved
dramatically. Patient also reported
strong improvement of other symptoms,
such as fatigue and depression.
Fleisher, 2004 56 year old female Single dose of Crotalus
cascavella 1 M
Patient reported that fatigue and muscle
pain were reduced by more than 80%.
She also felt more relaxed.
Jones and
Whitmarsh, 2008
64 year old female Rhus toxicodendron 6c, three
times daily; Lachesis
200c,three times for a day,
then LM1 five drops daily
Patient reported lifted mood, better
ability to cope and less muscle pain.
45 year old female Calcium carbonicum 200c,
three times for a day, then LM1
five drops daily, later increase
to LM2
Patient reported decrease of pain and
increased calmness. She also decided to
deal with marital problems.
Saltzman, 2008 40 year old female Papaver somniferum 30c Patient showed very positive personal
development, physical and mental
complaints disappeared.
Walters, 2011 female, age not
reported
Carcinosin, Aurum, Syphilinum,
Nux vomica, Natrum
muriaticum, Folliculinum
No improvements of physical symptom
were observed, but patients felt positive
and fulfilled.
Diarrhoea was reported during one of
the treatment phases.
female, age not
reported
Rhus toxicodendron, Aurum,
Carcinosum
Patient showed improved general
health, but she also reported shoulder
pain and exotosis.
an improvement of more than 20% and a smaller group (34%
after five weeks and 20% after ten weeks) that demonstrates
an improvement of more than 30% (up to 81%) of the total
FIQ-score.
Another uncontrolled trial by Walters et al.19
found that
29 patients, who had received individual homeopathic reme-
dies, showed significant improvement in the Fibromyalgia
Impact questionnaire, symptoms measured by the MYMOP
and quality of life. The homeopathic treatment included a
maximum of 9 homeopathic consulting sessions; outcomes
were assessed after 52 weeks.
The same author published a service evaluation of 56
patients with fibromyalgia;21
however no cumulative results
were reported in the manuscript. The 2 cases described in
this study can be found in Table 1.
Controlled clinical trial
One controlled but not randomized clinical trial from
Spain was found,22
see Table 3. Researchers investigated
the short term effectiveness (8 weeks) of a pharmaco-
logical antihomotoxic treatment (Traumeel®
, Spascupreel®
,
Graphites Homaccord®
, Cerebrum compositum®
and Tha-
lamus compositum®
) versus a placebo (physiologic serum)
(double blind) in 20 patients diagnosed of fibromyalgia. The
obtained results showed a significant improvement in the
muscular and psychological symptoms with regard to the
previous state in the treatment groups.
Randomized controlled trials
In a British study by Fisher23
for 3 months 24 patients were
prescribed, according to indication, one of three home-
opathic remedies (Arnica, Bryonia, Rhus toxicodendron)
where each patient remaining on the same remedy through-
out. They were followed monthly on the parameters pain,
number of tender spots and sleep. An ‘indication score’ was
allotted to each prescription. The results showed a statis-
tically significant improvement for the homeopathy group,
but only when the prescribed remedy was well indicated.

6. 736 K. Boehm et al.
Table 2 Study characteristics: uncontrolled observational trials.
Reference Patients (N, age, diagnosis) Homeopathic remedy Results
Baars, 2010 42 patients with
fibromyalgia diagnosed by
rheumatologist
Age: 47 years (range 22—65)
Females: 39/42
Hepar Magnesium 10d
intravenously
Weekly administration of
10 ml for 10 weeks
No adjunctive therapies
Significant improvement in the
Fibromyalgia impact questionnaire
(FIQ) at week 10
Walters et al.,
2011
29 patients with
fibromyalgia
Gender and age unknown
Individualized homeopathic
remedies
Max. 9 homeopathic
consulting sessions, 1 h
each, at 5 week intervals
Significant decrease in Fibromyalgia
impact questionnaire (FIQ) at week
52.
Significant decrease in measure your
medical outcomes profile at week 52
(MYMOP-symptoms).
Significant increase in quality of life
at week 40 (EuroQol).
Walters, 2011 56 patients with
fibromyalgia
Gender and age unknown
Individualized homeopathic
remedies
No cumulative result reported
(results of two cases see table)
In 1988 Fisher24
published another study where they ran-
domized 30 patients suffering from fibromyalgia. The active
preparation was Rhus toxicodendron 6c (Boiron) prepared
from a tincture of the leaves of poison oak diluted 1:99
in ethanol and then vigorously shaken. This process was
repeated six times to give the 6c potency — a dilution of
102 of the tincture. This was then put up on 125 mg lac-
tose tablets. Results showed that the patients did better
in all variables when they took active treatment rather
than placebo. The number of tender spots was reduced by
about a quarter (P < 0005). Thus, it was concluded that Rhus
toxicodendron 6c was effective for a selected subgroup of
patients.
The American research team Bell et al.25
randomized
n = 62 fibromyalgia patients to receive oral daily liquid LM
(1/50 000) potencies with an individually chosen homeo-
pathic remedy or an indistinguishable placebo. Outcome
parameters included tender point count, tender point pain,
quality of life, pain, mood and global health and they were
measured at baseline, 2 months and 4 months. Results
showed that participants on active treatment showed sig-
nificantly greater improvements in tender point count and
tender point pain, quality of life, global health and a
trend towards less depression compared with those on
placebo.
Finally, in 2009 another British research group published
the findings of an RCT led by Relton et al.26
Forty seven
patients were recruited of which 11 had dropped-out by
the end of the trial. Adjusted for baseline, there was a
significantly greater mean reduction in the FIQ total score
(function) in the homeopath care group than the usual care
group (−7.62 versus 3.63). There were significantly greater
reductions in the homeopathy group in the McGill pain score,
FIQ fatigue and tiredness upon waking scores. Researchers
also found a small effect on pain score (0.21, 95%CI −1.42
to 1.84); but a large effect on function (0.81, 95%CI −8.17
to 9.79).
Data from all RCTs is presented in Table 3.
Meta-analysis
Meta-analyses of RCTs revealed effects of homeopathy
on tender point count (SMD = −0.42; 95%CI −0.78, −0.05;
P = 0.03), pain intensity (SMD = −0.54; 95%CI −0.97, −0.10;
P = 0.02), and fatigue (SMD = −0.47; 95%CI −0.90, −0.05;
P = 0.03) compared to placebo. Pain on the McGill pain sen-
sory or affective pain subscales, and depression did not
differ between groups (Fig. 2).
In subgroup analyses, when only studies that used indi-
vidualized homeopathy were considered, the effect on pain
intensity was no longer significant (SMD: −0.36; 95%CI:
−0.85 to 0.13; P = 0.15). Heterogeneity was reduced from
I2
= 42% (P = 0.18) to I2
= 13% (P = 0.28). No other changes in
results were found. Due to the paucity of included studies,
no separate subgroup analyses for studies on homotoxico-
logical or anthroposophic treatment were possible.
Quality assessment
Two randomized trials had low risk of selection bias,25,26
while the two randomized cross-over trials did not report
methods of randomization or allocation concealment.23,24
While only 2 trials reported adequate blinding of partici-
pants and personnel,24,25
all trials but 122
reported adequate
blinding of outcome assessment. Risk of attrition, reporting
or other bias was low in most trials.
Discussion
The treatment of fibromyalgia is still a challenge for patients
and physicians. Due to quite heterogeneous courses of the
disease a variety of therapeutic options have been investi-
gated so far, including a variety of complementary therapies.
Perry et al.8
had reported on the effects of homeopathy in
fibromyalgia and concluded that ‘‘homoeopathy was better
than the control interventions in alleviating the symptoms

7. Homeopathyinthetreatmentoffibromyalgia737
Table 3 Study characteristics: controlled and randomized controlled trials.
Reference Study type Patients (N, age,
diagnosis)
Intervention groups (programme
length, frequency, duration)
Follow-up Outcome measures Results
Treatment Control
Egocheaga
and del Valle,
2004
CCT (case
control study)
20 patients with
fibromyalgia
Pharmacological
antihomotoxic injection
(Traumeel, Spascupreel,
Graphites Homaccord,
Cerebrum compositum,
Thalamus compositum)
8 weeks, twice weekly
Placebo injection
8 weeks, twice
weekly
8 weeks (1) Pain intensity on a
numeric rating scale
(NRS)
(1) Significant group
difference in favour of
homeopathy
Gender: female only
Age: 28—64 years
(2) Psychological
wellbeing on a
numeric rating scale
(NRS)
(2) No significant group
differences
Fisher, 1986 RCT 24 patients with
fibrositis
(fibromyalgia) and
indication for Rhus
toxicodendron
prescription
Gender and age
unknown
One of the three remedies:
Arnica montana, Bryonia
alba or Rhus toxicodendron
(potency 6c)
3 months, twice daily intake
Placebo
3 months, twice
daily intake
3 months (1) Tender point
counts (TPC)
(2) Pain intensity on a
visual analogue scale
(VAS)
(3) Analgesic
consumption
(1) No significant group
differences at 3 months
(2) No significant group
differences at 3 months
(3) Not reported
Fisher, 1988 RCT 30 patients with
fibromyalgia
Mean age: 48.4 years
(range from 29 to 64)
Females: 23/30
Rhus toxicodendron
(potency 6c)
1 month, three times daily
2 tablets
Placebo
1 month, three
times daily 2
tablets
1 month (1) Tender point
counts (TPC)
(2) Pain intensity on a
visual analogue scale
(VAS)
(3) Sleep quality on a
visual analogue scale
(VAS)
(1) No significant group
differences at 1 month,
significant group
differences regarding
change from baseline in
favour of homeopathy
(2) No significant group
differences at 1 month,
significant group
differences regarding
change from baseline in
favour of homeopathy
(3) No significant group
differences at 1 month

8. 738K.Boehmetal.
Table 3 (Continued)
Reference Study type Patients (N, age,
diagnosis)
Intervention groups (programme
length, frequency, duration)
Follow-up Outcome measures Results
Treatment Control
Bell et al.,
2004
RCT 62 patients with
fibromyalgia
according to the ACR
criteria
Mean age: 49.1 ± 9.9
years (Homeopathy)
47.9 ± 10.8 years
(Placebo)
Females:
29/30 (Homeopathy)
29/32 (Placebo)
Individualized homeopathic
remedies, daily intake
Homeopathic consulting at
0, 2, 4, 6 months
Placebo, daily
intake
Homeopathic
consulting at 0, 2,
4, 6 months
3 months (1) Tender point
count (TPC)
(2) McGill pain
questionnaire short
form (sensory
component, affective
component)
(3) Profile of Mood
states (POMS)
(4) Appraisal of
disease interaction
with life goals
(5) Global health
rating
(1) Significant group
difference in favour of
homeopathy
(2) No significant group
differences
(3) No significant group
differences
(4) Significant group
difference in favour of
homeopathy
(5) Significant group
difference in favour of
homeopathy
Relton et al.,
2009
RCT 47 patients with
fibromyalgia
according to the ACR
criteria
Mean age: 43.9 ± 8.9
years (Homeopathy)
47.4 ± 9.2 years
(Usual care)
Females: 22/23
(Homeopathy)
22/24 (Usual care)
Individualized homeopathic
treatment
1 initial homeopathic
interview of 60 min
4 homeopathic interviews
of 30 min every 4—6 weeks
+Usual care
Usual care 22 weeks (1) Tender point
count (TPC)
(2) McGill pain
questionnaire
(sensory component,
affective component)
(3) Fibromyalgia
impact questionnaire
(FIQ)
(4) Hospital Anxiety
and Depression Scale
(HADS)
(5) Measure your
medical outcomes
profile (MYMOP)
(6) Pain intensity on a
visual analogue scale
(VAS)
(7) Quality of life
(EuroQol)
(1) No significant group
differences at 22 weeks
(2) No significant group
differences at 22 weeks,
significant group
differences regarding
change from baseline in
favour of homeopathy
(3) No significant group
differences at 22 weeks,
significant group
differences regarding
change from baseline in
favour of homeopathy
(4) No significant group
differences at 22 weeks
(5) No significant group
differences at 22 weeks
(6) No significant group
differences at 22 weeks,
significant group
differences regarding
change from baseline in
favour of homeopathy
(7) No significant group
differences at 22 weeks

9. Homeopathy in the treatment of fibromyalgia 739
Fig. 2 Forrest plots for outcomes.

10. 740 K. Boehm et al.
of FMS’’ but also pointed out problems in the quality of the
clinical trials.
In 2010 the American College of Rheumatology criteria
for the diagnosis of FMS changed and all the RCTs included
in this review were conducted before then. The most signifi-
cant difference is that the 2010 guidelines no longer require
a tender point count for the diagnosis of FMS. The previous
ACR criteria proposed for the classification of fibromyalgia
for the included studies were (1) widespread pain in combi-
nation with (2) tenderness at 11 or more of the 18 specific
tender point sites.31
Our analysis for the first time provides a comprehensive
overview of homeopathic literature in the treatment of FMS
including a summary of single case descriptions, a review
of current observational studies and a meta-analysis of RCTs
including 1 RCTs not included in prior reviews. Thus, our
approach not only provides the most current evidence base
by quantifying the effectiveness homeopathic treatment of
fibromyalgia but also covers the perspective of the practi-
cal homeopath, and delivers a source of information i.e. in
terms of single case descriptions.
Meta-analysis
In accordance to Perry et al.8
quality assessment revealed
potential sources of bias in the included studies. Similarly
to another meta-analysis on the use of Hypericum perfora-
tum (St. John’s Wort) for pain conditions in dental practice
by Raak et al.27
we found that studies had several limita-
tions by means of biases. In contrast to Raak et al.27
older
studies like those of Fisher23,24
had a sufficient quality while
Egocheaga and del Valle22
i.e. failed on reporting several
study essentials.
Single cases
All single cases were published after the studies of
Fisher.23,24
Thus, descriptions of Gemmell et al.,14
Jones and
Whitmarsh,17
and Walters21
more or less adopted the home-
opathic treatment strategy described there and used Rhus
toxicodendron as a single remedy14
or with some modifica-
tions in Jones and Whitmarsh17
and Walters.21
Rhus toxicodendron according to the repertory is appro-
priate in restless patients with apprehension at night
accompanied by heavy feeling in the head, joint stiffness
and a sensibility for cold weather. However there are other
remedies like Calcium carbonicum or the exotic L. reclusa
or P. somniferum which potentiated in 30c also seem to
lower FMS symptoms in the cases described by Jones and
Whitmarsh,17
Klein15
and Saltzman.18
However Rhus toxico-
dendron still remains the most evaluated remedy so far.
Our review also includes potentiated remedies which
according to their origin cannot directly be interconnected
with the classical homeopathic approach of a potentiated
single agent. For example the study of Egocheaga and
del Valle22
used pharmacological antihomotoxic injection in
their RCT and thus not only differ in the type of remedy
but also in its application. This also holds for the obser-
vational study of Baars and Ellis20
applying 10 ml of Hepar
Magnesium 10d, a potentiated remedy of anthroposophical
medicine intravenously.
Strengths and limitations
This is the first available meta-analysis on homeopathy for
treating fibromyalgia. In order to evaluate the totality of
available evidence, uncontrolled and single case studies
were included besides randomized trials. It is debatable
whether this meta-analysis is limited by the inclusion of tri-
als of different study design. According to recent discussion
regarding the use of hierarchical research evidence we pro-
pose that a circular evidence perspective, specifically an
‘evidence mosaic’ can be adapted, as previously suggested
by academic proponents of CAM research.34,39,40
Additionally, one could argue that the data presented
here are too heterogeneous for carrying out a meta-analysis
and that this should only be considered when a group of
trials is sufficiently homogeneous in terms of condition
treated, interventions and outcomes.35
Up to date there
is no guideline to explain the meaning of ‘‘sufficiently’’ or
‘‘meaningful’’ in this context except that Higgins mentions
I2
values beyond 50% as a substantial heterogeneity.36
In
fact, Higgins himself argues that ‘‘any amount of hetero-
geneity is acceptable, providing both that the predefined
eligibility criteria for the meta-analysis are sound and that
the data are correct. The challenge is then to decide on
the most appropriate way to analyze heterogeneous stud-
ies, and this will depend on the aims of the synthesis and,
to an extent, the observed directions and magnitudes of
effects.’’37
Furthermore, we know from previous research that all
statistical tests for heterogeneity are weak, including I2
. The
clinical implications of this must be examined on a case by
case basis. Putting too much trust in homogeneity of effects
may give a false sense of reassurance that one size fits all.
Lack of evidence of heterogeneity cannot be interpreted as
evidence of homogeneity. Conversely, putting too much trust
in the presence of heterogeneity of effects may lead to spu-
rious subgroup and exploratory analyses. Given that I2
is not
precise, 95% confidence intervals should always be given.38
A substantial limitation of this meta-analysis is the low
methodological quality of the included studies. As in prior
reviews,8
the interpretation of the findings is clearly limited
due to the insufficient reporting of research methodol-
ogy. Moreover, the heterogeneity of interventions in the
included studies further limits interpretability. While Bell
et al.25
and Relton et al.26
used a strictly individualized
approach without restriction of the chosen remedy, other
controlled trials (semi-)standardized the remedies that
were administered.23,24
Finally, while all other controlled
trials used single remedies based on classical homeopa-
thy, Egocheaga and del Valle22
prescribed pharmacological
antihomotoxic injection, i.e. complex remedies. The trial
of Fisher28
did not report sufficient data in the original
publication; data for meta-analysis was extracted from a
reanalysis.29
Furthermore, endpoint definitions differed among stud-
ies (see the above discussion on change of diagnosis of
tender points in 2010).
We carried out a sensitivity analysis to counteract the
heterogeneity of interventions, which in homeopathy is a
quite common meta-analytic issue due to the individualistic
nature of the intervention. With the sensitivity analy-
sis heterogeneity was reduced although there remained a

11. Homeopathy in the treatment of fibromyalgia 741
substantial residual heterogeneity. However, the effect on
pain intensity was no longer significant. Lack of patient level
data prevented a further analysis of the current results strat-
ified by age or sex.
Generally, we feel that our group of trials is sufficiently
homogeneous in terms of condition treated, interventions
and outcomes.
Implications for further research
In line with prior reviews,8
the interpretability of evidence
found in this meta-analysis is limited by the low method-
ological quality of the included studies. Future trials should
ensure rigorous methodology and reporting, mainly ade-
quate randomization, allocation concealment, intention-to
treat analysis, and blinding. Future research should also
try to investigate the comparative effectiveness of classical
homeopathy, clinical homeopathy, and the use of complex
remedies.
Conclusions
Given the low number and included trials and the low
methodological quality, any conclusion based on the results
of this review have to be regarded as preliminary. However,
as single case studies and clinical trials indicate a positive
effect, homeopathy could be considered a complementary
treatment for patients with fibromyalgia.
Conflict of interest statement
The authors declare that they have no conflicts of interest.
Funding
No funding was received from any source by any of the
authors specifically for this review.
Box 1 Key messages
• Available data suggest that homeopathic treatment
of fibromyalgia is helpful in pain management and
reduction of fatigue.
• Further studies are merited in terms of multicenter
trials to broaden the evidence base.
References
1. Häuser W, Hayo S, Biewer W, Gesmann M, Kühn-Becker H, Pet-
zke F, et al. Diagnosis of fibromyalgia syndrome—–a comparison
of Association of the Medical Scientific Societies in Germany,
survey, and American College of Rheumatology criteria. Clin J
Pain 2010;26(6):505—11.
2. Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Katz RS,
Mease P, et al. The American College of Rheumatology prelim-
inary diagnostic criteria for fibromyalgia and measurement of
symptom severity. Arthritis Care Res 2010;62(5):600—10.
3. Wolfe F, Brahler E, Hinz A, Häuser W. Fibromyalgia preva-
lence, somatic symptom reporting, and the dimensionality of
polysymptomatic distress: results from a survey of the general
population. Arthritis Care Res 2013;65(5):777—85.
4. Branco JC, Bannwarth B, Failde I, Abello Carbonell J, Blot-
man F, Spaeth M, et al. Prevalence of fibromyalgia: a
survey in five European countries. Semin Arthritis Rheum
2010;39(6):448—53.
5. Berger A, Dukes E, Martin S, Edelsberg J, Oster G. Charac-
teristics and healthcare costs of patients with fibromyalgia
syndrome. Int J Clin Pract 2007;61(9):1498—508.
6. Berger A, Sadosky A, Dukes E, Martin S, Edelsberg J, Oster
G. Characteristics and patterns of healthcare utilization of
patients with fibromyalgia in general practitioner settings in
Germany. Curr Med Res Opin 2008;24(9):2489—99.
7. Wahner-Roedler DL, Elkin PL, Vincent A, Thompson JM, Oh
TH, Loehrer LL, et al. Use of complementary and alterna-
tive medical therapies by patients referred to a fibromyalgia
treatment program at a tertiary care center. Mayo Clin Proc
2005;80(1):55—60.
8. Perry R, Terry R, Ernst E. A systematic review of homoeopa-
thy for the treatment of fibromyalgia. Clin Rheumatol
2010;29(5):457—64.
9. Langhorst J, Häuser W, Bernardy K, Lucius H, Settan M, Winkel-
mann A, et al. Complementary and alternative therapies for
fibromyalgia syndrome. Systematic review, meta-analysis and
guideline. Schmerz 2012;26(3):311—7 [in German].
10. Baranowsky J, Klose P, Musial F, Häuser W, Dobos G, Langhorst
J. Qualitative systemic review of randomized controlled tri-
als on complementary and alternative medicine treatments in
fibromyalgia. Rheumatol Int 2009;30(1):1—21.
11. Ostermann T, Zillmann H, Matthiessen PF. CAMbase–the real-
isation of an XML-based bibliographical database system for
complementary and alternative medicine. Z ärztl Fortbild Qual
Sich 2004;98(6):501—7 [in German].
12. Borenstein M, Hedges LV, Higgins JPT, Rothstein HR. Introduc-
tion to meta-analysis (statistics in practice). West Sussex: John
Wiley & Sons; 2009.
13. Higgins JPT, Green S. Cochrane handbook for systematic reviews
of interventions. West Sussex: John Wiley & Sons Ltd.; 2008.
14. Gemmell HA, Jacobson BH, Banfield K. Homeopathic Rhus tox-
icodendron in the treatment of fibromyalgia. Chiropr J Aust
1991;21(1):2—6.
15. Klein L. Loxosceles reclusa, a new proving. Homeopathic
2001;21(3):26—9.
16. Fleisher MA. A case of chronic fatigue and fibromyalgia. Am J
Homeopath Med 2004;97(2):109—10.
17. Jones A, Whitmarsh T. Fibromyalgia. Health Homeopathy
2008;(Summer):21—3.
18. Saltzman S. A case of severe fibromyalgia and gastroparesis. Am
J Homeopath Med 2008;101(4):227—8.
19. Walters C, Raw J, Smith C, Adebajo A. Fibromyalgia syndrome.
A service evaluation. Homeopathic 2011;30(3):9—11.
20. Baars EW, Ellis EL. The effect of Hepar Magnesium D 10
on fibromyalgia syndrome: a pilot study. Eur J Integr Med
2010;2(1):15—21.
21. Walters C. Don’t touch me, I hurt too much. Homeopathic
2011;29(4):23—6.
22. Egocheaga J, del Valle M. Use of antihomotoxic drug therapy for
the management of symptoms associated to fibromyalgia. Rev
Soc Esp Dolor 2004;11:4—8 [in Spanish].
23. Fisher P. An experimental double-blind clinical trial method in
homoeopathy. Br Homeopath J 1986;75(3):142—7.
24. Fisher P. Rhus toxicodendron in the treatment of Fibromyalgia:
a double-blind, placebo controlled trial, with cross over. J OMHJ
1988;1(3):26—8.
25. Bell IR, Lewis 2nd DA, Brooks AJ, Schwartz GE, Lewis SE,
Walsh BT, et al. Improved clinical status in fibromyalgia
patients treated with individualized homeopathic remedies
versus placebo. Rheumatology 2004;43(5):577—82.
26. Relton C, Smith C, Raw J, Walters C, Adebajo AO, Thomas KJ,
et al. Healthcare provided by a homeopath as an adjunct to

12. 742 K. Boehm et al.
usual care for Fibromyalgia (FMS): results of a pilot Randomised
Controlled Trial. Homeopathy 2009;98(2):77—82.
27. Raak C, Bussing A, Gassmann G, Boehm K, Ostermann T. A
systematic review and meta-analysis on the use of Hypericum
perforatum (St. John’s Wort) for pain conditions in dental prac-
tice. Homeopathy 2012;101(4):204—10.
28. Fisher P, Greenwood A, Huskisson EC, Turner P, Belon P. Effect
of homeopathic treatment on fibrositis (primary fibromyalgia).
BMJ 1989;299(6695):365—6.
29. Colquhoun D. Re-analysis of clinical trial of homoeopathic treat-
ment in fibrositis. Lancet 1990;336(8712):441—2.
30. Moher D, Liberati A, Tetzlaff J, Altman DG, The PRISMA Group.
Preferred reporting items for systematic reviews and meta-
analyses: the PRISMA statement. PLoS Med 2009;6(6):e1000097,
http://dx.doi.org/10.1371/journal.pmed1000097.
31. Wolfe F, Smythe HA, Yunus MB, Bennett RM, Bombardier C,
Goldenberg DL, et al. The American College of Rheuma-
tology 1990 criteria for the classification of fibromyalgia.
Report of the multicenter criteria committee. Arthritis Rheum
1990;33(2):160—72.
32. Carville SF, Arendt-Nielsen S, Bliddal H, Blotman F, Branco JC,
Buskila D, et al. EULAR evidence-based recommendations for
the management of fibromyalgia syndrome. Ann Rheum Dis
2008;67(4):536—41.
33. Sarzi-Puttini P, Atzeni F, Salaffi F, Cazzola M, Benucci M, Mease
PJ. Multidisciplinary approach to fibromyalgia: what is the
teaching? Best Pract Res Clin Rheumatol 2011;25(2):311—9,
http://dx.doi.org/10.1016/j.berh.2011.03.001.
34. Walach H. Zirkulär statt hierarchisch: Methodologische Grund-
prinzipien bei der Evaluation der therapeutischen Effekte
von Komplementärmedizin und anderer komplexer Maßnahmen
[Circular instead of hierarchical: Methodological principles in
the evaluation of complementary medicine and other com-
plex interventions] Informatik. Biomet Epidemiol Medizin Biol
2004;35:229—42.
35. Higgins JP, Thompson SG. Cochrane handbook for systematic
reviews of interventions, Version 5.1.0 [updated March 2011].
The Cochrane Collaboration; 2011.
36. Higgins JPT, Thompson SG, Deeks JJ, Altman DG. Measuring
inconsistency in meta-analyses. Br Med J 2003;327:557e60.
37. Higgins JPT. Commentary heterogeneity in meta-analysis should
be expected and appropriately quantified. Int J Epidemiol
2008;37(5):1158—60.
38. Ioannidis JPA, Patsopoulos NA, Evangelou E. Uncertainty in het-
erogeneity estimates in meta-analyses. BMJ 2007;335:914.
39. Walach H, Falkenberg T, Fønnebø V, Lewith G, Jonas WB. Cir-
cular instead of hierarchical: methodological principles for the
evaluation of complex interventions. BMC Med Res Methodol
2006;6.
40. van Haselen R. Medical study formats: an overview. J Biomed
Ther 2010;4(2):26—7.
41. Borenstein M, Hedges LV, Higgins JPT, Rothstein HR. Fixed-
effect versus random-effects models. In: Introduction to
meta-analysis. Chichester, UK: John Wiley & Sons, Ltd; 2009.
42. Cohen J. Statistical power analysis for the behavioral sciences.
Hillsdale, MI: Lawrence Erlbaum Associates; 1988.