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VOLUME 7 NUMBER 3 2002 ISSN: 0965-0288

Effective
Bulletin on the effectiveness
of health service interventions
for decision makers
Health Care
Homeopathy
This bulletin summarises
the research evidence ■ Homeopathy is a ■ The evidence base for
system of treating homeopathy needs to
on the effectiveness of patients using very low be interpreted with
homeopathy. dose preparations caution. Many of the
according to the areas that have been
principle ‘like should be researched are not
cured with like’. representative of the
conditions that
■ Increasing numbers of homeopathic
patients are seeking practitioners usually
information on treat. Additionally, all
complementary conclusions about
medicines from NHS effectiveness should be
health professionals. It considered together
has been estimated that with the
there are around methodological
470,000 users of problems of the
homeopathic remedies research.
in England every year.
■ There is currently
■ Given the large number insufficient evidence of
of users, and the effectiveness either to
availability of recommend
homeopathy within the homeopathy as a
NHS, it is important to treatment for any
establish the specific condition, or to
effectiveness of warrant significant
homeopathy as a changes in the current
treatment. provision of
homeopathy.

NHS CENTRE FOR REVIEWS AND DISSEMINATION


Box 1. Methods of homeopathic prescribing5, 6
A. Introduction
Complementary medicine refers Classical Use of a single remedy prescribed according to the individual’s
presentation and history
to a diverse group of health-
related therapies and disciplines
Complex More than one remedy used concurrently
which are outside of mainstream
medical care. In the UK, the most
Fixed Same single agent used for a group of patients (often used in research)
established complementary
therapies are osteopathy, Isopathy Preparation based on causal agent
chiropractic, homeopathy,
acupuncture and herbalism. Phytotherapy The administration of herbs or low potencies of herbs
Increasing numbers of patients
are seeking information on
complementary medicines from What is homeopathy? symptoms, e.g., weather or
NHS health professionals.1 In activity). The symptoms are then
Homeopathy was introduced
order to advise about matched to remedies using either
during the late 18th and early
complementary medicine, health a repertory (an index in the
19th centuries and is a system of
professionals need to understand homeopathic Materia Medica) or
treating patients using very low
its potential benefits and ‘pattern recognition’. In private
dose preparations according to the
limitations.1 The Department of practice, a consultation may last
similia principle: ‘like should be
Health, in collaboration with the for an hour or more, although
cured with like’. It is based on the
Foundation for Integrated some NHS GPs may provide a
hypothesis that a substance which
Medicine, NHS Alliance and basic homeopathic assessment and
can cause certain symptoms may
National Association of Primary treatment within 10-15 minutes.5
also be able to resolve similar
Care have produced an
symptoms. Homeopathic dilutions Methods of prescribing vary
information pack designed to
are often known as potencies and among homeopathic practitioners
provide primary care groups
are prepared by a process of serial (see Box 1). Following
(PCGs) with a basic source of
dilution with succussion (vigorous administration of a remedy, the
reference on the complementary
shaking).5,7 There are two main homeopathic practitioner follows
and alternative therapies most
series of dilutions: decimal (tenfold the patient’s progress, and pays
commonly provided by PCGs.2
dilutions, denoted x in the UK) attention to the development of
This issue of Effective Health and centesimal (hundred fold, symptoms, and will repeat or
Care summarises the research denoted c in the UK). Such adjust the prescription depending
evidence on the effectiveness of dilutions are known as on what is observed.7
one of the most established ultramolecular in that they are
complementary disciplines – diluted to such a degree that not
homeopathy. even a single molecule of the

Use of homeopathy
starting substance is likely to
remain. The claim that these B. Homeopathy
A recent (1999) BBC telephone
dilutions have a specific activity is
the source of most of the scientific and the NHS
survey reported that 17% of controversy surrounding
Whilst the majority of
1204 randomly selected British homeopathy.
complementary medicine is
adults had used homeopathy
provided outside the NHS, it is also
within the past year.3 Results of Homeopathic treatment available within the NHS. A 1995
a 1998 survey of use and
Most of the conditions that survey of general practices in
expenditure on complementary
homeopaths treat are chronic or England reported that an
medicine in England suggested
recurrent. Homeopaths also treat a estimated 39% of practices
that 28% of respondents had
large number of patients with ill- provided access to some form of
either visited a complementary
defined illnesses that have not complementary therapy for their
therapist or had purchased an
been given a conventional NHS patients.8 Around 21% of
over-the-counter herbal or
diagnosis.5 general practices offered access via
homeopathic remedy in the past
a member of the primary health
year. Eight percent of
Initially, a very detailed history is care team, 6% employed an
respondents reported that they
taken from the patient, a clinical ‘independent’ complementary
had bought an over-the-counter
examination is performed, and all therapist, and an estimated 24% of
homeopathic remedy in the past
signs and symptoms are recorded. partnerships had made NHS
year. It was estimated from this
Attention is paid to alternating or referrals for complementary
that there could be over 470,000
unusual symptoms and therapies. Homeopathy accounted
recent users of homeopathic
information is sought on the for half the NHS referrals for
remedies in England.4
impact of modalities (conditions complementary therapies
providing relief or aggravation of reported.8

2 EFFECTIVE HEALTH CARE Homeopathy VOLUME 7 NUMBER 3 2002


Homeopathy has been part of the effectiveness of homeopathy is not and as such, were unable to draw
NHS since its inception.9 There are representative of routine firm conclusions about the general
currently five homeopathic homeopathic practice, as effectiveness of homeopathy. It
hospitals, of which the two largest homeopathic treatment is highly should be noted that the analyses
in Glasgow and London have individualised, in that two patients undertaken in two of the reviews
inpatient units. The hospitals showing similar symptoms may involved the statistical pooling of
provide a range of conventional receive different treatments.13 clinically heterogeneous data, and
and complementary treatments in Whilst it is possible to carry out therefore the estimates shown
addition to homeopathy. As with RCTs evaluating the efficacy of should be viewed with caution.16, 17
other complementary medicines, homeopathy, researchers have
homeopathic services are currently tended to focus on conducting Reviews of individualised (classical)
accessed either through GP placebo controlled RCTs either to
homeopathy (Table 2)
referral or through referral by test the effects of a single remedy
another primary or secondary care on a particular condition and/or to In classical or individualised
health professional.10 Referrals are explore the placebo issue. As such, homeopathy, practitioners aim to
subject to the service agreements conditions like delayed-onset identify a single homeopathic
between PCG/Ts or Health muscle soreness have been studied preparation that matches a
Authorities and providers of NHS whereas skin conditions like patient’s general ‘constitution’.
homeopathy. eczema, which homeopaths Constitution refers to a ‘picture’
commonly treat, have been composed of different information
overlooked.13 such as personal and medical
history, the medical history of
C. Nature of Most RCTs of homeopathy have
involved small numbers of patients
family members, and the patient’s
personality, behaviour, and
the evidence and have suffered from low
statistical power. Given the
preferences (e.g. for certain types
of food). Due to differences in
Around 200 randomised controversy surrounding the elements of patients’ constitutions,
controlled trials (RCTs) evaluating plausible mechanism of action for two patients with identical
homeopathy have been homeopathy, there have been calls conventional diagnoses may
conducted, and there are also for stronger levels of evidence for receive different homeopathic
several systematic reviews of these the effectiveness of homeopathy prescriptions.
trials. This bulletin is based mainly than would normally be required
for other conventional Two reviews were identified.18, 19
on an overview of existing
interventions.6, 14 Again, the scope of these reviews
systematic reviews of RCTs.
was general and selection criteria
Individual RCTs published
relating to participant
subsequent to the included
characteristics and outcome
reviews with a specific scope are
also included (see appendix for D. Effectiveness measurements were unspecified.
Methodological problems with the
further details of methods).
primary studies were reported in
There are a number of problems
Reviews with a general scope (Table 1) both reviews.18, 19
and controversies surrounding the Four systematic reviews were
identified.6,15-17 The purpose of One review assessed the
existing evidence base for
these reviews was to determine effectiveness of individualised
homeopathy.
whether there is any evidence for homeopathy compared with
Firstly, there is much debate over the effectiveness of homeopathic placebo, no treatment, or another
whether homeopathy shows any treatment generally. Patients with therapy, and included randomised,
effect over and above placebo (a any disease were included, as quasi-randomised, or double-blind
dummy medication or treatment opposed to investigating effects trials (32 trials included).18 The
given to participants in trials). within a specific group, e.g. people results from a pooled analysis of
Sceptics have argued that with asthma. Due to the general 19 trials indicated a statistically
homeopathy cannot work because nature of all four reviews, significant result in favour of
of the use of remedies that are participant characteristics and homeopathy. However, when the
diluted to such a degree that not outcomes were not specified in the analysis was limited to six trials of
even a single molecule of the selection criteria for primary higher methodological quality, the
starting substance remains. Given studies and both participants and difference between homeopathy
the absence of a plausible interventions varied greatly. All and control treatments was no
mechanism of action, it has been four reviews included RCTs and longer statistically significant.
argued that the existing evidence one also included controlled It should be noted that clinically
base represents little more than a clinical trials.6 Each review covered heterogeneous data were
series of placebo versus placebo several different types of combined in the analyses, and
trials.11, 12 homeopathy including classical, assessments of statistical
fixed, complex, and isopathy. All heterogeneity were not reported.
Others have argued that much of reviews identified methodological Therefore, results should be
the research conducted into the problems with the primary studies, interpreted with caution.18

2002 VOLUME 7 NUMBER 3 EFFECTIVE HEALTH CARE Homeopathy 3


Legend for Tables 1–3

Abbreviations for assessment of methodological quality: 1 – selection criteria, 2 – search strategy, 3 – validity assessment of primary studies,
4 – presentation of details of primary studies, 5 – data synthesis. RCT = randomised controlled trial, OR = odds ratio, RR = relative risk, OA
= osteoarthritis, NSAID = non-steroidal anti-inflammatory drug.

Table 1 Reviews with a general scope

Author,year Results Authors’ conclusions & reviewer’s notes Quality assessment

Hill15 40 RCTs included. (period: 1966-89) Author’s conclusions: The therapeutic value of 1. Fair/Poor
1990 homeopathy cannot be considered to have been 2. Fair
Half of the trials concluded that demonstrated. 3. Fair
homeopathy was effective, seven 4. Fair
concluded that results were promising but Reviewer’s notes: The earliest general review of 5. Fair
that the studies were underpowered. Of homeopathy. Few details were provided relating to the
the three largest trials, one concluded that search strategy used, and it is possible that this may
homeopathy was effective whilst the other have been more rigorous than is apparent from the
two found no statistically significant paper.
difference between homeopathy and
control.

Kleijnen6, 45 107 trials met inclusion criteria; 68 were Authors’ conclusions: Evidence of clinical trials is 1. Fair
1991 RCTs (period: 1943-90) positive but not sufficient to draw definitive conclusions 2. Good
because of low methodological quality and the 3. Good
Of 105 trials with interpretable results, 81 unknown role of publication bias. 4. Fair
had positive results in favour of 5. Fair
homeopathy, and in 24 no positive effects Reviewer’s notes: Most of the trials from an earlier
of homeopathy were found. Positive results review15 are also included in this review.
were more likely to be found in trials with
lower methodological quality.

Linde16 119 RCTs met the inclusion criteria Author’s conclusions: Results of meta-analysis not 1. Fair
1997 (period: 1966-95). Of these, 30 had compatible with the hypothesis that the clinical effects 2. Good
inadequate information to allow statistical of homeopathy are completely due to placebo. 3. Good
pooling, leaving 89 RCTs that met all Insufficient evidence was found that homeopathy is 4. Fair
inclusion criteria. clearly efficacious for any single clinical condition. 5. Poor

The overall OR (all trials) was 2.45 (95% Reviewer’s notes: Clinically heterogeneous data were
CI: 2.05, 2.93) in favour of homeopathy. combined, and the results of the test of heterogeneity
were not reported, even though this was carried out.
Further analyses showed that trials with Therefore the estimates shown should be interpreted
better methodological quality were less with caution.
likely to show positive results in favour of
homeopathy.46

Cucherat17 17 comparisons in 16 RCTs met the Author’s conclusions: There is some evidence that 1. Fair
2000 inclusion criteria (period: 1967-98) homeopathic treatments are more effective than 2. Fair
placebo; however, the strength of this evidence is low 3. Fair
11 of the 17 comparisons (65%) showed because of the low methodological quality of the trials. 4. Fair
statistically significant results in favour of Studies of high methodological quality were more likely 5. Poor
homeopathy. Overall pooled p-value (17 to be negative than the lower quality studies.
comparisons) was 0.000036.
Reviewer’s notes: The pooled p-values are based on
Sensitivity analyses: clinically heterogeneous data. This method should be
Double-blind RCTs only (n=16) used and interpreted with caution, since it may mask
p=0.000068 some fundamental differences between studies.

Double-blind RCTs of highest


methodological quality (n=5) p=0.082.

Analysis of the likelihood of publication


bias indicated that it was unlikely.

The second review assessed the each involving a different disease. therapy may be better than
effectiveness of individualised Results suggested that homeopathy for proctocolitis
homeopathy compared with homeopathic remedies may be (inflammation of the rectum and
allopathic (conventional) superior to conventional drug colon) and tonsillitis in children.
medications, and included RCTs therapy for rheumatoid arthritis No between-group differences
and non-randomised controlled and otitis media in children. were found for trials of irritable
trials.19 Six studies were included, However, conventional drug bowel syndrome and malaria. This

4 EFFECTIVE HEALTH CARE Homeopathy VOLUME 7 NUMBER 3 2002


Table 2 Reviews of individualised (classical) homeopathy

Author,year Results Authors’ conclusions & reviewer’s notes Quality assessment

Linde 32 randomised, quasi-randomised, or Authors’ conclusions: Results suggest that individualised 1. Fair
(1998)18 double-blind design trials met inclusion homeopathy has an effect over placebo. However, the 2. Good
criteria (Period: 1966-1998). evidence is not convincing because of methodological 3. Good
shortcomings of, and inconsistencies between, the 4. Fair
The methodological quality of trials was trials. 5. Poor
variable. 19 placebo-controlled trials
presented the results in sufficient detail to Reviewer’s notes: The authors have pooled clinically
be included in the meta-analysis. heterogeneous data both for the overall pooling, and
for the sensitivity analysis according to methodological
quality. Statistical assessments of heterogeneity are not
Overall rate ratio (n=19) 1.62 (95% CI reported. Therefore results should be viewed with
1.17, 2.23) in favour of homeopathy caution. There is some overlap between this review and
the previous, more general paper.16 There is a slight
Sensitivity analysis: Methodologically best discrepancy between the abstract/main text and tables
trials (n=6): rate ratio 1.12 (95% CI 0.87, for the overall rate ratio figures.
1.44)

Ernst 199919 Two double-blind RCTs, one unblinded Authors’ conclusions: All of the included trials had 1. Fair
RCT, three non-randomised trials met the serious methodological flaws. Thus the value of 2. Fair
inclusion criteria (Period: 1978-1998) individualised homeopathy relative to allopathic 3. Fair / Poor
treatments is unknown. 4. Fair / Poor
Two trials suggested that homeopathic 5. Fair
remedies may be superior to conventional Reviewer’s notes: This is the only identified review to
drug therapy. Two other trials suggested address the comparison between homeopathy and
that conventional drug therapy may be conventional treatments. Assessments of tests of
superior to homeopathy. Results of the last statistical significance for between-group comparisons
two trials suggested no between group within trials were not presented.
differences.

review did not present sufficient the proportion of women migraine was identified,24 and will
details of individual studies, and experiencing more than 30% be discussed later.25
therefore it was difficult to judge improvement (38% versus 90%,
the validity of the review’s p=0.037). There were no Since all of the reviews discussed
findings. statistically significant differences so far have aimed to assess
between groups for consumption whether homeopathy as a general
Four further RCTs of classical of medications such as system shows any effect over and
homeopathy, all of reasonable tranquillisers and painkillers above placebo, there are no
methodological quality, were during the seven days prior to specific implications for clinical
identified.20-23 Although two of menstruation. practice that can be derived. The
these trials were included in one of following sections provide details
the above reviews,18 they are Another trial assessed the effects of reviews with a more specific
discussed here as they were of classical homeopathy in treating focus in terms of patient or
previously reported only in children with a recent history of intervention characteristics.
abstract form.20,21 diarrhoea.22 Results suggested that
homeopathy was significantly Reviews with a more specific scope
In the earliest trial, patients with more effective than placebo in
mild traumatic brain injury were (Table 3)
reducing the frequency of
recruited.20 After four months, diarrhoea and the duration of Eight reviews were identified with
statistically significant effects in illness. The same research group a specific focus in terms of the
favour of homeopathy were conducted another trial on homeopathic agent being
observed for changes in some children with acute otitis media.23 evaluated or the type of
scores of physical, cognitive, and No statistically significant participants recruited.24,26-32
affective symptoms, and functional between-group differences were One review focused on the
disability. seen for treatment failure or effectiveness of homeopathic
middle ear effusion. This was a arnica.27 Six reviews were
A small trial (n=23) assessed the small pilot study (n=75) and may concerned with specific
effectiveness of homeopathy not have been large enough to conditions: post-operative ileus,26
versus placebo in relieving detect the true treatment effects. delayed-onset muscle soreness
symptoms associated with the (DOMS),30 arthritis and other
premenstrual syndrome (PMS).21 In addition to the above, a follow- musculoskeletal disorders,31,32
Results were seen in favour of up study relating to a trial of headaches and migraine,24 and
homeopathy for improvement in classical homeopathy included in a asthma.29 The last review focused
menstrual symptoms at three review on homeopathic on the use of homeopathic
months (p=0.057), mean symptom prophylaxis of headaches and oscillococcinum in influenza.28
improvement rate (p=0.048), and

2002 VOLUME 7 NUMBER 3 EFFECTIVE HEALTH CARE Homeopathy 5


Table 3 Reviews with a specific scope

Author,year Results Authors’ conclusions & reviewer’s notes Quality assessment

Ernst Eight controlled clinical trials met inclusion criteria Author’s conclusions: The claim that 1. Fair
(1998)27 (n=338) (period 1966-1997) homeopathic arnica is efficacious beyond a 2. Fair
placebo effect is not supported by rigorous 3. Good
Potencies of arnica differed across the trials. Two clinical trials. 4. Fair
Arnica trials showed a statistically significant result in 5. Fair
favour of arnica (one delayed-onset muscle soreness Reviewer’s notes: more information on
and one prevention of post-operative individual study details would have been
complications). The remaining six trials did not welcome, particularly relating to results in
demonstrate statistically significant between group terms of actual numbers and p-values. Two
differences. of the included studies were of experimentally
induced trauma; possible problems of
Most of the trials had methodological problems, and generalisation to usual clinical practice. There
the higher quality studies tended to have negative is some overlap with two of the more general
findings. reviews.6, 16

Barnes Six controlled clinical trials met inclusion criteria Author’s conclusions: Homeopathic treatment 1. Fair
(1997)26 (n=1,076) (period ?-1996) administered immediately after abdominal 2. Fair
surgery may reduce the time to first flatus 3. Fair
Post- The pooled weighted mean difference (n=6) showed when compared with placebo. Analyses do 4. Fair
operative a reduction in the delay in restoration of intestinal not provide evidence for the use of a 5. Fair
ileus peristalsis, as measured by time to first flatus, with particular homeopathic remedy or for a
homeopathic treatment compared with placebo (- combination of remedies for postoperative
7.4 hours, 95% CI –4.0, -10.8 hours, p<0.05). ileus. Several drawbacks inherent in primary
studies and in the methodology of meta-
Sensitivity analysis of higher quality trials (n=4): analysis preclude a firm conclusion.
WMD –6.11 hours (95% CI –2.31, -9.91 hours,
p<0.05) Reviewer’s notes: overlap with some of the
more general reviews.6, 16, 17 More details on
The largest and most rigorous study showed no participants (age and surgery type) would
statistically significant differences between groups. have been useful. Test for heterogeneity not
reported.

Ernst Eight trials met inclusion criteria (three randomised) Author’s conclusions: The published evidence 1. Fair
(1998)30 (n=311) (period 1966-1997) does not support the hypothesis that 2. Fair
homeopathic remedies are more effective 3. Fair
Delayed There was a high level of heterogeneity between than placebo in alleviating the symptoms of 4. Poor
onset muscle included studies, with regard to the type of DOMS. 5. Fair
soreness homeopathic remedy used, and the type of exercise
(DOMS) used to induce DOMS. Reviewer’s notes: There is some overlap with
the more general reviews.6,16 Since few details
Three RCTs all reported non-significant differences of the primary studies are presented, it is
between groups for all outcome measures. Results difficult to determine whether the authors’
from the non-randomised studies were inconsistent. conclusions follow from the evidence.
The three RCTs were rated as being of higher
methodological quality than the other studies

Jonas Six RCTs met inclusion criteria (n=392) Author’s conclusions: All studies were 1. Fair
(2000)31 (period 1966-1995) statistically but not clinically homogenous with 2. Good
regard to patient selection, treatment 3. Good
Rheumatic Three RCTs on RA were included (n=226), and one strategies, and outcomes. 4. Fair
disease each on OA (n=36), fibromyalgia (n=30), and 5. Poor
myalgia (n=60). Reviewer’s notes: This review is a subset of a
larger review.16 Some of this summary and
The pooled OR (6 RCTs) was 2.19 (95% CI: 1.55, assessment has been based on information
3.11). Pooled OR for five high quality trials was provided in the larger review. This paper
2.11 (95% CI: 1.32, 3.35). provided few details of the individual trials,
and the outcome measurements used were
not mentioned. Since clinically heterogeneous
data have been pooled, the results should be
interpreted with great caution.

6 EFFECTIVE HEALTH CARE Homeopathy VOLUME 7 NUMBER 3 2002


Table 3 (continued) Reviews with a specific scope

Author,year Results Authors’ conclusions & reviewer’s notes Quality assessment

Long Four RCTs met inclusion criteria (n=406) Author’s conclusions: The small number of 1. Fair
(2001)32 (period: up to 2000) RCTs conducted to date preclude firm 2. Good
conclusions as to the effectiveness of 3. Fair
OA All RCTs were judged as being of high combination homeopathic remedies for OA. 4. Fair
methodological quality, but none were free of flaws. The standardised treatments used in the trials 5. Fair
All recruited people with knee OA and assessed are unlikely to represent common
improvement in pain (duration range 2-5 weeks). homeopathic practice, where treatment tends
One RCT found a statistically significant difference to be individualised.
in favour of a homeopathic gel compared with an
NSAID gel. Another RCT, which also recruited Reviewer’s notes: The results of the review
people with hip OA, showed a statistically also preclude firm conclusions as findings
significant difference in favour of fenoprofen when were inconsistent across trials.
compared with homeopathy or placebo, with no
difference observed between homeopathy and
placebo. The other two trials did not show any
statistically significant differences between
homeopathy and control.

Ernst Four double-blind RCTs met inclusion criteria Author’s conclusions: These data do not 1. Fair
(1999)24 (n=284) (period 1966-1998) suggest that homeopathy is effective in the 2. Fair
prophylaxis of migraine or headache beyond 3. Fair
Headaches One RCT was of poor methodological quality, two a placebo effect. 4. Fair
and were intermediate, and one good. One RCT found 5. Fair
migraine statistically significant improvement in all outcomes Reviewer’s notes: Overlap with two of the
in favour of homeopathy. A second found no more general reviews.16, 18 The author’s
significant between-group differences in terms of conclusions follow on from the results but
frequency, intensity, or duration of attacks, nor should be viewed with caution because of the
analgesic consumption, although the neurologist’s small number of studies available and limited
assessment of attack frequency suggested a methodological quality of three out of the four
statistically significant difference in favour of studies.
homeopathy. Two trials did not find any statistically
significant differences between groups.

Linde Three placebo-controlled, double-blind RCTs met Author’s conclusions: There is not enough 1. Good
(2001)29 inclusion criteria (n=154) (period 1966?-1997). evidence to reliably assess the possible role of 2. Fair
homeopathy in asthma. As well as RCTs, 3. Good
Asthma RCTs used different homeopathic treatments which there is a need for observational data to 4. Fair
precluded quantitative pooling of results. document the different methods of 5. Fair
homeopathic prescribing and how patients
respond.
Treatments in the RCTs were unrepresentative of
common homeopathic practice. Reviewer’s notes: Cochrane review. Dates for
search strategy unclear. There is some
In one trial, severity of symptoms significantly overlap with one of the general reviews.16
lessened in the homeopathy group compared with
placebo. In another, lung function measures and
medication use showed improvement in the
homeopathy group compared to placebo (this trial
was of lowest methodological quality). The third trial
found improvement in both groups, but no
statistically significant difference between groups.

Vickers Seven RCTs met inclusion criteria; three prevention Author’s conclusions: Oscillococcinum 1. Good
(2001)28 (n=2,265) and four treatment (n=1,194) (period probably reduces the duration of illness in 2. Fair
1966-1999). patients presenting with influenza symptoms. 3. Good
Influenza Though promising, the data are not strong 4. Fair
Problems with methodological quality and quality of enough to make a general recommendation 5. Fair
reporting were found with the trials. to use oscillococcinum for first-line treatment
of influenza. Current evidence does not
support a preventive effect of homeopathy in
Prevention: heterogeneity was found between trials influenza.
(chi squared=6.5, p=0.01) for the occurrence of
influenza. There was no evidence that homeopathic
treatment can prevent influenza-like syndrome (RR Reviewer’s notes: Cochrane review
0.64, 95% CI 0.28, 1.43).

Treatment: oscillococcinum reduced length of


influenza illness by 0.26 days (95% CI 0.47, 0.05)
and increased the chance of a patient considering
treatment effective (RR 1.08, 95% CI 1.17, 1.00).

2002 VOLUME 7 NUMBER 3 EFFECTIVE HEALTH CARE Homeopathy 7


Arnica and reported that adverse events flatus occurs), the patient can
One review focused on the were equally distributed between begin a small intake of clear fluids,
effectiveness of homeopathic treatment groups.34 and can gradually build up to the
arnica.27 Findings did not indicate usual dietary and fluid intake.
A small and probably
that homeopathic arnica is any underpowered trial (n=23) of One review assessed the
more effective than placebo. Some bench-stepping provided no effectiveness of homeopathic
study details were lacking, information on study withdrawals, treatment versus placebo in
particularly with regard to results and reported no statistically resolving post-operative ileus, and
and methodological quality, and significant between-group included six trials (four were RCTs)
therefore it is difficult to assess the differences for severity and of patients undergoing abdominal
reliability of the evidence. duration of soreness.33 or gynaecological surgery.26 All
Eight placebo-controlled trials trials used fixed homeopathic
The surgical trials focused on preparations (as opposed to
(including four RCTs) were recovery after total abdominal
included. The conditions individualised prescription).
hysterectomy36 and saphenous Findings indicated that
represented included: DOMS, post- stripping (stripping of varicose
operative care, trauma, stroke, and homeopathic treatment
veins).37 administered immediately after
experimental bruising (bruising
deliberately induced in healthy abdominal surgery may reduce the
Patients booked for total time to first flatus when compared
volunteers under laboratory abdominal hysterectomy received
conditions). Two trials showed a with placebo. However, the
either arnica or identical placebo possibility of bias and
statistically significant result in pre-operatively and up to five days
favour of arnica when used to inappropriate pooling of data
post-operatively.36 This trial had a means that these findings should
treat DOMS and to prevent post- large proportion of withdrawals
operative complications. However, be treated with caution. In
(20/73 patients), and analyses were addition, the largest and most
the remaining six trials did not not conducted on an intention-to-
demonstrate statistically well-conducted study, as rated by
treat basis. No statistically the authors of the review, showed
significant between-group significant differences were found
differences.27 no difference between
between groups in terms of post- homeopathy and placebo. No
operative pain and other aspects of further RCTs were identified.
A further five RCTs concerning the post-operative recovery. This trial
use of homeopathic arnica were may have been too small to detect
identified.33-37 Three were the true treatment effect. Further Delayed-onset muscle soreness
concerned with DOMS,33-35 and two evidence is required before (DOMS)
with surgical patients.36, 37 drawing conclusions about the The effectiveness of homeopathy
In the trials of DOMS, role of homeopathic arnica in in reducing DOMS was assessed in
homeopathic arnica was compared patients undergoing total a review of eight trials, including
with placebo in reducing muscle abdominal hysterectomy. three RCTs.30 The results
soreness after long-distance suggested that homeopathic
33 In the other trial, 130 patients remedies were no more effective
running34, 35 and bench-stepping. undergoing saphenous stripping than placebo in alleviating DOMS.
For the studies of long-distance received pre- and post-operative
running, one trial was large doses of either arnica or identical Participants were healthy
(n=519) and of good placebo.37 No statistically volunteers who had undergone
methodological quality.34 The significant differences were found some form of exercise in order to
other was smaller (n=71 at start of between groups for the incidence induce DOMS. There was a high
trial - 25 withdrawals) and did not of post-operative haematomae level of heterogeneity between
conduct analysis on an intention- (swelling/bruising). included studies, in terms of the
to-treat basis (i.e. all participants homeopathic remedies, and the
are analysed according to the Post-operative ileus (bowel type of exercise used to induce
intervention to which they were muscle paralysis) DOMS. The three RCTs all
assigned, whether or not they reported non-significant
Post-operative ileus refers to differences between treatment
completed the trial).35 The smaller cessation of peristalsis (alternate
trial found a statistically significant groups, whilst results from the
waves of contraction and non-randomised studies were
difference in favour of arnica in relaxation of the gut, necessary for
terms of reduced muscle soreness inconsistent.30
digestion) due to paralysis of the
immediately after the run, but not bowel muscle following surgery or A further three RCTs concerning
during the subsequent three-day trauma to the bowel. Normal the homeopathic management of
follow-up. No adverse events were bowel action is usually restored DOMS were identified and have
reported.35 The larger trial did not within the first few post-operative been discussed above in the
find statistically significant days, but during this time the section on homeopathic arnica.33-35
between-group differences for patient cannot eat or drink. Once
severity and duration of soreness, bowel sounds are observed (or first

8 EFFECTIVE HEALTH CARE Homeopathy VOLUME 7 NUMBER 3 2002


Arthritis and other not effective. Four trials of prevention and four treatment
musculoskeletal disorders classical homeopathy versus RCTs were included. Findings
placebo were included. One trial of indicated that oscillococcinum
Two reviews were identified.31,32
poor methodological quality found may reduce the duration of
One examined the effectiveness of
a statistically significant influenza by 0.26 days (95%
homeopathy in people with
improvement in all outcomes in CI 0.47, 0.05), but there was
rheumatoid arthritis, osteoarthritis,
favour of homeopathy, whereas insufficient evidence to suggest a
and other types of musculoskeletal
the trials of better quality all preventive effect. One trial
disorders.31 The review included
reported no statistically significant reported a higher rate of adverse
six placebo-controlled RCTs. Three
differences between groups.24 events in the homeopathy group
recruited patients with rheumatoid
(most frequent symptoms were
arthritis, and one trial each No new RCTs were identified. aching muscles and fever).
covered osteoarthritis, myalgia However, follow-up data were Problems with methodological
(muscle pain), and fibrositis (pain, identified for one trial rated in the quality and reporting were noted
muscular stiffness and review as having good in all the trials. No further RCTs
inflammation affecting the soft methodological quality.39 At one were identified concerning the use
tissues of the arms, legs, and year, between-group differences of homeopathic oscillococcinum,
trunk). Most of the trials were for headache frequency, duration or any other homeopathic
rated by the review’s authors as and intensity remained statistically preparation, in preventing or
being of high methodological non-significant.25 treating influenza.
quality. Although the overall
pooled estimate indicated that
homeopathy was superior to Asthma Induction of labour
placebo, the data were clinically A well-conducted review assessed One systematic review assessing
heterogeneous. In addition, the the effectiveness of homeopathy in the role of homeopathy for the
outcome measurements used in treating stable chronic asthma or induction of labour was
the pooling were not defined, but, asthma-like symptoms.29 The identified.42 Only one RCT (n=40)
when referring to a related three included RCTs were of was identified, which compared
publication, it seems likely that variable methodological quality. homeopathic caulophyllum with
these were highly heterogeneous.16 Two showed results in favour of placebo. Although statistically
Therefore, the findings of this homeopathy (symptom significant differences were found
review should be treated with improvement, lung function between treatment groups, this
caution. improvement, and less use of trial may have been too small to
corticosteroids) and one found no detect the true treatment effect.
The second review focused more statistically significant differences This review has not been shown in
specifically on osteoarthritis and between groups. Table 3 as only one trial was
included four RCTs.32 Fixed, rather involved. No further RCTs were
than individualised, treatments Two additional RCTs were identified.
were used in all trials. Results identified.40, 41 Both trials recruited
between trials were inconsistent patients with chronic asthma
and the authors noted treated with corticosteroids for at Excluded meta-analyses and
methodological problems in all least five years prior to study entry systematic reviews
trials. This meant that firm and assessed changes in Two meta-analyses were identified
conclusions could not be drawn. respiratory function and which did not employ full
corticosteroid use. Neither study systematic review methods, and
One additional RCT was detected statistically significant for this reason were not included
identified.38 Patients with between-group differences for in the above review of systematic
gonarthrosis (joint disease) change in respiratory function. reviews.43, 44
received either Zeel compound However, one study showed
tablets (a preparation containing results in favour of homeopathy Details of reviews that failed to
several homeopathic remedies) or for a reduction in the daily dose of meet the inclusion criteria (see
diclofenac (a non-steroidal anti- corticosteroids and number of appendix) are available on request.
inflammatory drug). No infections.41 Results from both
statistically significant between- studies should be interpreted with Overlap between reviews
group differences were observed in caution due to lack of details on
pain, stiffness, functional ability, or patient and intervention Varying degrees of overlap have
global symptoms. characteristics, and been noted in terms of the primary
methodological problems. studies included in the different
systematic reviews on
Headaches/migraine
homeopathy. In particular, both
One systematic review focused on Influenza reviews on classical
the effectiveness of homeopathy A good quality systematic review homeopathy18, 19 and most of the
as a prophylactic agent for assessed the use of homeopathic reviews with a more specific focus
headaches and migraine.24 Results oscillococcinum in preventing and have some degree of overlap with
suggested that homeopathy was treating influenza.28 Three the two larger general reviews.6, 16

2002 VOLUME 7 NUMBER 3 EFFECTIVE HEALTH CARE Homeopathy 9


E. Implications from Current Contents Clinical
Medicine, MEDLINE, CINAHL,
outcomes (e.g. if they reported
results of laboratory tests only), if
PsycINFO, ERIC, BIOSIS Previews they were ultimately available
■ The evidence base for
and AMED) were searched. This only as an abstract, or if they had
homeopathy needs to be
was supplemented by searches of already been included in one of
interpreted with caution. Many
EMBASE (1980 onwards), AMED the systematic reviews.
of the areas that have been
(1999 and 2000) and MANTIS
researched are not
(1880 onwards). In order to Methods
representative of the conditions
update evidence in areas covered
that homeopathic practitioners Titles and abstracts were examined
by systematic reviews with a
usually treat. Additionally, all for relevance by two independent
specific clinical focus, further
conclusions about effectiveness reviewers. Full papers were
literature searches were
should be considered together examined by two reviewers.
undertaken to identify recent
with the methodological Data extraction and assessment of
primary studies. The databases
inadequacies of the primary methodological quality were
searched were: Cochrane
studies and some of the undertaken by one reviewer and
Controlled Trials Register
systematic reviews. checked by a second reviewer.
(Cochrane Library 2001 issue 1);
MEDLINE (1995 to December All disagreements were resolved
■ Common problems with the by discussion. Data were
methodological quality of the 2000); EMBASE (1995 to Feb
2001); AMED (1995 to Dec 2000); synthesised narratively.
primary studies included under-
powered studies, failure to MANTIS (1995 to April 2000);
Data extraction and
analyse by intention-to-treat, CISCOM (1995 to April 2001) and
methodological assessment of
and failure to use allocation HOM-INFORM (The British
systematic reviews is shown in
concealment (process used to Homeopathic Library’s database)
Tables 1-3. Details of data
prevent investigators having (1911 onwards). In addition,
extraction and methodological
prior knowledge of group several researchers were contacted
assessment for trials is available
assignment in an RCT). The and asked to provide their up-to-
from
main problem with some of the date lists of RCTs of homeopathy,
http://www.york.ac.uk/inst/crd/.
systematic reviews was the the SIGLE database was searched
pooling of clinically and the bibliographies of retrieved
heterogeneous data. reviews and trials were examined.

■ There are currently insufficient


No language restrictions were
applied to the search strategy. References
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Amsterdam. Amsterdam: 2000.

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2002 VOLUME 7 NUMBER 3 EFFECTIVE HEALTH CARE Homeopathy 11


Acknowledgements ■ Klaus Linde, Technische

Effective Effective Health Care would like to


acknowledge the helpful
Universität, München
■ David Reilly, Glasgow
Health Care assistance of the following, who
commented on the text:
Homeopathic Hospital
■ Janet Richardson, University of
■ Yemi Atiku, Department of Westminster
This bulletin is based on an Health ■ Anne-Toni Rodgers, National
overview of systematic reviews ■ Mark Baker, Yorkshire Cancer Institute for Clinical Excellence
conducted by Susan O'Meara, Network
Paul Wilson, Chris Bridle, ■ Kate Thomas, University of
■ Edzard Ernst, University of Sheffield
Jos Kleijnen and Kath Wright at
the NHS Centre for Reviews and Exeter
■ Erica Warren, Bradford HA
Dissemination, University of York. ■ Alison Evans, University of Leeds
■ Peter Fisher, Royal London ■ Colin Waine, Sunderland HA
Homoeopathic Hospital ■ Adrian White, University of
The bulletin was written and
produced by staff at the NHS ■ Sheila Gibson, Glasgow Exeter
Centre for Reviews and Homeopathic Hospital ■ Andrew Vickers, Memorial
Dissemination, University of York. ■ Mike Lavender, Sloan-Kettering Cancer Center,
Northumberland HA New York

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