Ralf Jeutter Ph.D. RSHom

"The truth is incontrovertible; malice may attack it, ignorance my deride it, but in the end, there it is."
Winston Churchill

Evidence and Homeopathy

Evidence and Homeopathy have become hotly contested issues in recent times. Modern science, and in particular, Evidence Based Medicine demands clear proof of the efficacy for any therapy used in a medical context. Homeopathy has never shied away from being measured by the latest developments in medicine. What is presented here is a brief overview over the currently available evidence. The evidence is not always pro homeopathy. One could cite various reasons for the failures showing the efficacy of homeopathy, but equally one could point out certain flaws concerning the evidence pro homeopathy. Therefore, it seems wise to me to take the accumulative effect of the available evidence, which points clearly to an efficacy beyond the placebo effect (the main criticism levelled against homeopathy by its staunchest critics). To reduce the available evidence to the placebo effect seems to me to be driven by an irrational determination to ignore the uncomfortable fact that homeopathy poses questions which modern science cannot yet fully answer.

There are basically six kinds of evidence available when it comes to homeopathy:

  • Modern trials: randomised double-blind, placebo controlled
  • Homeopathy in epidemics
  • Cohort studies (prophylaxis and treatment)
  • Outcome studies
  • Cost-effectiveness studies
  • Evidence of ultra dilutions
  • Modern trials:

In a literature review from 2005 van Wassenhoven counted 475 clinical and laboratory trials testing the efficacy of homeopathy.

In the light of clinical studies, a team of German and American physicians and scientists published in The Lanceta review of 89 clinical studies (Linde, 1997). They found that on average those patients given a homeopathic medicine were 2.45 times more likely to experience a positive result than those given a placebo. This review of research evaluated various experiments that tested the efficacy of homeopathic remedies in the treatment of hay fever, asthma, migraine headache, ear infection, upper respiratory infection, rheumatoid arthritis, diarrhoea, indigestion, influenza, childbirth, post-surgical complications, varicose veins, sprains and strains, amongst many others.

Even a sceptic of homeopathy who responded in The Lancetto this research admitted that this review of research was "completely state of the art."

A study of clinical trials of homeopathy by Kleijnen et al. (BMJ 1991; 302:316-323) concluded: ‘Overall, of the 105 trials with interpretable results, 81 trials (77%) indicated positive results.’ They also stated: ‘At the moment the evidence of clinical trials is positive but not sufficient to draw definite conclusions.’ David Taylor et al. wrote in the Lancet in 1994 (ii:1601-1606): ‘Our results lead us to conclude that homeopathy differs from placebo in an inexplicable but reproducible way.’ In a study in the Lancet (1986; ii:881-886), the same author writes: ‘No evidence emerged to support the idea that placebo action fully explains the clinical responses to homeopathic drugs.’ In another study (a meta-analysis of placebo controlled trials), again published in the Lancet (1997;ii:834-843) the author Klaus Linde states: ‘The results of our meta-analysis are not compatible with the hypothesis that the clinical effects of homeopathy are completely due to the placebo effect.’ They also state that no definite evidence is available for the efficacy of homeopathy in individual disease conditions. For homeopaths this is a sore point, which needs more investigation, esp. when it comes to the design of studies trying to show the efficacy of homeopathy. Erudite arguments have been put forward, which try to explain away this particular lack of evidence. From a homeopathic point of view, it is certainly understandable why some trails will inevitably show negative results due to the fact that they simply do not take into consideration how homeopathy works in practice. On the other hand, a medical discipline, which sees itself as part of modern scientific medicine, cannot hide behind philosophical excuses. The following trial shows that homeopathy can be tested under stringent conditions without losing its peculiar character:

In 2005 Dr Heiner Frei published a double-blind, randomised, placebo-controlled trial regarding the treatment of children suffering from ADHD (Attention Deficit Hyperactivity Disorder). This was carried out together with the medical faculty at the University of Bern. Even critics of homeopathy acknowledge that the design of the study cannot be faulted. Here is concise summary of the study:

  • Summary of ADD/ADHD trial in Switzerland

1. Trial design:

In the first phase all children received individual homeopathic treatment (screening phase). Those who experienced a (pre-defined) amelioration of their symptoms could take part in the randomised, placebo-controlled, double-blind cross-over study.

There were two arms to the double-blind part of the study:

a) Children received verum for 6 weeks, followed by placebo for 6 weeks

b) Children received placebo for 6 weeks, then verum for 6 weeks.

After that both groups received verum for another 6 weeks (not blind)

a) VPV

b) PVV

2. Criteria for including participants:

Children in the age range between 6 and 16, where ADD/ADHD was confirmed according to DSM-IV criteria and the necessity to treat.

Absence of any other chronic physical, neurological or mental diseases.

Children were examined in the Department of neurology and neuro-psychology at the university clinic Bern (Switzerland) in order to confirm diagnosis of ADD/ADHD.

In order to take part in the double-blind trial the children had to achieve an improvement of the initial CGI (Connors Global Index) of at least 50% in the screening phase.

3. Therapeutic intervention:

Screening-phase: Each child received individual homeopathic treatment according to the guidelines of Hahnemann and Boenninghausen with daily Q-potencies. Once the right remedy was found the child was transferred to the university clinic for the cross-over phase of the trial.

4. Results:

Total amount of children: 140.

Of those 83 entered the screening-phase.

70 achieved the criteria for inclusion in the cross-over study. 62 took part in this.

Children had an average CGI score of 19 (range 15-25), after screening phase the average score was 8 (range 4-15). The average time to reach this score was 5.1 months.

The following remedies were used in potencies of Q3 to Q42 (the Q potencies were used in steps of three, e.g. Q3, Q9, Q12, Q15, etc.), frequency is given in brackets.

Calc Carb (15); Sulfur (8), Chamomilla (5); Lycopodium (5); Silica (5); Hepar Sulph. (4); Nux Vom (4); China (3); Ignatia (3); Merc Sol (3); Capsicum (1); Caust. (1); Hyos. (1); Phos (1); Phos.ac. (1); Sepia (1); Staph. (1).

During screening phase highly significant improvements could be seen in the ability to recognise visual details; to divide attention and in impulsivity. At beginning of cross-over phase CGI score: 8

Cross-over phase 1: After 6 weeks CGI score for arm a) 12 (verum), for arm b) 13 (placebo)

End of cross-over phase 2: a) CGI 12 (placebo), b) CGI 9 (verum).

After further 6 weeks of open treatment with verum, both CGI scores went down to the score before cross-over phase started: 8.

After 14 weeks of treatment (verum) the Connors Parents’ Rating Scale (CPRS) still showed significant improvement: CGI 10 ( a little higher than after cross-over phase, possibly due to reduced compliance with the treatment).

After 19 months of open treatment (verum): CGI score 7.

Critical Lancet study

In 2005 the Lancet (2005; ii; 690) published a study proclaiming the ‘end of homeopathy’. It was a meta-analysis purporting to show that homeopathy has no effect beyond the placebo effect. The study had a damaging impact (for homeopathy) on the policies of Primary Care Trusts, and has slowed down the use of homeopathy within the NHS. This is despite the fact that the study can only be described as a shambles and flawed and biased. The authors did not even follow the guidelines for meta-analyses as laid down by the Lancet(by, for example never publicising the trials which were used for the meta-analysis), and the Lancet did not interfere. In scientific circles the study is discredited.

For a critique of the study, see:

  • HOMEOPATHY AND THELANCET: THE HIDDEN FACTS

The homeopathic community has raised a strong international protest against prejudice and manipulation in scientific research. This was caused by a recent, controversial publication in the renowned medical journal TheLancet. The outspoken conclusion in the editorial was that homeopathy is no more than placebo and that doctors need to be bold and honest with their patients about homeopathy’s lack of benefit.

The conclusion of this extremely dubious research study is based on only eight, anonymous, clinical trials. Out of 110 homeopathy trials that met their inclusion criteria, matched with 110 conventional medical trials, the authors identified 21 homeopathy trials and 8 allopathy trials that are of higher standard according to their own set criteria. They then proceeded to further select a ridiculously small subset of trials of purportedly larger and higher methodological quality (8 homeopathy trials and 6 conventional medicine trials), from which the paper's main conclusion is drawn, i.e. that the clinical effects of homeopathy, but not those of conventional medicine, are unspecific placebo or context effects. They do not present a comparative analysis of this subset of trials. The reader cannot verify which studies were classified as methodically high quality, which interventions were examined or what results the individual studies had. As a matter of fact, the study is a black box with complete opacity.

Although no one exactly knows which 8 larger studies were used for the article’s conclusion, there are some hints. When searching in the list of references for the largest 8 studies of high methodological quality, the following picture emerges. Three studies deal with the prevention of flu (two of them were negative), two with the treatment of flu (both positive), one with the prevention of conjunctivitis (negative), one with the treatment of acute respiratory inflammations (positive) and one with the treatment of muscle soreness in long-distance runners (negative). These studies may have a high methodological quality, but their external validity, in other words their validity for actual homeopathic practice, may be poor. The larger numbers of the negative studies, however, have a decisive impact in the authors’ analysis.

Mikel Aickin, a biostatistician at the University of Arizona, maintains that there are several areas in which the Lancet article does not meet the minimum, conventional criteria for publication in biomedicine.

For example, the difference between the treatment effects in the two groups is 0.41 (SDE=0.249) with p=0.10, which by the conventional criteria is not statistically significant. In addition, the negative result is reported with a miniscule sample size, and no power computation at all. In his opinion the most serious problem with the article is how in the hands of the authors the meta-analysis as a tool – in principle a precise and useful form to collect scattered literature into one place, to apply uniform criteria for study selection and analysis, and to come to a conclusion about the best therapeutic approach – “has degraded into an unrecognizable hash, in which any papers on any topic can be bundled together in an investigation of questions of unlimited ambiguity.” His full, highly recommended article was published in the Journal of Alternative and Complementary Medicine.

In a letter to the Lancet editor, Dr Peter Fisher and 31 other signatories wrote: “Shang et al state that ‘eight trials of homeopathic remedies in acute infections of the upper respiratory tract …indicated a substantial beneficial effect…sensitivity analyses might suggest that there is robust evidence that the treatment under investigation works. However, the biases that are prevalent in these publications, as shown by our study, might promote the conclusion that the results cannot be trusted.’ They state that 8 studies is too few to question their conclusion about the whole set of publications. Their conclusion about the whole set, however, was also based on 8 studies. Is eight enough or not? The authors simply refuse to believe the results of positive clinical trials of homeopathy.”

Kate Chatfield (University of Central Lancashire) and Clare Relton (University of Sheffield) assert: “The authors display their own bias in interpretation when they dismiss out of hand the substantially beneficial pooled effect from 8 trials of homeopathic remedies in upper respiratory tract infections. This in spite of the fact that the trials perform well in the authors own set test of funnel plot asymmetry which demonstrated that there was no significant difference between effects in the higher quality trials and the lower quality trials. Here the authors speak of biases prevalent in these publications to excuse the effect without specifying in any way how they relate to these trials and indicate that conclusions from these trials cannot be trusted.”

Sceptic researchers such as Shang et al assume that the effects observed in placebo-controlled trials of homeopathy cannot but be explained by a combination of methodological deficiencies and biased reporting. They make the following extraordinary statement: “We assumed that the effects observed in placebo-controlled trials of homoeopathy could be explained by a combination of methodological deficiencies and biased reporting. Conversely, we postulated that the same biases could not explain the effects observed in comparable placebo-controlled trials of conventional medicine. Our results confirm these hypotheses.” These pre-assumptions exhibit extreme bias from the start of the study and are totally inappropriate in a study that sets out to objectively compare two different methodologies. Here alone the study fails by its own standards - not to mention by proper scientific standards.

  • SWISS EFFECTIVENESS STUDIES ALMOST SWEPT UNDER THE CARPET

The Lancet meta-analysis was a part of an exhaustive Swiss study (PEK) in which homeopathic treatment and other CAM therapies were compared with conventional treatment. The study showed that patients are more satisfied with the care provided in practices offering complementary medicine, that side effects are reported by markedly fewer patients than with conventional care, and that the total annual costs are markedly lower than the average for conventional care. Costs of homeopathic practice were about 50% of those of conventional practice. If all 269 homeopathic doctors who were involved in the project would practise conventional medicine, the annual costs would increase with 95-100 million Swiss Francs (€ 60-65 million). The study is accessible at the following website:

In spite of this positive outcome, the Swiss government decided to exclude all CAM therapies from the compulsory health insurance scheme as from 30 June 2005, much to the dissatisfaction of the CAM community (since 1999 they were reimbursed under the compulsory health insurance scheme for the purpose of the PEK study). The reason: there is no scientific evidence for the effectiveness of homeopathy. Especially the meta-analysis that was recently published in The Lancet was decisive.

A literature review, which was another part of the PEK study, came to a conclusion different from that of the meta-analysis, namely that there is sufficient evidence for its clinical effectiveness. The contradiction is based mainly on the fact that the predominantly positive results of the totality of the studies, which was also confirmed in the meta-analysis, was interpreted as reliable to a large extent in the literature review, but not in the meta-analysis. The PEK management asserted that ‘prejudices’ and methodical priorities had determined the conclusions to a large extent and that a lack of plausibility could not be considered as evidence of ineffectiveness, nor as a stringent criterion in evidence-based medicine.

The Swiss authorities – both the government and the National Health Office (BAG) – initially tried to sweep the results of the PEK study under the carpet. A conference scheduled for April 2005 to present and discuss the results of the PEK study had to be cancelled because the National Health Office suppressed the publication of the study data. Some collaborators were even coerced into deleting all PEK related data from their computers. A final meeting of the international Review Board of six professors from Switzerland, Germany, Denmark and the UK – responsible for the scientific quality of the PEK study – to be held in June 2005 for a final assessment of the project, was cancelled. The recommendation in the final draft that homeopathy, anthroposophical medicine and herbal medicine should stay in the compulsory health insurance scheme was deleted in the final publication. Later on the government allowed some reports to be put onto the BAG website and the data files to be available for perusal at the BAG office in Bern.

Unsurprisingly, the medical establishment was far from pleased with the results of the PEK study. Already at the end of 2004 at a conference of the SwissAcademy of Medical Science some professors of the medical university faculties agreed to do anything possible to prevent CAM from remaining available in the compulsory health insurance scheme (they would even “throw grenades”).