Peter Fisher, Alison Greenwood, E C Huskisson,Paul Turner, Philippe Belon
In scientific research negative results are often more difficult to interpret than positive ones, as was shown by a clinical trial in which the homoeopathic medicine
Rhus toxicodendron 6x was compared with a placebo and fenoprofen in the treatment of osteoarthritis. The homoeopathic medicine was found to be ineffective whereas fenoprofen gave an improvement.' There were two interpretations: either the effects of homoeopathy are only a placebo effect-that is, a true negative -or the result was a false negative one because of flaws in the design. Another trial had previously
suggested that homoeopathy was effective in rheumatoid arthritis.
We designed a trial to clarify these results by overcoming the methodological criticisms while retaining a rigorous design. The main problem in designing
clinical trials of homoeopathy is that prescriptions are based on criteria such as the pattern of symptoms as well as the diagnosis. A clinical trial based solely on
diagnosis is therefore inappropriate. In a pilot study we had shown that Rhus toxicodenidron 6c was the most commonly indicated homoeopathic medicine for
fibrositis in our patients, being indicated in 42%.
Patients, methods, and results
We used the diagnostic criteria of Yunus et al for
fibrositis.' Only patients with this syndrome, in whom the homoeopathic medicine Rhus toxicodendron 6c was positively indicated were entered into the study.
Thirty patients meeting the admission criteria were recruited in the rheumatology clinic of this hospital.
The clinical characteristics of the patients were similar to those of other reported series regarding age, sex distribution, duration of symptoms, modalities, and
number of tender points. The trial was double blind, placebo controlled, and of crossover design.
After entry there was no further contact between the homoeopathic doctor and the patient until the treatment was finished. The clinical metrologist dispensed
the treatment and performed the assessments and analyses blind. Patients received active treatment and an identical placebo for one month each in random sequence. The dose was two tablets sucked three times daily.
The active preparation was R 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 lactose tablets (2% volume per weight). Preparation was as specified in the French national pharmacopoeia. The placebo was identical lactose tablets to which only pharmaceutical ethanol had been added (2% volume per weight). Blind testing of the active and placebo preparations for a battery of drugs yielded negative results. Assessment comprised the number of tender spots, 10 cm visual analogue scales of pain and sleep, and overall assessment.
Comparison was made between values at the end of active and placebo treatment periods.
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). We reduced subjective data to nominal measurements (worse or better). If the null hypothesis were correct the direction of change after placebo and active treatment would be randomly distributed.
Analysis showed a significant difference in favour of the homoeopathic medicine (table). Overall assessment also showed a preference for the active treatment,
which was not significant. BMJ VOLUME 299 5 AUGUST 1989 365
Assessment of patients with fibrositis after treatment with Rhus toxicodendron (ac-tive) and placebo
Placebo Active p Value
Mean No of tender points 14-1 10-6 <0.005*
No of patients with improved pain
or sleep (visual analogue scores) 27 53 0-0052t
*Wilcoxon rank sum test. tPaircd t test.
Fibrositis (primary fibromyalgia) is a controversial condition but is becoming increasingly accepted.4 It is difficult to treat. We showed that the homoeopathic
medicine R toxicodendron 6c was effective for a selected subgroup of patients with fibrositis. The improvement in tenderness, which is the best discriminator of
fibrositis,5 was particularly distinct. The improvement experienced by our patients while receiving active treatment was at least as great as that reported for any
other treatment that has been assessed double blind.
We thank Jean Boiron for his advice and encouragement.
I Shipley M, Berry H, Brostcr G, Jeilkinis M, Closer A, Williams 1. Conitrolled
trial ott homoeopathic treatment of osteoarthritis. Lancet 1983;i:97-8.
2 Gibsott RU, Gibson SLMNI, MacNeill DA, Watson-Buchanan W. Homoeopathic
therapy in rhettmatoid arthritis: evalitation by double-blind clinical trial.
Br] Clin Phtarmacol 1980;9:453-9.
3 Yttnus M, Alasi AT, Calabro JJ, et al. IPrimary fibromyalgia (fibrositis): clinical
study of 50 paticnts with matched normal controls. Semin Arthritis Rthe2m
4 Yunus MB. Fibromyalgia syndrome: new research on an old condition.
Br Medj 1989;289:474-5.
S Wolfe F, Hawley DJ, Cathey MA, et a/. Fibrositis: symptom frequency and
criteria for diagnosis.]7 Rheumatol 1985;12:1159-68.
(Accepted 28 April 1989)