Br. J. clin. Pharmac. (1990), 30
Personal view
173
Is homoeopathy a placebo? In 1985, 14% of the readers of a British consumer magazine had sought complementary treatment. Most had been treated previously by their GPs but were dissatisfied with the results. Eighty-two % of the patients treated by complementary methods claimed to have been cured by these (Anonymous, 1986). Feeling the pressure from patients, doctors in Britain and elsewhere are growing more interested in complementary medicine, particularly homoeopathy, yet know little about it (Wharton & Lewith, 1986). The general consensus for orthodox doctors (like myself) used to be that it equals a placebo, not harmful unless it prevents some form of effective treatment to take place. It might be time to reconsider this attitude in the light of recent placebo-controlled, double-blind trials in humans, published in non-homoeopathic journals of the highest reputation and executed, at least in part, by non-homoeopathic doctors. On the basis of positive preliminary results, Gibson and co-workers (1978) compared two groups of out-patients suffering from rheumatoid arthritis (Gibson et al., 1980). The patients were allocated to two groups of 23 each, according to whether they showed typical homoeopathic prescriptible conditions or not. One group re-
ceived non-steroidal anti-inflammatory drugs plus various homoeopathic remedies in keeping with classic homoeopathic prescribing techniques. The other group got exactly the same medications but was administered placebo in addition. The conventional drugs were kept unaltered during the 3 months' trial period. Double-blind standards were followed by involving three doctors who were fully blinded. Nineteen patients improved subjectively on homoeopathic remedies and only five on placebo. Objective variables, such as articular index, grip strength, etc. improved significantly only in the homoeopathic group. There were no changes in blood tests in either group. This trial has several pitfalls: patient matching was not ideal, the dilutions of the homoeopathic remedies are not given, there was no randomization and not one, but several homoeopathic drugs were tested. In 1986, a Scottish group conducted a randomized placebo-controlled, double-blind trial on 144 patients with acute hay-fever (Reilly et al., 1986). The homoeopathically treated group fared significantly better in terms of patient or doctor assessed symptoms. The response to the homoeopathic preparation, a 30c potency of mixed grass pollen, was associated with halving
of the need for antihistamines. The authors diluted the preparation to a point where theoretically none of the original material should have remained in the medication. A French group published results on homoeopathic treatment of influenza-like symptoms (Ferley et al., 1989). In this multicentre, placebocontrolled trial, patients were randomized to receive placebo or anas barbariae hepatis plus cordis extractum C200 for 3 days. In both groups, additional orthodox drugs were allowed. The 48 h recovery rate (fall in body temperature and resolution of symptoms) was 17% in the homoeopathic and 10% in the placebo group (P = 0.03). The main criticism of this study is that influenza was not diagnosed with objective tests. Fisher et al. (1989a) admitted 30 patients with fibrositis who, from a homoeopathic point of view should receive Rhus toxicodendron C6, to a double-blind, placebo-controlled, cross-over trial. Each treatment phase lasted 1 month. The homoeopathic treatment reduced the number of tender spots significantly, while placebo did not bring about any changes. The same applied for more subjective symptoms. The authors conclude that this homoeopathic remedy is at least as effective as any other known treatment for fibrositis. This paper prompted several comments. It was criticised because its cross-over design may have introduced carryover effects which could have clouded the outcome and because the homoeopathic preparation was said to be inadequately standardized (Berry, 1989; Davies & Davey, 1989). Others speculated that the blindness had been inadvertently breeched (Wall, 1989). Yet, in their reply (Fisher et al., 1989b), the authors convincingly refute all these possibilities. While the above studies imply that homoeopathy can work, this notion is apparently opposed by a double-blind, placebo-controlled, cross-over trial with patients suffering from osteoarthritis (Shipley et al., 1983). Only patients were included who, from the homoeopathic point of view, should have received Rhus toxicodendron. The medication was given in random order vs placebo and fenprofen. Only the latter was effective, while there were no differences between placebo and the homoeopathic remedy. One might, however, argue that a treatment period of 2 weeks is too short to give a result in a chronic disease like osteoarthritis. In summary, the above data imply that
174
Personal view
homoeopathy works for certain conditions and is ineffective in others. There are however, at least two points of concern. Firstly, none of the 'positive' studies is faultless, thus there is a need for controlled trials with flawless designs. Secondly, we have no clue as to how homoeopathy might work. This issue was discussed extensively following the 'Benveniste affair' (Anonymous, 1988; Davenas etal., 1988; Fisher, 1988). Nevertheless it seems slightly absurd to exclude homoeopathy from clinical investigations just because we are not aware of a definite rationale. There are enough examples for orthodox treatments being applied without full understanding
of all operative mechanisms. The opposite conclusion would be more appropriatehomoeopathy needs to be tested much more thoroughly with the highest degree of scrutiny. Maybe one day then will we be able to solve the homoeopathy-orthodox controversy. E. ERNST
Department of Physical Medicine and Rehabilitation, University of Vienna-A. K. H. 1090 Vienna, Austria (Received 12 January 1990, accepted 2 April 1990)
References Anonymous (1986). Magic or Medicine? Which Magazine, October issue, 443445. Anonymous (1988). When to believe the unbelievable. Nature, 334, 787. Berry, H. (1989). Homoeopathic treatment and fibrositis. Br. med. J., 299, 858. Davenas, E., Beauvais, F., Amara, J., Oberbaum, M., Robinzon, B., Miadonna, A., Tedeschi, A., Pomeranz, B., Fortner, P. & Belon, P. (1988). Human basophil degranulation triggered by very dilute antiserum against IgE. Nature, 333, 816-818. Davies, A. E. & Davey, R. W. (1989). Effect of homoeopathic treatment on fibrositis. Br. med. J., 299, 918. Ferley, J. P., Zmirou, D., D'Adhemar, D. & Balducci, F. (1989). A controlled evaluation of a homoeopathic preparation in the treatment of influenzalike syndromes. Br. J. clin. Pharmac., 27,335-339. Fisher, P. (1988). Orthodoxy and homoeopathy. Nature, 335, 292. Fisher, P., Greenwood, A., Huskisson, E. C., Turner, P. & Belon, P. (1989a). Effect of homoeopathic treatment on fibrositis (primary fibromyalgia). Br. med. J., 299, 365-366. Fisher, P., Huskisson, E. C., Turner, P. & Belon, P. (1989b). Complementary medicine. Br. med. J., 299, 1401-1402.
Gibson, R. E. G., Gibson, S. L. M., MacNeill, A. D., Gray, G. H., Carson Dick, W. & WatsonBuchanan, W. (1978). Salicylates and homoeopathy in rheumatoid arthritis, preliminary observations. Br. J. clin. Pharmac., 6, 391-395. Gibson, R. E. G., Gibson, S. L. M., MacNeill, A. D. & Buchanan, W. W. (1980). Homoeopathic therapy in rheumatoid arthritis: evaluation by double-blind clinical therapeutic trial. Br. J. clin. Pharmac., 9, 453-459. Reilly, D. T., Taylor, M. A., McSharry, Ch. & Aitchinson, T. (1986). Is homoeopathy a placebo response? Controlled trial of homoeopathic potency, with pollen in hay fever as model. Lancet, ii, 881886. Shipley, M., Berry, H., Broster, G., Jenkins, M., Clover, A. & Williams, J. (1983). Controlled trial of homoeopathic treatment of osteoarthritis. Lancet, i, 97-98. Wall, P. D. (1989). Complementary medicine. Br. med. J., 299, 1401. Wharton, R. & Lewith, G. (1986). Complementary medicine and the General Practitioner. Br. med. J., 292, 1498-1500.
Personal view
173
Is homoeopathy a placebo? In 1985, 14% of the readers of a British consumer magazine had sought complementary treatment. Most had been treated previously by their GPs but were dissatisfied with the results. Eighty-two % of the patients treated by complementary methods claimed to have been cured by these (Anonymous, 1986). Feeling the pressure from patients, doctors in Britain and elsewhere are growing more interested in complementary medicine, particularly homoeopathy, yet know little about it (Wharton & Lewith, 1986). The general consensus for orthodox doctors (like myself) used to be that it equals a placebo, not harmful unless it prevents some form of effective treatment to take place. It might be time to reconsider this attitude in the light of recent placebo-controlled, double-blind trials in humans, published in non-homoeopathic journals of the highest reputation and executed, at least in part, by non-homoeopathic doctors. On the basis of positive preliminary results, Gibson and co-workers (1978) compared two groups of out-patients suffering from rheumatoid arthritis (Gibson et al., 1980). The patients were allocated to two groups of 23 each, according to whether they showed typical homoeopathic prescriptible conditions or not. One group re-
ceived non-steroidal anti-inflammatory drugs plus various homoeopathic remedies in keeping with classic homoeopathic prescribing techniques. The other group got exactly the same medications but was administered placebo in addition. The conventional drugs were kept unaltered during the 3 months' trial period. Double-blind standards were followed by involving three doctors who were fully blinded. Nineteen patients improved subjectively on homoeopathic remedies and only five on placebo. Objective variables, such as articular index, grip strength, etc. improved significantly only in the homoeopathic group. There were no changes in blood tests in either group. This trial has several pitfalls: patient matching was not ideal, the dilutions of the homoeopathic remedies are not given, there was no randomization and not one, but several homoeopathic drugs were tested. In 1986, a Scottish group conducted a randomized placebo-controlled, double-blind trial on 144 patients with acute hay-fever (Reilly et al., 1986). The homoeopathically treated group fared significantly better in terms of patient or doctor assessed symptoms. The response to the homoeopathic preparation, a 30c potency of mixed grass pollen, was associated with halving
of the need for antihistamines. The authors diluted the preparation to a point where theoretically none of the original material should have remained in the medication. A French group published results on homoeopathic treatment of influenza-like symptoms (Ferley et al., 1989). In this multicentre, placebocontrolled trial, patients were randomized to receive placebo or anas barbariae hepatis plus cordis extractum C200 for 3 days. In both groups, additional orthodox drugs were allowed. The 48 h recovery rate (fall in body temperature and resolution of symptoms) was 17% in the homoeopathic and 10% in the placebo group (P = 0.03). The main criticism of this study is that influenza was not diagnosed with objective tests. Fisher et al. (1989a) admitted 30 patients with fibrositis who, from a homoeopathic point of view should receive Rhus toxicodendron C6, to a double-blind, placebo-controlled, cross-over trial. Each treatment phase lasted 1 month. The homoeopathic treatment reduced the number of tender spots significantly, while placebo did not bring about any changes. The same applied for more subjective symptoms. The authors conclude that this homoeopathic remedy is at least as effective as any other known treatment for fibrositis. This paper prompted several comments. It was criticised because its cross-over design may have introduced carryover effects which could have clouded the outcome and because the homoeopathic preparation was said to be inadequately standardized (Berry, 1989; Davies & Davey, 1989). Others speculated that the blindness had been inadvertently breeched (Wall, 1989). Yet, in their reply (Fisher et al., 1989b), the authors convincingly refute all these possibilities. While the above studies imply that homoeopathy can work, this notion is apparently opposed by a double-blind, placebo-controlled, cross-over trial with patients suffering from osteoarthritis (Shipley et al., 1983). Only patients were included who, from the homoeopathic point of view, should have received Rhus toxicodendron. The medication was given in random order vs placebo and fenprofen. Only the latter was effective, while there were no differences between placebo and the homoeopathic remedy. One might, however, argue that a treatment period of 2 weeks is too short to give a result in a chronic disease like osteoarthritis. In summary, the above data imply that
174
Personal view
homoeopathy works for certain conditions and is ineffective in others. There are however, at least two points of concern. Firstly, none of the 'positive' studies is faultless, thus there is a need for controlled trials with flawless designs. Secondly, we have no clue as to how homoeopathy might work. This issue was discussed extensively following the 'Benveniste affair' (Anonymous, 1988; Davenas etal., 1988; Fisher, 1988). Nevertheless it seems slightly absurd to exclude homoeopathy from clinical investigations just because we are not aware of a definite rationale. There are enough examples for orthodox treatments being applied without full understanding
of all operative mechanisms. The opposite conclusion would be more appropriatehomoeopathy needs to be tested much more thoroughly with the highest degree of scrutiny. Maybe one day then will we be able to solve the homoeopathy-orthodox controversy. E. ERNST
Department of Physical Medicine and Rehabilitation, University of Vienna-A. K. H. 1090 Vienna, Austria (Received 12 January 1990, accepted 2 April 1990)
References Anonymous (1986). Magic or Medicine? Which Magazine, October issue, 443445. Anonymous (1988). When to believe the unbelievable. Nature, 334, 787. Berry, H. (1989). Homoeopathic treatment and fibrositis. Br. med. J., 299, 858. Davenas, E., Beauvais, F., Amara, J., Oberbaum, M., Robinzon, B., Miadonna, A., Tedeschi, A., Pomeranz, B., Fortner, P. & Belon, P. (1988). Human basophil degranulation triggered by very dilute antiserum against IgE. Nature, 333, 816-818. Davies, A. E. & Davey, R. W. (1989). Effect of homoeopathic treatment on fibrositis. Br. med. J., 299, 918. Ferley, J. P., Zmirou, D., D'Adhemar, D. & Balducci, F. (1989). A controlled evaluation of a homoeopathic preparation in the treatment of influenzalike syndromes. Br. J. clin. Pharmac., 27,335-339. Fisher, P. (1988). Orthodoxy and homoeopathy. Nature, 335, 292. Fisher, P., Greenwood, A., Huskisson, E. C., Turner, P. & Belon, P. (1989a). Effect of homoeopathic treatment on fibrositis (primary fibromyalgia). Br. med. J., 299, 365-366. Fisher, P., Huskisson, E. C., Turner, P. & Belon, P. (1989b). Complementary medicine. Br. med. J., 299, 1401-1402.
Gibson, R. E. G., Gibson, S. L. M., MacNeill, A. D., Gray, G. H., Carson Dick, W. & WatsonBuchanan, W. (1978). Salicylates and homoeopathy in rheumatoid arthritis, preliminary observations. Br. J. clin. Pharmac., 6, 391-395. Gibson, R. E. G., Gibson, S. L. M., MacNeill, A. D. & Buchanan, W. W. (1980). Homoeopathic therapy in rheumatoid arthritis: evaluation by double-blind clinical therapeutic trial. Br. J. clin. Pharmac., 9, 453-459. Reilly, D. T., Taylor, M. A., McSharry, Ch. & Aitchinson, T. (1986). Is homoeopathy a placebo response? Controlled trial of homoeopathic potency, with pollen in hay fever as model. Lancet, ii, 881886. Shipley, M., Berry, H., Broster, G., Jenkins, M., Clover, A. & Williams, J. (1983). Controlled trial of homoeopathic treatment of osteoarthritis. Lancet, i, 97-98. Wall, P. D. (1989). Complementary medicine. Br. med. J., 299, 1401. Wharton, R. & Lewith, G. (1986). Complementary medicine and the General Practitioner. Br. med. J., 292, 1498-1500.
