Rapid Responses to:
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Rapid Responses: Rapid Responses published:
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![[Read Rapid Response]](/icons/misc/sectionDOWN.gif)
Placebo group not unethical
- Lewis Mehl-Madrona (23 April 2000)
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St.John's Wort and common sense
- Joel Simon Hochman (25 April 2000)
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Herb Pharming
- T P L Watts (26 April 2000)
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The use of medicinal herbs is not "complementary medicine"
- Peter von Kaehne (26 April 2000)
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Understandable conflict
- Paulo Quadros (27 April 2000)
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Re: Understandable conflict
- Lucio Sibilia, MD (20 February 2008)
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Lewis Mehl-Madrona, Clinical Program Director, Center for Health and Healing Beth Israel Medical Center
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I disagree with Andrew Vickers' letter that the use of placebo group in an antidepressant trial is unethical. Suggestions continue to be made, especially from French psychiatry, that antidepressants are primarily placebo. We do not know for certain that antidepressants are significantly better than placebo medications. Whenever possible we should evaluate new therapies against placebo, and not just standard, acceptable therapy. For example, in a recent clinical trial on venlafaxine, placebo was effective 48% of the time; venlafaxine, 64%. This still is a narrow difference, and we know that enthusiastic prescribers with believing patients can achieve 70% effectiveness with placebo. Unfortunately, suicide is inevitable in some cases of depression -- even with the best treatments. The presence of suicide should not be used as an argument against a placebo control group. One suicide is not a phenomenon that would achieve any statistical significance, as tragic as this is. It would take a larger study and many more cases to make the argument that suicide is more common among placebo control groups in anti- depressant trials. This has never been demonstrated. Sincerely yours, Lewis Mehl-Madrona, MD, PhD |
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Joel Simon Hochman, Solo private practice Houston, Texas
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Hypericum clearly has a place in the overall scheme of antidepressent therapy. From clinical experience it appears to be most effective in the treatment of mild to moderate deressions, in perhap 60% to 70% of patients. Additionally, it seems useful as an adjunctive measure in approximately the same percentage of more seriously depressed patients. (Interestingly, the percentage of effectiveness seems approximately the same as the "first line" antidepressents.) When it is effective, it works relatively quickly - thus providing clinical relief during the initiation phase of anti-depressent therapy with the commercial pharmaceutical agents, all of which have a lag time before effectiveness. The subject study is flawed by noncomparability of doses. Many of the available comparison studies declare imipramine to be as effective as the new agents. Practical experience does not support this finding, however. Generally, the doses employed were not comparable. Common sense argues that hypericum is neither a panacea nor a placebo. It is simply another tool in our armamentarium, about which we must learn through clinical experience. |
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T P L Watts, Senior Lecturer and Consultant in Periodontology GKT Dental Institute
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The correspondence on this and other Hypericum matters emphasize a conclusion I came to about herbal medicine some time ago. Briefly, I would like the drug to be effective, the dose to be right, the preparation to be pure, and the toxicology to be understood for any such remedy prescribed to me. This means that I would like good clinical trials, pharmacology and toxicology. In short, there should be no long-term place for anything like herbal medicine, although observations about herbs may be one starting point for new pharmacological developments. |
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Peter von Kaehne, SHO Orthopaedics
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The lumping together of use of medicinal herbs with all sorts of other treatments under the title "complementary medicine" is misguiding and annoying. These treatments are neither connected by philosophy nor by treatment modus. The use of medicinal herbs is the historical base of most of our modern medicine and fits very well into the philosophocial framework of the same. Medicinal herbs are still full of surprises and deserve enthusiastical research. The view of some herbalists that whole plants are always superior to single components is maybe a bit too much of a blanket statement but should not stand in the way of responsible research and use. Iridology, Homoeopathy, Magnetism and other similarly bizarre schemes have nothing to do with scientific medicine and should be treated accordingly. The use of the all-covering term "complementary medicine" for all these treatment forms is blocking research and ultimately progress in many important medical areas. It should be abolished. |
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Paulo Quadros, Health Adviser NHC Clinic
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EDITOR I read with interest all the letters commenting on the hypericum study by Philipp at al. It seems to me that the authors of most of the letters are trying to fit a cube into a round hole. The fact is that when we shave the angles of the cube, it is not a cube any more. It is not that the medical professionals are right or wrong about their concerns. Professionals of main-stream medicine are trying to fit a discipline which is based on a completely different philosophy and principle, into their own. Main- stream and 'holistic' (to which herbalism belongs) are two different and complementary ways of approaching lack of health – none better or worse than the other. It is no coincidence that, since manufacturers started standardising herbal supplements presumably to make them acceptable to main-stream medicine, we have started seeing more and more side-effects from those supplements. Isolating or increasing the amount of any particular chemical component creates an imbalance between all the other normally synergistic ones. In this respect I strongly disagree with Tim Gorski. Personally I feel that the reply by Michael Philipp at al to Mr Gorski points to the appropriate direction and shows a great understanding of how herbs work. There are a variety of chemicals which exist in all herbs in very small quantities working together synergistically, balancing each other’s effects. They have roughly the same effect on our bodies even though they may be chemically different. The total effect that they produce is more powerful than any of them individually. For instance: the white willow has always been used as an anti-inflammatory, anti-fever, and mild analgesic. In fact, it has all the properties of aspirin. This is not a surprise since aspirin was developed by isolating the most active chemical in white willow (salicin) and then artificially synthesising it, leaving out all the other chemicals such as salinigrin and tannins. When we take aspirin, we are taking only one of the chemicals which exist naturally in the white willow but in a much greater quantity – this, as is now widely known, can lead to stomach upsets, stomach bleeding and a number of side- effects. Yes, there is a need for some form of standardisation and yes, there is a real need for main-stream medicine to better understand the make-up of herbs. There is only one process which I have recently found which combines the advantages of standardisation and the natural chemical balance of herb and plants. It is called ‘holistic standardisation’ and has been developed by a Swiss company. |
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Lucio Sibilia, MD, Docente di Psichiatria Dept. of Clinical Sciences, Università degli Studi di Roma La Sapienza Viale del Policlinico - Roma
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It seems likely from empirical evidence provided by the study of Thornett et al. that hypericum is more effective than imipramine for treating moderate depression, at a dose giving less negative effects than the one used for imipramine. Only, the medical community do not seems ready to accept this evidence. Is it because we do not know its mechannism of action? Not credible: we ignore the mode of action of tryciclic antidepressants as well. The neurotransmitters theory is a theory, not yet a solid knowledge. Moreover, albeit it would be desirable to use a drug with a complete knowledge of pharmacological and toxicological properties of its components, it does not fit with the history of medicine and its advancement. Aspirin is perhaps the best known example, but many others could be given. Rather, the opposite case is more common: at first a herbal remedy has been used, then knowledge about it cumulates, from various sources of research. The input and motivation for that research work is given just from the initial clinical evidence of its effectiveness. Had the use of aspirin been stopped because of incomplete knowledge of its mechanism of action, I sense that a lot of useful research would NOT have been done. Is the evidence questioned really because imipramine was not used at an adequate dose? Even less credible. Whether the dose of imipramine was adequate or not in the study, is seems largely an arbitrary judgement; what matters is that it empirically has resulted to be a dose sufficent to produce a significantly higher rate of secondary effects than hypericum. Why should we ask for higher doses of imipramine? Is it because of our ignorance about the relative effects of the different compounds of the herb? I do not share the opinion that we need to make a "holistic" choice about the matter; obviously, a single study cannot give us all the answers we would like to have, but once the effectivenes (and safety) of the "whole" is established, then we can start to examine its components. Is it because hypericum has been (wrongly, in my opinion too) associated with "alternative medicine"? Then it would be just a mislabelling problem, not a rational difficulty. Is it because the study has been judged "methodologically flawed"? But on what ground, I do not really understand. So, the more I think about such unpreparedness to accept this evidence, the more I am puzzled. Is there some "understandable conflict"? Lucio Sibilia, MD Docente di Psichiatria
Competing interests: None declared |
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