Rapid Responses to:

RESEARCH:
Jon C Tilburt, Ezekiel J Emanuel, Ted J Kaptchuk, Farr A Curlin, and Franklin G Miller
Prescribing "placebo treatments": results of national survey of US internists and rheumatologists
BMJ 2008; 337: a1938 [Abstract] [Full text]
*Rapid Responses: Submit a response to this article

Rapid Responses published:

[Read Rapid Response] Placebos for CFS have shown poor results
Tom Kindlon   (24 October 2008)
[Read Rapid Response] Is a placebo by any other name still a placebo?
Thomas M Morgan, Nashville, TN   (24 October 2008)
[Read Rapid Response] Placebo research
Mitchell Kahn   (24 October 2008)
[Read Rapid Response] Placebos: trick or treat
Hugh Mann   (24 October 2008)
[Read Rapid Response] Extraterrestrials are among us
Dr. Ivan Torshin   (24 October 2008)
[Read Rapid Response] Patients, pills, and professionals: the ethics of placebos
William R. Phillips   (24 October 2008)
[Read Rapid Response] Value in the placebo response
David C. Flemming   (25 October 2008)
[Read Rapid Response] And further bias...
Teresa T. Goodell, RN,CNS,PhD   (26 October 2008)
[Read Rapid Response] Treatment of “fibromyalgia” with vitamin D
William B. Grant   (26 October 2008)
[Read Rapid Response] Whose interests are served?
Christopher M Rayner   (26 October 2008)
[Read Rapid Response] Using placebos - why not tell the patient?
Nikola M. Biller-Andorno, Margrit Faessler, Markus Gnaedinger, Thomas Rosemann   (29 October 2008)
[Read Rapid Response] Placebo: Illusionism in medicine is diseases mongering.
Alain Braillon, Aurore Bernardy-Prud’homme   (31 October 2008)
[Read Rapid Response] Re: Treatment of “fibromyalgia” with vitamin D
Celine M Aranjo   (31 October 2008)
[Read Rapid Response] In many instances placebos are worthwile
Cristian Baicus, Sos Stefan cel Mare 19-21, sect.2, 020125 Bucharest, Romania   (31 October 2008)
[Read Rapid Response] This placebo study is painful
Jeffrey Thewes MA, MD   (2 November 2008)
[Read Rapid Response] Response to Thomas M Morgan (24th October 2008)
Richard Bartley   (3 November 2008)
[Read Rapid Response] Damaging to doctor-patient relationship
Rajiv Malhotra   (13 November 2008)
[Read Rapid Response] The Body Heals Itself= Placebo
Andrew Sikorski   (25 November 2008)
[Read Rapid Response] Pavlov smiling in 2008
Dov B Henis, none   (14 December 2008)

Placebos for CFS have shown poor results 24 October 2008
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Tom Kindlon,
Information Officer (voluntary position)
Irish ME/CFS Association

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Re: Placebos for CFS have shown poor results

Although I can not see a specific reference to it in the published paper, over 100 media outlets[1] are reporting that this study found, amongst other conditions, doctors have prescribed placebos for Chronic Fatigue Syndrome (CFS) patients.

Many people may not be aware that there has actually been a systematic review and meta-analysis of the placebo response in the treatment of chronic fatigue syndrome[2]. It found that "the pooled placebo response was 19.6% (95% confidence interval, 15.4-23.7), lower than predicted and lower than in some other medical conditions." The authors summarised this as, "In contrast with the conventional wisdom, the placebo response in CFS is low."

Another study found that positive thinking ("positivity in illness") did not improve outcomes in CFS[3].

These studies suggest that, although at the current time CFS can be a frustrating condition for professionals to deal with (partly because of a lack of biomedical research and clinical trials in the area), it may not be the best condition if one wants to see good outcomes from using placebos. And of course, as the authors point out, there are ethical issues involved in using placebos anyway.

[1] Results from a Google (www.google.com) search under the News heading.

[2] Cho HJ, Hotopf M, Wessely S. The placebo response in the treatment of chronic fatigue syndrome: a systematic review and meta- analysis. Psychosom Med. 2005 Mar-Apr;67(2):301-13.

[3] Hyland ME, Sodergren SC, Lewith GT. Chronic fatigue syndrome: the role of positivity to illness in chronic fatigue syndrome patients. J Health Psychol. 2006 Sep;11(5):731-41.

Competing interests: None declared

Is a placebo by any other name still a placebo? 24 October 2008
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Thomas M Morgan,
Assistant Professor of Pediatrics
Vanderbilt University,
Nashville, TN

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Re: Is a placebo by any other name still a placebo?

Tilbert et al report a startlingly high rate of "placebo" prescription among physicians. However, their findings are perhaps not so surprising given that virtually any medication with little or no efficacy was considered a placebo. I would define a placebo as an inert substance deliberately administered to a patient who believes he or she is receiving an active pharmaceutical agent. By the authors' looser standard, however, even an over-the-counter cold medicine would count as a placebo, given that this class of medications has no proven efficacy. Physicians often relent to the wishes of their patients, explaining that perhaps some individuals do benefit from such medicines, and that it's OK to take it. That's hardly the same as prescribing a sugar pill to dupe a patient into feeling well.

Competing interests: None declared

Placebo research 24 October 2008
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Mitchell Kahn,
Physician
Bellingham, WA, 98225 USA

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Re: Placebo research

This article is quite misleading and is being used by the media to further bash physicians as unethical (see New York Times article today).

By defining a placebo as "a treatment whose benefits derive from positive patient expectations and not from he physiological mechanism of the treatment itself" the authors would include such measures as reassurance (as in, "the spot on your x-ray is not cancer") as a placebo.

By lumping together "potentially beneficial medicine" with "treatment not typically used for their condition" on the survey they guaranteed that they would get results which would make physicians look like they routinely cheat patients, which is the implication of the conclusion that physicians routinely precribe placebos.

Imagine the scenario of a patient coming in to the office demanding antibiotics for their viral respiratory infection: 87% of physicians apparently do the right thing and not prescribe antibiotics, often at the cost of alienating the patient. Only 13%, tired of arguing 20 times a day with patients that antibiotics don't treat viruses, give in, but "only rarely explicitly describe them as placebos." Giving a patient a prescription with a caveat that it won't do any good anyhow is not going to promote a relationship with a patient and almost certainly will result in a patient feeling insulted.

Although the authors conclude that half of doctors "routinely" prescribe placebos,the data showed that half of doctors recommended such treatments 2 -3 times/ month. Given the over 400 patient visits/month of the average internist, this is hardly "routine".

It seems to me that if a dextrose pill is shown in a randomized clincal trial to result in a better outcome than no treatment, it fully meets the gold standard of evidence based medicine and thus should be accepted as legitimate treatment. By asking physicians whether they theoretically would then prescribe such a placebo and use the response to trumpet that physicians routinely use placebos does a great disservice.

Competing interests: Practicing, ethical internist upset about poor quality research being used to paint physicians in an unfavorable light

Placebos: trick or treat 24 October 2008
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Hugh Mann,
Physician
Eagle Rock, MO 65641 USA

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Re: Placebos: trick or treat

Psychoanalysis teaches us that there are two kinds of thinking: primary process and secondary process. Primary process is magical thinking characteristic of children. Secondary process is rational thinking characteristic of adults. Since we never really outgrow our childhood, we never fully give up our primary process thinking. Ironically, education sometimes promotes primary process thinking, rather than secondary process thinking. This happens in medical education, in which medical students are taught that the use of placebos promotes a sense of “healing” in the patient, and moreover, promotes a sense of “success” in the physician. Sadly, a sugar pill is being used to “treat” both patient and physician. Since health care is ostensibly based on science and secondary process thinking, it’s time to dispense with placebos and to stop dispensing them to patients.

Competing interests: None declared

Extraterrestrials are among us 24 October 2008
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Dr. Ivan Torshin,
PI
119899, Moscow, Comp Center of RAS, Lab of comptational and systems biology

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Re: Extraterrestrials are among us

Today is not 1st April. And yet, again our humour abilities are tested - by a study that calls vitamins as "placebo".

I do remember when some bright heads in Russia, about 10 years ago or so, used vitamins as "placebo" in a number of clinical trials. No surprise, most of those trials were outright failures.

Decades of basic research in biochemistry, molecular biology and biophysics proven 100 times that "vitamins" and "minerals" are arch- important cofactors of protein function. It is very wierd that all of this research, presented in tens of thousands of PubMed abstracts, is totally ignored by many individuals who say they are directly related to medicine. It is as if fundametal research is done on alpha Centauri and some of the clinical science - on yet another far-off system.

Dr. T.M. Morgan of Vanderbilt University commenting on the article did have the point: "authors' looser standard". Considering, for instance, the tens of proteins which are directly affected by vitamin C, hundreds of proteins directly affected by magnesium etc, it is indeed very loose (if not lousy) an attitude to call a vitamin "placebo".

Competing interests: Author is the science consultant of the Trace Element Institute for UNESCO (Russian branch)

Patients, pills, and professionals: the ethics of placebos 24 October 2008
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William R. Phillips,
Clinical Professor of Family Medicine
University of Washington, Seattle, WA 09115 USA

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Re: Patients, pills, and professionals: the ethics of placebos

The care of patients is more than the writing of prescriptions. It includes help and hope and healing. Transparency is good, but not always better than the relief of suffering. Ethical practice of medicine requires attention to individuals and their situations.(1)

In this thought-provoking study, the investigators worded their questions with a finesse that has been largely lost by the journalists reporting the findings to the public.(2) Doctor deception is headline news. Care of difficult patients is timeless art. Both practice and evidence advance over time, but only partly because of the formal links between the two. We have much to offer patients that still lies somewhere in the realms of off-label prescribing, empiric treatment, and the power of the placebo.

Research that pursues the questions raised by this study can help doctors help patients.

1. Phillips WR. Patients, pills, and professionals: the ethics of placebo therapy. Pharos Alpha Omega Alpha Honor Med Soc. 1981 Winter;44(1):21-5.

2. Harris G. Half of doctors routinely prescribe placebos. New York Times. October 24, 2008, A12. http://www.nytimes.com/2008/10/24/health/24placebo.html? _r=1&scp=2&sq=placebo&st=cse&oref=slogin (Accessed 10/24/2008)

Competing interests: None declared

Value in the placebo response 25 October 2008
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David C. Flemming,
Anesthesiologist
Heywood Hospital, Gardner, MA 01440

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Re: Value in the placebo response

If both subjective symptoms and physical signs of a physical disease respond to an inert process or substance it means the patient did something that caused the response, in essence, to successfully self- treat. Neither the process nor the substance did anything--they were specifically chosen because they are powerless to do anything, and neither did the clinician. This is noncontroversial and demonstrates a huge gap in our conceptual thinking about a model in which physical disease can be rooted in, or vectored by processes over which the mind and body have some control. If a patient demonstrates this capacity to self treat, physicians should be scraping their astonished jaws off the floor and asking at least two serious questions, namely: 1. How can I teach this patient to do this on his own without the placebo crutch? 2. If this patient can do this on his own, what's getting in his way of doing it all the time? Question 2 may carry the highest significance because the answer may give insight into the disease's true nature. Question 2 may explain the seemingly inevitable long term fading of placebo responses.

Verbiage about placebo and deceit obfuscates the need to re-examine physical diseases for behavioral components which may be treatable. Yes, use of placebo simply to get a troubling patient out of the office can be considered malpractice, and a physician who is convinced that an inert process is clinically effective is ignorant. But, failing to explore the concept that patients who demonstrate ability to self treat might use it to gain long term relief or remission when medical, behavioral and rehabilitative treatments are integrated represents failure of academic thinking.

Competing interests: None declared

And further bias... 26 October 2008
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Teresa T. Goodell, RN,CNS,PhD,
assistant professor
Portland, Oregon, USA

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Re: And further bias...

And further bias, aside from that mentioned in prior comments, is betrayed by the lack of data on why rheumatologists were chosen for the study and, more importantly, a breakdown of the gender distribution of the physician respondents' practices.

While internists treat men and women patients in comparable (or at least representative) proportions, rheumatologists treat disorders prominent in women, e.g., lupus, chronic fatigue syndrome, rheumatoid arthritis, Sjogren's syndrome.

The medical profession's long history of dismissing "female troubles" as psychosomatic is well known, yet the authors do not acknowledge sexism's role in the selection of placebos as a treatment option. It is anachronistic and distressing that these authors, and the editors of BMJ, would allow such an imposing elephant to go wholly unmentioned as it stands before us in the room.

Competing interests: Female, which apparently constitutes a special interest.

Treatment of “fibromyalgia” with vitamin D 26 October 2008
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William B. Grant,
Health researcher
SUNARC, San Francisco 94164-1603

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Re: Treatment of “fibromyalgia” with vitamin D

The paper by Tilburt et al. (1) raises an interesting ethical, medical and scientific issue: do doctors know the best treatment for fibromyalgia and, if not, should they prescribe a placebo?

A reading of the journal literature uncovers the finding that those with fibromyalgia are at increased risk for osteoporosis (2) and that low serum 25-hydroxyvitamin D [25(OH)D] is a risk factor for fibromyalgia (3- 6). In addition, some of those diagnosed with fibromyalgia actually have osteomalyasia (7-9). Supplementation with vitamin D should, therefore, be one of the ways to treat those diagnosed with fibromyalgia (9,10).

Given all the health benefits now associated with vitamin D for diseases including cancer, cardiovascular disease, bacterial and viral infections, autoimmune diseases (11-18), all patients should have their serum 25(OH)D levels measured and, if less than 40 ng/mL (100 nmol/L), encouraged to increase to that value through supplements or ultraviolet B (UVB) irradiance.

To rephrase an old saying, “two thousand IU of vitamin D a day keeps the doctor away.”

Disclosure I receive funding from the UV Foundation (McLean, VA), the Vitamin D Society (Canada), and the European Sunlight Association (Brussels).

References 1. Tilburt JC, Emanuel EJ, Kaptchuk TJ, Curlin FA, Miller FG. Prescribing “placebo treatments”: results of national survey of US internists and rheumatologists. BMJ 2008;337:a1938

2. Swezey RL, Adams J. Fibromyalgia: a risk factor for osteoporosis. J Rheumatol. 1999 Dec;26(12):2642-4.

3. Huisman AM, White KP, Algra A, Harth M, Vieth R, Jacobs JW, Bijlsma JW, Bell DA. Vitamin D levels in women with systemic lupus erythematosus and fibromyalgia. J Rheumatol. 2001 Nov;28(11):2535-9.

4. Gerwin RD. A review of myofascial pain and fibromyalgia--factors that promote their persistence. Acupunct Med. 2005 Sep;23(3):121-34.

5. Faiz S, Panunti B, Andrews S. The epidemic of vitamin D deficiency. J La State Med Soc. 2007 Jan-Feb;159(1):17-20; quiz 20, 55.

6. Armstrong DJ, Meenagh GK, Bickle I, Lee AS, Curran ES, Finch MB. Vitamin D deficiency is associated with anxiety and depression in fibromyalgia. Clin Rheumatol. 2007 Apr;26(4):551-4.

7. Reginato AJ, Falasca GF, Pappu R, McKnight B, Agha A. Musculoskeletal manifestations of osteomalacia: report of 26 cases and literature review. Semin Arthritis Rheum. 1999 Apr;28(5):287-304.

8. Erkal MZ, Wilde J, Bilgin Y, Akinci A, Demir E, Bödeker RH, Mann M, Bretzel RG, Stracke H, Holick MF. High prevalence of vitamin D deficiency, secondary hyperparathyroidism and generalized bone pain in Turkish immigrants in Germany: identification of risk factors. Osteoporos Int. 2006;17(8):1133-40.

9. Shinchuk LM, Holick MF. Vitamin D and rehabilitation: improving functional outcomes. Nutr Clin Pract. 2007 Jun;22(3):297-304.

10. Holick MF. Optimal vitamin D status for the prevention and treatment of osteoporosis. Drugs Aging. 2007;24(12):1017-29.

11. Grant WB, Holick MF. Benefits and requirements of vitamin D for optimal health: a review. Altern Med Rev. 2005 Jun;10(2):94-111.

12. Holick MF. High prevalence of vitamin D inadequacy and implications for health. Mayo Clin Proc. 2006 Mar;81(3):353-73.

13. Holick MF. Vitamin D deficiency. N Engl J Med. 2007 Jul 19;357(3):266-81.

14. Mullin GE, Dobs A. Vitamin D and its role in cancer and immunity: a prescription for sunlight. Nutr Clin Pract. 2007 Jun;22(3):305-22.

15. Schwalfenberg, G., Not enough vitamin D: health consequences for Canadians. Can Fam Physician, 2007;53(5):841-54.

16. Cannell J, Hollis B, Zasloff M, Heaney R. Diagnosis and treatment of vitamin D deficiency. Expert Opin Pharmacother. 2008 Jan;9(1):107-118.

17. Cannell JJ, Hollis BW. Use of vitamin D in clinical practice. Altern Med Rev. 2008 Mar;13(1):6-20.

18. Cherniack EP, Florez H, Roos BA, Troen BR, Levis S. Hypovitaminosis D in the elderly: from bone to brain. J Nutr Health Aging. 2008 Jun-Jul;12(6):366-73.

Competing interests: I receive funding from the UV Foundation (McLean, VA), the Vitamin D Society (Canada), and the European Sunlight Association (Brussels).

Whose interests are served? 26 October 2008
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Christopher M Rayner,
GP Principal
Elstead Surrey GU6 8EJ

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Re: Whose interests are served?

The placebo response has long been acknowledged as a powerful therapeutic component of the doctor patient relationship. From my memory of "The Doctor, His Patient, and The Illness" my copy of which has sadly gone missing, Balint mentions the value of the prescription as a physical talisman of the doctor-patient therapeutic relationship.

When I entered general practice as a principal in 1976 I was puzzled to see two large bottles of tonic in the dispensary of my partner's surgery. These were red and green. The red one had a sweet musty taste, while the green one was bitter with a hint of sweetness about it. Both contained sundry active ingredients of little or no therapeutic value. My partner often prescribed them to patients with minor self-limiting illnesses with the assurance that while no effect was guaranteed there could be little harmful effect, and that the illness might recover more quickly and be less troublesome in the meantime. For patients with more serious pathology for which no effective treatment was known, these products might also be offered as being of little proven benefit, but that in his experience patients sometimes did better with them than without. I have, of course, no proof that this practice improved the patients' health, but I think it is at least reasonable to suppose that in some cases a placebo response would have been elicited.

Nowadays these products are available on sale from pharmacists, but we are forbidden to prescribe them on the NHS. I still try to impress on patients that no medicine is appropriate in many cases, but there are still a number of patients who crave a talismanic prescription. Now I and my colleagues are obliged to choose from the range of effective, and so toxic, medications on offer for prescription. All too often the choice falls upon an antibiotic or a non-steroidal anti-inflammatory. I fear that the iron discipline of evidence based medicine has deprived us and our patients of the honest and proper use of harmless placebos. I am not sure who benefits from this state of afairs.

Competing interests: GP who used to prescribe 'tonics' before they were taken off the NHS prescription list

Using placebos - why not tell the patient? 29 October 2008
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Nikola M. Biller-Andorno,
Director, Institute of Biomedical Ethics, University of Zurich
8008 Zurich, Switzerland,
Margrit Faessler, Markus Gnaedinger, Thomas Rosemann

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Re: Using placebos - why not tell the patient?

Many physicians find themselves in a double bind: They want to use the “powers of the placebo” for the therapeutic benefit of their patients but at the same time they believe – as Tilburt et al show – that they cannot confront their patients with the fact of their being offered a treatment that works through positive expectations or other non-specific effects rather than through a physiological mechanism triggered by certain properties of a drug or procedure. But is openly providing placebos really incompatible with a modern patient-physician-relationship that considers the patient a partner in therapeutic decisions? From our own ongoing research involving Swiss primary care providers we gather that a substantial percentage of physicians fear patients would be disappointed if they found out they had received a placebo. We are not certain if this assumption is justified given that many patients use medicine and unconventional approaches in parallel, many of them hiding the fact of their “dual use” from their physician. (1) There may be a mutual misunderstanding of expectations: physicians believing patients would be disappointed or even insulted if they made use of placebo treatments in an open way, and patients fearing their physicians would be offended if they knew their patients were trying approaches patients themselves might consider as having more to do with their own expectations and psychophysiological responses than with a specific effect of the intervention. In order to settle this important issue we urgently need to investigate the patient perspective and compare it to physicians’ attitudes. It may turn out patients are much more open and willing to experiment with placebo interventions than is generally assumed.

1. Eisenberg DM, Kessler RC, Foster C, Norlock FE, Calkins DR, Delbanco TL. Unconventional medicine in the United States: prevalence, costs, and patterns of use. N Engl J Med 1993;328:246-52.

Competing interests: None declared

Placebo: Illusionism in medicine is diseases mongering. 31 October 2008
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Alain Braillon,
Public Health
University hospitals. 80000 Amiens. France,
Aurore Bernardy-Prud’homme

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Re: Placebo: Illusionism in medicine is diseases mongering.

Alain Braillon MD, PhD, Aurore Bernardy-Prud’homme Public Health, University hospitals. Amiens. France.

Correspondence: braillon.alain@chu-amiens.fr

Tilburt et al’s study demonstrated that a majority of specialists, despite numerous years spent at the university and a board certification, are either practicing magic or insane (prescribing a placebo and telling it).1 The placebo “effect” is known for long time: at the end of the 18th century when Benjamin Franklin and Antoine Lavoisier investigated Franz Mesmer’s magnetic healing techniques. Now, scientific analysis describes three components with the patient’s responses to: a) observation and assessment; b) a ritual; c) the interaction with the practitioner.2 Pragmatically, it is just a belief. Belief is a powerful and dangerous tool. It spoils the doctor-patient relationship which is based upon trust, strengths medical arrogance and infantilise patients. The first point exposes to risky backlash. The second and the third in this case have a name: diseases mongering. The “what this study adds” box missed the point: the leaders in diseases mongering are physicians themselves. Be strong et good courage, you have nothing! Why too many doctors are learning away from telling people the truth? Even oncologists have learned how to inform their patients. Use of placebo must be limited to clinical trials to measure the "nuisance" effects in the experimental setting. This is the sole indication. Call a spade a spade, and not for ethical debate.

1 Tilburt JC, Emanuel EJ, Kaptchuk TJ, Curlin FA , Miller FG. Prescribing "placebo treatments": results of national survey of US internists and rheumatologists. BMJ 2008, 337(oct23 2). DOI: 10.1136/bmj.a1938

2 Kaptchuk TJ, Kelley JM, Conboy LA et al. Components of placebo effect: randomised controlled trial in patients with irritable bowel syndrome. BMJ 2008;336:999-1003

Competing interests: None declared

Re: Treatment of “fibromyalgia” with vitamin D 31 October 2008
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Celine M Aranjo,
Retired GP
Sydney, NSW, 2208,Australia

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Re: Re: Treatment of “fibromyalgia” with vitamin D

This is one of several other rapid responses which not only make for good reading, but also for sensible medicine and prescribing. One other such response is 'Extraterrestirals are among us'from Dr Ivan Torshin, Moscow. Key words in 'treatment of fibromyalgia with vitamin D' are 'doctors do not know the best treatment for fibromyalgia' and to this I might add 'Is it indeed fibro-myalgia'? Dr Ivan Torshin says and rightly so, all the publishings including Pubmed articles about Vitamins and Minerals have been totally ignored---why? Could it be a total lack of knowledge in 'modern medicine' about these topics, thus branding such treatments 'placebos'? An example: the case of a Type 2 diabetic who has be prescribed oral hypoglycaemic drugs and has returned with numbness in both feet after a few months of treatment---the medical professional promptly attributes this to diabetic neuropathy, quite unaware that a marginal, unsymptomatic dietary Vitamin B group as well as Vit.B12 deficiency could be unmasked, causing the symptom/s due to the Adverse side-effects of the oral hypoglycaemic agent. Another example:'peripheral neuropathy' and 'myopathy' associated in some who are prescribed a statin drug is more often not attributed to these drugs, resulting in the persistence of the statin drug intake and the diagnosis of some other 'new' medical condition.

Competing interests: None declared

In many instances placebos are worthwile 31 October 2008
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Cristian Baicus,
associate professor
Spitalul Colentina, Internal Medicine / Clinical epidemiology unit,
Sos Stefan cel Mare 19-21, sect.2, 020125 Bucharest, Romania

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Re: In many instances placebos are worthwile

One colleague wrote that evidence Based medicine "deprived us and our patients of the honest and proper use of harmless placebos", but this is not true.

The randomized clinical trials showed us that the effect of the drugs is only a little better than that of placebo in many instances, and the latter one is bigger than the difference between the effect of the drug and the placebo effect (which I call the intrinsic effect of the drug).

In knee and hip osteoarthritis, for example, the effect of paracetamol is very close to that of placebo, while the effect of anti- inflammatory nonsteroidal drugs (AINS) is very close to that of paracetamol[1]; the intrinsic effect of topical diclofenac (the difference between the total effect and the placebo effect) is lesser than the effect of topical placebo on the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) scale (1.4 points against 2.5 obtained with placebo for pain, 4.5 points against 7.1 obtained with placebo for the improvement of the physical function, and 0.2 points against 0.6 obtained with placebo for the stiffness)[2]. Concerning the effect of ketoprofen patch in tendinitis of recent onset (measured on a 100 mm visual analogue scale), the decrease in pain was of 25.8 mm in the placebo group, and 38.4 mm in the treatment group (difference = 12.6 mm)[3].

In chronic obstructive pulmonary disease (COPD), a treatment that improves the score of St George's questionnaire is considered slightly efficacious for a 4 units change, moderately efficacious for an 8 units change, and very efficacious for a 12 units change. Placebo improved the score with almost 3 points, so it was not far from being slightly efficacious, while the combination salmeterol/fluticasone or tiotropium, which brought each a 4.5 point improvement, were certainly "slightly efficacious"[4,5]. We can remark again that, while placebo decreased the score with almost 3 units, the difference between the combination and placebo was only 2.2 units, so the effect owed to the treatment was lesser than that of placebo. We must stress the fact that, while the AINS have many important adverse effects, both salmeterol/fluticasone and tiotropium are expansive, while not deprived of adverse effects.

The placebo effect is almost as powerful as the medication effect in irritable bowel syndrome[6] and depression[7], too.

Concerning the awareness of the patient about the fact that he was prescribed a placebo - will the placebo effect take place, anymore, if the patient is aware? I think that informed consent is against the idea of placebo.

What is really unethical is to prescribe, as placebo, drugs with important potential adverse effects as antibiotics and AINS.

References

1. Towheed TE, Maxwell L, Judd MG et al. Acetaminophen for osteoarthritis (Cochrane review). In: The Cochrane Library 2008, Issue 1. Chichester, UK: John Wiley and Sons, Ltd.

2. Bookman AA, Williams KS, Shainhouse JZ. Effect of a topical diclofenac solution for relieving symptoms of primary osteoarthritis of the knee: a randomized controlled trial. CMAJ 2004;171:333¡V8.

3. Mazieres B, Rouanet S, Guillon Y, Scarsi C, Reiner V. Topical ketoprofen patch in the treatment of tendinitis: a randomized, double blind, placebo controlled study. J Rheumatol. 2005;8:1563-70.

4. Calverley PM, Anderson JA, Celli B et al for the TORCH investigators. Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease. N Engl J Med. 2007; 356:775-89.

5. Casaburi R, Mahler DA, Jones PW et al. A long-term evaluation of once-daily inhaled tiotropium in chronic obstructive pulmonary disease. Eur Respir J 2002; 19:217-224.

6. Jailwala J, Imperiale TF, Kroenke K. Pharmacological treatment of the irritable bowel syndrome: a systematic review of randomized controlled trials. Annals of Internal Medicine 2000; 133:136-147.

7. Kirsch I, Deacon BJ, Huedo-Medina TB, Scoboria A, Moore TJ, Johnson BT. Initial severity and antidepressant benefits: a meta-analysis of data submitted to the Food and Drug Administration. PLoS Med. 2008;5:e45.

Competing interests: None declared

This placebo study is painful 2 November 2008
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Jeffrey Thewes MA, MD,
Emergency Physician, Ethicist
Providence Hospital, 16001 W. 9 mile Rd.Southfield, Michigan 48075

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Re: This placebo study is painful

This study generated a lot of headlines in the popular press that were painful to read but easy to explain away.

The problem with getting info from poplular press, especially papers like the New York Times and the AP is that they often have an unstated editorial agenda. It is mainly to sell papers and sometimes this happens by sensationalizing a rather weak conclusion as is the case in this paper.

If you look at the paper, the investigators actually went through a rather diabolical system of trying to get doctors to say what the investigators wanted them to say and then reached even further in their conclusions to say that doctors prescribe plecebo treatments.

As an ethicist my job is to discern the truth, and clearly the authors of this study and the reporters of the press articles had no interest in the truth.

The press articles imply that doctors all across america are prescribing sugar pills for diseases like skin cancer, when in fact according to the article only about 2 percent of the doctors studied ever really prescribe what most people think of as plecebo treatments, namely sugar pills or saline water.

The article goes through a complex and deceptive survey to get physicians to admit what we already know. Sometimes doctors prescribe treatments that may not work because the patients ask for them or because physicians think patients want them. Many of us are guilty of prescribing a new NSAID for a chronic pain condition, being pretty sure it will not work, but at the same time realizing that it may, and also that there is little downside. We may also be guilty of prescribing antibiotics for a cold, being pretty sure that it won't make a difference, but because we think the patient wants it, and just maybe it is an early pneumonia that isn't showing up on xray yet.

I've often ordered and ankle film on a sprained ankle, even though I know it is a sprain because the patient wants it, and also because I am fallible and have missed fractures that I was sure were sprains.

While this is not exactly great medical care it is a far cry from the more ethically circumspect practice of prescribing placebo treatments, yet this is what the study investigators conclude. They imply that anyone who writes antibiotics for what is probably a viral illness, but may be a bacterial infection is engaging in unethical subturfuge.

These conclusions are a lie and need to be disputed. They do nothing but undermine the doctor patient relationship and society's confidence in the medical profession.

Sincerly,

Jeffrey Thewes MA, MD

Competing interests: None declared

Response to Thomas M Morgan (24th October 2008) 3 November 2008
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Richard Bartley,
Physiotherapist
Denbigh, Wales

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Re: Response to Thomas M Morgan (24th October 2008)

Is there really a difference between ‘prescribing a sugar pill to dupe a patient into feeling well’ and an over the counter cold medicine (with no proven ingredients) sold to a dupable patient?

I would suggest there isn't. However within the context of an ethical RCT, the patient should at least know there is (lets say) a 50% chance of either getting the real McCoy or a sugar pill, thus resulting in no actual duping.

Competing interests: None declared

Damaging to doctor-patient relationship 13 November 2008
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Rajiv Malhotra,
Senior House Officer
Bristol

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Re: Damaging to doctor-patient relationship

Editor.

For the intended benefit of the placebo-effect to occur, the physician must withhold vital information from the patient. This prevents the obtaining of valid consent and also denies patient autonomy. Times have changed and this paternalistic method of medicine ("doctor knows best") has been consigned to the rubbish tips. Involving patients in their care and trusting them with the information needed to make decisions is vital to ensuring a good doctor-patient relationship. Any hint of deceit will erode this relationship indefinately. Risk this at your peril.

Competing interests: None declared

The Body Heals Itself= Placebo 25 November 2008
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Andrew Sikorski,
GP
Wadhurst UK

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Re: The Body Heals Itself= Placebo

Sir

The derogatory term 'placebo' may simply be a misnomer for the body's wisdom, self maintenance and repair. Anything giving these healing attributes time and space to work will result in an healthier individual.

This innate, some would say God given, ability seems sadly ignored by conventional medical and surgical academics and research yet there is a plethora of research on how to encourage the body to heal itself better- including work on placebo surgery!

How refreshing to find clinicians in the frontline being shown to consciously or subconsciously side with their patients healing abilities and feel comfortable to follow Hippocrates dictum of 'Primo Non Nocere'.

Competing interests: Primary Care NHS Integrative GP Acupuncturist Homeopath

Pavlov smiling in 2008 14 December 2008
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Dov B Henis,
retired
retired,
none

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Re: Pavlov smiling in 2008

Why Pavlov Is Smiling In 2008

The GGRPVR Chain: Genes, God, Religion, Placebo, Virtual Reality.

A. Imagination Medicine

http://www.sciencenews.org/view/feature/id/39046/title/Imagination_Medicine Brain imaging reveals the substance of placebos. Expectation alone triggers the same neural circuits and chemicals as real drugs.

"It all boils down to expectation. If you expect pain to diminish, the brain releases natural painkillers. If you expect pain to get worse, the brain shuts off the processes that provide pain relief. Somehow, anticipation trips the same neural wires as actual treatment does.

Scientists are using imaging techniques to probe brains on placebos and watch the placebo effect in real time. Such studies show, for example, that the pleasure chemical dopamine and the brain’s natural painkillers, opioids, work oppositely depending on whether people expect pain to get better or worse. Other research shows that placebos can reduce anxiety."

B. Placebos: some background info

http://www.cerebromente.org.br/n09/mente/pavlov_i.htm

http://www.cerebromente.org.br/n09/mente/placebo1_i.htm

http://thjuland.tripod.com/placebos.html

The concept of a placebo comes from medieval times, when professional mourners were paid to stay by the bedside of. deceased person, reciting a psalm beginning "Placebo Domino..." or "I shall please the Lord." "Placebo" gradually became the word used for the paid mourner, whose grief was, in fact, false.

C. Life's Manifest

http://www.the-scientist.com/community/posts/list/112.page#578

Genes are the primal, first stratum, Earth's organism.

D. Of Science and Religion

http://www.physforum.com/index.php?showtopic=18243&st=0&#entry267674

E. So why is Pavlov smiling in 2008?

Pavlov demonstrated effecting placebo phenomena in multicelled organisms by manipulation of their drives-reactions. Now placebo phenomena are demonstrated in the multicelled organism's genes and genomes, in our primal first stratum and 2nd stratum base organisms...a very good reason to smile.

Now an interesting chain is exposed to our view, the GGRPVR Chain, the Genes-God-Religion-Placebo-Virtual Reality chain, a most intriguing cultural evolution chain, extending from the genes genesis to nowadays...

Dov Henis

(A DH Comment From The 22nd Century)

http://blog.360.yahoo.com/blog-P81pQcU1dLBbHgtjQjxG_Q--?cq=1

Competing interests: None declared