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OBSERVATIONS: Douglas Kamerow Placebo pills for children BMJ 2008; 336: 1339 [Full text]

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Say No to Drugs Without Drugs

Daniel L Sontheimer   (18 June 2008)

More placebo research in children is needed

Ricardo C Fernandes, Joaquim J Ferreira MD, Cristina Sampaio MD PhD   (18 June 2008)

When psychology can help biology: the placebo effect has to be well managed

Gianluca Castelnuovo   (20 June 2008)

Say No to Drugs Without Drugs 18 June 2008
Daniel L Sontheimer, Residency Program Director Springfield, MO 65804 Send response to journal: Re: Say No to Drugs Without Drugs	A lifelong American, I suspect there are moments when every citizen of any country, is left befuddled by his/her culture. While not a source for shame as a nation, the launch of placebos for children motivates to me say "Surely, we can do better." Over twenty years ago, Nancy Reagan launched a pithy campaign against illegal drug use, "Just Say No." Many argued this message was too simple to confront the reality of the drug problem. However, the idea certainly has merit in the face of this product offering. Instructing parents to teach children their bodies need outside help in the forms of pills, medicalizes coping and caring. The reality is children's bodies heal without pills and ministrations in the presence of caring parents the vast majority of the time, and to trivialize that miraculous capacity with fake pills is disservice to the integrity of each and everyone of us. Competing interests: None declared
More placebo research in children is needed 18 June 2008
Ricardo C Fernandes, MD Department of Paediatrics, Hospital de Santa Maria, 1649-028 Lisboa, Portugal, Joaquim J Ferreira MD, Cristina Sampaio MD PhD Send response to journal: Re: More placebo research in children is needed	After a placebo-like pill for children became recently commercially available in the US, Kamerow presented reasonable reservations regarding the use of placebos by parents (1). These pills are marketed as dietary supplements-therefore not requiring the US FDA approval, and with both media exposure and internet availability we can expect this discussion to reach other markets (2). While we are also worried by an improper use of placebo in pediatrics, we feel this should not obscure the need for more research into the placebo effect in this age range. The ethical debate over placebos in clinical practice remains unsettled (3,4). Available results from small surveys suggest considerable use of placebos by health professionals (5,6), but none focused on child care practitioners. In our pediatric practice we have certainly seen our share of “magical” potions of saline and “miraculous” sugar pills, whose variable positive effects on certain childhood conditions usually rely on a not-so-supernatural recipe of practitioner’s confidence, child soothing and parental reassuring. Kamerow strikes a relevant pediatric note when he addresses the role of parents as therapeutic proxies and highlights possible consequences of child deceiving. But is there a scientific rationale for a placebo effect in children? Despite the ongoing controversy regarding its magnitude and nature, few studies have analyzed it in pediatrics (7). We recently showed a high and variable placebo response rate in pediatric migraine trials, which was superior to adults (8). Many factors, including the natural history of pediatric migraine or the type of pain scale used, can explain this response. But there are clues for further study in this field, including the influence of parental reporting on trial outcomes, how expectations may work “by proxy” and how they may differ in children and adolescents. This may allow a rational analysis of the contribution of child-parent- practitioner interactions and therapeutic rituals in the placebo response (9,10), whether they include a pill, a plaster, or a prescribed and certified hug. Additionally, it may also help address the long ongoing methodological and ethical controversy regarding the use of placebos in clinical trials (11). All in all, indiscriminate clinical or parental placebo use might be a bad idea, but further pediatric placebo research does sound like a good one. (1) Kamerow D. Placebo pills for children. BMJ 2008; 336(7657):1339. (2) Aschwanden C. Experts Question Placebo Pill for Children. New York Times 2008 May 27. Available at http://www.nytimes.com/2008/05/27/health/27plac.html (accessed June 17th 2008) (3) Lichtenberg P, Heresco-Levy U, Nitzan U. The ethics of the placebo in clinical practice. J Med Ethics 2004; 30(6):551-554. (4) Pittrof R, Rubenstein I. The thinking doctor's guide to placebos. BMJ 2008; 336(7651):1020. (5) Nitzan U, Lichtenberg P. Questionnaire survey on use of placebo. BMJ 2004; 329(7472):944-946. (6) Sherman R, Hickner J. Academic physicians use placebos in clinical practice and believe in the mind-body connection. J Gen Intern Med 2008; 23(1):7-10. (7) Hrobjartsson A, Gotzsche PC. Is the placebo powerless? An analysis of clinical trials comparing placebo with no treatment. N Engl J Med 2001; 344(21):1594-1602. (8) Fernandes R, Ferreira JJ, Sampaio C. The placebo response in studies of acute migraine. J Pediatr 2008; 152(4):527-33, 533. (9) Hrobjartsson A. What are the main methodological problems in the estimation of placebo effects? J Clin Epidemiol 2002; 55(5):430-435. (10) Kaptchuk TJ, Kelley JM, Conboy LA, Davis RB, Kerr CE, Jacobson EE et al. Components of placebo effect: randomised controlled trial in patients with irritable bowel syndrome. BMJ 2008; 336(7651):999-1003. (11) Miller FG, Wendler D, Wilfond B. When do the federal regulations allow placebo-controlled trials in children? J Pediatr 2003; 142(2):102- 107. Competing interests: None declared
When psychology can help biology: the placebo effect has to be well managed 20 June 2008
Gianluca Castelnuovo, PhD, PsyD, Professor of Psychology and Researcher in Clinical Psychology Istituto Auxologico Italiano IRCCS, Psychology Research Laboratory and Catholic University of Milan Send response to journal: Re: When psychology can help biology: the placebo effect has to be well managed	Kamerow reported important critical considerations about the use of placebos for children provided by parents (1). One important remark regarding the use of “Obecalp” in not severe (and perhaps not clinical) situations is related to the recognized importance of psychology (and psychological phenomena) in producing significant brain changes that involves cerebral chemistry and biology. Taking into account that there are many possibilities for the “psychology” to produce healthy benefits for our “biology”, it is important to use all the therapeutic tools that are available in any situation. The placebo could be defined as a substance, a procedure, a ritual, a ceremony, a rite, a formal procedure which a patient accepts as something medical, therapeutic, even if it has no specific therapeutic activity . We usually use different unaware kinds of placebo, but many elements have to be contemporary present to obtain a good suggestion for our minds: a clinical rite or procedure managed by a non professional person has not the same value of the “ceremony” directed by an expert professional (even better if the person is a professor with the white coat). So, in order to avoid a loss of suggestion power and efficacy in prescribing “Obecalp”, the context has to remain clinical and medical oriented. The same pill, if prescribed by a doctor or provided by a parent, has not the same therapeutic value. If we would like to use the placebo effect in its complete and powerful version, we have to follow some rules, such as considering “Obecalp” as a real drug that needs a doctor prescription. A good placebo has to be built considering different factors where the substance is only one (we have to consider the place of prescription, the professional and social role of the clinicians involved in the prescription, the language used, the relationship between doctor and patient, etc...). More research is needed to check if these placebo mechanisms work also in children. (1) Kamerow D. Placebo pills for children. BMJ 2008; 336(7657):1339. Competing interests: None declared