JUST IN TIME FOR THE REIMPORTATION DEBATE

:Sweet relief: Researchers at Harvard Medical School are putting the lowly placebo to the test. Can it establish itself as a legitimate remedy? (Harvey Blume, 8/3/2003, Boston Globe)

In addition to analyzing past clinical studies and designing their own, the group regularly discusses and dissects some of what might be called the accumulating folklore of the placebo. Take, for example, the tale of internal mammary ligation, a form of heart surgery now known to have been based on bogus assumptions about the body's circulatory system. Before being discredited, however, internal mammary ligation led to a 90 percent reduction of angina pain in one clinical trial-the same rate of improvement, incidentally, that resulted from the placebo surgery used in that trial.

And then there's the placebo's evil twin, the nocebo effect. After all, if an inert substance plus positive spin can have medical benefits, why shouldn't an inert substance plus negative spin induce distress? It has been reported, for example, that all 13 recruits to one Japanese clinical trial broke out in a rash when informed that the innocuous leaves being rubbed on their arms were poison ivy. Score that one for the nocebo.

The Harvard group's new $2.1 million study is one of the first of a wave of NIH-sponsored trials explicitly designed to address Hrobjartsson and Gotzsche's anti-placebo critique. It has a no-treatment arm in addition to two placebo arms and one verum arm. (Recruits who are randomized into the no-treatment arm can, if they like, be treated for free after the study ends with the verum under investigation.)

The no-treatment arm is not this trial's only innovation. Another goal is, as Kerr puts it, ''to crack open the black box of clinical trials.'' Throughout the study, patients will confer with practitioners about what it's like to receive medical treatment in the unusual setting of a clinical trial. Kerr and others in the group suspect that medical ritual influences clinical outcomes. In the ''interaction between the practitioner and the patient,'' Kerr told me, ''there are particular ways of talking and listening that may drive therapeutic change.'' By controlling the practitioner's approach to patients, she will be able to test this hypothesis.

Details of this study-it concerns a chronic condition-are still being ironed out, and cannot be made public at this time. More can be said about the clinical trial completed last June that involved 270 people who suffer from repetitive stress injury (RSI), including carpal tunnel syndrome and tendinitis. That study has two verum arms (acupuncture and the drug Amitriptyline) and two placebo arms (sham acupuncture and a placebo pill).

In sham acupuncture, the needles are retracted back into their casing, never piercing the skin. Nevertheless sham acupuncture involves more patient/practitioner contact, more medical ritual, than merely swallowing a pill. If one of the placebos outperforms the other, that may yield information about the impact of ritual on healing. It would also suggest that there is something going on with placebo effects that cannot be ascribed to the natural history of disease.

Results of this study will be published in the fall, but preliminary reports confirm the placebo's power to generate paradox.

That should take care of the problem of folks getting phony drugs when they buy from abroad. They probably don't need the real thing anyway. Posted by Orrin Judd at August 3, 2003 5:45 PM