Very Few Clinical Trials Report Composition of Placebo Drug

Review finds only 8 percent of placebo-controlled trials list pill ingredients
By Lindsey Marcellin
HealthDay Reporter

TUESDAY, Oct. 19 (HealthDay News) -- The composition of placebos used in clinical trials -- including pills, injectables, and other substances -- are not regulated and rarely reported, which may ultimately compromise the integrity of clinical research, according to a study in the Oct. 19 issue of the Annals of Internal Medicine.

Beatrice A. Golomb, M.D., of the University of California San Diego School of Medicine, and colleagues conducted a study of placebos used in clinical trials published in four high-impact, English-language general and internal medicine journals. There are no regulations governing the composition of placebos, and the researchers wanted to determine how often investigators include information about the composition of these substances in published clinical trials.

The reviewed journals included 167 eligible studies, of which the majority included either pill or injection placebos. The researchers found that the composition of pills, injections, and other approaches were revealed in 8.24, 26.3, and 27.8 percent of journal articles, respectively.

"In conclusion, failure to describe placebo ingredients breaches basic scientific standards of rigor," the authors write. "Because inferences from clinical trials propagate to clinical practice, failure to report placebo composition compromises the foundation on which medical decisions are based, and on which the fate of lives may rest."

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