Placebos in clinical trials of peptic ulcer. ACG Committee on FDA-Related Matters.

Placebo use in controlled clinical trials is often challenged as being unethical, as though the investigator in a clinical trial and the clinician are in conflict, one interested primarily in scientific validity, the other in patient care. This paper will review the specific issues in trials for short term (4-8 wk) peptic ulcer disease, demonstrating that controlled trials utilizing placebo are worthwhile, are safe, offer distinct advantages over alternative trials, and impose no real ethical conflict. The ethics regarding the use of a placebo for a controlled trial have been reviewed previously in this column (1). Placebo controls are appropriate in therapeutic trials when 1) standard therapy is either unavailable, of unproven efficacy, or possesses unacceptable side effects, 2) placebo itself is an effective therapy, or 3) the ongoing disease has little adverse effect on the patient. Furthermore, the use of placebo is considered advisable (2), "when the disease process is characterized by frequent spontaneous exacerbations and remissions." Certainly, peptic ulcer is such a disease. It has been argued that the decision to utilize placebo might be between only two individuals, the physician and his patient (3), but realistically, many more must approve the trial, through multi-center participation, involvement by the pharmaceutical industry, and peer review (including human research committee approvals).