The Trials and Tribulations of Selecting Comparison Groups in Randomized Trials of Nonpharmacological Complementary and Integrative Health Interventions

Abstract

Editor's Note: For over two decades, JACM Editorial Board member Karen Sherman, PhD has been among the most respected clinical trialists in complementary and integrative health research. The epidemiologist and Senior Researcher at Kaiser Permanente Washington Health Research Institute has focused on pain conditions and has led or been part of teams exploring the roles of such therapies as yoga, acupuncture, mind-body and manual therapies. In this Invited Commentary, Sherman shares wisdom gleaned from the process: trial designs, principles for selecting controls, benefits and liabilities of placebo and sham controls, attention controls, usual care controls, and more. She also discusses the effects of comparison groups on sample sizes, comparison groups for mechanistic studies, and other comparison groups' considerations. This commentary should prove a useful primer wherever research methods in complementary and integrative health are taught. We are pleased to offer it here through JACM. -John Weeks, Editor-in-Chief, JACM (johnweeks-integrator.com).

Keywords: attention controls; clinical trials; complementary and integrative health; control groups; research design.