Trials in Complementary and Integrative Health Interventions

Abstract

Trials of complementary and integrative health approaches study a variety of health interventions, such as natural products and mind and body practices, in diverse clinical settings. The nature and level of pre-existing information on these interventions have a large impact on trial planning, as lack of a standardized intervention and potential intervention complexity pose unique challenges for trial planning and analysis. Natural products, including dietary supplement trials, are in many ways similar to conventional drug trials but typically require considerable early-phase data prior to actually launching efficacy studies. Some botanical or herbal natural products are mixtures of compounds that are challenging for reliable product characterization. By contrast, mind and body approaches encompass a number of practices that are delivered in either individual or group sessions, and trials by design are not fully masked. Standardizing intervention delivery remains a critical factor for many of these interventions; and those delivered in a group setting bring greater complexity to trial designs and analyses. With widespread use by the public of these interventions, there is expanding interest in performing appropriately designed clinical trials to generate an evidence base for both safety and efficacy of complementary and integrative health approaches.