Clinical trials in allied medical fields: A cross-sectional analysis of World Health Organization International Clinical Trial Registry Platform

J Ayurveda Integr Med. 2016 Mar;7(1):48-52. doi: 10.1016/j.jaim.2015.09.003. Epub 2016 May 24.

Abstract

Background: Clinical trials are mandatory for evidence-based practice. Hardly, any data are available regarding the number of clinical trials and their methodological quality that are conducted in allied fields of medicine.

Objective: The present study was envisaged to assess methodological quality of trials in allied medical fields.

Materials and methods: Registered clinical trials in World Health Organization International Clinical Trials Registry Platform (http://apps.who.int/trialsearch/AdvSearch.aspx) in the following fields were extracted: Acupuncture; Ayurveda; biofeedback; complementary and alternate medicine; herbal; homeopathy; massage; naturopathy; Reiki; Siddha; Unani; and yoga. The eligible studies were assessed for the following key details: Type of sponsors; health condition in which the trial has been conducted; recruitment status; study design; if randomization was present, method of randomization and allocation concealment; single or multi-centric; retrospective or prospective registration; and publication status in case of completed studies.

Results: A total of 276 clinical trials were registered majority of which have been proposed to be conducted in the field of oncology and psychiatry. Most of the clinical trials were done in single centers (87.75%), and almost all the clinical trials were investigator-initiated with pharmaceutical company sponsored studies contributing to a maximum extent of 24.5%. A large majority of the study designs were interventional where almost 85% of the studies were randomized controlled trials. However, an appropriate method of randomization was mentioned only in 27.4%, and the rate of allocation concealment was found to be just 5.5%. Only 1-2% of the completed studies were published, and the average rate of retrospective registration was found to be 23.6% in various fields.

Conclusion: The number of clinical trials done in allied fields of medicine other than the allopathic system has lowered down, and furthermore focus is required regarding the methodological quality of these trials and more support from various organizations.

Keywords: Complementary and alternate medicine; Evidence-based medicine; Research.