Evaluation of Efficacy and Safety of Ayurvedic Interventions in Anxiety Disorder

Abstract

Introduction: Anxiety disorder is one of the psychosomatic disorders characterized by persistent and irrational fear, anxiety, or avoidance of social or performance situations. Ayurveda incorporates different types of regimen, both therapeutic and non-therapeutic, in the management of psychiatric disorders. Till date, no systematic review of the evidence has been conducted focused on the safety and efficacy of Ayurvedic interventions in anxiety disorders. The current systematic review aims to generate evidence regarding the safety and efficacy of the Ayurveda interventions in the treatment of anxiety disorders through analysis of available data on clinical trials. Materials and methods: The relevant full papers and abstracts will be sought from electronic databases such as PubMed, the Cochrane Library, DHARA, AYUSH Research Portal, CTRI, and Google Scholar. Randomized controlled trials (RCTs), non-randomized controlled trials (NRCTs), quasi- randomized controlled trials (QRCTs), controlled clinical trials (CCTs), randomized/non-randomized placebo-controlled trials, controlled before- and-after studies (CBA), before-and-after comparisons, parallel arm comparative trials, and multiarm clinical trials will be included. Study selection will follow the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines and the methodological appraisal of the studies will be assessed by the Cochrane risk-of-bias tool as well as Jadad Scale for RCTs and risk-of-bias in non-randomized Studies tool for NRCTs. Primary outcomes will include measures related with response to the treatment and any serious adverse events. There will be no language restrictions on the data sought and searches run on research studies published from January 1980 to till date will be eligible for inclusion. The selection of the research studies, data abstraction, and validation of the studies will be performed independently; in case of disparity or other issues regarding the suitability of study for inclusion, the opinion of the third person will be sought for consensus. A meta-analysis will be conducted and effect sizes will be generated using Hedges'g score for both fixed and random effect models, only if sufficient data are available. Ethics and dissemination: As this will be a systematic review, which does not involve human beings, there will be no requirement for ethical approval. Findings will be disseminated widely through peer-reviewed publication and through conferences or symposia. Trial registration number: CRD42019139230.