Adverse drug events in AYUSH interventions for cervical and lumbar spondylosis

Abstract

Abstract Introduction: The prevalence of musculoskeletal disorders ranges between 20%–33% and also varies by age and diagnosis. In India, low back and neck pain are important leading contributors to the disability burden irrespective of gender. Many Ayurveda, Yoga and naturopathy, Unani, Siddha and Sowa-rigpa and Homeopathy (AYUSH) interventions used for the treatment of cervical and lumbar spondylosis conditions due to its availability and accessibility. Even though it's widely practiced, there is no documentation of adverse events of AYUSH interventions for cervical and lumbar spondylosis. The primary objective of this systematic review is to synthesize evidence of adverse events attributable to pharmacological and non-pharmacological AYUSH interventions for cervical and lumbar spondylosis. Methods: We will conduct a systematic search in all standard biomedical databases and AYUSH system portals to identify and retrieve both the published and unpublished research articles. We will include all study designs such as the randomized and non-randomized controlled trials (RCTs), cross-sectional studies, prospective and retrospective cohort studies, case-control studies, case series, and case studies. They should have reported the Adverse events of AYUSH systems of interventions for cervical and lumbar spondylosis. Using predefined search strategy with suitable medical subject headings terms and field terms, we will retrieve all the relevant articles from PubMed, Embase, Scopus, Google Scholar, ProQuest, AYUSH research portal, Digital Helpline for Ayurveda Research Articles, Shodhganga and reports of National Pharmacovigilance Centres. We will include the articles that are in English language. Data synthesis will be conducted using meta-analysis. Results: The systematic review will provide adverse events information attributable to pharmacological and non-pharmacological AYUSH interventions for cervical and lumbar spondylosis. Discussion: We will generate a report on the frequency and types of adverse drug events among patients with lumbar and cervical spondylosis treated with AYUSH system and characteristics of adverse event such as type and nature of medications. This study may help Indian AYUSH pharmacovigilance centres to develop methods to improve quality of data on adverse events. Systematic review registration number: PROSPERO CRD42020167433 (https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020167433)