Efficacy and Safety of Homeopathic Medicines in Diabetes, Pre-Diabetes, and Related Complications: Protocol for a Systematic Review and Meta-Analysis

Background Diabetes mellitus and pre-diabetes affect nearly one billion adults globally and carry a substantial complication burden including peripheral neuropathy. A significant proportion of patients with diabetes use homeopathic medicines as adjunctive therapy. Despite this, the controlled-trial evidence for homeopathic interventions across the full diabetes-complications spectrum has not been quantitatively synthesised. Objectives This protocol describes the methods for a systematic review and meta-analysis to evaluate the efficacy and safety of homeopathic medicines compared with placebo in adults with pre-diabetes, Type 1 or Type 2 diabetes mellitus, or established diabetic complications, on glycaemic outcomes (fasting blood glucose [FBS], 2-hour oral glucose tolerance test [OGTT], glycosylated haemoglobin [HbA1c]), neuropathic symptom scores (Neuropathy Total Symptom Score-6 [NTSS-6]), disease progression, and adverse events. Methods Five electronic databases (PubMed/MEDLINE, Scopus, Cochrane CENTRAL, CAM-Quest) and grey literature sources (CTRI India, ClinicalTrials.gov, WHO ICTRP, ProQuest Dissertations) will be searched from inception without language restriction. Randomised controlled trials (RCTs) and controlled clinical trials (CCTs) with concurrent control groups are eligible. Two independent reviewers will screen, extract, and assess risk of bias using Cochrane RoB 2 (RCTs) and ROBINS-I (CCTs). Where ≥ 2 clinically comparable studies report the same outcome, random-effects meta-analysis (DerSimonian-Laird; Hartung-Knapp-Sidik-Jonkman [HKSJ] correction) will be applied. Certainty of evidence will be assessed using the GRADE framework. The review is reported in accordance with PRISMA-P 2015 ¹ and PRISMA 2020. ² Dissemination: Findings will be published in a peer-reviewed journal and the completed systematic review submitted alongside this protocol.