La Clinica terapeutica
Individualized Homoeopathy Added to Standard Pharmacological Care for Migraine: A Pragmatic Randomized Open-Label Blinded-Endpoint Controlled Trial
By Prasad S, Ratnasabapathy E, Venkatesan H and 1 others.
Abstract
Background
Migraine is the second leading cause of years lived with disability worldwide and the leading cause among young women; daily functioning, rather than attack frequency alone, is now a priority outcome. Individualized homoeopathy is widely used as an adjunct, yet adjunctive pragmatic evidence in tertiary public-sector Indian care is scarce.
Methods
In a pragmatic, two-arm, parallel-group, 1:1 randomized, open-label, blinded-endpoint (PROBE) trial, 120 adults (18-60 years) with ICHD-3 migraine and baseline HIT-6 ≥ 50 were allocated to individualized classical homoeopathy plus standard pharmacological care (n = 60) or standard pharmacological care alone (n = 60). The co-primary endpoints were change in HIT-6 and change in monthly migraine days from baseline to 6 months, analysed by intention-to-treat with baseline-adjusted ANCOVA under hierarchical (fixed-sequence) testing. Responder (≥6-point HIT-6 reduction, a prespecified threshold derived from chronic-migraine evidence), Patient Global Impression of Change (PGIC), medication use, safety, and exploratory subgroup and 12-month analyses were secondary.