Individualized Homoeopathy Added to Standard Pharmacological Care for Migraine: A Pragmatic Randomized Open-Label Blind-ed-Endpoint Controlled Trial

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. RESULTS: At 6 months, all 120 randomized participants were included in the intention-to-treat primary analysis (60 per arm). Because both co-primary endpoints were specified in advance and tested in a fixed sequence, HIT-6 was tested first and monthly migraine days second. The homoeopathy arm showed a greater reduction in HIT-6 (16.8 vs 9.1 points; baseline-adjusted difference 7.86, 95% CI 5.59-10.12; p < 0.001; Cohen's d = 1.24) and monthly migraine days (9.1 vs 4.8 days; adjusted difference 3.64, 95% CI 3.02-4.26; p < 0.001; d = 1.14). Acute-medication-day reduction was also larger (adjusted difference 4.54, 95% CI 3.92-5.16; p < 0.001). MCID response was 98.3% vs 66.7% (risk difference 31.7 percentage points; number-needed-to-treat ≈ 3), and 80.0% vs 28.3% reported being much/very much improved (PGIC ≥ 6). At 6 months, 53.3% of the homoeopathy arm had no current prophylactic medication recorded versus none of the standard-care arm. Any adverse event occurred in 23.3% vs 33.3%; no statistically clear between-group difference in overall adverse-event frequency was demonstrated. Initial aggravation was recorded in 71.7% of the homoeopathy arm; its clinical definition and characteristics require verification from the source records. CONCLUSIONS: Adjunctive individualized homoeopathy was associated with clinically meaningful improvement in migraine-related daily functioning and headache-day burden at 6 months, with concordant medication-use findings. Because the design was open-label and the intervention involved additional clinician contact, the findings estimate the effect of the adjunctive individualized-homoeopathy care package rather than isolated specific-remedy efficacy. Overall adverse-event frequency did not differ clearly between groups, but the sample size does not establish broad safety.