Integrated homeopathy with standardized levothyroxine therapy for hypothyroidism: A double-blind, randomized, placebo-controlled trial in children and adults

ABSTRACT Background: Hypothyroidism is a prevalent hormonal disorder symptoms often persist despite levothyroxine therapy. Adjunctive individualized homeopathic medicines (IHMs) may improve clinical outcomes, biochemical markers, and quality of life, robust evidence of efficacy remains limited. Objective: The objective of the study was to evaluate the efficacy of add-on IHMs alongside standard levothyroxine therapy in the treatment of hypothyroidism in children and adults. Methods: A 3-month, double-blind, randomized, placebo-controlled trial was conducted in a homeopathic hospital involving 64 trial subjects with hypothyroidism undergoing levothyroxine therapy. The participants received either IHMs plus levothyroxine (verum; n = 32) or placebo plus levothyroxine (control; n = 32) for 3 consecutive months. The primary outcome was the Zulewski’s Clinical Scoring (ZCS); secondary outcomes included thyroid-stimulating hormone (TSH), T3, T4, and ThyroPRO-39 scores. Results: Both groups showed significant improvement in symptoms and thyroid indices. Between-group difference in ZCS was nonsignificant (mean diff: 0.1, 95% confidence interval [CI] −0.3–0.6, P = 0.567), but significant in T3 (mean diff: −0.2, 95% CI − 0.4 to − 0.1, P = 0.002), T4 (mean diff: 1.6, 95% CI 1.2–2.0, P < 0.001), and TSH (mean diff: −3.0, 95% CI − 5.8 to − 0.3, P = 0.033), favoring homeopathy against placebo. Quality-of-life changes were minimal, though some ThyroPRO-39 domains improved significantly with IHMs (e.g., symptoms, P < 0.001; tiredness, P = 0.012; nervousness and tension, P = 0.001; and daily activity, P = 0.001). Conclusion: Adjunctive IHMs did not improve symptoms or quality-of-life outcomes over placebo conclusively, but revealed favorable biochemical changes, meriting further long-term studies. Trial registration: CTRI/2023/04/051311