Efficacy of individualized homeopathy in bronchial asthma in adults: Double-blind, randomized, placebo-controlled, clinical trial in the context of usual care. Issue 2 (May 2019) - Qutubuddin, Mohammad
Abstract: Background: Asthma remains a major public health problem despite recent advances in management. Sizeable minorities of asthma patients prefer complementary therapies, including homeopathy, for treatment. This trial examines whether usual care plus individualized homoeopathy (UC + IH) can produce significantly different treatment effects compared to usual care plus placebo (UC + P) in adults suffering from bronchial asthma. Methods: In this double-blind, randomized, placebo-controlled, parallel arm, efficacy trial, 140 adults suffering from bronchial asthma were randomized to receive either UC + IH (verum: n = 70) or UC + P (control: n = 70). The trial was of 3.5 years duration. Spirometric measures, blood eosinophil percentage and serum immunoglobulin E were primary outcomes and symptom severity and different questionnaire scores were secondary outcomes; measured at baseline, and after 3 and 6 months. Results: Eighteen patients dropped out (verum: 8, control: 10). Intention to treat sample (n = 140) was analyzed. The two trial arms were comparable at baseline. Group differences over 3 and 6 months showed significant differences in improvement in UC + IH compared to UC + P ( P < 0.01) with moderate to large effect sizes (Cohen's d) for both primary and secondary outcome measures. Conclusion: UC + IH produced significantly better effect than UC + P in this trial, indicating homeopathy seemed superior to placebo. Further evaluation involving a larger sample in a multi-centre design is necessary prior to making firm recommendations. [Trial registration: CTRI/2017/08/009192].