Efficacy of individualised Homoeopathy in Bronchial asthama in adults Double blind randomized placebo controlled clinical trial in the context of usual care

Abstract

Introduction: Asthma is one of the major public health problems for the developed and developing countries despite recent advances in its management. Because of the immense human and economic burden, sizeable minorities of asthma patients prefer complementary therapies including homoeopathy. The investigators intended to evaluate whether usual/standard care plus individualized homoeopathy can produce any significant effect different from usual care plus placebo in treatment of bronchial asthma. newlineMethods:In this interventional, double-blind, randomized, placebo-controlled, parallel arm, efficacy trial, 140 adults suffering from bronchial asthma were enrolled at the Homoeopathy Outpatient, Dist. Medical College and Hospital, Darbhanga, Bihar and were randomized in 1:1 ratio to receive either usual care plus individualized homoeopathy (UC+IH; verum: n=70) or usual care plus placebo (UC+P; control: n=70). The trial was of 31/2 years duration (January 2014 to June 2017). Spirometric measures and blood parameters were taken as primary outcomes and symptom severity and different questionnaire scores as secondary outcomes; all measured at baseline, after 3 months and 6 months. newlineiii newlineObservations and Results: Eighteen patients dropped out (verum: 8, control: 10), rest 122 (verum: 62, placebo: 60) completed the trial. Intention to treat population (n=140) was analyzed. Two trial arms were comparable at baseline. In the verum arm, except FEV1/FVC (P = 0.884; repeated measure ANOVA), rest of the outcomes improved significantly (Plt 0.0001; repeated measure ANOVA) over 6 months. In the control arm, few outcomes improved (Plt 0.0001; repeated measure ANOVA); e.g. FEV1, FEV1/FVC, frequency of asthmatic attacks last week, sleep interference, patient assessed severity, and ACQ score. Group differences after 3 months and 6 months were statistically significant (Plt 0.05; independent t test). newlineConclusion: Usual care plus homoeopathy produced significantly better effect than usual care plus placebo in treatment of bronchial asthma. Homoeopathy appeared to be superior to placebo; still, further rigorous evaluation involving larger sample size in multi-Centre design and independent replications are necessary prior making any firm recommendations. newline