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Author(s)
James Michael, Subhas Singh, Satarupa Sadhukhan, Arunava Nath, Nivedita Kundu, Nitin Magotra, Susmit Dutta, Maneet Parewa, Munmun Koley, Subhranil Saha
Journal
Complementary Therapies in Medicine Volume 43, April 2019, Pages 53-59, DOI:https://doi.org/10.1016/j.ctim.2019.01.007
Abstract
Background
Insomnia is the most common sleep-related complaint associated with impaired day-time functioning, reduced quality of life, increased morbidity and substantial societal cost. We evaluated whether individualized homeopathy (IH) could produce significant effect beyond placebo in treatment of insomnia.Methods
In this double-blind, randomized, placebo-controlled, two parallel arms trial, 60 patients were randomized to receive either IH/verum or control/placebo (1:1). Patient-administered sleep diary (6 items; 1: latency to fall asleep, 2: minutes awake in middle of night, 3: minutes awake too early, 4: hours spent in bed, 5: total sleep time in hours, and 6: sleep efficiency) and Insomnia Severity Index (ISI) were taken as the primary and secondary outcomes respectively, measured at baseline, and after 3 months.Results
Five patients dropped out (verum: 2, control: 3). Intention to treat sample (n = 60) was analyzed. Trial arms were comparable at baseline. In the verum group, except sleep diary item 3 (P = 0.371), rest of the outcomes improved significantly (all P < 0.01). In the control group, there were significant improvements in diary item 6 and ISI score (P < 0.01) and just significant improvement in item 5 (P = 0.018). Group differences were significant for items 4, 5 and 6 (P < 0.01) and just significant (P = 0.014) for ISI score with moderate to large effect sizes; but non-significant (P > 0.01) for rest of the outcomes.Conclusion
IH seemed to produce significantly better effect than placebo. Rigorous trials and independent replications are warranted.Keywords
Efficacy, Homeopathy, Insomnia, Sleep diary, Clinical trial
Category: Human Studies
External url
https://www.sciencedirect.com/science/article/abs/pii/S096522991830829X?via%3Dihub
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