Efficacy of individualized homeopathic treatment of insomnia: Double-blind, randomized, placebo-controlled clinical trial
| Autor: | Subhranil Saha, Maneet Parewa, Susmit Dutta, Arunava Nath, Subhas Singh, James Michael, Nitin Magotra, Nivedita Kundu, Munmun Koley, Satarupa Sadhukhan |
|---|---|
| Rok vydání: | 2019 |
| Předmět: |
Adult
Male Complementary and Manual Therapy medicine.medical_specialty Placebo Double blind Young Adult 03 medical and health sciences 0302 clinical medicine Double-Blind Method Quality of life Sleep Initiation and Maintenance Disorders Internal medicine medicine Insomnia Humans Prospective Studies 030212 general & internal medicine Advanced and Specialized Nursing Intention-to-treat analysis business.industry Homeopathy Middle Aged Clinical trial Treatment Outcome Complementary and alternative medicine Quality of Life Female Sleep diary medicine.symptom Sleep business 030217 neurology & neurosurgery |
| Zdroj: | Complementary Therapies in Medicine. 43:53-59 |
| ISSN: | 0965-2299 |
| DOI: | 10.1016/j.ctim.2019.01.007 |
| Popis: | 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.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.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.IH seemed to produce significantly better effect than placebo. Rigorous trials and independent replications are warranted. |
| Databáze: | OpenAIRE |
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