Efficacy of individualized homeopathic treatment of insomnia: Double-blind, randomized, placebo-controlled clinical trial

Complement Ther Med. 2019 Apr;43:53-59. doi: 10.1016/j.ctim.2019.01.007. Epub 2019 Jan 9.


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: Clinical trial; Efficacy; Homeopathy; Insomnia; Sleep diary.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Double-Blind Method
  • Female
  • Homeopathy / methods
  • Humans
  • Male
  • Middle Aged
  • Prospective Studies
  • Quality of Life
  • Sleep / drug effects
  • Sleep Initiation and Maintenance Disorders / drug therapy*
  • Treatment Outcome
  • Young Adult