Insomnia placebo-controlled clinical trial

Chronic insomnia, if untreated, can have social, economic and occupational impacts on the individual.

Insomnia is the most commonly reported sleep problem in industrialized nations, leading to emotional distress, daytime fatigue and loss of productivity.

The outpatient department of National Institute of Homoeopathy (NIH) is often consulted by many patients suffering from sleep disorders. Hence, it provided a promising setting to conduct an efficacy trial of individualized homeopathy, IH, in insomnia. JM and S. Singh were the main study organisers.

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 in 1:1 ratio to receive either individualized homeopathy IH or placebo, .

• 55 continued treatment to conclusion.
• Severity of symptoms were analysed and every client had their own sleep diary that they wrote in every day to see the effectiveness of the homeopathic treatment.

• The index below are the questions answered in the sleep diary. 1-6. The protocols were on the these main symptoms;

• 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, 6: sleep efficiency

   Conclusion

• After 3 months of intervention, outcome data was recorded again.

• IH seemed to produce significantly better effect than placebo in treatment of insomnia.

  All the other outcomes improved so strongly that the probability the result is due to chance is less than 1%.

• The symptomology of No’s 1,2,4,5,6, especially responded better.
• For the placebo group there was no significant change.

The study protocol was approved by the Institutional Ethical Committee (IEC) [Ref. No. 5-023/NIH/PG/Ethical Comm. 2009/Vol. III/ 1957 (A/S); dated March 27, 2017] and was registered prospectively in the Clinical Trials Registry – India [CTRI/2017/05/00845