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

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

Author information

1
Dept. of Organon of Medicine and Homoeopathic Philosophy, National Institute of Homoeopathy, Block GE, Sector III, Salt Lake, Kolkata 700106, West Bengal, India. Electronic address: jamesmichael312@gmail.com.
2
Dept. of Organon of Medicine and Homoeopathic Philosophy, National Institute of Homoeopathy, Block GE, Sector III, Salt Lake, Kolkata 700106, West Bengal, India. Electronic address: drssubhas@gmail.com.
3
Dept. of Organon of Medicine and Homoeopathic Philosophy, National Institute of Homoeopathy, Block GE, Sector III, Salt Lake, Kolkata 700106, West Bengal, India. Electronic address: satarupadrsadhukhan@hotmail.com.
4
Dept. of Organon of Medicine and Homoeopathic Philosophy, National Institute of Homoeopathy, Block GE, Sector III, Salt Lake, Kolkata 700106, West Bengal, India. Electronic address: arunava_nath80@yahoo.com.
5
Dept. of Organon of Medicine and Homoeopathic Philosophy, National Institute of Homoeopathy, Block GE, Sector III, Salt Lake, Kolkata 700106, West Bengal, India. Electronic address: drniveditakundu@gmail.com.
6
Dept. of Organon of Medicine and Homoeopathic Philosophy, National Institute of Homoeopathy, Block GE, Sector III, Salt Lake, Kolkata 700106, West Bengal, India. Electronic address: nitin_magotra21@yahoo.com.
7
Dept. of Organon of Medicine and Homoeopathic Philosophy, National Institute of Homoeopathy, Block GE, Sector III, Salt Lake, Kolkata 700106, West Bengal, India; 82A, Pramanick Ghat Road, Kolkata 700036, West Bengal, India. Electronic address: duttasusmit83@gmail.com.
8
Dept. of Repertory, National Institute of Homoeopathy, Block GE, Sector III, Salt Lake, Kolkata 700106, West Bengal, India. Electronic address: mntparewa@gmail.com.
9
Village Champsara, PO Baidyabati, Hooghly 712222, West Bengal, India. Electronic address: dr.mkoley@gmail.com.
10
93/2/1, Shibpur Road, PO and PS Shibpur, Howrah 711102, West Bengal, India. Electronic address: drsubhranilsaha@hotmail.com.

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:

Clinical trial; Efficacy; Homeopathy; Insomnia; Sleep diary

PMID:
30935555
DOI:
10.1016/j.ctim.2019.01.007

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