James Michael1, Subhas Singh2, Satarupa Sadhukhan3, Arunava Nath4, Nivedita Kundu5, Nitin Magotra6, Susmit Dutta7, Maneet Parewa8, Munmun Koley9, Subhranil Saha10. 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.
RCT Entities:
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.