Efficacy of individualized homeopathic treatment of insomnia: Double-blind,randomized, placebo-controlled clinical trial |
| |
| Affiliation: | 1. Dept. of Organon of Medicine and Homoeopathic Philosophy, National Institute of Homoeopathy, Block GE, Sector III, Salt Lake, Kolkata 700106, West Bengal, India;2. 82A, Pramanick Ghat Road, Kolkata 700036, West Bengal, India;3. Dept. of Repertory, National Institute of Homoeopathy, Block GE, Sector III, Salt Lake, Kolkata 700106, West Bengal, India;4. Village Champsara, PO Baidyabati, Hooghly 712222, West Bengal, India;5. 93/2/1, Shibpur Road, PO and PS Shibpur, Howrah 711102, West Bengal, India;1. College of Pharmaceutical Sciences, Catholic University of Campinas, Brazil;2. College of Biological Sciences, Catholic University of Campinas, Brazil;1. Department of Pediatiric Otolaryngology, IdiPAZ, Health Research Institute, La Paz University Hospital, Spain;2. Department of Otolaryngology, Toledo Hospital Complex, Spain;3. Department of Otolaryngology, IdiPAZ, Health Research Institute, La Paz University Hospital, Spain;4. Boiron SIH, Spain;1. LA-SER, 10 Place de Catalogne, 75014 Paris, France;2. Conservatoire national des arts et métiers (CNAM), 292 Rue Saint-Martin, 75003 Paris, France;3. LA-SER Europe Limited, 66 Chiltern St, London W1U 4JT, United Kingdom;4. Department of Epidemiology, London School of Hygiene & Tropical Medicine, Keppel St, Bloomsbury, London WC1E 7HT, United Kingdom;5. Faculty of Medicine, University of Franche Comté, 9 Rue Ambroise Paré, 25000 Besançon, France;6. Pasteur Institute, 28 Rue du Docteur Roux, 75015 Paris, France;7. University of Paris-Ile de France Ouest, 9 Boulevard d''Alembert, 78280 Guyancourt, France;8. Cyklad Group, 16 Rue André Le Nôtre, 69140 Rillieux-la-Pape, France;9. INSERM U1018, Centre for Epidemiology and Population Health, Hôpital Paul Brousse, Bât 15/16, 16 Avenue Paul Vaillant Couturier, 94807 Villejuif, France;10. Faculty of Medicine, University Pierre and Marie Curie, 4 Place Jussieu, 75005 Paris, France;11. Department of Epidemiology, Biostatistics and Occupational Health, McGill University, 1020 Pine Avenue West, Montreal, Quebec H3A 1A2, Canada;12. Sainte-Anne Hospital, University of Paris V René Descartes, 100 Rue de la Santé, 75674 Paris, France;13. INSERM U657, University of Bordeaux Segalen, 146 Rue Léo Saignat, 33076 Bordeaux, France;1. Department of Pediatric Oncology, Dana-Farber Cancer Institute, 450 Brookline Avenue, Boston, MA 02215, USA;2. Boston Medical Center, Boston University School of Medicine, 1 Boston Medical Center Place, Boston, MA 02218, USA;3. Division of Pulmonary, Critical Care, and Sleep Medicine, Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, 330 Brookline Avenue, Boston, MA 02215, USA |
| |
| Abstract: | BackgroundInsomnia 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.MethodsIn 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.ResultsFive 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.ConclusionIH seemed to produce significantly better effect than placebo. Rigorous trials and independent replications are warranted. |
| |
| Keywords: | Efficacy Homeopathy Insomnia Sleep diary Clinical trial |
| 本文献已被 ScienceDirect 等数据库收录！ |
|
