Naudé David Francis, Stephanie Couchman Ingrid Marcelline, Maharaj Ashnie
Department of Homoeopathy, Faculty of Health Sciences, Durban University of Technology, P.O. Box 1334, Durban 4000, South Africa.
Homeopathy. 2010 Jan;99(1):63-8. doi: 10.1016/j.homp.2009.11.001.
Chronic primary insomnia is defined as difficulty in initiating or maintaining sleep or of non-restorative sleep that lasts for at least 1 month and causes significant distress or impairment in social, occupational or other important areas of functioning. The homeopathic simillimum is that remedy which most closely corresponds to the totality of symptoms; remedy selection is based on a full evaluation of the patient's physical, emotional and mental characteristics.
AIM/PURPOSE: The purpose of this randomised, double-blind, placebo-controlled study was to evaluate the efficacy of homeopathic simillimum in the treatment of chronic primary insomnia.
30 participants were selected in accordance with DSM-IV TR (2000)(1) criterion 307.42 Primary Insomnia and then randomly divided between treatment and placebo groups. The measurement tools used were a Sleep Diary (SD) and the Sleep Impairment Index (SII).(2) After an initial consultation, 2 follow-up consultations at 2-week intervals took place. Homeopathic medication was prescribed at the first and second consultations. The SII was completed at each consultation and participants were instructed at the first consultation to start the SD.
SD data revealed that verum treatment resulted in a significant increase in duration of sleep throughout the study, compared to the placebo treatment which resulted in no significant increase in duration of sleep. A significant improvement in SII summary scores and number of improved individual questions were found in the verum group, responses to all 11 questions having improved significantly upon completion of the study. An initial improvement occurred in the placebo group, but was not sustained. Comparison of results between the groups revealed a statistically significant difference.
The homeopathic simillimum treatment of primary insomnia was effective, compared to placebo. Homeopathy is a viable treatment modality for this condition and further research is justified.
慢性原发性失眠的定义为入睡困难或维持睡眠困难，或睡眠不能恢复精力，持续至少1个月，并在社交、职业或其他重要功能领域造成明显痛苦或损害。顺势疗法中的最相似药物是指与全部症状最相符的药物；药物选择基于对患者身体、情感和心理特征的全面评估。
本随机、双盲、安慰剂对照研究的目的是评估顺势疗法中最相似药物治疗慢性原发性失眠的疗效。
根据《精神疾病诊断与统计手册》第四版修订版（2000年）（1）标准307.42原发性失眠选取30名参与者，然后随机分为治疗组和安慰剂组。使用的测量工具为睡眠日记（SD）和睡眠损害指数（SII）。（2）在初次咨询后，每隔2周进行2次随访咨询。在第一次和第二次咨询时开具顺势疗法药物。每次咨询时完成SII，在第一次咨询时指导参与者开始记录SD。
SD数据显示，与安慰剂治疗组睡眠时长无显著增加相比，在整个研究过程中，真药治疗组的睡眠时长显著增加。真药组的SII总分及改善的单个问题数量有显著改善，在研究结束时，对所有11个问题的回答均有显著改善。安慰剂组最初有改善，但未持续。两组结果比较显示有统计学显著差异。
与安慰剂相比，顺势疗法中最相似药物治疗原发性失眠有效。顺势疗法是治疗这种疾病的一种可行治疗方式，值得进一步研究。
