Inada Toshiya, Nozaki Shoko, Inagaki Ataru, Furukawa Toshiaki A
Department of Psychiatry and Psychobiology, Nagoya University, Graduate School of Medicine, 65 Tsurumai, Nagoya, Japan.
Hum Psychopharmacol. 2003 Aug;18(6):483-7. doi: 10.1002/hup.510.
Diazepam is one of the most widely used, broad-spectrum anti-anxiety agents. The aim of this study was to evaluate the efficacy of diazepam, and to establish whether it is more effective than a placebo in improving the various neurotic anxiety states seen in patients with neurosis or psychosomatic disease. Of the recently established comprehensive register of psychotropic drug trials carried out in Japan, a total of 17 double-blind, randomized controlled trials were identified on the treatment of neurosis using anti-anxiety compounds, in which both diazepam and placebos were used. Meta-analysis of these 17 studies demonstrated that diazepam is significantly more effective than a placebo (relative risk 1.35, 95% confidence interval 1.21-1.51, number needed to treat 9). The maximal effective dose of diazepam seems to be 12 or 18 mg/day with a treatment duration of 2 or more weeks. There was no significant difference between the effects of placebo and a diazepam dose of 6 mg/day. Caution should be exercised in assessing these results, however, since this is the first meta-analysis showing the significant effectiveness of diazepam in the treatment of neurosis or psychosomatic disease.
地西泮是使用最广泛的广谱抗焦虑药物之一。本研究的目的是评估地西泮的疗效，并确定其在改善神经症或心身疾病患者出现的各种神经质性焦虑状态方面是否比安慰剂更有效。在日本最近建立的精神药物试验综合登记册中，共确定了17项使用抗焦虑化合物治疗神经症的双盲随机对照试验，其中同时使用了地西泮和安慰剂。对这17项研究的荟萃分析表明，地西泮比安慰剂显著更有效（相对风险1.35，95%置信区间1.21 - 1.51，需治疗人数9）。地西泮的最大有效剂量似乎为12或18毫克/天，治疗持续时间为2周或更长时间。安慰剂与6毫克/天地西泮剂量的效果之间无显著差异。然而，在评估这些结果时应谨慎，因为这是第一项显示地西泮在治疗神经症或心身疾病方面具有显著疗效的荟萃分析。
