Trazodone for the treatment of insomnia: a meta-analysis of randomized placebo-controlled trials
Trazodone for the treatment of insomnia: a meta-analysis of randomized placebo-controlled trials
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曲唑酮治疗失眠：随机安慰剂对照试验的荟萃分析
DOI：
10.1016/j.sleep.2018.01.010
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发表时间：
2018
期刊：
影响因子：
4.8
通讯作者：
Zhou Xin yu
中科院分区：
文献类型：
--
作者：
Yi Xiao yan;Ni Shi fen;Ghadami Mohammad Rasoul;Meng Hua qing;Chen Ming yan;Kuang Li;Zhang Yu qing;Zhang Li;Zhou Xin yu
目的比较曲唑酮与安慰剂治疗失眠症的疗效和耐受性。方法检索电子数据库，手工筛选相关报告，筛选符合条件的试验。仅纳入随机安慰剂对照试验。采用随机效应模型估计标准化平均差异（SMD）和优势比（OR）。主要疗效指标包括睡眠效率（SE%）和自我报告睡眠质量（SQ）。次要疗效指标包括睡眠潜伏期（SL）、总睡眠时间（TST）、醒来次数（NAs）、睡眠后醒来时间（WASO）。耐受性结果通过因不良事件停药的患者数量来衡量，可接受性结果通过因所有原因停药的患者数量来衡量。结果纳入7项试验，429例患者。曲唑酮在SE%方面无显著改善（SMD = 0.09, 95%可信区间(CI) - 0.19 ~ 0.38，P= 0.53），异质性不显著（I2= 0%，P= 0.59）。然而，曲唑酮组患者的SQ优于安慰剂组（SMD = - 0.41, 95% CI = - 0.82至- 0.00，P= 0.05），且不存在显著的中度异质性（I2= 65%，P= 0.06）。至于次要疗效结果，我们发现与安慰剂相比，曲唑酮在NAs中的显著降低（SMD = - 0.51, 95%CI - 0.97至- 0.05），而曲唑酮与安慰剂在SL、TST或WASO方面无显著差异。此外，耐受性和可接受性的结果没有明显差异。结论氟唑酮可通过减少早醒次数有效维持睡眠，可显著改善感知睡眠质量，但对睡眠效率及其他客观指标无明显改善。曲唑酮短期治疗失眠症耐受性较好。
ObjectiveTo assess the efficacy and tolerability of trazodone compared with placebo in patients with insomnia.MethodsElectronic databases were searched and relevant reports were hand-screened to identify eligible trials. Only randomized placebo-controlled trials were included. Standardized mean differences (SMD) and the odds ratios (OR) were estimated using a random-effect model. Primary efficacy outcomes included sleep efficiency (SE%) and self-reported sleep quality (SQ). Secondary efficacy outcomes included sleep latency (SL), total sleep time (TST), the number of awakenings (NAs), waking time after sleep onset (WASO). Tolerability outcome was measured by the number of patients who discontinued for adverse events and acceptability outcome was measured by the number of patients who discontinued for all causes.ResultsSeven trials involving 429 patients were included. There was no significant improvement for trazodone in SE% (SMD = 0.09, 95% confidence interval (CI) −0.19 to 0.38,P= 0.53) with a non-significant heterogeneity (I2= 0%,P= 0.59). However, patients receiving trazodone perceived better SQ than those receiving the placebo (SMD = −0.41, 95% CI −0.82 to −0.00,P= 0.05) with a non-significantly moderate heterogeneity (I2= 65%,P= 0.06). As to secondary efficacy outcomes, we only found a significant reduction for trazodone in NAs (SMD = −0.51, 95%CI −0.97 to −0.05) compared to the placebo, with non-significant differences found in SL, TST, or WASO between trazodone and placebo. Moreover, no significant difference was found in the outcome of tolerability or acceptability.ConclusionsTrazodone was effective in sleep maintenance by decreasing the number of early awakenings and it could significantly improve perceived sleep quality, although there were no significant improvements in sleep efficiency or other objective measures. Trazodone however, presented good tolerance in the short-term treatment of insomnia.