Instituto de Neurociencias y Centro de Investigaciones Biomédicas, Universidad de Granada, Granada, Spain.
BMC Musculoskelet Disord. 2010 Sep 10;11:204. doi: 10.1186/1471-2474-11-204.
Despite its frequent use as a hypnotic, trazodone has not been systematically assessed in fibromyalgia patients. In the present study have we evaluated the potential effectiveness and tolerability of trazodone in the treatment of fibromyalgia.
A flexible dose of trazodone (50-300 mg/day), was administered to 66 fibromyalgia patients for 12 weeks. The primary outcome measure was the Pittsburgh Sleep Quality Index (PSQI). Secondary outcome measures included the Fibromyalgia Impact Questionnaire (FIQ), the Beck Depression Inventory (BDI), the Hospital Anxiety and Depression Scale (HADS), the Brief Pain Inventory (BPI), the Short-Form Health Survey (SF-36), and the Patients' Global Improvement Scale (PGI). Trazodone's emergent adverse reactions were recorded. Data were analyzed with repeated measures one-way ANOVA and paired Student's t test.
Trazodone markedly improved sleep quality, with large effect sizes in total PSQI score as well on sleep quality, sleep duration and sleep efficiency. Significant improvement, although with moderate effect sizes, were also observed in total FIQ scores, anxiety and depression scores (both HADS and BDI), and pain interference with daily activities. Unexpectedly, the most frequent and severe side effect associated with trazodone in our sample was tachycardia, which was reported by 14 (21.2%) patients.
In doses higher than those usually prescribed as hypnotic, the utility of trazodone in fibromyalgia management surpasses its hypnotic activity. However, the emergence of tachycardia should be closely monitored.
This trial has been registered with ClinicalTrials.gov number NCT-00791739.
尽管曲唑酮常被用作催眠药，但尚未在纤维肌痛患者中进行系统评估。在本研究中，我们评估了曲唑酮治疗纤维肌痛的潜在疗效和耐受性。
对 66 例纤维肌痛患者给予曲唑酮（50-300mg/天）的灵活剂量，治疗 12 周。主要疗效指标为匹兹堡睡眠质量指数（PSQI）。次要疗效指标包括纤维肌痛影响问卷（FIQ）、贝克抑郁量表（BDI）、医院焦虑抑郁量表（HADS）、简明疼痛量表（BPI）、健康调查简表（SF-36）和患者总体改善量表（PGI）。记录曲唑酮的不良反应。采用重复测量的单因素方差分析和配对学生 t 检验进行数据分析。
曲唑酮显著改善了睡眠质量，PSQI 总分及睡眠质量、睡眠时间和睡眠效率的效应量较大。FIQ 总分、焦虑和抑郁评分（HADS 和 BDI）以及疼痛对日常活动的干扰也有显著改善，尽管效应量适中。出乎意料的是，曲唑酮在我们的样本中最常见和最严重的副作用是心动过速，有 14 例（21.2%）患者报告了心动过速。
在高于通常作为催眠药的剂量下，曲唑酮在纤维肌痛管理中的效用超过其催眠作用。然而，应密切监测心动过速的发生。
本试验已在 ClinicalTrials.gov 注册号 NCT-00791739 下注册。
