Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA.
World J Biol Psychiatry. 2009;10(4 Pt 2):435-41. doi: 10.1080/15622970902789155.
We conducted a post-hoc analysis to determine whether a history of physical or sexual abuse was associated with response to treatment in a double-blind, randomized, placebo-controlled trial of paroxetine controlled release (CR) in fibromyalgia.
A randomized, double-blind, placebo-controlled trial of paroxetine controlled release (CR) (dose 12.5-62.5 mg/day) was conducted in patients with fibromyalgia for 12 weeks. A total of 112 subjects provided complete information on childhood history of abuse that was recorded using the Sexual and Physical Abuse Questionnaire and randomized to treatments. Outcome evaluations in the abuse subgroup were identical to those in the entire sample. Health Status was determined using the 36-Item Short Form Health Survey (SF-36), the Sheehan Disability Scale (SDS), and the Perceived Stress Scale (PSS). Fibromylagia symptom severity was determined using the Fibromyalgia Impact Questionnaire (FIQ) and the Visual Analogue Scale for Pain (VAS). The primary outcome was treatment response defined as > or = 25% reduction in the FIQ-total score. Secondary outcomes include changes in scores on the Clinical Global Impression-Severity and Improvement (CGI-S and CGI-I respectively) and SF-36.
The rate of childhood physical and/or sexual abuse was 52.7% (n=59). The baseline characteristics (health status, perceived stress, symptom severity) were not associated with abuse history. In logistic regression, the history of abuse did not predict treatment response as measured by > or = 25% reduction in FIQ-total score (OR = 1.16, 95% CI = 1.18-1.60, P = 0.35), while the drug status (paroxetine CR) was significantly associated with treatment response (OR = 2.51, 95% CI = 1.12-5.64, P = 0.02). Abuse history did not predict CGI-I (P = 0.32) or CGI-S (P = 0.74) improvements during treatment. After 12 weeks of treatment, subjects with sexual abuse history showed significantly lower mean change in health status (SF-36) than those without sexual abuse history (P = 0.04).
Although, a significant proportion of patients with fibromyalgia reported a history of abuse, it does not appear to have any significant clinical correlates at baseline. History of abuse did not predict response to treatment in patients with fibromyalgia participating in a controlled trial of paroxetine controlled release. Prospective, well-designed studies are needed to confirm whether selective serotonin uptake inhibitors are effective in patients with fibromyalgia irrespective of their abuse history.
我们进行了一项事后分析，以确定在一项氟西汀控释剂（CR）治疗纤维肌痛的双盲、随机、安慰剂对照试验中，身体或性虐待史是否与治疗反应相关。
对 112 例纤维肌痛患者进行了氟西汀控释剂（CR）（剂量 12.5-62.5mg/天）的随机、双盲、安慰剂对照试验，为期 12 周。共有 112 例患者提供了完整的童年虐待史信息，使用性和身体虐待问卷记录，并随机分组进行治疗。在整个样本中，对滥用亚组的疗效评估是相同的。健康状况采用 36 项简短健康调查问卷（SF-36）、Sheehan 残疾量表（SDS）和感知压力量表（PSS）进行评估。纤维肌痛症状严重程度采用纤维肌痛影响问卷（FIQ）和疼痛视觉模拟量表（VAS）进行评估。主要结局为 FIQ 总分降低≥25%的治疗反应定义。次要结局包括临床总体印象严重程度和改善评分（CGI-S 和 CGI-I）以及 SF-36 的变化。
儿童期身体和/或性虐待的发生率为 52.7%（n=59）。基线特征（健康状况、感知压力、症状严重程度）与虐待史无关。在逻辑回归中，虐待史不能预测治疗反应，即 FIQ 总分降低≥25%（OR=1.16，95%CI=1.18-1.60，P=0.35），而药物状态（氟西汀 CR）与治疗反应显著相关（OR=2.51，95%CI=1.12-5.64，P=0.02）。虐待史不能预测 CGI-I（P=0.32）或 CGI-S（P=0.74）的改善。经过 12 周的治疗，有性虐待史的患者健康状况（SF-36）的平均变化显著低于无性虐待史的患者（P=0.04）。
尽管相当一部分纤维肌痛患者报告有虐待史，但在基线时似乎没有任何显著的临床相关性。在参加氟西汀控释剂对照试验的纤维肌痛患者中，虐待史不能预测治疗反应。需要前瞻性、精心设计的研究来证实选择性 5-羟色胺再摄取抑制剂是否对有或无虐待史的纤维肌痛患者有效。
