Reddy Sireesha Y, Warner Hiral, Guttuso Thomas, Messing Susan, DiGrazio William, Thornburg Loralei, Guzick David S
Department of Obstetrics and Gynecology, University of Rochester School of Medicine and Dentistry, Rochester, New York 14642, USA.
Obstet Gynecol. 2006 Jul;108(1):41-8. doi: 10.1097/01.AOG.0000222383.43913.ed.
To compare the efficacy of gabapentin, estrogen, and placebo in the treatment of hot flushes.
We performed a randomized, double-blind, placebo-controlled trial of 60 postmenopausal women to assess the efficacy of estrogen and gabapentin in the treatment of moderate-to-severe hot flushes. Participants were randomly assigned to receive either 0.625 mg/d of conjugated estrogens (n = 20), placebo (n = 20), or gabapentin titrated to 2,400 mg/d (n = 20) for 12 weeks. Participants recorded frequency and severity of baseline hot flushes on a hot flush diary for 2 weeks before randomization and for 12 weeks after randomization. The primary outcome measure was the weekly hot flush composite score, which takes into account both severity and frequency of hot flushes. Secondary outcome measures were differences in pre- and posttreatment scores pertaining to depression (Zung Depression Scale) and other climacteric symptoms (Greene Climacteric Scale).
Intention-to-treat analysis showed that the reduction in the hot flush composite score for both estrogen (72%, P = .016) and gabapentin (71%, P = .004) was greater than the reduction associated with placebo (54%) at the conclusion of the 12th week. The extent of reduction in hot flush composite score, however, was not significantly different between estrogen and gabapentin (P = .63). No differences were seen between groups in the Zung Depression Scale, or in any of the Greene Climacteric subscales except for the Somatic Symptom cluster, which was significantly greater in the gabapentin arm than in the placebo arm. Despite a lack of group differences in adverse events, the Headache, Dizziness, and Disorientation cluster appeared with greater frequency in the gabapentin group. Estimation of the number needed to harm in this cluster suggests that these symptoms may occur with every fourth patient treated with gabapentin.
Despite the small scale of this study, gabapentin appears to be as effective as estrogen in the treatment of postmenopausal hot flushes.
Clinicaltrials.gov, NCT 00276081.
I.
比较加巴喷丁、雌激素和安慰剂治疗潮热的疗效。
我们对60名绝经后女性进行了一项随机、双盲、安慰剂对照试验，以评估雌激素和加巴喷丁治疗中度至重度潮热的疗效。参与者被随机分配接受以下治疗，为期12周：每日0.625毫克结合雌激素（n = 20）、安慰剂（n = 20）或滴定至每日2400毫克的加巴喷丁（n = 20）。参与者在随机分组前2周和随机分组后12周，通过潮热日记记录基线潮热的频率和严重程度。主要结局指标是每周潮热综合评分，该评分同时考虑了潮热的严重程度和频率。次要结局指标是治疗前后与抑郁（zung抑郁量表）和其他更年期症状（格林更年期量表）相关评分的差异。
意向性分析显示，在第12周结束时，雌激素组（72%，P = 0.016）和加巴喷丁组（71%，P = 0.004）潮热综合评分的降低幅度均大于安慰剂组（54%）。然而，雌激素组和加巴喷丁组潮热综合评分的降低程度无显著差异（P = 0.63）。在zung抑郁量表或格林更年期量表的任何子量表中，除躯体症状集群外，各组之间均无差异，加巴喷丁组的躯体症状集群显著高于安慰剂组。尽管不良事件在各组之间没有差异，但头痛、头晕和定向障碍集群在加巴喷丁组中出现的频率更高。对该集群中伤害所需人数的估计表明，每四名接受加巴喷丁治疗的患者中可能会出现这些症状。
尽管本研究规模较小，但加巴喷丁在治疗绝经后潮热方面似乎与雌激素一样有效。
Clinicaltrials.gov，NCT 00276081。
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