Gabapentin, estrogen, and placebo for treating hot flushes: a randomized controlled trial.
Gabapentin, estrogen, and placebo for treating hot flushes: a randomized controlled trial.
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加巴喷丁、雌激素和安慰剂治疗潮热：一项随机对照试验。
DOI：
10.1097/01.aog.0000222383.43913.ed
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发表时间：
2006
影响因子：
7.2
通讯作者：
Guzick,DavidS
中科院分区：
文献类型：
--
作者：
Reddy,SireeshaY;Warner,Hiral;GuttusoJr,Thomas;Messing,Susan;DiGrazio,William;Thornburg,Loralei;Guzick,DavidS
目的：比较加巴喷丁、雌激素和安慰剂治疗潮热的疗效。方法：采用随机、双盲、安慰剂对照试验，对60例绝经后妇女进行雌激素和加巴喷丁治疗中重度潮热的疗效评价。参与者被随机分配到接受0.625 mg/d的结合雌激素(n=20)、安慰剂(n=20)或加巴喷丁(n=20)，滴定至2400 mg/d(n=20)，为期12周。受试者在随机化前2周和随机化后12周在潮热日记上记录基线潮热的频率和严重程度。主要的结果衡量标准是每周潮热综合评分，它同时考虑了潮热的严重程度和频率。次要结果指标是治疗前后抑郁(Zung抑郁量表)和其他更年期症状(Greene更年期量表)评分的差异。结果：意向处理分析显示，两种雌激素治疗后潮热综合评分下降了72%，P=。016)和加巴喷丁(71%，P=.004)大于第12周结束时与安慰剂相关的降幅(54%)。然而，雌激素和加巴喷丁对潮热综合评分的降低程度没有显著差异(P=。63)。在Zung抑郁量表或任何Greene更年期子量表上，两组之间没有差异，除了躯体症状组，加巴喷丁组明显大于安慰剂组。尽管在不良事件方面没有组间差异，但头痛、头晕和定向障碍在加巴喷丁组出现的频率更高。对这组患者所需的伤害数量的估计表明，每四名患者中就可能出现这些症状。结论：尽管这项研究规模较小，加巴喷丁在治疗绝经后潮热方面似乎与雌激素一样有效。临床试验登记：临床试验。GOV，NCT 00276081.证据水平：伊卡巴喷丁是治疗潮热的雌激素的有效替代品。大约75%的更年期妇女经历潮热和其他更年期症状。1-3雌激素是治疗潮热和相关更年期症状的有效方法。然而，最近的数据表明，给更年期妇女服用雌激素可能与某些风险有关。一级和二级预防试验6和7不仅得出结论，雌激素对老年更年期妇女预防心脏病无效，而且在治疗的第一年，雌激素增加了冠状动脉和血栓栓塞事件的风险。此外，妇女健康倡议的证据表明，与雌激素使用有关的乳腺癌风险增加6，并可能增加阿尔茨海默病的风险。8尽管未来对年轻、围绝经期妇女的雌激素研究9可能会或可能不会证实这些与雌激素相关的健康风险，但许多进入更年期的妇女现在不愿服用雌激素。需要一种有效和安全的替代方案。
OBJECTIVE:To compare the efficacy of gabapentin, estrogen, and placebo in the treatment of hot flushes.METHODS: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).RESULTS: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.CONCLUSION:Despite the small scale of this study, gabapentin appears to be as effective as estrogen in the treatment of postmenopausal hot flushes.CLINICAL TRIAL REGISTRATION:Clinicaltrials. gov, NCT 00276081.LEVEL OF EVIDENCE:IGabapentin is an effective alternative to estrogen for the treatment of hot flushes.Approximately 75% of menopausal women experience hot flushes and other symptoms of the climacteric. 1–3 Estrogen is an effective treatment for hot flushes and associated menopausal symptoms. 4, 5 Recent data, however, indicate that administration of estrogen to menopausal women may be associated with some risk. Both primary and secondary prevention trials 6, 7 have not only concluded that estrogen is ineffective in preventing heart disease among older menopausal women, but that estrogen increases the risk of coronary and thromboembolic events during the first year of treatment. Moreover, evidence from the Women’s Health Initiative points to an increased risk of breast cancer associated with estrogen use 6 and possibly an increased risk of Alzheimer’s disease. 8 Although future studies of estrogen in younger, perimenopausal women 9 may or may not confirm these estrogen-associated health risks, many women entering menopause are now reluctant to take estrogen. An efficacious and safe alternative is needed.
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影响因子：
9.8
作者：
Archer, David F.;Dupont, Caroline M.;Olivier, Sophie
通讯作者：
Olivier, Sophie
影响因子：
2
作者：
Imai, Atsushi;Matsunami, Kazutoshi;Ichigo, Satoshi
通讯作者：
Ichigo, Satoshi
DOI：
10.1097/gme.0000000000000320
发表时间：
2015-03-01
影响因子：
2.7
作者：
Sarrel, Philip;Portman, David;Aupperle, Peter M.
通讯作者：
Aupperle, Peter M.
血管舒缩症状的激素和非激素治疗。
影响因子：
3.2
作者：
M. Krause;S. Nakajima
通讯作者：
S. Nakajima
琥珀酸去甲文拉法辛治疗更年期血管舒缩症状的疗效和耐受性：随机对照试验
影响因子：
7.2
作者：
L. Speroff;M. Gass;G. Constantine;S. Olivier
通讯作者：
S. Olivier