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托吡酯治疗神经性贪食症的随机、双盲、安慰剂对照试验,第2部分:精神指标改善情况

Treatment of bulimia nervosa with topiramate in a randomized, double-blind, placebo-controlled trial, part 2: improvement in psychiatric measures.

作者信息

Hedges Dawson W, Reimherr Frederick W, Hoopes Scott P, Rosenthal Norman R, Kamin Marc, Karim Rezaul, Capece Julie A

机构信息

Department of Psychology, Brigham Young University, Provo, Utah 84602, USA.

出版信息

J Clin Psychiatry. 2003 Dec;64(12):1449-54. doi: 10.4088/jcp.v64n1208.

DOI:10.4088/jcp.v64n1208
PMID:14728106
Abstract

BACKGROUND

We conducted a 10-week, randomized, double-blind, placebo-controlled trial to examine the efficacy of topiramate in the treatment of bulimia nervosa. Primary efficacy analyses showed that topiramate treatment significantly reduced days on which patients binged and/or purged. This article describes further analyses investigating topiramate's effect on psychological symptoms associated with disordered eating.

METHOD

Patients with DSM-IV bulimia nervosa were randomly assigned to receive topiramate (N = 35) or placebo (N = 34) for 10 weeks. Topiramate treatment was started at 25 mg/day and titrated by 25 to 50 mg/week to a maximum of 400 mg/day. Secondary psychiatric endpoints, including the Eating Disorder Inventory (EDI), Eating Attitudes Test (EAT), Hamilton Rating Scale for Anxiety (HAM-A), Hamilton Rating Scale for Depression (HAM-D), and Patient Global Improvement (PGI) were assessed for change from baseline in the topiramate versus placebo group.

RESULTS

Thirty-one patients receiving topiramate and 33 receiving placebo were included in the intent-to-treat analysis. Percent change from baseline on the EDI indicated significantly greater improvement in the topiramate group compared with the placebo group for subscales measuring bulimia/uncontrollable overeating (p =.005), body dissatisfaction (p =.007), and drive for thinness (p =.002). The EAT showed significant improvement in the topiramate group compared with the placebo group for the bulimia/food preoccupation (p =.019) and dieting (p =.031) subscales and the total score (p =.022). For the topiramate group, the reduction in mean HAM-A score was significantly greater (p =.046) than that in the placebo group, while reduction in HAM-D scores was greater in the topiramate group compared with the placebo group but did not reach statistical significance (p =.069). Significantly more patients treated with topiramate compared with placebo reported improvement on the PGI (p =.004).

CONCLUSION

Topiramate treatment improves multiple behavioral dimensions of bulimia nervosa. Binge and purge behaviors are reduced, and treatment is associated with improvements in self-esteem, eating attitudes, anxiety, and body image. These results support topiramate as a viable therapeutic option for the treatment of bulimia nervosa. Additional, longer-term multicenter trials are indicated.

摘要

背景

我们开展了一项为期10周的随机双盲安慰剂对照试验,以研究托吡酯治疗神经性贪食症的疗效。主要疗效分析表明,托吡酯治疗能显著减少患者暴饮暴食和/或催吐的天数。本文描述了进一步的分析,以研究托吡酯对与饮食失调相关的心理症状的影响。

方法

将符合《精神疾病诊断与统计手册》第四版(DSM-IV)标准的神经性贪食症患者随机分为两组,分别接受托吡酯治疗(N = 35)或安慰剂治疗(N = 34),为期10周。托吡酯治疗起始剂量为25毫克/天,每周递增25至50毫克,最大剂量为400毫克/天。评估次要精神科终点,包括饮食失调问卷(EDI)、饮食态度测试(EAT)、汉密尔顿焦虑量表(HAM-A)、汉密尔顿抑郁量表(HAM-D)以及患者整体改善情况(PGI),比较托吡酯组与安慰剂组从基线开始的变化。

结果

意向性分析纳入了31例接受托吡酯治疗的患者和33例接受安慰剂治疗的患者。EDI量表中,与安慰剂组相比,托吡酯组在测量神经性贪食/无法控制的暴饮暴食(p = 0.005)、身体不满(p = 0.007)和追求瘦身(p = 0.002)的分量表上,从基线的百分比变化显示出显著更大的改善。EAT量表中,托吡酯组在神经性贪食/食物关注(p = 0.019)、节食(p = 0.031)分量表及总分(p = 0.022)方面与安慰剂组相比有显著改善。对于托吡酯组,HAM-A量表平均得分的降低显著大于安慰剂组(p = 0.046),而托吡酯组HAM-D量表得分的降低幅度大于安慰剂组,但未达到统计学显著性(p = 0.069)。与安慰剂组相比,接受托吡酯治疗的患者在PGI上报告改善的人数显著更多(p = 0.004)。

结论

托吡酯治疗可改善神经性贪食症的多个行为维度。暴饮暴食和催吐行为减少,且治疗与自尊、饮食态度、焦虑和身体形象的改善相关。这些结果支持托吡酯作为治疗神经性贪食症的一种可行治疗选择。还需要进行更多的长期多中心试验。

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