Berlant Jeffrey
Dr. Berlant is from the Clinical Faculty, Department of Psychiatry, University of Washington, Seattle.
Psychiatry (Edgmont). 2006 Mar;3(3):40-5.
Since the original publication of open-label suggestions of efficacy of adjunctive and monotherapy topiramate as a novel therapy for chronic posttraumatic stress disorder, three small, double-blind, placebo-controlled clinical trials conducted as pilot trials have been made public. The results of these studies, including efficacy, termination rates, and adverse effects resulting in termination are reviewed critically, including methodological limitations to interpretation of the findings. One study finds separation from placebo over 12 weeks for a reduction in total CAPS scores with a large effect size (d=1.63); a second finds significant benefit for re-experiencing but not total CAPS scores; and a third finds numerical superiority for topiramate but no significant benefit for any score reduction. Several problems, including unexpectedly high dropout rates in one study, limit the generalizability of these findings, but overall there is a signal of potential efficacy that warrants more adequately powered future clinical trials.
自从最初公开关于托吡酯辅助治疗和单一疗法作为慢性创伤后应激障碍新疗法的疗效的开放标签建议以来,三项作为试点试验进行的小型双盲、安慰剂对照临床试验已经公布。对这些研究的结果进行了批判性审查,包括疗效、终止率以及导致终止的不良反应,还包括对研究结果解释的方法学局限性。一项研究发现,在12周内与安慰剂分离,总儿童创伤后应激障碍症状量表(CAPS)评分降低,效应量较大(d = 1.63);第二项研究发现,在重新体验方面有显著益处,但总CAPS评分没有显著变化;第三项研究发现托吡酯在数值上占优,但在任何评分降低方面没有显著益处。包括一项研究中意外高的脱落率在内的几个问题,限制了这些发现的普遍性,但总体而言,有潜在疗效的信号,值得未来进行更有充分效力的临床试验。