Finzi Eric, Rosenthal Norman E
Chevy Chase Cosmetic Center, Chevy Chase, MD 20815, USA.
Capital Clinical Research Associates, Rockville, MD 20852, USA; Georgetown Medical School, Washington, DC 20057, USA.
J Psychiatr Res. 2014 May;52:1-6. doi: 10.1016/j.jpsychires.2013.11.006. Epub 2013 Dec 1.
Converging lines of evidence suggest a role for facial expressions in the pathophysiology and treatment of mood disorders. To determine the antidepressant effect of onabotulinumtoxinA (OBA) treatment of corrugator and procerus muscles in people with major depressive disorder, we conducted a double blind, randomized, placebo-controlled trial. In an outpatient clinical research center, eighty-five subjects with DSM-IV major depression were randomized to receive either OBA (29 units for females and 40 units for males) or saline injections into corrugator and procerus frown muscles (74 subjects were entered into the analysis). Subjects were rated at screening, and 3 and 6 weeks after OBA treatment. The primary outcome measure was the response rate, as defined by ≥ 50% decrease in score on the Montgomery-Asberg Depression Rating Scale (MADRS). Response rates at 6 weeks from the date of injection were 52% and 15% in the OBA and placebo groups, respectively (Chi-Square (1) = 11.2, p < 0.001, Fisher p < 0.001). The secondary outcome measure of remission rate (MADRS score of 10 or less) was 27% with OBA and 7% with placebo (Chi-square (1) = 5.1, p < 0.02, Fisher p < 0.03). Six weeks after a single treatment, MADRS scores of subjects were reduced on average by 47% in those given OBA, and by 21% in those given placebo (Mann-Whitney U, p < 0.0005). In conclusion, a single treatment with OBA to the corrugator and procerus muscles appears to induce a significant and sustained antidepressant effect in patients with major depression.
clinicaltrials.gov Identifier: NCT01556971.
越来越多的证据表明面部表情在情绪障碍的病理生理学和治疗中发挥作用。为了确定A型肉毒毒素（OBA）治疗重度抑郁症患者皱眉肌和降眉间肌的抗抑郁效果，我们进行了一项双盲、随机、安慰剂对照试验。在一个门诊临床研究中心，85名符合《精神疾病诊断与统计手册》第四版（DSM-IV）重度抑郁症诊断标准的受试者被随机分为两组，分别接受OBA（女性29单位，男性40单位）或向皱眉肌和降眉间肌注射生理盐水（74名受试者纳入分析）。在筛选时、OBA治疗后3周和6周对受试者进行评分。主要结局指标是缓解率，定义为蒙哥马利-阿斯伯格抑郁评定量表（MADRS）评分降低≥50%。从注射之日起6周时，OBA组和安慰剂组的缓解率分别为52%和15%（卡方检验（1）=11.2，p<0.001，费舍尔检验p<0.001）。次要结局指标缓解率（MADRS评分为10分或更低）在OBA组为27%，在安慰剂组为7%（卡方检验（1）=5.1，p<0.02，费舍尔检验p<0.03）。单次治疗6周后，接受OBA治疗的受试者MADRS评分平均降低47%，接受安慰剂治疗的受试者平均降低21%（曼-惠特尼U检验，p<0.0005）。总之，单次使用OBA治疗皱眉肌和降眉间肌似乎能在重度抑郁症患者中诱导出显著且持续的抗抑郁效果。
clinicaltrials.gov标识符：NCT01556971。
