Goldbloom D S, Olmsted M P
Department of Psychiatry, Toronto Hospital, Ont., Canada.
Am J Psychiatry. 1993 May;150(5):770-4. doi: 10.1176/ajp.150.5.770.
The authors used an individual change model to examine the clinically significant effect of pharmacotherapy with fluoxetine on the attitudes and beliefs characteristic of bulimia nervosa.
Three hundred eighty-two women meeting DSM-III-R criteria for bulimia nervosa participated in a multicenter, double-blind, randomized clinical trial of placebo, 20 mg of fluoxetine, and 60 mg of fluoxetine for 8 weeks. Behavioral change was assessed with self-monitored measures of binge eating and purging, and psychological change was measured with the self-rating Eating Disorder Inventory and the Hamilton Rating Scale for Depression. A specific statistical method was used to determine clinically significant change in psychological measures.
On the majority of psychological measures, more of the subjects receiving active drug than those receiving placebo showed clinically significant change. Behavioral improvement was significantly associated with the likelihood of demonstrating clinically significant psychological change. The observed effect of pharmacotherapy on attitudinal change was not related to the presence of depression at baseline. These results compare favorably with other interventions for bulimia nervosa.
Measures of change in treatment studies should reflect clinical as well as statistical significance. In the short-term, treatment of bulimia nervosa with fluoxetine appears to produce clinically significant attitudinal and behavioral changes.
作者采用个体变化模型来检验氟西汀药物治疗对神经性贪食症的态度和信念特征的临床显著效果。
382名符合《精神疾病诊断与统计手册第三版修订版》（DSM-III-R）神经性贪食症标准的女性参与了一项多中心、双盲、随机临床试验，分别接受安慰剂、20毫克氟西汀和60毫克氟西汀治疗，为期8周。通过自我监测的暴饮暴食和清除行为来评估行为变化，并用自评饮食失调量表和汉密尔顿抑郁评定量表来测量心理变化。使用一种特定的统计方法来确定心理测量指标的临床显著变化。
在大多数心理测量指标上，接受活性药物治疗的受试者比接受安慰剂治疗的受试者有更多出现临床显著变化。行为改善与出现临床显著心理变化的可能性显著相关。观察到的药物治疗对态度变化的效果与基线时是否存在抑郁无关。这些结果优于其他针对神经性贪食症的干预措施。
治疗研究中的变化测量应反映临床意义和统计学意义。短期内，用氟西汀治疗神经性贪食症似乎能产生临床显著的态度和行为变化。
