Wyatt R J, Henter I D, Bartko J J
National Institute of Mental Health, National Institutes of Health, Bethesda, Maryland 20892, USA.
Biol Psychiatry. 1999 Oct 15;46(8):1092-105. doi: 10.1016/s0006-3223(99)00227-9.
It has been hypothesized that placebo periods may increase long-term morbidity for patients with schizophrenia. In this study, the long-term effect of a placebo period was evaluated in a group of relatively treatment-refractory patients with chronic schizophrenia.
This retrospective study examined behavioral rating scores for 127 patients with chronic schizophrenia who were placed in a double-blind placebo study on the inpatient units of the National Institute of Mental Health Neuropsychiatric Research Hospital. Patients were rated daily with the Psychiatric Symptom Assessment Scale (PSAS), an extended and anchored version of the Brief Psychiatric Rating Scale (BPRS). At the end of the placebo phase, most patients were placed on haloperidol. Pre-placebo baseline PSAS ratings were compared with, first, discharge ratings and second, post-placebo ratings. To determine expected variability in the course of illness, patients in the placebo group were compared with patients hospitalized during the same time period, but who did not enter the placebo study.
By discharge, ratings for placebo patients had returned to baseline. Post-placebo ratings were quite variable. Although many of the placebo patients had returned to baseline by day 3 of the post-placebo phase, others had not returned to baseline by post-placebo day 42. PSAS Total Scores for patients who left the study early were no different at baseline, placebo, or through post-placebo day 35 compared with patients who completed the study.
The results indicate that given a sufficiently lengthy recovery period, patients with chronic schizophrenia who go through a placebo phase return to baseline, but that the speed with which they attain that recovery is highly variable.
有假设认为，安慰剂期可能会增加精神分裂症患者的长期发病率。在本研究中，对一组相对难治的慢性精神分裂症患者进行了安慰剂期的长期效果评估。
这项回顾性研究检查了127名慢性精神分裂症患者的行为评分，这些患者在国立精神卫生神经精神病学研究所医院的住院部接受了双盲安慰剂研究。患者每天使用精神症状评估量表（PSAS）进行评分，该量表是简明精神病评定量表（BPRS）的扩展版且有锚定标准。在安慰剂阶段结束时，大多数患者开始服用氟哌啶醇。将安慰剂前的基线PSAS评分首先与出院时的评分进行比较，其次与安慰剂后的评分进行比较。为了确定疾病过程中的预期变异性，将安慰剂组的患者与同一时期住院但未进入安慰剂研究的患者进行比较。
到出院时，安慰剂组患者的评分已恢复到基线水平。安慰剂后的评分差异很大。尽管许多安慰剂组患者在安慰剂后阶段的第3天已恢复到基线水平，但其他患者在安慰剂后第42天仍未恢复到基线水平。与完成研究的患者相比，提前退出研究的患者在基线、安慰剂阶段或安慰剂后第35天的PSAS总分没有差异。
结果表明，给予足够长的恢复期后，经历安慰剂阶段的慢性精神分裂症患者会恢复到基线水平，但他们恢复到该水平的速度差异很大。
