Koek Ralph J, Hejran Rhine N, Mintz Jim
Sepulveda Ambulatory Care Clinic, Veterans Affairs Greater Los Angeles Healthcare System, Los Angeles, California, USA.
Contemp Clin Trials. 2005 Jun;26(3):338-48. doi: 10.1016/j.cct.2005.02.002. Epub 2005 Mar 28.
The controlled trial is now the standard for assessing efficacy of new treatments in Psychiatry, as it is in the rest of medicine. Psychiatric outcomes with treatment are influenced by concurrent psychosocial factors. Psychotherapy, alone or in combination with pharmacotherapy is an effective treatment. Thus, if concomitant receipt of psychotherapy is not controlled for in a psychopharmacology trial, outcome may be biased. In this study, all peer reviewed journal articles describing the results of randomized, controlled psychopharmacology trials in two separate years were carefully reviewed to assess the possible influence of control versus lack of explicit control for effect of concomitant psychotherapy on clinical outcome. One hundred sixteen articles, published in the years 1996 and 2000, were reviewed. Those with categorically positive or non-positive global outcome were assessed for description of concomitant receipt of psychotherapy by subjects randomized to different pharmacotherapy treatments. Description of comparability in potentially confounding demographic and clinical variables was present in all studies. Only 22% of 89 studies meeting inclusion criteria explicitly controlled for concomitant psychotherapy. Seventy five percent of 20 studies that did, and only 46% of 69 studies that did not, found different outcomes in groups randomized to different pharmacotherapy interventions (p=.024). This result was not accounted for by other aspects of study design such as placebo-vs.-active control comparison, trial size, length, geographic location, number of sites or authors, source of funding, or diagnostic composition)-suggesting that uncontrolled receipt of psychotherapy may reduce likelihood of finding a difference between a new treatment and a control pharmacotherapy intervention. If confirmed by further investigation, the results may warrant adoption of relevant recommendations for controlled trial design in psychopharmacology research. The method used in this report may be useful in other areas of controlled trial research to assess influence of confounding variables.
与其他医学领域一样，对照试验如今已成为评估精神病学新疗法疗效的标准。治疗过程中的精神科治疗效果会受到同时存在的社会心理因素影响。单独使用心理治疗或与药物治疗联合使用都是有效的治疗方法。因此，如果在精神药理学试验中未对同时接受心理治疗的情况进行控制，结果可能会有偏差。在本研究中，我们仔细查阅了所有在两个不同年份发表的、描述随机对照精神药理学试验结果的同行评审期刊文章，以评估对同时进行的心理治疗效果进行对照与未进行明确对照对临床结果的可能影响。我们查阅了1996年和2000年发表的116篇文章。对于那些总体结果明确为阳性或非阳性的文章，我们评估了随机接受不同药物治疗的受试者同时接受心理治疗的情况描述。所有研究都对潜在混杂的人口统计学和临床变量的可比性进行了描述。在符合纳入标准的89项研究中，只有22%明确对同时进行的心理治疗进行了控制。在进行了控制的20项研究中，75%发现随机接受不同药物治疗干预的组有不同结果；而在未进行控制的69项研究中，只有46%发现有不同结果（p = 0.024）。这一结果无法用研究设计的其他方面来解释，如安慰剂与活性对照比较、试验规模、时长、地理位置、研究地点或作者数量、资金来源或诊断构成等，这表明未控制的心理治疗接受情况可能会降低发现新治疗与对照药物治疗干预之间差异的可能性。如果进一步调查证实这一结果，那么这些结果可能会促使人们在精神药理学研究的对照试验设计中采纳相关建议。本报告中使用的方法可能对其他对照试验研究领域评估混杂变量的影响有用。
