Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen, Am Deimelsberg 34a, 45276 Essen, Germany.
Institute for Integrative Medicine, Department of Health, Witten/Herdecke University, Gerhard-Kienle-Weg 4, 58313 Herdecke, Germany.
Complement Ther Med. 2014 Dec;22(6):1053-9. doi: 10.1016/j.ctim.2014.09.007. Epub 2014 Oct 6.
Determining efficacy in complementary medicine research requires valid placebo/sham control groups that are credible to patients and ensure successful blinding. Within the scope of this study, a light touch sham-control intervention for trials of Craniosacral Therapy (CST) was developed and tested for its credibility.
Patients of a randomized controlled trial on chronic non-specific neck pain (NCT01526447) obtained the Credibility/Expectancy Questionnaire and the Helping Alliance/Satisfaction Questionnaire. Treatment and sham group respectively received 8 weekly sessions of CST or light touch. Data without (N=50) and with multiple imputation (N=54) were analyzed separately using logistic regression models. Adjusted odds ratios (AOR) and 95% confidence intervals (CI) were calculated to assess whether group outcome could be predicted from patients' credibility ratings. An additional t-test for analysis of the overall compliance/attendance was conducted.
Patients' ratings of treatment expectancy, credibility and therapeutic alliance were not found to have significant power for classifying patients into CST or sham group (p≥.05). Only satisfaction with treatment revealed a significant impact (AOR: 6.83; 95% CI: [1.54|30.24]; p=.011) in the non-imputed analysis, but not in the multiple imputation analysis (AOR: 4.09; 95% CI: [0.94|17.76]; p=.060). Compliance of both groups was not significantly different (p>.05) as were reasons for non-attendance. No serious adverse events were reported.
Patients' expectancy, credibility and therapeutic alliance did not appear to affect study outcomes, blinding patients to group allocation was possible, and sham intervention was tolerable and safe. The design can therefore be recommended as control for non-specific treatment effects in future CST clinical trials.
在补充医学研究中确定疗效需要有效的安慰剂/假对照，这些对照需要对患者具有可信度，并确保成功的盲法。在本研究范围内，开发了一种针对颅骶疗法（CST）试验的轻柔触摸假对照干预措施，并对其可信度进行了测试。
接受慢性非特异性颈部疼痛随机对照试验（NCT01526447）的患者获得了可信度/期望问卷和帮助联盟/满意度问卷。治疗组和假处理组分别接受 8 周的 CST 或轻柔触摸治疗。分别使用逻辑回归模型对未进行（N=50）和进行多重插补（N=54）的数据分析。计算调整后的优势比（AOR）和 95%置信区间（CI），以评估患者的可信度评分是否可以预测组间结果。还进行了总体依从性/出勤率的 t 检验分析。
未发现患者对治疗期望、可信度和治疗联盟的评分具有将患者分类为 CST 或假处理组的显著能力（p≥.05）。只有对治疗的满意度显示出显著影响（AOR：6.83；95%CI：[1.54|30.24]；p=.011），在未进行多重插补的分析中，但在多重插补分析中则不然（AOR：4.09；95%CI：[0.94|17.76]；p=.060）。两组的依从性无显著差异（p>.05），且失访原因也无显著差异。未报告严重不良事件。
患者的期望、可信度和治疗联盟似乎不会影响研究结果，对患者进行分组盲法是可行的，假处理干预是可耐受和安全的。因此，该设计可作为未来 CST 临床试验中针对非特异性治疗效果的对照推荐。
