Comprehensive Cancer Center, University of Alabama at Birmingham, Birmingham, AL, USA.
Program of Placebo Studies and the Therapeutic Encounter, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.
Sci Rep. 2018 Feb 9;8(1):2784. doi: 10.1038/s41598-018-20993-y.
The purpose of this 21-day assessor blinded, randomized-controlled trial was to compare an open-label placebo (OLP) to treatment as usual (TAU) for cancer survivors with fatigue. This was followed by an exploratory 21-day study in which TAU participants received OLPs while OLP participants in the main study were followed after discontinuing placebos. Cancer survivors (N = 74) who completed cancer treatment 6 months to 10 years prior to enrollment reporting at least moderate fatigue (i.e., ≥4 on a 0-10 scale) were randomized to OLP or TAU. Those randomized to OLP took 2 placebo pills twice a day for 21 days. Compared to those randomized to TAU, OLP participants reported a 29% improvement in fatigue severity (average difference in the mean change scores (MD) 12.47, 95% CI 3.32, 21.61; P = 0.008), medium effect (d = 0.63), and a 39% improvement in fatigue-disrupted quality of life (MD = 11.76, 95% CI 4.65, 18.86; P = 0.002), a large effect (d = 0.76). TAU participants who elected to try OLP for 21-days after the main study reported reductions in fatigue of a similar magnitude for fatigue severity and fatigue-disrupted quality of life (23% and 35%, respectively). OLP may reduce fatigue symptom severity and fatigue-related quality of life disruption in cancer survivors.
本 21 天评估员盲法、随机对照试验的目的是比较开放标签安慰剂 (OLP) 与癌症幸存者疲劳的常规治疗 (TAU)。随后进行了一项探索性的 21 天研究，其中 TAU 参与者在接受 OLPs 的同时，主要研究中的 OLP 参与者在停止使用安慰剂后进行了随访。在入组前完成癌症治疗 6 个月至 10 年且报告至少中度疲劳（即，0-10 量表上≥4）的癌症幸存者（N=74）被随机分配至 OLP 或 TAU。随机分配至 OLP 的参与者连续 21 天每天服用 2 片安慰剂，每天两次。与随机分配至 TAU 的参与者相比，OLP 参与者的疲劳严重程度改善了 29%（平均变化评分的平均差异（MD）为 12.47，95%置信区间为 3.32，21.61；P=0.008），具有中等效果（d=0.63），疲劳破坏生活质量改善了 39%（MD=11.76，95%置信区间为 4.65，18.86；P=0.002），具有大效应（d=0.76）。主要研究结束后，选择尝试 OLP 治疗 21 天的 TAU 参与者报告疲劳严重程度和疲劳破坏生活质量的改善程度相似（分别为 23%和 35%）。OLP 可能会降低癌症幸存者的疲劳严重程度和与疲劳相关的生活质量受损。
