Integrative Medicine Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.
Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York.
JAMA Oncol. 2021 May 1;7(5):720-727. doi: 10.1001/jamaoncol.2021.0310.
The opioid crisis creates challenges for cancer pain management. Acupuncture confers clinical benefits for chronic nonmalignant pain, but its effectiveness in cancer survivors remains uncertain.
To determine the effectiveness of electroacupuncture or auricular acupuncture for chronic musculoskeletal pain in cancer survivors.
DESIGN, SETTING, AND PARTICIPANTS: The Personalized Electroacupuncture vs Auricular Acupuncture Comparative Effectiveness (PEACE) trial is a randomized clinical trial that was conducted from March 2017 to October 2019 (follow-up completed April 2020) across an urban academic cancer center and 5 suburban sites in New York and New Jersey. Study statisticians were blinded to treatment assignments. The 360 adults included in the study had a prior cancer diagnosis but no current evidence of disease, reported musculoskeletal pain for at least 3 months, and self-reported pain intensity on the Brief Pain Inventory (BPI) ranging from 0 (no pain) to 10 (worst pain imaginable).
Patients were randomized 2:2:1 to electroacupuncture (n = 145), auricular acupuncture (n = 143), or usual care (n = 72). Intervention groups received 10 weekly sessions of electroacupuncture or auricular acupuncture. Ten acupuncture sessions were offered to the usual care group from weeks 12 through 24.
The primary outcome was change in average pain severity score on the BPI from baseline to week 12. Using a gatekeeping multiple-comparison procedure, electroacupuncture and auricular acupuncture were compared with usual care using a linear mixed model. Noninferiority of auricular acupuncture to electroacupuncture was tested if both interventions were superior to usual care.
Among 360 cancer survivors (mean [SD] age, 62.1 [12.7] years; mean [SD] baseline BPI score, 5.2 [1.7] points; 251 [69.7%] women; and 88 [24.4%] non-White), 340 (94.4%) completed the primary end point. Compared with usual care, electroacupuncture reduced pain severity by 1.9 points (97.5% CI, 1.4-2.4 points; P < .001) and auricular acupuncture reduced by 1.6 points (97.5% CI, 1.0-2.1 points; P < .001) from baseline to week 12. Noninferiority of auricular acupuncture to electroacupuncture was not demonstrated. Adverse events were mild; 15 of 143 (10.5%) patients receiving auricular acupuncture and 1 of 145 (0.7%) patients receiving electroacupuncture discontinued treatments due to adverse events (P < .001).
In this randomized clinical trial among cancer survivors with chronic musculoskeletal pain, electroacupuncture and auricular acupuncture produced greater pain reduction than usual care. However, auricular acupuncture did not demonstrate noninferiority to electroacupuncture, and patients receiving it had more adverse events.
ClinicalTrials.gov Identifier: NCT02979574.
阿片危机给癌症疼痛管理带来了挑战。针灸对慢性非恶性疼痛有临床疗效,但在癌症幸存者中的有效性仍不确定。
确定电针或耳针治疗癌症幸存者慢性肌肉骨骼疼痛的效果。
设计、地点和参与者:个性化电针与耳针比较疗效(PEACE)试验是一项随机临床试验,于 2017 年 3 月至 2019 年 10 月(2020 年 4 月完成随访)在纽约和新泽西州的一个城市学术癌症中心和 5 个郊区站点进行。研究统计人员对治疗分配情况不知情。纳入的 360 名成年人有既往癌症诊断,但目前没有疾病证据,报告有至少 3 个月的肌肉骨骼疼痛,且自我报告的简明疼痛量表(BPI)疼痛强度为 0(无痛)至 10(可想象到的最严重疼痛)。
患者被随机分为 2:2:1 组,分别接受电针(n = 145)、耳针(n = 143)或常规护理(n = 72)。干预组接受 10 次每周电针或耳针治疗。常规护理组在第 12 周至第 24 周接受 10 次针灸治疗。
主要结局是基线至第 12 周时 BPI 平均疼痛严重程度评分的变化。使用门控多重比较程序,使用线性混合模型比较电针和耳针与常规护理的疗效。如果两种干预措施均优于常规护理,则测试耳针是否不劣于电针。
在 360 名癌症幸存者(平均[标准差]年龄,62.1[12.7]岁;平均[标准差]基线 BPI 评分,5.2[1.7]分;251[69.7%]女性;88[24.4%]非白人)中,340 名(94.4%)完成了主要终点。与常规护理相比,电针治疗组疼痛严重程度降低 1.9 分(97.5%CI,1.4-2.4 分;P < .001),耳针治疗组降低 1.6 分(97.5%CI,1.0-2.1 分;P < .001)。未证明耳针不劣于电针。不良事件轻微;15 名接受耳针治疗的 143 名患者(10.5%)和 1 名接受电针治疗的 145 名患者(0.7%)因不良事件停止治疗(P < .001)。
在这项针对慢性肌肉骨骼疼痛的癌症幸存者的随机临床试验中,电针和耳针比常规护理更能减轻疼痛。然而,耳针并没有表现出优于电针的非劣效性,而且接受它的患者有更多的不良事件。
ClinicalTrials.gov 标识符:NCT02979574。