针刺与按摩治疗晚期癌症患者疼痛的效果比较:IMPACT 随机临床试验。
Acupuncture vs Massage for Pain in Patients Living With Advanced Cancer: The IMPACT Randomized Clinical Trial.
机构信息
Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.
Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Diego.
出版信息
JAMA Netw Open. 2023 Nov 1;6(11):e2342482. doi: 10.1001/jamanetworkopen.2023.42482.
IMPORTANCE
Pain is challenging for patients with advanced cancer. While recent guidelines recommend acupuncture and massage for cancer pain, their comparative effectiveness is unknown.
OBJECTIVE
To compare the effects of acupuncture and massage on musculoskeletal pain among patients with advanced cancer.
DESIGN, SETTING, AND PARTICIPANTS: A multicenter pragmatic randomized clinical trial was conducted at US cancer care centers consisting of a northeastern comprehensive cancer center and a southeastern cancer institute from September 19, 2019, through February 23, 2022. The principal investigator and study statisticians were blinded to treatment assignments. The duration of follow-up was 26 weeks. Intention-to-treat analyses were performed (linear mixed models). Participants included patients with advanced cancer with moderate to severe pain and clinician-estimated life expectancy of 6 months or more. Patient recruitment strategy was multipronged (eg, patient database queries, mailings, referrals, community outreach). Eligible patients had English or Spanish as their first language, were older than 18 years, and had a Karnofsky score greater than or equal to 60 (range, 0-100; higher scores indicating less functional impairment).
INTERVENTIONS
Weekly acupuncture or massage for 10 weeks with monthly booster sessions up to 26 weeks.
MAIN OUTCOMES AND MEASURES
The primary end point was the change in worst pain intensity score from baseline to 26 weeks. The secondary outcomes included fatigue, insomnia, and quality of life. The Brief Pain Inventory (range, 0-10; higher numbers indicate worse pain intensity or interference) was used to measure the primary outcome. The secondary outcomes included fatigue, insomnia, and quality of life.
RESULTS
A total of 298 participants were enrolled (mean [SD] age, 58.7 [14.1] years, 200 [67.1%] were women, 33 [11.1%] Black, 220 [74.1%] White, 46 [15.4%] Hispanic, and 78.5% with solid tumors). The mean (SD) baseline worst pain score was 6.9 (1.5). During 26 weeks, acupuncture reduced the worst pain score, with a mean change of -2.53 (95% CI, -2.92 to -2.15) points, and massage reduced the Brief Pain Inventory worst pain score, with a mean change of -3.01 (95% CI, -3.38 to -2.63) points; the between-group difference was not significant (-0.48; 95% CI, -0.98 to 0.03; P = .07). Both treatments also improved fatigue, insomnia, and quality of life without significant between-group differences. Adverse events were mild and included bruising (6.5% of patients receiving acupuncture) and transient soreness (15.1% patients receiving massage).
CONCLUSIONS AND RELEVANCE
In this randomized clinical trial among patients with advanced cancer, both acupuncture and massage were associated with pain reduction and improved fatigue, insomnia, and quality of life over 26 weeks; however, there was no significant different between the treatments. More research is needed to evaluate how best to integrate these approaches into pain treatment to optimize symptom management for the growing population of people living with advanced cancer.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT04095234.
重要性
疼痛是晚期癌症患者面临的挑战。尽管最近的指南建议将针灸和按摩用于癌症疼痛,但它们的相对有效性尚不清楚。
目的
比较针灸和按摩对晚期癌症患者肌肉骨骼疼痛的影响。
设计、地点和参与者:这是一项在美国癌症护理中心进行的多中心实用随机临床试验,包括一个东北综合癌症中心和一个东南癌症研究所,研究时间为 2019 年 9 月 19 日至 2022 年 2 月 23 日。主要研究者和研究统计人员对治疗分配进行了盲法。随访时间为 26 周。采用意向治疗分析(线性混合模型)。参与者包括患有晚期癌症、疼痛中度至重度且临床医生估计预期寿命为 6 个月或以上的患者。患者招募策略是多管齐下的(例如,患者数据库查询、邮件、转诊、社区外展)。合格患者的第一语言为英语或西班牙语,年龄大于 18 岁,Karnofsky 评分大于或等于 60(范围 0-100;分数越高,功能障碍越小)。
干预措施
每周接受 10 次针灸或按摩治疗,每月进行一次增强治疗,持续 26 周。
主要结局和测量指标
主要终点是从基线到 26 周时最差疼痛强度评分的变化。次要结局包括疲劳、失眠和生活质量。使用简短疼痛量表(范围 0-10;数字越高表示疼痛强度或干扰越严重)来衡量主要结局。次要结局包括疲劳、失眠和生活质量。
结果
共纳入 298 名参与者(平均[标准差]年龄 58.7[14.1]岁,200[67.1%]名女性,33[11.1%]名黑人,220[74.1%]名白人,46[15.4%]名西班牙裔,78.5%为实体瘤)。基线时最差疼痛评分的平均值(标准差)为 6.9(1.5)。在 26 周期间,针灸降低了最差疼痛评分,平均变化为-2.53(95%CI,-2.92 至-2.15)分,按摩降低了 Brief Pain Inventory 最差疼痛评分,平均变化为-3.01(95%CI,-3.38 至-2.63)分;组间差异无统计学意义(-0.48;95%CI,-0.98 至 0.03;P=0.07)。两种治疗方法均改善了疲劳、失眠和生活质量,且组间无显著差异。不良反应轻微,包括瘀伤(接受针灸治疗的患者中 6.5%)和短暂疼痛(接受按摩治疗的患者中 15.1%)。
结论和相关性
在这项针对晚期癌症患者的随机临床试验中,针灸和按摩均与疼痛减轻以及 26 周内疲劳、失眠和生活质量的改善相关;然而,两种治疗方法之间没有显著差异。需要进一步研究以评估如何最好地将这些方法整合到疼痛治疗中,以优化日益增长的晚期癌症患者的症状管理。
试验注册
ClinicalTrials.gov 标识符:NCT04095234。