School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, 1200 Cailun Road, Shanghai, 201203, China.
Shanghai University of Traditional Chinese Medicine, Yueyang Hospital of Integrated Traditional Chinese Medicine and Western Medicine, 110 Ganhe Road, Shanghai, 200437, China.
Breast Cancer Res. 2024 May 21;26(1):80. doi: 10.1186/s13058-024-01838-1.
Cancer-related fatigue (CRF) is a pervasive, persistent, and distressing symptom experienced by cancer patients, for which few treatments are available. We investigated the efficacy and safety of infrared laser moxibustion (ILM) for improving fatigue in breast cancer survivors.
A three-arm, randomized, sham-controlled clinical trial (6-week intervention plus 12-week observational follow-up) was conducted at a tertiary hospital in Shanghai, China. The female breast cancer survivors with moderate to severe fatigue were randomized 2:2:1 to ILM (n = 56) sham ILM (n = 56), and Waitlist control (WLC)(n = 28) groups. Patients in the ILM and sham ILM (SILM) groups received real or sham ILM treatment, 2 sessions per week for 6 weeks, for a total of 12 sessions. The primary outcome was change in the Brief Fatigue Inventory (BFI) score from baseline to week 6 with follow-up until week 18 assessed in the intention-to-treat population.
Between June 2018 and July 2021, 273 patients were assessed for eligibility, and 140 patients were finally enrolled and included in the intention-to-treat analysis. Compared with WLC, ILM reduced the average BFI score by 0.9 points (95% CI, 0.3 to 1.6, P = .007) from baseline to week 6, with a difference between the groups of 1.1 points (95% CI, 0.4 to 1.8, P = .002) at week 18. Compared with SILM, ILM treatment resulted in a non-significant reduction in the BFI score (0.4; 95% CI, -0.2 to 0.9, P = .206) from baseline to week 6, while the between-group difference was significant at week 18 (0.7; 95% CI, 0.2 to 1.3, P = .014). No serious adverse events were reported.
While ILM was found to be safe and to significantly reduce fatigue compared with WLC, its promising efficacy against the sham control needs to be verified in future adequately powered trials.
Clinicaltrials.gov: NCT04144309. Registered 12 June 2018.
癌症相关性疲劳（CRF）是癌症患者普遍存在、持续存在且令人痛苦的症状，目前针对该症状的治疗方法寥寥无几。我们研究了红外激光灸（ILM）改善乳腺癌幸存者疲劳的疗效和安全性。
在中国上海的一家三级医院进行了一项三臂、随机、假对照临床试验（6 周干预加 12 周观察随访）。将中重度疲劳的女性乳腺癌幸存者随机分为 2:2:1 至 ILM（n=56）假 ILM（n=56）和候补对照（WLC）（n=28）组。ILM 和假 ILM（SILM）组的患者接受真实或假 ILM 治疗，每周 2 次，共 6 周，共 12 次。主要结局是根据意向治疗人群，从基线到第 6 周的 Brief Fatigue Inventory（BFI）评分变化，随访至第 18 周。
2018 年 6 月至 2021 年 7 月，对 273 名患者进行了资格评估，最终有 140 名患者入组并进行了意向治疗分析。与 WLC 相比，ILM 从基线到第 6 周降低了平均 BFI 评分 0.9 分（95%CI，0.3 至 1.6，P=0.007），第 18 周两组间差异为 1.1 分（95%CI，0.4 至 1.8，P=0.002）。与 SILM 相比，ILM 治疗从基线到第 6 周的 BFI 评分无显著降低（0.4；95%CI，-0.2 至 0.9，P=0.206），而第 18 周两组间差异显著（0.7；95%CI，0.2 至 1.3，P=0.014）。未报告严重不良事件。
虽然 ILM 被发现是安全的，并且与 WLC 相比显著降低了疲劳，但需要在未来足够有力的试验中验证其对假对照的有希望的疗效。
Clinicaltrials.gov：NCT04144309。2018 年 6 月 12 日注册。
