Supplementary Material for: Acupuncture relative to sham control in managing breast cancer-related hot flashes: a meta-analysis of randomized controlled trials

Introduction: Breast cancer is the leading cause of morbidity and mortality among female cancers globally. Hot flashes are among the most bothersome complications in women with breast cancer. Acupuncture is a common complementary approach for cancer worldwide. Here we aim to determine the differential effect between acupuncture and sham acupuncture on hot flashes among breast cancer patients. Methods: Eight English and Chinese databases through 10 October 2024, such as PubMed, Cochrane Library, ScienceDirect, Web of Science, etc. were searched to identify the randomized controlled trials (RCTs) about acupuncture relative to sham control treating breast cancer patients experiencing hot flashes. Outcomes included hot flash frequency per day, hot flash severity score, quality of life related to hot flashes, response rate. Continuous variables and categorical ones were expressed as standardized mean difference (SMD) or MD, and risk ratio (RR), with 95% confidence interval (CI), respectively, for meta-analysis. Sensitivity analysis and Grading of Recommendations, Assessment, Development and Evaluations (GRADE) of evidence were conducted additionally. Results: Eight RCTs involving 493 participants were included. Relative to sham control, acupuncture was significantly more efficacious in improving the quality of life of breast cancer patients experiencing hot flashes (165 participants, SMD [95%CI]:-1.01 [-1.99, -0.03], I2=88%, P=0.04) at the end of treatment, as well as at follow-up of over three months (59 participants, MD [95%CI]: -3.38 [-4.83, -1.93]). With respect to response rate, acupuncture achieved a higher rate versus sham acupuncture (118 subjects, RR[95%CI]:2.66 [1.63, 4.36], I2=0, P＜0.0001). Sensitivity analysis solely supported the statistically significant difference between the two groups in terms of response rate (RR [95%CI]: 2.14 [1.03, 4.44]) or 3.20 [1.64, 6.23]). As for frequency and hot flash severity, no difference was noted between groups. GRADE of evidence showed low to very low quality. Conclusions: Acupuncture reached a significantly higher response rate compared to sham control in breast cancer patients with hot flashes, whereas its efficacy on the quality of life showed inconsistency. Given significant heterogeneity and low quality of evidence, future large-sample-size and high-quality RCTs are warranted.

引言：乳腺癌是全球女性恶性肿瘤中发病率与死亡率最高的疾病。潮热是乳腺癌女性患者最令人困扰的并发症之一。针灸是目前全球范围内应用广泛的癌症辅助治疗手段。本研究旨在明确针灸与假针灸对乳腺癌患者潮热症状的差异化干预效果。

研究方法：截至2024年10月10日，我们检索了PubMed、Cochrane图书馆、ScienceDirect、Web of Science等8个中英文数据库，以筛选对比针灸与假针灸对照治疗乳腺癌潮热患者的随机对照试验（randomized controlled trial, RCT）。结局指标包括每日潮热频率、潮热严重程度评分、潮热相关生活质量及应答率。连续性变量与分类变量分别采用标准化均数差（standardized mean difference, SMD）或均数差（mean difference, MD）、风险比（risk ratio, RR）结合95%置信区间（confidence interval, CI）进行Meta分析。此外，本研究还开展了敏感性分析及证据质量分级系统（Grading of Recommendations, Assessment, Development and Evaluations, GRADE）。

研究结果：本研究共纳入8项随机对照试验，涉及493名受试者。与假针灸对照相比，针灸可在治疗结束时显著改善乳腺癌潮热患者的生活质量（165名受试者，SMD[95%CI]：-1.01[-1.99, -0.03]，I²=88%，P=0.04），且该效果在随访超过3个月时仍可维持（59名受试者，MD[95%CI]：-3.38[-4.83, -1.93]）。在应答率方面，针灸组的应答率显著高于假针灸组（118名受试者，RR[95%CI]：2.66[1.63, 4.36]，I²=0，P＜0.0001）。敏感性分析仅证实两组在应答率维度存在统计学差异（RR[95%CI]：2.14[1.03, 4.44]或3.20[1.64, 6.23]）。而在潮热频率与严重程度方面，两组未观察到显著差异。GRADE证据分级显示本研究证据质量为低至极低水平。

研究结论：相较于假针灸对照，针灸可显著提升乳腺癌潮热患者的应答率，但在改善生活质量方面的疗效存在不一致性。鉴于本研究存在显著异质性且证据质量较低，未来需开展大样本量、高质量的随机对照试验以进一步验证相关结论。