Data_Sheet_1_Acupuncture as a Complementary Therapy for Cancer-Induced Bone Pain: A Systematic Review and Meta-Analysis.pdf

BackgroundCancer-induced bone pain (CIBP) is a special type of cancer pain and lacks safe and effective treatments. Acupuncture is a potentially valuable treatment for CIBP, studies evaluating the effect of acupuncture on CIBP have increased significantly, but the safety and efficacy of acupuncture to control CIBP remains controversial.
ObjectiveTo provide the first meta-analysis to evaluate the safety and efficacy of acupuncture in CIBP management.
Data SourcesCNKI, CBM, Wanfang, VIP Database, PubMed, Embase, and Cochrane Library were searched from their inception until 1 June 2022.
Study SelectionRCTs with primary bone tumor patients or other types of primary cancer companied by bone metastases as the research subjects and to evaluate the efficacy of acupuncture treatment alone or combined with the control treatment were included. Meanwhile, RCTs should choose the pain score as the primary outcome and pain relief rate, frequency of breakthrough pain, analgesic onset time, analgesia duration, quality of life, and adverse events as reference outcomes.
Data Collection and AnalysisWe designed a data-extraction form that was used to extract key information from the articles. Data extraction study evaluation was conducted independently by two reviewers, and a third reviewer would resolve any disagreements. The risk of bias was assessed by the Cochrane Collaboration's tool for assessing the risk bias. The quality of the evidence for main outcomes was evaluated by the GRADE system. Mean differences (MD), relative risk (RR), and 95% confidence intervals (CIs) were calculated. The forest plots were performed using the Review Manager Software (5.3 version). Subgroup analysis was used to investigate the possible sources of potential heterogeneity. Descriptive analysis was performed in case of unacceptable clinical heterogeneity.
ResultsThirteen RCTs (with 1,069 patients) were included, and all studies were at high risk of bias owing to lack of blinding or other bias. Eleven studies evaluated the effectiveness of acupuncture as a complementary therapy, and showed that acupuncture plus control treatment (compared with control treatment) was connected with reduced pain intensity (MD = −1.34, 95% CI −1.74 to −0.94; Q < 0.1; I2 = 98%, P < 0.01). Subgroup analyses based on acupoints type partly explain the potential heterogeneity. The results also showed that acupuncture plus control treatment (compared with control treatment) was connected with relieving pain intensity, increasing the pain relief rate, reducing the frequency of breakthrough pain, shortening analgesic onset time, extending the analgesic duration, and improving the quality of life. We have no sufficient evidence to prove the effectiveness of acupuncture alone. Four RCTs reported only adverse events related to opioids' side effects. Evidence was qualified as “very low” because of low methodological quality, considerable heterogeneity, or a low number of included studies.
ConclusionAcupuncture has a certain effect as a complementary therapy on pain management of CIBP, which not only mitigates the pain intensity but also improves the quality of life and reduces the incidence of opioids' side effects, although the evidence level was very low. In future, a larger sample size and rigorously designed RCTs are needed to provide sufficient evidence to identify the efficacy and safety of acupuncture as a treatment for CIBP.

### 背景
癌性骨痛（Cancer-induced bone pain, CIBP）是一类特殊的癌痛类型，目前尚缺乏安全有效的治疗手段。针刺疗法是一种具有潜在应用价值的癌性骨痛治疗方案，相关评估针刺对癌性骨痛疗效的研究数量显著增长，但针刺用于控制癌性骨痛的安全性与有效性仍存在争议。

### 研究目的
本研究旨在开展首项荟萃分析，评估针刺疗法在癌性骨痛管理中的安全性与有效性。

### 数据来源
本研究检索了建库至2022年6月1日的中国知网（CNKI）、中国生物医学文献数据库（CBM）、万方数据知识服务平台、维普资讯中文期刊服务平台、PubMed、Embase及考克兰图书馆（Cochrane Library）。

### 研究筛选
纳入以原发性骨肿瘤患者或伴骨转移的其他类型原发性恶性肿瘤患者为研究对象，评估单纯针刺治疗或针刺联合对照治疗疗效的随机对照试验（Randomized Controlled Trial, RCT）。同时，纳入的随机对照试验需以疼痛评分作为主要结局指标，并以疼痛缓解率、爆发痛频率、镇痛起效时间、镇痛持续时间、生活质量及不良事件作为次要结局指标。

### 数据收集与分析
本研究设计了数据提取表，用于从纳入文献中提取关键信息。由2名评价员独立完成数据提取与研究质量评价，若出现评价分歧，则由第三名评价员进行裁决。采用考克兰协作网偏倚风险评估工具评价研究的偏倚风险，使用GRADE系统评估主要结局指标的证据质量。计算均数差（Mean Differences, MD）、相对危险度（Relative Risk, RR）及95%置信区间（Confidence Intervals, CIs）。使用Review Manager软件（5.3版本）绘制森林图。采用亚组分析探究潜在异质性的可能来源，若存在无法接受的临床异质性则进行描述性分析。

### 研究结果
本研究共纳入13项随机对照试验，涉及1069例患者，所有研究均因未实施盲法或存在其他偏倚而被判定为高偏倚风险。其中11项研究评估了针刺作为辅助治疗的疗效，结果显示，针刺联合对照治疗组相较于单纯对照治疗组，可显著降低疼痛强度（均数差=-1.34，95%置信区间：-1.74~-0.94；Q<0.1，I²=98%，P<0.01）。基于穴位类型的亚组分析部分解释了潜在异质性。研究结果同时表明，针刺联合对照治疗可缓解疼痛强度、提高疼痛缓解率、降低爆发痛频率、缩短镇痛起效时间、延长镇痛持续时间并改善患者生活质量。目前尚无充分证据证实单纯针刺治疗的有效性。另有4项随机对照试验仅报告了与阿片类药物不良反应相关的不良事件。由于方法学质量较低、异质性显著或纳入研究数量较少，相关证据被评定为极低等级。

### 研究结论
尽管现有证据等级较低，但针刺作为辅助治疗手段在癌性骨痛的疼痛管理中具有一定效果，不仅可减轻疼痛强度，还能改善患者生活质量并降低阿片类药物不良反应的发生率。未来需开展大样本量、设计严谨的随机对照试验，以提供充分证据明确针刺疗法用于癌性骨痛治疗的有效性与安全性。