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针刺与假针刺或等待对照治疗芳香化酶抑制剂相关性关节痛的比较:一项随机临床试验。

Comparison of Acupuncture vs Sham Acupuncture or Waiting List Control in the Treatment of Aromatase Inhibitor-Related Joint Pain: A Randomized Clinical Trial.

机构信息

Columbia University Irving Medical Center, New York, New York.

Fred Hutchinson Cancer Center, Seattle, Washington.

出版信息

JAMA Netw Open. 2022 Nov 1;5(11):e2241720. doi: 10.1001/jamanetworkopen.2022.41720.


DOI:10.1001/jamanetworkopen.2022.41720
PMID:36367721
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9652759/
Abstract

IMPORTANCE: Aromatase inhibitors (AIs) have proven efficacy for the treatment of hormone-sensitive breast cancer; however, arthralgias (pain and stiffness) contribute to nonadherence with therapy for more than 50% of patients. OBJECTIVE: To examine the effect of acupuncture in reducing AI-related joint pain through 52 weeks. DESIGN, SETTING, AND PARTICIPANTS: A randomized clinical trial was conducted at 11 sites in the US from May 1, 2012, to February 29, 2016, with a scheduled final date of follow-up of September 5, 2017, to compare true acupuncture (TA) with sham acupuncture (SA) or waiting list control (WC). Women with early-stage breast cancer were eligible if they were taking an AI and scored 3 or higher on the Brief Pain Inventory Worst Pain (BPI-WP) item (score range, 0-10; higher scores indicate greater pain). Analysis was conducted for data received through May 3, 2021. INTERVENTIONS: Participants were randomized 2:1:1 to the TA (n = 110), SA (n = 59), or WC (n = 57) group. The TA and SA protocols were composed of 6 weeks of intervention at 2 sessions per week (12 sessions overall), followed by 6 additional weeks of intervention with 1 session per week. Participants randomized to WC received no intervention. All participants were offered 10 acupuncture sessions to be used between weeks 24 and 52. MAIN OUTCOMES AND MEASURES: In this long-term evaluation, the primary end point was the 52-week BPI-WP score, compared by study group using linear regression, adjusted for baseline pain and stratification factors. RESULTS: Among 226 randomized women (mean [SD] age, 60.7 [8.6] years; 87.7% White; mean [SD] baseline BPI-WP score, 6.7 [1.5]), 191 (84.5%) completed the trial. In a linear regression, 52-week mean BPI-WP scores were 1.08 (95% CI, 0.24-1.91) points lower in the TA compared with the SA group (P = .01) and were 0.99 (95% CI, 0.12-1.86) points lower in the TA compared with the WC group (P = .03). In addition, 52-week BPI pain interference scores were statistically significantly lower in the TA compared with the SA group (difference, 0.58; 95% CI, 0.00-1.16; P = .05). Between 24 and 52 weeks, 12 (13.2%) of TA, 6 (11.3%) of SA, and 5 (10.6%) of WC patients reported receipt of acupuncture. CONCLUSIONS AND RELEVANCE: In this randomized clinical trial, women with AI-related joint pain receiving 12 weeks of TA had reduced pain at 52 weeks compared with controls, suggesting long-term benefits of this therapy. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01535066.

摘要

重要性:芳香化酶抑制剂(AIs)已被证明对治疗激素敏感型乳腺癌有效;然而,关节痛(疼痛和僵硬)导致超过 50%的患者不遵守治疗方案。

目的:通过 52 周来研究针灸在减少 AI 相关关节疼痛中的作用。

设计、地点和参与者:这项在美国 11 个地点进行的随机临床试验于 2012 年 5 月 1 日至 2016 年 2 月 29 日进行,计划的最终随访日期为 2017 年 9 月 5 日,以比较真实针灸(TA)与假针灸(SA)或候补名单对照(WC)。如果患者患有早期乳腺癌,正在服用 AI,并且 Brief Pain Inventory Worst Pain(BPI-WP)项目得分为 3 或更高(得分范围为 0-10;得分越高表示疼痛越严重),则符合条件。分析是在 2021 年 5 月 3 日之前收到的数据进行的。

干预措施:参与者被随机分为 TA(n=110)、SA(n=59)或 WC(n=57)组,2:1:1。TA 和 SA 方案由 6 周的每周 2 次干预(共 12 次)组成,随后是另外 6 周每周 1 次的干预。随机分配到 WC 的参与者未接受任何干预。所有参与者都被提供了 10 次针灸治疗,用于 24 周到 52 周之间。

主要结果和测量:在这项长期评估中,主要终点是第 52 周的 BPI-WP 评分,通过线性回归进行比较,调整了基线疼痛和分层因素。

结果:在 226 名随机女性中(平均[标准差]年龄,60.7[8.6]岁;87.7%为白人;平均[标准差]基线 BPI-WP 评分,6.7[1.5]),191 名(84.5%)完成了试验。在线性回归中,与 SA 组相比,TA 组第 52 周的平均 BPI-WP 评分低 1.08 分(95%置信区间,0.24-1.91;P=0.01),与 WC 组相比,TA 组低 0.99 分(95%置信区间,0.12-1.86;P=0.03)。此外,与 SA 组相比,TA 组第 52 周的 BPI 疼痛干扰评分显著降低(差异,0.58;95%置信区间,0.00-1.16;P=0.05)。在 24 周到 52 周之间,12 名(13.2%)TA 患者、6 名(11.3%)SA 患者和 5 名(10.6%)WC 患者报告接受了针灸治疗。

结论和相关性:在这项随机临床试验中,接受 12 周 TA 治疗的 AI 相关关节疼痛女性在第 52 周时疼痛减轻,表明这种治疗具有长期益处。

试验注册:ClinicalTrials.gov 标识符:NCT01535066。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/59bc/9652759/e2ddc1c5a0e7/jamanetwopen-e2241720-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/59bc/9652759/8bd87be411e3/jamanetwopen-e2241720-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/59bc/9652759/0620fcaa4cc0/jamanetwopen-e2241720-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/59bc/9652759/e2ddc1c5a0e7/jamanetwopen-e2241720-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/59bc/9652759/8bd87be411e3/jamanetwopen-e2241720-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/59bc/9652759/0620fcaa4cc0/jamanetwopen-e2241720-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/59bc/9652759/e2ddc1c5a0e7/jamanetwopen-e2241720-g003.jpg

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[1]
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本文引用的文献

[1]
A neuroanatomical basis for electroacupuncture to drive the vagal-adrenal axis.

Nature. 2021-10

[2]
Effectiveness of Electroacupuncture or Auricular Acupuncture vs Usual Care for Chronic Musculoskeletal Pain Among Cancer Survivors: The PEACE Randomized Clinical Trial.

JAMA Oncol. 2021-5-1

[3]
Acupuncture for Arthralgia Induced by Aromatase Inhibitors in Patients with Breast Cancer: A Systematic Review and Meta-analysis.

Integr Cancer Ther. 2021

[4]
Personalized electro-acupuncture versus auricular-acupuncture comparative effectiveness (PEACE): A protocol of a randomized controlled trial for chronic musculoskeletal pain in cancer survivors.

Medicine (Baltimore). 2020-5-22

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A randomized, double-blind, placebo-controlled trial of testosterone for treatment of postmenopausal women with aromatase inhibitor-induced arthralgias: Alliance study A221102.

Support Care Cancer. 2020-5-6

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Randomized controlled trial of high-dose versus standard-dose vitamin D3 for prevention of aromatase inhibitor-induced arthralgia.

Breast Cancer Res Treat. 2019-6-19

[7]
Omega-3 fatty acid use for obese breast cancer patients with aromatase inhibitor-related arthralgia (SWOG S0927).

Breast Cancer Res Treat. 2018-8-29

[8]
Effect of Acupuncture vs Sham Acupuncture or Waitlist Control on Joint Pain Related to Aromatase Inhibitors Among Women With Early-Stage Breast Cancer: A Randomized Clinical Trial.

JAMA. 2018-7-10

[9]
Acupuncture for Chronic Pain: Update of an Individual Patient Data Meta-Analysis.

J Pain. 2017-12-2

[10]
Randomized, Multicenter, Placebo-Controlled Clinical Trial of Duloxetine Versus Placebo for Aromatase Inhibitor-Associated Arthralgias in Early-Stage Breast Cancer: SWOG S1202.

J Clin Oncol. 2017-11-14

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