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针灸临床研究设计中的关键因素:源自《美国医学会杂志》的两篇文章

Pivotal factors concerned in design of acupuncture clinical research: From two articles in JAMA.

作者信息

Wu Jia-Ni, Qin Zong-Shi, Liu Zhi-Shun

机构信息

Department of Acupuncture, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China.

出版信息

Chin J Integr Med. 2017 Nov;23(11):809-811. doi: 10.1007/s11655-017-2790-4. Epub 2017 Oct 28.

DOI:10.1007/s11655-017-2790-4
PMID:29080200
Abstract

Two randomized controlled trials of acupuncture concerning polycystic ovary syndrome (PCOS) and stress urinary incontinence (SUI) were published simultaneously in the 24th issue, 2017 of The Journal of the American Medical Association (JAMA). A trial involving PCOS indicated that active acupuncture did not increase live birth compared with sham acupuncture; meanwhile, another trial referring to SUI showed that electroacupuncture resulted in less urine leakage compared with sham electroacupuncture. With an eye to the negative and positive results of acupuncture, three pivotal factors should be contemplated: (1) proper illness for acupuncture, that is, a problem need to be solved in current medical science, and acupuncture may really work for it; (2) proper pre-studied primary outcome, which is better be objective and repeatedly measurable to reveal the therapeutic effect of acupuncture truly and objectively; (3) proper sham control, which can blind the patients to the upmost extent with minimal biological effects. Through the publication of clinical trials of acupuncture in high-impact journals in recent years, researchers should have confidence in their clinical trials by pondering over these three pivotal factors.

摘要

两项关于多囊卵巢综合征(PCOS)和压力性尿失禁(SUI)的针灸随机对照试验于2017年第24期的《美国医学会杂志》(JAMA)上同时发表。一项涉及PCOS的试验表明,与假针灸相比,真针灸并没有增加活产率;与此同时,另一项关于SUI的试验显示,与假电针相比,电针导致的漏尿更少。着眼于针灸的阴性和阳性结果,应考虑三个关键因素:(1)适合针灸治疗的疾病,即当前医学科学中需要解决的问题,且针灸可能确实对其有效;(2)经过预先研究的合适的主要结局,最好是客观且可重复测量的,以真实、客观地揭示针灸的治疗效果;(3)合适的假对照,它能在最大程度上使患者产生盲法效应,同时生物效应最小。通过近年来在高影响力期刊上发表针灸临床试验,研究人员应通过思考这三个关键因素对他们的临床试验有信心。

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Pivotal factors concerned in design of acupuncture clinical research: From two articles in JAMA.针灸临床研究设计中的关键因素:源自《美国医学会杂志》的两篇文章
Chin J Integr Med. 2017 Nov;23(11):809-811. doi: 10.1007/s11655-017-2790-4. Epub 2017 Oct 28.
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Is acupuncture actually not effective for polycystic ovary syndrome? : Analysis of the trial published in jama.针刺治疗多囊卵巢综合征真的无效吗?:对《美国医学会杂志》发表的试验的分析。
Chin J Integr Med. 2017 Dec;23(12):883-886. doi: 10.1007/s11655-017-2831-z. Epub 2017 Dec 13.
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Is acupuncture actually not effective for polycystic ovary syndrome? : Analysis of the trial published in jama.

本文引用的文献

1
Effect of Electroacupuncture on Urinary Leakage Among Women With Stress Urinary Incontinence: A Randomized Clinical Trial.电针对压力性尿失禁女性尿失禁的影响:一项随机临床试验
JAMA. 2017 Jun 27;317(24):2493-2501. doi: 10.1001/jama.2017.7220.
2
Effect of Acupuncture and Clomiphene in Chinese Women With Polycystic Ovary Syndrome: A Randomized Clinical Trial.针刺与克罗米芬对中国多囊卵巢综合征女性的影响:一项随机临床试验
JAMA. 2017 Jun 27;317(24):2502-2514. doi: 10.1001/jama.2017.7217.
3
Surgical Treatment of Female Stress Urinary Incontinence: AUA/SUFU Guideline.
针刺治疗多囊卵巢综合征真的无效吗?:对《美国医学会杂志》发表的试验的分析。
Chin J Integr Med. 2017 Dec;23(12):883-886. doi: 10.1007/s11655-017-2831-z. Epub 2017 Dec 13.
女性压力性尿失禁的外科治疗:AUA/SUFU 指南。
J Urol. 2017 Oct;198(4):875-883. doi: 10.1016/j.juro.2017.06.061. Epub 2017 Jun 15.
4
Publication Trends in Acupuncture Research: A 20-Year Bibliometric Analysis Based on PubMed.针灸研究的出版趋势:基于PubMed的20年文献计量分析
PLoS One. 2016 Dec 14;11(12):e0168123. doi: 10.1371/journal.pone.0168123. eCollection 2016.
5
Is sham acupuncture as effective as traditional Chinese acupuncture? It's too early to say.假针灸与传统中医针灸的效果一样吗?现在下结论还为时过早。
Chin J Integr Med. 2016 Jul;22(7):483-9. doi: 10.1007/s11655-016-2458-5. Epub 2016 Apr 13.
6
Prevalence of polycystic ovary syndrome in women in China: a large community-based study.多囊卵巢综合征在中国女性中的流行情况:一项大型基于社区的研究。
Hum Reprod. 2013 Sep;28(9):2562-9. doi: 10.1093/humrep/det262. Epub 2013 Jun 27.
7
[Effect of abdominal acupuncture therapy on the endocrine and metabolism in obesity-type polycystic ovarian syndrome patients].腹针疗法对肥胖型多囊卵巢综合征患者内分泌及代谢的影响
Zhen Ci Yan Jiu. 2010 Aug;35(4):298-302.
8
Impact of electro-acupuncture and physical exercise on hyperandrogenism and oligo/amenorrhea in women with polycystic ovary syndrome: a randomized controlled trial.电针和体育锻炼对多囊卵巢综合征妇女高雄激素血症和稀发/闭经的影响:一项随机对照试验。
Am J Physiol Endocrinol Metab. 2011 Jan;300(1):E37-45. doi: 10.1152/ajpendo.00495.2010. Epub 2010 Oct 13.
9
Acupuncture for patients with migraine: a randomized controlled trial.针刺治疗偏头痛患者:一项随机对照试验。
JAMA. 2005 May 4;293(17):2118-25. doi: 10.1001/jama.293.17.2118.