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Archive for the ‘JAMA’ Category

http://www.mdweekly.com.cn/m/view.php?aid=3452, accessed 071617

针刺联合西药治疗多囊卵巢综合征获得重要进展 ——吴效科团队研究成果刊发于国际顶级期刊《美国医学会杂志》

由国家中医临床研究基地妇儿病团队首席科学家、黑龙江中医药大学附属第一医院妇产科主任吴效科教授领衔完成的国家重大科技专项——“针刺联合西药克罗米芬治疗多囊卵巢综合征不孕症”研究成果,近日被全文刊发于国际顶级综合医学期刊《美国医学会杂志》(JAMA,影响因子44分)。该项课题基于我国PCOS疾病特征,规范评价中西医结合方法治疗多囊卵巢综合征的生殖和代谢临床疗效,这在中医临床研究上尚属开创之举。

多囊卵巢综合征(PCOS)是生育年龄妇女常见的一种复杂的内分泌及代谢异常所致的疾病,以慢性无排卵(排卵功能紊乱或丧失)和高雄激素血症(妇女体内男性激素产生过剩)为特征,主要临床表现为闭经、多毛、肥胖及不孕四大病症,患者可具备以上典型症状,也可以只有部分症状,治疗起来十分困难。吴效科团队的该项临床试验,采用的是被国际同行所高度认可的统计学上析因设计方案。课题组共筛选病例4645例,入组病例1000例,分布在国内25家医院,平均年龄28岁,不孕时间约2年,针刺和用药4个月,妊娠随访10个月。结果显示,试验受孕总数320例,妊娠总数达218例,活产人次205例,共出生婴儿数218名。

吴效科教授团队研究发现,针刺的两种方案联合西药一线促排卵药“克罗米芬”的“针药联合”方案,治疗多囊卵巢综合征(PCOS)不孕症妇女的4个月累积排卵率达93.2%,活产率约28.7%;针刺的两种方案联合西药安慰剂4个月排卵率达69.9%,活产率为15.4%;双胎妊娠率前者为9%,后者下降到3%。研究还发现,一线促排卵药克罗米芬会使PCOS女性妊娠晚期的腰背痛显著增加16.4%,而针刺干预能有效降低腰背痛发病率约6.6-14.3%。二次分析数据发现,克罗米芬的使用会加重PCOS妊娠女性的糖脂代谢异常,针刺则能明显改善这一代谢异常,并降低向心性肥胖参数。本项研究还首次在大样本量与严格的纳排标准的PCOS人群中,系统阐明了PCOS患者的痰湿、血瘀和肝郁等中医症候不同分类客观化特征。相关论文还在今年6月中旬在香港举办的第25届亚太妇产科学大会上被评为“最佳演讲论文”。

自2013年到现在,吴效科教授团队在系列研究中,规范评价了中西医多种方法医治PCOS的生殖和代谢临床疗效;利用模型动物和人体生物样本,系统而深入探讨了PCOS疾病病机和药效机制,首次发现PCOS综合中枢边缘系统(杏仁核与海马)GABA能神经元中5-羟色胺、r-氨基丁酸等改变情志、子宫内膜糖代谢障碍和胰岛素抵抗机理、卵巢亢进参数指标等。有关论文陆续发表于《美国科学院院刊》、《科学报道》、《人类生殖》等,并被《自然》系列杂志、《新英格兰医学杂志》、《英国医学会会刊》、《内分泌述评》等权威期刊多次引用。

另据介绍,本研究的运行模式是在国内外、中西医领域顶级团队合作的基础上,采用美国国立卫生研究院生殖医学协作网模式。功能委员会包括:方案优化委员会、项目执行委员会、数据协作委员会、数据与安全监测委员会、论文发表委员会,形成了重大研究的“图纸设计团队”、项目“施工团队”、质量“监管团队”、“受试者保护团队”、“成果产出团队”。以上临床试验中的专门机构设计和运行,为上述课题进行“全过程”和“纵深度”的国际合作,推进中医临床研究向国际化的大踏步迈进,提供了高度学术保障与组织运行保证。该项目成果的发表,凸显了国家中医临床研究基地的创新体系,在中医药“双一流”的学术发展中的带动作用。

(责任编辑:毕雪立)

这个报道刻意回避了针灸无效这个在JAMA上报道的结论

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Original article source: http://tcmaaa.org/JAMAresponse.shtml

In 2009, NHMRC funded a research grant (No. 566783; $687,239) to Dr. Rana S Hinman and her team as “ Laser acupuncture in patients with chronic knee pain: a randomised placebo-controlled trial ”. The grant resulted in a publication in the October 2014 issue of the Journal of American Medical Association (JAMA) titled “ Acupuncture for Chronic Knee Pain: A Randomized Clinical Trial ”. The authors (Hinman and her colleagues) concluded that “in patients older than 50 years with moderate or severe chronic knee pain, neither laser nor needle acupuncture conferred benefit over sham for pain or function. Our findings do not support acupuncture”. Following the publication, expert researchers called for explanations to study errors and inconsistencies. With unsatisfactory answers from Hinman and her colleagues, acupuncture organizations (23 organizations) filed three complaints with the University of Melbourne in May through July 2015, but in a letter dated 16 September 2015, the University denied all complaints without providing any reasonable supporting evidence and research documents…     Click here to read more …

Dr. Arthur Yin Fan published a series of articles poking the flaws in Hinman’s study:
► The methodology flaws in Hinman’s acupuncture clinical trial, Part I: Design and results interpretation
► The methodology flaws in Hinman’s acupuncture clinical trial, Part II: Zelen design and effectiveness dilutions
► The methodology flaws in Hinman’s acupuncture clinical trial, Part III: Sample size calculation

Article on Medical Acupuncture by Dr. Kehua Zhou:
► Acupuncture for Chronic Knee Pain: A Critical Appraisal of an Australian Randomized Controlled Trial

Response to JAMA by Dr. Qinhong Zhang et al:
► Acupuncture treatment for chronic knee pain: study by Hinman et al underestimates acupuncture efficacy

Commentary on Acupuncture in Medicine by White A and Cummings M.:
► Hinman’s Trial underestimated the acupuncture effectiveness

Article on The American Acupuncturist Summer 2015 by Jacob Godwin and Arthur Y Fan
► Evidence-Based Medicine Skills for Acupuncturists Part I: The Hinman Trial on Chronic Knee Pain…

Responses to JAMA:
► Responses to JAMA by Dr. Yong Ming Li, Lixing Lao, Hongjian He, etc.

Interview by Acupuncture Today:
► Chinese Doctors Poke Holes in Australian Study By Bill Reddy, LAc, Dipl. Ac.

Dr. Changzheng Gong’s article on International Journal of Clinical Acupuncture:
► Acupuncture Storms JAMA

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|http://blogs.poz.com/mikebarr/2014/12/bmj_editors_hit_and.html
BMJ Editors Hit–and Hit Hard–Over Careless Interpretation of Acupuncture for Chronic Knee Pain Study (JAMA 10/1/2014)

Let’s start with the conclusion, lest I lose you between here and the end.

Acupuncture is more likely to provide relief for chronic knee pain due to osteoarthritisthan any other modality. Pooled studies (a meta analysis) that compared physical interventions for chronic knee pain showed the following “effect sizes:”

(Electro-) Acupuncture: ES of 0.89
Warm baths: ES 0.65
Exercise: ES 0.55

To put this in perspective, the “Minimum Clinically Important Difference” or minimally significant Effect Size, according to patients suffering from chronic knee pain, is 0.39. And the Effect Size threshold the UK’s National Institute for Health and Care Excellence (NICE) uses to determine reimbursement is 0.50.

Call them acupuncture activists. And really brainy ones.

When an Australian group published (in October 1st JAMA) an impressively large (N=282, but there were 4 groups) clinical trial of 12 weeks of acupuncture for chronic (moderate to severe) knee pain in persons 50 years and older, they concluded no difference between the sham control and actual acupuncture. Editors of the premier acupuncture journal in the world (the BMJ group’s Acupuncture In Medicine), however, cried foul. And lamented the lost opportunity to help millions of chronic knee pain suffers. There were determined to set the record straight.

Their protest and clarification letter to JAMA was summarily rejected.

But guess what? They just happen to have their own journal. (Take that, AMA.) And not one of the enumerable, embarrassing American titles. As noted above, we’re talking The British Medical Journal (Even if the quality of the studies AIM publishes sometimes causes a cringe here and there, the White and his staff are doing the best with what they have to work with.) And so AIM editor and British Medical Acupuncture Society chief Mike Cummings proceeded to publish their quibbles today for inclusion, I imagine, in the January 2015 print edition, and set about to educate folks about how to consider clinically relevant results.

For expediency’s sake, I will extract the key arguments from their brilliantly prepared letter today. Then over the next week or so I will work on paraphrasing and whittling it down.

1. BACKGROUND OF THE CLINICAL PROBLEM. Patients with OA knee pain are suffering the commonest cause of pain and disability in older people. More than half have inadequate pain relief.2 They face a choice between ineffective paracetamol, non-steroidal drugs that can harm the heart, (kidneys) and gastrointestinal tract, gels that scarcely work, physiotherapy, opioids that cause dependency and lose effectiveness, arthroscopic washouts that do nothing or surgery.3 They deserve a fuller, more considered answer to their question: “Is it worth trying acupuncture?”

2. NIFTY DESIGN OF TRIAL. The neat part of the Zelen design that Hinman et al used was that the control group, who were not given acupuncture, were not even aware that their pain scores were used in a trial of acupuncture so disappointment could not influence their scores, as was claimed for other studies. This ‘no acupuncture’ group was compared with acupuncture (manual) and with sham laser (and with real laser, which is not considered here, to keep things simple).

3. WHERE THE ANALYSIS BEGINS TO STUMBLE. The problems started with the trialists’ choice of the threshold minimum clinically important difference (MCID) to estimate sample size. They chose a value based on one chosen by six self-styled ‘expert’ physicians,4 namely a 35% fall in baseline pain score (1.8/sample mean baseline 5.1). This is equivalent to an effect size (ES) of 0.6, calculated using their assumed baseline SD of 30 (the actual SD was 21, giving a higher threshold ES of 0.86). A different figure for MCID was generated by 192 patients with OA, who registered improvement scores as well as changes in pain.5 This showed a more modest MCID, equivalent to an ES of 0.39 (shown in figure 1). The National Institute for Health and Care Excellence (NICE) did not regard any value for MCID as valid6 and chose a generic value of 0.5 (see figure 1). Hinman et al chose a high threshold and also failed to discuss the effect that alternative threshold MCID values would have on the interpretation of their findings. We also note that the MCID for any treatment should be chosen to take account of acceptability, safety and cost-effectiveness,7 which would argue for a lower threshold for acupuncture for knee pain.

4. THE OLD “BETA ERROR” BUGABOO: SHORT ON STATISTICAL POWER. Hinman et alapplied this ‘clinically important’ difference to a ‘clinically irrelevant’ comparison–acupuncture versus sham laser. Sham laser is not an available therapy. The only reason for comparing acupuncture with sham would be to estimate the effects of the needles themselves, but this is already well known from the Cochrane review8 and an individual patient data meta-analysis (figure 1).9 It is known that the effect of needles alone is small, and so is unlikely to be identifiable reliably with sample sizes of less than about 800.10 The sample size in the study by Hinman et al (n=70) clearly appears to be inadequate for the question, according to the existing evidence, and not best use of resources. The resulting ES of acupuncture against sham that was actually found by Hinman is similar to that shown by the best evidence8 (see figure 1), although the wide CI means the data can only be of any importance when they are included in a meta-analysis in the future.

5. WHO DECIDES WHAT TREATMENT EFFECT IS MEANINGFUL? Hinman et al found that, after 12 weeks, knee pain was significantly reduced by acupuncture compared with no acupuncture control, with an ES of 0.6 (data from their table 2; see figure 1). The difference did not quite meet the MCID they had postulated–although the estimated ES is the same size as the MCID–but it more than meets the MCID chosen by patients themselves (ES 0.39) and that selected by NICE (ES 0.5). In interpreting this result, the secondary outcomes should also have been brought into thoughtful consideration: there were significant differences in favour of acupuncture for six out of eight secondary outcomes (see eTable 5 in their paper) and the response rate, which is the most patient-orientated measure of success,7 was 76% in the acupuncture group compared with 32% in the no acupuncture control group.

6. TO MAKE MATTERS WORSE, THE AUSTRALIANS STUDIED THE LEAST EFFECTIVE ACUPUNCTURE TECHNIQUE. Hinman et al did not apply optimal acupuncture. Use of electroacupuncture has been shown superior to manual stimulation for knee pain in 2010.8

A couple of weeks ago, I also came across a study of “needle-less” acupuncture, also for chronic knee pain of the OA variety. Basically it involved warming the knee with these stick on cones of burning mugwort–sort of like (very carefully) burning incense around your knee cap. That too showed clinical effectiveness, although now I am prompted to dig up the original study and see if we can fit that “effect size” into our acupuncture, warm baths, exercise line-up above. Stay tuned.

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