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Archive for the ‘acupuncture clinical trial’ 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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Reporting Error Revealed in Knee Pain Acupuncture Study, Catastrophe Avoided

June 2016 | by Jonathan Gilbert

http://thegilbertclinic.com/reporting-error-revealed-in-knee-pain-acupuncture-study

On October 1st, 2014, the prestigious Journal of the American Medical Association (JAMA) published a study entitled “Acupuncture for Chronic Knee Pain: A Randomized Clinical Trial”[1]. It was a major study whose results stated that neither acupuncture nor laser acupuncture was useful to patients aged 50 and older with moderate-to-severe knee pain. Enter Dr. Arthur Fan…

In March of 2016 Dr. Fan and associates published a reevaluation of this study. It found serious flaws in its methodology and analysis. Not only that, but when properly evaluated, it appears that the study actually showed significant improvement in patients undergoing acupuncture and laser acupuncture in the clinical trial.

Dr. Fan is a consultant and long term researcher in Traditional Chinese Medicine who has been published in many of the world’s foremost medical journals. He has received numerous awards and commendations including a letter of thanks from the President himself. And thanks to him a grave reporting error was averted and an catastrophe avoided.

What is of interest to this writer is how such a mistake could have been made by one of the most respected, peer reviewed, medical publications in the world? I leave that, along with the link to Dr. Fan’s paper, “Acupuncture is Effective for Chronic Knee Pain: A Reanalysis of the Australian Acupuncture Trial”[2] to your discerning minds. Be well. ♥

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From: 
To: “Arthur Yin Fan,CMD,PhD,LAc” <arthurfan@chinesemedicinedoctor.us>
Sent: Friday, August 26, 2016 3:36 PM
Subject: please let me know how is everything’s going?

Hi, Dr. Fan,

I’m pretty well stocked for now- I’ve only had to take 6 capsules a day for a while now, coupled with once a week acupuncture, nd my conversational speech has been pretty near perfect (a few challenging moments here and there, but for the most part I forget I have the condition- Recording booth/broadcasting is still difficult, but I get by there too).
Thanks!
Take care,
E
Oct 12 at 12:43 PM

Dear Dr. Fan,

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News: Dr. Arthur Fan is invited by NCI(National Cancer Institute) as a speaker in a Conference focus on acupuncture on cancer patient symptom management on June 16, 2016. His topic is “Clinical Considerations of Sham acupuncture”.

Anyone who is interested in acupuncture and cancer symptom managements is welcomed to attend this conference. NCI invites 18 scholars internationally to talk on this topic in this conference (06/16-06/17, 2016).

Acupuncture Agenda Final With NCI Branding[2]

The conference is open to the public. Below are the agenda and visitors’ parking instruction.

DIVISION OF CANCER TREATMENT AND DIAGNOSIS

Office of Cancer Complementary and Alternative Medicine

Conference On

ACUPUNCTURE FOR CANCER SYMPTOM MANAGEMENT

Thursday, June 16 – Friday, June 17, 2016

Natcher Auditorium, Balcony B

NIH Main Campus, Bethesda, Maryland

DAY 1 – THURSDAY, JUNE 16

8:00 – 8:30 Arrival and On-Site Registration

8:30 – 8:35 Welcome

Jeffrey D. White MD, National Cancer Institute, Director OCCAM

8:35 – 8:45 Conference Overview &amp; Objectives

Farah Zia, MD, Meeting Chair, National Cancer Institute

Session 1 Moderator: Lixing Lao PhD CMD LAc

8:45 – 9:00 NCI’s Portfolio: Acupuncture Research

Oluwadamilola Olaku MD, Meeting Co-Chair , National Cancer Institute

9:00 – 9:30 Utilization of Acupuncture by Cancer Patients

Gary Deng MD PhD, Memorial Sloan Kettering Cancer Center

9:30 – 10:00 Classical &amp; Electro-Acupuncture, Acupressure, TENS

Weidong Lu MB PhD MPH, Dana Farber Cancer Institute

10:00 – 10:15 * BREAK

Assemble for group photograph in main lobby.

10:15 – 10:45 Mechanism of Action: Mechanical Tissue Stimulation and Acupuncture

Helene Langevin MD, Harvard Medical School

10:45 – 11:15 Role of Functional MRI in Acupuncture Research

Vitaly Napadow PhD, Harvard Medical School

11:15 – 11:30 Q/A/Discussion Moderator

Lixing Lao PhD CMD (China) LAc, University of Hong Kong

11:30– 12:30 * Lunch

*All food and beverage is on your own. Cafeteria is located on the

main level.

U.S. Department of Health &amp; Human Services | National Institutes of Health

Session 2 Moderator: Peter Johnstone MD

12:30 – 1:00 Acupuncture for Cancer Pain and Fatigue

Jun Mao MD, Memorial Sloan Kettering Cancer Center

1:00 – 1:30 Acupuncture for N/V &amp; xerostomia

Mary K. Garcia DrPh LAc, MD Anderson Cancer Center

1:30 – 2:00 Acupuncture for Symptoms of Endocrine Therapies

Jun Mao MD, Memorial Sloan Kettering Cancer Center

2:00 – 2:15 Q/A/Discussion Moderator

Peter Johnstone MD, H. Lee Moffitt Cancer Center &amp; Research Institute

2:15 – 2:30 * BREAK

Session 3 Moderator: Wayne Jonas, MD

2:30 – 3:00 Conducting Robust Acupuncture Clinical Trials

Claudia Witt MD MBA, University of Zurich

3:00 – 3:30 Placebo Effect in Acupuncture and Conventional Treatment

Prof Ted Kaptchuk, Harvard Medical School

3:30 – 4:00 Statistical Perspective of Acupuncture Clinical Trials

Telecon – Andrew Vickers PhD, Memorial Sloan Kettering Cancer Center

4:00 – 4:30 Clinical Considerations of Sham Acupuncture

Arthur Yin Fan, PhD LAc, McLean Center for Complementary & Alternative Medicine

4:30 – 5:00 Q/A/Discussion Moderator

Wayne Jonas MD, Samuelli Institute

5:00 Day 1 Adjourned

*All food and beverage is on your own. The Cafeteria is located on the main level.

DAY 2 – FRIDAY JUNE 17

Session 4 Moderator: Gary Deng MD PhD

8:30 – 9:00 Safety of Acupuncture

Weidong Lu MB PhD MPH, Harvard Medical School

9:00 – 9:30 Acupuncture for Lymphedema &amp; Peripheral Neuropathy

Ting Bao MD DABMA, Memorial Sloan Kettering Cancer Center

9:30 – 10:00 Role of Acupuncture in Palliative and End of Life Care

Ann Berger MD, NIH Clinical Center

10:00 – 10:30 Role of Acupuncture in Pediatric Cancer Patients

Elena Ladas PhD RD, Columbia University Medical Center

10:30 – 10:45 Q/A/Discussion – Moderator

Gary Deng MD PhD, Memorial Sloan Kettering Cancer Center

10:45 – 11:00 *BREAK

Session 5 Moderator: Richard Niemtzow MD PhD MPH

11:00 – 11:30 Patient Reported Outcomes Research Methodology

Shelly Wang MD MPH, MD Anderson Cancer Center

11:30 – 12:00 Cost effectiveness of Acupuncture

Patricia Herman PhD ND, RAND Corporation

12:00 -12:15 * BREAK

12:15-12:45 Acupuncture: Chinese Experience

Lixing Lao PhD CMD LAc, University Of Hong Kong

12:45 – 1:15 Disparities in Acupuncture Treatment- 10 minutes for each speaker

European Experience

Claudia Witt MD MBA, University Of Zurich

Chinese Experience

Lixing Lao PhD CMD LAc, University of Hong Kong

United States Experience:

Jun Mao MD, Memorial Sloan Kettering Cancer Center

1:15 – 1:30 Q/A/Discussion – Moderator

Richard Niemtzow MD PhD MPH, col (ret) USAF

1:30 – 1:35 Brief Closing Statement, Formal Meeting Adjourned

Farah Zia MD, National Cancer Institute

1:35 – 2:30 *Lunch

2:30 – 5:00 Convene for First Draft of White Papers, adjourn

Thank You! Sincerely, The Meeting Chairs, Dr’s Zia &amp; Olaku
Main Vehicle Entrance:

NIH Gateway Drive

Rockville Pike & NIH Gateway Drive

NIH Gateway Center

Vehicle Inspection:

5am – 10pm, Monday-Friday

After 10pm on weekdays, all day weekends and

holidays, all visitor (commercial, non-
commercial) vehicles, motorcycles and bicycles

must enter campus at the Commercial Vehicle

Inspection Facility (CVIF) — Building 67 (on

Rockville Pike between North and Wilson Drives)

Pedestrians:

* Open Monday – Friday, 6 am – 10 pm

* Closed on Weekends and Observed Holidays

After 10 pm on weekdays, all day weekends and

holidays, pedestrian visitors should enter campus

via the Commercial Vehicle Inspection Facility

(CVIF) – Building 67 (on Rockville Pike between

North Drive and Wilson Drive)

West Gateway Center (Pedestrians Only)

Near Old Georgetown Rd & South Dr

6am – 12pm Monday – Friday

Patient and Patient Visitor Entrance

Cedar Lane & West Drive

Valet Parking at Clinical Center Main Entrance

(Monday-Friday, 7am – 7pm)

Inbound Traffic Only: 6am – 10pm, 7 days a week

Commercial Vehicle Inspection Facility (CVIF)

Building 67: Commercial Vehicles Only

Rockville Pike – between North Dr. and Wilson Dr.

Open 24 hours a day, 7 days a week

After 10pm on weekdays, all day weekends and

holidays, all visitors in vehicles or as

pedestrians should enter via the CVIF.

To learn more about visitor and security issues at

the NIH, visit:

http://www.nih.gov/about/visitor/index.htm

For questions about campus access, please contact

the ORS Information Line at orsinfo@mail.nih.gov

or 301-594-6677, TTY – 301-435-1908.

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Recently, I read an article from John Weeks, the Chief editor of Journal of Alternative and Complementary Medicine. I totally agree with him, the holistic method is important in acupuncture research.

Top Integrative Pain Researcher Urges End to Reductionist Dominance

http://www.huffingtonpost.com/john-weeks/integrative-pain-research_b_9775060.html

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In their recent report in the Annals of Internal Medicine, Ee et al1 state that Chinese medical acupuncture was no better than non-insertive sham acupuncture for women with moderately severe menopausal hot flashes in a randomised controlled trial. The authors conclude that they “cannot recommend skin-penetrating acupuncture as an efficacious treatment of this indication”.1 In my opinion, the authors might have misinterpreted the results.

The ‘sham acupuncture’ used in this clinical trial was the Park sham device, which is supposed to serve as a placebo treatment. It uses a 0.35×40 mm blunt needle supported by a plastic ring and guide tube (base unit) attached to the skin with a double-sided adhesive ring. The needle telescopes into itself and shortens on manipulation, giving the visual and physical impression of insertion into the skin.1 Although the blunt needle does not insert into the skin, it does cause considerable pressure and thereby mechanical stimulation, especially given the small diameter at its tip. This Park sham device should arguably be relabelled as an acupressure device, instead of a form of sham acupuncture treatment. Indeed, this type of device and needling method is historically recognised as an active form of treatment; it is otherwise known as a Di needle (鍉针 or Di Zhen, a style of pressing needle that does not penetrate the skin), as documented in The Spiritual Pivot: Nine Needles and Twelve Source Points (Ling Shu: Jiu Zhen Shi Er Yuan) in the second part of the Yellow Emperor’s Inner Classics, which was published 2000 years ago.2 For this reason, the trial design contained an obvious weakness; it compared acupuncture with acupressure, rather than acupuncture with truly inert sham acupuncture.

According to the trial’s results, hot flash scores decreased after both interventions by about 40% between baseline and the end of treatment (10 sessions, ending after 8 weeks) and these effects were sustained for 6 months. Statistically, there is no evidence that acupuncture was better than acupressure (called ‘sham acupuncture’ in the paper) in its impact on quality of life, anxiety or depression.1 This can equally be interpreted as evidence that both acupuncture and acupressure effectively decrease hot flashes and related symptoms, as well as quality of life, if we compare the results immediately after treatment (8 weeks) and at the 3- and 6-month follow-up, with baseline in the same group (self-control) or comparator group (as a waiting list-like control).

As regards the placebo effect, evidence from the literature3 and a review of multiple trials4 shows that patients receiving placebo interventions exhibit an average decrease of 21–25% in hot flash frequency and intensity. Therefore, a 40% decrease in hot flash symptom scores with either acupuncture or acupressure treatment is notably higher than that expected with a placebo and likely to be clinically significant. Further research with a more appropriate control group is needed. Meanwhile, however, if a patient declines or cannot tolerate conventional drug treatment, then it would not be unreasonable to offer either acupuncture or acupressure as an alternative treatment for this condition.

References 1. Ee C, Xue C, Chondros P, et al. Acupuncture for menopausal hot flashes: a randomized trial. Ann Intern Med 2016;164:146–54. doi:10.7326/M15-1380 [Medline] 2. Wu JN (translator). Ling Shu or The Spiritual Pivot. University of Hawaii Press, 2002. 3. Loprinzi CL, Michalak JC, Quella SK, et al. Megestrol acetate for the prevention of hot flashes. N Engl J Med 1994;331:347–52. doi:10.1056/NEJM199408113310602 [CrossRef][Medline][Web of Science] 4. Sloan JA, Loprinzi CL, Novotny PJ, et al. Methodologic lessons learned from hot flash studies. J Clin Oncol 2001;19:4280–90. [Abstract/FREE Full text]

Fan AY. Trial suggests both acupuncture and acupressure are effective at reducing menopausal hot flashes. Acupunct Med doi:10.1136/acupmed-2016-011119.

http://aim.bmj.com/content/early/2016/04/19/acupmed-2016-011119.full

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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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