Archive for the ‘acupuncture clinical trial’ Category

Our clinical trial protocol has been published recently in Journal of Integrative Medicine, the PDF of whole article is available based on request.

Effectiveness of two different acupuncture strategies in patients with vulvodynia: Study protocol for a pilot pragmatic controlled trial.

Fan AY, Alemi SF, Zhu YH, Rahimi S, Wei H, Tian H, He D, Gong C, Yang G, He C, Ouyang H.  J Integr Med. 2018 Oct 10. pii: S2095-4964(18)30103-1. doi: 10.1016/j.joim.2018.10.004. [Epub ahead of print]



Vulvodynia, or vulvar pain, is a common condition in women; however, there are few evidence-based clinical trials evaluating nonpharmacological therapies for this condition. Acupuncture is one complementary and integrative medicine therapy used by some patients with vulvodynia. This study evaluates two different acupuncture strategies for the treatment of vulvodynia and aims to evaluate whether either of the acupuncture protocols reduces vulvar pain, pain duration or pain with intercourse. The study also examines how long the effect of acupuncture lasts in women with vulvodynia.


The study is designed as a randomized controlled trial, focused on two acupuncture protocols. Fifty-one patients who have had vulvodynia for more than 3 months will be recruited. Among them, 34 patients will be randomized into Groups 1a and 1b; those who are unwilling to receive acupuncture will be recruited into the standard care group (Group 2). Patients in Group 1a will have acupuncture focused on the points in the pudendal nerve distribution area, while patients in Group 1b will receive acupuncture focused on traditional (distal) meridian points. Patients in Group 2 will receive routine conventional treatments, such as using pain medications, local injections and physical therapies or other nonsurgical procedures. Acupuncture will last 45 min per session, once or twice a week for 6 weeks. The primary outcome measurement will be objective pain intensity, using the cotton swab test. The secondary outcome measurement will be subjective patient self-reported pain intensity, which will be conducted before cotton swab test. Pain intensities will be measured by an 11-point Numeric Pain Rating Scale. Pain duration and pain score during intercourse are recorded. Local muscle tension, tenderness and trigger points (Ashi points) are also recorded. All measurements will be recorded at baseline (before the treatment), at the end of each week during treatment and at the end of the 6 weeks. Follow-up will be done 6 weeks following the last treatment.


Results of this trial will provide preliminary data on whether acupuncture provides better outcomes than nonacupuncture treatments, i.e., standard care, and whether acupuncture focused on the points in pudendal nerve distribution, near the pain area, has better results than traditional acupuncture focused on distal meridian points for vulvodynia.


Clinicaltrials.gov: NCT03481621. Register: March 29, 2018.


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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》








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Reporting Error Revealed in Knee Pain Acupuncture Study, Catastrophe Avoided

June 2016 | by Jonathan Gilbert


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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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).
Take care,
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.


Office of Cancer Complementary and Alternative Medicine

Conference On


Thursday, June 16 – Friday, June 17, 2016

Natcher Auditorium, Balcony B

NIH Main Campus, Bethesda, Maryland


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.


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)


* 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:


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


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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.


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