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A Randomized Clinical Trial of Acupuncture Compared with Sham Acupuncture in Fibromyalgia

Nassim P. Assefi, MD; Karen J. Sherman, PhD; Clemma Jacobsen, MS; Jack Goldberg, PhD; Wayne R. Smith, PhD; and Dedra Buchwald, MD
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From the University of Washington and The Group Health Cooperative Center for Health Studies, Seattle, Washington.

Acknowledgments: The authors thank the research staff at the University of Washington (Roxanne Geller, Leigh Kochan, and Jovine Umali) and at the Clinical Monitoring Unit at the Group Health Cooperative Center for Health Studies (Rene Talenti, John Ewing, and Christel Kratohvil), the acupuncturists, and the study participants.

Grant Support: By grant RO1AT00003 from the National Center for Complementary and Alternative Medicine.

Potential Financial Conflicts of Interest: Grants received: N.P. Assefi, J. Goldberg, W.R. Smith, D. Buchwald (National Center for Complementary and Alternative Medicine).

Corresponding Author: Dedra Buchwald, MD, Box 359780, 1730 Minor Avenue, Suite 1760, Seattle, WA 98101.

Current Author Addresses: Dr. Assefi: Management Sciences for Health, House 24, Darulaman Road, Ayub Khan Mina, Kabul, Afghanistan.

Drs. Buchwald, Goldberg, and Smith and Ms. Jacobsen: Box 359780, 17360 Minor Avenue, Suite 1700, Seattle, WA 98101.

Dr. Sherman: 1730 Minor Avenue, Suite 1600, Seattle, WA 98101.

Author Contributions: Conception and design: K.J. Sherman, D. Buchwald.

Analysis and interpretation of the data: N.P. Assefi, K.J. Sherman, C. Jacobsen, J. Goldberg, W.R. Smith, D. Buchwald.

Drafting of the article: N.P. Assefi, K.J. Sherman, C. Jacobsen.

Critical revision of the article for important intellectual content: N.P. Assefi, K.J. Sherman, C. Jacobsen, J. Goldberg, W.R. Smith, D. Buchwald.

Final approval of the article: N.P. Assefi, K.J. Sherman, C. Jacobsen, J. Goldberg, W.R. Smith, D. Buchwald.

Provision of study materials or patients: D. Buchwald.

Statistical expertise: C. Jacobsen, J. Goldberg, W.R. Smith.

Administrative, technical, or logistic support: N.P. Assefi, K.J. Sherman, W.R. Smith.

Collection and assembly of data: N.P. Assefi, K.J. Sherman, C. Jacobsen, W.R. Smith.

Ann Intern Med. 2005;143(1):10-19. doi:10.7326/0003-4819-143-1-200507050-00005
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Acupuncture has been used for more than 2 millennia in China. Since its reintroduction in the United States in the early 1970s, acupuncture has become a widely used form of complementary and alternative medicine, particularly to treat chronic pain (7). We found that directed acupuncture for fibromyalgia was no better than sham acupuncture at relieving pain. Possible explanations include a nonspecific response to the acupuncturist's healing presence or the relaxing environment of the acupuncture clinic, a psychological response to participation in a clinical trial, or fluctuations in the natural history of disease. A usual-care control group would have helped to differentiate among these 3 possibilities.

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Figure 1.
Participant flow.

*One participant assigned to the simulated acupuncture group was mistakenly administered directed acupuncture. This person was included in the originally assigned simulated acupuncture group for all analyses, yielding 24 total participants in that group.

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Figure 2.
Mean values for the visual analogue scale (VAS) outcomes and total number of participants for whom valid data were available at weeks 0 (baseline); 1, 4, 8, and 12 (duration of treatment); and 24 and 36 (3 and 6 months of follow-up), by treatment group, by week.

A. Pain intensity.  > 0.2. B. Fatigue intensity.  = 0.19. C. Sleep quality.  = 0.18. D. Overall well-being.  > 0.2. All P values are from the generalized estimating equation model comparing the directed acupuncture group with the pooled sham-intervention control group. *The pooled sham-intervention control group includes acupuncture for an unrelated condition, sham needling, and simulated acupuncture.

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Figure 3.
Mean values for the Short Form-36 (SF-36) outcomes and total number of participants for whom valid data were available at weeks 0 (baseline); 1, 4, 8, and 12 (duration of treatment); and 24 and 36 (3 and 4 months of follow-up), by treatment group.

Top. Physical Component Summary score. Bottom. Mental Component Summary score. For both panels, P > 0.2 (from generalized estimating equation model comparing the directed acupuncture group with the pooled sham-intervention control group). *The pooled sham-intervention control group includes acupuncture for an unrelated condition, sham needling, and simulated acupuncture.

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Appendix Figure.
Acupoint and sham needling regimens used in each treatment group.
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Effectiveness of Acupuncture and Placebo Effect
Posted on July 6, 2005
Tao Liu
TCM Department, the 2nd Teaching Hospital, Jilin University, 218 Ziqiang Street,
Conflict of Interest: None Declared

Another randomized controlled trial (RCT) done by Affesi and colleagues drew the conclusion that acupuncture was no more effective than sham control, 1 or in other words, that acupuncture is not superior to placebo. But does it make any difference whether an RCT draws a positive or negative conclusion, given so many serious methodological flaws concerning RCTs evaluating the effectiveness of acupuncture. 2 More and more people question the validity of RCTs in testing acupuncture, and doubt the necessity for further RCTs to be conducted with the same methodological defects as previous ones had, because they do not help make a decisive conclusion. All are expecting high-quality trials concerning acupuncture, but what is high quality in approach to evaluating acupuncture? What we have obtained from RCTs does not accord with that we get from daily clinical experience, as shown in another recent, pragmatic, non-placebo controlled, randomized trial evaluating the effectiveness of acupuncture on headache in practice.3 It is due to the reason that acupuncture treatment applied in RCTs is reduced to a mere ¡° needling¡± deprived of its Traditional Chinese Medicine (TCM) theory basis. TCM identifies symptoms in a different approach to form a characteristic diagnosis, and a particular acupuncture treatment is TCM diagnosis specific. When patients are recruited and classified by biomedical diagnosis as selection criteria to achieve homogeneity in study samples in an RCT, which results in actual heterogeneity according to TCM diagnosis, is it possible to evaluate the effectiveness of acupuncture appropriately? RCTs seem not fit for complex non-pharmacological treatment such as acupuncture.2

Acupuncture is widely accepted and used, especially in chronic conditions, without sufficient evidence supporting its efficacy. But what is evidence? Is it the sole valid evidence supporting the effectiveness of acupuncture that acupuncture has more than placebo effect? Placebo effect has long been ignored and discounted as unreliable untruthfulness, until recently more and more people view placebo effect with a new eye. A conference held at the National Institutes of Health in the United States in 2002 called for in-depth research on brain and body pathways that mediate placebo effects.4 It seems that effect of acupuncture is neither a specific effect nor a placebo effect¡ªif they can be divided; but an interaction mechanism existing between them functioning as the whole effect of acupuncture. Still we do not know how it works, and how it affects overall effectiveness. Acupuncture, entangled with placebo effect, may provide a new way to study and understand placebo effect¡ªat least, make research of placebo effect less intangible.

References 1 Assefi NP, Sherman kJ, Jacobsen C, Goldberg J, Smith WR, Buchwald D. A Randomized Clinical Trial of Acupuncture Compared with Sham Acupuncture in Fibromyalgia. Ann Intern Med. 2005; 143: 10-19. 2 Charlotte Paterson, Paul Dieppe. Characteristic and incidental (placebo) effects in complex interventions such as acupuncture. BMJ. 2005;330:1202¨C5 3 Andrew J Vickers, Rebecca W Rees, Catherine E Zollman, et al. Acupuncture for chronic headache in primary care: large, pragmatic, randomised trial. BMJ.2004;328;744-49. 4 David Spiegel.Placebos in practice. BMJ.2004;329;927-928.

Conflict of Interest:

None declared

Adopting Novel Research Designs in the Evaluation of Complex Health Conditions
Posted on July 7, 2005
Adam Burke
Institute for Holistic Healing Studies, San Francisco State University, San Francisco, CA 94132
Conflict of Interest: None Declared

Dr. Assefi and colleagues must be commended on the high quality RCT they conducted comparing acupuncture with sham in the treatment of fibromyalgia. There are, however, limitations in the study that result in non-generalizable findings in terms of the actual clinical practice of acupuncture and traditional Chinese medicine (TCM). First, it is important to remember that fibromyalgia syndrome (FMS) is a recently recognized western medical diagnosis (1). You will not typically find references to the disease in TCM texts, and correspondingly you will not find standard TCM treatments. The authors acknowledge this lack of a "gold standard" in their article. Even within the medical community there is no consensus regarding etiology, with hypothesized causes including neuroendocrine dysregulation, genetics, and sleep abnormalities; and there is no truly effective conventional medical treatment. Western medicine and alternative medicine are equally challenged by such syndromic diagnoses. To date some of the best results have actually been with moderate exercise (2). Given the poor prognosis for these patients they naturally begin to seek alternatives, acupuncture being one of them. One high quality acupuncture study (3), which the authors cite, showed the efficacy of electroacupuncture with FMS symptoms. Electroacupuncture is a useful therapeutic adjunct in pain treatment, and its addition as another arm in the Assefi study could have been informative. Considering how acupuncture has shown evidence of utility with other musculoskeletal disorders in high quality RCT's, such as research by Berman on osteoarthritis of the knee (4), the lack of efficacy in the current study may have more to do with the study design than with acupuncture mechanisms. Unfortunately we cannot say either with confidence given this study alone. Ultimately this very sound RCT study may point to limitations in our current CAM research strategies. The recent Institute of Medicine report on complementary and alternative medicine (5) recommends more novel study designs in the evaluation of traditional medicines, such as bundled studies focusing on standard practice. A bundled study of TCM for fibromyalgia might potentially include acupuncture, herbs, massage, lifestyle counseling, and provide treatment for a significantly longer period of time. At this point minimizing the value of acupuncture for the treatment of FMS would be premature. What this study suggests is that it is time for the next stage of research to emerge. Given the significant personal, social, clinical and economic costs of FMS, this is undoubtedly what our patients would hope for.

1. Wolfe F. Fibromyalgia. Rheum Dis Clin North Am. 1990;16(3):681-98. 2. Sim J, Adams N. Systematic review of randomized controlled trials of nonpharmacological interventions for fibromyalgia. Clin J Pain. 2002 Sep- Oct;18(5):324-36. 3. Deluze C, Bosia L, Zirbs A. Chantraine A. Vischer TL. Electroacupuncture in fibromyalgia: results of a controlled trail. BMJ. 1992;305:1249-1252. 4. Berman BM, Lao L, Langenberg P, Lee WL, Gilpin AM, Hochberg MC. Effectiveness of acupuncture as adjunctive therapy in osteoarthritis of the knee: a randomized, controlled trial. Ann Intern Med. 2004;141(12):901 -10. 5. Institute of Medicine. Complementary and Alternative Medicine in the United States. Washington, DC: National Academies Press, 2005.

Conflict of Interest:

None declared

What Shall We Conclude From This Randomized Clinical Trial Of Acupuncture?
Posted on July 15, 2005
Lan x Chen
University of Pennsylvania
Conflict of Interest: None Declared

Assefi et al have performed an extensive study and attempted to address an important issue about the role of acupuncture in fibromyalgia patients. They have enrolled 25 patients into "true active acupuncture treatment" and 75 patients into assumed control groups. They have concluded that "acupuncture was no better than sham acupuncture at relieving pain in fibromyalgia" (1). A more appropriate conclusion might be "A fixed-points acupuncture protocol based on an interpretation of the Traditional Chinese Medicine (TCM) was no better than pseudo sham acupuncture interventions in a small sample study."

Acupuncture is a procedure oriented intervention and its effectiveness is felt by TCM practitioners to be largely dependent on the performers with their selected points. In this study, the acupuncture points were chosen by an acupuncturist with 15 years of experience and were approved by 3 other senior acupuncturists. No information was given by the authors about how these acupuncturists decided to choose these points. What was the TCM diagnosis they have reached for these FM patients? Was any such traditional approaches used to select the points? It is sad that this randomized Clinical Trial has not supported the acupuncturist's 15 years experience. Its conclusion can not be generalized to any other acupuncture for fibromyalgia patients. Other regimens need to be tested.

One of the control groups received acupuncture sessions using points based on an unrelated condition, "early menses due to Blood Heat". The acupuncture points for this so-called unrelated condition are mainly regulating Liver and Spleen meridians, which are two meridians, that could have been affected in fibromyalgia patients based on TCM theory (2). TCM proposes that these points are not inert; they could be beneficial or even deleterious. It is a pseudo sham control at best, which has been a problem in acupuncture research as Dr. Liu has pointed out in his response to this study.

As for fibromyalgia, this is a patient population that has varying constellations of symptoms or even a variety of etiologies as Dr. Burke said in his Letter to the Editor. Pain in one of the manifestation of their underlying disorders, but it is not the only one. The primary outcome measurement in this study is a simple 10 cm visual analogue scale, a measurement for subjective pain. Wouldn't it have been more appreciate to use the validated Fibromyalgia Impact Questionnaires (FIQ)?

Even thought approximately 100 patients enrolled into this study, only 25 were chosen into presumably "true TCM based acupuncture group". Is this really a large enough group to detect any significant effectiveness for acupuncture treatment, an ancient therapy with marginal or moderate effectiveness at best (3)? Furthermore, the study reported here is single blind study, which will probably always be the case for all acupuncture study, because it is impossible to blind acupuncturists who need to relay on many aspects of the treatment melodious sensation (Deqi) to deliver its supposed efficacy.

Acupuncture is an experience driven, ancient technique developed in the pre-scientific era. Its role in our modern evidenced based, scientific proven patient care certainly needs further studies. Great attention was placed by Assefi et al to many details of their study. However, we should evaluate this non-pharmacologic approach by the same standards as we do for another other interventions. This requires adequate understanding and knowledge about the details of administering this ancient technique. It is frustrating to see that the Annals has published this limited acupuncture study with a broadly implied conclusion about acupuncture for our fibromyalgia patients without more consideration of its limitations.

Lan Chen MD, PhD University of Pennsylvania Philadelphia, PA 19104

Reference 1.Assefi NP, Sherman KJ, Jacobsen C, Goldberg J, Smith WR, and Buchwald D Ann Intern Med 2005;143 10-19 2. Zhang Hua The Traditional Chinese Medicine (TCM) Acupuncture Treatment Manual, Shanghai Medical University Publisher, Shanghai, China 1998 3. Berman BM, Lao L, Langenberg P, Lee WL, Gilpin AM, Hochberg MC. Ann Intern Med. 2004 Dec 21;141(12):901-10.

Conflict of Interest:

None declared

Re: What Shall We Conclude From This Randomized Clinical Trial Of Acupuncture?
Posted on July 16, 2005
Jan M. Keppel Hesselink
Ores, Institute of Neuroacupuncture, Soest, NL
Conflict of Interest: None Declared

If this study would have been a pharmaceutical study, including only 100 patients, distributed in 4 different arms of 25 patients only, and single blind, no journal would have accepted it. Apart from being insufficient in its study methodology, the authors selected acupuncture points not widely used to treat fibromyalgia, and they ommited specific analgesic points such as Galbladder 21, Colon 4, Stomack 36.

Furthermore, in the control group they needled a point which is even diagnostic for fibromyalgia, spleen 10.

To test whether acupuncture works in fibromyalgia one needs no fixed acupuncture formula, one needs to include triggerpoints and much more patients need to be included in less arms!

Conflict of Interest:

None declared

Evaluation of Acupuncture trials
Posted on October 16, 2006
Dr Miklos A Prekop
Conflict of Interest: None Declared

The very basic difficulty with acupuncture trials that since every individual has different background to the ailment, hence will need different aproach in the TCM treatment. You can not give the same acupuncture treatment to individulas since they greatly differ in backgounds and this will give completely false results, since the prescribed treatment may benefit only 1-2 patients the rest would need different points. We do not have an objective method to specify pain intensity, it is very individual, some patients with electro acupuncture complain on the very lowest setting about intensive pain, others on very high electric settings still feel comfortable. I think we have to admit that there is no way to find objective measures to define the effectivness of needling. After 16 years practising as an acupuncturist full time, I do not feel I need any more evidence about the effectivness of the traditional chinese acupuncture (not the modified western counterpart)the patients tell it all.

Conflict of Interest:

None declared

Submit a Comment/Letter

Summary for Patients

Acupuncture To Treat Fibromyalgia Pain

The summary below is from the full report titled “A Randomized Clinical Trial of Acupuncture Compared with Sham Acupuncture in Fibromyalgia.” It is in the 5 July 2005 issue of Annals of Internal Medicine (volume 143, pages 10-19). The authors are N.P. Assefi, K.J. Sherman, C. Jacobsen, J. Goldberg, W.R. Smith, and D. Buchwald.


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