Eric Manheimer, MS; Klaus Linde, MD, PhD; Lixing Lao, PhD, LAc; Lex M. Bouter, PhD; Brian M. Berman, MD
Note: All study data, including full details of the characteristics of each included RCT and all outcome data extracted from each included RCT, are included in a RevMan file, which will be made available to researchers on request for reproducing these results.
Acknowledgments: The authors thank Nancy Min, PhD, for her support in calculating estimated SDs of change from baseline for publications that did not directly report these but did report other data that could be used to estimate SDs of change; Byungmook Lim, MD, MPH, PhD, for performing data extraction for Witt and colleagues' 2005 RCT (47); Marcos Hsu, LAc, for assessing the adequacy of the acupuncture administered in the RCTs; and Elizabeth Kimbrough Pradhan, PhD, for providing helpful comments on the manuscript. They also thank Claudia Witt, PhD, for providing unpublished data specific to patients with only knee osteoarthritis from Witt and colleagues' 2006 RCT (48), and Birgitte Christensen, MD; Wenlin Lee, PhD; Jorge Vas, MD; and Steffen Witte, PhD, all coauthors of included RCTs, for confirming and providing data related to their respective RCTs.
Grant Support: Mr. Manheimer and Dr. Berman were funded by a grant from the National Institutes of Health, National Center for Complementary and Alternative Medicine (R24 AT001293). Drs. Lao and Berman were also funded by a grant from the National Center for Complementary and Alternative Medicine (P01 AT002605-01A1).
Potential Financial Conflicts of Interest: Honoraria: K. Linde (German Medical Acupuncture Society [Deutsche Ärztegesellschaft für Akupunktur], British Medical Acupuncture Society); Grants received: L. Lao (National Institutes of Health), K. Linde (Deutsche Angestellten Krankenkasse, Barmer Ersatzkasse, Kaufmännische Krankenkasse, Hamburg Münchener Krankenkasse, Hanseatische Krankenkasse, Gmünder Ersatzkasse, HZK Krankenkasse für Bau- und Holzberufe, Brühler Ersatzkasse, Krankenkasse Eintracht Heusenstamm, Buchdrucker Krankenkasse), B.M. Berman (National Institutes of Health); Grants pending: L. Lao (National Institutes of Health).
Requests for Single Reprints: Eric Manheimer, MS, Center for Integrative Medicine, University of Maryland School of Medicine, 2200 Kernan Drive, Kernan Hospital Mansion, Baltimore, MD 21207.
Current Author Addresses: Mr. Manheimer and Drs. Lao and Berman: Center for Integrative Medicine, University of Maryland School of Medicine, 2200 Kernan Drive, Kernan Hospital Mansion, Baltimore, MD 21207.
Dr. Linde: Centre for Complementary Medicine Research, Department of Internal Medicine II, Technische Universität München, Kaiserstrasse 9, 80801 Munich, Germany.
Dr. Bouter: VU University, Executive Board, VU-Windesheim, De Boelelaan 1105, Room 2d-18, 1081 HV Amsterdam, the Netherlands.
Manheimer E., Linde K., Lao L., Bouter L., Berman B.; Meta-analysis: Acupuncture for Osteoarthritis of the Knee. Ann Intern Med. 2007;146:868-877. doi: 10.7326/0003-4819-146-12-200706190-00008
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Published: Ann Intern Med. 2007;146(12):868-877.
Knee osteoarthritis is a major cause of pain and functional limitation.
To evaluate the effects of acupuncture for treating knee osteoarthritis.
Cochrane Central Register of Controlled Trials, MEDLINE, and EMBASE databases to January 2007. No language restrictions were applied.
Randomized trials longer than 6 weeks in duration that compared needle acupuncture with a sham, usual care, or waiting list control group for patients with knee osteoarthritis.
Two authors independently agreed on eligibility, assessed methodological quality and acupuncture adequacy, and extracted outcome data on pain and function measures.
Eleven trials met the selection criteria, and 9 reported sufficient data for pooling. Standardized mean differences were calculated by using differences in improvements from baseline between patients assigned to acupuncture and those assigned to control groups. Compared with patients in waiting list control groups, patients who received acupuncture reported clinically relevant short-term improvements in pain (standardized mean difference, âˆ’0.96 [95% CI, âˆ’1.21 to âˆ’0.70]) and function (standardized mean difference, âˆ’0.93 [CI, âˆ’1.16 to âˆ’0.69]). Patients who received acupuncture also reported clinically relevant short- and long-term improvements in pain and function compared with patients in usual care control groups. Compared with a sham control, acupuncture provided clinically irrelevant short-term improvements in pain (standardized mean difference, âˆ’0.35 [CI, âˆ’0.55 to âˆ’0.15]) and function (standardized mean difference, âˆ’0.35 [CI, âˆ’0.56 to âˆ’0.14]) and clinically irrelevant long-term improvements in pain (standardized mean difference, âˆ’0.13 [CI, âˆ’0.24 to âˆ’0.01]) and function (standardized mean difference, âˆ’0.14 [CI, âˆ’0.26 to âˆ’0.03]).
Sham-controlled trials had heterogeneous results that were probably due to the variability of acupuncture and sham protocols, patient samples, and settings.
Sham-controlled trials show clinically irrelevant short-term benefits of acupuncture for treating knee osteoarthritis. Waiting listâ€“controlled trials suggest clinically relevant benefits, some of which may be due to placebo or expectation effects.
Deparment of Psychiatry, U of Pittsburgh
June 20, 2007
If acupuncture is "clinicallly irrelevant" so is fluoxetine
Dear Sirs, Manheimer et al. (1) show that the effect size of acupuncture for osteoarthritis when compared to sham acupuncture is 0.35 and label it as "clinically irrelevant". They therefore suggest that the much larger effect sizes observed when acupuncture is compared to a waiting list or usual care control (0.45 to 0.96) can be attributed to a placebo effect.
Before jumping to this conclusion, it is important to bear in mind that the effect size of fluoxetine in the short-term treatment (at least 6 weeks) of major depressive disorder is at best 0.37 when it, too, is compared to a placebo. (2)
Yet, few psychiatrists or internists would be comfortable relinquishing their reliance on fluoxetine or equivalent antidepressants (none of which have ever been found to be more effective than fluoxetine) in the treatment of major depressive disorder. Certainly, few among us would consider fluoxetine to be "clinically irrelevant".
1. Manheimer E, Linde K, Lao L, Bouter LM, Berman BM. Meta-analysis: Acupuncture for Osteoarthritis of the Knee. Archives of Internal Medicine 2007;146(12):868-77.
2. Bech P, Cialdella P, Haugh MC, et al. Meta-analysis of randomised controlled trials of fluoxetine v. placebo and tricyclic antidepressants in the short-term treatment of major depression. British Journal of Psychiatry 2000;176:421-8.
An T. Tran
Howard University College of Medicine
June 27, 2007
Needling With Acupuncture May Still Have A Benefit
It is with great interest into both the article and subject matter that we reviewed the article "Meta-analysis: Acupuncture for Osteoarthritis of the Knee" by Manheimer et al. As a medical student doing a rheumatology summer scholar program we have much interest into acupuncture and other complementary medicine modalities. However, before dismissing the role of acupuncture in the treatment of osteoarthritis, we have several concerns about the conclusions from this meta-analysis.
We are impressed with the result of acupuncture showing short term improvement in pain (-0.96) and function (-0.93) compare to wait list control and short and long term improvement compare to the usual care control group. However, when acupuncture is compared to the sham control group there is no difference in improvement. The author mentioned patient preference, expectations, and drop-out rates as being possible confounding variables preventing accurate interpretation. These nonrandomized patient selection bias can be avoided if the experiments are done using cross over design studies, in which each patients have a period of treatment and then nontreatment and can act as their own control, thereby minimizing variability between patients and between acupuncturists. And wash out periods may be put in between to avoid carry over effects. With cross over studies everyone will get treated, thus avoiding the high drop out rate. Also, it will not be necessary to have multiple (shame, usual care, wait list) control groups. In addition, the lack of reliable long term studies on the effect of acupuncture seems to be a limitation in the study.
Hopefully, further studies will further clarify the role of acupuncture and other CAM's in the treatment of OA and other rheumatic disorders.
Medical Director, British Medical Acupuncture Society
June 29, 2007
Acupuncture for OA knee is unlikely to be principally placebo
To the editor: We congratulate the authors of this paper for performing a rigorous review of acupuncture for osteoarthrosis of the knee (1). We also performed a review with meta-analysis, and our results were very similar (2). Our interpretation of the findings differed however, and we would like to draw this to the attention of your readers.
The methodological difficulties of devising a suitable placebo in order to study the specific effects of acupuncture have been debated for some time (3). As Manheimer et al themselves recognise, sham acupuncture usually involves inserting needles and is likely to have a direct physiological effect. Therefore it is unfair to demand that acupuncture must show a clinical superiority over sham acupuncture; statistical superiority is enough to demonstrate that acupuncture has a biologic effect. When it comes to choosing treatments for patients, we should look to the comparisons with usual care, or standard care, since this is the choice faced by patients and their physicians. The large effect identified by Manheimer et al (standardised mean difference (SMD) 0.62 for pain compared with usual care) is in line with our own calculations (4) and is clinically highly relevant. The largest trial included in these reviews (n=1007), published in this journal, demonstrated that both acupuncture and sham acupuncture were superior (SMD = 0.67 for acupuncture) to standard care involving physiotherapy and as-needed anti-inflammatory drugs (5). We suggest that the overall effect of acupuncture is due to the physiological effects of needle insertion at any point (shown in sham acupuncture) together with the specific effect of correct stimulation (as in real acupuncture). Both these effects are facilitated by expectation, as has been demonstrated for analgesic drugs (6). It seems inherently unlikely that these large effects of acupuncture are due principally to placebo, as suggested by Manheimer et al in their conclusion.
In our review, we applied "˜adequacy of acupuncture' as an inclusion criterion. This was an important methodological innovation. We also applied criteria for the suitability of sham. Only one trial used what we would consider to be optimal acupuncture from a physiological perspective, and compared this with a suitable (non-penetrating) sham (7). The effect size in this trial was much larger than the rest, and while this was a relatively small trial (n=97), we hope that it will guide future trial designs and reviews in this field.
(1) Manheimer E, Linde K, Lao L, Bouter LM, Berman BM. Meta- analysis: acupuncture for osteoarthritis of the knee. Ann Intern Med. 2007;146:868-77.
(2) White A, Foster NE, Cummings M, Barlas P. Acupuncture treatment for chronic knee pain: a systematic review. Rheumatology (Oxford). 2007;46:384-90.
(3) White AR, Filshie J, Cummings TM. Clinical trials of acupuncture: consensus recommendations for optimal treatment, sham controls and blinding. Complement Ther Med. 2001;9:237-45.
(4) White A, Kawakita K. The evidence on acupuncture for knee osteoarthritis - editorial summary on the implications for health policy. Acupunct Med. 2006;24 Suppl:S71-S76.
(5) Scharf HP, Mansmann U, Streitberger K, Witte S, Kramer J, Maier C et al. Acupuncture and knee osteoarthritis: a three-armed randomized trial. Ann Intern Med. 2006;145:12-20.
(6) Colloca L, Lopiano L, Lanotte M, Benedetti F. Overt versus covert treatment for pain, anxiety, and Parkinson's disease. Lancet Neurol. 2004;3:679-84.
(7) Vas J, Mendez C, Perea-Milla E, Vega E, Panadero MD, Leon JM et al. Acupuncture as a complementary therapy to the pharmacological treatment of osteoarthritis of the knee: randomised controlled trial. BMJ. 2004;329:1216.
Lead author is employed by the British Medical Acupuncture Society, which is a registered charity in the UK, set up to encourage the use and scientific evaluation of acupuncture for the public benefit.
November 3, 2010
Why not adding a fluid stimulation to the metal stimulation of the same acupuncture needle
perhaps it would be interesting to combine acupuncture and injection of current drugs, allopathic or not, into the acupuncture point (Mesopuncture) or into the dermis (Mesotherapy): The patient is the major beneficiary, if, moreover, there is only one needle insertion into the skin. Injecting drug into the acupuncture point is a mode of treatment initiated by the Chinese Medicine, it is a fluid stimulation of the acupuncture needle (distilled water, salt solution, vitamins, trace elements and more).If, moreover, the product has a direct effect on osteoarthritis (Diclofenac, pyroxicam..)and if, when removing the needle into the dermis we create various mesotherapy points with the same product, The patient suffering from osteoarthritis of the knee will be the big beneficiary of this technique of three treatments with a unic needle insertion.
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Rheumatology, Osteoarthritis, Prevention/Screening.
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