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Acupuncture and Knee Osteoarthritis: A Three-Armed Randomized Trial

Hanns-Peter Scharf, MD; Ulrich Mansmann, PhD; Konrad Streitberger, MD; Steffen Witte, PhD; Jürgen Krämer, MD; Christoph Maier, MD; Hans-Joachim Trampisch, PhD; and Norbert Victor, PhD
[+] Article and Author Information

From University of Heidelberg, Heidelberg, Germany, and University of Bochum, Bochum, Germany.


Central Registration No. ISRCTN27450856.

Acknowledgments: The authors thank Albrecht Molsberger, MD, for supporting the development of the acupuncture schemes and Christina Klose for data management.

Potential Financial Conflicts of Interest: Grants received: C. Maier, H.-J. Trampisch, N. Victor (Consortium of Allgemeine Ortskrankenkassen, Betriebskrankenkassen, Innungskrankenkassen, Bundesknappschaft, Landwirtschaftliche Krankenkassen, and See-Krankenkassen).

Requests for Single Reprints: Norbert Victor, PhD, Institute of Medical Biometry and Informatics, University of Heidelberg, Im Neuenheimer Feld 305, D-69120 Heidelberg, Germany.

Current Author Addresses: Dr. Scharf: Orthopedic Clinic, University Hospital Mannheim, Theodor-Kutzer-Ufer 1-3, D-68167 Mannheim, Germany.

Dr. Mansmann: Department of Medical Informatics, Biometry and Epidemiology, University of Munich, Marchionistrasse 15, D-81377 Munich, Germany.

Dr. Streitberger: Department of Anesthesiology, University of Heidelberg, Im Neuenheimer Feld 100, D-69120 Heidelberg, Germany.

Drs. Witte and Victor: Institute of Medical Biometry and Informatics, University of Heidelberg, Im Neuenheimer Feld 305, D-69120 Heidelberg, Germany.

Dr. Krämer: Orthopedic Clinic, University of Bochum, St. Josef-Hospital, Gudrunstrasse 56, D-44791 Bochum, Germany.

Dr. Maier: Department of Pain Management, BG-Kliniken Bergmannsheil, Buerkle de la Camp Platz 1, D-44789 Bochum, Germany.

Dr. Trampisch: Department of Medical Informatics, Biometry and Epidemiology, University of Bochum, Overbergstrasse 17, D-44780 Bochum, Germany.

Author Contributions: Conception and design: H.-P. Scharf, U. Mansmann, K. Streitberger, S. Witte, J. Krämer, C. Maier, H.-J. Trampisch, N. Victor.

Analysis and interpretation of the data: H.-P. Scharf, U. Mansmann, K. Streitberger, S. Witte, N. Victor.

Drafting of the article: H.-P. Scharf, U. Mansmann, K. Streitberger, S. Witte, N. Victor.

Critical revision of the article for important intellectual content: H.-P. Scharf, U. Mansmann, K. Streitberger, S. Witte, N. Victor.

Final approval of the article: H.-P. Scharf, U. Mansmann, K. Streitberger, S. Witte, J. Krämer, C. Maier, H.-J. Trampisch, N. Victor.

Statistical expertise: U. Mansmann, S. Witte, N. Victor.

Obtaining of funding: C. Maier, H.-J. Trampisch, N. Victor.

Administrative, technical, or logistic support: S. Witte, C. Maier, H.-J. Trampisch, N. Victor.

Collection and assembly of data: C. Maier, H.-J. Trampisch.


Ann Intern Med. 2006;145(1):12-20. doi:10.7326/0003-4819-145-1-200607040-00005
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This study shows that both TCA and sham acupuncture improve pain and functionality in patients with osteoarthritis of the knee more than conservative therapy. The effect was assessed by success rates based on the WOMAC scores. Surprisingly, no differences were observed between the TCA and sham acupuncture groups. Superiority of TCA and sham acupuncture over conservative therapy and no detectable difference between TCA and sham acupuncture also held true for all secondary end points. Additional sensitivity analyses with adjustment for potential influencing factors support these findings. Apart from hematomas, no obvious adverse effects due to acupuncture were detected. This supports known statements about the safety of acupuncture (29). To our knowledge, our study is the largest reported randomized, controlled trial on the efficacy and safety of acupuncture in patients with symptomatic osteoarthritis of the knee and moderate to severe chronic pain. Blinding between TCA and sham acupuncture was successful, the number of patients who left the study was kept low, and homogeneous treatment groups could be created with respect to demographic characteristics and baseline values. However, our study has several limitations. Adherence to the predefined acupuncture schemes could not be monitored. The recruited patients assumedly had an interest in acupuncture, possibly introducing a selection effect.

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This blind-study was not blind
Posted on July 9, 2006
Dieter Wettig, PhD, MD
Private Practice (GP)
Conflict of Interest: None Declared

The German Acupuncture Study (GERAC) for gonarthrosis (osteoarthritis of the knee with jointpain) has been potentially broadly unblinded long before the study ended. There have been plenty of print and online publications giving secret details of the study design to the public. Being a double blind study its blinding involved both patients and telephone-interviewers. The reliability of the study depended profoundly on not telling patients and telephone-interviewers, that real acupuncture points with deep needeling technique were used in the verum-acupuncture- group and non-acupuncture-points with superficial needeling technique in the sham- or placebo-acupuncture group. A third group of patients was treated with physiotherapy and / or NSAR and could therefore not be blinded.

Recruitment for this study ended on February, 27th, 2004, therefore the last telephone interview was conducted around September or October 2004. But the following online resources published the choosen study design for a worldwide audience long before the end of the study.

1. The masterplan version V9.0 was made available on GERAC`s official site www.gerac.de

URL: http://www.gerac.de/deu/download/Masternplan_V9.0_BK.doc

It is telling in chapter 9 details about sham-acupuncture.

The following news-group post proves that this plan has been in public disussion since 2002-11-09: http://groups.google.de/groups?q=gerac&hl=de&lr=&ie=UTF- 8&edition=de&selm=4e6ba8e7.0211091620.6c39e942%40posting.google.com&rnum=2

2. The studyplan version V4.2 was made public under http://www.amib.ruhr-uni-bochum.de/download/Studienplan_V4.2.pdf on the website of the Ruhr-University in Bochum,

telling in chapter 4 about the studydesign and sham-acupuncture.

3. In 2002 Trampisch et al. published in the German weekly "Deutsches Ärzteblatt" : "Trampisch, Hans Joachim; Victor, Norbert et al.: GERAC- Akupunktur-Studien: Modellvorhaben zur Beurteilung der Wirksamkeit Deutsches Ärzteblatt 99, Ausgabe 26 vom 28.06.2002, Seite A-1819 / B-1539 / C-1435 MEDIZIN: http://www.aerzteblatt.de/v4/archiv/artikel.asp?id=32190 ".

This article tells the medical and non-medical public "....In der Sham-Akupunktur werden Nadeln oberflächlich an definierten Nichtakupunkturpunkten gesetzt...." That means: "....In sham-acupuncture needles will be inserted superfiacially and at defined non-acupuncture- points ....".

This journal has a weekly distribution of 370.000 copies. The online- edition of this journal has 2.080.000 page impressions per month and also carries the same article freely and without password-restriction.

4. The final and complete study plan in German and English "Prüfplan GERAC - Wirksamkeit und Sicherheit von Akupunktur bei gonarthrosebedingten chronischen Schmerzen, , Heidelberg, Februar 2003"

was made public through: http://www.biometrie.uni- heidelberg.de/publikationen/44_gerac.pdf on the website of University of Heidelberg.

It gave away all and every details of the gonarthrosis-study.

This plan was also made available through theses public libraries to the general public and the patients:

a) Badische Landesbibliothek

b) Deutsche Bücherei

c) Zentralbibliothek für Medizin (ZBMED)

5. The article

"Efficacy and safety of acupuncture for chronic pain caused by gonarthrosis: A study protocol of an ongoing multi-centre randomised controlled clinical trial [ISRCTN27450856] Konrad Streitberger, Steffen Witte, Ulrich Mansmann. BMC Complementary and Alternative Medicine 2004, 4:6 doi:10.1186/1472-6882-4-6. The electronic version of this article is the complete one and can be found online at: http://www.biomedcentral.com/1472-6882/4/6"

available as an Open Access article free of charge through the Internet contributed to the wide and unrestricted distribution of secret study details.

I believe that unblinded patients from the placebo- (sham-)group tended to apply additional therapies against their painful joint-condition without telling their acupuncturist or telephone interviewer that they did so. Easily they could have bought additional treatment from external sources because they were paid a substantial amount of money for joining and ending the study under discussion. This might also have been a reason for them to keep quiet about forbidden additional therapies: They might have feared financial sanctions when telling the truth about forbidden additional therapies. Thereby the treatment results of the sham- acupuncture-group might have been influenced on a large scale.

It is evident that telephone interviewers might have tended to classify treatment information differently (biased) when unblinded.

Therefore the GERAC study for gonarthrosis seems to be a sad example of scientific misconduct. It was unfair to both patients and acupuncturist doctors to unblind the study prematurely.

Conflict of Interest:

I participated in this study as a doctor performing acupuncture.

Puzzling Questions about Acupuncture
Posted on July 11, 2006
Franklin G Miller
Department of Clinical Bioethics, National Institutes of Health
Conflict of Interest: None Declared

To the editor:

The results of the large-scale, well-designed trial reported by Scharf et al. provide highly valuable data but raise puzzling questions.1 Is acupuncture clinically worthless for this condition because it was shown to be no better than a sham intervention involving superficial needling at non-acupuncture points? Or is acupuncture an important therapeutic modality for knee osteoarthritis because it was shown to be substantially better than standard physiotherapy and anti-inflammatory drugs? Should practitioners of acupuncture continue to follow traditional methods or adopt superficial needling because it is less invasive and no less effective? Can a therapy still be called "acupuncture" if it no longer has the characteristics of acupuncture (e.g., precise needle location and exact depth of needle insertion) and more closely resembles peripheral sensory stimulation or counter-irritation? Although determining the mechanism responsible for the effects of acupuncture is scientifically interesting, it will not settle these evaluative questions, which deserve critical thinking and debate.

(1) Scharf H-P, Mansmann U, Streitberger K, Whitte S, Krämer J, Maier C, Trampisch HJ, Victor N. Acupuncture and knee osteoarthritis. A three- armed randomized trial. Ann Intern Med 2006; 145: 12-20.

Franklin G. Miller, Ph.D.* Department of Clinical Bioethics National Institutes of Health

Ted J. Kaptchuk Osher Institute Harvard Medical School

*The opinions expressed are the views of the author and do not necessarily reflect the policy of the National Institutes of Health, the Public Health Service, or the U.S. Department of Health and Human Services.

Conflict of Interest:

None declared

Inherent difficulties in the use of sham acupuncture
Posted on July 17, 2006
Shin-ichi Muramatsu
Division of Oriental Medicine, Jichi Medical University, Japan
Conflict of Interest: None Declared

The impressive finding in the recent study by Scharf and colleagues is that treatment outcomes do not differ significantly between patients treated with sham or verum acupuncture.1 Similar result that verum acupuncture is no better than sham acupuncture was reported in a previous study for prophylaxis of migraine.2 Inherent difficulties in the use of sham procedures make interpretation difficult. What is verum or genuine acupuncture? How does it differ from sham acupuncture? Although the protocol carefully avoided deep insertion and manual stimulation of needles in sham acupunctures, these technical modifications alone do not exclude the possibility to elicit typical acupuncture sensation of deqi. In addition, patients do not have to feel anything on needling for treatment to succeed in some Japanese acupuncture techniques.3 More importantly, the choice of verum and sham points is controversial. Diagnosis procedure of traditional Chinese medicine does not depend on blood tests or biomedical techniques but instead on observable signs and symptoms that are hardly quantified. Even granting pattern recognition is capable of consistent repeatability at least among acupuncturists of similar training, there is a considerable theoretical variety for selection of points among international experts. In addition, exact anatomical locations of many acupuncture points are contentious and international standardization is still underway. Consensus- building among experts is necessary for more accurate assessment of sham acupuncture.

1. Scharf H-P, Mansmann U, Streitberger K, Whitte S, Kraemer J, Maier C, et al. Acupuncture and knee osteoarthritis. A three- armed randomized trial. Ann Intern Med 2006; 145:12-20.

2. Diener HC, Kronfeld K, Boewing G, Lungenhausen M, Maier C, Molsberger A et al. Efficacy of acupuncture for the prophylaxis of migraine: a multicentre randomised controlled clinical trial. Lancet Neurol 2006; 5:310-6.

3. Birch SJ, Felt RL. Cultural influences on acupuncture treatment. In: Understanding acupuncture. Edinburgh: Churchill Livingston, 1999: 256-259.

Conflict of Interest:

None declared

This blind-study was not blind (2)
Posted on July 18, 2006
Dieter Wettig
Private Practice (GP)
Conflict of Interest: None Declared

Another drawback of the study under discussion is the fact that acupuncture experienced patients were allowed to participate. http://www.biometrie.uni-heidelberg.de/publikationen/44_gerac.pdf : "ž....jemals gegen gonarthrosebedingte Beschwerden durchgeführte Behandlung mit Nadel-Körperakupunktur ODER jede Nadel-Körperakupunktur im letzten Jahr, ...." That means: "Patients, who had acupuncture more than a year ago were allowed to participate, unless it was acupuncture against gonarthrosis."

These patients could easily distinguish between minimal- and verum- acupuncture. Sham-patients could then improve their results secretly with additional therapy. Even selfmedication with ASS would do the job.

In 2001 A. White wrote that placebo-acupuncture works only on acupuncture virgins: Martindale, Diane: Needlework", New Scientist, Nr. 2292, 26.5.2001, S. 42-5 ( http://www.newscientist.com/article.ns?id=mg17022924.800 ), citing Adrian White: ".... The drawback is it will only work on acupuncture virgins. As long as we have a supply of those we`re OK."

The GERAC-studies, including the study under discussion, consequently were criticised repeatedly in German medical journals:

1. Ärzte Zeitung (6.7.2005, p 11): "ž"¦Ein Grund für die kontroversen Diskussionen war unter anderen, daß das Studiendesign für jeden Interessierten im Internet nachzulesen war, "¦."

That means: "One reason for controverse discussion was - among other reasons - that the study design could be read in the Internet, ...."

2. Ärzte Zeitung (1.12.2005, p 2): "ž"¦.Kritisiert wird bei GERAC- Studien etwa, daß Patienten das Studiendesign hätten kennen können, weil es im Internet einsehbar war"¦."

That means: "It is being criticised concerning the GERAC-studies that the study design was visible for patients in the Internet."

3. Ärzte Zeitung (1.12.2005, p 2): "....Andere sagten, daß die GERAC- Ergebnisse nicht aussagekräftig sein können, weil das Studiendesign für jeden, also auch Patienten, im Internet zugänglich und keine Verblindung gegeben war...."

That means: " Others said, that the GERAC results can not be valid, because the study design could be obtained through the Internet for everybody, also for patients and therefore there was no blinding...." (http://www2.aerztezeitung.de/docs/2005/12/01/217a0205.asp , http://www2.aerztezeitung.de/docs/2005/12/01/217a0203.asp )

One GERAC author even admited (http://www.gerac.de/deu/pdf/3Molsberger2.pdf , 16.11.2005 and http://www.facm.de/pages/download/presse/gerac/Molsberger.pdf ), that there were unblinded patients in one GERAC study : ""¦.So wurden zusätzlich zu allen Patienten, "¦., auch alle diejenigen Patienten als Misserfolg gewertet, die entblindet worden sind, "¦."

Because of all these problems I question the validity of this study. "Success of blinding is a fundamental issue in many clinical trials. The validity of a trial may be questioned if this important assumption is violated." .... "A fundamental assumption for this method ("Assessment of blinding in clinical trials") to be valid is that participants who answer DK ("Don`t know") are truly uncertain about their treatment assignment, not just giving a socially acceptable answer. This assumption cannot be verified in the absence of any supporting information from people who answer DK". (Bang, H. et al., Assessment of blinding in clinical trials, Controlled Clinical Trials 25 (2004) 143-56)

On 27.1.2006 it was annnounced in "Deutsches Ärzteblatt" (DÄ) that the GERAC studies were scheduled to be published in DÄ later, but they never were. ( http://www.aerzteblatt.de/v4/archiv/artikel.asp?src=suche&id=49979 : "....Die Ergebnisse des Modellvorhabens der AOK (GERAC) werden in absehbarer Zeit an dieser Stelle folgen....")

But there was already one publication (192 pages) of this study in December 2005 on the homepage of Uniklinik Heidelberg: http://www.klinikum.uni- heidelberg.de/fileadmin/inst_med_biometrie/pdf/51_geracGA_Bericht.pdf "GERAC - Wirksamkeit und Sicherheit von Akupunktur bei gonarthrosebedingten chronischen Schmerzen: Multizentrische, randomisierte, kontrollierte Studie Dezember 2005"

Conflict of Interest:

I participated in this study as a doctor performing acupuncture

Overestimation of placebo effect in clinical trials
Posted on August 1, 2006
Michal R. Pijak
Department of Internal Medicine, University Hospital, 833 05 Bratislava, Slovakia
Conflict of Interest: None Declared

TO THE EDITOR: Scharf and colleagues(1) reported that addition of traditional Chinese acupuncture (TCA) was superior to conservative therapy though not to sham acupuncture for osteoarthritis of the knee. They suggest that "....because complete blinding was impossible, this study does not allow us to determine whether the observed effectiveness of TCA and sham acupuncture was due to placebo effects, intensity of provider contact, or a physiologic effect of needling" However, two related points need to be emphasized.

First there is a possibility that either placebo effects or "time effects " might have led to an overestimation of the differences between blinded and unblinded arms coupled with narrowing of the discernable difference between real and sham acupuncture. For example, subjects receiving real or sham acupuncture might experience a stronger placebo effect. Conversely, those receiving only conservative therapy might report worse results because of reduced patient-provider interaction ("žritual of treatment") and their awareness that they were not given additional treatment.

However, analysis of three-armed trials with a natural-history control group in addition to treatment and placebo showed that the significance of the true placebo effect (the "meaning response") has been grossly overestimated(2). This is consistent with findings that reduced expectations for improvement are a critical factor underlying reduced placebo responding(3). Likewise, there is evidence that the "time effects " such as regression to the mean are large enough to account for the observed improvement after placebo treatment(4). Therefore, it seems possible that identification and elimination of the "žtime effects" may unmask hidden differences between placebo and real acupuncture. Indeed, recent reanalysis of acupuncture trials reversed the results of the original papers and found that effectiveness of acupuncture could not be ascribed entirely to a placebo effect.(5)

My second point relates to the fact that some other recent studies that have reported superiority of TCA over sham acupuncture involved a more intensive acupuncture regimen and less invasive sham acupuncture(6). One might therefore expect that deeper and more painful needling may produce a more powerful placebo and/or physiological effects than superficial needling. The first of these possibilities seems unlikely, because the estimates of true or false acupuncture by patients were roughly random. However, confounding by non-specific physiologic effects of needling cannot be excluded; hence minimally active forms of placebo control (e.g. Streitberger device) should be used. To further investigate whether benefits of acupuncture are specific effects of needling traditional meridians, two acupuncture treatments differing only in needling positions should be compared.

References

1. 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.

2. Hrobjartsson A, Gotzsche PC. Is the placebo powerless? An analysis of clinical trials comparing placebo with no treatment. N Engl J Med. 2001;344:1594-602.

3. Pollo A, Amanzio M, Arslanian A, Casadio C, Maggi G, Benedetti F. Response expectancies in placebo analgesia and their clinical relevance. Pain. 2001;93:77-84.

4. Kienle GS, Kiene H. The powerful placebo effect: fact or fiction? J Clin Epidemiol. 1997;50:1311-8.

5. Vickers AJ. Statistical reanalysis of four recent randomized trials of acupuncture for pain using analysis of covariance. Clin J Pain. 2004;20:319-23.

6. 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;141:901-10.

Conflict of Interest:

None declared

This blind-study was not blind
Posted on August 6, 2006
Dieter Wettig
Private Practice (GP)
Conflict of Interest: None Declared

Dr. Beyerle writes in his column about the beginning of the GERAC- gonarthrosis study (My translation):

"....As a highlight of the "blinding-strategy" patients were .... invited (to participate) with the following words by GERAC:

"Welcome to GERAC.... Do you have back-pain or pain in your knees ? Then you will profit from GERAC ....

When you participate at these studies you will outdo the pain at the end....

Patients report fantastic things about acupuncture....

TCM is somehow ahead of us...."." (1)

I do not think that this kind of information was suitable to prepare patients in an objective and neutral manner.

After reading this information on GERAC`s official homepage patients could be under the strong impression, that acupuncture is somehow fantastic (much better than physiotherapy) and ahead of us, i.e. our conventional "western" treatments. Those receiving only conservative therapy might have been utterly disappointed and reported bad results.

1. Ärztezeitung, Aug., 3rd, 2006, page 14

http://www2.aerztezeitung.de/docs/2006/08/03/143a1401.asp

"Die Vertragsdoktores sind frustriert: Die Nadel trifft den Akupunktur-Ballon Von Dr. Ludger Beyerle

.... Der genaue Blick legt Groteskes frei .... Als Höhepunkt der "Verblindungsstrategie" wurden die Patienten suggestiv zur Teilnahme an der Studie mit folgendem GERAC-Originalton eingeworben: "Herzlich willkommen bei GERAC"¦ Haben Sie Schmerzen im Knie oder im Rücken? Dann profitieren Sie von GERAC ("¦) Wenn Sie an den Studien teilnehmen, werden Sie am Ende den Schmerz allemal ausstechen ("¦) Ãœber die Akupunktur berichten die Patienten Fantastisches ("¦) Die Traditionelle Chinesische Medizin (TCM) hat uns etwas voraus ("¦) Bis Mitte 2003 haben Sie die Chance, sich bei einem von 400 ausgesuchten Ärzten behandeln zu lassen. Dann nehmen Sie an Studien teil, die weltweit große Beachtung finden ("¦) Wir, das Team der Wissenschaftler von GERAC, würden uns freuen, Sie als Patienten in unseren Studien begrüßen zu dürfen...."

Conflict of Interest:

I participated in this study as a doctor performing acupuncture

Methodology in Acupuncture Research
Posted on August 16, 2006
Peggy M.P.C. Bosch
School of Human Sciences, The University of Surrey, Guildford, UK
Conflict of Interest: None Declared

We read the study by Scharf and colleagues(1) with great interest. When it comes to acupuncture, they found that their treatment outcomes did not differ significantly between patient groups treated with sham acupuncture and those treated with standardised Traditional Chinese Acupuncture (TCA).

The result that standardised TCA is no better than sham acupuncture was also reported in a previous study for prophylaxis of migraine(2). From these studies, the question arises whether it really does not matter where one sticks the needles? Research questions like this one depend upon a correct choice of treatment and control group. Furthermore, the choice of control group is important in particular in acupuncture studies, since there is no ideal control group.

In this study, the authors chose a sham acupuncture treatment that resembles the so called "˜real acupuncture' as much as possible. That is a good thing, however, it was found from fMRI research(3), that wherever a needle enters the skin, it influences the brain and results can be found in fMRI. Furthermore, from TCA principles, the whole body is covered not only in meridians, but also in meridian areas(4). It would only be logical from this background, to expect some results from the sham acupuncture treatment. However, we would not expect the results to be as large as in this study, because the "˜real' acupuncture points should give a much greater effect than the non-acupuncture points. Why not in this study then? One answer to this question might be found in the treatment group. The research background of this study appears to be a request from insurance companies to find out whether acupuncture adds something to pain treatment in patients with osteoarthritis of the knee.

In a follow up study, it would be interesting to add another treatment group; a non-standardised acupuncture group. That would tell the difference between acupuncture, standardised acupuncture and a control group and might tell us more on the importance of point location and point choice. Finally, we agree with the statement that consensus-building among experts is necessary for more accurate assessment of (sham) acupuncture.

References

1. Scharf H-P, Mansmann U, Streitberger K, Whitte S, Kraemer J, Maier C, et al. Acupuncture and knee osteoarthritis. A three-armed randomized trial. Ann Intern Med 2006; 145:12-20.

2. Diener HC, Kronfeld K, Boewing G, Lungenhausen M, Maier C, Molsberger A et al. Efficacy of acupuncture for the prophylaxis of migraine: a multicentre randomised controlled clinical trial. Lancet Neurol 2006; 5:310-6.

3. Bosch MPC, Van den Noort MWML. Neuroimaging and Acupuncture: A Comprehensive Meta-analysis. NeuroImage 2005; 26(S1): 63.

4. Deadman P, Al-Khafaji M, Baker K. A Manual of Acupuncture. California: Eastland Press, 1999.

Conflict of Interest:

None declared

Rejoinder
Posted on September 4, 2006
Norbert Victor
Heidelberg University
Conflict of Interest: None Declared

We thank Dr. Pijak and Dr. Muramatsu for their comments and for discussing different possibilities to explain our results. In our paper, we mentioned as possible reasons for the observed efficacy of acupuncture: effects of needling, more intensive provider interaction and differences in expectation (placebo effect in the strict sense). Like Dr. Pijak, we do not assume that the superiority of acupuncture can be ascribed entirely to a placebo effect but we assume that all three mentioned reasons contribute to the observed effect. We agree that more intensive verum acupuncture schemes and less invasive sham acupuncture schemes exist as those chosen in our study, and we agree that the definition of appropriate sham acupuncture is an unsolved problem. Our results suggest that our sham scheme is not a placebo scheme but a real minimal acupuncture. Furthermore, the definition of an optimal acupuncture concept is still in discussion and it is questionable whether an optimal point selection exists. We agree with Dr. Muramatsu that deep needling seems not to be important for specific acupuncture effects. It has to be considered that specific and non-specific effects of acupuncture as a complex therapeutic intervention are intertwined (1). Hence, as Dr. Pijak states, investigations with other schemes and devices are necessary to clarify if there are specific effects of traditional acupuncture techniques. Our study could not answer these questions as it was designed as a pragmatic approach to clarify if acupuncture as commonly used in German health care is justified as a treatment component for knee pain.

Dr. Wettig is right that we have published our study protocol in advance. He cited correctly articles informing that our study compared verum and sham acupuncture. We remain convinced that a publication of study protocols in advance is good scientific practice. Additionally, we like to remind that by ethical reasons in randomised trials study physicians are obliged to inform the patient about all possible therapies they could be allocated. We doubt that many patients studied the techniques described in the protocol publication in detail to become aware what type of acupuncture they have received. Our careful analysis showed that blinding of patient regarding acupuncture was successful. Even about half of those patients who were convinced to know the type of acupuncture they received went wrong with their guesses. Moreover, the knowledge to receive a sham acupuncture would not favour the effect in this group, but reduce a placebo effect evoked by the expectation. The constructed conjecture of Dr. Wettig regarding many unreported additional therapies in the sham group is extremely unlikely. The additional therapies including medication reported to the blinded interviewer were comparable in both acupuncture groups.

Conflict of Interest:

None declared

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Summary for Patients

Adding Acupuncture to Physical Therapy and Anti-Inflammatory Drugs in the Treatment of Knee Osteoarthritis

The summary below is from the full report titled “Acupuncture and Knee Osteoarthritis. A Three-Armed Randomized Trial.” It is in the 4 July 2006 issue of Annals of Internal Medicine (volume 145, pages 12-20). The authors are H.-P. Scharf, U. Mansmann, K. Streitberger, S. Witte, J. Krämer, C. Maier, H.-J. Trampisch, and N. Victor.

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