Email updates

Keep up to date with the latest news and content from BMC Complementary and Alternative Medicine and BioMed Central.

Open Access Highly Accessed Study protocol

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, Christine Knauer, Jürgen Krämer, Hanns-Peter Scharf and Norbert Victor

BMC Complementary and Alternative Medicine 2004, 4:6  doi:10.1186/1472-6882-4-6

PubMed Commons is an experimental system of commenting on PubMed abstracts, introduced in October 2013. Comments are displayed on the abstract page, but during the initial closed pilot, only registered users can read or post comments. Any researcher who is listed as an author of an article indexed by PubMed is entitled to participate in the pilot. If you would like to participate and need an invitation, please email info@biomedcentral.com, giving the PubMed ID of an article on which you are an author. For more information, see the PubMed Commons FAQ.

Letter to the Editor regarding 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

Dieter Wettig, Ph.D., M.D.   (2005-01-18 15:51)  Private Practice / G.P. email

Letter to the Editor regarding

"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 "

Dear Madam,

Dear Sir,

I herewith submit my comment to the "Multi-centre randomised controlled clinical trial gonarthrosis study (GERAC-Gonarthrosis)" and ask you to publish my letter. I also ask you to confirm the reception of this e-mail. Thank you.

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, maybe in an attempt to win the "race of publications". 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 (Design 1). A third group of patients was treated with physiotherapy and / or NSAR and could therefore not be blinded.

Indeed the study design could have been different for the placebo-group:

a) One could have used real acupuncture points, but points, which were not indicated (Design 2),

b) Or real and indicated points but without inserting the covered needle deeply (Design 3):

(I can e-mail the following table, if you want):

-------------------table---------------

Studydesign

Verum-Acupuncture

Plazebo- (Sham-) Acupuncture

Standardtherapy

1

„True“ and indicated acupuncture-points

Non- acupuncture-points

Physiotherapy etc.

2

„True“ and indicated acupuncture-points

„True“, but non-indicated acupuncture-points

Physiotherapy etc.

3

„True“ and indicated acupuncture-points inserted deeply and covered (non-visible for the patient)

„True“ and indicated acupuncture-points inserted superficially and covered (non-visible for the patient)

Physiotherapy etc.

---------------end of table----------------

It was therefore essential not to publish these details before the last patient had been treated and interviewed.

But the following online resources published the choosen study design for a worldwide audience long before the end of the study. Recruitment for this study ended on February, 27th, 2004 [ http://www.biometrie.uni-heidelberg.de/projekte/gerac/ ] , therefore the last telephone interview was conducted around September or October 2004.

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

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 carried the same article freely and without password-restriction to whoever has access to the internet.

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 though the internet contributed to the wide and unrestricted distribution of study details also to the non-medical public.

I believe that unblinded patients from the placebo-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 this gonarthrosis-study. 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 placebo-group might have been influenced on a large scale.

It is evident that telephone interviewers might have tended to classify treatment information differently 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. GERAC with its other study arms was a large scale study and cost about 10.000.000 Euro or 12.500.000 US $.

Dieter Wettig, Ph.D., M. D.

Erlkönigweg 8 - 65199 Wiesbaden-Dotzheim

GERMANY

Tel.: 0611-9410541, Fax: -9410217, Mobil: 0160-98219818

Competing interests

I participated in the mentioned study as an acupuncturist.

top

Post a comment