The German ART Acupuncture Studies

The German ART Acupuncture Studies for gonarthrosis
and low back pain (lbp) have been potentially broadly
unblinded before the study ended. There have been
print and online publications giving important details
of the study design to the public, maybe in an attempt
to win the "race of publications" against other German
acupuncture studies, f. e. the GERAC-acupuncture-
studies. The reliability of the ART studies depended
profoundly on not telling patients, that real
acupuncture points with deep needeling technique were
used in the verum-acupuncture-group and "minimal
acupuncture" or "acupuncture at non-acupuncture-
points" with "superficial" needeling technique in the
control group (I call it simplified "Design 1"). A
third group of patients was treated with acupuncture
after being on a waiting list.

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

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

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

c) Or insert needles deeply at non-acupuncture-points
(Design 4).

It was therefore essential not to publish these
details before the last patient had been treated and
before the follow up period had ended.

According to information about recruitment dates for
the four ART-studies provided to me by one of the
authors of (1) recruitment for the lbp-study ended on
October 2002, for gonarthrosis on January 2003, the
study duration with follow-up for both studies was 52
weeks (1), therefore the respective study ended
October 2003 or January 2004 or later, depending on
when screening was finished and treatment started.
Recruitment for the migraine study ended January 2003,
for the headache study it ended in January 2004. The
study duration for both studies was 28 weeks (3),
therefore the respective study ended August 2003 or
August 2004 or later.

But the following online and print resources published
the study designs already in August 2003:

1. Brinkhaus B, Becker-Witt C, Jena S, Linde K, Streng
A, Wagenpfeil S, Irnich D, Hummelsberger J, Melchart
D, Willich SN:
Acupuncture Randomized Trials (ART) in Patients with
Chronic Low Back Pain and Osteoarthritis of the Knee -
Design and Protocols.
Forsch Komplementärmed Klass Naturheilkd 2003;10:185-
191 (DOI: 10.1159/000073474)

(published in August 2003 and available in German
libraries more or less free of charge).

2. http://content.karger.com/ProdukteDB/produkte.asp?
Aktion=ShowPDF&ProduktNr=224242&Ausgabe=229609&ArtikelN
r=73474&filename=73474.pdf .

This summary gives some very important and secret
details (*....minimal acupuncture at non-acupuncture
points*. ") about the control group treatment of the
gonarthrosis or lbp study and was also published in
August 2003, available free of charge.

3. Melchart D, Linde K, Streng A, Reitmayr S, Hoppe A,
Brinkhaus B, Becker-Witt C, Wagenpfeil S, Pfaffenrath
V, Hammes M, Willich SN, Weidenhammer W:
Acupuncture Randomized Trials (ART) in Patients with
Migraine or Tension-Type Headache - Design and
Protocols.
Forsch Komplementärmed Klass Naturheilkd 2003;10:179-
184 (DOI: 10.1159/000073473)

(published in August 2003 and also available in German
libraries more or less free of charge)


4. http://content.karger.com/ProdukteDB/produkte.asp?
Aktion=ShowAbstract&ArtikelNr=73473&ProduktNr=224242&Au
sgabe=229609 .

This summary also gives details (*.... standardized
minimal acupuncture....") about the control group
treatment of the migraine or headache study and was
also published in August 2003, also free of charge.

I believe that unblinded patients from the minimal-
acupuncture group tended to apply additional therapies
against their painful condition without telling their
acupuncturist or monitor that they did so. Thereby the
treatment results of the control-group might have been
influenced on a large scale. Obviously a bias against
verum-acupuncture, maybe improving the outcome of the
control-group. Potentially unblinded studies should
not be used for serious research.


Dieter Wettig, Ph.D., M. D.
Erlkönigweg 8 - 65199 Wiesbaden-Dotzheim
GERMANY www.wettig.de praxis@wettig.de