German Acupuncture Trials

from Wikipedia, the free encyclopedia

The GERAC studies (German Acupuncture Trials, 2002–2007) were the world's largest prospective and randomized studies on the effectiveness of acupuncture . They compared acupuncture with a guideline-oriented standard therapy for the economically relevant indications of chronic low back pain , chronic pain associated with osteoarthritis of the knee , chronic tension headache and chronic migraine . In the case of chronic low back pain and chronic knee pain due to osteoarthritis of the knee, acupuncture and sham acupuncture were found to have a better effect in an open comparison with standard therapy. An effect that differentiates acupuncture from the placebo group (sham acupuncture) could not be demonstrated. Side effects occur equally frequently with acupuncture, sham acupuncture and standard therapy. The GERAC studies were the basis for the introduction of acupuncture as a German health insurance benefit for the clinical pictures of chronic low back pain and chronic knee pain in osteoarthritis of the knee .

methodology

A management committee at the Ruhr University Bochum (H.-J. Trampisch (statistics, Bochum), J. Kraemer (orthopedics, Bochum), HC Diener (neurology, Essen), J. Michaelis (statistics, Mainz), A. Molsberger (Acupuncture Research Group, Düsseldorf), H. Schaefer (Statistics, Marburg), N. Victor (Statistics, Heidelberg), M. Zenz (Pain, Bochum)) coordinated the Germany-wide studies. Six universities with a total of up to 100 scientists were responsible for the partial studies: migraine from the University of Essen and the University of Mainz , tension headache from the Ruhr University Bochum , osteoarthritis of the knee from the University of Heidelberg and low back pain from the University of Marburg . The scientific society research group acupuncture played a decisive role in the conception, management and implementation of the study . 500 resident physicians who had received at least 140 hours of acupuncture training from various German acupuncture societies and had at least two years of clinical experience with acupuncture were specially trained for GERAC and carried out the test therapies in their practices. The GERAC studies were financed by a consortium of large German statutory funds (including the AOK , BKK and IKK ).

The three-armed studies compared the effectiveness of acupuncture on Chinese acupuncture points ( verum , Latin for real) with acupuncture on non-Chinese points ( sham , English for pretense) and conventional (pharmacological, physiotherapy, etc.) therapy on over 3500 randomized patients . Moxibustion and electrical stimulation of acupuncture points were not permitted in the GERAC studies. In total, over 35,000 acupuncture treatments were performed. The patients were blinded to the type of acupuncture (verum or sham).

The study protocol was already freely published during the studies. Some critics consider the value of the GERAC studies to be inferior because of this unblinding. Further criticisms of the LWS study are:

  1. Different therapy contacts: 10 or 15 sessions of acupuncture are compared with 6 or 9 sessions of physical therapy.
  2. Incorrect regulations in the study protocol for verum and sham points. For example, in the protocols for sham acupuncture, “8 punctures” (8 punctures each on both sides) are required, but in verum acupuncture “8 punctures” (4 (!) Punctures on both sides) are required. The acupuncturists who carried out the sham acupuncture used 16 instead of 8 points, so these two groups are not comparable.
  3. Incorrect telephone follow-up questioning. In the follow-up questionnaire, the “Physiotherapy” group was not asked whether the patient had continued these exercises independently, as physiotherapy, after the end of the physical therapy. This would result in incorrect results, because the patients in the acupuncture group could not continue the therapy carried out independently.

Main results

The main results were collected six months after the start of therapy.

  • With chronic osteoarthritis of the knee, 24% more patients receive pain relief through a combination of acupuncture and conservative therapy than with conservative therapy alone. Since no difference was determined between traditional acupuncture and sham acupuncture, the difference to conservative therapy could be explained by placebo effects, differences in the intensity of contact with the treating person or a physiological effect that is not based on TCA.
  • In the case of chronic low back pain, approx. 12 acupuncture treatments within 6 weeks are effective in 20% more patients than conventional standard therapy; Acupuncture patients took less medication in comparison.
  • In the prophylaxis of chronic migraines, no statistically significant difference was found between acupuncture, sham acupuncture and standard therapy.
  • In tension headache, no statistically significant difference between acupuncture and sham acupuncture could be found for the primary endpoint. The comparison with the standard therapy had to be stopped because too few patients were willing to take amitriptyline .
  • Side effects do not occur to a statistically significant different extent with acupuncture, sham acupuncture and standard therapy.
  • A significant difference between acupuncture and sham acupuncture was not shown in any of the studies.

Significance for the German health system

On the basis of these results, the Federal Joint Committee decided that acupuncture will be a health insurance benefit from January 1, 2007 for back pain and chronic joint pain. The unproven difference between acupuncture at Chinese and non-Chinese points has an impact on the training content of medical training and further education in acupuncture. "A medical acupuncture training with acupuncture advanced and advanced training seminars, which mainly focuses on a selection of Chinese acupuncture points that is only based on historical facts, can no longer be legitimized by these study results," said A. Molsberger, GERAC management committee.

Scientific and medical policy response

The GERAC studies received a positive response in Germany and internationally. Decisive for this were the high quality of the studies (standards of Good Clinical Practice were exceeded), the large number of cases, the verification of the blinding success, the guideline-oriented standard therapy, which exceeds the generally usual care in the German statutory health insurance, and the individualized acupuncture taking into account the Chinese diagnostics. The similarly good effectiveness of verum and sham acupuncture points gave placebo research new impetus and led to a discussion about the specificity of acupuncture points. The 2009 updated international Cochrane reviews on tension headaches and migraines, the résumé of which were significantly influenced by the results of the GERAC studies, suggest that acupuncture "can represent a valuable non-pharmacological therapy option for patients with frequent episodic tension headaches" and that "acupuncture in the case of migraines at least as effective, possibly also more effective, as prophylactic drug therapy, and this with fewer undesirable effects ”.

criticism

Both the design and the blinding as well as the cultural as well as the experience and training-related background of the therapists must be viewed critically. The criticism includes the following points:

  • the non-documentation of the points used for sham acupuncture. So the comparable effect of sham acupuncture z. This can be explained, for example, by the fact that, although no standard points were used, substitute points that lie on the same conductor path were used. The fact that the same pathway was stimulated, even if not in the optimal places, does not change anything, neither the reduced stitch depth nor the lack of needle stimulation, which causes a toning.
  • insufficient training of therapists. In contrast to the at least 140 hours required here for the A diploma, the WHO recommends a training time for additional TCM training of at least 800 hours, including 675 hours of theory and 185 hours of monitored clinical practice. Correct acupuncture, in the sense of Chinese medicine, also requires the establishment of a diagnosis according to the rules of Chinese medicine, including the inclusion of very subjective and therefore not so quickly learned standard procedures such as e.g. B. the pulse diagnostics.

Web links

Individual evidence

  1. ↑ a b H. G. Endres, M. Zenz, C. Schaub, A. Molsberger, M. Haake, K. Streitberger, G. Skipka, C. Maier: German Acupuncture Trials (gerac) address problems of methodology associated with acupuncture studies. In: pain. 19 (3), Jun 2005, pp. 201-204, 206, 208-210.
  2. ↑ gerac.de
  3. ^ A b A. F. Molsberger, K. Streitberger, J. Kraemer, CS Brittinger, S. Witte, G. Boewing, M. Haake: Designing an acupuncture study: II. The nationwide, randomized, controlled German acupuncture trials on low-back pain and gonarthrosis. In: J Altern Complement Med. 12 (8), Oct 2006, pp. 733-742.
  4. ↑ a b A. F. Molsberger, G. Boewing, HC Diener, HG Endres, N. Kraehmer, K. Kronfeld, M. Zenz: Designing an acupuncture study: the nationwide, randomized, controlled, German acupuncture trials on migraine and tension-type headache . In: J Altern Complement Med. 12, 2006, pp. 237-245.
  5. ^ Acupuncture and Knee Osteoarthritis - Ann Intern Med (English) Annals.org. Retrieved June 19, 2010.
  6. ↑ D. Wettig: The German acupuncture study (GERAC) -Arthritis-Study :: are patients and interviewers previously blinded? In: The pain. Vol. 19 (4), 2005, pp. 330-331.
  7. ↑ D. Wettig: Acupuncture helps in knee osteoarthritis. What it really a blind study? In: MMW Fortschr Med. 147 (49-50), Dec 8, 2005, p. 22.
  8. ↑ The general practitioner. 6/2004; German Ztschr. F. Acupup. 47, 2/2004, p. 60.
  9. ↑ a b c Hanns-Peter Scharf, Ulrich Mansmann, Konrad Streitberger, Steffen Witte, Jürgen Krämer: Acupuncture and knee osteoarthritis: a three-armed randomized trial . In: Annals of Internal Medicine . tape 145 , no. 1 , July 4, 2006, ISSN  1539-3704 , p. 12-20 , PMID 16818924 .
  10. ↑ a b c Michael Haake; Hans-Helge Müller; Carmen Schade-Brittinger; Heinz D. Basler; Helmut Schäfer; Christoph Maier; Heinz G. Endres; Hans J. Trampisch; Albrecht Molsberger: German Acupuncture Trials (Gerac) For Chronic Low Back Pain - Randomized, Multicenter, Blinded, Parallel-Group Trial With 3 Groups . In: Archives of Internal Medicine . tape 167 , no. 17 , September 24, 2007, ISSN  0003-9926 , p. 1892 , doi : 10.1001 / archinte.167.17.1892 ( jamanetwork.com [accessed November 11, 2018]).
  11. ^ A b Hans-Christoph Diener, Kai Kronfeld, Gabriele Boewing, Margitta Lungenhausen, Christoph Maier: Efficacy of acupuncture for the prophylaxis of migraine: a multicentre randomized controlled clinical trial . In: The Lancet Neurology . tape 5 , no. 4 , April 2006, ISSN  1474-4422 , p. 310-316 , doi : 10.1016 / s1474-4422 (06) 70382-9 .
  12. ^ A b c Heinz G. Endres, Gabriele Böwing, Hans-Christoph Diener, Stefan Lange, Christoph Maier: Acupuncture for tension-type headache: a multicentre, sham-controlled, patient-and observer-blinded, randomized trial . In: The Journal of Headache and Pain . tape 8 , no. 5 , October 2007, ISSN  1129-2369 , pp. 306-314 , doi : 10.1007 / s10194-007-0416-5 , PMID 17955168 , PMC 3476149 (free full text).
  13. ↑ Press release of the Federal Joint Committee for Acupuncture for the Treatment of Back and Knee Pain is funded , April 18, 2006.
  14. ^ A. Molsberger: GERAC Trials in Germany - Overview, results and impact. Keynote lecture at the 10 Years Post-NIH Consensus Conference, Nov 8-11. 2007. University of Maryland, Baltimore, MD, USA
  15. ^ A. Molsberger: GERAC Trials in Germany - Method and Results in respect to the influence of the acupuncture situation in the US. Nov. Ov. 12th, 2007. University of North Carolina, Chapel Hill
  16. ^ Klaus Linde, Gianni Allais, Benno Brinkhaus, Eric Manheimer, Andrew Vickers: Acupuncture for tension-type headache . In: Cochrane Database of Systematic Reviews . John Wiley & Sons, Ltd, Chichester, UK January 21, 2009, doi : 10.1002 / 14651858.cd007587 .
  17. ↑ K. Linde, G. Allais, B. Brinkhaus, E. Manheimer, A. Vickers, AR White: Acupuncture for migraine prophylaxis. In: Cochrane Database Syst Rev. (1), Jan 21, 2009, Art. No. CD001218. Review.
  18. ↑ HG Endres et al.: Acupuncture for chronic headaches. In: Dtsch Arztebl. 104 (3), 2007, pp. A-114 / B-105 / C-101.
  19. ^ Claudia Focks: Atlas Acupuncture. 2nd Edition. 2006, p. 721.
  20. ^ WHO: Benchmarks for Training in Traditional Chinese Medicine. 2010, p. 13. (PDF; 516 kB)