First Results from "World's Largest Acupuncture Study" Available
Randomized Trial Phase Now Underway
By Editorial Staff
BOCHUM, Germany -- This month, hundreds of health care practitioners will begin work on the second phase of what is being called the largest acupuncture study ever conducted.
The study, known as GerAc (short for German Acupuncture Trials), will build on the work of previous trials in an attempt to prove that acupuncture is a safe and effective form of pain relief.
"The GerAc studies are getting to the bottom of acupuncture · For the first time in the history of clinical studies, acupuncturists and doctors of traditional medicine are working together to find the best possible form of therapy for you," enthused a press release on the study's website. The release added that the study's goals are to demonstrate whether acupuncture works better than conventional Western medicine, and to determine which methods of acupuncture are most effective for relieving pain.
The GerAc study had its beginnings in a meeting of the German National Committee of Doctors and Health Insurance Agencies, which convened on October 16, 2000 to discuss the merits of acupuncture. At that meeting, it was decided that a large trial comparing orthodox medical treatments with acupuncture be conducted, with a goal of treating 500,000 people suffering from chronic pain.
The first phase of GerAc was a cohort study that began in March 2001. Though not as large as originally planned, it involved more than 7,300 practitioners and 40,000 patients. To ensure a high standard of quality, only practitioners with certified training in acupuncture were allowed to take part in the study. Patients in the trial had previously been diagnosed with one of four conditions: low back pain; migraine or tension-type headaches; knee or hip arthrosis (a degenerative joint disease); or a combination of symptoms lasting a minimum of six months.
Participants were given acupuncture twice a week for five weeks, for a total of 10 sessions. Immediately after the last session, the practitioner documented which complaints were treated; the number of sessions performed; whether or not the ailments improved (and, if so, at what point the patient began to feel better); and any adverse effects experienced during treatment.
Results from the cohort phase showed that approximately nine out of every 10 participants (89.9%) experienced relief from pain after being treated with acupuncture. Of those patients who experienced relief, 50.7% said the pain had subsided within two weeks, usually after four treatments or less. Side-effects, such as local infections or fainting, were seen at a rate of "much less than one percent," and no deaths were recorded during the first phase of the trial.
While the findings are encouraging, Dr. Hans-Joachim Trampisch, a professor at the Ruhr University in Bochum and GerAc's coordinator, stressed that the results are still preliminary. In a brief interview with Reuters Health, Trampisch noted that the results from the first phase of the study could have been skewed because a control group was not used to rule out the placebo effect.
GerAc's second phase, set to begin this month, will remedy that situation by using a randomized, controlled trial format. The trial phase will involve 400 practitioners and 4,000 chronic pain patients. Patients will be treated for pain relief using one of three methods: conventional Western forms of care; real acupuncture, using points based on the concepts of traditional Chinese medicine; or sham acupuncture, using "fake" points along the body. Practitioners will use the same criteria to measure the effectiveness of care as in the first phase of the study.
The second phase of the GerAc trial is expected to last through mid-2003. Data from both phases will then be compiled into a final report, which will be published in 2004.
The full cost of the study is being estimated at 7.5 million euros (approximately $6.8 million U.S. dollars). In a somewhat unprecedented move, the funding for GerAc is being provided by six of Germany's largest public health insurers - a fact that should not be lost on insurance companies in the United States, considering that ailments such as back pain, headaches and joint pain account for hundreds of millions of dollars in hospital bills, insurance claims and lost revenue due to time missed from work each year.
For more information on the German Acupuncture Study, visit www.gerac.de.