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Background: To our knowledge, verum acupuncture has never been directly compared with sham acupuncture and guideline-based conventional therapy in patients with chronic low back pain., Methods: A patient- and observer-blinded randomized controlled trial conducted in Germany involving 340 outpatient practices, including 1162 patients aged 18 to 86 years (mean +/- SD age, 50 +/- 15 years) with a history of chronic low back pain for a mean of 8 years. Patients underwent ten 30-minute sessions, generally 2 sessions per week, of verum acupuncture (n = 387) according to principles of traditional Chinese medicine; sham acupuncture (n = 387) consisting of superficial needling at nonacupuncture points; or conventional therapy, a combination of drugs, physical therapy, and exercise (n = 388). Five additional sessions were offered to patients who had a partial response to treatment (10%-50% reduction in pain intensity). Primary outcome was response after 6 months, defined as 33% improvement or better on 3 pain-related items on the Von Korff Chronic Pain Grade Scale questionnaire or 12% improvement or better on the back-specific Hanover Functional Ability Questionnaire. Patients who were unblinded or had recourse to other than permitted concomitant therapies during follow-up were classified as nonresponders regardless of symptom improvement., Results: At 6 months, response rate was 47.6% in the verum acupuncture group, 44.2% in the sham acupuncture group, and 27.4% in the conventional therapy group. Differences among groups were as follows: verum vs sham, 3.4% (95% confidence interval, -3.7% to 10.3%; P = .39); verum vs conventional therapy, 20.2% (95% confidence interval, 13.4% to 26.7%; P < .001); and sham vs conventional therapy, 16.8% (95% confidence interval, 10.1% to 23.4%; P < .001., Conclusions: Low back pain improved after acupuncture treatment for at least 6 months. Effectiveness of acupuncture, either verum or sham, was almost twice that of conventional therapy.

Background: In the nationwide German Acupuncture Trials (GERAC), verum acupuncture, mirroring the Traditional Chinese Medicine (TCM) acupuncture style, was tested against sham acupuncture and guideline standard therapy for the entities classified in the West as chronic low back pain (LBP) and gonarthrosis (GON)., Objective: The objective was to develop broadly consensual acupuncture and control protocols for the treatment of LBP and GON in the GERAC trials., Methodology: Extensive literature study and consultation with acupuncture experts were consulted. Personal interviews, both free and structured, e-mail discussions, and phone conferences were used as well., Results: Broadly consensual acupuncture protocols for LBP and GON for verum and invasive sham acupuncture were developed. They included semistandardized point combinations with clearly described point selection rules based on TCM acupuncture diagnosis. A procedure was developed to help ensure homogenous treatment quality in a large multicenter trial., Conclusions: With 1162 randomized patients for LBP and 1039 patients for GON, the GERAC study design allowed acupuncture to be tested in a naturalistic environment. The rigorous study design and large number of physician investigators guaranteed a high external validity for the results. The results will help determine the significance of Chinese acupuncture in the context of Western medicine for the treatment of LBP and GON.

Objective: Conflicting or ambivalent findings on the effectiveness of body acupuncture in pain treatment are often attributed to flaws in study methodology. The paper describes the methodology used for the German Acupuncture Trials (gerac), which demonstrates that it is possible to design acupuncture studies in accordance with the standards of good clinical practice., Method: Approximately 1000 chronic pain sufferers per indication (migraine, tension-type headache, low back pain (cLBP), or gonarthrosis) are randomly allocated to one of three treatment groups (verum acupuncture, sham acupuncture, or established conservative therapy). Patients are blind to the type of acupuncture. All patients receive ten sessions of treatment (two per week) with an option of adding five more treatments in cases of slight but insufficient improvement (number of headache days or von Korff pain score). Participating physicians are in private practice, representing a variety of specialties. All have completed at least a 140-hour training course in acupuncture. Mandatory and optional verum and sham points are predefined. The point selection is individualized according to the criteria of traditional Chinese medicine (TCM). Primary outcome measures are number of headache days per month, von Korff Graded Chronic Pain Scale or Hannover Functional Ability Questionnaire (cLBP), or WOMAC scores (gonarthrosis). Data are assessed by trained telephone interviewers not involved in treatment and blind to types of acupuncture., Present Status: Over 500 participating physicians in ten urban areas of Germany. Patient recruitment for cLBP and gonarthrosis was completed in November 2003 and March 2004 respectively. Recruitment for chronic headaches will be completed in autumn 2004., Conclusions: The gerac trials prove that it is possible to design and carry out acupuncture studies in accordance to stringent standards of methodology and clinical practice. The results will form a basis for the assessment of acupuncture effectiveness in Germany and abroad.

Background: The efficacy of acupuncture treatment for chronic low-back pain has not been reliably proven because of a lack of good quality studies, leading to the necessity of developing the German Acupuncture Trial for Chronic Low-Back Pain (GERAC-cLBP) study., Objective: The aim is to assess the effectiveness of traditional Chinese acupuncture for chronic low-back pain compared to sham acupuncture and with a conventional standard therapy., Methods: This trial is a nationwide, multicenter, randomized, prospective, partially blinded study. The primary endpoint is the success rate after 6 months. Success is defined as an improvement of 33% or more of three pain-related items on the Van-Korff Pain Score or an improvement of 12% or more in the disability measured by the Hanover Functional Ability Questionnaire. Assessment of the effectiveness of the blinding of patients to the form of acupuncture they received will be conducted. All clinical endpoints are assessed centrally by blinded independent observers. The sample size, with a total of 1062 patients to be enrolled, is based on power calculations. Independent central randomization, data collection, data processing, and statistical analysis are provided. Success rates will be tested for differences using two-sided Fisher exact tests. In the primary analysis, all tests will be carried out on the basis of the intention-to-treat principle. Secondary analyses will be conducted according to protocol approaches., Trial Status: The pilot phase of the trial started in February 2002, the estimated duration of the study is 2.5 years. Enrollment is anticipated to be completed in the winter of 2003., Conclusion: The GERAC-cLBP study is currently the world's largest controlled trial of the effectiveness of acupuncture treatment for low-back pain. It will contribute to the evaluation of efficacy by means of evidence based medicine.

Acupuncture has been used for over 2000 years for a wide variety of complaints with minimal side effects. Based on the experience in Chinese medicine and the anticipated positive effects, acupuncture has been widely accepted in Western medicine as well. Some clinical evidence supports the efficacy of acupuncture treatment, but randomized controlled trials have been conducted for only a few of all possible locomotive disorder indications, and the results have been equivocal. Other indications have not yet been systematically studied, and application is based on clinical experience and consensus among practitioners. One of the outcomes on which consensus appears to exist is that 10-20 sessions are generally necessary, and that initial improvement can be expected to occur by the 10th treatment. Rigorous trials should be conducted to improve clinical validity and provide scientific proof of the efficacy of acupuncture. Clinical trials like the German Acupuncture Trials (gerac), funded by the German health insurance companies, have been launched with the aim of furthering knowledge in this area.

Acupuncture has been used for over 2000 years for a wide variety of complaints with minimal side effects. Based on the experience in Chinese medicine and the anticipated positive effects, acupuncture has been widely accepted in Western medicine as well. Some clinical evidence supports the efficacy of acupuncture treatment, but randomized controlled trials have been conducted for only a few of all possible locomotive disorder indications, and the results have been equivocal. Other indications have not yet been systematically studied, and application is based on clinical experience and consensus among practitioners. One of the outcomes on which consensus appears to exist is that 10-20 sessions are generally necessary, and that initial improvement can be expected to occur by the 10th treatment. Rigorous trials should be conducted to improve clinical validity and provide scientific proof of the efficacy of acupuncture. Clinical trials like the German Acupuncture Trials (gerac), funded by the German health insurance companies, have been launched with the aim of furthering knowledge in this area.