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Summary Objectives To investigate which patients receive acupuncture in the framework of statutory health insurance in Germany, how treatment was carried out, and what results were achieved. Design Basic documentation (carried out by physician) within a prospective observational study. Setting 454,920 patients with at least one of the three chronic pain conditions including headache, low back pain and osteoarthritis treated by 8727 medical acupuncturists (panel doctors) within the scope of a reimbursement program. Results Fifty-three percent of the patients were treated by general practitioners, 19% by orthopaedists and 9% by internists. Eighty percent of patients were female, mean age was 53.6 (S.D. = 15.7) years. Primary indication for acupuncture was low back pain (45%), headache (36%), and osteoarthritis (12%). Median time since the initial diagnosis was 3 years. 8.4 (S.D. = 3.0) acupuncture sessions (body acupuncture) were administered on average. In 28% a concomitant treatment was reported. Effectiveness of acupuncture was rated by physicians in 22% of the patients as marked, in 54% as moderate, in 16% as minimal and in 4% as poor (unchanged). In 8% of the patients mild adverse reactions were reported, severe side effects occurred in 13 patients (0.003%). Orthopaedists rated the effectiveness of acupuncture lower, showing shortest time for face-to-face contact with the patient. More acupuncture training did not correspond to better therapeutic effect assessed by physicians. Conclusions Acupuncture proved a highly demanded treatment option for chronic pain conditions within the German research program. Results indicate that acupuncture provided by qualified therapists is safe, and patients benefited from the treatment.

Summary Objective The aim of this paper is to describe the treatment and physician characteristics in a randomised trial of acupuncture for osteoarthritis of the knee. Design Three-armed, randomised, controlled multicentre trial with 1-year follow-up. Setting Twenty-eight outpatient centres in Germany. Interventions A total of 294 patients with osteoarthritis of the knee were randomised to 12 sessions of semi-standardised acupuncture (at least 6 local and 2 distant points needled per affected knee from a selection of predefined points, but individual choice of additional body or ear acupuncture points possible), 12 sessions of minimal acupuncture (superficial needling of at least 8 of 10 predefined, bilateral, distant non-acupuncture points) or a waiting list control (2 months no acupuncture). Outcome Participating trial physicians and interventions. Results Forty-seven physicians specialised in acupuncture (mean age 43 ± 8 years, 26 females) provided study interventions in 28 outpatient centres in Germany. The median duration of acupuncture training completed by participating physicians was 350 h (range 140–2508). The total number of needles used was 17.4 ± 4.8 in the acupuncture group compared to 12.9 ± 3.3 in the minimal acupuncture group. In total, 39 physicians (83%) stated that they would have treated patients in either a similar or in exactly the same way outside of the trial, whereas 7 (15%) stated that they would have treated patients differently (1 missing). Conclusions Our documentation of the trial interventions shows that semi-standardised acupuncture strategy represents an acceptable compromise for efficacy studies. However, a substantial minority of participating trial physicians stated that they would have treated patients differently outside of the trial.

Objective : To investigate the effectiveness of a clinical treatment program with traditional Chinese medicine for migraine and tension-type headache. Methods : Ninety-one patients with migraine, episodic or chronic tension-type headache according to the criteria of the International Headache Society were randomised into an experimental or a waiting list control group. Patients in the experimental group were treated 4 weeks in a hospital for traditional Chinese medicine after a baseline period of one month. Patients in the waiting list group continued their previous headache treatment. Main outcome measure was the difference in the number of days with headache of at least moderate intensity during baseline (month 1) and month 7. Results : The difference in the number of days with headache of at least moderate intensity was 5.6 (S.D., 6.1) days in the experimental group and 1.2 (S.D., 4.5) days in the waiting list group ( P Conclusion : The results of this study indicate that treatment in the hospital for traditional Chinese medicine in Kotzting is associated with lasting improvements in the majority of patients.

Summary Quality assurance and related topics have become increasingly important in healthcare — a development which cannot be ignored in complementary medicine. This article discusses basic issues of quality assurance and management, and introduces the concept of scientific quality management as a new tool particularly useful for complementary medicine. Scientific quality management consists of two components: medical quality management, and attendent scientific research. Its intention is to evaluate and optimise the benefit from the patient's view as well as the costs and risks. The specific problems of scientific quality management in complementary medicine are discussed. Finally, objectives, methods, and the actual state of a scientific quality management project in a network of clinics in Germany (Klinikverbund ‘Munchener Modell’) are outlined.

To investigate the effectiveness of a clinical treatment program with traditional Chinese medicine for migraine and tension-type headache.Ninety-one patients with migraine, episodic or chronic tension-type headache according to the criteria of the International Headache Society were randomised into an experimental or a waiting list control group. Patients in the experimental group were treated 4 weeks in a hospital for traditional Chinese medicine after a baseline period of one month. Patients in the waiting list group continued their previous headache treatment. Main outcome measure was the difference in the number of days with headache of at least moderate intensity during baseline (month 1) and month 7.The difference in the number of days with headache of at least moderate intensity was 5.6 (S.D., 6.1) days in the experimental group and 1.2 (S.D., 4.5) days in the waiting list group (P0.001). A reduction of more than 50% in headache days was observed in 52% of the patients in the experimental group and 16% in the waiting list group. Patients with migraine and a combination of migraine and episodic tension-type headaches improved more than patients with other headaches.The results of this study indicate that treatment in the hospital for traditional Chinese medicine in Kotzting is associated with lasting improvements in the majority of patients.

Summary Background: Use of traditional Chinese drug treatment is widespread. While cases of hepatotoxic effects have been reported, little is known about the frequency of such effects. Objectives: To investigate the frequency, magnitude and course of liver enzyme elevations in patients treated with traditional Chinese drugs. Design: Retrospective study. Setting: Hospital for traditional Chinese medicine in Germany. Patients: All 1507 patients admitted for inpatient treatment between February1994 and July 1995. Main outcome measure: Number of patients who presented at discharge with a more than 2-fold elevation of alanine amino transferase (ALT) levels (over maximum normal values or elevated admission values). Results: A more than 2-fold elevation of ALT values was observed in 14 patients (0.9%). In 13 cases a causal relationship with Chinese drug therapy seemed possible and, for one patient, likely. However, all patients were also on non-Chinese drug treatment. Follow-up values of ALT within 8 weeks after discharge were normal in 11 patients (six of them had continued to take traditional Chinese drugs) and close to normal in the remaining three. In five patients there were indications for previous liver damage. Conclusions: In the population and setting studied, clinically relevant liver enzyme elevations occurred in about 1/100 patients treated with traditional Chinese drugs.