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Resumen Antecedentes Los estudios cientificos integrados en los proyectos piloto de la seguridad social alemana tuvieron el objetivo de estudiar la eficacia y seguridad terapeutica de la acupuntura para tratar la cefalea cronica, los dolores de la columna lumbar y los dolores por artrosis, tanto en condiciones controladas como de la vida diaria. El resultado del tratamiento se tomo como criterio de una acupuntura de gran calidad. El contraste del estudio observacional con los datos de una encuesta realizada a profesionales medicos permite deducir cierta informacion sobre las caracteristicas relevantes de pacientes, tratamiento y terapeutas. Objetivo Revision de las correlaciones ya publicadas a traves un grupo de indicacion homogeneo. Metodo Combinacion de los datos de pacientes procedentes de un estudio observacional prospectivo con los de sus acupuntores obtenidos mediante una encuesta. Los valores registrados de los pacientes fueron la intensidad del dolor, la funcion en la vida diaria, la calidad de vida y el numero de dias con dolor tanto al inicio de la acupuntura como 6 meses mas tarde. Despues del tratamiento se realizo una valoracion global de resultados, aparicion de efectos secundarios y satisfaccion de los pacientes. Del lado de los acupuntores se estudiaron los siguientes aspectos: especialidad, cualificacion como acupuntor, proporcion de pacientes sometidos a tratamiento de acupuntura en la practica y uso de otros metodos de la medicina complementaria. Resultados Se incorporaron al analisis 1.727 pacientes con dolores cronicos de la columna lumbar (edad promedio, 58 anos, 79% mujeres) que habian sido tratados por 1.061 medicos acupuntores. En lo que respecta a los resultados del tratamiento, se compararon 2 grupos extremos (445 individuos no respondedores y 261 buenos respondedores). No se observo ninguna diferencia en cuanto a resultados terapeuticos entre los pacientes tratados por acupuntores en posesion del Diploma A (formacion mas corta) y del Diploma B (mas larga). Hubo menos pacientes tratados por ortopedas en el grupo de pacientes que mostraban resultados especialmente satisfactorios. Los pacientes de medicos con mas horas de dedicacion a la acupuntura en su practica profesional y de aquellos que tambien ofrecian otros metodos de la medicina natural mostraban con mas frecuencia buenos resultados. Tambien se observo que los pacientes de los medicos que contaban con un periodo de formacion y una experiencia mas dilatada referian efectos secundarios con menos frecuencia. Los pacientes, hombres y mujeres, estaban mas satisfechos cuando la acupuntura la realizaba una doctora. En los ortopedas de sexo masculino la duracion media del contacto medico-paciente durante la acupuntura era llamativamente mas baja. Conclusion A pesar de ciertas limitaciones metodologicas, determinadas caracteristicas de los medicos pudieron identificarse como “indicadores de calidad” utiles para la mejora de la atencion de acupuntura.

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 compare patient characteristics and outcomes between a randomized controlled trial (RCT) and an observational study (OS) of acupuncture treatment in patients with migraine. Study Design and Setting Within the framework of a research program for acupuncture for chronic pain, both an RCT and an OS of routine care were performed in patients with migraine. One hundred forty-five patients received acupuncture in the RCT and 732 in the OS. All patients completed a pain questionnaire, including instruments evaluating disability, quality of life, and depression, at baseline and at 6-month follow-up. Results At baseline, patients participating in the RCT had a significantly longer history of complaints and more headache days but better quality of life and fewer depressive symptoms than patients participating in the OS. In unadjusted analyses, improvements after 6 months were more pronounced in the OS than in the RCT. After adjustment for potential confounders, the differences decreased but were still significant for several outcomes. Conclusion Participants of the RCT were probably not representative of migraine patients undergoing acupuncture treatment in routine care under current regulations in Germany. However, changes after treatment were similar in the RCT and the OS of routine care.

Zusammenfassung Ziel Beschreibung der am Modellvorhaben Akupunktur der Ersatzkassen teilnehmenden Arzte bzw. Arztpraxen hinsichtlich Merkmalen zur Struktur- und allgemeinen Prozessqualitat. Methodik Schriftliche Befragung der Arzte sechs Monate nach dem Start des Modellvorhabens mit Erfassung von demographischen Daten, Niederlassungsdauer, Praxisgrose, Akupunkturqualifikation und Indikations- und Methodenschwerpunkten im Zeitraum eines Jahres vor der Befragung. Die Daten wurden fur das Gesamtkollektiv und stratifiziert nach Akupunkturqualifikation (A- bzw. B-Diplom) und Facharztgruppe (Allgemein-/Praktische Arzte, Orthopaden, Sonstige) analysiert. Ergebnisse 5.217 (57 %) von 9.182 Arzten beantworteten den Fragebogen (Alter im Median 46 Jahre; 64 % mannlich; 28 % mit B-Diplom). Der Anteil von Allgemein-/Praktischen Arzten lag bei 51 %, der von Orthopaden bei 18 %. Akupunktur wurde im Median seit sieben Jahren eingesetzt, bei im Durchschnitt 5 % aller Praxis-Patienten; dafur wurde 10 % der Zeit der therapeutischen Tatigkeit aufgewendet. 87 % der Arzte nutzten auch Mikrosystemverfahren. B-Diplom-Trager setzten eine grosere Vielfalt an Akupunkturverfahren und haufiger auch klassische Naturheilverfahren, Homoopathie und chinesische Phytotherapie ein. Orthopaden unterschieden sich bezuglich der Qualifikation nicht von den anderen Facharztgruppen, verwendeten aber eine geringere Vielfalt an Akupunkturmethoden. Schlussfolgerung Die Stratifizierungen nach Akupunkturqualifikation bzw. Facharztgruppe zeigten erhebliche Unterschiede in Struktur- und Prozessmerkmalen.

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.

We aimed to investigate: (1) whether patient and intervention characteristics, design-independent quality aspects, and response rates differ between randomized and non-randomized trials of acupuncture for chronic headache; (2) whether non-randomized studies provide useful additional information (regarding long-term effects, prognostic factors, adverse effects, and generalizability); (3) reasons for potential differences in response rates. Studies including at least five patients and reporting clinical outcome data were identified through searches in Medline, Embase, the Cochrane Controlled Trials Register, other databases and checking of bibliographies. Twenty-four randomized trials and 35 non-randomized studies (five non-randomized controlled cohort studies, 10 prospective uncontrolled studies, 10 case series, and 10 cross-sectional surveys) met the inclusion criteria. Studies were heterogeneous regarding patients, interventions, outcome measurements and results. On average, randomized trials had smaller sample sizes, met more quality criteria, and had lower response rates (0.59 [95% confidence interval 0.48-0.69] vs. 0.78 [0.72-0.83]). Whether randomized or not, studies meeting more quality criteria had lower response rates. Non-randomized studies did not have significantly longer follow-up periods, three included an analysis of prognostic variables, only one reported on adverse effects, and the degree of generalizability was unclear. In the case of acupuncture for chronic headache, non-randomized studies confirmed the finding of a systematic review of randomized trials that the treatment is likely to be effective but provided little relevant additional information on long-term effects, prognostic factors, and adverse effects.

We investigated the influence of indicators of methodological quality on study outcome in a set of 89 placebo-controlled clinical trials of homoeopathy in three different ways: (1) The results of studies meeting single criteria (explicit statement of random allocation, allocation concealment, double-blinding, completeness of follow-up) of methodological quality were compared with those of studies not meeting the criteria in univariate and multivariate analyses; (2) The results of studies scoring above and below predefined scores in two quality assessment scales were compared; (3) Primary studies were consecutively entered into a cumulative meta-analysis according to the summary scores derived from the quality assessment scales. All analyses were performed using meta-regression methods. Studies that were explicitly randomized and were double-blind as well as studies scoring above the cut-points yielded significantly less positive results than studies not meeting the criteria. In the cumulative meta-analyses, there was a trend for increasing effect sizes when more studies with lower-quality scores were added. However, there was no linear relationship between quality scores and study outcome. We conclude that in the study set investigated, there was clear evidence that studies with better methodological quality tended to yield less positive results. Because summarizing disparate study features into a single score is problematic, meta-regression methods simultaneously investigating the influence of single study features seem the best method for investigating the impact of study quality on outcome.

Summary Background Homoeopathy seems scientifically implausible, but has widespread use. We aimed to assess whether the clinical effect reported in randomised controlled trials of homoeopathic remedies is equivalent to that reported for placebo. Methods We sought studies from computerised bibliographies and contacts with researchers, institutions, manufacturers, individual collectors, homoeopathic conference proceedings, and books. We included all languages. Double-blind and/or randomised placebo-controlled trials of clinical conditions were considered. Our review of 186 trials identified 119 that met the inclusion criteria. 89 had adequate data for meta-analysis, and two sets of trial were used to assess reproducibility. Two reviewers assessed study quality with two scales and extracted data for information on clinical condition, homoeopathy type, dilution, "remedy", population, and outcomes. Findings The combined odds ratio for the 89 studies entered into the main meta-analysis was 2·45 (95% CI 2·05, 2·93) in favour of homoeopathy. The odds ratio for the 26 good-quality studies was 1·66 (1·33, 2·08), and that corrected for publication bias was 1·78 (1·03, 3·10). Four studies on the effects of a single remedy on seasonal allergies had a pooled odds ratio for ocular symptoms at 4 weeks of 2·03 (1·51, 2·74). Five studies on postoperative ileus had a pooled mean effect-size-difference of −0·22 standard deviations (95% Cl −0·36, −0·09) for flatus, and −0·18 SDs (−0·33, −0·03) for stool (both p Interpretation The results of our meta-analysis are not compatible with the hypothesis that the clinical effects of homoeopathy are completely due to placebo. However, we found insufficient evidence from these studies that homoeopathy is clearly efficacious for any single clinical condition. Further research on homoeopathy is warranted provided it is rigorous and systematic.

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.