Albrecht Molsberger

Efficacy of acupuncture for the prophylaxis of migraine: a multicentre randomised controlled clinical trial

BACKGROUND Our aim was to assess the efficacy of a part-standardised verum acupuncture procedure, in accordance with the rules of traditional Chinese medicine, compared with that of part-standardised sham acupuncture and standard migraine prophylaxis with beta blockers, calcium-channel blockers, or antiepileptic drugs in the reduction of migraine days 26 weeks after the start of treatment. METHODS This study was a prospective, randomised, multicentre, double-blind, parallel-group, controlled, clinical trial, undertaken between April 2002 and July 2005. Patients who had two to six migraine attacks per month were randomly assigned verum acupuncture (n=313), sham acupuncture (n=339), or standard therapy (n=308). Patients received ten sessions of acupuncture treatment in 6 weeks or continuous prophylaxis with drugs. Primary outcome was the difference in migraine days between 4 weeks before randomisation and weeks 23-26 after randomisation. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN52683557. FINDINGS Of 1295 patients screened, 960 were randomly assigned to a treatment group. Immediately after randomisation, 125 patients (106 from the standard group) withdrew their consent to study participation. 794 patients were analysed in the intention-to-treat popoulation and 443 in the per-protocol population. The primary outcome showed a mean reduction of 2 .3 days (95% CI 1.9-2.7) in the verum acupuncture group, 1.5 days (1.1-2.0) in the sham acupuncture group, and 2.1 days (1.5-2.7) in the standard therapy group. These differences were statistically significant compared with baseline (p<0.0001), but not across the treatment groups (p=0.09). The proportion of responders, defined as patients with a reduction of migraine days by at least 50%, 26 weeks after randomisation, was 47% in the verum group, 39% in the sham acupuncture group, and 40% in the standard group (p=0.133). INTERPRETATION Treatment outcomes for migraine do not differ between patients treated with sham acupuncture, verum acupuncture, or standard therapy.

Does acupuncture improve the orthopedic management of chronic low back pain – a randomized, blinded, controlled trial with 3 months follow up

&NA; This prospective, randomised controlled trial, with three parallel groups, patient and observer blinded for verum and sham acupuncture and a follow up of 3 months raises the question: “Does a combination of acupuncture and conservative orthopedic treatment improve conservative orthopedic treatment in chronic low back pain (LBP). 186 in‐patients of a LBP rehabilitation center with a history of LBP ≥6 weeks, VAS ≥50 mm, and no pending compensation claims, were selected; for the three random group 4 weeks of treatment was applied. 174 patients met the protocol criteria and reported after treatment, 124 reported after 3 months follow up. Patients were assorted 4 strata: chronic LBP, ≤0.5 years, 0.5–2 years, 2–5 years, ≥5 years. Analysis was by intention to treat. Group 1 (Verum+COT) recieved 12 treatments of verum acupuncture and conservative orthopedic treatment (COT). Group 2 (Sham+COT) recieved 12 treatments of non‐specific needling and COT. Group 3 (nil+COT) recieved COT alone. Verum‐ and Sham acupuncture were blinded against patient and examiner. The primary endpoints were pain reduction ≥50% on VAS 3 months after the end of the treatment protocol. Secondary endpoints were pain reduction ≥50% on VAS and treatment efficacy on a four‐point box scale directly after the end of the treatment protocol and treatment efficacy after 3 months. In the whole sample a pain relief of ≥50% on VAS was reported directly after the end of treatment protocol: Verum+COT 65% (95%CI 51–77%), Sham+COT 34% (95%ci 22–49%), nil+COT 43% (95%ci 29–58%) – results are significant for Verum+COT over Sham+COT (P≤0.02). The results after 3 months are: Verum+COT 77% (95%ci 62–88%), Sham+COT 29% (95%ci 16–46%), nil+Cot 14% (95%ci 4–30%) – effects are significant for Verum+COT over Sham+COT (P≤0.001) and for Verum+COT over nil+COT (P<0.001). No difference was found in the mobility of the patients nor in the intake of NSAID diclofenac. Our conclusion is that acupuncture can be an important supplement of conservative orthopedic treatment in the management of chronic LBP.

Acupuncture for tension-type headache: a multicentre, sham-controlled, patient-and observer-blinded, randomised trial.

Acupuncture treatment is frequently sought for tension-type headache (TTH), but there is conflicting evidence as to its effectiveness. This randomised, controlled, multicentre, patient-and observer-blinded trial was carried out in 122 outpatient practices in Germany on 409 patients with TTH, defined as ≥0 headache days per month of which ≤1 included migraine symptoms. Interventions were verum acupuncture according to the practice of traditional Chinese medicine or sham acupuncture consisting of superficial needling at nonacupuncture points. Acupuncture was administered by physicians with specialist acupuncture training. Ten 30-min sessions were given over a six-week period, with additional sessions available for partial response. Response was defined as >50% reduction in headache days/month at six months and no use of excluded concomitant medication or other therapies. In the intent-to-treat analysis (all 409 patients), 33% of verum patients and 27% of sham controls (p=0.18) were classed as responders. Verum was superior to sham for most secondary endpoints, including headache days (1.8 fewer; 95% CI 0.6, 3.0; p=0.004) and the International Headache Society response criterion (66% vs. 55% response, risk difference 12%, 95% CI: 2%-21%; p=0.024).). The relative risk on the primary and secondary response criterion was very similar (∼0.8); the difference in statistical significance may be due to differences in event rate. TTH improves after acupuncture treatment. However, the degree to which treatment benefits depend on psychological compared to physiological effects and the degree to which any physiological effects depend on needle placement and insertion depth are unclear.

German Randomized Acupuncture Trial for chronic shoulder pain (GRASP) - a pragmatic, controlled, patient-blinded, multi-centre trial in an outpatient care environment.

&NA; The German Randomized Acupuncture Trial for chronic shoulder pain (GRASP) comprised 424 outpatients with chronic shoulder pain (CSP) ≥6 weeks and an average pain score of VAS ≥50 mm, who were randomly assigned to receive Chinese acupuncture (verum), sham acupuncture (sham) or conventional conservative orthopaedic treatment (COT). The patients were blinded to the type of acupuncture and treated by 31 office‐based orthopaedists trained in acupuncture; all received 15 treatments over 6 weeks. The 50% responder rate for pain was measured on a VAS 3 months after the end of treatment (primary endpoint) and directly after the end of the treatment (secondary endpoint). Results: In the ITT (n = 424) analysis, percentages of responders for the primary endpoint were verum 65% (95% CI 56–74%) (n = 100), sham 24% (95% CI 9–39%) (n = 32), and COT 37% (95% CI 24–50%) (n = 50); secondary endpoint: verum 68% (95% CI 58–77%) (n = 92), sham 40% (95% CI 27–53%) (n = 53), and COT 28% (95% CI 14–42%) (n = 38). The results are significant for verum over sham and verum over COT (p < 0.01) for both the primary and secondary endpoints. The PPP analysis of the primary (n = 308) and secondary endpoints (n = 360) yields similar responder results for verum over sham and verum over COT (p < 0.01). Descriptive statistics showed greater improvement of shoulder mobility (abduction and arm‐above‐head test) for the verum group versus the control group immediately after treatment and after 3 months. The trial indicates that Chinese acupuncture is an effective alternative to conventional orthopaedic treatment for CSP.

The Status and Future of Acupuncture Clinical Research

On November 8-9, 2007, the Society for Acupuncture Research (SAR) hosted an international conference to mark the tenth anniversary of the landmark National Institutes of Health Consensus Development Conference on Acupuncture. More than 300 acupuncture researchers, practitioners, students, funding agency personnel, and health policy analysts from 20 countries attended the SAR meeting held at the University of Maryland School of Medicine, Baltimore, MD. This paper summarizes important invited lectures in the area of clinical research. Specifically, included are: a review of the recently conducted German trials and observational studies on low-back pain (LBP), gonarthrosis, migraine, and tension-type headache (the Acupuncture Research Trials and the German Acupuncture Trials, plus observational studies); a systematic review of acupuncture treatment for knee osteoarthritis (OA); and an overview of acupuncture trials in neurologic conditions, LBP, womens health, psychiatric disorders, and functional bowel disorders. A summary of the use of acupuncture in cancer care is also provided. Researchers involved in the German trials concluded that acupuncture is effective for treating chronic pain, but the correct selection of acupuncture points seems to play a limited role; no conclusions could be drawn about the placebo aspect of acupuncture, due to the design of the studies. Overall, when compared to sham, acupuncture did not show a benefit in treating knee OA or LBP, but acupuncture was better than a wait-list control and standard of care, respectively. In womens health, acupuncture has been found to be beneficial for patients with premenstrual syndrome, dysmenorrhea, several pregnancy-related conditions, and nausea in females who have cancers. Evidence on moxibustion for breech presentation, induction of labor, and reduction of menopausal symptoms is still inconclusive. In mental health, evidence for acupunctures efficacy in treating neurologic and functional bowel disorder is still inconclusive. For chronic cancer-related problems such as pain, acupuncture may work well in stand-alone clinics; however, for acute or treatment-related symptoms, integration of acupuncture care into a busy and complex clinical environment is unlikely, unless compelling evidence of a considerable patient benefit can be established.

Role of acupuncture in the treatment of migraine

Since the last Cochrane review of acupuncture and headache in 2001, which found methodological and/or reporting shortcomings in the majority of the studies, several large, randomized trials on the effectiveness of acupuncture as a treatment for headache have been published. Following a brief overview of the pathophysiology of migraine and possible action mechanisms of acupuncture, we look at current studies on acupuncture and migraine and discuss the results. From these results and our own studies on acupuncture and migraine, we conclude that a 6-week course of acupuncture is not inferior to a 6-month prophylactic drug treatment, but that specific Chinese point selection, point stimulation and needling depth are not as important as had been thought. The review suggests that acupuncture should be integrated into existing migraine therapy protocols.

The German Multicenter, Randomized, Partially Blinded, Chronic Low-Back Pain: A Preliminary Report on the Prospective Trial of Acupuncture for Rationale and Design of the Trial

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. Th...

Akupunktur bei Schmerzen des Bewegungsapparats

88 klinische Akupunkturstudien zur Erkrankungen des Bewegungsapparats und Schmerzerkrankungen des Kopfs werden hinsichtlich ihrer handwerklichen Qualität in 6 Kategorien unterteilt und bewertet. Für die Beurteilung der Akupunkturqualität wurden Mindestanforderungen definiert: Angabe zur Dauer einer Akupunktursitzung (gefordert mindestens 15 min), Angabe zur Häufigkeit von Akupunkturanwendungen (gefordert mindestens 10 Sitzungen vor Abbruch der Therapie) und genaue Beschreibung der gestochenen Akupunkturpunkte. Unabhängig von handwerklichen und biometrischen Mängeln zeigen 75 von 88 Studien (85,2%) ein positives Ergebnis der Akupunktur. Keine der 16 Studien, die den handwerklichen Mindestanforderungen genügten, konnte eine fehlende Wirksamkeit der Akupunktur nachweisen. Von diesen 16 Studien sind 3 Studien kontrolliert. Die Ergebnisse der Untersuchung werden mit Metaanalysen verglichen, die Akupunkturstudien allein hinsichtlich der biometrischen Qualität untersuchten. Die Wertigkeit der Akupunkturtherapie bei orthopädischen Erkrankungen im Vergleich zu konventionellen Therapieverfahren wird diskutiert, und es werden Empfehlungen zu Akupunkturindikationen bei Schmerzerkrankungen des Bewegungsapparats herausgearbeitet.88 clinical acupuncture studies concerning the treatment of locomotive disorders are compared. The studies are evaluated according to treatment quality and categorised into 6 categories. For the assessment of acupuncture treatment quality minimal criteria are defined: reporting the duration of one acupuncture treatment (at least 15 min.), reporting the frequency of acupuncture treatments (at least 10 sessions before canceling the therapy), exact description of used acupuncture points. Without respect to biostatistical and therapeutical qualities, 75 of 88 studies (85.2%) showed positive results for the acupuncture treatment. None of the 16 studies, that met the minimal criteria we defined, could prove that acupuncture is non-effective. Only two of the 16 studies are controlled trials. Our results were compared with those of meta-analytical reviews, which discussed acupuncture studies solely on the basis of the biometrical aspects. In comparison to conventional orthopedic therapies, certain locomotive disorders are recommended for acupuncture therapy.

[Acupuncture in the treatment of locomotive disorders - status of research and situation regarding clinical application].

Zusammenfassung. Indikationsbreite, geringe Nebenwirkungen und ein Beobachtungszeitraum von über 2000 Jahren führten auch in der westlichen Medizin zu einer verbreiteten Anwendung der Akupunktur. Einzelne Wirksamkeitsnachweise, aber auch widersprüchliche Studien unterschiedlicher Qualität, existieren zu einem Teil der möglichen Indikationen am Bewegungsapparat. Andere Indikationen sind bisher nur wenig untersucht, die Akupunkturanwendung erfolgt hier nach klinischer Erfahrung und Expertenkonsens. Hierzu gehört auch die Einschätzung, dass zum Therapieerfolg in der Regel 10–20 Akupunktursitzungen erforderlich sind und eine erste Besserung je nach Erkrankung bis zur 10. Sitzung zu erwarten ist. Die in Deutschland von den Kassen finanzierten Modellvorhaben, wie die german acupuncture trials (gerac), sollen die Nachweislage verbessern.Abstract. 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.

Akupunkturanästhesie bei Leistenbruchoperation – ein Selbstversuch

There are references in the media and in the literature to the use of acupuncture as an anaesthetic in surgical operations. The author, an experienced acupuncturist, tested the anaesthetic effect of acupuncture during an inguinal hernia repair in a self-experiment. Acupuncture combined with electrostimulation was administered for the 6-cm skin cut and preparation to 15 mm in depth. However, acupuncture alone provided an inadequate anaesthetic effect for the entire operation and an additional local anaesthetic had to be administered.In den öffentlichen Medien und in der Akupunkturliteratur finden sich Hinweise auf alleinige Akupunkturanästhesie bei Operationen. Der in Akupunktur erfahrene Autor prüfte im Selbstversuch die Wirkung von Akupunkturanästhesie bei einer Leistenoperation. Akupunktur mit Elektrostimulation gewährleistete die Anästhesie für den Hautschnitt von 6 cm Länge und die Präparation bis zu 15 mm in die Tiefe; für die alleinige Anästhesie der gesamten OP war die Akupunktur nicht ausreichend. Lokalanästhetika mussten zusätzlich verabreicht werden.