-
[show abstract]
[hide abstract]
ABSTRACT: Transparency is essential for the efficient transfer of scientific knowledge from research into practice but is often impaired by non-publication of whole studies or by inappropriate publication of trial results. Prospective trial registration has the potential to increase transparency in scientific research because it allows the evaluation of trial methodology and the appraisal of potential publication bias. Trial registration is a scientific, ethical and moral obligation which needs self-commitment of researchers and sponsors to prospective trial registration. The urological trial register of the German Society of Urology is now affiliated with the German Register of Clinical Studies, a national primary register, which enables easy registration in the register network of the WHO.
Der Urologe 06/2012; 51(9):1278-81. · 0.50 Impact Factor
-
[show abstract]
[hide abstract]
ABSTRACT: Deutschland ist ein wichtiger Standort für die urologische Forschung. Hierbei bilden klinische Studien einen wesentlichen
Pfeiler für die moderne evidenzbasierte Medizin. Die Deutsche Gesellschaft für Urologie (DGU) hat im September 2010 ein fachspezifisches
klinisches Studienregister in Betrieb genommen. Der umfassende Überblick über laufende und abgeschlossene klinische Studien
in der Urologie soll helfen, die Transparenz in der Wissenschaft zu erhöhen, Forschungsförderung gezielter einzusetzen, wiederholte
Studiendurchführungen zu vermeiden und letztendlich Ressourcen im Gesundheitswesen effizienter zu nutzen. Angestrebt wird
eine Kooperation als Partnerregister an das nationale Primärregister, um einen automatischen Eintrag in das Registernetzwerk
der WHO zu gewährleisten und somit eine ICMJE-konforme Registrierung ohne großen Aufwand zu ermöglichen.
Germany is an important hub for urological research and clinical trials are therefore very important for evidence-based medicine.
In September 2010, the German Society of Urology commissioned a subject-specific clinical trial registry. The broad overview
of ongoing and completed clinical trials in urology should help to increase transparency in research and to deploy resources
in health care more efficiently. The urological trial registry aims to negotiate cooperation with a national primary registry
to allow an automatic inclusion in the WHO Registry Network and to enable an ICMJE-compliant registry.
SchlüsselwörterEvidenzbasierte Medizin–Register–Urologie–Publikationsbias–Deutschland
KeywordsEvidence-based medicine–Registries–Urology–Publication bias–Germany
Der Urologe 04/2012; 50(4):462-465. · 0.50 Impact Factor
-
[show abstract]
[hide abstract]
ABSTRACT: Germany is an important hub for urological research and clinical trials are therefore very important for evidence-based medicine. In September 2010, the German Society of Urology commissioned a subject-specific clinical trial registry. The broad overview of ongoing and completed clinical trials in urology should help to increase transparency in research and to deploy resources in health care more efficiently. The urological trial registry aims to negotiate cooperation with a national primary registry to allow an automatic inclusion in the WHO Registry Network and to enable an ICMJE-compliant registry.
Der Urologe 02/2011; 50(4):462-5. · 0.50 Impact Factor
-
[show abstract]
[hide abstract]
ABSTRACT: We aimed to investigate the effectiveness of acupuncture in addition to routine care in patients with primary headache (> 12 months, two or more headaches/month) compared with treatment with routine care alone and whether the effects of acupuncture differ in randomized and non-randomized patients. In a randomized controlled trial plus non-randomized cohort, patients with headache were allocated to receive up to 15 acupuncture sessions over 3 months or to a control group receiving no acupuncture during the first 3 months. Patients who did not consent to randomization received acupuncture treatment immediately. All subjects were allowed usual medical care in addition to study treatment. Number of days with headache, intensity of pain and health-related quality of life (SF-36) were assessed at baseline, and after 3 and 6 months using standardized questionnaires. Of 15,056 headache patients (mean age 44.1 +/- 12.8 years, 77% female), 1613 were randomized to acupuncture and 1569 to control, and 11,874 included in the non-randomized acupuncture group. At 3 months, the number of days with headache decreased from 8.4 +/- 7.2 (estimated mean +/-s.e.) to 4.7 +/- 5.6 in the acupuncture group and from 8.1 +/- 6.8 to 7.5 +/- 6.3 in the control group (P < 0.001). Similarly, intensity of pain and quality of life improvements were more pronounced in the acupuncture vs. control group (P < 0.001). Treatment success was maintained through 6 months. The outcome changes in non-randomized patients were similar to those in randomized patients. Acupuncture plus routine care in patients with headache was associated with marked clinical improvements compared with routine care alone.
Cephalalgia 07/2008; 28(9):969-79. · 3.43 Impact Factor
-
[show abstract]
[hide abstract]
ABSTRACT: The aim was to assess costs and cost-effectiveness of additional acupuncture treatment in patients with headache compared with patients receiving routine care alone. A randomized, controlled trial was conducted, including patients (> or =18 years old) with primary headache (more than 12 months, at least two headaches/month). Outcome parameters were quality of life (Short Form 36), direct and indirect costs differences during the 3-month study period and the incremental cost-effectiveness ratio (ICER) of acupuncture treatment. A total of 3182 patients (1613 acupuncture; 1569 controls) with headache were included (77.4% women, mean age and standard deviation 42.6 +/- 12.3; 22.6% men, 47.2 +/- 13.4). Over 3 months costs were higher in the acupuncture group compared with the control [euro857.47; 95% confidence interval 790.86, 924.07, vs. euro527.34 (459.81, 594.88), P < 0.001, mean difference: euro330.12 (235.27, 424.98)]. This cost increase was primarily due to costs of acupuncture [euro365.64 (362.19, 369.10)]. The ICER was euro11 657 per QALY gained. According to international cost-effectiveness threshold values, acupuncture is a cost-effective treatment in patients with primary headache.
Cephalalgia 05/2008; 28(4):334-45. · 3.43 Impact Factor
-
B Brinkhaus,
C M Witt, S Jena,
K Linde,
A Streng,
J Hummelsberger,
D Irnich,
M Hammes,
D Pach,
D Melchart,
S N Willich
[show abstract]
[hide abstract]
ABSTRACT: The aim of this paper is to describe the treatment and physician characteristics in a randomised trial of acupuncture for osteoarthritis of the knee.
Three-armed, randomised, controlled multicentre trial with 1-year follow-up.
Twenty-eight outpatient centres in Germany.
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).
Participating trial physicians and interventions.
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).
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.
Complementary Therapies in Medicine 10/2007; 15(3):180-9. · 1.87 Impact Factor
-
[show abstract]
[hide abstract]
ABSTRACT: We report on the study design and protocols of two randomized controlled trials (Acupuncture Randomized Trials = ART) that investigate the efficacy of acupuncture in the treatment of chronic low back pain and osteoarthritis of the knee, respectively.
To investigate whether acupuncture is more efficacious than (a) no treatment or (b) minimal acupuncture in the treatment of low back pain and osteoarthritis.
Two randomized, controlled, multicenter trials with three treatment arms and a total follow-up time of 52 weeks.
30 practitioners and outpatient units in Germany specialized in acupuncture treatment.
300 patients will be included in each study. In the low back pain trial, patients will be included according to clinical diagnosis. In the osteoarthritis pain trial, patients will be included according to the American College of Rheumatology criteria.
Patients are randomly assigned to receive either (1) semi-standardized acupuncture (150 patients), (2) minimal acupuncture at non-acupuncture points (75 patients), or (3) no treatment for two months followed by semi-standardized acupuncture (75 patients, waiting list control). Acupuncture treatment consists of 12 sessions per patient over a period of 8 weeks.
The main outcome measure is the difference between baseline and the end of the 8-week treatment period in the following parameters: pain intensity as measured by a visual analogue scale (VAS; 0-100 mm) in the low back pain trial and by the Western Ontario and McMaster Universities Osteoarthritis Score (WOMAC) in the osteoarthritis trial.
The results of these two studies (available in 2004) will provide health care providers and policy makers with the information needed to make scientifically sound assessments of acupuncture therapy.
Forschende Komplementärmedizin und Klassische Naturheilkunde / Research in Complementary and Classical Natural Medicine 09/2003; 10(4):185-91.
-
[show abstract]
[hide abstract]
ABSTRACT: Acupuncture is widely used by patients with chronic pain although there is little evidence of its effectiveness. We investigated the efficacy of acupuncture compared with minimal acupuncture and with no acupuncture in patients with osteoarthritis of the knee.
Patients with chronic osteoarthritis of the knee (Kellgren grade < or =2) were randomly assigned to acupuncture (n=150), minimal acupuncture (superficial needling at non-acupuncture points; n=76), or a waiting list control (n=74). Specialised physicians, in 28 outpatient centres, administered acupuncture and minimal acupuncture in 12 sessions over 8 weeks. Patients completed standard questionnaires at baseline and after 8 weeks, 26 weeks, and 52 weeks. The primary outcome was the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) index at the end of week 8 (adjusted for baseline score). All main analyses were by intention to treat.
294 patients were enrolled from March 6, 2002, to January 17, 2003; eight patients were lost to follow-up after randomisation, but were included in the final analysis. The mean baseline-adjusted WOMAC index at week 8 was 26.9 (SE 1.4) in the acupuncture group, 35.8 (1.9) in the minimal acupuncture group, and 49.6 (2.0) in the waiting list group (treatment difference acupuncture vs minimal acupuncture -8.8, [95% CI -13.5 to -4.2], p=0.0002; acupuncture vs waiting list -22.7 [-27.5 to -17.9], p<0.0001). After 52 weeks the difference between the acupuncture and minimal acupuncture groups was no longer significant (p=0.08).
After 8 weeks of treatment, pain and joint function are improved more with acupuncture than with minimal acupuncture or no acupuncture in patients with osteoarthritis of the knee. However, this benefit decreases over time.
The Lancet 366(9480):136-43. · 38.28 Impact Factor
