Designing an Acupuncture Study: The Nationwide, Randomized, Controlled, German Acupuncture Trials on Migraine and Tension-Type Headache

Molsberger, Albrecht; Boewing, Gabriele; Diener, Hans Christoph; Endres, Heinz G.; Kraehmer, Nils; Kronfeld, Kai; Zenz, M.

doi:10.1089/acm.2006.12.237

Cited by 40 publications

(38 citation statements)

References 15 publications

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“…The exact mode of acupuncture is published elsewhere [12]. In brief, verum and sham points were selected from prescribed lists.…”

Section: Interventionsmentioning

confidence: 99%

“…Needles were inserted superficially (1-3 mm) and were not stimulated, so as to avoid De Qi in the sham group. The number (10)(11)(12)(13)(14)(15)(16)(17)(18)(19)(20)(21)(22)(23)(24)(25) and type of needles (sterile, singleuse needles, coated, 0.25-0.30 mm thick, 25-40 mm long), and number (10)(11)(12)(13)(14)(15), length (30 min) and frequency (2/week) of treatment sessions were the same in each group. Investigators were instructed to treat patients in each group identically in all ways other than the placement of needles.…”

Section: Interventionsmentioning

confidence: 99%

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

Böwing²,

et al. 2007

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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.

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“…The exact mode of acupuncture is published elsewhere [12]. In brief, verum and sham points were selected from prescribed lists.…”

Section: Interventionsmentioning

confidence: 99%

Section: Interventionsmentioning

confidence: 99%

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

Böwing²,

et al. 2007

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“…There is evidence that acupuncture is at least as effective as, or possibly more effective than, prophylactic drug treatment and has fewer adverse effects. 1,2 Additionally, acupuncture is a costeffective treatment option among patients with primary headache according to international cost-effectiveness threshold values. 3 However, its mode of action remains unknown.…”

Section: Introductionmentioning

confidence: 99%

Cerebrovascular Response in Migraineurs During Prophylactic Treatment with Acupuncture: A Randomized Controlled Trial

Wallasch

Weinschuetz²,

Mueller

et al. 2012

The Journal of Alternative and Complementary Medicine

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“…In fact, external validity has increasingly become an issue of concern and has been raised by several acupuncture researchers. [19][20][21][22][23] Miao 23 conducted a systematic review to determine the external validity of the RCTs of acupuncture for low back pain and found major problems in the external validity of all cases. Ahmad et al 15 conducted a review and reported inadequate reporting data related to external validity specifi cally from RCTs assessing pharmacological and non-pharmacological treatments for hip and knee osteoarthritis (OA).…”

Section: Introductionmentioning

confidence: 99%

External Validity in Randomised Controlled Trials of Acupuncture for Osteoarthritis Knee Pain

et al. 2012

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Objectives To assess two aspects of the external validity of acupuncture research for osteoarthritis knee pain and determine the common acupoints and treatment parameters used. Methods The external validity of 16 randomised controlled trials (RCTs) was investigated using a scale consisting of two aspects: reporting and performance. The reporting aspect included acupuncturist's background, study location, treatment detailed, patient characteristics, positive trial results, adverse effects and between-group statistical differences, whereas treatment appropriateness, appropriate controls and outcomes were classifi ed as the performance aspect. Acupuncture treatment in RCTs was compared with common practice according to the literature sources and survey of acupuncturists working in different parts of Thailand. Results The levels of external validity for the reporting and performance aspects were in the range of 31.3% to 100%. Statistic values such as mean difference and confi dence interval were reported by the minority of trials (43.8%). Patient satisfaction and quality of life were seldom used (31.3%). There were minor differences between research and practice in terms of the points used (25.0%), number of treatment sessions (6.3%) and frequency (12.5%). The most frequently used points were ST34, ST35, ST36, SP6, SP9, SP10, GB34, Xiyan and ah shi points, and the commonly used treatment parameters were 20 minutes, 10-15 sessions and two treatments weekly. Conclusions Reporting of the external validity of acupuncture RCTs for knee pain was notably inadequate in terms of trial setting, treatment provider and statistical reporting. The majority of studies involved appropriate controls and outcomes and applied acupuncture treatments in line with practice.

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Designing an Acupuncture Study: The Nationwide, Randomized, Controlled, German Acupuncture Trials on Migraine and Tension-Type Headache

Cited by 40 publications

References 15 publications

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

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

Cerebrovascular Response in Migraineurs During Prophylactic Treatment with Acupuncture: A Randomized Controlled Trial

External Validity in Randomised Controlled Trials of Acupuncture for Osteoarthritis Knee Pain

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