Acupuncture for patients with migraine: a randomized controlled trial.
Klaus Linde,Andrea Streng,Susanne Jürgens,Andrea Hoppe,Benno Brinkhaus,Claudia M. Witt,Stephan Wagenpfeil,V. Pfaffenrath,Michael Hammes,Wolfgang Weidenhammer,Stefan N. Willich,Dieter Melchart +11 more
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TLDR
It is found that acupuncture was no more effective than sham acupuncture in reducing migraine headaches although both interventions were moreeffective than a waiting list control.Abstract:
ContextAcupuncture is widely used to prevent migraine attacks, but the available
evidence of its benefit is scarce.ObjectiveTo investigate the effectiveness of acupuncture compared with sham acupuncture
and with no acupuncture in patients with migraine.Design, Setting, and PatientsThree-group, randomized, controlled trial (April 2002-January 2003)
involving 302 patients (88% women), mean (SD) age of 43 (11) years, with migraine
headaches, based on International Headache Society criteria. Patients were
treated at 18 outpatient centers in Germany.InterventionsAcupuncture, sham acupuncture, or waiting list control. Acupuncture
and sham acupuncture were administered by specialized physicians and consisted
of 12 sessions per patient over 8 weeks. Patients completed headache diaries
from 4 weeks before to 12 weeks after randomization and from week 21 to 24
after randomization.Main Outcome MeasuresDifference in headache days of moderate or severe intensity between
the 4 weeks before and weeks 9 to 12 after randomization.ResultsBetween baseline and weeks 9 to 12, the mean (SD) number of days with
headache of moderate or severe intensity decreased by 2.2 (2.7) days from
a baseline of 5.2 (2.5) days in the acupuncture group compared with a decrease
to 2.2 (2.7) days from a baseline of 5.0 (2.4) days in the sham acupuncture
group, and by 0.8 (2.0) days from a baseline if 5.4 (3.0) days in the waiting
list group. No difference was detected between the acupuncture and the sham
acupuncture groups (0.0 days, 95% confidence interval, −0.7 to 0.7 days; P = .96) while there was a difference between
the acupuncture group compared with the waiting list group (1.4 days; 95%
confidence interval; 0.8-2.1 days; P<.001). The
proportion of responders (reduction in headache days by at least 50%) was
51% in the acupuncture group, 53% in the sham acupuncture group, and 15% in
the waiting list group.ConclusionAcupuncture was no more effective than sham acupuncture in reducing
migraine headaches although both interventions were more effective than a
waiting list control.read more
Citations
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Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration.
TL;DR: This elaboration and explanation document is developed from a review of the literature to provide examples of adequate reporting in trials of nonpharmacologic treatments and should help to improve the reporting of RCTs performed in this field.
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Biological, clinical, and ethical advances of placebo effects
TL;DR: Promotion and integration of laboratory and clinical research will allow advances in the ethical use of placebo mechanisms that are inherent in routine clinical care, and encourage the use of treatments that stimulate placebo effects.
Journal ArticleDOI
Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): Extending the CONSORT statement.
Hugh MacPherson,Douglas G. Altman,Richard Hammerschlag,Li Youping,Wu Taixiang,Adrian White,David Moher +6 more
TL;DR: The STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) as mentioned in this paper were published in five journals in 2001 and 2002 and were designed to improve reporting of acupuncture trials, particularly the interventions, thereby facilitating their interpretation and replication.
Journal ArticleDOI
Acupuncture for Chronic Pain: Individual Patient Data Meta-analysis
Andrew J. Vickers,Angel M. Cronin,Alexandra C. Maschino,George Lewith,Hugh MacPherson,Nadine E. Foster,Karen J. Sherman,Claudia M. Witt,Klaus Linde +8 more
TL;DR: In this paper, the authors conducted a systematic review to identify randomized controlled trials (RCTs) of acupuncture for chronic pain in which allocation concealment was determined unambiguously to be adequate.
Journal ArticleDOI
Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): extending the CONSORT statement.
Hugh MacPherson,Douglas G. Altman,Richard Hammerschlag,Li Youping,Wu Taixiang,Adrian White,David Moher +6 more
TL;DR: It is intended that the revised STRICTA, in conjunction with both the main CONSORT Statement and extension for nonpharmacologic treatment, will raise the quality of reporting of clinical trials of acupuncture.
References
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Journal ArticleDOI
Prevalence and Burden of Migraine in the United States: Data From the American Migraine Study II
TL;DR: The prevalence, sociodemographic profile, and the burden of migraine in the United States in 1999 and to compare results with the original American Migraine Study, a 1989 population‐based study employing identical methods are described.
Journal ArticleDOI
Is the placebo powerless? An analysis of clinical trials comparing placebo with no treatment.
TL;DR: A systematic review of clinical trials in which patients were randomly assigned to either placebo or no treatment found that placebo had no significant effect on binary outcomes, regardless of whether these outcomes were subjective or objective.
Book
Sample Size Tables for Clinical Studies
David Machin,David Machin +1 more
TL;DR: The aim of this book is to help designers and marketers better understand their clients' needs and improve the quality of their work.
An Analysis of Clinical Trials Comparing Placebo with No Treatment
TL;DR: Although placebos had no significant effects on objective or binary outcomes, they had possible small benefits in studies with continuous subjective outcomes and for the treatment of pain.