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Acupuncture for Episodic Migraine

Manual acupuncture versus sham acupuncture and usual care for prophylaxis of episodic migraine without aura: multicentre, randomised clinical trial

Year of Publication: 2020

Authors: Shabei Xu, Lingling Yu, Xiang Luo, ..., Wei Wang

Journal: BMJ

Citation: BMJ 2020;368:m697

Link: https://www.bmj.com/content/368/bmj.m697

PDF: https://www.researchgate.net/publication...2851caef49ebc04


Clinical Question

Is manual acupuncture effective for the prophylactic treatment of episodic migraine without aura in acupuncture-naive patients?

Bottom Line

Manual acupuncture significantly reduced migraine days and attacks compared to sham acupuncture and usual care, supporting its use as an effective non-drug prophylactic treatment for episodic migraine without aura.

Major Points

  • 150 acupuncture-naive patients with episodic migraine were randomized to manual acupuncture, sham acupuncture, or usual care
  • 20 sessions were administered over 8 weeks with 12-week follow-up (total 20 weeks)
  • Manual acupuncture significantly reduced migraine days and attacks vs sham and usual care
  • Blinding was successful, with no difference in perceived penetration between manual and sham groups
  • Manual acupuncture improved quality of life scores and disability scores more than controls
  • No serious adverse events were reported

Design

Study Type: Multicentre, randomized, controlled clinical trial

Randomization: 1

Blinding: Participants, outcome assessors, and statisticians were blinded

Enrollment Period: 5 June 2016 to 15 November 2018

Follow-up Duration: 20 weeks (8 weeks treatment, 12 weeks follow-up)

Centers: 7

Countries: China

Sample Size: 150

Analysis: Intention-to-treat (full analysis set); ANCOVA and linear mixed models; Bonferroni correction for secondary outcomes


Inclusion Criteria

  • Aged 15–65 years
  • Diagnosed with episodic migraine without aura (ICHD-3β)
  • Migraine history >12 months
  • Onset before age 50
  • 2–8 attacks during 4-week baseline phase
  • Acupuncture naive

Exclusion Criteria

  • Other types of headache
  • Severe mental illness or other major medical conditions
  • Pregnancy or breastfeeding
  • Non-adherence to baseline diary

Baseline Characteristics

Age, years: 36.6 (12.0) vs 36.0 (10.9)

Sex - Female: 78% vs 83%

BMI: 20.4 (19.5–23.1) vs 22.0 (20.3–23.4)

Disease duration, years: 10.0 (5.0–19.5) vs 10.0 (6.0–14.0)

Nausea or vomiting: 88% vs 85%

Photophobia or phonophobia: 87% vs 87%

Migraine days: 5.8 (2.6) vs 6.3 (3.8)

Migraine attacks: 3.8 (1.4) vs 4.1 (2.6)

VAS score: 5.1 (1.3) vs 5.3 (1.3)


Arms

FieldManual AcupunctureSham AcupunctureControl
Intervention20 sessions of 30-minute manual acupuncture at true acupuncture points20 sessions of non-penetrating sham acupuncture at non-acupuncture pointsEducation on migraine self-management and lifestyle; no acupuncture
Duration8 weeks8 weeks8 weeks

Outcomes

OutcomeTypeControlInterventionHR / OR / RRP-value
Change in number of migraine days and migraine attacks per 4-week period from baseline to weeks 17–20PrimaryMigraine days: -1.4; attacks: -0.4Migraine days: -3.9; attacks: -2.3<0.001
≥50% reduction in migraine daysSecondary17.9%82.5%<0.001
Visual analogue scale reductionSecondary-0.0-2.2<0.001
MIDAS scoreSecondary-0.5-15.00.006
Any acupuncture-related eventAdverse0%8%

Subgroup Analysis

No subgroup analyses reported; pooled treatment effects were consistent across centers


Criticisms

  • Short follow-up (only 12 weeks after treatment)
  • No active drug comparator (e.g., pharmacologic prophylaxis)
  • Results may not generalize to patients with prior acupuncture experience

Funding

National Natural Science Foundation of China; Hubei University of Chinese Medicine; no sponsor involvement in study conduct

Based on: Acupuncture for Episodic Migraine (BMJ, 2020)

Authors: Shabei Xu, Lingling Yu, Xiang Luo, ..., Wei Wang

Citation: BMJ 2020;368:m697

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