The Long-term Effect of Acupuncture for Migraine Prophylaxis: A Randomized Clinical Trial

Zhao et al. · JAMA Internal Medicine · 2017

🔬Three-Arm RCT👥n=245 participantsHigh Impact - JAMA

Evidence Level

STRONG
85/ 100
Quality
5/5
Sample
4/5
Replication
4/5
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OBJECTIVE

To investigate the long-term effects of true acupuncture vs sham vs waiting list for migraine prophylaxis

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WHO

249 patients aged 18–65 years with migraine without aura, having 2–8 attacks per month

⏱️

DURATION

4 weeks of treatment + 20 weeks of follow-up (24 weeks total)

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POINTS

GB-20, GB-8 mandatory + 2 points based on differentiation: TE-5, GB-34, BL-60, SI-3, LI-4, ST-44, LR-3, GB-40

🔬 Study Design

245participants
randomization

True acupuncture

n=83

Electroacupuncture with De Qi, 20 sessions

Sham acupuncture

n=80

Electroacupuncture at non-points, without De Qi, 20 sessions

Waiting list

n=82

No treatment during the study period

⏱️ Duration: 24 weeks (4 weeks of treatment + 20 weeks of follow-up)

📊 Results in numbers

-3.2 attacks

Reduction in attack frequency (true acupuncture)

-2.1 attacks

Reduction in attack frequency (sham)

-1.4 attacks

Reduction in attack frequency (waiting list)

p = 0.002

Difference true acupuncture vs sham

0%

Dropout rate

Percentage highlights

2.4%
Dropout rate

📊 Outcome Comparison

Reduction in migraine attacks (week 16)

True Acupuncture
3.2
Sham
2.1
Waiting List
1.4
💬 What does this mean for you?

This study showed that true acupuncture is significantly more effective than sham or no treatment in preventing migraine attacks. The benefits were maintained for at least 20 weeks after treatment ended, suggesting that acupuncture can be a valuable and durable option for migraine sufferers.

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Article summary

Plain-language narrative summary

Migraine is one of the most disabling neurologic disorders worldwide, affecting about 15% of the population in the United States and up to 12% of the Asian population. This condition causes intense, throbbing headaches, often accompanied by nausea and sensitivity to light or sound. Preventive treatment is necessary for approximately one quarter of migraine patients, but conventional medications such as divalproex sodium, topiramate, metoprolol, and propranolol can cause significant side effects, including weight gain, fatigue, sleep disturbances, and gastrointestinal problems. Faced with these limitations, many patients and clinicians look for safer and more effective alternatives.

Acupuncture has been widely used to treat migraine in both China and Western countries, especially for patients who do not respond well to conventional medications. Although prior studies have shown mixed results regarding the efficacy of true acupuncture compared with sham acupuncture, one fundamental question remained unanswered: whether true acupuncture is superior to sham in preventing future migraine attacks over time. This research was designed to address that question through a rigorous, long-duration study.

The study was a randomized controlled trial conducted over 24 weeks at three medical centers in China between October 2012 and September 2014. The investigators recruited 249 participants aged 18 to 65 years who suffered from migraine without aura, a specific form of migraine that does not include neurologic symptoms such as visual disturbances or sensory changes that precede the headache. Selected patients had 2 to 8 migraine attacks per month and were randomly assigned to three groups: true acupuncture, sham acupuncture, or waiting list. The first two groups received 20 electroacupuncture sessions over 4 weeks, while the waiting list group received no treatment during the study period.

The primary outcome was the change in migraine attack frequency between baseline and week 16, with patients keeping detailed attack diaries throughout the period.

The results demonstrated clear and lasting benefits of true acupuncture. At week 16 after treatment initiation, the true acupuncture group had a mean reduction of 3.2 migraine attacks per month, compared with 2.1 attacks in the sham acupuncture group and only 1.4 attacks in the waiting list group. The difference between true and sham acupuncture was statistically significant, with an additional reduction of 1.1 attacks per month. Even more important, true acupuncture showed persistent superiority over the waiting list group, with a difference of 1.8 fewer attacks per month.

The benefits of true acupuncture remained consistent throughout the entire 24-week follow-up period, including reductions in days with migraine, pain intensity, and use of acute medications. Patients who received true acupuncture also showed improvements in migraine-related emotional quality of life.

For patients with migraine, these results offer real hope of an effective and safe preventive treatment option. True acupuncture proved superior both to sham acupuncture and to no treatment, providing benefits that persisted for at least 20 weeks after the end of treatment sessions. This is particularly important because it means that a relatively brief course of treatment can offer prolonged relief. For clinicians, the study provides robust evidence that acupuncture can be considered a legitimate preventive treatment option for patients with migraine without aura, especially those who experience unacceptable side effects with conventional medications or prefer non-pharmacologic approaches.

The safety profile of acupuncture was excellent, with only mild and transient adverse events reported by some participants.

The study has several important limitations. First, a semi-standardized acupoint prescription was used instead of fully personalized treatment that an experienced acupuncturist could develop for each patient. Second, the waiting list group could not be blinded to its assignment, which may have influenced results through psychological factors. Third, and perhaps most important for clinical practice, the study did not compare acupuncture with standard preventive medications for migraine, leaving an important question about relative efficacy unanswered.

Despite these limitations, the research represents one of the largest and most rigorous evaluations of acupuncture for migraine prevention to date, providing compelling evidence that true acupuncture can deliver lasting and clinically meaningful benefits for patients with migraine without aura, justifying its consideration as a valid therapeutic option among available preventive treatments.

Strengths

  • 1Multicenter study with sound randomization
  • 2Extended 24-week follow-up
  • 3Very low dropout rate (2.4%)
  • 4Publication in a high-impact journal
  • 5Analysis vs both sham and waiting list
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Limitations

  • 1Acupuncturists could not be blinded
  • 2Semi-standardized prescription may not reflect real clinical practice
  • 3Did not compare with standard medications
  • 4Only migraine without aura was studied
Dr. Marcus Yu Bin Pai

Expert Commentary

Dr. Marcus Yu Bin Pai

MD, PhD · Pain Medicine · Physical Medicine and Rehabilitation · Medical Acupuncture

Clinical Relevance

Migraine prophylaxis remains one of the most difficult clinical challenges in pain practice: beta-blockers cause exercise intolerance in active patients, topiramate produces cognitive complaints that compromise adherence, and divalproex is absolutely contraindicated in women of childbearing age. The work by Zhao et al. provides level A evidence for acupuncture as a true prophylactic alternative, not merely palliative. The superiority of true acupuncture over sham with p = 0.002 and 24-week follow-up eliminate the argument that the effect would be purely expectation or regression to the mean. In practice, this elevates acupuncture from a second-line adjuvant option to a first-line option in patients with migraine without aura who decline or do not tolerate pharmacotherapy, concretely expanding the therapeutic armamentarium without adding systemic adverse-effect burden.

Notable Findings

The most robust finding is not the absolute magnitude of reduction — 3.2 fewer attacks per month in the true acupuncture group — but the persistence of the effect for 20 weeks after the end of sessions. This implies that 20 sessions concentrated over four weeks produce sustained neuroplasticity in trigeminovascular nociceptive processing, possibly via descending serotonergic modulation and normalization of central sensitization. The second point worth noting is the quantitative difference between true and sham acupuncture of 1.1 attacks per month: in patients with 4 to 6 attacks per month, this difference represents a functional step-change — fewer disabling days, less triptan consumption, less absenteeism. The 2.4% dropout rate over 24 weeks is also a level of adherence rarely seen in trials of long-term pharmacologic prophylaxis.

From My Experience

In my practice in the headache clinic, I have reserved acupuncture as primary prophylaxis especially for three profiles: pregnant patients in whom any prophylactic medication requires careful justification, patients with metabolic syndrome in whom topiramate and valproate create additional risks, and the menstrual migraine subgroup, which tends to respond particularly consistently. I usually observe noticeable reduction in frequency starting in the third or fourth week of treatment, which coincides with the consolidation period of the 20-session protocol studied. For maintenance, my routine is one session every two weeks for two to three months after the intensive phase, precisely to sustain the effect this trial documented at 24 weeks. I systematically combine this with sleep hygiene guidance and trigger control — caffeine and irregular schedules are the most prevalent triggers I see. Patients with chronic migraine and medication overuse respond less and require first the withdrawal of the agent causing rebound headache before any prophylaxis, including acupuncture.

PhD in Health Sciences, University of São Paulo. Board-certified in Pain Medicine, Physical Medicine and Rehabilitation, and Medical Acupuncture.

Full original article

Read the full scientific study

JAMA Internal Medicine · 2017

DOI: 10.1001/jamainternmed.2016.9378

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Scientific Review

Marcus Yu Bin Pai, MD, PhD

Marcus Yu Bin Pai, MD, PhD

CRM-SP: 158074 | RQE: 65523 · 65524 · 655241

PhD in Health Sciences, University of São Paulo. Board-certified in Pain Medicine, Physical Medicine and Rehabilitation, and Medical Acupuncture. Scientific review and curation of every entry in this library.

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Medical disclaimer: This content is for educational purposes only and does not replace consultation, diagnosis, or treatment by a qualified professional. Some information may be assisted by artificial intelligence and is subject to inaccuracies. Always consult a physician.

Content reviewed by the medical team at CEIMEC — Integrated Centre for Chinese Medicine Studies, a reference in Medical Acupuncture for over 30 years.