The Efficacy and Safety of Acupuncture for Prophylaxis of Menstrually Related Migraine

Launched by GUANG'ANMEN HOSPITAL OF CHINA ACADEMY OF CHINESE MEDICAL SCIENCES · Jun 14, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether acupuncture can help prevent migraines that are linked to the menstrual cycle, called menstrually related migraines (MRM). While acupuncture is often used to reduce headaches and has shown benefits for some types of migraines, it’s not yet clear if it works specifically for menstrual migraines or if any improvement is due to other factors like the placebo effect. This study aims to find out how effective and safe acupuncture is for women who regularly experience these migraines.

Women between the ages of 18 and 45 who have had a confirmed diagnosis of menstrual migraines for at least a year may be eligible to join. To qualify, participants need to have regular menstrual cycles and experience migraines around their periods, with a certain number of headache days each month. Before the trial, they will keep a headache diary to track their migraines. During the study, participants will receive acupuncture treatments and be monitored to see if their migraines improve. It’s important to note that women who have irregular periods, other serious health problems, or a fear of needles would not be eligible. If you meet the criteria and are interested, this study might offer a new way to manage menstrual migraines.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. meet the diagnostic criteria for MRM according to the ICHD-3, with a documented history of MRM for at least 12 months;
• • 2. have a confirmed diagnosis of migraine by a neurologist;
• • 3. aged 18-45 years;
• • 4. have regular menstrual cycles (28 ± 7 days) with menstruation lasting 3-7 days;
• • 5. have experienced ≥3 headache days during each menstrual cycle (days -2 to +3) and ≥5 total headache days per cycle over the past 3 months and baseline period; migraine attacks must last 4-72 hours without acute medication, or at least 2 hours when treated;
• • 6. have completed a headache diary during the screening period (covering at least one full menstrual cycle), demonstrating good compliance;
• • 7. headache diary data during screening period must meet the ICHD-3 criteria for MRM and fulfill criteria (4) and (5);
• • 8. voluntarily sign the informed consent.
• Exclusion Criteria:
• • 1. irregular menstrual cycles, defined as cycle length outside the range of 28±7 days or menstruation duration \<3 days or \>7 days;
• • 2. presence of secondary headache disorders, facial neuralgia, or cranial neuralgia;
• • 3. combined with serious primary diseases such as cardiovascular, hepatic, renal, gastrointestinal, or hematological disorders that may interfere with the treatment protocol, or comorbid neurological conditions such as epilepsy, parkinson's disease, or other central nervous system disorders;
• • 4. headache symptoms caused by other conditions, such as moderate to severe head or neck trauma, perimenstrual infections, intracranial tumors, intracranial infections, endocrine or metabolic disorders;
• • 5. receipt of preventive treatment for headache within 1 month prior to the screening visit;
• • 6. afraid of needles or received acupuncture treatment within 3 months;
• • 7. unwillingness to undergo the study intervention or failure to sign the informed consent.