Sishun Formula for acute migraine attack: study protocol for a double-blind, randomized, placebo-controlled trial

Area of Science:

• Neurology
• Integrative Medicine
• Pharmacology

Background:

• Migraine is a leading cause of global disability, impacting over 1.1 billion people.
• Current acute treatments have limitations including contraindications and adverse events.
• The Sishun Formula (SSF), a traditional Chinese medicine, shows potential for acute migraine therapy.

Purpose of the Study:

• To rigorously evaluate the efficacy and safety of the Sishun Formula (SSF) for treating acute migraine attacks.
• To assess SSF as a potential alternative pharmacotherapy for migraine sufferers.
• To investigate SSF's effects on patients with "Ying-Wei disharmony" syndrome.

Main Methods:

• A multicenter, randomized, double-blind, placebo-controlled trial involving 144 participants.
• Participants received a single dose of SSF or placebo within 0.5 hours of migraine onset.
• Primary outcome: headache freedom at 2 hours post-dose; secondary outcomes include relief, symptom absence, sustained effects, VAS scores, and safety.

Main Results:

• The study is designed to yield high-quality evidence on SSF's clinical effectiveness.
• Anticipated to demonstrate significant improvements in headache freedom and relief compared to placebo.
• Safety and tolerability of SSF will be thoroughly assessed through monitoring of adverse events and vital signs.

Conclusions:

• Findings are expected to validate SSF's efficacy and safety for acute migraine.
• SSF may offer a promising new therapeutic option for managing acute migraine attacks.
• This research contributes to understanding traditional Chinese medicine's role in modern headache management.