Effectiveness and safety of herbal medicine on treatment of dysmenorrhea: An analysis of a multicenter, prospective observational study

Background

This study aimed to evaluate the effectiveness and safety of individually prescribed decoction herbal medicine for the treatment of dysmenorrhea. Herbal decoction was compared to other herbal formulations and combined treatment modalities, focusing on reductions in menstrual pain intensity, duration, and analgesic use. Personalized herbal treatments were hypothesized to alleviate symptoms more effectively by addressing individual constitutional imbalances.

Methods

This prospective observational study was conducted at 33 Korean medicine clinics and one Korean medicine hospital in South Korea, enrolling 135 participants. Based on the treatment they received, participants were categorized into three groups: herbal decoction only group (Decoction only Group, n = 82), herbal decoction with adjunctive therapies such as acupuncture or moxibustion (Combination Group, n = 37), and non-herbal decoction formulations (Non-decoction Group, n = 16). Treatments were administered over at least one menstrual cycle, and outcomes were assessed after each cycle. Primary outcomes included changes in pain intensity (numerical rating scale), duration of menstrual pain, and frequency of analgesic use. Safety was assessed through adverse event monitoring during clinic visits.

Results

Herbal decoction only showed significant reductions in menstrual pain intensity, pain duration, and analgesic use compared to those receiving other herbal formulations. Most adverse events were mild gastrointestinal symptoms related to oral intake, which resolved without intervention. No serious adverse events were reported.

Conclusions

Herbal decoction group significantly decreased the intensity and duration of menstrual pain and analgesic dosage. These findings suggest that herbal decoction may be a safe and effective personalized treatment option for dysmenorrhea.