A Kampo medicine, kamishoyosan, ameliorates menstruation-associated symptoms in patients with premenstrual syndrome: An exploratory open-label, randomized controlled trial.
Jun Chikumi, Eri Sato, Ai Ikebuchi et al.
✦ AI-curated · Sources linked
In 30 seconds
This open-label, exploratory randomized controlled trial evaluated the efficacy and safety of oral kamishoyosan (KSS) for premenstrual syndrome in 50 patients treated over three menstrual cycles. The primary outcome was change in the premenstrual Menstrual Distress Questionnaire (MDQ) total score, which was significantly improved after KSS treatment. MDQ scores also decreased during the menstrual cycle, with improvements in several symptom domains and daily-reported symptoms. Activity impairment was lower in the KSS group, and overall impressions favored treatment. One KSS-related adverse event, headache, was reported.
Key findings
- The premenstrual MDQ total score, the primary endpoint, significantly improved after KSS treatment.
- MDQ subscales for pain, concentration, behavioral change, and negative feelings decreased during the premenstrual cycle.
- Daily symptom reports indicated improvement in irritability, anxiety, emotional instability, abdominal distension, coldness, and stiff shoulders.
- One KSS-related adverse event was reported: headache in one case.
Why it matters
PMS can involve psychological and physical symptoms, and this trial assessed symptom burden across menstrual cycles using questionnaire-based outcomes. The findings suggest possible improvement across several symptom domains and in activity impairment, while also documenting an adverse event. They provide preliminary evidence relevant to evaluating KSS as a potential option, but the exploratory, open-label design warrants cautious interpretation.
What to keep in mind
The trial was exploratory and open-label, and the abstract does not report quantitative effect sizes for the outcomes.