Open-Label Placebo Plus Treatment Rationale Effective for PMS
FRIDAY, March 28, 2025 -- Open-label placebo (OLP) provided with a treatment rationale is effective and safe for premenstrual syndrome (PMS), according to a study published online March 25 in BMJ Evidence-Based Medicine.
Antje Frey Nascimento, from the University of Basel in Switzerland, and colleagues conducted a randomized controlled trial involving 150 women aged 18 to 45 years with PMS or premenstrual dysphoric disorder. Participants were randomly assigned to treatment as usual (TAU; 50 women), OLP without treatment rationale (OLP−; 50 women), or OLP with treatment rationale (OLP+; 50 women); OLP consisted of two placebo pills per day for six weeks.
The researchers found that across three menstrual cycles (MC1 to MC3), there was a difference between the groups in symptom intensity and interference. At MC3, mean symptom intensity was lower for OLP+ versus TAU and OLP− (b = −9.97 and −6.10), while no difference was seen between TAU and OLP−. At MC3, mean interference was lower for OLP+ than for TAU or OLP− (b = −1.23 and −1.10), with no difference between TAU and OLP−. There were reports of four nonserious adverse events in OLP− and OLP+ (one and three, respectively). High adherence was seen to the OLP intervention (93.18 ± 18.95 percent), with no between-group difference.
"Considering our results as much as the individual and societal burden of PMS, OLP treatment could serve as an acceptable, efficacious, and safe intervention for PMS," the authors write.
Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.
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