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Randomised trial, 2025

How effective are non-hormonal treatments for severe PMS?

All three tested treatments significantly reduced PMS symptoms more than placebo. Calcium-vitamin D was most effective, followed by cognitive behavioral therapy and lifestyle changes.

Strong study design 120 women aged 18-45 with severe PMS

What they did

This 12-month randomized trial enrolled 120 women aged 18-45 with severe PMS at a single center. Women were randomly assigned to: calcium-vitamin D supplement (600 mg plus 400 IU twice daily), cognitive behavioral therapy (8 weekly sessions), combined lifestyle intervention (exercise, diet, stress management), or placebo. Symptoms were measured at 3 and 6 months.

What they found

At 3 months, calcium-vitamin D reduced DRSP scores by 63.7 points versus 14.9 for placebo, CBT by 58.2 points, and lifestyle by 49.6 points, all significantly better than placebo (p<0.001). For achieving at least 50 percent symptom reduction, calcium-vitamin D achieved 76.9 percent, CBT 69.2 percent, lifestyle 57.7 percent, and placebo 15.4 percent (p<0.001). Benefits were sustained at 6-month follow-up.

What it means for you

Non-hormonal treatments can effectively manage severe PMS. Calcium-vitamin D was most effective overall and worked best for physical symptoms. Cognitive behavioral therapy was best for mood symptoms. Lifestyle changes showed balanced effects. The study was at a single center, so broader testing may help confirm results.

120

women with severe PMS studied

76.9%

achieved 50 percent reduction with calcium-vitamin D

3

months to primary outcome

About the study

Original title
Efficacy of Non-Hormonal Treatments for Managing Severe Premenstrual Syndrome: A Randomized Controlled Trial
Authors
Lata K Mankani, Santosh S Ankalagi
Journal
Journal of Neonatal Surgery
Year
2025
Study design
Randomised trial
Participants
120
What was tested
Calcium-vitamin D supplement, cognitive behavioral therapy, combined lifestyle intervention, or placebo
Open access
Yes
Original abstract

Background: Premenstrual syndrome (PMS) affects 20-40% of reproductive-age women, with 3-8% experiencing severe symptoms that significantly impair daily functioning. While hormonal treatments are considered first-line therapy, many women prefer non-hormonal alternatives due to side effects, contraindications, or personal beliefs. This study evaluated the efficacy of evidence-based non-hormonal treatments for managing severe PMS. Methods: This 12-month, single-center, multi-arm, parallel-group, randomized, placebo-controlled trial enrolled 120 women (aged 18-45 years) with severe PMS. Participants were randomized to receive calcium-vitamin D supplementation (600mg+400IU twice daily), cognitive behavioral therapy (CBT, 8 weekly sessions), combined lifestyle intervention (structured exercise, dietary counseling, and stress management), or placebo. The primary outcome was reduction in Daily Record of Severity of Problems (DRSP) scores after 3 months. Secondary outcomes included proportion achieving ≥50% symptom reduction, domain-specific improvements, and quality of life measures. Results: At 3 months, mean DRSP score reductions were significantly greater in all intervention groups compared to placebo: calcium-vitamin D (63.7±7.2 vs. 14.9±5.8, p<0.001), CBT (58.2±6.9, p<0.001), and lifestyle intervention (49.6±7.4, p<0.001). The proportion of participants achieving ≥50% symptom reduction was highest with calcium-vitamin D (76.9%), followed by CBT (69.2%), lifestyle intervention (57.7%), and placebo (15.4%), p<0.001. Domain analysis showed differential effects with calcium-vitamin D more effective for physical symptoms (71.2% reduction), CBT for psychological symptoms (74.8% reduction), and lifestyle interventions showing balanced effects across domains. Treatment effects were maintained at 6-month follow-up. Conclusion: Non-hormonal treatments demonstrated significant efficacy in managing severe PMS, with calcium-vitamin D supplementation showing the greatest overall benefit. These findings provide evidence-based alternatives for women seeking non-hormonal PMS management and suggest that treatment selection should consider predominant symptom domains

Reproduced under CC-BY.

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