MENOXTINA Trial

Research Hypothesis: This study tests the hypothesis that a 12-week daily treatment with 20mg paroxetine is superior to a placebo in reducing the severity of vasomotor symptoms and improving overall quality of life in women experiencing surgical menopause.

Data Description & Collection: The dataset contains results from a double-blind, randomized, placebo-controlled clinical trial (the MENOXTINA TRIAL). Ninety (90) participants were randomly assigned to either a Paroxetine (20mg/day) or Placebo group. Data was gathered at four time points: baseline (day 1), 1 month, 2 months, and 3 months. Primary measures include the total score on the Menopause Rating Scale (MRS), where a higher score indicates more severe symptoms, and the SF-36 quality of life survey, where a higher score indicates better health. Adverse events were also recorded.

Notable Findings & Interpretation: Intention-to-treat analysis revealed that both groups improved over time, demonstrating a significant placebo effect. However, the paroxetine group showed a statistically significantly greater reduction in MRS scores by the third month (16.9 vs. 22.6, p=0.000251) and a greater improvement in SF-36 scores (91 vs. 86.9, p=0.0012). This indicates that paroxetine provides a clinically meaningful benefit beyond placebo. The most common side effects (headache, fatigue) were mild and transient. The data supports the conclusion that paroxetine is an effective and well-tolerated non-hormonal treatment for managing surgical menopausal symptoms.

How to Use: The dataset can be used to assess the primary and secondary outcomes over time, analyze the demographic and clinical baseline characteristics of the sample, and explore the safety profile of the intervention. The repeated-measures structure allows for analysis of the trajectory of symptom change.