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Background and Objective <p>This randomized pilot study compared the efficacy and safety of&#xa0;Pep2Dia® (a milk protein hydrolysate)&#xa0;versus metformin&#xa0;as adjuncts to letrozole&#xa0;for ovulation induction in overweight women with&#xa0;PCOS resistant to letrozole monotherapy.</p> Methods <p>Hundred participants were randomized (1:1) to receive either metformin (500&#xa0;mg thrice daily)&#xa0;or&#xa0;Pep2Dia (1400&#xa0;mg once daily)&#xa0;alongside letrozole (2.5&#xa0;mg/day, days 3–7)&#xa0;for up to three cycles. The primary outcome was pregnancy rate (chemical and clinical). Secondary outcomes included ovulation rate (confirmed by mid-luteal progesterone), menstrual regularity, metabolic changes (body mass index and fasting blood glucose), and tolerability.</p> Results <p>The metformin group&#xa0;showed significantly higher ovulation rates (68% vs. 46%,&#xa0;<i>p</i> = 0.026), clinical pregnancy (46% vs. 26%,&#xa0;<i>p</i> = 0.037), and menstrual regularity (64% vs. 36.1%,&#xa0;<i>p</i> = 0.032) compared to Pep2Dia. Metformin also yielded greater reductions in BMI (−1.8 vs. −0.9&#xa0;kg/m<sup>2</sup>,&#xa0;<i>p</i> &lt; 0.001) and fasting glucose (<i>p</i> = 0.013). However,&#xa0;Pep2Dia was better tolerated, with fewer gastrointestinal side effects (12% vs. 34%,&#xa0;<i>p</i> = 0.002).</p> Conclusion <p>While metformin remains superior&#xa0;for improving reproductive and metabolic outcomes in PCOS,&#xa0;Pep2Dia offers a safer alternative&#xa0;for women intolerant to metformin. Further large-scale trials are warranted to validate these findings.</p>

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Metformin vs. Pep2Dia as Adjuvant Therapy to Letrozole in Overweight Women with Polycystic Ovarian Syndrome: A Comparison of the Efficacy and Safety Profile

  • 期刊论文

  • 发表日期：

    2025年11月27日

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  • Ali Mohmed El-Atfy,
  • Mofeed Fawzy Mohamed,
  • Muhamed Ahmed Abdelmoaty,
  • Ahmed Soliman

摘要

Background and Objective

This randomized pilot study compared the efficacy and safety of Pep2Dia® (a milk protein hydrolysate) versus metformin as adjuncts to letrozole for ovulation induction in overweight women with PCOS resistant to letrozole monotherapy.

Methods

Hundred participants were randomized (1:1) to receive either metformin (500 mg thrice daily) or Pep2Dia (1400 mg once daily) alongside letrozole (2.5 mg/day, days 3–7) for up to three cycles. The primary outcome was pregnancy rate (chemical and clinical). Secondary outcomes included ovulation rate (confirmed by mid-luteal progesterone), menstrual regularity, metabolic changes (body mass index and fasting blood glucose), and tolerability.

Results

The metformin group showed significantly higher ovulation rates (68% vs. 46%, p = 0.026), clinical pregnancy (46% vs. 26%, p = 0.037), and menstrual regularity (64% vs. 36.1%, p = 0.032) compared to Pep2Dia. Metformin also yielded greater reductions in BMI (−1.8 vs. −0.9 kg/m2, p < 0.001) and fasting glucose (p = 0.013). However, Pep2Dia was better tolerated, with fewer gastrointestinal side effects (12% vs. 34%, p = 0.002).

Conclusion

While metformin remains superior for improving reproductive and metabolic outcomes in PCOS, Pep2Dia offers a safer alternative for women intolerant to metformin. Further large-scale trials are warranted to validate these findings.