International Journal of Drug Delivery Technology
Volume 16, Issue 2s

Metformin Alone Versus Metformin Combined with Inositol for Menstrual Regulation in Women with Polycystic Ovary Syndrome: A Randomized Controlled Trial from Pakistan

Dr. Saima Shaikh1, Prof. Dr. Jahan Ara Hasan2, Dr. Sadia Detho3, Dr. Faria4, Dr. Amina Begum5, Dr. Hajira Khalid6, Dr. Amber Shams7

1MBBS, Chandka Medical College, FCPS, Dow University of Health Sciences
2Dow University of Health Sciences, MBBS, MCPS, FCPS, PhD
3MBBS, Liaquat University of Medical & Health Sciences (LUMHS), Civil Hospital, Karachi
4MBBS, Liaquat University of Medical & Health Sciences (LUMHS), FCPS
5MBBS, Chandka Medical College, Larkana, FCPS, Dow University of Health Sciences, Karachi
6MBBS, Dow Medical College
7MBBS, Liaquat University of Medical & Health Sciences (LUMHS), Jamshoro, Pakistan; Professional Diploma in Gynaecology & Obstetrics, Royal College of Physicians of Ireland (RCPI)
ORCID: https://orcid.org/0009-0001-2702-0648

ABSTRACT

Objective: To compare the efficacy of metformin alone versus metformin combined with inositol in regulating menstrual cycles in women with polycystic ovary syndrome (PCOS).

Study Design: Randomized controlled trial.

Place and Duration of Study: Department of Obstetrics and Gynecology, Unit III, Civil Hospital Karachi, over six months.

Methodology: A total of 208 women aged 15–40 years diagnosed with PCOS according to the Rotterdam diagnostic framework were enrolled. Participants were randomly allocated into two equal groups. Group A received metformin 500 mg three times daily, while Group B received metformin 500 mg three times daily in combination with inositol 1 g twice daily. The primary outcome was achievement of menstrual cycle regularity, defined as three consecutive menstrual cycles of 21–35 days within six months. Data were analyzed using SPSS version 20.

Results: Regular menstrual cycles were achieved in 100% of women receiving metformin with inositol compared to 26% in the metformin-alone group (p <0.001). The superiority of combination therapy remained consistent across all stratified subgroups including age, body mass index (BMI), Ferriman–Gallwey score, and duration of PCOS.

Conclusion: Metformin combined with inositol is significantly more effective than metformin alone in restoring menstrual regularity in women with PCOS and should be considered a preferred therapeutic option...

Keywords: Polycystic ovary syndrome; Metformin; Inositol; Menstrual irregularities; Insulin resistance.

How to cite this article: Shaikh S, Hasan JA, Detho S, Faria, Begum A, Khalid H, Shams A, Metformin Alone Versus Metformin Combined with Inositol for Menstrual Regulation in Women with Polycystic Ovary Syndrome: A Randomized Controlled Trial from Pakistan. Int J Drug Deliv Technol. 2026;16(2s): 354-357; DOI: 10.25258/ijddt.16.354-357