The efficacy and safety of DLBS3233, a combined bioactive fraction of Cinnamomum burmanii and Lagerstroemia speciosa compared to metformin on endocrine-metabolic profile of women with polycystic ovary syndrome: A randomized clinical trial

Articles in Press

Document Type : Original Article

Authors

1 Division of Reproductive Immunoendocrinology, Department of Obstetrics and Gynecology Faculty of Medicine, Universitas Indonesia / dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia

2 Division of Reproductive Endocrinology and Fertility, Department of Obstetrics and Gynecology, Faculty of Medicine, University of Padjajaran / Hasan Sadikin Hospital, Bandung, Indonesia

3 Dexa Laboratories of Biomolecular Sciences, Dexa Medica Group, Cikarang, Indonesia

4 department of obstetric and gynaecology, faculty of medicine, university of indonesia

5 Department of Obstetrics and Gynecology, Faculty of Medicine, Universitas Padjadjaran - Dr. Hasan Sadikin Hospital

10.22074/ijfs.2023.551350.1283

Abstract

Background: DLBS3233, a bioactive fraction derived from Cinnamomum burmanii and Lagerstroemia speciosa, has recently been used for type-2-diabetes treatment due to its favorable effect on insulin sensitivity. Insulin resistance leading to metabolic syndrome is closely linked to hyperandrogenemia in polycystic ovary syndrome (PCOS). This study aimed to evaluate metabolic and reproductive efficacy and safety of DLBS3233 in PCOS women with insulin resistance.

Patients and methods: This was a 2-arm, randomized, double-blind, controlled clinical study over a 6-month therapy with DLBS3233 100-mg daily in 124 PCOS women with insulin resistance, with a non-inferiority design to metformin-XR 750 mg twice daily. The primary efficacy endpoint was the improvement of Homeostasis-Model-Assessment–Insulin-Resistance (HOMA-IR). Secondary endpoints were improvements in other metabolic and reproductive parameters. Safety endpoints were based on blood pressure, heart rate, electrocardiogram findings, liver and renal function, and adverse events.

Results: HOMA-IR was significantly improved after three and six months of DLBS3233 or metformin-XR treatment. After 6 months, HOMA-IR improvement in DLBS3233-treated Group (–1.030.50) and metformin-XR (–1.190.50) were comparable (within the set non-inferiority margin of  0.5; 95% confidence-interval –1.24, 1.56; p=0.3168). In general, there was no significant between-group difference in all secondary endpoints. Both DLBS3233 and metformin-XR treatment did not adversely affect laboratory-safety parameters. Markedly fewer adverse events occurred in DLBS3233- than in Metformin-XR- treated Group and most were mild clinically and had been resolved by the end of study.

Conclusions: Treatment with DLBS3233 100-mg daily in PCOS women demonstrated comparable efficacy to that of metformin-XR 750-mg twice daily in improving insulin resistance. However, the non-inferiority of DLBS3233 to metformin-XR remains inconclusive. DLBS3233 was evidently more tolerable than metformin-XR.

Keywords

International Journal of Fertility and Sterility

Articles in Press, Accepted Manuscript
Available Online from 21 October 2023

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