TY - JOUR
T1 - The Efficacy and Safety of DLBS3233, A Combined Bioactive Fraction of Cinnamomum burmanii and Lagerstroemia speciosa Plants on The Endocrine-Metabolic Profile of Women with Polycystic Ovary Syndrome
T2 - A Randomized Clinical Trial
AU - Hestiantoro, Andon
AU - Permadi, Wiryawan
AU - Tjandrawinata, Raymond R.
AU - Wiweko, Budi
AU - Ritonga, Mulyanusa A.
AU - Ferrina, Ade Indra
AU - Sumapraja, Kanadi
AU - Muharam, R.
AU - Djuwantono, Tono
N1 - Publisher Copyright:
© 2024, Royan Institute (ACECR). All rights reserved.
PY - 2024/6
Y1 - 2024/6
N2 - Background: A bioactive fraction of Cinnamomum burmanii and Lagerstroemia speciosa, DLBS3233, has recently been used for type-2-diabetes treatment due to its favorable effect on insulin sensitivity. The insulin resistance leading to metabolic syndrome is closely linked to hyperandrogenemia in polycystic ovary syndrome (PCOS). This study evaluated the metabolic and reproductive efficacy and safety of DLBS3233 in insulin-resistant PCOS women. Materials and Methods: This was a 2-arm, randomized, double-blind, controlled, noninferiority clinical study over a 6-month therapy with DLBS3233 100-mg daily in comparison to metformin-XR 750 mg twice daily, involving 124 PCOS women with insulin resistance. 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: After 6 months, HOMA-IR improvement in DLBS3233-treated group (-1.03 ± 0.50) and metformin-XR (-1.19 ± 0.50) were comparable, with a between-group difference fell within the pre-set non-inferiority margin (0.16; 95% confidence interval (CI):-1.24, 1.56; P=0.3168). The HOMA-IR in both groups were significantly improved from baseline. On all secondary endpoints, both groups showed comparable effects. Markedly fewer adverse events occurred in the DLBS3233 treated group than in the Metformin-XR-treated group and most were mild clinically and had been resolved by the end of the study. Conclusion: Treatment with DLBS3233 100-mg daily in PCOS women demonstrated comparable efficacy to metformin-XR 750-mg twice daily in improving insulin resistance. However, the non-inferiority of DLBS3233 to metformin-XR remains inconclusive. DLBS3233 was more tolerable than metformin-XR (registration number: NCT01733459).
AB - Background: A bioactive fraction of Cinnamomum burmanii and Lagerstroemia speciosa, DLBS3233, has recently been used for type-2-diabetes treatment due to its favorable effect on insulin sensitivity. The insulin resistance leading to metabolic syndrome is closely linked to hyperandrogenemia in polycystic ovary syndrome (PCOS). This study evaluated the metabolic and reproductive efficacy and safety of DLBS3233 in insulin-resistant PCOS women. Materials and Methods: This was a 2-arm, randomized, double-blind, controlled, noninferiority clinical study over a 6-month therapy with DLBS3233 100-mg daily in comparison to metformin-XR 750 mg twice daily, involving 124 PCOS women with insulin resistance. 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: After 6 months, HOMA-IR improvement in DLBS3233-treated group (-1.03 ± 0.50) and metformin-XR (-1.19 ± 0.50) were comparable, with a between-group difference fell within the pre-set non-inferiority margin (0.16; 95% confidence interval (CI):-1.24, 1.56; P=0.3168). The HOMA-IR in both groups were significantly improved from baseline. On all secondary endpoints, both groups showed comparable effects. Markedly fewer adverse events occurred in the DLBS3233 treated group than in the Metformin-XR-treated group and most were mild clinically and had been resolved by the end of the study. Conclusion: Treatment with DLBS3233 100-mg daily in PCOS women demonstrated comparable efficacy to metformin-XR 750-mg twice daily in improving insulin resistance. However, the non-inferiority of DLBS3233 to metformin-XR remains inconclusive. DLBS3233 was more tolerable than metformin-XR (registration number: NCT01733459).
KW - Cinnamomum burmanii
KW - DLBS3233
KW - Insulin Resistance
KW - Lagerstroemia speciosa
KW - Polycystic Ovary Syndrome
UR - http://www.scopus.com/inward/record.url?scp=85201808635&partnerID=8YFLogxK
U2 - 10.22074/ijfs.2023.551350.1283
DO - 10.22074/ijfs.2023.551350.1283
M3 - Article
AN - SCOPUS:85201808635
SN - 2008-076X
VL - 18
SP - 35
EP - 47
JO - International Journal of Fertility and Sterility
JF - International Journal of Fertility and Sterility
ER -