ArticleCureus2024
A Phase III, Double-Blind, Randomized, Multicenter, Clinical Trial to Evaluate the Efficacy and Safety of a Fixed-Dose Combination of Metformin Hydrochloride and Myo-Inositol Compared to Metformin in Patients With Polycystic Ovary Syndrome.
Article in Cureus, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
- Therapeutic potential of natural products in polycystic ovary syndrome.Molecular biology reports · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background Polycystic ovary syndrome (PCOS) poses a significant health concern among reproductive-aged women and is characterized by ovarian dysfunction, hyperandrogenism, and insulin resistance. This study aims to assess the efficacy and safety of metformin and myo-inositol combination therapy compared to metformin monotherapy in patients with PCOS. Materials and methods This was a phase III, double-blind, randomized controlled clinical trial. A total of 196 patients with PCOS were randomized in a 1:1 ratio to receive either a fixed-dose combination of metformin hydrochloride 500 mg and myo-inositol 600 mg (Met-Myo) or metformin 500 mg alone (Met) twice daily for 24 weeks. The primary study endpoints were improvement in insulin resistance (homeostatic model assessment of insulin resistance, HOMA-IR) at week 24 and improvement in menstrual cycle disturbances at 12 and 24 weeks. Results The Met-Myo combination demonstrated a significantly superior response with 63 (75%) patients showing improvement in HOMA-IR compared to 54 (60.67%) in the Met group (p = 0.049) at week 24. The improvement in the number of patients with heavy menstrual blood flow (>80 mL) was significantly greater in the Met-Myo group (four patients, 4.76%) compared to the Met group (six patients, 6.74%) at week 24 (p = 0.029). Improvement in the percentage of patients with normal menstrual frequency and infrequent menstruation from baseline to week 24 was significantly greater in the Met-Myo group compared to the Met group (p = 0.049). Safety assessments revealed a low and comparable incidence of mild adverse events. Conclusion Metformin-myo-inositol combination therapy is superior to metformin monotherapy in addressing menstrual irregularities and improving insulin resistance in PCOS patients, thereby providing a promising avenue for optimizing the management of PCOS.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.