Myoinositol vs. Metformin in Women with Polycystic Ovary Syndrome: A Randomized Controlled Clinical Trial
Abstract
:1. Introduction
2. Materials and Methods
2.1. Outcomes
2.2. Blood Samples and Assays
2.3. Menstrual Cycle, Ovarian Ultrasound
2.4. FG Score
2.5. Adverse Effects and Pregnancies
2.6. Questionnaires
2.7. Statistics
2.8. Ethical Approval
3. Results
3.1. Metabolic Changes
3.2. Anthropometric Values
3.3. Cycle Length
3.4. FG Score
3.5. Gonadotrophins, Sex Hormones, and AMH
3.6. Adverse Effects, Non-Completion, and Pregnancy
3.7. Quality of Life
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Intervention | Myoinositol (n = 16) | Metformin (n = 12) | |||||
---|---|---|---|---|---|---|---|
Time | Baseline | 6 Months | Δ p | Baseline | 6 Months | Δ p | Δ vs. Δ p |
HOMA-IR (pmol mmol L−2) | 28.5 (19.6;45.6) | 33.7 (27.1;49.6) | 0.31 | 30.9 (24.9;32.4) | 18.8 (14.3;29.6) | 0.11 | 0.09 |
Insulin (pmol/L) | 126 (85;190) | 119 (78;219) | 0.38 | 117 (112;143) | 80 (65;121) | 0.21 | 0.13 |
Glucose (mmol/L) | 5.2 (5.0;5.4) | 5.4 (5.3;5.7) | 0.00 | 5.3 (5.1;5.7) | 5.2 (4.8;5.3) | 0.04 | 0.00 |
HbA1c (mmol/mol) | 32.0 (30.0;36.0) | 33.0 (31.0;34.0) | 0.18 | 33.5 (32.0;35) | 32.0 (31.5;33.5) | 0.47 | 0.12 |
Triglycerides (mmol/L) | 1.2 (1.0;1.4) | 1.3 (1.0;1.6) | 0.09 | 1.0 (0.9;1.2) | 1.0 (0.8;1.5) | 0.81 | 0.25 |
HDL (mmol/L) | 1.2 (1.0;1.3) | 1.2 (1.1;1.3) | 0.92 | 1.3 (1.2;1.4) | 1.4 (1.2;1.6) | 0.04 | 0.07 |
LDL (mmol/L) | 2.9 (2.4;3.2) | 2.9 (2.5;3.1) | 0.44 | 3.1 (2.6;3.3) | 2.9 (2.6;3.3) | 0.93 | 0.64 |
Cholesterol (mmol/L) | 4.6 (4.1;4.9) | 4.7 (4.1;5.1) | 0.46 | 4.8 (4.3;5.2) | 4.8 (4.2;5.3) | 0.69 | 0.42 |
Age (years) | 25 (22;34) | - | 27 (24;33) | - | - | ||
Weight (kg) | 96.7 (84.5;107.6) | 94.4 (84.9;107.0) | 0.98 | 99.8 (86.4;108.9) | 93.7(81.7;106.8) | 0.00 | 0.02 |
BMI (kg/m2) | 34.2 (30.9;37.2) | 34.5 (29.9;36.8) | 0.96 | 35.2 (31.0;39.8) | 32.8 (29.8;38.5) | 0.00 | 0.02 |
Waist (cm) | 103 (93;108) | 100 (93;104) | 0.31 | 99 (92;106) | 100 (90;105) | 0.41 | 0.62 |
Hip (cm) | 122 (108;125) | 119 (110;125) | 0.84 | 123 (114;129) | 119 (110;128) | 0.06 | 0.11 |
Cycle length (days) | 45 (35;175) | 36 (32;60) | 0.03 | 47 (35;82) | 34 (28;37) | 0.03 | 0.92 |
FG score | 6 (0;17) | 8 (3;12) | 0.79 | 6 (2;12) | 6 (2;12) | 0.40 | 0.49 |
SHBG (nmol/L) | 30 (18;46) | 30 (14;37) | 0.78 | 35 (27;57) | 38 (29;44) | 0.88 | 0.92 |
Free testosterone (nmol/L) | 0.032 (0.025;0.038) | 0.028 (0.025;0.045) | 0.89 | 0.027 (0.019;0.035) | 0.021 (0.017;0.028) | 0.06 | 0.70 |
Total testosterone (nmol/L) | 1.5 (1.1;1.7) | 1.2 (1.0;1.8) | 0.39 | 1.5 (1.3;1.8) | 1.2 (0.9;1.7) | 0.10 | 0.28 |
AMH (pmol/L) | 37.7 (25.1;51.8) | 36.0 (31.6;44.4) | 0.96 | 38.9 (33.9;78.4) | 38.3 (25.8;57.0) | 0.46 | 0.74 |
FSH (IU/L) | 5.8 (4.6;7.0) | 5.4 (4.9;7.0) | 0.67 | 5.4 (3.3;6.0) | 5.7 (4.3;6.6) | 0.26 | 0.26 |
LH (IU/L) | 8.9 (6.2;11.8) | 12.0 (9.4;16.0) | 0.15 | 12.5 (8.2;16.0) | 10.4 (5.0;13.5) | 0.16 | 0.04 |
Estradiol (nmol/L) | 0.19 (0.14;0.41) | 0.18 (0.15;0.25) | 0.16 | 0.26 (0.17;0.70) | 0.19 (0.13;0.29) | 0.08 | 0.34 |
Intervention | Myoinositol (n = 14) | Metformin (n = 12) | |||||
---|---|---|---|---|---|---|---|
Time | Baseline | 6 Months | Δ p | Baseline | 6 Months | Δ p | Δ vs. Δ p |
SF-36 | |||||||
Physical functioning | 90 (75;95) | 90 (80;95) | 0.14 | 90 (85;95) | 95 (85;100) | 0.16 | 0.78 |
RPH | 88 (50;100) | 100 (50;100) | 0.57 | 100 (75;100) | 100 (50;100) | 0.29 | 0.25 |
REP | 100 (0;100) | 100 (33;100) | 0.58 | 100 (50;100) | 100 (17;100) | 0.28 | 0.29 |
Energy/fatigue | 50 (35;60) | 53 (30:65) | 0.59 | 40 (25;65) | 48 (30;73) | 0.61 | 0.22 |
Emotional well-being | 74 (60;84) | 80 (52;84) | 0.57 | 72 (58;84) | 70 (52:84) | 0.32 | 0.31 |
Social functioning | 59 (45;80) | 69 (38;80) | 0.92 | 53 (36;73) | 64 (40;79) | 0.43 | 0.55 |
Pain | 58 (45;90) | 68 (55;90) | 0.61 | 74 (68;95) | 69 (68;90) | 0.52 | 0.50 |
General health | 65 (50;80) | 63 (35;75) | 0.25 | 58 (38;80) | 68 (38;78) | 0.42 | 0.17 |
MDI | |||||||
Score | 11 (9;20) | 10 (7;22) | 0.92 | 13 (5;29) | 15 (6;27) | 0.87 | 1.0 |
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Ravn, P.; Gram, F.; Andersen, M.S.; Glintborg, D. Myoinositol vs. Metformin in Women with Polycystic Ovary Syndrome: A Randomized Controlled Clinical Trial. Metabolites 2022, 12, 1183. https://doi.org/10.3390/metabo12121183
Ravn P, Gram F, Andersen MS, Glintborg D. Myoinositol vs. Metformin in Women with Polycystic Ovary Syndrome: A Randomized Controlled Clinical Trial. Metabolites. 2022; 12(12):1183. https://doi.org/10.3390/metabo12121183
Chicago/Turabian StyleRavn, Pernille, Freja Gram, Marianne S. Andersen, and Dorte Glintborg. 2022. "Myoinositol vs. Metformin in Women with Polycystic Ovary Syndrome: A Randomized Controlled Clinical Trial" Metabolites 12, no. 12: 1183. https://doi.org/10.3390/metabo12121183