Table 2.
Primary and secondary outcomes.
| Outcome | EA (n=53) | SA (n=53) | Difference between groups Z/t | P | ||
|---|---|---|---|---|---|---|
| Mean change from baseline (95%CI) | P | Mean change from baseline (95%CI) | P | |||
| Primary Outcome | ||||||
| BMI | ||||||
| Intervention phase | ||||||
| Week 12 | -2.46 (-2.67, -2.18) | -0.95 (-1.14, -0.75) | <.001 | |||
| Follow-up phase | ||||||
| Week 12 | -3.49 (-3.85, -3.13) | -1.73 (-2.01, -1.46) | <0.001 | |||
| Secondary Outcomes | ||||||
| WHR | ||||||
| Week 12 | -0.04 (-0.06, -0.04) | -0.02 (-0.02, -0.01) | <0.001* | |||
| BFM | ||||||
| Week 12 | -4.56 (-5.10, -4.02) | -1.64 (-1.94, -1.33) | <0.001* | |||
| SMM | ||||||
| Week 12 | 0.52 (-0.06, 1.10) | -0.01 (-0.60, 0.5) | 0.205 | |||
| BMR | ||||||
| Week 12 | 29.26 (4.63, 53.9) | -6.68 (-34.78, 21.42 | 0.056 | |||
| Glucose Metabolism Indicators | ||||||
| FPG (mmol/L) | ||||||
| Week 12 | -0.30 (-0.41, -0.18) | <0.001 | -0.10 (-0.19, -0.00) | 0.028 | -1.80 | 0.008* |
| 2hPG (mmol/L) | ||||||
| Week 12 | -0.04 (-0.22, 0.14) | 0.372 | -0.10 (-0.26, 0.19) | 0.758 | -0.91 | 0.977 |
| FINS (pmol/L) | ||||||
| Week 12 | -46.03 (-61.27, -30.79) | <0.001 | -4.59 (-9.20, 0.02) | 0.019 | -2.10 | <0.001* |
| HOMA-IR | ||||||
| Week 12 | -12.70 (-18.58, -6.81) | <0.001 | -1.55 (-3.40, -0.06) | 0.014 | -1.89 | <0.001* |
| Lipid Metabolism Indicators | ||||||
| TC (mmol/L) | ||||||
| Week 12 | -0.30 (-0.40, -0.20) | <0.001 | -0.07 (-0.27, 0.13) | 0.491 | -2.10 | 0.034 |
| TG (mmol/L) | ||||||
| Week 12 | -0.44 (-0.64,-0.25) | <0.001 | -0.01 (-0.10, 0.07) | 0.735 | -0.89 | <0.001* |
| LDL-C (mmol/L) | ||||||
| Week 12 | -0.30 (-0.43, -0.16) | <0.001 | -0.07 (-0.18, 0.04) | 0.235 | -2.04 | 0.011* |
| HDL-C (mmol/L) | ||||||
| Week 12 | -0.00 (-0.04, 0.04) | 0.802 | -0.02 (-0.09, -0.04) | 0.846 | -1.66 | 0.529 |
| Sex Hormone Index | ||||||
| FSH (mIU/L) | ||||||
| Week 12 | 0.48 (0.09, 0.86) | 0.038 | 0.08 (-0.33, 0.49) | 0.015 | -1.01 | 0.160 |
| LH (mIU/L) | ||||||
| Week 12 | -0.64 (-1.61, 0.32) | 0.185 | -2.53 (-6.92, 1.85) | 0.609 | -0.66 | 0.393 |
| PRL (mIU/L) | ||||||
| Week 12 | -109.10 (-154.60, -62.63) | <0.001 | –40.27 (-79.86, -0.68) | 0.066 | -1.99 | 0.024 |
| T (nmol/L) | ||||||
| Week 12 | -0.17 (-0.26, -0.07) | <0.001 | -0.06 (-0.16, 0.04) | 0.098 | -0.41 | 0.117 |
| E2 (nmol/L) | ||||||
| Week 12 | 12.99 (-17.45, 43.43) | 0.256 | -46.14 (-95.60, 3.32) | 0.170 | -2.69 | 0.042 |
| Endometrial Thickness and Ovarian Volume | ||||||
| Endometrial Thickness (mm) | ||||||
| Week 12 | 1.83 (1.31, 2.35) | <0.001 | 2.10 (1.57, 2.62) | <0.001 | -0.06 | 0.471 |
| OV (ml) | ||||||
| Week 12 | -4.05 (-4.49, -3.62) | <0.001 | -3.89 (-4.22, -3.55) | <0.001 | -0.50 | 0.544 |
| Days of Menstrual Cycle (day) | ||||||
| Week 12 | -6.50 (-9.13, -3.87) | <0.001 | -7.39 (-10.86, -3.91) | <0.001 | -0.93 | 0.353 |
| PCOSQ (score) | ||||||
| Intervention phase | ||||||
| Week 4 | 15.43 (11.82, 19.05) | 9.30 (6.24, 12.37) | 2.59 | 0.011 | ||
| Week 8 | 20.66 (16.05, 25.28) | 11.98 (8.54, 15.42) | 3.03 | 0.03 | ||
| Week 12 | 26.70 (22.03, 31.37) | 16.19 (12.15, 20.23) | 3.42 | <0.001 | ||
| Follow-up phase | ||||||
| Week 16 | 29.81 (25.20, 34.43) | 19.34 (15.26, 23.72) | 3.41 | <0.001 | ||
| Week 20 | 33.58 (28.68, 38.49) | 21.09 (13.47, 25.72) | 3.72 | <0.001 | ||
| Week 24 | 36.58 (31.41, 41.76) | 22.11 (17.41, 26.81) | 4.15 | <0.001 | ||
* indicates that after Bonferroni correction, the P-values for intergroup comparisons remain statistically significant (P < 0.05/number of comparisons; see the Methods section for details on the exact number of comparisons).