3.1 Mean menstrual blood loss at end of study |
2 |
|
Mean Difference (IV, Fixed, 95% CI) |
Totals not selected |
3.1.1 Mean PBAC score at 12 months |
2 |
|
Mean Difference (IV, Fixed, 95% CI) |
Totals not selected |
3.2 Improvement in HMB |
8 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
3.2.1 Amenorrhoea within 12 months |
8 |
431 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.21 [0.85, 1.72] |
3.2.2 Hypomenorrhoea within 12 months |
4 |
200 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.98 [0.73, 1.33] |
3.2.3 Eumenorrhoea within 12 months |
3 |
160 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.55 [0.30, 1.00] |
3.2.4 Improvement in bleeding pattern within 12 months |
3 |
172 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.20 [1.02, 1.41] |
3.3 PBAC score after treatment (descriptive results) |
6 |
|
Other data |
No numeric data |
3.4 Proportion of women satisfied with treatment |
7 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
3.4.1 Within one year follow‐up |
5 |
317 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.95 [0.85, 1.07] |
3.4.2 At 2 years follow up |
2 |
319 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.89 [0.80, 1.00] |
3.4.3 At 5 years follow‐up |
1 |
52 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.25 [1.01, 1.53] |
3.5 Quality of life (SF36) within 12 months follow‐up |
2 |
|
Mean Difference (IV, Fixed, 95% CI) |
Subtotals only |
3.5.1 Physical functioning |
1 |
33 |
Mean Difference (IV, Fixed, 95% CI) |
‐3.10 [‐11.10, 4.90] |
3.5.2 Role limitation (physical) |
1 |
33 |
Mean Difference (IV, Fixed, 95% CI) |
‐2.50 [‐9.32, 4.32] |
3.5.3 Bodily pain |
1 |
33 |
Mean Difference (IV, Fixed, 95% CI) |
0.40 [‐6.43, 7.23] |
3.5.4 General health |
1 |
33 |
Mean Difference (IV, Fixed, 95% CI) |
‐14.40 [‐22.63, ‐6.17] |
3.5.5 Vitality |
1 |
33 |
Mean Difference (IV, Fixed, 95% CI) |
‐5.20 [‐11.46, 1.06] |
3.5.6 Social functioning |
1 |
33 |
Mean Difference (IV, Fixed, 95% CI) |
‐6.70 [‐12.82, ‐0.58] |
3.5.7 Role limitation (emotional) |
1 |
33 |
Mean Difference (IV, Fixed, 95% CI) |
‐10.10 [‐17.03, ‐3.17] |
3.5.8 Mental health |
1 |
33 |
Mean Difference (IV, Fixed, 95% CI) |
‐11.20 [‐17.08, ‐5.32] |
3.5.9 Overall SF36 score |
1 |
79 |
Mean Difference (IV, Fixed, 95% CI) |
2.60 [‐5.98, 11.18] |
3.6 Quality of life (QOL) scores at 12 months (SF36) ‐ descriptive results |
2 |
|
Other data |
No numeric data |
3.7 Quality of life within 5 years follow‐up (proportion with improved wellbeing) |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
3.7.1 Physical |
1 |
52 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.46 [1.11, 1.92] |
3.7.2 Emotional |
1 |
52 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.59 [1.09, 2.30] |
3.8 Quality of life within 5 years ‐ psychological wellbeing (continuous) |
1 |
28 |
Mean Difference (IV, Fixed, 95% CI) |
10.30 [‐6.18, 26.78] |
3.9 Total proportion of women with adverse events |
3 |
201 |
Risk Ratio (M‐H, Fixed, 95% CI) |
2.06 [1.44, 2.94] |
3.10 Individual adverse events |
6 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
3.10.1 Endometritis |
2 |
120 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.70 [0.21, 2.35] |
3.10.2 Pelvic pain or PID |
3 |
180 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.18 [0.46, 3.01] |
3.10.3 Myometritis |
1 |
41 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.38 [0.02, 8.89] |
3.10.4 Adenomyosis |
1 |
41 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.38 [0.02, 8.89] |
3.10.5 Abnormal PAP |
1 |
41 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.16 [0.01, 2.99] |
3.10.6 Oedema |
1 |
41 |
Risk Ratio (M‐H, Fixed, 95% CI) |
3.45 [0.15, 80.03] |
3.10.7 Breast pain |
3 |
201 |
Risk Ratio (M‐H, Fixed, 95% CI) |
7.57 [1.78, 32.23] |
3.10.8 Weight gain |
2 |
141 |
Risk Ratio (M‐H, Fixed, 95% CI) |
2.60 [1.16, 5.84] |
3.10.9 Mood swings |
2 |
132 |
Risk Ratio (M‐H, Fixed, 95% CI) |
2.33 [0.36, 15.32] |
3.10.10 Bloating |
2 |
141 |
Risk Ratio (M‐H, Fixed, 95% CI) |
4.57 [1.63, 12.82] |
3.10.11 Acne or greasy skin |
3 |
201 |
Risk Ratio (M‐H, Fixed, 95% CI) |
8.40 [1.57, 44.76] |
3.10.12 Nausea |
1 |
72 |
Risk Ratio (M‐H, Fixed, 95% CI) |
9.00 [0.50, 161.29] |
3.10.13 Headache |
3 |
201 |
Risk Ratio (M‐H, Fixed, 95% CI) |
2.04 [0.64, 6.50] |
3.10.14 Leg pain |
2 |
141 |
Risk Ratio (M‐H, Fixed, 95% CI) |
3.04 [0.32, 28.57] |
3.10.15 Dysmenorrhoea |
2 |
151 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.25 [0.03, 2.17] |
3.10.16 Lower abdominal pain |
4 |
242 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.65 [0.55, 4.97] |
3.10.17 Actinomycoses |
1 |
79 |
Risk Ratio (M‐H, Fixed, 95% CI) |
2.93 [0.12, 69.74] |
3.10.18 Decreased libido |
1 |
69 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.03 [0.15, 6.90] |
3.10.19 Hair loss |
1 |
69 |
Risk Ratio (M‐H, Fixed, 95% CI) |
5.14 [0.26, 103.35] |
3.10.20 Anxiety or depression |
1 |
69 |
Risk Ratio (M‐H, Fixed, 95% CI) |
2.06 [0.20, 21.67] |
3.10.21 Hypertension |
1 |
69 |
Risk Ratio (M‐H, Fixed, 95% CI) |
3.09 [0.13, 73.21] |
3.10.22 Endometriosis |
1 |
41 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.38 [0.02, 8.89] |
3.10.23 Bleeding or spotting |
4 |
241 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.39 [0.74, 2.58] |
3.10.24 Hematometra |
1 |
60 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.33 [0.01, 7.87] |
3.10.25 Vaginitis |
1 |
60 |
Risk Ratio (M‐H, Fixed, 95% CI) |
2.00 [0.40, 10.11] |
3.10.26 Genital ulceration |
1 |
60 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.33 [0.01, 7.87] |
3.11 Treatment failure: discontinuation of initial treatment, adjunct medical therapy or persistent HMB) |
5 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
3.11.1 at 12 months |
5 |
320 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.78 [1.09, 2.90] |
3.11.2 at 24 months |
3 |
199 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.51 [0.94, 2.42] |
3.11.3 at 36 months |
1 |
60 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.50 [0.61, 3.69] |
3.12 Treatment failure: requirement for surgery for the treatment of HMB (ablation or hysterectomy) |
4 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
3.12.1 at 12 months |
3 |
174 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.47 [0.67, 3.23] |
3.12.2 at 24 months |
2 |
139 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.77 [0.31, 1.91] |
3.12.3 at 36 months |
1 |
60 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.11 [0.01, 1.98] |
3.13 Treatment failure: requirement for hysterectomy |
6 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
3.13.1 at 12 months |
3 |
400 |
Risk Ratio (M‐H, Fixed, 95% CI) |
2.56 [1.48, 4.42] |
3.13.2 at 24 months |
2 |
142 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.14 [0.50, 2.60] |
3.13.3 at 5 years |
1 |
58 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.16 [0.02, 1.21] |
3.14 Total cost per woman |
1 |
|
Other data |
No numeric data |