2.1 Mean menstrual blood loss at end of study |
2 |
|
Mean Difference (IV, Random, 95% CI) |
Totals not selected |
2.1.1 Alkaline haematin method (mL) |
2 |
|
Mean Difference (IV, Random, 95% CI) |
Totals not selected |
2.1.2 PBAC score |
2 |
|
Mean Difference (IV, Random, 95% CI) |
Totals not selected |
2.2 Percentage reduction in blood loss at end of study (from baseline) |
3 |
|
Mean Difference (IV, Random, 95% CI) |
Subtotals only |
2.2.1 Alkaline haematin method |
2 |
170 |
Mean Difference (IV, Random, 95% CI) |
66.91 [42.61, 91.20] |
2.2.2 PBAC score |
3 |
335 |
Mean Difference (IV, Random, 95% CI) |
55.05 [27.83, 82.28] |
2.3 Menstrual blood loss by alkaline haematin ‐ descriptive results |
3 |
|
Other data |
No numeric data |
2.4 PBAC scores for menstrual blood loss ‐ descriptive results |
1 |
|
Other data |
No numeric data |
2.5 Percentage change in MBL (from baseline to end of study) |
2 |
|
Other data |
No numeric data |
2.6 Improvement in HMB |
1 |
35 |
Risk Ratio (M‐H, Fixed, 95% CI) |
11.05 [0.67, 182.23] |
2.6.1 Amenorrhoea greater than 3 months |
1 |
35 |
Risk Ratio (M‐H, Fixed, 95% CI) |
11.05 [0.67, 182.23] |
2.7 Total menstrual fluid loss ‐ descriptive results |
1 |
|
Other data |
No numeric data |
2.8 Proportion of women satisfied with treatment up to one year follow up |
3 |
141 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.28 [1.01, 1.63] |
2.9 Quality of life (good or excellent) |
2 |
170 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.20 [0.72, 2.00] |
2.10 Quality of life (unhealthy days and lost days) |
2 |
|
Mean Difference (IV, Fixed, 95% CI) |
Subtotals only |
2.10.1 Unhealthy days in past month (physical) |
2 |
170 |
Mean Difference (IV, Fixed, 95% CI) |
‐1.40 [‐2.17, ‐0.63] |
2.10.2 Unhealthy days in past month (mental) |
2 |
170 |
Mean Difference (IV, Fixed, 95% CI) |
1.44 [0.61, 2.27] |
2.10.3 Activity limitation in past month (lost days) |
2 |
170 |
Mean Difference (IV, Fixed, 95% CI) |
‐5.07 [‐5.79, ‐4.35] |
2.11 Quality of life scores (between group difference in SF36 and EQ5D over 2 years) |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Subtotals only |
2.11.1 Overall MMAS |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
13.40 [9.89, 16.91] |
2.11.2 SF36: physical functioning |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
2.70 [‐0.00, 5.40] |
2.11.3 SF36: physical role |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
5.90 [2.65, 9.15] |
2.11.4 SF 36: Emotional role |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
4.60 [1.25, 7.95] |
2.11.5 SF 36: Social functioning |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
5.10 [2.04, 8.16] |
2.11.6 SF 36: Mental health |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
1.50 [‐0.95, 3.95] |
2.11.7 SF 36: Energy and vitality |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
5.30 [2.46, 8.14] |
2.11.8 SF 36: Pain |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
7.80 [4.55, 11.05] |
2.11.9 SF 36: Perception of general health |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
2.90 [0.06, 5.74] |
2.11.10 EQ5D descriptive |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
0.01 [‐0.02, 0.04] |
2.11.11 EQ5D visual analogue scale |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
2.00 [‐0.55, 4.55] |
2.11.12 over 2 years |
0 |
|
Mean Difference (IV, Fixed, 95% CI) |
Not estimable |
2.12 Quality of life scores (between group difference in SF36 and EQ5D over 5 years) |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Subtotals only |
2.12.1 Overall MMAS |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
3.90 [‐0.60, 8.40] |
2.12.2 SF 36 Physical functioning |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
1.60 [‐2.70, 5.90] |
2.12.3 SF36: Physical role |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
2.70 [‐2.10, 7.50] |
2.12.4 SF 36: Emotional role |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
‐2.00 [‐6.80, 2.80] |
2.12.5 SF36 Social functioning |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
2.20 [‐2.50, 6.90] |
2.12.6 SF 36 Mental health |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
‐1.60 [‐5.20, 2.00] |
2.12.7 SF 36 Energy/vitality |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
2.80 [‐1.20, 6.80] |
2.12.8 SF 36 Pain |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
3.70 [‐1.30, 8.70] |
2.12.9 SF 36 General health perception |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
4.70 [0.60, 8.80] |
2.12.10 EQ‐5D Descriptive system |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
‐0.02 [‐0.06, 0.02] |
2.12.11 EQ‐5D VAS |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
0.60 [‐3.20, 4.40] |
2.13 Quality of life (menorrhagia severity score) |
1 |
|
Other data |
No numeric data |
2.14 Quality of Life (WHO QoL‐Bref TR) |
1 |
320 |
Mean Difference (IV, Fixed, 95% CI) |
‐0.18 [‐2.55, 2.19] |
2.14.1 Physical domain |
1 |
64 |
Mean Difference (IV, Fixed, 95% CI) |
‐0.38 [‐6.04, 5.28] |
2.14.2 Psychological domain |
1 |
64 |
Mean Difference (IV, Fixed, 95% CI) |
0.56 [‐5.18, 6.30] |
2.14.3 Social domain |
1 |
64 |
Mean Difference (IV, Fixed, 95% CI) |
‐0.02 [‐7.10, 7.06] |
2.14.4 Environmental |
1 |
64 |
Mean Difference (IV, Fixed, 95% CI) |
‐0.43 [‐4.93, 4.07] |
2.14.5 Environmental‐TR |
1 |
64 |
Mean Difference (IV, Fixed, 95% CI) |
‐0.32 [‐4.92, 4.28] |
2.15 Proportion of women with serious adverse events |
1 |
571 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.91 [0.63, 1.30] |
2.16 Individual adverse events |
6 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
2.16.1 Pelvic pain |
4 |
823 |
Risk Ratio (M‐H, Fixed, 95% CI) |
2.22 [0.94, 5.23] |
2.16.2 Mood swings |
1 |
31 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.08 [0.60, 1.95] |
2.16.3 Intermenstrual bleeding and menstrual irregularity |
2 |
70 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.98 [0.53, 1.82] |
2.16.4 Breast tenderness |
3 |
244 |
Risk Ratio (M‐H, Fixed, 95% CI) |
2.85 [1.29, 6.29] |
2.16.5 Nausea |
1 |
51 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.52 [0.10, 2.59] |
2.16.6 Diarrhoea |
1 |
51 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.26 [0.03, 2.17] |
2.16.7 Upper respiratory infection |
2 |
213 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.73 [0.67, 4.44] |
2.16.8 Ovarian cysts |
3 |
784 |
Risk Ratio (M‐H, Fixed, 95% CI) |
3.28 [1.31, 8.21] |
2.16.9 Headache |
4 |
823 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.20 [0.75, 1.93] |
2.16.10 Vaginitis |
1 |
162 |
Risk Ratio (M‐H, Fixed, 95% CI) |
3.08 [0.86, 10.95] |
2.16.11 Acne |
1 |
162 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.02 [0.31, 3.41] |
2.16.12 Hypertension |
1 |
162 |
Risk Ratio (M‐H, Fixed, 95% CI) |
5.12 [0.61, 42.90] |
2.16.13 Sinusitis |
1 |
162 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.71 [0.42, 6.91] |
2.16.14 Fatigue |
1 |
162 |
Risk Ratio (M‐H, Fixed, 95% CI) |
2.05 [0.39, 10.88] |
2.16.15 Urinary tract infection |
1 |
162 |
Risk Ratio (M‐H, Fixed, 95% CI) |
2.05 [0.53, 7.92] |
2.16.16 Increased weight |
1 |
162 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.82 [0.23, 2.94] |
2.16.17 Lower abdominal pain |
2 |
201 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.42 [0.13, 1.44] |
2.16.18 Any adverse events |
2 |
101 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.13 [0.85, 1.48] |
2.17 Withdrawal from treatment |
4 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
2.17.1 For adverse events |
4 |
819 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.07 [0.74, 1.54] |
2.17.2 For any reason |
1 |
571 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.49 [0.39, 0.60] |
2.18 Treatment failure (PBAC > 100 at end of treatment or requirement for alternative treatment ) |
6 |
535 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.34 [0.26, 0.44] |