Table 3.
Summary of findings table for the LNG-IUS compared with conventional medical treatment in patients with menorrhagia.
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of Participants (studies) | Quality of the evidence (GRADE) | Comments | |
|---|---|---|---|---|---|---|
| Assumed risk Medical therapy | Corresponding risk LNG-IUS | |||||
| PBAC scores | The mean PBAC score in the intervention group was 136 higher (74.43 to 197.57 higher) | 288 (3 studies) | ⊕⊕⊖⊖ low†,‡ | |||
| Rate of satisfaction | 559 per 1000 | 868 per 1000 (776 to 926) | OR 5.19 (2.73 to 9.86) | 1112 (9 studies) | ⊕⊕⊖⊖ low†,§ | |
| Treatment failures | 310 per 1000 | 75 per 1000 (43 to 133) | OR 0.18 (0.1 to 0.34) | 1116 (9 studies) | ⊕⊕⊕⊖ moderate† | |
| Rate of discontinuation | 289 per 1000 | 137 per 1000 (75 to 231) | OR 0.39 (0.2 to 0.74) | 833 (6 studies) | ⊕⊕⊕⊖ moderate† | |
| Serious adverse events | 127 per 1000 | 113 per 1000 (79 to 162) | OR 0.88 (0.59 to 1.33) | 918 (6 studies) | ⊕⊕⊖⊖ low†,¶ | |
| Quality of life | See comment | See comment | Not estimable | 646 (3 studies) | See comment | Three studies reported quality of life by different measurements |
CI – confidence interval; LNG-IUS – levonorgestrel-releasing intrauterine system; OR – odds ratio; PBAC – pictorial bleeding assessment chart. GRADE Working Group grades of evidence. High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI);
some trials did not have adequate allocation concealment, blinding not clear, or the risk of selective outcome reporting unknown;
there was substantial heterogeneity across studies;
when studies did not report rate of satisfaction, we used surrogate outcomes (major problem resolved/menstrual symptoms successfully treated/willing to continue with the treatment);
small sample size, wide confidence intervals, or both reported.