Table.
GRADE Evaluation of interventions for Menorrhagia.
| Important outcomes | Anaemia, Intraoperative and postoperative complications, Menstrual blood loss, Need for re-treatment, Patient satisfaction, Postoperative recovery, Quality of life | ||||||||
| Studies (Participants) | Outcome | Comparison | Type of evidence | Quality | Consistency | Directness | Effect size | GRADE | Comment |
| What are the effects of medical treatments for menorrhagia? | |||||||||
| 12 (313) | Menstrual blood loss | NSAIDs versus placebo | 4 | 0 | 0 | –1 | 0 | Moderate | Directness point deducted for differences in regimens between trials |
| 2 (61) | Menstrual blood loss | NSAIDs versus each other | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for sparse data. Directness point deducted for small number of comparisons |
| 3 (79) | Menstrual blood loss | NSAIDs versus danazol | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for sparse data |
| 2 (48) | Menstrual blood loss | NSAIDs versus oral progestogens (luteal phase) | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for sparse data |
| 3 (at least 340) | Menstrual blood loss | Tranexamic acid versus placebo | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete presentation of results |
| 1 (187) | Quality of life | Tranexamic acid versus placebo | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for sparse data |
| 4 (164) | Menstrual blood loss | Tranexamic acid versus NSAIDs | 4 | –3 | 0 | 0 | 0 | Very low | Quality points deducted for sparse data, poor follow-up, and other methodological flaws |
| 1 (81) | Menstrual blood loss | Tranexamic acid versus etamsylate | 4 | –3 | 0 | 0 | 0 | Very low | Quality points deducted for sparse data, poor follow-up, and other methodological flaws |
| 2 (146) | Menstrual blood loss | Tranexamic acid versus oral progestogens (luteal phase) | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for sparse data and methodological flaws |
| 1 (81) | Menstrual blood loss | Etamsylate versus NSAIDs | 4 | –3 | 0 | 0 | 0 | Very low | Quality points deducted for sparse data, poor follow-up, and other methodological flaws |
| 4 (193) | Menstrual blood loss | Danazol versus placebo | 4 | –2 | 0 | –1 | 0 | Very low | Quality points deducted for sparse data and incomplete presentation of results. Directness point deducted for indirect comparisons |
| 1 (38) | Menstrual blood loss | Combined oral contraceptives versus NSAIDs | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for sparse data |
| 1 (38) | Menstrual blood loss | Combined oral contraceptives versus danazol | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for sparse data |
| 2 (151) | Menstrual blood loss | Combined oral contraceptives versus intrauterine progestogens | 4 | –1 | –1 | –1 | 0 | Very low | Quality point deducted for sparse data. Consistency point deducted for conflicting results. Directness point deducted for different doses of contraceptive |
| 2 (151) | Quality of life | Combined oral contraceptives versus intrauterine progestogens | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for sparse data and incomplete reporting of results |
| 1 (39) | Anaemia | Combined oral contraceptives versus intrauterine progestogens | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for sparse data |
| 2 (51) | Menstrual blood loss | Progestogens (oral) in the luteal phase versus danazol | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for sparse data |
| 1 (162) | Menstrual blood loss | Intrauterine progestogens versus oral progestogen (luteal phase) | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for sparse data |
| 2 (<74) | Menstrual blood loss | Intrauterine progestogens versus oral progestogen (long cycle) | 4 | –3 | 0 | –1 | 0 | Very low | Quality points deducted for sparse data, incomplete reporting of results, and baseline differences in severity of menorrhagia. Directness point deducted for analysis of indirect comparisons |
| 1 (44) | Patient satisfaction | Intrauterine progestogens versus oral progestogen (long cycle) | 4 | –2 | 0 | –1 | 0 | Very low | Quality points deducted for sparse data and incomplete reporting of results. Directness point deducted for unclear clinical importance of outcome measure |
| 2 (<81) | Menstrual blood loss | Intrauterine progestogens versus NSAIDs | 4 | –3 | 0 | –2 | 0 | Very low | Quality points deducted for sparse data, incomplete reporting of results, and baseline differences in severity of menorrhagia. Directness points deducted for multiple drugs in comparison and analysis of indirect comparisons |
| 1 (30) | Menstrual blood loss | Intrauterine progestogens versus danazol | 4 | –3 | 0 | –2 | 0 | Very low | Quality points deducted for sparse data, incomplete reporting of results, and baseline differences in severity of menorrhagia. Directness points deducted for multiple drugs in comparison and analysis of indirect comparisons |
| at least 5 (at least 317) | Menstrual blood loss | Intrauterine progestogens versus endometrial destruction (ablation) | 4 | –1 | –1 | –1 | 0 | Very low | Quality point deducted for incomplete reporting of results. Consistency point deducted for conflicting results. Directness point deducted for study involving mainly women <40 years |
| 3 at least (310 at most) | Need for re-treatment | Intrauterine progestogens versus endometrial destruction (ablation) | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 4 at most (at least 274) | Patient satisfaction | Intrauterine progestogens versus endometrial destruction (ablation) | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 3 (210 at most) | Quality of life | Intrauterine progestogens versus endometrial destruction (ablation) | 4 | –1 | –1 | 0 | 0 | Low | Quality point deducted for incomplete reporting of results. Consistency point deducted for conflicting results |
| 1 (33) | Anaemia | Intrauterine progestogens versus endometrial destruction (ablation) | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for for sparse data and incomplete reporting of results |
| 1 (232) | Patient satisfaction | Intrauterine progestogens versus hysterectomy | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for incomplete reporting. Directness point deducted for high switch rates to surgery |
| 1 (232) | Quality of life | Intrauterine progestogens versus hysterectomy | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for incomplete reporting. Directness point deducted for high switch rates to surgery |
| 1 (228) | Anaemia | Intrauterine progestogens versus hysterectomy | 4 | 0 | 0 | –1 | 0 | Moderate | Directness point deducted for high switch rates to surgery |
| What are the effects of surgical treatments for menorrhagia? | |||||||||
| 3 (440) | Menstrual blood loss | Hysterectomy versus endometrial destruction | 4 | 0 | 0 | 0 | 0 | High | |
| 1 (708) | Need for re-treatment | Hysterectomy versus endometrial destruction | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for wide confidence intervals in largest RCT contributing results regarding this outcome |
| at least 5 (at least 836) | Patient satisfaction | Hysterectomy versus endometrial destruction | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 2 (394) | Quality of life | Hysterectomy versus endometrial destruction | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for incomplete reporting. Directness point deducted for no direct comparison between groups |
| at least 7 (at least 1066) | Postoperative recovery | Hysterectomy versus endometrial destruction | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| at least 2 (at least 708) | Intraoperative and postoperative complications | Hysterectomy versus endometrial destruction | 4 | –1 | –1 | 0 | 0 | Low | Quality point deducted for incomplete reporting of results. Directness point deducted for contradictory results |
| 3 (733) | Menstrual blood loss | Subtotal hysterectomy versus total hysterectomy | 4 | 0 | 0 | –1 | 0 | Moderate | Directness point deducted for analysis not limited to women with menorrhagia |
| 2 (411) | Intraoperative and postoperative complications | Subtotal hysterectomy versus total hysterectomy | 4 | 0 | 0 | –1 | 0 | Moderate | Directness point deducted for analysis not limited to women with menorrhagia |
| 23 (1728) | Postoperative recovery | Abdominal hysterectomy versus vaginal or laparoscopic hysterectomy | 4 | 0 | 0 | –1 | 0 | Moderate | Directness point deducted for analysis not limited to women with menorrhagia |
| 1 (187) | Menstrual blood loss | Endometrial destruction (resection or ablation) versus oral drugs | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for sparse data. Directness point deducted for range of drugs in comparison |
| 4 (2085) | Menstrual blood loss | First-generation versus second-generation techniques | 4 | 0 | 0 | 0 | 0 | High | |
| 7 (1028) | Need for re-treatment | First-generation versus second-generation techniques | 4 | 0 | 0 | 0 | 0 | High | |
| 11 (1690) | Patient satisfaction | First-generation versus second-generation techniques | 4 | 0 | 0 | 0 | 0 | High | |
| 8 (1885) | Intraoperative and postoperative complications | First-generation versus second-generation techniques | 4 | 0 | –1 | 0 | 0 | Moderate | Consistency point deducted for conflicting results |
| 4 (391) | Menstrual blood loss | First-generation techniques versus each other | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 3 (438) | Need for re-treatment | First-generation techniques versus each other | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 3 (462) | Patient satisfaction | First-generation techniques versus each other | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting |
| 2 (486) | Intraoperative and postoperative complications | First-generation techniques versus each other | 4 | 0 | –1 | 0 | 0 | Moderate | Consistency point deducted for conflicting results |
| 4 (517) | Menstrual blood loss | Second-generation techniques versus each other | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 2 (241) | Need for re-treatment | Second-generation techniques versus each other | 4 | –1 | –1 | 0 | 0 | Low | Quality point deducted for incomplete reporting of results. Consistency point deducted for conflicting results |
| 2 (286) | Patient satisfaction | Second-generation techniques versus each other | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 1 (81) | Quality of life | Second-generation techniques versus each other | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for sparse data |
| 3 (367) | Intraoperative and postoperative complications | Second-generation techniques versus each other | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| What are the effects of endometrial thinning before endometrial destruction in treating menorrhagia? | |||||||||
| 8 (618) | Menstrual blood loss | Gonadorelin analogues (GnRHa) versus placebo or no treatment | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for no objective measure of menorrhagia |
| 3 (340) | Menstrual blood loss | GnRHa versus danazol | 4 | 0 | 0 | 0 | 0 | High | |
| 3 (202) | Menstrual blood loss | Danazol versus placebo | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for sparse data and incomplete reporting of results |
| 2 (70) | Menstrual blood loss | Oral progestogens versus no treatment | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for sparse data and incomplete reporting |
We initially allocate 4 points to evidence from RCTs, and 2 points to evidence from observational studies. To attain the final GRADE score for a given comparison, points are deducted or added from this initial score based on preset criteria relating to the categories of quality, directness, consistency, and effect size. Quality: based on issues affecting methodological rigour (e.g., incomplete reporting of results, quasi-randomisation, sparse data [<200 people in the analysis]). Consistency: based on similarity of results across studies. Directness: based on generalisability of population or outcomes. Effect size: based on magnitude of effect as measured by statistics such as relative risk, odds ratio, or hazard ratio.