Table.
GRADE evaluation of interventions for menopausal symptoms
| Important outcomes | Vasomotor symptoms; urogenital symptoms; psychological, cognitive, and sleep symptoms; quality of life; adverse effects | ||||||||
| Number of studies (participants) | Outcome | Comparison | Type of evidence | Quality | Consistency | Directness | Effect size | GRADE | Comment |
| What are the effects of medical treatments for menopausal symptoms? | |||||||||
| 3 (1253) | Vasomotor symptoms | Tibolone v placebo | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 1 (38) | Urogenital symptoms | Tibolone v placebo | 4 | –3 | 0 | 0 | 0 | Very low | Quality points deducted for sparse data, no reporting of pre-crossover results, and lack of washout period |
| 1 (3148) | Adverse effects (breast cancer recurrence) | Tibolone v placebo | 4 | 0 | 0 | 0 | 0 | High | |
| 2 (672) | Vasomotor symptoms | Tibolone v oestrogens plus progestogen | 4 | –1 | –1 | 0 | 0 | Low | Quality point deducted for incomplete reporting of results. Consistency point deducted for conflicting results |
| 2 (487) | Urogenital symptoms | Tibolone v oestrogens plus progestogen | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 9 (at least 5367) | Vasomotor symptoms | Oestrogens v placebo | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| At least 7 (at least 1566) | Urogenital symptoms | Oestrogens v placebo | 4 | 0 | 0 | 0 | 0 | High | |
| 5 (at least 3430) | Psychological, cognitive, and sleep symptoms | Oestrogens v placebo | 4 | –3 | 0 | 0 | 0 | Very low | Quality points deducted for incomplete reporting of results, inclusion of cohort studies, and weak methods |
| 2 (324) | Quality of life | Oestrogens v placebo | 4 | 0 | 0 | 0 | 0 | High | |
| at least 31 (at least 41,113) | Adverse effects | Oestrogens v placebo | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for inclusion of combined HRT preparations in the analysis |
| 4 (615) | Urogenital symptoms | Different oestrogen preparations versus each other | 4 | 0 | –1 | –1 | 0 | Low | Consistency point deducted for conflicting results. Directness point deducted for small number of events in some analyses |
| 1 (43) | Vasomotor symptoms | Oestrogens versus progestins | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for sparse data and incomplete reporting of results |
| At least 4 (20,328) | Vasomotor symptoms | Oestrogens plus progestogens v placebo | 4 | –1 | 0 | 0 | +1 | High | Quality point deducted for incomplete reporting of results. Effect size point added for OR greater than 2 |
| 3 (16,834) | Urogenital symptoms | Oestrogens plus progestogens v placebo | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 2 (20,952) | Psychological, cognitive, and sleep symptoms | Oestrogens plus progestogens v placebo | 4 | 0 | –1 | –1 | 0 | Low | Consistency point deducted for inconsistent results depending on outcome measure used. Directness point deducted for large RCT in atypical age group |
| 2 (16,882) | Quality of life | Oestrogens plus progestogens v placebo | 4 | 0 | –1 | –1 | 0 | Low | Consistency point deducted for inconsistent results depending on outcome measure used. Directness point deducted for RCT in atypical age group |
| at least 28 (at least 39,769) | Adverse effects | Oestrogens plus progestogens v placebo | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for single agents included in analysis |
| 1 (74) | Quality of life | Different preparations of oestrogens plus progestogens versus each other | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for sparse data and incomplete reporting of results |
| 5 (327) | Vasomotor symptoms | Progestogens v placebo | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for post-crossover analysis and low follow-up in one RCT |
| 11 (1456) | Vasomotor symptoms | Antidepressants v placebo | 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 inclusion of a co-intervention |
| 4 (446) | Vasomotor symptoms | Clonidine v placebo | 4 | –1 | 0 | –2 | 0 | Very low | Quality point deducted for short follow-up. Directness points deducted for co-intervention, and results sensitive to analysis undertaken |
| 6 (1115) | Urogenital symptoms | Testosterone plus oestrogen-containing HRT v oestrogen-containing HRT alone | 4 | –1 | –1 | 0 | 0 | Low | Quality point deducted for weak methods. Consistency point deducted for different results for different outcomes |
| 1 (40) | Psychological, cognitive, and sleep symptoms | Testosterone plus oestrogen-containing HRT v oestrogen-containing HRT alone | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for sparse data and incomplete reporting of results |
| What are the effects of non-prescribed treatments for menopausal symptoms? | |||||||||
| 40 (at least 2730) | Vasomotor symptoms | Phyto-oestrogens v placebo | 4 | –3 | –1 | –1 | 0 | Very low | Quality points deducted for weak methods, incomplete reporting of results, unclear comparisons, and lack of standardisation of interventions. Consistency point deducted for conflicting results. Directness point deducted for lack of standard dosing |
| 2 (154) | Urogenital symptoms | Phyto-oestrogens v placebo | 4 | –2 | 0 | –2 | 0 | Very low | Quality points deducted for sparse data and crossover design. Directness points deducted for use of non-clinical assessment and lack of standardised dosing |
| 2 (172) | Psychological, cognitive, and sleep symptoms | Phyto-oestrogens v placebo | 4 | –2 | 0 | –1 | 0 | Very low | Quality points deducted for sparse data and incomplete reporting of results. Directness point deducted for lack of standardised dosing |
| 1 (376) | Adverse effects | Phyto-oestrogens v placebo | 4 | 0 | 0 | –2 | 0 | Low | Directness points deducted for non-standard dose and small number of events |
| 1 (79) | Vasomotor symptoms | Phyto-oestrogens v oestrogen | 4 | –2 | 0 | –1 | 0 | Very low | Quality points deducted for sparse data and incomplete reporting of results. Directness point deducted for lack of standard preparations and dosing |
| 1 (136) | Vasomotor symptoms | Phyto-oestrogens v oestrogen plus progestogen | 4 | –2 | 0 | –1 | 0 | Very low | Quality points deducted for sparse data and incomplete reporting of results. Directness point deducted for lack of standard preparations and dosing |
Type of evidence: 4 = RCT Consistency: similarity of results across studies. Directness: generalisability of population or outcomes. Effect size: based on relative risk or odds ratio.