Summary of findings of comparative effects of DDAVP vs hormonal therapy in women with VDB and HMB
| . | |||||
|---|---|---|---|---|---|
| Outcomes . | Anticipated absolute effects (95% CI)* . | Relative effect (95% CI) . | Participants, n (studies) . | Certainty of the evidence (GRADE) . | |
| Risk with hormonal therapy . | Risk with DDAVP . | ||||
| Effectiveness assessed according to alleviation of symptoms; median follow-up, 30 mo | 857 per 1000 | 771 per 1000 (566-1000) | RR 0.90 (0.66-1.23) | 36 (1 observational study) | ⨁◯◯◯ VERY LOW†,‡ |
| Menstrual flow assessed according to mean PBAC score over median follow-up of 30 mo | The mean menstrual flow was 105.1 points | MD 0.9 points higher (9.89 lower to 11.69 higher) | — | 36 (1 observational study) | ⨁◯◯◯ VERY LOW† |
| Adverse events (not serious) assessed by patient self-reports at median follow-up of 30 mo | 0 per 1000 | 0 per 1000 (0-0) | RR 5.87 (0.34-101.31) | 36 (1 observational study) | ⨁◯◯◯ VERY LOW†,‡ |
| . | |||||
|---|---|---|---|---|---|
| Outcomes . | Anticipated absolute effects (95% CI)* . | Relative effect (95% CI) . | Participants, n (studies) . | Certainty of the evidence (GRADE) . | |
| Risk with hormonal therapy . | Risk with DDAVP . | ||||
| Effectiveness assessed according to alleviation of symptoms; median follow-up, 30 mo | 857 per 1000 | 771 per 1000 (566-1000) | RR 0.90 (0.66-1.23) | 36 (1 observational study) | ⨁◯◯◯ VERY LOW†,‡ |
| Menstrual flow assessed according to mean PBAC score over median follow-up of 30 mo | The mean menstrual flow was 105.1 points | MD 0.9 points higher (9.89 lower to 11.69 higher) | — | 36 (1 observational study) | ⨁◯◯◯ VERY LOW† |
| Adverse events (not serious) assessed by patient self-reports at median follow-up of 30 mo | 0 per 1000 | 0 per 1000 (0-0) | RR 5.87 (0.34-101.31) | 36 (1 observational study) | ⨁◯◯◯ VERY LOW†,‡ |
In all of the studies, we were very uncertain about the evidence for the comparative effects of the 2 treatments. The following outcomes: major bleeding, the need for surgery, the need for additional treatment, menstruation duration, and absence from school, work, and other necessary activities were not reported in any of the studies.
GRADE Working Group grades of evidence:
High certainty: we are very confident that the true effect lies close to that of the estimate of the effect
Moderate certainty: we are moderately confident in the effect estimate. The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different.
Low certainty: our confidence in the effect estimate is limited. The true effect may be substantially different from the estimate of the effect.
Very low certainty: we have very little confidence in the effect estimate. The true effect is likely to be substantially different from the estimate of effect.
MD, mean difference.
The risk in the intervention group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
Assignment to treatment was according to clinician and patient preference. No matching or control of confounding.
The CI suggests the possibility of appreciable benefit and appreciable harm. Small sample size.