Summary of findings of comparative effects of DDAVP vs TxA in women with VWD and HMB
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|---|---|---|---|---|---|---|
| Outcome . | Anticipated absolute effects (95% CI)* . | Relative effect (95% CI) . | Participants, n (studies) . | Certainty of the evidence (GRADE) . | Comments . | |
| Risk with TxA . | Risk with DDAVP (range) . | |||||
| Change in menstrual blood loss assessed as the change from baseline on PBAC follow-up, at 2 mo | The mean change in menstrual blood loss was 105.9. | MD 41.6 higher (19.6-63.6 higher) | — | 116 (1 RCT) | ⨁⨁⨁◯ MODERATE†,‡ | DDAVP probably reduces menstrual blood loss less than TxA. |
| Quality of life assessed with several scales (HRQoL, SF-36, CES-D, RUTA); at follow-up, 2 mo | The researchers did not provide an explicit comparison between the groups. Scores across instruments and domains suggested improvement for both interventions, but this was the only category to show a statistically significant difference. | — | 116 (1 RCT) | ⨁⨁◯◯ LOW‡,§ | There may be no important differences in HRQoL between the interventions. | |
| Side effects (most common, headaches) assessed at 2 mo follow-up | 52 per 1000 | 0 per 1000 (0-0) | Not estimable | 232 (1 RCT) | ⨁⨁◯◯ LOW†,‡,ǁ | There may be no important differences in side effects between the interventions. |
| Severe side effects follow-up at 2 mo | 0 per 1000 | 0 per 1000 (0-0) | Not estimable | 232 (1 RCT) | ⨁⨁◯◯ LOW†,‡,ǁ | There may be no important differences in severe side effects between the interventions. |
| Major bleeding, not reported | — | — | — | — | — | — |
| Need for surgery, not reported | — | — | — | — | — | — |
| Need for additional treatment, not reported | — | — | — | — | — | — |
| Menstruation duration, not reported | — | — | — | — | — | — |
| Absence from school, work, and other necessary activities, not reported | — | — | — | — | — | — |
| . | ||||||
|---|---|---|---|---|---|---|
| Outcome . | Anticipated absolute effects (95% CI)* . | Relative effect (95% CI) . | Participants, n (studies) . | Certainty of the evidence (GRADE) . | Comments . | |
| Risk with TxA . | Risk with DDAVP (range) . | |||||
| Change in menstrual blood loss assessed as the change from baseline on PBAC follow-up, at 2 mo | The mean change in menstrual blood loss was 105.9. | MD 41.6 higher (19.6-63.6 higher) | — | 116 (1 RCT) | ⨁⨁⨁◯ MODERATE†,‡ | DDAVP probably reduces menstrual blood loss less than TxA. |
| Quality of life assessed with several scales (HRQoL, SF-36, CES-D, RUTA); at follow-up, 2 mo | The researchers did not provide an explicit comparison between the groups. Scores across instruments and domains suggested improvement for both interventions, but this was the only category to show a statistically significant difference. | — | 116 (1 RCT) | ⨁⨁◯◯ LOW‡,§ | There may be no important differences in HRQoL between the interventions. | |
| Side effects (most common, headaches) assessed at 2 mo follow-up | 52 per 1000 | 0 per 1000 (0-0) | Not estimable | 232 (1 RCT) | ⨁⨁◯◯ LOW†,‡,ǁ | There may be no important differences in side effects between the interventions. |
| Severe side effects follow-up at 2 mo | 0 per 1000 | 0 per 1000 (0-0) | Not estimable | 232 (1 RCT) | ⨁⨁◯◯ LOW†,‡,ǁ | There may be no important differences in severe side effects between the interventions. |
| Major bleeding, not reported | — | — | — | — | — | — |
| Need for surgery, not reported | — | — | — | — | — | — |
| Need for additional treatment, not reported | — | — | — | — | — | — |
| Menstruation duration, not reported | — | — | — | — | — | — |
| Absence from school, work, and other necessary activities, not reported | — | — | — | — | — | — |
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.
CES-D, Center for Epidemiologic Studies Depression scale; HRQoL, health-related quality of life; MD, mean difference; RCT, randomized control trial; SF-36, short form 36-question health survey.
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).
Allocation sequence generation and concealment unclear in the publication. However, we clarified with the researchers the procedures they used.
Patients analyzed had not responded to treatment with oral contraceptives. Patients seeking for first line treatment may be importantly different from those seeking second-line treatment.
Lack of blinding could have affected the reporting of this subjective outcome.
Few events; results are likely to be fragile.