| Outcomes | Illustrative Assumed risk* (MTX) | Illustrative Corresponding risk* (DACT) | Relative effect (95% CI) | No of Participants (studies) | Quality of the evidence (GRADE) | Comments |
|---|---|---|---|---|---|---|
| Primary cure (remission) | 530 per 1000 | 828 per 1000 (697 to 981) |
RR 0.64 (0.54 to 0.76) | 513 women (5 studies) | ⊕⊕⊕○ moderate |
DACT is significantly more likely to achieve a primary cure than MTX We downgraded this evidence because 64% of the data came from comparisons of weekly IM MTX which may be less effective than the 5- or 8- day regimens |
| Failure of first-linetherapy | 447 per 1000 | 115 per 1000 (50 to 268) |
RR 3.81 (1.64 to 8.86) | 513 women (5 studies) | ⊕⊕⊕○ moderate |
DACT as a first-line treatment is significantly less likely to fail than MTX We downgraded this evidence because 70% of the data came from comparisons of weekly IM MTX which may be less effective than the 5- or 8-day regimens |
| Severe adverse events (≥ grade 3) | 102 per 1000 (23 to 481) |
290 per 10001 | RR 0.35 (0.08 to 1.66) | 515 women (5 studies) | ⊕⊕○○ low |
There was no significant difference between interventions overall, however, the point estimate and subgroup analyses favoured MTX. We downgraded this evidence due to the low consistency and heterogeneity (I2 = 60%). SAEs occurred in only 2 out of 5 studies |
| Nausea | 280 per 1000 | 171 per 1000 81 to 353) |
RR 0.61 (0.29 to 1.26) | 466 women (4 studies) | ⊕⊕⊕○ moderate |
There is no significant difference between the interventions in the rate of nausea. We downgraded this evidence due to the heterogeneity (I2 = 80%) |
| Alopecia | Subtotals only | ⊕⊕○○ low |
Data not pooled due to substantial subgroup differences. Five-day DACT was associated with significantly more alopecia than MTX, but there was no significant difference in alopecia between groups in the studies that used pulsed DACT |
The basis for the assumed risk is the median control group risk across studies. 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).
CI: Confidence interval; RR: Risk Ratio
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.
Assumed risk calculated for DACT (not MTX) using the median control group risk across included studies.