Summary of findings for the main comparison. Any pharmaceutical treatment compared with placebo or no treatment for heartburn in pregnancy.
| Any pharmaceutical treatment compared with placebo or no treatment for heartburn in pregnancy | ||||||
| Patient or population: pregnant women with heartburn in pregnancy Settings: US and UK Intervention: any pharmaceutical treatment Comparison: placebo or no treatment | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Placebo or no treatment | Any pharmaceutical treatment | |||||
| Complet relief of heartburn | Study population | RR 1.85 (95% CI 1.36 to 2.50) | 256 (2 RCTs) | ⊕⊕⊕⊝ MODERATE 1 | ||
| 301 per 1000 | 557 per 1000 (409 to 752) | |||||
| Moderate | ||||||
| 291 per 1000 | 539 per 1000 (396 to 728) | |||||
| Partial relief of heartburn | Study population | RR 1.35 (95% CI 0.38 to 4.76) | 256 (2 RCTs) | ⊕⊝⊝⊝ VERY LOW 1,2,3 | ||
| 252 per 1000 | 340 per 1000 (96 to 1000) | |||||
| Moderate | ||||||
| 238 per 1000 | 321 per 1000 (90 to 1000) | |||||
| Side effects | Study population | RR 0.63 (95% CI 0.21 to 1.89) | 256 (2 RCTs) | ⊕⊝⊝⊝ VERY LOW 4,5 | ||
| 57 per 1000 | 36 per 1000 (12 to 108) | |||||
| Moderate | ||||||
| 48 per 1000 | 30 per 1000 (10 to 91) | |||||
| Quality of life | Study population | not estimable | (0 studies) | |||
| 0 per 1000 | 0 per 1000 (0 to 0) | |||||
| Maternal satisfaction | Study population | not estimable | (0 studies) | |||
| 0 per 1000 | 0 per 1000 (0 to 0) | |||||
| Low birthweight | Study population | not estimable | (0 studies) | |||
| 0 per 1000 | 0 per 1000 (0 to 0) | |||||
| Preterm labour | Study population | not estimable | (0 studies) | |||
| 0 per 1000 | 0 per 1000 (0 to 0) | |||||
| *The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. 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; | ||||||
| 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. CI: confidence interval; RR: risk ratio | ||||||
1Most studies contributing data had design limitations (‐1)
2Statistical heterogeneity, I2 = 88% (‐1).
3Small sample size and wide confidence interval crossing the line of no effect (‐2).
4Most weight from a study with design limitations (‐1). Reisfield 1971 excluded 6 women for having side effects.
5Few events and wide confidence interval crossing the line of no effect (‐2).