Summary of findings 4. HC (15 mg/m²/day) vs HC (25 mg/m²/day) with fludrocortisone (0.1 mg/day) for treating CAH.
| HC (15 mg/m²/day) vsus HC (25 mg/m²/day) with fludrocortisone (0.1 mg/day) for treating CAH | ||||||
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Patient or population: people with CAH Settings: outpatients, tertiary centre Intervention: HC (15 mg/m²/day) Comparison: HC (25 mg/m²/day) with fludrocortisone (0.1 mg/day) | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of participants (trials) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| HC with fludrocortisone | HC | |||||
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QoL Follow‐up: 6 months |
Outcome not reported. | NA | NA | NA | ||
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Androgen normalisation Follow‐up: 6 months |
See comments. | NA | 26 (1 cross‐over trial) |
⊕⊝⊝⊝a,b,c very low |
17 OHP (nmol/L) Results presented as medians (IQR) and split for prepubertal and pubertal participants. For prepubertals, the levels of 17 OHP were higher in the HC 15 mg/m²/day group, 113.7 (0.5 to 1207) compared to 11.5 (0.6 to 819.9) in the HC 25 mg/m²/day group. For the pubertal group, the levels of 17 OHP were lower in the 15 mg/m²/day group, 91.7 (6.8 to 453.0) compared to 314.2 (66.5 to 568.7) in the HC 25 mg/m²/day group. Androstenedione (nmol/L) Results show that for prepubertals androstenedione levels were higher in the HC 15 mg/m²/day group, 3.4 (0.5 to 40.2) compared to the HC 25 mg/m²/day group, 1.6 (0.1 to 31.8). For the pubertal group, androstenedione levels were lower in the HC 15 mg/m²/day group, 11 (6.1 to 41.9) compared to the HC 25 mg/m²/day group, 22.3 (10.5 to 47.5). Testosterone (nmol/L) Results show that testosterone levels for prepubertals were higher in the HC 15 mg/m²/day group, 2.5 (0.8 to 9.1) compared to the HC 25 mg/m²/day group, 2.3 (1.2 to 11.3). For the pubertal group, the levels of testosterone were lower in the HC 15 mg/m²/day group, 4.7 (3.9 to 6.9) compared to the HC 25 mg/m²/day group, 6.2 (3.5 to 9.2). |
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Prevention of adrenal crisis Follow‐up: 6 months |
Outcome not reported. | NA | NA | NA | ||
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Presence of osteopenia Follow‐up: 6 months |
Outcome not reported. | NA | NA | NA | ||
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Presence of testicular or ovarian adrenal rest tumours Follow‐up: 6 months |
Outcome not reported. | NA | NA | NA | ||
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Subfertility Follow‐up: 6 months |
Outcome not reported. | NA | NA | NA | ||
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Final adult height Follow‐up: 6 months |
See comments. | The mean difference in height velocity between the 2 groups was 0.34 higher (0.27 higher to 0.41 higher). | NA | 26 (1 cross‐over trial) |
⊕⊝⊝⊝a,b,c very low | The results are for height velocity which is a surrogate measure for final adult height. |
| *The basis for the assumed risk (e.g. the median control group risk across trials) 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). 17 OHP: 17‐hydroxyprogesterone; CAH: congenital adrenal hyperplasia; CI: confidence interval; HC: hydrocortisone; IQR: interquartile range; NA: not applicable; QoL: quality of life. | ||||||
| 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. | ||||||
a Downgraded once for high risk of bias due to incomplete outcome data and selective reporting. b Downgraded once due to potential risk of bias: unclear details related to methodological design. c Downgraded due to uncertainty: small sample size and wide IQR.