Table 2. The GRADE quality assessment.
Iron polymaltose complex (IPC) compared to ferrous sulphate (FS) for children with iron deficiency anaemia | ||||||
Patient or population: children with iron deficiency anaemia | ||||||
Setting: outpatient or community clinic | ||||||
Intervention: iron polymaltose complex (IPC) | ||||||
Comparison: ferrous sulphate (FS) | ||||||
Outcomes | Anticipated absolute effects*(95% CI) | Relative effect (95% CI) | No. of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
Risk with ferrous sulphate (FS) | Risk with iron polymaltose complex (IPC) | |||||
Hb level | The mean Hb level was 0 | MD 0.81 lower (1.08 lower to 0.53 lower) | – | 368 (6 RCTs) | ⊕⊕⊕⊕ HIGH | Iron polymaltose complex (IPC) results in a slight reduction in Hb level compared to ferrous sulphate |
Ferritin | The mean ferritin was 0 | MD 21.24 lower (39.26 lower to 3.23 lower) | – | 183 (3 RCTs) | ⊕⊕⊕⊝ MODERATE 1 | Iron polymaltose complex (IPC) likely results in a reduction in ferritin level compared to ferrous sulphate. |
Iron level | The mean iron level was 0 | MD 14.3 lower (33.03 lower to 4.43 higher) | – | 183 (3 RCTs) | ⊕⊕⊕⊝ MODERATE 2 | Iron polymaltose complex (IPC) probably results in little to no difference in iron level compared to ferrous sulphate |
MCV level | The mean MCV level was 0 | MD 3.2 lower (5.35 lower to 1.05 lower) | – | 103 (1 RCT) | ⊕⊕⊝⊝ LOW 34 | Iron polymaltose complex (IPC) may result in a slight reduction in MCV level compared to ferrous sulphate |
MCH level | The mean MCH level was 0 | MD 0.9 lower (1.85 lower to 0.05 higher) | – | 103 (1 RCT) | ⊕⊕⊝⊝ LOW 34 | Iron polymaltose complex (IPC) may result in little to no difference in MCH level compared to ferrous sulphate |
Adverse effects | Study population | RR 0.78 (0.47 to 1.31) | 274 (3 RCTs) | ⊕⊕⊕⊕HIGH | Iron polymaltose complex (IPC) results in no difference in adverse effects compared to ferrous sulphate | |
212 per 1,000 | 165 per 1,000 (99 to 277) |
Notes.
The risk in the intervention group (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 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
Explanations
Substantial heterogeneity presence with minimal overlapping of confidence intervals (CI) across the included trials and I2 of 65% ( P = 0.06)
Substantial heterogeneity presence across the included trials with I2 of 57% ( P = 0.10)
Only one trial included. The trial has high risk of selection bias
Small sample size from one trial on 103 participants only