Summary of findings 1. Summary of findings.
| Oral calorie supplements compared with control for cystic fibrosis | ||||||
|
Patient or population: adults and children with cystic fibrosis Settings: outpatients Intervention: oral calorie supplements Comparison: control (no intervention, dietary advice or nutritional counselling) | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Control (no intervention, dietary advice or nutritional counselling) | Oral calorie supplements | |||||
|
Change in weight (kg):1 at 12 months Follow‐up: up to 12 months |
The mean change in weight was 2.97 kg gained in the control group. | The mean change in weight was 0.16 kg extra gained (0.68 kg lost to 1.00 kg extra gained) in the treatment group. | NA | 102 (1 trial) |
⊕⊕⊕⊝ moderate2 | There was also no significant difference between treatment groups at 3 months (MD 0.32 kg, 95% CI ‐0.09 kg to 0.72 kg, 112 participants, 2 trials) or at 6 months (MD 0.47 kg, 95% CI ‐0.07 kg to 1.02 kg, 117 participants, 2 trials). There was also no significant difference in change in weight centile between treatment groups at 3, 6 and 12 months. |
|
Change in height (cm):1 at 12 months Follow‐up: up to 12 months |
The mean change in height was 5.85 cm gained in the control group. | The mean change in height was 0.06 cm extra gained (0.50 cm lost to 0.62 cm extra gained) in the treatment group. | NA | 102 (1 trial) |
⊕⊕⊕⊝ moderate2 | There was also no significant difference between treatment groups at 3 months (MD ‐0.04 cm, 95% CI ‐0.36 cm to 0.29 cm, 112 participants, 2 trials) or at 6 months (MD ‐0.47 cm, 95% CI ‐1.32 cm to 0.38 cm, 101 participants, 1 trial). There was also no significant difference in change in height centile between treatment groups at 3, 6 and 12 months. |
|
Change in total calories (Kcal/day): at 12 months Follow‐up: up to 12 months |
The mean change in total calories was 139.52 Kcal/day in the control group. | The mean change in total calories was 265.70 Kcal/day higher (42.94 to 488.46 Kcal/day higher) in the treatment group. | NA | 58 (1 trial) | ⊕⊕⊝⊝ low2,3 | There was also a significant advantage to the treatment group over the control group at 6 months (MD 304.86 Kcal/day, 95% CI 5.62 kcal/day to 604.10 Kcal/day, 48 participants, 1 trial). There was no significant difference between treatment groups at 3 months (MD 115.09 Kcal/day, 95% CI ‐121.34 Kcal/day to 351.52 Kcal/day, 58 participants, 2 trials). |
|
Change in total protein (g/day): at 12 months Follow‐up: up to 12 months |
The mean change in total protein was 5.75 g/day in the control group. | The mean change in total calories was 6.82 g/day higher (2.36 g/day lower to 16.00 g/day higher) in the treatment group. | NA | 58 (1 trial) | ⊕⊕⊝⊝ low2,3 | There was also no significant difference between treatment groups at 3 months (MD 2.51 g/day, 95% CI ‐6.74 g/day to 11.77 g/day, 58 participants, 2 trials) or at 6 months (MD 8.77 g/day, 95% CI ‐1.24 g/day to 18.78 g/day, 48 participants, 1 trial). |
|
Change in total fat (g/day): at 12 months Follow up: up to 12 months |
The mean change in total fat was 12.23 g/day in the control group. | The mean change in total calories was 8.85 g/day higher (4.64 g/day lower to 22.34 g/day higher) in the treatment group. | NA | 58 (1 trial) | ⊕⊕⊝⊝ low2,3 | There was also no significant difference between treatment groups at 3 months (MD ‐1.10 g/day, 95% CI ‐15.05 g/day to 12.85 g/day, 58 participants, 2 trials) or at 6 months (MD 11.74 g/day, 95% CI ‐2.96 g/day to 26.44 g/day, 48 participants, 1 trial). |
|
Adverse events: Follow up: up to 12 months |
See comment | See comment | NA | Not stated (1 trial) |
⊕⊝⊝⊝ very low4 | One trial investigated gastro‐intestinal symptoms with a questionnaire and reported no significant difference between the groups. |
|
Change in lung function ‐ FEV₁ (% predicted): at 12 months Follow‐up: up to 12 months |
The mean change in FEV₁ (% predicted) was ‐1.5 in the control group. | The mean change in FEV₁ (% predicted) 1.91 lower (8.57 lower to 4.75 higher) in the treatment group. | NA | 70 (1 trial) | ⊕⊕⊝⊝ low2,5 | There was a significant decline in FEV₁ (% predicted) in the treatment group compared to the control group at 3 months (MD ‐7.96, 95% CI ‐13.52 to ‐2.40). There was no significant difference between treatment groups at 6 months (MD ‐3.39, 95% CI ‐9.97 to 3.19). There was also no significant difference in change in FVC between treatment groups at 3, 6 and 12 months. |
| *The basis for the assumed risk is the mean 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). BMI: body mass index; CI: confidence interval; FEV₁: forced expiratory volume at 1 second; FVC: forced vital capacity; MD: mean difference; NA: not applicable | ||||||
| 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. | ||||||
1. There was also no significant difference in terms of other indices of nutrition or growth; weight for height (percentage) at 3 months, change in BMI (kg/m²) at 3, 6 and 12 months and change in BMI centile at 3 and 12 months. There was a significant advantage for oral calorie supplements over control at 6 months (MD 5.75, 95% CI 0.22 to 11.28, 101 participants, 1 trial).
2. Downgraded once due to applicability; results apply only to children between the ages of 2 and 15 years, results not applicable to adults.
3. Downgraded once due to incomplete outcome data; 58 out of 102 children returned the 12 month dietary diary, 44 who did not return the diary are excluded from analysis.
4. Downgraded twice due to imprecision and once due to risk of selective outcome reporting bias; adverse events of treatment were reported in only a single trial and very limited information was provided about the rate of adverse events.
5. Downgraded once due to applicability; Spirometry data recorded only for children over the age of 5 years, lung function outcomes are not applicable to children between the ages of 2 to 5 years from this study.