Suplementos calóricos orales para la fibrosis quística
Información
- DOI:
- https://doi.org/10.1002/14651858.CD000406.pub5Copiar DOI
- Base de datos:
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- Cochrane Database of Systematic Reviews
- Versión publicada:
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- 04 mayo 2017see what's new
- Tipo:
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- Intervention
- Etapa:
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- Review
- Grupo Editorial Cochrane:
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Grupo Cochrane de Fibrosis quística y enfermedades genéticas
- Copyright:
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- Copyright © 2017 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Cifras del artículo
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Autores
Contributions of authors
Rosalind Smyth and Sarah Walters wrote the protocol and independently assessed studies for inclusion in this review. Rosalind Smyth extracted the data and wrote the remainder of the text. Rosalind Smyth wrote the updates of this review with comments from Sarah Walters (up to 2012) and from Oli Rayner (from 2014 onwards).
Rosalind Smyth acts as guarantor of this review.
Sources of support
Internal sources
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No sources of support supplied
External sources
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National Institute for Health Research, UK
This systematic review was supported by the National Institute for Health Research, via Cochrane Infrastructure funding to the Cochrane Cystic Fibrosis and Genetic Disorders Group.
Declarations of interest
Professor Rosalind Smyth was principle investigator in the CALICO trial which is included in this review.
Oli Rayner acts as a consultant to the UK Cystic Fibrosis Trust, a charitable organisation which supports basic and clinical research in cystic fibrosis. He has carried out work on this review on a pro bono basis and it is entirely unrelated to any work with the UK Cystic Fibrosis Trust. The UK Cystic Fibrosis Trust has no financial interest in the outcome of this review and nor does he.
Acknowledgements
We are grateful to Daina Kalnins, The Hospital for Sick Children, Toronto, Canada who provided additional data for one of the included trials.
The current authors of the review would like to thank Dr Sarah Walters for her previous input into the development of this review.
This project was supported by the National Institute for Health Research, via Cochrane Infrastructure funding to the Cochrane Cystic Fibrosis and Genetic Disorders Group. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the Systematic Reviews Programme, NIHR, NHS or the Department of Health.
Version history
| Published | Title | Stage | Authors | Version |
| 2017 May 04 | Oral calorie supplements for cystic fibrosis | Review | Rosalind L Smyth, Oli Rayner | |
| 2014 Nov 03 | Oral calorie supplements for cystic fibrosis | Review | Rosalind L Smyth, Oli Rayner | |
| 2012 Oct 17 | Oral calorie supplements for cystic fibrosis | Review | Rosalind L Smyth, Sarah Walters | |
| 2007 Jan 24 | Oral calorie supplements for cystic fibrosis | Review | Rosalind L Smyth, Sarah Walters | |
| 2000 Apr 24 | Oral calorie supplements for cystic fibrosis | Review | Rosalind L Smyth, Sarah Walters | |
Differences between protocol and review
In November 2006, a post hoc change was made to the list of secondary outcomes and 'Activity levels' was added.
Notes
Please refer to the following Cochrane Review, which assesses the effectiveness of this intervention for children with chronic disease:
Francis DK, Smith J, Saljuqi T, Watling RM. Oral protein calorie supplementation for children with chronic disease. Cochrane Database of Systematic Reviews 2015, Issue 5. Art. No.: CD001914. DOI: 10.1002/14651858.CD001914.pub2.
Keywords
MeSH
Medical Subject Headings (MeSH) Keywords
Medical Subject Headings Check Words
Adult; Child; Humans;
PICO
Comparison 1: Oral calorie supplements versus no intervention or additional nutritional advice, Outcome 1: Change in weight (kg)
Comparison 1: Oral calorie supplements versus no intervention or additional nutritional advice, Outcome 2: Change in weight centile (percentile points)
Comparison 1: Oral calorie supplements versus no intervention or additional nutritional advice, Outcome 3: Change in height (cm)
Comparison 1: Oral calorie supplements versus no intervention or additional nutritional advice, Outcome 4: Change in height centile (percentile points)
Comparison 1: Oral calorie supplements versus no intervention or additional nutritional advice, Outcome 5: Change in weight for height (percentage)
Comparison 1: Oral calorie supplements versus no intervention or additional nutritional advice, Outcome 6: Change in BMI (kg/m2)
Comparison 1: Oral calorie supplements versus no intervention or additional nutritional advice, Outcome 7: Change in BMI centile (percentile points)
Comparison 1: Oral calorie supplements versus no intervention or additional nutritional advice, Outcome 8: Change in mid‐upper arm circumference (cm)
Comparison 1: Oral calorie supplements versus no intervention or additional nutritional advice, Outcome 9: Change in total Kcal/day
Comparison 1: Oral calorie supplements versus no intervention or additional nutritional advice, Outcome 10: Change in total protein (g)/day
Comparison 1: Oral calorie supplements versus no intervention or additional nutritional advice, Outcome 11: Change in total fat (g)/day
Comparison 1: Oral calorie supplements versus no intervention or additional nutritional advice, Outcome 12: Change in FEV₁ (% predicted)
Comparison 1: Oral calorie supplements versus no intervention or additional nutritional advice, Outcome 13: Change in FVC (% predicted)
Comparison 1: Oral calorie supplements versus no intervention or additional nutritional advice, Outcome 14: Change in activity (% 24 hours)
| 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 | No of participants | Quality of the evidence | 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) | ⊕⊕⊕⊝ | 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) | ⊕⊕⊕⊝ | 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 | ⊕⊕⊝⊝ | 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 | ⊕⊕⊝⊝ | 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 | ⊕⊕⊝⊝ | 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) | ⊕⊝⊝⊝ | 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 | ⊕⊕⊝⊝ | 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). | ||||||
| GRADE Working Group grades of evidence | ||||||
| 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. | ||||||
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1.1 Change in weight (kg) Show forest plot | 3 | Mean Difference (IV, Fixed, 95% CI) | Subtotals only | |
| 1.1.1 3 months | 2 | 112 | Mean Difference (IV, Fixed, 95% CI) | 0.32 [‐0.09, 0.72] |
| 1.1.2 6 months | 2 | 117 | Mean Difference (IV, Fixed, 95% CI) | 0.47 [‐0.07, 1.02] |
| 1.1.3 12 months | 1 | 102 | Mean Difference (IV, Fixed, 95% CI) | 0.16 [‐0.68, 1.00] |
| 1.2 Change in weight centile (percentile points) Show forest plot | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 1.2.1 3 months | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 1.2.2 6 months | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 1.2.3 12 months | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 1.3 Change in height (cm) Show forest plot | 2 | Mean Difference (IV, Fixed, 95% CI) | Subtotals only | |
| 1.3.1 3 months | 2 | 112 | Mean Difference (IV, Fixed, 95% CI) | ‐0.04 [‐0.36, 0.29] |
| 1.3.2 6 months | 1 | 101 | Mean Difference (IV, Fixed, 95% CI) | ‐0.47 [‐1.32, 0.38] |
| 1.3.3 12 months | 1 | 102 | Mean Difference (IV, Fixed, 95% CI) | 0.06 [‐0.50, 0.62] |
| 1.4 Change in height centile (percentile points) Show forest plot | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 1.4.1 3 months | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 1.4.2 6 months | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 1.4.3 12 months | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 1.5 Change in weight for height (percentage) Show forest plot | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 1.5.1 3 months | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 1.6 Change in BMI (kg/m2) Show forest plot | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 1.6.1 3 months | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 1.6.2 6 months | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 1.6.3 12 months | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 1.7 Change in BMI centile (percentile points) Show forest plot | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 1.7.1 3 months | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 1.7.2 6 months | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 1.7.3 12 months | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 1.8 Change in mid‐upper arm circumference (cm) Show forest plot | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 1.8.1 3 months | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 1.8.2 6 months | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 1.8.3 12 months | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 1.9 Change in total Kcal/day Show forest plot | 2 | Mean Difference (IV, Fixed, 95% CI) | Subtotals only | |
| 1.9.1 3 months | 2 | 58 | Mean Difference (IV, Fixed, 95% CI) | 115.09 [‐121.34, 351.52] |
| 1.9.2 6 months | 1 | 48 | Mean Difference (IV, Fixed, 95% CI) | 304.86 [5.62, 604.10] |
| 1.9.3 12 months | 1 | 58 | Mean Difference (IV, Fixed, 95% CI) | 265.70 [42.94, 488.46] |
| 1.10 Change in total protein (g)/day Show forest plot | 2 | Mean Difference (IV, Fixed, 95% CI) | Subtotals only | |
| 1.10.1 3 months | 2 | 58 | Mean Difference (IV, Fixed, 95% CI) | 2.51 [‐6.74, 11.77] |
| 1.10.2 6 months | 1 | 48 | Mean Difference (IV, Fixed, 95% CI) | 8.77 [‐1.24, 18.78] |
| 1.10.3 12 months | 1 | 58 | Mean Difference (IV, Fixed, 95% CI) | 6.82 [‐2.36, 16.00] |
| 1.11 Change in total fat (g)/day Show forest plot | 2 | Mean Difference (IV, Fixed, 95% CI) | Subtotals only | |
| 1.11.1 3 months | 2 | 58 | Mean Difference (IV, Fixed, 95% CI) | ‐1.10 [‐15.05, 12.85] |
| 1.11.2 6 months | 1 | 48 | Mean Difference (IV, Fixed, 95% CI) | 11.74 [‐2.96, 26.44] |
| 1.11.3 12 months | 1 | 58 | Mean Difference (IV, Fixed, 95% CI) | 8.85 [‐4.64, 22.34] |
| 1.12 Change in FEV₁ (% predicted) Show forest plot | 2 | Mean Difference (IV, Fixed, 95% CI) | Subtotals only | |
| 1.12.1 3 months | 2 | 82 | Mean Difference (IV, Fixed, 95% CI) | ‐7.96 [‐13.52, ‐2.40] |
| 1.12.2 6 months | 1 | 70 | Mean Difference (IV, Fixed, 95% CI) | ‐3.39 [‐9.97, 3.19] |
| 1.12.3 12 months | 1 | 70 | Mean Difference (IV, Fixed, 95% CI) | ‐1.91 [‐8.57, 4.75] |
| 1.13 Change in FVC (% predicted) Show forest plot | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 1.13.1 3 months | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 1.13.2 6 months | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 1.13.3 12 months | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 1.14 Change in activity (% 24 hours) Show forest plot | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 1.14.1 3 months | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 1.14.2 6 months | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 1.14.3 12 months | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
