Oral calorie supplements for cystic fibrosis

Rosalind L Smyth; Oli Rayner

doi:10.1002/14651858.CD000406.pub5

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منابع دیگر نسخه‌های منتشرشده این مرور

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منابع مطالعات واردشده در این مرور
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منابع اضافی

Smyth RL, Walters S. Oral calorie supplements for cystic fibrosis. Cochrane Database of Systematic Reviews 2000, Issue 1. Art. No: CD000406. [DOI: 10.1002/14651858.CD000406]

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Characteristics of studies

Characteristics of included studies [ordered by study ID]

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estudios excluidos
estudios a la espera de clasificación

Hanning 1993

*Study characteristics*
Methods	Random allocation using sealed envelopes. Parallel design, no intention‐to‐treat analysis. Duration: 6 months. Location: single centre in Canada.
Participants	20 children with CF and mild to moderate lung disease, aged 7 ‐ 15 years. Lung function (FEV₁ % predicted) (mean (SD)): control group 84.2% (26.3); supplemented group 101.4% (19.4). % WFH (mean (SD)); control group 95.6% (12.1); supplement group 92.8% (11.3). 20 randomised (12 males), 16 (10 males) studied.
Interventions	Dietary supplements, drink powders, milk shakes, tinned puddings to achieve 25% of normal energy recommendations in addition to normal diet. No intervention in control groups.
Outcomes	Skeletal muscle strength and power Pulmonary function* and respiratory muscle strength Height, weight and anthropometric measurements* Habitual physical activity Body composition Dietary energy* and nutrient intake* Energy* and nutrient* intake from supplements Laboratory measures of nutritional status (e.g. albumin, amino acids)
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Random allocation using based on a table of random numbers.
Allocation concealment (selection bias)	Low risk	Used sealed envelopes.
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Investigators performing skeletal and lung muscle‐function tests and anthropometry were unaware of the participant's study group.
Incomplete outcome data (attrition bias) All outcomes	Low risk	No ITT analysis. 20 randomised, 16 studied. Four participants did not complete the trial because they found the time demands for testing or the travelling distance to be excessive.
Selective reporting (reporting bias)	Unclear risk	No adverse events reported; not clear if no events occurred or if not reported.
Other bias	High risk	The treated group appeared to be in better clinical condition at baseline.

Kalnins 2005

*Study characteristics*
Methods	Quasi‐randomised controlled trial. Parallel design. Duration: 3 months. Location: single centre in Canada.
Participants	CF participants aged > 10 years. Age on entry to trial: advice group mean (SD) 16.4 years (6.7); supplement group mean (SD) 19.5 years (11.3). < 90% ideal WFH or 5% reduction in ideal WFH over 3 months. Most recent published report states 15 were enrolled but 2 dropped out. Gender split: 3/13 were males. Although 2 out of 7 in the supplement group did not continue taking supplements, they were analysed as ITT.
Interventions	High calorie drink to increase energy intake by 20% of predicted energy needs. Control group received nutritional counselling to increase energy intake by 20% of predicted energy needs by eating high calorie foods.
Outcomes	Z scores for weight* and height, WFH Anthropometric measures* Pulmonary function* Energy* and nutrient* intake Faecal balance studies
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quasi‐randomised controlled trial: participants were segregated by age and sex, initial participants from each group randomly allocated to intervention or control (paper does not state how initial randomisation occurred), then each subsequent participant was allocated a different group from the previous one.
Allocation concealment (selection bias)	High risk	Inadequate, used alternate allocation.
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Not possible to blind dietitian or participant ‐ it was stated that apart from the 'study monitors' (nurse and dietitian), all other investigators were blinded, but it was not clear whether all investigators who assessed the outcome measures were blinded.
Incomplete outcome data (attrition bias) All outcomes	Low risk	2 participants dropped out, one in each group after completing baseline (reasons included feeling unwell and change of mind) and were not followed up; 2 out of 7 participants allocated to the supplement group were not taking supplements at 3 months, but were included in the analysis, which was judged to be ITT.
Selective reporting (reporting bias)	Unclear risk	No adverse events reported; not clear if no events occurred or if not reported. Did not report the change from baseline values for outcome measures in the original publication, but has since provided summary statistics for the change from baseline to the authors of this review.
Other bias	Unclear risk	Unable to make clear judgement.

Poustie 2006

*Study characteristics*
Methods	Randomised controlled trial. Parallel design. Duration: 12 months. Location: multicentre in UK.
Participants	102 children (54 males) aged 2 ‐ 15 years with CF and at least one of following criteria: BMI < 25th centile but > 0.4th centile; or no increase in weight over the previous 3 months; or 5% decrease in weight from baseline over a period of < 6 months.
Interventions	Oral calorie supplements (range of different brands used, but daily amount to increase usual energy intake by 20%) plus routine dietetic advice compared with dietary advice alone.
Outcomes	Change in BMI* Change in BMI percentile* Change in weight* Change in height* Change in weight percentile* Change in height percentile* Mid‐upper arm circumference* Energy* and macro‐nutrient* intake FEV₁ and FVC expressed as % predicted for age, sex and height* Gastro‐intestinal symptoms* Outcomes measured at 3, 6 and 12 months. All participants were followed up to 12 months.
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Generation of the randomisation sequence used random number tables.
Allocation concealment (selection bias)	Low risk	Used sealed opaque envelopes.
Blinding (performance bias and detection bias) All outcomes	Low risk	Not possible to blind clinicians and participants, but the researcher undertaking the analysis of outcomes was masked as to the allocation groups.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Analysis was by ITT. All 102 randomised children completed the trial. However, unable to collect interim data on 2 children from the supplement group (owing to parental choice or illness) and 1 child from the standard care group (illness). Nine children failed to return the baseline diet diary, and 39 failed to return the 12‐month diet diary, so dietary intake data are based on the 58 children who completed both baseline and 12 month diaries. Spirometry data available for 70 of the 72 participants aged 5 and above.
Selective reporting (reporting bias)	Low risk	All outcomes described in the Methods section of the published paper (including adverse events) reported on.
Other bias	Low risk	No other potential source of bias identified.

*Outcomes to be included in review
BMI: body mass index
CF: cystic fibrosis
FEV₁: forced expiratory volume in 1 second
ITT: intention‐to‐treat
SD: standard deviation
WFH: weight for height

Characteristics of excluded studies [ordered by study ID]

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estudios incluidos
estudios a la espera de clasificación

Study	Reason for exclusion
Abdulhamid 2008	Intervention is zinc supplementation, not an OCS.
Adde 1997	Intervention was only given in hospital and while it does not explicitly state the duration of the intervention it is highly unlikely to meet our inclusion criteria of at least one month. Furthermore, there is no evidence of randomisation.
Best 2004	OCS not given to increase calorie intake.
Bruzzese 2007	Intervention is a pro‐biotic, not an OCS.
Caramia 2003	OCS not given to increase calorie intake.
Ellis 1998	The products used were formula‐based infant milks and not OCS.
Grey 2003	Supplements used for reasons other than to increase calorie input.
Haworth 2004	Intervention is calcium and vitamin D supplements, not an OCS.
Kane 1991	OCS taken for less than one month. Both groups received OCS.
Lepage 2002	No comparison with a group not receiving OCS.
Lloyd‐Still 2001	Intervention not an OCS.
McKenna 1985	Supplements not given orally.
Milla 1996	OCS not given to increase calorie intake. OCS given for period less than one month.
Oudshoorn 2007	Intervention uses micronutrient supplements not OCS.
Papas 2007	Pharmacokinetic trial of different formulations of vitamin E supplementation, not OCS.
Patchell 2001	Not a randomised controlled trial.
Sondel 1987	OCS taken for less than one month. Both intervention groups received supplements.
Steinkamp 2000	Groups not comparable at the start of the study and quasi‐randomised design.

OCS: oral calorie supplements

Characteristics of studies awaiting classification [ordered by study ID]

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estudios incluidos
estudios excluidos

MacDonald 2001

Methods	Randomised parallel study comparing supplementation with control in CF.
Participants	People with CF.
Interventions	Supplementary feed 'Healthshake'.
Outcomes	Growth and biochemistry.
Notes	Publication ID: N0045006074. Title: Evaluation of supplementary feed (Healthshake) in the nutritional management of children with cystic fibrosis. NRR data provider: Birmingham Children's Hospital NHS Foundation Trust.

CF: cystic fibrosis

Data and analyses

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Comparison 1. Oral calorie supplements versus no intervention or additional nutritional advice

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
Open in figure viewer Analysis 1.1 Comparison 1: Oral calorie supplements versus no intervention or additional nutritional advice, Outcome 1: Change in weight (kg)
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
Open in figure viewer Analysis 1.2 Comparison 1: Oral calorie supplements versus no intervention or additional nutritional advice, Outcome 2: Change in weight centile (percentile points)
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
Open in figure viewer Analysis 1.3 Comparison 1: Oral calorie supplements versus no intervention or additional nutritional advice, Outcome 3: Change in height (cm)
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
Open in figure viewer Analysis 1.4 Comparison 1: Oral calorie supplements versus no intervention or additional nutritional advice, Outcome 4: Change in height centile (percentile points)
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
Open in figure viewer Analysis 1.5 Comparison 1: Oral calorie supplements versus no intervention or additional nutritional advice, Outcome 5: Change in weight for height (percentage)
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
Open in figure viewer Analysis 1.6 Comparison 1: Oral calorie supplements versus no intervention or additional nutritional advice, Outcome 6: Change in BMI (kg/m2)
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
Open in figure viewer Analysis 1.7 Comparison 1: Oral calorie supplements versus no intervention or additional nutritional advice, Outcome 7: Change in BMI centile (percentile points)
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
Open in figure viewer Analysis 1.8 Comparison 1: Oral calorie supplements versus no intervention or additional nutritional advice, Outcome 8: Change in mid‐upper arm circumference (cm)
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
Open in figure viewer Analysis 1.9 Comparison 1: Oral calorie supplements versus no intervention or additional nutritional advice, Outcome 9: Change in total Kcal/day
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
Open in figure viewer Analysis 1.10 Comparison 1: Oral calorie supplements versus no intervention or additional nutritional advice, Outcome 10: Change in total protein (g)/day
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
Open in figure viewer Analysis 1.11 Comparison 1: Oral calorie supplements versus no intervention or additional nutritional advice, Outcome 11: Change in total fat (g)/day
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
Open in figure viewer Analysis 1.12 Comparison 1: Oral calorie supplements versus no intervention or additional nutritional advice, Outcome 12: Change in FEV₁ (% predicted)
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
Open in figure viewer Analysis 1.13 Comparison 1: Oral calorie supplements versus no intervention or additional nutritional advice, Outcome 13: Change in FVC (% predicted)
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
Open in figure viewer Analysis 1.14 Comparison 1: Oral calorie supplements versus no intervention or additional nutritional advice, Outcome 14: Change in activity (% 24 hours)
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

Analysis 1.1

Comparison 1: Oral calorie supplements versus no intervention or additional nutritional advice, Outcome 1: Change in weight (kg)

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Analysis 1.2

Comparison 1: Oral calorie supplements versus no intervention or additional nutritional advice, Outcome 2: Change in weight centile (percentile points)

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Analysis 1.3

Comparison 1: Oral calorie supplements versus no intervention or additional nutritional advice, Outcome 3: Change in height (cm)

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Analysis 1.4

Comparison 1: Oral calorie supplements versus no intervention or additional nutritional advice, Outcome 4: Change in height centile (percentile points)

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Analysis 1.5

Comparison 1: Oral calorie supplements versus no intervention or additional nutritional advice, Outcome 5: Change in weight for height (percentage)

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Analysis 1.6

Comparison 1: Oral calorie supplements versus no intervention or additional nutritional advice, Outcome 6: Change in BMI (kg/m2)

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Analysis 1.7

Comparison 1: Oral calorie supplements versus no intervention or additional nutritional advice, Outcome 7: Change in BMI centile (percentile points)

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Analysis 1.8

Comparison 1: Oral calorie supplements versus no intervention or additional nutritional advice, Outcome 8: Change in mid‐upper arm circumference (cm)

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Analysis 1.9

Comparison 1: Oral calorie supplements versus no intervention or additional nutritional advice, Outcome 9: Change in total Kcal/day

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Analysis 1.10

Comparison 1: Oral calorie supplements versus no intervention or additional nutritional advice, Outcome 10: Change in total protein (g)/day

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Analysis 1.11

Comparison 1: Oral calorie supplements versus no intervention or additional nutritional advice, Outcome 11: Change in total fat (g)/day

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Analysis 1.12

Comparison 1: Oral calorie supplements versus no intervention or additional nutritional advice, Outcome 12: Change in FEV₁ (% predicted)

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Analysis 1.13

Comparison 1: Oral calorie supplements versus no intervention or additional nutritional advice, Outcome 13: Change in FVC (% predicted)

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Analysis 1.14

Comparison 1: Oral calorie supplements versus no intervention or additional nutritional advice, Outcome 14: Change in activity (% 24 hours)

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Summary of findings 1. Summary of findings

Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of participants (studies)	Quality of the evidence (GRADE)	Comments
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)
	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)	⊕⊕⊝⊝ low^2,3	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)	⊕⊕⊝⊝ low^2,3	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)	⊕⊕⊝⊝ low^2,3	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)	⊕⊕⊝⊝ low^2,5	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.

Summary of findings 1. Summary of findings

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Comparison 1. Oral calorie supplements versus no intervention or additional nutritional advice

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

Comparison 1. Oral calorie supplements versus no intervention or additional nutritional advice

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Referencias

منابع مطالعات واردشده در این مرور

Hanning 1993 {published data only}

Kalnins 2005 {published and unpublished data}

Poustie 2006 {published and unpublished data}

منابع مطالعات خارج‌شده از این مرور

Abdulhamid 2008 {published data only}

Adde 1997 {published data only}

Best 2004 {published data only}

Bruzzese 2007 {published data only}

Caramia 2003 {published data only}

Ellis 1998 {published data only}

Grey 2003 {published data only}

Haworth 2004 {published data only}

Kane 1991 {published data only}

Lepage 2002 {published data only}

Lloyd‐Still 2001 {published data only}

McKenna 1985 {published data only}

Milla 1996 {published data only}

Oudshoorn 2007 {published data only}

Papas 2007 {published data only}

Patchell 2001 {published data only (unpublished sought but not used)}

Sondel 1987 {published data only}

Steinkamp 2000 {published data only}

منابع مطالعات در انتظار ارزیابی

MacDonald 2001 {published data only}

منابع اضافی

CFF 2016

Francis 2015

MacDonald 1996

Marin 2004

Murray 1991

RLCH 2006

Shepherd 1980

Shepherd 1988

Sinaasappel 2002

Stallings 2008

UK CF Trust 2010

UK CF Trust 2013

منابع دیگر نسخه‌های منتشرشده این مرور

Smyth 2000

Smyth 2007

Smyth 2012

Smyth 2014

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Characteristics of excluded studies [ordered by study ID]

Characteristics of studies awaiting classification [ordered by study ID]

Data and analyses

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