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

Figuras y tablas -
Analysis 1.1

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)

Figuras y tablas -
Analysis 1.2

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)

Figuras y tablas -
Analysis 1.3

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)

Figuras y tablas -
Analysis 1.4

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)

Figuras y tablas -
Analysis 1.5

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)

Figuras y tablas -
Analysis 1.6

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)

Figuras y tablas -
Analysis 1.7

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)

Figuras y tablas -
Analysis 1.8

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

Figuras y tablas -
Analysis 1.9

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

Figuras y tablas -
Analysis 1.10

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

Figuras y tablas -
Analysis 1.11

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)

Figuras y tablas -
Analysis 1.12

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)

Figuras y tablas -
Analysis 1.13

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)

Figuras y tablas -
Analysis 1.14

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

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.

Figuras y tablas -
Summary of findings 1. Summary of findings
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

Figuras y tablas -
Comparison 1. Oral calorie supplements versus no intervention or additional nutritional advice