Vitamin E supplementation in people with cystic fibrosis

Peter O Okebukola; Sonal Kansra; Joanne Barrett

doi:10.1002/14651858.CD009422.pub4

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Figure 1

Study flow diagram

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Analysis 1.1

Comparison 1: Water‐miscible vitamin E supplementation versus control, Outcome 1: Serum vitamin E levels

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Analysis 1.2

Comparison 1: Water‐miscible vitamin E supplementation versus control, Outcome 2: Weight

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Analysis 2.1

Comparison 2: Fat‐soluble vitamin E supplementation versus control, Outcome 1: Serum vitamin E levels

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Summary of findings 1. Summary of findings: water‐soluble vitamin E compared with control for cystic fibrosis

Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of participants (studies)	Quality of the evidence (GRADE)	Comments
Water‐soluble vitamin E compared with control for cystic fibrosis
Patient or population: children and adults with cystic fibrosis Settings: outpatients Intervention: 10 mg/kg/day of oral vitamin E tocopherol (d‐l alpha‐tocopheryl acetate) in water‐miscible solution Comparison: no supplementation (Harries 1969; Wong 1988) or placebo (Levin 1961)
	Assumed risk	Corresponding risk
	No supplementation or placebo	Water‐soluble oral vitamin E
Vitamin E total lipid ratio	This outcome was not measured.
Vitamin E levels in serum: umol/L Follow‐up: 6 months	The mean serum level of vitamin E in the control group was 4.6 umol/L.	The mean serum level of vitamin E in the intervention group was 19.74 umol/L higher (13.48 umol/L higher to 26.00 umol/L higher).	MD 19.74 (13.48 to 26.00).	45 (1)	⊕⊕⊝⊝ low^a,b	Only 1 study reported this outcome at the 6‐month time point ( Levin 1961 ). 2 further studies reported serum levels of vitamin E at 1 month and found a statistically significant result in favour of the supplemental group, MD 17.66 (95% CI 10.59 to 24.74) (Harries 1969; Wong 1988).
Neuropathy due to vitamin E deficiency	This outcome was not measured.
Retinopathy due to vitamin E deficiency	This outcome was not measured.
BMI	This outcome was not measured.
Height	This outcome was not measured.
FEV₁ % predicted: change from baseline	This outcome was not measured.
The basis for the assumed risk* (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% CI) 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 in 1 second; MD: mean difference.
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.
a. Downgraded once becasue of indirectness in the data. The single study reporting at 6 months included only children and therefore the effect on adults is unknown. b. Downgaded once due to imprecision resulting from small numbers of participants (n = 45).

Summary of findings 1. Summary of findings: water‐soluble vitamin E compared with control for cystic fibrosis

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Summary of findings 2. Summary of findings: fat‐soluble vitamin E compared with control for cystic fibrosis

Outcomes	*Illustrative comparative risks (95% CI)**		Comments
Fat‐soluble vitamin E compared with control for cystic fibrosis
Patient or population: children and adults with cystic fibrosis Settings: outpatients Intervention: fat‐soluble vitamin E 10 mg/kg/day in 2 trials (Harries 1969; Wong 1988); participants < 20 kg = 600 IU/Day < 20 kg; participants > 20 kg = 1200 IU/day in 1 trial (Keljo 2000) Comparison: no supplementation (Harries 1969; Wong 1988) or placebo (Keljo 2000)
	Assumed risk	Corresponding risk
	No supplementation or placebo	Fat‐soluble oral vitamin E
Vitamin E total lipid ratio	This outcome was not measured post‐intervention.
Vitamin E levels in serum: umol/l Follow‐up: six months	None of the trials measured this outcome at the 6‐month time point.		2 studies reported serum levels of vitamin E at 1 month and found a statistically significant result in favour of the supplemental group, MD 13.59 (95% CI 9.52 to 17.66) (Harries 1969; Wong 1988). 1 study reported serum levels of vitamin E at 3 months and found no statistically significant difference between intervention and control, MD 6.40 (95% CI ‐1.45 to 14.25) (Keljo 2000).
Neuropathy due to vitamin E deficiency	This outcome was not measured.
Retinopathy due to vitamin E deficiency	This outcome was not measured.
BMI	This outcome was not measured.
Height	This outcome was not measured.
FEV₁ % predicted: change from baseline	This outcome was not measured.
The basis for the assumed risk* (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% CI) 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 in 1 second; MD: mean difference.
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.

Summary of findings 2. Summary of findings: fat‐soluble vitamin E compared with control for cystic fibrosis

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Comparison 1. Water‐miscible vitamin E supplementation versus control

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1.1 Serum vitamin E levels Show forest plot	3		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

1.1.1 Up to 1 month	2	32	Mean Difference (IV, Fixed, 95% CI)	17.66 [10.59, 24.74]
1.1.2 Up to 3 months	1	45	Mean Difference (IV, Fixed, 95% CI)	11.61 [4.77, 18.45]
1.1.3 Up to 6 months	1	45	Mean Difference (IV, Fixed, 95% CI)	19.74 [13.48, 26.00]
1.2 Weight Show forest plot	1		Mean Difference (IV, Random, 95% CI)	Totals not selected

1.2.1 Up to 3 months	1		Mean Difference (IV, Random, 95% CI)	Totals not selected
1.2.2 Up to 6 months	1		Mean Difference (IV, Random, 95% CI)	Totals not selected

Comparison 1. Water‐miscible vitamin E supplementation versus control

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Comparison 2. Fat‐soluble vitamin E supplementation versus control

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
2.1 Serum vitamin E levels Show forest plot	3		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

2.1.1 Up to 1 month	2	36	Mean Difference (IV, Fixed, 95% CI)	13.59 [9.52, 17.66]
2.1.2 Up to 3 months	1	36	Mean Difference (IV, Fixed, 95% CI)	6.40 [‐1.45, 14.25]

Comparison 2. Fat‐soluble vitamin E supplementation versus control

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