| Methods |
3‐month, parallel design trial. Randomised using random number generator. |
| Participants |
43 children and adults with "severe" CF mutations (age range 7 to 41 years); 35 participants completed the study; 18 female, 17 males. 20 participants were chronically infected with Pseudomonas aeruginosa. 8 participants discontinued the study and the inclusion parameters of these patients did not differ from those who completed the study. |
| Interventions |
50 mg/kg per day of 1 of 3 fatty acid blend capsules over 3 months; group A capsules contained predominantly EPA and DHA, group C contained high proportion of linoleic acid and arachidonic acid and group B (placebo) contained predominantly saturated fatty acids. Participants increased their pancreatic enzymes by 10% to 20% to maintain normal stools. |
| Outcomes |
Outcomes included in this review:
changes in serum phospholipid essential fatty acid content;
changes in inflammatory markers;
adverse effects;
BMI and weight;
lung function;
medical treatment. |
| Notes |
Actual dose of EPA and DHA administered not described. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Randomised using random number generator. |
| Allocation concealment (selection bias) |
Unclear risk |
Not discussed in paper. |
| Blinding (performance bias and detection bias)
All outcomes |
Unclear risk |
Described as double‐blind; treatment was assumed to be administered as identical capsules; however, 2 participants complained of fish smell in group A. |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
45 participants were initially randomised, but 2 were excluded due to acute exacerbations and therefore did not enter the study. Withdrawls from study were described: 35 participants completed the study; 8 discontinued because of low compliance (n = 4), stomach pains (n = 2) and weight gain (n = 2). Study did not include all participants in the data analysis, therefore data was not analysed as 'intention to treat'. |
| Selective reporting (reporting bias) |
Unclear risk |
Protocol not available for comparison, so unable to definitely eliminate selective reporting. |
| Other bias |
High risk |
The lack of information on dosage is a potential risk of bias. |
