Panchaud 2006.
Methods | RCT. Design: cross‐over trial with no washout period. Duration: 1 year (2 x 6‐month periods). Location: single centre in Switzerland (Lausanne CF Center). |
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Participants | 17 children and young adults with CF and PI; 1 participant discontinued study after 8 months for personal convenience. Age, mean (SD): 18 (9) years). Gender: 10 males, 7 females. |
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Interventions | Intervention Group: liquid dietary supplement containing PUFA mixture (EPA, DHA, GLA and STA). Control Group: liquid dietary supplement without PUFA mixture. Volume of supplementation was determined according to participant's weight; intake ranged from 100 mg ‐ 300 mg DHA. and 200 mg ‐ 600 mg EPA per day. |
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Outcomes | Outcomes included in this review: number of people experiencing adverse events; number of deaths; changes in peripheral blood neutrophil membrane composition; in vitro neutrophilic response to inflammatory stimuli; changes in in vitro neutrophil chemotaxis. | |
Notes | Relatively low daily dose of EPA and DHA compared to previous clinical trials. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Did not state the randomisation technique. |
Allocation concealment (selection bias) | Unclear risk | No details were provided in the primary paper. |
Blinding (performance bias and detection bias) All outcomes | Low risk | Described as double blind, placebo treatment was not stated to be identical but it was described as the same liquid dietary supplement as the intervention but without the PUFA mixture. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 17 participants were randomised; 16 completed the study and one discontinued after 8 months for personal convenience. Due to technical reasons, data could not be analysed for several participants' samples at baseline (4 participants), after treatment with omega‐3 supplements (1) and after placebo (2). High possibility of attrition bias since the analysis of the final cohort differed from the original cohort. |
Selective reporting (reporting bias) | Unclear risk | Protocol not available for comparison, so unable to definitely eliminate selective reporting. |
Other bias | Low risk | No additional bias identified. |
AA: arachidonic acid BMI: body mass index CF: cystic fibrosis DHA: docosahexaenoic acid EPA: eicosapentaenoic acid GLA: gamma‐linolenic acid ITT: intention‐to‐treat PI: pancreatic insufficient PUFA: polyunsaturated fatty acids RCT: randomised controlled trial SD: standard deviation STA: stearidonic acid