Pinheiro 2007.
| Methods |
Study design: randomized, parallel‐group, controlled trial Study site(s): single‐center Number randomized (total and per group): 38 participants in total; 13 participants in the flaxseed 1 g group; 12 participants in the flaxseed 2 g group; 13 participants in the placebo group Unit of randomization (individual or eye): individual Exclusions after randomization: not reported Losses to follow‐up: not reported Unit of analysis (individual or eye): individual (average of both eyes) Reported power calculation? (Y/N): N Reported subgroup analysis? (Y/N): N |
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| Participants |
Participant characteristics Country: Brazil Age (mean ± SD, range): range 21 to 55 years Gender: 38 women Inclusion criteria: 1. TBUT ≤ 8 seconds 2. Schirmer test type ≤ 8 mm/5 min 3. van Bjisterveld with a score of 3 to 7 Exclusion criteria: not reported Equivalence of baseline characteristics? (Y/N): Y |
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| Interventions |
Intervention #1: oral flaxseed oil capsule 1 g, 1 capsule (Douglas Laboratories, Pittsburgh, PA, USA, imported by "Langfor Import and Distribution" São Paulo, SP, Brazil) plus a placebo capsule (950 mg synthetic mineral oil, 50 mg of evening primrose oil) Intervention #2: oral flaxseed oil capsule 1 g, 2 capsules (2 g in total) Intervention #3 (control): placebo capsule (950 mg synthetic mineral oil, 50 mg evening primrose oil), 2 capsules (2 g) Length of follow‐up: 180 days Notes: none |
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| Outcomes | Primary and secondary outcome measures not clearly distinguished Specified outcome(s): OSDI; conjunctival impression cytology; TBUT; Schirmer test with anesthesia Adverse events reported? (Y/N): N Measurement time points (specify intervals at which outcomes were assessed): baseline, day 180 Other issues with outcome assessment (eg, quality control for outcomes, if any): none |
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| Notes |
Study dates: not reported Funding source(s): not reported Conflicts of interest: not reported Publication language: Portuguese Registered on clinical trials registry? (Y/N): N |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Method of random sequence generation was not reported |
| Allocation concealment (selection bias) | Unclear risk | Allocation concealment was not reported |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | "Double‐blind" study; placebo capsule had identical appearance to treatment capsule; details of masking of personnel were not reported |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | "Double‐blind" study, but details of masking of outcome assessors were not reported |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Numbers of participants who were excluded, lost to follow‐up, and included in the final analysis were not reported |
| Selective reporting (reporting bias) | Unclear risk | No access to study protocol or clinical trials registry |
| Other bias | Unclear risk | Funding source(s) and conflicts of interest were not reported |