Papas 2007.
| Methods |
Study design: randomized, parallel‐group, controlled trial Study site(s): not reported if single‐ or multi‐center Number randomized (total and per group): not reported Unit of randomization (individual or eye): not reported Exclusions after randomization: not reported Losses to follow‐up: not reported Number analyzed (total and per group): 41 participants in total Unit of analysis (individual or eye): not reported Reported power calculation? (Y/N): N Reported subgroup analysis? (Y/N): N |
|
| Participants |
Baseline characteristics Country: not reported Age (mean ± SD, range): not reported Gender: not reported Inclusion criterion: 1. Sjögren’s syndrome as defined by the European Criteria and a positive blood rest or lip biopsy Exclusion criteria: not reported Equivalence of baseline characteristics? (Y/N): Y (salivary flow) |
|
| Interventions |
Intervention #1 (treatment group): omega‐3 supplement containing a flaxseed and fish oil blend; dose not reported (TheraTears Nutrition, Advanced Vision Research) Intervention #2 (control group): placebo (germ seed oil); dose not reported Length of follow‐up: 3 months Notes: none |
|
| Outcomes |
Primary outcome(s): symptoms of dry eye; symptoms of dry mouth; unstimulated and stimulated salivary flow, all reported as data at study endpoint Secondary outcome(s): gingival index; plaque index Adverse events reported? (Y/N): N Measurement time points (specify intervals at which outcomes were assessed): not reported Other issues with outcome assessment (eg, quality control for outcomes, if any): none |
|
| Notes |
Study dates: not reported Funding source(s): not reported Conflicts of interest: not reported Publication language: English Registered on clinical trials registry? (Y/N): Y ‐ although not referenced in the abstract, this report appears to relate to the clinical trial registry entry: http://www.isrctn.com/ISRCTN10758297 |
|
| 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‐masked" study, but details of masking were not reported |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | "Double‐masked" study, but details of masking were not reported |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Numbers randomized, lost to follow‐up, and excluded were not reported |
| Selective reporting (reporting bias) | High risk | Although not referenced in the record (abstract), this report appears to relate to the clinical trial registry entry: http://www.isrctn.com/ISRCTN10758297, which lists only "increased oral and ocular comfort at 3 months" as the primary outcome measure, which is different from that reported in the abstract |
| Other bias | Unclear risk | This study was published in abstract form only, and a follow‐up publication was not identified |