Theander 2002.

Methods	Study design: randomized, parallel‐group, controlled trial Study site(s): single‐center Number randomized (total and per group): 90 participants in total; 30 participants in each intervention group Unit of randomization (individual or eye): individual Exclusions after randomization: 4 participants in the treatment group (1 participant due to a diagnosis of malignancy, 1 participant due to psychosocial problems, 2 participants due to gastrointestinal side effects); 1 participant in the control group (due to gastrointestinal side effects) Losses to follow‐up: none Number analyzed (total and per group): 85 participants in total; 29 participants in the low‐dose treatment group; 27 participants in the high‐dose treatment group; 29 participants in the control group Unit of analysis (individual or eye): individual Reported power calculation? (Y/N): Y (80% power) Reported subgroup analysis? (Y/N): Y (status of Sjögren’s syndrome)
Participants	Baseline characteristics Country: Sweden Age (mean ± SD, range): median 62 years, interquartile range 50 to 68 years Gender: 8 men and 79 women Inclusion criterion: 1. Diagnosis of Sjögren’s syndrome according to the Copenhagen criteria or the European criteria Exclusion criteria: 1. Patients with unstable concomitant disease 2. Patients participating in other clinical trials 3. Patients already using commercially available omega‐6 fatty acids Equivalence of baseline characteristics? (Y/N): Y
Interventions	Intervention #1: oral γ‐linolenic acid 800 mg daily (Scotia Pharmaceutical Ltd.) Intervention #2: oral γ‐linolenic acid 1600 m daily (Scotia Pharmaceutical Ltd.) Intervention #3 (control group): placebo (corn oil); dose not reported. Length of follow‐up: 6 months Notes: participants were allowed to reduce their analgesic or anti‐inflammatory medication and tear substitutes without being actively encouraged to do so
Outcomes	Primary outcome(s): change from baseline in visual analogue scale (VAS) for fatigue, and average time staying in bed trying to rest, sleep, or relax Secondary outcome(s): change from baseline in VAS for dry eye, dry mouth, muscle pain, hand or finger joint pain, and feeling of depression; Schirmer I test; TBUT; lissamine green staining; average number of daily doses of tear substitutes Adverse events reported? (Y/N): Y Measurement time points (specify intervals at which outcomes were assessed): baseline, months 3 and 6 Other issues with outcome assessment (eg, quality control for outcomes, if any): none
Notes	Study dates: between November 1996 and December 1997 Funding source(s): "this study was supported by Scotia Pharmaceuticals Ltd., Guilford, Surrey, UK" Conflicts of interest: not reported Publication language: English Registered on clinical trials registry? (Y/N): N
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, but details of masking were not reported
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	"Double‐blind" study, but details of masking were not reported
Incomplete outcome data (attrition bias) All outcomes	High risk	"An intention to treat analysis was not performed due to the small number of excluded patients" 3/90 participants (3.3%) were excluded (1 participant due to a diagnosis of malignancy, 1 participant due to psychosocial problems, 1 participant due to gastrointestinal side effects), and they were not included in the final analysis
Selective reporting (reporting bias)	Unclear risk	No access to study protocol or clinical trials registry
Other bias	High risk	"Patients were only allowed to continue in the study when taking at least 50% of the prescribed amount of emulsion" "This study was supported by Scotia Pharmaceuticals Ltd., Guilford, Surrey, UK"