Oral sea buckthorn oil study 2010.

Methods	Study design: randomized, parallel‐group, controlled trial Study site(s): single‐center Number randomized (total and per group): 100 participants in total; 52 participants in the fatty acid treatment group; 48 participants in the control group Unit of randomization (individual or eye): individual Exclusions after randomization: 4 participants in total; 3 participants in the treatment group; 1 participant in the control group Losses to follow‐up: 10 participants in total; 4 participants in the fatty acid treatment group; 6 participants in the control group Number analyzed (total and per group): 100 participants in total; 52 participants in the fatty acid treatment group; 48 participants in the control group, in the intention‐to‐treat analysis Unit of analysis (individual or eye): eye (TBUT); individual (other outcomes) Reported power calculation? (Y/N): Y (˜ 80% power) Reported subgroup analysis? (Y/N): Y (contact lens status; age)
Participants	Participant characteristics Country: Finland Age (mean ± SD, range): 45 ± 18 years in the fatty acid treatment group; 46 ±17 years in the control group Gender: 8 men and 44 women in the fatty acid treatment group; 7 men and 41 women in the control group Inclusion criteria: 1. 20 to 75 years of age 2. Subjective symptoms of dry eye Exclusion criteria: 1. Severe illness 2. Pregnancy or breastfeeding 3. Smoking 4. Regular use of strongly anticholinergic drugs Equivalence of baseline characteristics? (Y/N): Y
Interventions	Intervention #1 (fatty acid treatment): oral capsule containing sea buckthorn oil (Aromtech Ltd.) twice daily, 1 capsule at a time. Daily dose of 2000 mg (comprising long‐chain omega‐3 and omega‐6 PUFAs) Intervention #2 (control treatment): placebo capsule containing medium‐chain fatty acids (dose not reported), twice daily, 1 capsule at a time Length of follow‐up: 3 months of intervention, and 1 to 2 months after suspension of treatment Notes: participants were advised not to use other oil supplements during the trial; linoleic acid 245 ± 34 mg/d and α‐linolenic acid 149 ± 21 mg/d
Outcomes	Primary outcome(s): change from baseline in each of tear film osmolarity; TBUT; Schirmer test; modified OSDI Secondary outcome(s): subjective symptoms (as reported in a log book) Adverse events reported? (Y/N): N Measurement time points (specify intervals at which outcomes were assessed): baseline, months 1 and 3, and 1 to 2 months after suspension of treatment Other issues with outcome assessment (eg, quality control for outcomes, if any): none
Notes	Study dates: enrollment between October and November in 2008 Funding source(s): "supported by the ABS Graduate School, Aromtech Ltd., Finnish Agency for Technology and Innovation, Finnsusp Ltd., Niemi Foundation, Shinyhorse Ltd., TYKS Foundation, and Valioravinto Ltd." Conflicts of interest: 2 authors were affiliated with pharmaceutical firms "R. L. Järvinen is an employee of Finnsusp Ltd. During the trial execution, B. Yang was an employee of Aromtech Ltd." Publication language: English Registered on clinical trials registry? (Y/N): Y ‐ (clinicaltrials.gov ‐ NCT00739713)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"Permuted block randomization was used" "A computer‐generated random generator was used" (personal communication)
Allocation concealment (selection bias)	Low risk	"Participants were interviewed for the inclusion and exclusion criteria. The included participants were randomized to treatment groups using age, sex, and contact lens wear as stratification factors in the randomization. Randomization was carried out by a statistician not otherwise involved in the study. The study products were given to the study personnel in boxes coded with the id‐numbers of the each participant. The code marking of the capsule boxes was done by a person not involved otherwise in the study and he kept the code in a sealed envelope during the study. The study personnel or the participants did not know the study groups or which participants were in the same groups with each other during the enrollment, or during the study" (personal communication)
Blinding of participants and personnel (performance bias) All outcomes	Low risk	"Both capsules had identical opaque gelatin shells. During the trial, the participants, study personnel, and researchers did not know who was getting the SB capsules. To study the success of blinding, the participants were asked to guess whether they were receiving the SB or placebo capsules at each study visit"
Blinding of outcome assessment (detection bias) All outcomes	Low risk	"Both capsules had identical opaque gelatin shells. During the trial, the participants, study personnel, and researchers did not know who was getting the SB capsules. To study the success of blinding, the participants were asked to guess whether they were receiving the SB or placebo capsules at each study visit"
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	7/52 participants (13.5%) and 7/48 participants (14.6%) were excluded or were lost to follow‐up, and the reasons were not reported "The primary data analyses were done including all randomized participants [intention to treat (ITT) participants]. Unless otherwise noted, the presented results concern the ITT participants"
Selective reporting (reporting bias)	High risk	Outcomes prespecified in the clinical trial registration information, including tear cytokines and inflammation mediators, were not included in the final report
Other bias	High risk	Two authors were affiliated with pharmaceutical firms