Oxholm 1986.
| Methods |
Study design: randomized, cross‐over, controlled trial Study site(s): not reported if single‐ or multi‐center Number randomized (total and per group): 28 participants Unit of randomization (individual or eye): individual Exclusions after randomization: not reported Losses to follow‐up: not reported Number analyzed (total and per group): 28 participants in total Unit of analysis (individual or eye): individual Reported power calculation? (Y/N): N Reported subgroup analysis? (Y/N): N |
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| Participants |
Participant characteristics Country: not reported Age (mean ± SD, range): 51 years, range 32 to 71 years Gender: 4 men and 24 women Inclusion criteria: 1. Primary Sjögren’s syndrome based on the Copenhagen criteria 2. Keratoconjunctivitis sicca defined as at least 2 of the following 3 objective tests for each organ proved abnormal; Schirmer test values < 10 mm/5 min; TBUT< 10 s; lissamine green staining score > 4 (on a scale of 0 to 9) for each eye 3. Xerostomia examined by histopathologic changes by lip biopsy; unstimulated sialometry values < 1.5 mL saliva/15 min; salivary gland scintigraphy Exclusion criteria: not reported Equivalence of baseline characteristics? (Y/N): not applicable (cross‐over study) |
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| Interventions |
Intervention #1 (fatty acid treatment group): oral capsule containing evening primrose oil (primarily including cis‐linoleic acid 365 mg and gamma linolenic acid 45 mg, Efamol), 6 capsules daily. Daily dose of linoleic acid 2190 mg and γ‐linolenic acid 270 mg (Efamol) Intervention #2 (control group): "placebo" (composition not reported) 500 mg capsule (dose not reported), 6 capsules daily Length of follow‐up: 8 weeks in each phase; 16 weeks in total Notes: participants were not allowed to take NSAID, bromhexine, or glucocorticosteroids for at least 2 weeks before the study or during the treatment period |
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| Outcomes | Primary and secondary outcome measures were not clearly distinguished Specified outcome(s): Schirmer I test; TBUT; van Bijisterveld score; tear lysozyme concentration; unstimulated sialometry; fatty acid levels in plasma and erythrocytes Adverse events reported? (Y/N): Y Measurement time points (specify intervals at which outcomes were assessed): baseline, months 1 and 2, in each phase Other issues with outcome assessment (eg, quality control for outcomes, if any): cross‐over study design, with any apparent washout between intervention phases |
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| Notes |
Study dates: not reported Funding source(s): not reported Conflicts of interest: 1 author was affiliated with Efamol Research Institute Publication language: English 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 randomization 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 | Unclear risk | Numbers of participants who were excluded or lost to follow‐up were not explicitly reported |
| Selective reporting (reporting bias) | Unclear risk | No access to study protocol or clinical trials registry |
| Other bias | High risk | Cross‐over design, without any apparent washout between phases; 1 author was affiliated with Efamol Research Institute |