Manthorpe 1984.
| Methods |
Study design: randomized, cross‐over, controlled trial Study site(s): not reported if single or multi‐center Number randomized (total and per group): 36 participants Unit of randomization (individual or eye): individual Exclusions after randomization: not explicitly reported, but 1 or 2 patients were not included in the analysis according to the graphs in the manuscript Losses to follow‐up: none reported Number analyzed (total and per group): 36 participants in total Unit of analysis (individual or eye): not reported Reported power calculation? (Y/N): N Reported subgroup analysis? (Y/N): N |
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| Participants |
Baseline characteristics Country: Denmark Age (mean ± SD, range): median 39 years in men, and 51 years in women, range 34 to 76 Gender: 3 men and 33 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, TBUT, and lissamine green staining by the van Bijsterveld score 3. Xerostomia examined by lip biopsy; unstimulated sialometry values; salivary gland scintigraphy Exclusion criteria: not reported Equivalence of baseline characteristics? (Y/N): not applicable (cross‐over) |
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| Interventions |
Intervention #1 (active treatment group): oral capsule containing cis‐linoleic acid 365 mg and γ‐linolenic acid 45 mg, Efamol twice daily (3 capsules at a time) plus tablet containing vitamin C 125 mg, pyridoxine 25 mg, niacin 25 mg, and ZnSo4 5 mg(Efavit), twice daily, 3 tablets at a time. Daily dose of linoleic acid 2190 mg and γ‐linolenic acid 270 mg Intervention #2 (control group): "placebo" (composition not reported) 500 mg capsule (dose not reported) and tablets, twice daily, 3 capsules at a time Length of follow‐up: 3 weeks in each phase, with 1‐week washout between phases; 7 weeks in total Notes: participants on NSAIDs were asked to reduce their usual intake, if possible, or to continue at the same dosage as usual. All other medications were kept constant during the trial, with the exception of bromhexine, which was discontinued at least 2 weeks before the start of the investigation |
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| Outcomes | Primary and secondary outcome measures were not clearly distinguished Specified outcome(s): change from baseline in: Schirmer test; TBUT; van Bijsterveld score; subjective feeling of dryness in mouth and eyes; biscuit‐eating time; amount of snake‐like nuclear chromatin in conjunctival epithelial cells; tear lysozyme concentration; saliva Na+ and K+ concentrations Adverse events reported? (Y/N): Y Measurement time points (specify intervals at which outcomes were assessed): baseline, week 3 in each phase 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: 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 about personnel were not reported "All patients received three capsules of Egamol and three tablets of Efavit twice daily or placebo of identical appearance and number" |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | "Double‐blind" study, but details of masking about outcome assessors were not reported |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | "All completed the investigation," but data in the graphs suggest that 1 or 2 participants were not included in the analyses |
| Selective reporting (reporting bias) | Unclear risk | No access to study protocol or clinical trials registry |
| Other bias | High risk | In this cross‐over design, there was only 1‐week washout period between intervention phases, which is likely inadequate; information regarding funding source and conflict of interest was not reported |