Abstract
Purpose::
We conducted a prospective, randomized, placebo-controlled, double-masked clinical trial to determine if the use of an omega-3 supplement containing a flaxseed and fish oil blend (TheraTears Nutrition®, Advanced Vision Research, Woburn, MA), designed to suppress inflammation and increase tear and saliva production, could help alleviate salivary hypofunction, erythema of the tissues, and perception of dry mouth and dry eyes in Sjögren’s patients.
Methods::
To date 41 volunteers who had Sjögren’s syndrome, as defined by the European Criteria and a positive blood test or lip biopsy have completed the study; enrollment is continuing. One-third of subjects were randomized to receive a placebo pill (germ seed oil), and two-thirds were randomized to receive the omega-3 supplement. At each visit whole unstimulated saliva (US) was collected by drooling into a preweighed container and stimulated saliva (SS) was collected by chewing paraffin wax. Both groups were not significantly different for salivary flow at baseline (US and SS). A visual analog scale (VAS) was used to measure the severity of xerostomia at the end of the study. Gingival index (GI) and Plaque Index (PI) were measured to record inflammation and plaque accumulation. A dental prophylaxis was performed at baseline. The subject’s data from the primary subjective endpoint of increased oral and ocular comfort and the objective endpoint of increased salivary flow were analyzed as well as improvement in PI and GI at 3 months.
Results::
Perception of ocular improvement was noted in 43% of the omega-3 group vs. 14% of the placebo group with an odds ratio of .24(95%CI .0.3-1.54) approaching significance with the Fisher exact test p=0.082. Perception of oral improvement was noted in 61% of the omega 3 group vs. 36% of the placebo group with an odds ratio 0.38(95% CI .0.08- 1.74) p = 0.158 MH. The unstimulated salivary flow for the omega-3 group was 0.069 +/- 0.082, and was significantly improved at 3 months to 0.115 +/- 0.12, with a paired p value of 0.029 for the improvement. The unstimulated salivary flow for the placebo was 0.042 +/- 0.051 and at 3 months 0.045 +/- 0.065 NS. When the Plaque Index (PI) was measured 35% had improved in the omega-3 group and 25% had improved in the placebo group. The Gingival Index (GI) was improved 69% with omega-3 treatment vs. 42% for placebo. Since both groups had periodontal prophylaxis improvement is expected at 3 months.
Conclusions::
This data demonstrates that treatment with TheraTears Nutrition omega-3 supplement can help improve salivary flow, and there was a trend noted in the subjective perception of oral and ocular improvement.
Clinical Trial::
www.ISRCTN.org pending
Keywords: cornea: tears/tear film/dry eye • cornea: clinical science • autoimmune disease