Dry eye disease due to meibomian gland dysfunction treated with Pinggan Yuyin Qingre formula(平肝育阴清热方):a stratified randomized controlled trial

OBJECTIVE:To observe the clinical efficacy on improving the quality of meibum in patients suffer from dry eye disease(DED)due to meibomian gland dysfunction(MGD)with hyperactivity of Yang due to Yin deficiency pattern after being treated with Pinggan Yuyin Qingre formula(平肝育阴清热方,PGYYQR).METHODS:Totally 120 patients who met the inclusion criteria were included and stratified into three levels according to the level of MGD(1-3),and patients in each level was randomly allocated into the treatment group and control group according to a 1∶1 ratio.Both groups were treated with sodium hyaluronate eye drops,and the treatment group was also given PGYYQR granules.Both groups were treated continuously for eight weeks.The score of the properties of meibomian gland(MG)secretion,the score of the palpebral margins,the average noninvasive tear breakup time(NITBUTav),lipid layer thickness(LLT),and Traditional Chinese Medicine(TCM)syndrome efficacy were compared between the two groups after treatment.RESULTS:A total of 116 cases were included in the statistical analysis.The differences were statistically significant in the score of the properties of MG secretion,the score of the palpebral margins,and NITBUTav between the two groups after treatment,the treatment group was superior to the control group;there was no evidence of a difference in LLT.In terms of TCM syndrome efficacy,the total effective rate was 84.7%in the treatment group and 50.9%in the control group,with the statistically significant difference.None of the included cases had adverse reactions.CONCLUSIONS:PGYYQR is effective in improving the quality of meibum,and the tear film stability which thereby relieving the ocular symptoms in MGD-related DED patients with hyperactivity of Yang due to Yin deficiency pattern.