Objective To observe the clinical efficacy of Bushen Runzao Fang（ 补肾润燥方

BRF） in treating middle-aged and elderly female patients with Sjogren’s Syndrome（ SS）. Methods Fifty-six middle-aged and elderly SS female patients with liver and kidney Yin deficiency type were randomized into a treatment group and a control group

with twenty-eight cases in each group. The control group was given oral Hydroxychloroquine Sulfate Tablets

100 mg each time

twice a day

while the treatment group was administered BRF with one dose a day. Both groups were treated for 12 weeks. EULAR Sjogren’s Syndrome Patient Reported Index（ ESSPRI） and EULAR Sjogren’s Syndrome Disease Activity Index（ ESSDAI） were evaluated. Schirmer’ s test

saliva flow rate（ SFR）

sex hormones

erythrocyte sedimentation rate（ ESR）

C-reactive protein（ CRP）

globulin and Ig G were detected before and after treatment. Clinical efficacy and adverse reactions were also observed. Results Twenty-five cases completed the treatment courses in the treatment group

and the total effective rate was 76%; while nineteen cases completed the courses in the control group

and the total effective rate was 21%. The clinical efficacy in the treatment group was significantly better than that in the control group（ P < 0. 05）. After treatment

ESSPRI

Schirmer’s test and SFR improved significantly in the treatment group（ P < 0. 05）

and compared with those in the control group

the ESSPRI in the treatment group were significantly lower

while Schirmer’s test and SFR in the treatment group improved significantly（ P <0. 05）. However

between before and after treatment as well as between the two groups

there was no significant differences in ESSDAI（ P > 0. 05）. After treatment

levels of testosterone and dehydroepiandrosterone sulfate（ DHEA-S） increased significantly than those before treatment in both groups（ P < 0. 05）

while there were no significant differences in level of estradiol between before and after treatment

as well as between the two groups（ P >0. 05）. Also there were no significant differences in levels of ESR

CRP

globulin and Ig G between before and after treatment

as well as between the two groups（ P > 0. 05）. Conclusion BRF seems to show good effect on improving the subjective symptoms

SFR and tear secretion function in middle-aged and elderly SS female patients. The mechanism might be associated with regulating sex hormone level.