ChatGPT In a randomized controlled trial, 136 patients with primary Sjögren's syndrome (pSS) meeting the inclusion criteria were enrolled and randomly divided into two groups of 68 each. The treatment group received an optimized program combining Chinese and Western medicine for pSS glandular injury, while the control group received a conventional program for pSS glandular damage. The primary efficacy endpoint was the 12-week non-stimulated salivary flow rate (UWS) score. Secondary efficacy endpoints included the glandular damage Visual Analog Scale (VAS) scores, the European Sjögren's Syndrome Patient Reported Index (ESSPRI), among others. The treatment course lasted 12 weeks. The efficacy and safety of the optimized program for pSS glandular injury were evaluated by comparing within and between groups before and after treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
136
The Yi Qi Yang Yin Decoction (Dihuang 15g, Baihe 12g, Nanshashen 15g, celery Qinghao 10g, Malt 10g, Shengma 6g, Chaihu 6g) prescription for patients eligible for qi and yin deficiency was 200 ml twice daily for 12 weeks.
Hydroxychloroquine Sulfate Tablets 200-400mg daily for 12 weeks.
China-Japan friendship hospital
Beijing, Beijing Municipality, China
UWS score
unstimulated flow rate of saliva score. it is positive if the UWS ≤1.5 ml/15 min（or 0.1 ml/min). Higher scores(ml/min) mean a better outcome.
Time frame: 12 weeks after treatment
VAS score
the glandular damage Visual Analog Scale score(dryness, fatigue and pain in the limbs). Patient self-assessed VAS scores ranged from 0 to 10. Higher scores mean a worse outcome.
Time frame: 12 weeks after treatment
ESSPRI
the European Sjögren's Syndrome Patient Reported Index, average of dryness, fatigue and pain in the limbs VAS scores. ESSPRI score varies from 0 to 10. Higher scores mean a worse outcome.
Time frame: 12 weeks after treatment
Schirmer test
Lacrimal secretion test. it is positive if the UWS ≤5 mm/5 min（or 1 mm/min). Higher scores(mm/min) mean a better outcome.
Time frame: 12 weeks after treatment
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