Sumartini -. Dewi, Indonesia
Dr. Hasan Sadikin Hospital/Indonesian Rheumatology Association Internal MedicinePresenter of 1 Presentation
SKIN ANTI-FIBROSIS EFFECT OF CIPLUKAN HERB (PHYSALIS ANGULATA LINN) IN SYSTEMIC SCLEROSIS (A DOUBLE BLIND RANDOMIZED CONTROLLED TRIAL)
Abstract
Background and Aims
Systemic sclerosis (SSc) is an autoimmune disease characterized by fibrosis and vascular abnormalities. No drug significantly influences the course of SSc, many patients resistant to standard treatment, it is suspected the addition of Physalis angulata Linn (Ciplukan herb) extract can improve the SSc skin fibrosis. The aim of this study was to evaluate the effect of Ciplukan extract on skin fibrosis based on MRSS, CRP, P1NP in SSc with standard therapy.
Methods
Double-blind randomized clinical trial was performed in SSc with stable disease at RSCM and RSHS (November 2015−March 2017) who met the inclusion criteria, continued the standard therapy. The subjects were randomly divided into two groups: the study group (Ciplukan 3 x 250 mg/day for 12 weeks) and the placebo group. MRSS, CRP, P1NP were performed every 4 weeks until the end of the study.
Results
Fifty-nine subjects, divided into two groups: 29 subjects (in the study group); 30 subjects (in the placebo group), the average age of 41 ± 9 years, the proportion of women: male = 9: 1. There was a significant improvement of skin fibrosis in the study group with a relative decrease in MRSS (35.9%) compared with placebo (6.3%; p <0.001), a relative decrease in P1NP (17.8%) versus placebo (0.7%; p = 0.002), and relative decrease in CRP (16,12%) versus placebo (3,29%; p = 0.181). The adverse effect was mild gastrointestinal symptoms.
Conclusions
Ciplukan extract with dose 3 x 250 mg for 12 weeks as adjuvant therapy on SSc with standard therapy, clinically and statistically improvement of skin fibrosis.