The efficacy and safety of herbal medicine combination for management of leg symptoms due to chronic venous diseasethai patients : a double blind ed randomized controlled trial.

Abstract

The herbal medicine combination containing 2% Asiaticoside and 1% Acemannan in a 2% Acetyl Salicylic Acid in beeswax encapsulation as an ACTIVE treatment ( HMC) was developed as a topical gel preparation as treatment options for Chronic Venous Disease (CVD) with mild-to-moderate severity. Methods: The efficacy and safety of HMC as compared with a CONTROL treatment (C) (2% Acetylsalicylic Acid) was investigated in a double-blind randomized controlled trial, 42 CVD patients, 21 of whom allocated either HMC or C, for 12-week continuous treatment. The efficacy assessment employed Venous Clinical Severity Score (VCSS), Physician-Rating Symptoms Perception Score (PRSPS), Patients Self-Rating Symptoms Score (PSSS) and two types of short-form health-related quality of life scores, a Medical Assessment Study, 14-item Chronic Venous Disease (MOS CIVIQ 14), and a 12-items Genearal Health (MOS SF 12). The short-term safety assessed with patients-self reported adverse events. The primary endpoint was a responder rate defined by 50% reduction of the VCSS after 4-weeks of treatment from baseline. The secondary endpoints assessed improvement of overall sympotms assessed by VCSS, PRSPS, PSSS, MOS CIVIQ 14 and MOS SF12 accordingly. Results: CVD Thai patients(N= 42) in general and regardless of clinical severity class (CEAP1/ CEAP2) or Comorbidity responded 57.14 % to HMC(N= 21) as compared with 9.52% for C(N= 21), the responder rate was significantly dependent on intervention, p= 0.003, P= 0.003 and p= 0.003 respectively. HMC reduced VCSS significantly better than C, overtime at 4-weeks 11.9048(6.4908) VS 22.4702 (7.9438) p<0.001. HMC reduced PRSPS and PSSS significantly better than C, at Basline to 2-weeks p=0.001 and p=0.017, 2-4 weeks p=0.001 and p= 0.004, and 8-12 weeks p= 0.001 and p= 0.003 respectively. After 12-weeks from baseline, both global and subscore for MOS SF 12 MOS CIVIQ-14, treatment with HMC and C significantly improved at p<0.001, p<0.001 (MOS CIVIQ 14) respectively. For adverse drug events reported, no statistical significant different between HMC and C from baseline to the end of 12-week follow-up (p= 0.756) . Conclusion. The herbal medicine combination containing 2% Asiaticoside, 1% Acemannan in 2% Acetyl Salicylic Acid in Beeswax encapsulation (HMC) as a gel preparation topical administration provided clinical responder rate better than the Control. Both HMC and C were not significant different in terms of safety assessment.