A randomized, double-blinded, controlled trial of herbal medicine combination for leg symptoms due to chronic venous disease

Abstract

Background: The herbal medicine combination (HMC) containing 2% Asiaticoside and 1% Acemannan, in a Beeswax encapsulation of 2% Acetylsalicylic acid base, was developed as a topical treatment option for mild-to-moderate chronic venous disease (CVD). For control (C), Beeswax encapsulation of 2% Acetylsalicylic acid base was used. Methods: A double-blinded, randomized controlled trial comparing HMC with C was investigated among 42 CVD patients; 21 patients was allocated to receive either HMC or C, for a continuous 12-week treatment. To assess the efficacy, the following were employed: (i) Venous Clinical Severity Score (VCSS), (ii) Patients Self-Rating Symptoms Score (PSSS), and (iii) Short-form health-related quality of life score based on a Medical Outcomes Study 14-item Chronic Venous Disease (MOS CIVIQ14). The short-term safety was assessed by the patients' self-reported adverse events. The primary endpoint was a responder rate defined by a 50% reduction of the VCSS from baseline after 4 weeks of treatment. The secondary endpoints were assessed by improvement of overall disability after employing VCSS, PSSS, and MOS CIVIQ14, accordingly. Results: CVD Thai patients (N=42), regardless of clinical severity of CEAP class (CEAP1/CEAP2)or co-morbidity, responded 57.14% to HMC (N=21) as compared with 9.52% to C (N=21) the responder rate was significantly dependent on intervention (p=0.003 and p=0.003, respectively). HMC reduced VCSS markedly better than C, over the 4 weeks: 11.9048 (6.4908) vs. 22.4702 (7.9438), p<0.001. HMC reduced VCSS and PSSS scores significantly better than C did: from baseline to 2 weeks (p=0.001 vs. p=0.017, respectively), from 2 to 4 weeks (p=0.001 vs. p=0.004, respectively), and from 8 to12 weeks (p=0.001 vs. p=0.003, respectively). After 12 weeks from baseline, from both the global and subscores for MOS CIVIQ14, treatment with HMC and C significantly improved scores (p<0.001 and p<0.001, respectively). For the adverse drug events reported, there were no statistically significantly differences between HMC and C from baseline to the end of the 12-week follow-up (p=0.756). Conclusion: The herbal medicine combination (HMC), consisting of 2% Asiaticoside and 1% Acemannan in Beeswax encapsulation of 2% Acetylsalicylic acid, as a topical administration in optional medical management for Thai patients with leg symptoms due to chronic venous disease, provided a clinical responder rate that was better than that of control. In terms of short-term safety assessments, no significant statistical differences for adverse events were reported with regards to incidence for both HMC and C treatments. Further studies are warranted to explore and develop this herbal medicine base combination. Trial registration no.: ISRCTN54360155