The hepatoprotective effect of birch bark extract (BBE) in patients with chronic hepatitis C (CHC) was studied. Forty-two patients with serologically confirmed chronic hepatitis C were treated for 12 weeks with 160 mg standardized BBE per day. The primary outcome parameter measured was the rate of alanine aminotransferase (ALT) normalization after 12 weeks. Secondary parameters included the course of ALT, aspartate aminotransferase (AST) levels, quantitative HCV RNA levels, subjective symptoms associated with CHC (fatigue, abdominal discomfort, depression, and dyspepsia), safety and compliance. The qualitative-quantitative analysis of BBE was made using high performance liquid chromatography to confirm the presence of 75% betulin and 3.5% betulinic acid. Significant differences in the mean ALT and HCV RNA levels were observed after 12 weeks of treatment. The level of ALT was decreased in 54.0% and normalized (p=0.046). HCV RNA was reduced in 43.2% (p=0.016). After 12 weeks of treatment, reports of fatigue and abdominal discomfort were reduced by 6-fold (p=0.028) and 3-fold (p=0.05), respectively. Dyspepsia was no longer reported (p=0.042) and the effect was significantly different from baseline. Because this study lacks a control group clinical relevance of the data can only be estimated in future by following controlled clinical trials.
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