34. A randomized double-blind placebo-controlled clinical trial on the effect of Bio-Normalizer on liver cirrhosis

O.Samar-Sy, A.Espiritu, E.Estadilla-Pornillos,R.Espiritu,S.Corpuz Jr, H.Te, R.Paduga Jr., and J.A Osato
Phil.J. Internal Medicine,35:189-194: July-Aug., 1997

   Bio-Normalizer is a natural health food product processed from papaya with demonstrated antioxidant and immunomodulatory capabilities. A randomized, double-blind, placebo-controlled clinical trial was performed at the Bicol Regional Hospital to determine the effect of Bio-Normalizer on patients with liver cirrhosis. Twenty nine patients from different areas of Bicol Region with confirmed diagnosis of cirrhosis participated of whom 22 were males and 7 were females. Their ages ranged from 20 to 80 years with the mean of 51.4 years. The patients were randomly assigned to one of two groups. Group A (n=16) was given Bio-Normalizer and Group B (n=13) received placebo for 2 months. The standard medications to treat the complications of cirrhosis were not withheld. The patients were monitored weekly and laboratory examinations were done at 2 weeks interval for 2 months. There were more drop-outs either because of death or withdrawal due to deteriorating condition in Group B. 8 out of the 13 patients who received placebo were not able to finish the 2 months study duration compared to only 3 of the 16 patients in the Bio-Normalizer group. The results showed that 81.2% of patients survived in the Bio-Normalizer group compared to 38.5% of the patients in the Placebo group. There was a statistically significant improvement noted for Bio-Normalizer on the general well-being (x2=6.53, p=0.01) and body malaise scores (x2=4.14, p=0.047). A follow-up study is necessary to increase the number of subjects yield and additional laboratory examinations should be included such as the in vivo detection of the immune system status and the free radical levels.