Protective effect of Tinospora cordifolia, Phyllanthus emblica and their combination against antitubercular drugs induced hepatic damage: an experimental study.

This study investigated the hepatoprotective effect of two Indian medicinal plants Tinospora cordifolia (Tc), Phyllanthus emblica (Pe), and their combination, in a rat model of isoniazid, rifampicin and pyrazinamide induced hepatic damage. Hepatic damage was assessed using a composite score assigned to histopathological findings of degeneration, necrosis and fibrosis. The antituberculosis treatment (ATT), when given for 90 days, induced significant degeneration and necrosis (score: 7.5; p < 0.01 vs vehicle) associated with morphological changes. However, no change was found in the serum bilirubin and liver enzymes. Co-administration of silymarin (positive control, 50 mg/kg) with ATT protected against necrosis (score: 1.5; p < 0.001 vs ATT). Tc (100 mg/kg) showed a reduction in liver damage (score: 6.5), which was not statistically significant. On the other hand, Pe (300 mg/kg) prevented the necrotic changes to a significant extent (grade 1.0; p < 0.05; score [corrected] 5.5). Combination of Tc and Pe in their therapeutic doses (1:3) significantly prevented the necrosis (score: 3.5; p < 0.001 vs ATT). Similar effects were seen even when the doses were halved and were comparable to the silymarin group. Thus, this study proves the synergistic protective effects exerted by the combination of Tc and Pe when co-administered with ATT.

A randomised double-blind study comparing sodium feredetate with ferrous fumarate in anaemia in pregnancy.

Iron deficiency anaemia is a major health problem in India especially in women of reproductive age group. The World Health Organisation recommends that the haemoglobin concentration should not fall below 11.0 g/dl at any time during pregnancy. The aim of study was to compare the efficacy and safety of two doses of sodium feredetate with ferrous fumarate in improving haemoglobin profile in pregnant anaemic women. Pregnant women with gestation period between 12 and 26 weeks having serum haemoglobin < 10 g/dl, serum ferritin levels less than 12 microg/l were included in the study. Patients were divided into 3 groups and drugs administered accordingly. A total of 48 patients were available for analysis which included 37 patients who had completed all the visits up to 75 days follow-up and 11 patients who were treatment failures. In group A combination of sodium feredetate (containing 33 mg of elemental iron) along with vitamin B12 (15 microg) and folic acid (1.5 mg) was administered twice a day. In group B combination of sodium feredetate (containing 66 mg of elemental iron) along with vitamin B12 (15 microg) and folic acid (1.5 mg) was administered twice a day. In group C combination of ferrous fumarate (containing 100 mg of elemental iron) along with vitamin B12 (15 microg) and folic acid (1.5 mg) was administered twice a day. Patients were evaluated for Hb, RBC count, MCV, MCH and MCHC at day 0, 30, 45, 60 and 75. Serum ferritin, serum iron, TIBC and transferrin saturation were assessed at recruitment and end study. Mean rise of haemoglobin at the completion of study, over that of basal values was 1.79 g/dl (0.71 to 2.87, 95% CI, p < 0.05) in group A, 1.84 g/dl (0.82 to 2.86, 95% CI, p < 0.05) in group B and 1.63 g/dl (0.38 to 2.88, 95% CI, p < 0.05) in group C. Safety assessment was done by doing liver and kidney function test at the time of recruitment and end study. Low doses of sodium feredetate (33 mg and 66 mg of elemental iron given twice daily) produce comparable results as higher dose of ferrous fumarate (100 mg elemental iron given twice daily). As there were no adverse effects reported with sodium feredetate, it can be concluded from this study that this new formulation appears to be effective in improving haemoglobin profile in pregnant anaemic women and is tolerated well.