The efficacy of Jujube syrup on the prevention of drug‐induced hepatotoxicity in pulmonary tuberculosis patients: A pilot randomized double‐blind placebo‐controlled clinical trial

Abstract

Liver injury is the most common complication of anti‐tuberculosis drugs that can cause significant problems. The study aimed to determine the effectiveness of Jujube syrup on the prevention of antituberculosis drug‐induced hepatotoxicity (DIH). This pilot randomized double‐blind study was conducted based on a placebo‐controlled design in patients with tuberculosis (TB). The patients were divided into two groups based on the block random allocation method and received 10 cc of jujube or placebo syrup per day. The liver enzyme levels were assessed as primary outcomes, and the severity of cough, anorexia, and nausea along with the quality of life (QOL) was assessed as secondary outcomes. Finally, eight and nine patients in the jujube and placebo groups completed the study, respectively. In the second week of the study, 27.3% of the patients in the placebo group developed hepatotoxicity. Moreover, there was no liver toxicity in the jujube group. This difference between the two groups was statistically significant (p = .037). Furthermore, the severity of cough in patients in the jujube group decreased significantly during weeks 2 and 4. The QOL significantly improved in the jujube group, compared to the placebo group. This study suggested that Jujube syrup could prevent anti‐TB DIH. It can also improve the severity of cough and the QOL in pulmonary TB patients.

A Literature Review of the Pharmacological Effects of Jujube

“…Jujube is traditionally considered a tonic for enhancing liver function and preventing hepatic diseases. As shown in Table 6, in a clinical study on tuberculosis patients, jujube syrup effectively prevented antituberculosis drug-induced liver damage [58]. According to animal and cellular experiments, jujube polysaccharide and flavonoid improved liver impairment by activating the body's antioxidant system and inhibiting inflammatory responses [8,12].…”

Unveiling the therapeutic promise of natural products in alleviating drug‐induced liver injury: Present advancements and future prospects

“…The results revealed a remarkable finding, as 27.3% of the placebo group exhibited hepatotoxicity, while no toxicity was observed in the jujube group. Additionally, the treatment group showed a significant improvement in the quality of life compared to the placebo group (Maddahi et al, 2022). In another double‐blind, randomized, placebo‐controlled trial (NCT01800487), the clinical effectiveness of silymarin against antituberculosis DILI was tested.…”

Dietary patterns and the risk of tuberculosis-drug-induced liver injury: a cohort study

“…Epidemiological studies indicated that body mass index (BMI) was negatively associated with the risk of TBLI (7). Randomized controlled trials indicated that carnitine, jujube syrup, and Lactobacillus casei could provide protection against TBLI (8)(9)(10). Carnitine and jujube syrup alleviated hepatocellular damage-type TBLI, which manifested as significant elevations of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) (8,9).…”

“…Randomized controlled trials indicated that carnitine, jujube syrup, and Lactobacillus casei could provide protection against TBLI (8)(9)(10). Carnitine and jujube syrup alleviated hepatocellular damage-type TBLI, which manifested as significant elevations of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) (8,9). The L. casei intervention alleviated cholestasis-type TBLI (manifested as significant elevations of alkaline phosphatase and total bilirubin) by modulating the gut microbiota, reducing the blood liposaccharide content, and improving intestinal permeability (10).…”