DOI: 10.14457/tu.the.2023.1019
title: Quality control and efficacy of Thatbunjob remedy in abdominal pain relief of patients with foodborne illness

description: This comprehensive study delves into the multifaceted aspects of Thatbunjob (TBJ), a Thai traditional medicine enlisted in Thailand's national essential medicines, primarily utilized for mitigating symptoms associated with diarrhea and bloating. Despite its extensive historical application, the lack of rigorous clinical studies has left the efficacy of TBJ unverified. This research aims to bridge this gap by conducting a meticulous examination involving In-vitro study, medicinal quality assessment, chemical analysis, and clinical trials to substantiate the therapeutic potential of Thatbunjob. The antimicrobial findings significantly contribute to reaffirming TBJ's confirmed antibacterial properties. Results align with previous research, demonstrating effectiveness against gastrointestinal pathogens such as S.aureus and S.dysenteriae, with MIC values of 1.25 and 5 mg/mL, respectively. The investigation into the anti-inflammatory properties of the 95% ethanolic extract from Thatbunjob involved a detailed assessment of its impact on nitric oxide, Interleukin 6, and tumor necrosis factor-alpha production in LPS-induced RAW 264.7 cells. The study revealed a substantial inhibitory effect on nitric oxide and IL-6 production, with an IC50 value of 64.13 ± 1.84 and 87.69 ± 0.07 μg/mL. No inhibitory effect was observed in tumor necrosis factor-alpha production. In the anti-foaming assay, Thatbunjob exhibited notable superiority over simethicone, showcasing a rapid onset in the initial phase. It is highlighted that Thatbunjob's potential significance in managing conditions characterized by excessive gastrointestinal gas offers a promising approach to relieve associated symptoms, such as abdominal discomfort. The chemical fingerprint analysis of Thatbunjob and confirmation through UV spectra provided substantial evidence supporting the identification of gallic acid, chebulagic acid, ellagic acid, and eugenol. The HPLC method validation adheres to ICH guidelines, suggesting its potential future use in controlling the amount of Thatbunjob's main chemical. The clinical trial process starts with drug production and quality testing. Once the drug met predefined standards, individuals aged 18 to 60 experiencing frequent diarrhea were evaluated for inclusion criteria. After treatment completion and questionnaire receipt from all 114 participants, statistical analysis of clinical results ensued.In the patients' enrollment and baseline clinical characteristics phase, the clinical trial utilized Thatbunjob and placebo capsules, adhering to defined quality standards. Of 114 initially enrolled participants, 109 subjects (Thatbunjob group = 55, placebo group = 54) completed the trial, with exclusions primarily due to non-compliance. Baseline characteristics analysis revealed no statistically significant differences in sex distribution and mean age between the Thatbunjob and Placebo groups. Both groups exhibited comparable male-to-female ratios and mean ages. Pre-intervention baseline VAS scores showed no significant differences, and an analysis of pain scores from the Applied Thai Short-form McGill Pain Questionnaire revealed no significant differences in various pain descriptors, except for the Sickening category (p-value = 0.042). The study exhibited a significant reduction in VAS scores among abdominal pain patients administered with Thatbunjob compared to the placebo group. This aligns with prior research highlighting herbal interventions' potential in ameliorating pain perception, indicating the potential therapeutic efficacy of Thatbunjob in managing symptoms associated with diarrhea. Results from the clinical trial provided compelling evidence of Thatbunjob's efficacy in alleviating abdominal pain and associated symptoms. Pain reduction within the initial 24 hours was significantly higher in the Thatbunjob group (52.7%) compared to the placebo group (9.3%). VAS scores for the Thatbunjob group were consistently significantly lower across multiple time points (24-, 48-, and 72-hours post-treatment), highlighting sustained efficacy in alleviating pain. In the initial 24-hour period, the Thatbunjob group exhibited significantly lower Buscopan tablet usage (16.4%) compared to the placebo cohort (44.4%), indicating reduced reliance on medication. No individuals in the Thatbunjob group required up to 3 Buscopan tablets per day, while a small percentage in the placebo group did. Although no significant difference in stool frequency was observed at the pretreatment assessment (0 hours), the Thatbunjob group exhibited significantly fewer stool occurrences at 24-48 hours post-treatment compared to the Placebo group, underscoring the effective properties of Thatbunjob in mitigating diarrhea.The quality control assessment of Thatbunjob products in Thailand's market, encompassing TBJ1 as the authentic drug and TBJ2 through TBJ8 as distinct products, involved a meticulous examination of physical and chemical attributes. The evaluation revealed that certain variations were observed among the products. Notably, deviations were found in water extractive value and ash content for some samples. Furthermore, microbial contamination testing identified areas for improvement in total aerobic bacterial testing for three samples. Comparisons of their concentrations of gallic acid, chebulagic acid, ellagic acid, and eugenol to the authentic drug (TBJ1) revealed significant variations. This emphasizes the impact of environmental factors on the secondary metabolites of medicinal plants. The observed differences underscore the necessity for robust quality control measures to maintain consistent levels of active compounds in Thatbunjob products.In summary, the presented findings offer valuable insights into the potential efficacy of Thatbunjob for alleviating gastrointestinal discomfort and associated symptoms. The results underscore the imperative for standardized production processes and emphasize the necessity for continued research in this domain.