The trial aimed to find whether metformin can reduce the time required for sputum culture to become negative in pulmonary TB patients.
Diabetes drug metformin can play a key role in preventing lung tissue fibrosis, and thereby improve the quality of life for patients who have undergone treatment for tuberculosis, results of a new clinical trial showed.
In 2021, India had around 1.93 million detected cases of TB, a disease the central government aims to eliminate by 2025. At present, metformin is prescribed for patients to control high blood sugar in people with Type-2 diabetes.
The clinical trial was conducted by ICMR National Institute for Research in TB (ICMR-NIRT), in collaboration with Pune-based ICMR National AIDS Research Institute (ICMR-NARI). The trial aimed to find whether metformin can reduce the time required for sputum culture to become negative in pulmonary TB patients.
“We had around 322 patients who were diagnosed with pulmonary TB and were found to have TB bacilli in their sputum. The risk of acquiring TB from such patients is high among their household contacts," said Dr Abhijit Kadam, scientist and co-investigator in the trial. He said metformin did not reduce the time required for sputum culture to become negative, but improved lung health by reducing tissue fibrosis.
The trial was performed at three different sites across India (ICMR NIRT, ICMR NARI and the All India Institute of Medical Sciences in Delhi) between 2018 and 2021. Patients over 18 years were screened and enrolled with the help of National TB Elimination Program (NTEP) staff.
A chest x-ray was done at the end of eight weeks, and again after six months of completing treatment for all participants. All trial-related documents and procedures were reviewed by regulatory bodies of the respective institutes. “Post-TB treatment many patients have extensive cough due to damages to lung tissues. The trial shows that metformin has diminished excess inflammation, thus reducing lung tissue damage as seen by faster clearance on x-ray. This anti-diabetic drug improves the quality of life of an individual after completion of TB treatment," Dr Kadam said. “For the initial eight weeks, participants received either the standard anti-tuberculosis treatment (ATT) or standard ATT plus metformin, given orally as 500mg once daily for one week, followed by 1000mg of metformin daily for the remaining seven weeks under supervision. All the participants were followed up at regular intervals till the participant completed six-month ATT. Sputum samples were collected once a week during the first eight weeks and once a month for the remaining 16 weeks and tested for AFB by smear and cultures," added Dr Megha Mamulwar, scientist and site principal investigator for the trial at ICMR-NARI.
The findings of the trial have been published in Clinical Infectious Diseases Journal of Oxford University Press. The health ministry has conducted a national TB prevalence survey (2019-2021) to know the actual disease burden in India at the national level. As per the survey findings, Delhi (534), Rajasthan (484), Uttar Pradesh (481), Haryana (465), Chhattisgarh (454) are top five States reporting prevalence of TB cases per lakh population.
Source: Mint