Mumbai Protocol: a safer solution to Tuberculosis

Mumbai Protocol: a safer solution to Tuberculosis

Tuberculosis is a disease known to all in the medical community and dreaded amongst the commoners. Despite of schemes at national and international levels, it remains a cause of morbidity and mortality in developing and under-developed nations worldwide. Primarily caused by Mycobaterium tuberculosis, it usually affects the lungs, causing pulmonary tuberculosis. But they can also affect other parts such as bones, urinary tract, abdomen etc., leading to extra-pulmonary tuberculosis. Other bacteria causing tuberculosis in rare instances are Mycobaterium canetti, Mycobacterium africanum, Mycobacterium bovis and Mycobacterium microti. The disease has been an intense topic of discussion and debate in the medical community for decades. But, the focus of our discussion here remains the treatment part of it.

The first line management globally (Conventionally recommended method) used to treat tuberculosis is 2 months intensive phase therapy, using a four drug regimen including Rifampicin, Ethambutol, Pyrazinamide and Isoniazid, after which TB is eliminated, but, in order to, avoid recurrence of the disease, the treatment is continued for 4 more months with Pyrazinamide and Isoniazid. Over the time, the bacteria has acquired resistance against many of the anti-tuberculosis drugs and has given rise to drug resistant varieties; mono-drug resistant type – having resistance only against one of the drug (Rifampicin here); polydrug resistant type – having resistance against more than one of the first line therapy drugs as mentioned above but not to Rifampicin and Isoniazid; and multidrug resistant type – having resistance against at least both Rifampicin and Isoniazid, the two most potent drugs.  


Another major setback in TB management is high toxicity of the drugs used. Rifampicin being regarded as the gold standard drug along with Pyrazinamid has intense hepato-toxicity (affects liver) and on the other hand Isoniazid is infamous for neurotoxicity (affects nervous system) and Ethambutol showing ototoxicity (affects the inner ear or auditory nerve) to some extent. Hence, at the current medical society, intensive research is underway regarding the choice of drugs against it and establishing a perfect approach in which the problem arising from drug resistance and toxicity would be eliminated.  

Treatment and dosage

The recent research and newly constructed regimen by Dr. S. Samajpaty and his co-worker has created the shot in darkness, the “Mumbai Protocol”. An experimental case study where the team cured middle aged woman with completely disrupted liver function with all LFT (Liver Function tests) parameters at an alarming level. A completely new set of drugs were used by the team that included Streptomycin, Cycloserine, P-amino salicylic acid and Ethambutol in a 2 months of intensive therapy. This is followed by a continuation phase of 4 months to avoid recurrence of the disease. In the 2 month phase, all the four drugs were used with Streptomycin IM injection of 1g was given to the patient twice a week only, in a gap of 3 days, Cycloserine (500mg) twice, P-amino salicylic acid (4g) was given once daily by sprinkling it on slightly acid food and Ethambutol (400mg) was given once daily. Within one month complete disappearance of tuberculosis was reported using blood test (IGRA) along with complete normalization of liver function; concluding that TB itself can cause hepatocyte destruction and in such instance importance of Mumbai Protocol becomes infallible.

This has been a major development in the strategy of TB management as the drugs which were used by Dr. S. Samajpaty and co-workers neither has any complaint of toxicity as such nor have been reported any significant development of resistance pharmacologically. At this epoch of time when we aim for complete eradication of tuberculosis globally by 2030, such development shares a bright spot in the clinical practice of medicine. The protocol might prove to be of high importance in countries like India, Russia and Middle Eastern countries which show promising dynamics in the mission of TB eradication.

For further reading: International Journal of Tropical Disease and Health

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