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BackgroundShortening tuberculosis (TB) treatment duration is a research priority. This paper presents data from a prematurely terminated randomized clinical trial, of 4-month moxifloxacin or gatifloxacin regimens, in South India.MethodsNewly diagnosed, sputum-positive HIV-negative pulmonary TB patients were randomly allocated to receive gatifloxacin or moxifloxacin, along with isoniazid and rifampicin for 4 months with pyrazinamide for first 2 months (G or M) or isoniazid and rifampicin for 6 months with ethambutol and pyrazinamide for first 2 months (C). All regimens were administered thrice-weekly. Clinical and bacteriological assessments were done monthly during treatment and for 24 months post-treatment. The Data and Safety Monitoring Board recommended termination of the trial due to high TB recurrence rates in the G and M regimens.ResultsOf 416 patients in intent-to-treat analysis, 6 (5%) of 124, 2 (2%) of 110 and 2 (2%) of 137 patients with drug-susceptible TB in the G, M and C arms respectively had unfavorable response at the end of treatment; during the next 24 months, 17 (15%) of 115, 11 (11%) of 104 and 8 (6%) of 132 patients respectively, had TB recurrence. Of 38 drug-resistant patients 1 of 8 and 3 of 26 in the G and C arms respectively had unfavourable response at the end of treatment; and TB recurrence occurred in 2 of 7 and 2 of 23 patients, respectively. The differences in TB recurrence rates between the G and C arms was statistically significant (p = 0.02). Gastro-intestinal symptoms occurred in 23%, 22% and 9% of patients in the G, M and C arms respectively, but most reactions were mild and manageable with symptomatic measures; 1% required regimen modification.Conclusions4-month thrice-weekly regimens of gatifloxacin or moxifloxacin with isoniazid, rifampicin and pyrazinamide, were inferior to standard 6-month treatment, in patients with newly diagnosed sputum positive pulmonary TB.Trial RegistrationClinical Trials Registry of India CTRI/2012/10/003060

The present study was undertaken to evaluate the efficacy of radiotherapy in palliation of dysphagia in patients with squamous cell carcinoma (SCC) of esophagus and to see the quality of life (QoL) following radiotherapy. This was a prospective clinical study done between September 2006 and May 2008. All consecutive patients with SCC of the esophagus, who are not candidates for definitive treatment, were included in the study. Dysphagia and QoL were assessed using modified Takita's grading and modified questionnaire based on EORTC QLQ 30 respectively. External beam radiotherapy (EBRT) was delivered to all patients using linear accelerator 6 Mv photons. Patients who had good response with EBRT were further subjected to intraluminal brachytherapy (ILBT) at 700 cGy using Iridium-192. The cumulative dose each patient received was 65 Gy. Patients were followed up at 6 weeks from completion of treatment to look for any difference in dysphagia grade and QoL following therapy. Thirty-three patients were included in the study. The mean age among males and females was 60.9 and 49.8 years, respectively. Nineteen patients (57.6 %) received EBRT followed by ILBT; the remaining patients received only EBRT. Seven were lost during follow-up, and seven (21.2 %) died during the study period of 6 weeks. Nineteen (57.6 %) were followed up. On follow-up endoscopy, evidence of residual stricture was observed in 57.9 %, and growth in 36.8 %. Of the patients, 27.8 % had biopsy-confirmed residual disease. The median dysphagia score decreased from 4 to 3 after treatment (p = 0.002) in 17 (89.5 %) patients. The mean QoL score improved from 107.5 to 114.1 at 6-week follow-up. Following radiotherapy, 26.3 % had persistent chest pain, increased cough with expectoration in 15.8 %, and hyperpigmentation of skin in 10.5 %. Radiotherapy gives significant relief of dysphagia and improves QoL in 90 % of patients with SCC of esophagus. However, following radiotherapy, a number of patients will have persistent stricture, ulceration, and residual disease.

We performed a randomised, controlled clinical trial to compare ambulant short-course chemotherapy with anterior spinal fusion plus short-course chemotherapy for spinal tuberculosis without paraplegia. Patients with active disease of vertebral bodies were randomly allocated to one of three regimens: a) radical anterior resection with bone grafting plus six months of daily isoniazid plus rifampicin (Rad6); b) ambulant chemotherapy for six months with daily isoniazid plus rifampicin (Amb6); or c) similar to b) but with chemotherapy for nine months (Amb9). Ten years from the onset of treatment, 90% of 78 Rad6, 94% of 78 Amb6 and 99% of 79 Amb9 patients had a favourable status. Ambulant chemotherapy for a period of six months with daily isoniazid plus rifampicin (Amb6) was an effective treatment for spinal tuberculosis except in patients aged less than 15 years with an initial angle of kyphosis of more than 30 degrees whose kyphosis increased substantially.

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