L-arginine and vitamin D adjunctive therapies in pulmonary tuberculosis: a randomised, double-blind, placebo-controlled trial.

BACKGROUND: Vitamin D (vitD) and L-arginine have important antimycobacterial effects in humans. Adjunctive therapy with these agents has the potential to improve outcomes in active tuberculosis (TB). METHODS: In a 4-arm randomised, double-blind, placebo-controlled factorial trial in adults with smear-positive pulmonary tuberculosis (PTB) in Timika, Indonesia, we tested the effect of oral adjunctive vitD 50,000 IU 4-weekly or matching placebo, and L-arginine 6.0 g daily or matching placebo, for 8 weeks, on proportions of participants with negative 4-week sputum culture, and on an 8-week clinical score (weight, FEV1, cough, sputum, haemoptysis). All participants with available endpoints were included in analyses according to the study arm to which they were originally assigned. Adults with new smear-positive PTB were eligible. The trial was registered at ClinicalTrials.gov NCT00677339. RESULTS: 200 participants were enrolled, less than the intended sample size: 50 received L-arginine + active vitD, 49 received L-arginine + placebo vit D, 51 received placebo L-arginine + active vitD and 50 received placebo L-arginine + placebo vitD. According to the factorial model, 99 people received arginine, 101 placebo arginine, 101 vitamin D, 99 placebo vitamin D. Results for the primary endpoints were available in 155 (4-week culture) and 167 (clinical score) participants. Sputum culture conversion was achieved by week 4 in 48/76 (63%) participants in the active L-arginine versus 48/79 (61%) in placebo L-arginine arms (risk difference -3%, 95% CI -19 to 13%), and in 44/75 (59%) in the active vitD versus 52/80 (65%) in the placebo vitD arms (risk difference 7%, 95% CI -9 to 22%). The mean clinical outcome score also did not differ between study arms. There were no effects of the interventions on adverse event rates including hypercalcaemia, or other secondary outcomes. CONCLUSION: Neither vitD nor L-arginine supplementation, at the doses administered and with the power attained, affected TB outcomes. REGISTRY: ClinicalTrials.gov. Registry number: NCT00677339.

Point-of-care testing of capillary glucose in the exclusion and diagnosis of diabetes in remote Australia.

OBJECTIVES: To determine the utility of point-of-care (POC) capillary blood glucose measurements in the diagnosis and exclusion of diabetes in usual practice in primary health care in remote areas. DESIGN: Cross-sectional study comparing POC capillary glucose results with corresponding venous glucose levels measured in a reference laboratory. PARTICIPANTS: 200 participants aged 16-65 years enrolled: 198 had POC capillary glucose measurements; 164 also had acceptable venous glucose laboratory results. SETTING: Seven health care sites in the Kimberley region of Western Australia from May to November 2006. MAIN OUTCOME MEASURES: Concordance and mean differences between POC capillary blood glucose measurement and laboratory measurement of venous blood glucose level; POC capillary blood glucose equivalence values for excluding and diagnosing diabetes, and their sensitivity, specificity and positive-predictive value. RESULTS: The concordance between POC and laboratory results was high (rho=0.93, P<0.001). The mean difference in results was 0.48 mmol/L (95% CI, 0.23-0.73; limits of agreement, - 2.6 to 3.6 mmol/L). The POC capillary glucose equivalence values for excluding and diagnosing diabetes were < 5.5 mmol/L (sensitivity, 53.3%; specificity, 94.4%; positive-predictive value, 88.9%; for a venous value of < 5.5 mmol/L) and >or= 12.2 mmol/L (sensitivity, 83.3%; specificity, 99.3%; positive-predictive value, 95.2%; for a venous value of >or= 11.1 mmol/L), respectively. While the choice of glucometer and whether or not patients were fasting altered these results, they did not have a significant influence on the diagnostic utility of POC glucose measurement in this setting. CONCLUSION: POC capillary blood glucose analysers can be used as part of the process of diagnosing and excluding diabetes in remote rural communities using these locally established capillary equivalence values.