Table 2

Changes in measured clinical variables from baseline to study completion
Measured disease parameter(s) Randomization p-value (95% CI)
Drug intervention (n = 132) Placebo intervention (n = 127)
TB Severity (clinical assessment)
Mean Δ in TB score (points) ± SD, (95 CI) - 3.19 ± 2.37, (−3.61, -2.75) - 2.79 ± 2.44, (−3.23, -2.34) 0.198
Mean Δ in weight (kg), (95% CI) + 4.02, (3.18 – 4.86) + 2.61, (1.99 – 3.23) 0.007
Mean Δ in BMI, (95% CI) + 1.48, (1.17 – 1.78) + 0.96, (0.72 – 1.20) 0.008
Mean Δ in MUAC (cm), (95% CI) + 1.34, (0.74 – 1.64) + 0.97, (0.68 – 1.26) 0.079
Chest X-Ray Involvement
Mean no. of zones1 involved ± SD 1.35 ± 1.13 1.82 ± 1.35 0.004
Sputum Smear
Smear Conversion, no. (%) 2 108 (81.8) 103 (81.1) 0.39
IFN-g levels (pg/ml) mean ± SD
Unstimulated levels 3.9 ±28.7 4.3 ± 45.2 0.325
ESAT6-stimulated* 387 ±920 206 ±665 0.077
MTBs-stimulated* 3092 ±1363 2987 ±1510 0.497

MUAC Mid Upper Arm Circumference; BMI Body Mass Index; 95 CI 95% Confidence Interval; SD Standard Deviation; s-25-(OH) D3 = serum 25-hydroxyvitamin D3.

1 Division of bilateral ling fields into a total of 6 zones (3 per each lung, ‘zone involvement’ = active parenchymal and cavitary disease, exclusive of old fibrotic scarring. 2 Includes all patients who were expectorating at baseline, and claimed ‘unable to expectorate’ at completion of treatment 12 weeks later. ESAT6 early secreted and T cell activated antigen-6 kDa; MTBs Mycobacterium tuberculosis whole sonicate antigen.

*Denotes cytokine levels after subtraction of background from unstimulated cells.

Salahuddin et al.

Salahuddin et al. BMC Infectious Diseases 2013 13:22   doi:10.1186/1471-2334-13-22

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