[Show abstract][Hide abstract] ABSTRACT: This Phase IIb, placebo-controlled study involved 55 TB patients treated with anti-TB therapy. They were divided into two groups, matched by age, gender, baseline bodyweight and clinical manifestations: one group (n = 27) received a once-daily V-5 Immunitor (V5) immunotherapy pill and the other (n = 28) received placebo. Only one (3.7%) and three (10.7%) subjects in V5 and placebo arms, respectively had first-diagnosed, drug-sensitive TB; the remaining patients had re-treated TB, multidrug-resistant TB or HIV-TB coinfection. After 1 month, 26 out of 27 patients (96.3%) became sputum smear negative in the V5 group (p < 0.0000001), whereas seven out of 28 (25%) in the placebo group had converted (p = 0.005). V5 contributed to the downregulation of TB-associated inflammation, as shown by normalization of high leukocyte counts, erythrocyte sedimentation rate and faster defervescence than controls. Patients in both arms experienced an increase in the levels of hemoglobin corresponding to 128.9 ± 17.6 versus 133.1 ± 14.7 g/l (p = 0.03) and 112.6 ± 14 versus 117 ± 11.7 g/l (p = 0.03) in V5 and placebo arms, respectively. In total, 19 out of 28 placebo patients (67.9%) gained, on average, 1.07 kg (59.1 ± 10 vs 60.1 ± 10.4 kg; p = 0.003). By contrast, all patients in the V5 group gained weight with mean 3.4 kg (59.7 ± 8 vs 63.1 ± 9 kg; p = 5.7E-007). Clinical symptoms improved among all patients in V5 arm, while 28.6% of patients on placebo reported satisfactory results (p = 0.007). No adverse or side effects attributable to V5 were seen at any time. Further studies are needed to gauge the extent of the benefits of V5 as safe and effective adjunct immunotherapy for TB.
[Show abstract][Hide abstract] ABSTRACT: Prognosis for TB/HIV co-infection is very unfavourable. In terminally-ill patients treatment options are often limited to palliative care. In our salvage, 2-month therapy of 40 late-stage TB/HIV patients we administered to half of the patients TB drugs along with over-the-counter botanical immunomodulator Dzherelo (Immunoxel). Despite best possible care 6 patients had died. Remaining 14 patients experienced marked clinical improvements and one patient was discharged due to full recovery. Among 20 matched subjects on conventional TB regimen, 12 died and only one was slightly better-off. These results indicate that Dzherelo might reduce mortality (P=0.055) and improve significantly the quality of life (P=0.00002). Improvement in quality of life is also supported by substantial weight gain (mean/median 3.3/4 kg) in much higherproportion of patients than among those who received TB drugs only, i.e., 16 vs. 1 (P=0.000001). At the end of two months 13 (65%) patients became sputum smear negative versus only one individual (5%) in ATT group (P=0.00007). These results suggest that adjuvant immunotherapy improves significantly therapy outcome andreduces mortality. Larger study is warranted to confirm the benefit of Dzherelo.
Journal of Antivirals and Antiretrovirals 01/2009; 01(02).
[Show abstract][Hide abstract] ABSTRACT: Open-label, salvage anti-tuberculosis therapy (ATT) combined with DZHERELO (IMMUNOXEL), SVITANOK, and LIZORM – over-the-counter immunomodulators from medicinal plants – was conducted in 20 Ukrainian patients, comprising seven who had HIV co-infection. Except five patients with HIV, all other individuals had multidrug-resistant TB (MDR-TB) including 7 (35%) patients with XDR-TB. Patients hospitalized in our TB dispensary were treated under directly observed therapy (DOT) until repeated negative culture conversion and recuperation from radiological and clinical symptoms. The average duration of therapy was 16.2 ± 5.2 weeks (range 10.6-30.3; median 16). The mean time to bacterial clearance was 4.4 ± 1.8 weeks (range 1.3-8.9, median 4.3). All patients (95%), except one, gained weight, ranging between 3-17 kg with average 8.7 kg (P=0.000009). The liver function tests revealed that the level of total bilirubin had decreased from 15.5 to 11.6 μmol/L (P=0.009). Alanine transaminase (ALT) declined from elevated 53.1 IU/L to normal 30.4 IU/L level (P=0.001). Hemoglobin levels increased from 103.2 to 117.3 g/L (P=0.00005). Inflammation-associated, elevated leukocyte counts returned back to normal from 8.9 to 6.9 × 10 9 cells/L (P=0.003). Patients improved clinically and radiologically and were hence discharged from the hospital. These findings support prior trials indicating clinical benefit of adding immunomodulators to TB treatment regimens. The combination of ATT with botanical preparations enhances the clinical efficacy of DOT and is safe and beneficial even to patients with poor prognosis due to drug resistance and/or co-infection with HIV.