[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: V-5 Immunitor (V5) has been evaluated in patients with chronic hepatitis C with concomitant HIV and Mycobacterium tuberculosis infections. Once-daily tablet of V5 was administered per os to 20 patients for one month. Every patient who entered the study had enlarged liver, elevated hepatic damage markers, which at the end of study have improved in 19 out 20 (95%) patients. The reduction was highly signifi cant, from 1.72±0.34 to 0.18±0.28 μmol/ml•h (P=5.0 E-012) and 22.1±3.4 to 10.9±2.5 μM/L (P=5.7 E-009) for ALT and total bilirubin respectively. Enlarged liver reduced from 3.5±1.4 to 0.95±1.1 cm above normal size (P=2.9 E-009). As patients were hospitalized in TB hospital they were treated with standard anti-TB therapy (ATT) in addition to V5. Surprisingly, V5 appeared to contribute to higher and faster than expected sputum conversion rate; 94.4% of smear-positive patients became negative within one month. TB-associated fever subsided within mean/median 4.1/3 days; indicators of infl ammation such as elevated erythrocyte sedimentation rate and high leukocyte counts returned back to normal from 32.3±11.4 to 9.9±6.4mm/h (P=3.7 E-008) and 14.3±3.9 to 4.7±1.4x109L (P=7.1 E-010) respectively. Average body weight gain was 7.7 kg (P=4.6 E-007) and hemoglobin levels increased from 114±7.1 to 123.4±6.6 g/L (P=1.4 E-007). No adverse events were observed at any time. After one month 17 out of 20 patients were deemed cured from TB and discharged from the dispensary. Further studies are needed to confi rm this preliminary observation suggesting that in addition to the benefi cial effect in managing chronic hepatitis, V5 might also be useful as a safe and effective means for immunotherapy of tuberculosi
No preview · Article · Oct 2010 · Journal of Vaccines and Vaccination
[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.
Preview · Article · Jan 2009 · Journal of Antivirals and Antiretrovirals
[Show abstract][Hide abstract] ABSTRACT: Open label trial of anti-tuberculosis therapy (ATT) combined with oral immunomodulators derived from medicinal plants, Dzherelo, Svitanok, and Lizorm, was conducted in a representative group of 14 Ukrainian patients, half of whom (7) were dually infected with HIV. Among them 9 individuals had multidrug-resistant form of TB (MDR-TB) including 2 (22%) patients who presented with extensively drug-resistant TB (XDR-TB). Patients hospitalized in our TB dispensary were treated under directly observed therapy (DOT) until they became culture negative and their radiological and clinical symptoms improved. All patients, except one, gained weight, ranging between 3-17 kg with median gain of 9 kg (P=0.0002). The liver function tests revealed that the level of total bilirubin had decreased from 15.5 to 12 mol/L - an improvement that was statistically significant (P=0.03). Alanine transaminase (ALT), another marker of hepatic damage, declined from abnormally high 55.4 IU/L to a normal 38.2 IU/L level (P=0.03). The median time to bacterial clearance was 32 days. The mean duration of therapy was 3.9 months - shorter than average 12 months time needed to treat drug-resistant TB. These findings indicate that the combination of Ekomed's phytopreparations with ATT enhances the efficacy of TB therapy and is safe and beneficial even to patients with poor prognosis due to drug resistance and/or co-infection with HIV.
Preview · Article · Dec 2007 · Journal of medicinal plant research
[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.