Herbal Immunotherapy for Multi-Drug (MDR) and Extensively Drug-Resistant Tuberculosis (XDR-TB) as well as TB with HIV

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Ukrainian company, Ekomed LLC, published clinical study of phytoconcentrates Dzherelo (Immunoxel), Lizorm and Svitanok used as an adjunct immunotherapy against multi-drug (MDR-TB), (XDR-TB), and in patients with concomitant HIV and Mycobacterium tuberculosis infections.

Ukrainian company, Ekomed LLC, published clinical study of phytoconcentrates Dzherelo (Immunoxel), Lizorm and Svitanok used as an adjunct immunotherapy against multi-drug (MDR-TB), (XDR-TB), and in patients with concomitant HIV and Mycobacterium tuberculosis infections.

The study appeared in the current issue of International Journal of Biomedical and Pharmaceutical Sciences (Vol. 2; Pages 59-64, 2008). Abstract of the paper can be found online at: http://www.globalsciencebooks.info/JournalsSup/08IJBPS_2_1.html

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 with late-stage pulmonary TB. In this study seven patients had XDR-TB and the remaining had MDR-TB. Among latter two patients had HIV co-infection but five other AIDS patients had drug-sensitive TB. Patients hospitalized in the 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 improved from 15.5 to 11.6 μmol/L (P=0.009). Alanine transaminase (ALT) came down to normal from 53.1 IU/L to 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 × 109 cells/L (P=0.003). CD4 T lymphocyte counts in HIV patients have increased from average 371 cells at baseline to 566 cells - an increase equal to 52% (P=0.07). The absolute numbers of CD8+ T-lymphocytes appeared to decline but no statistical significance has been reached (P=0.1). The increase in CD4 cells and decline in CD8 cells resulted in almost doubled ratio of CD4/CD8 cells, i.e., from baseline 0.475 to 0.848 at the end of therapy (P=0.03). Patients recovered clinically and radiologically and were hence discharged from the hospital after 4 months on average.

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. This unique combination results in significantly shortened duration of treatment and is more cost-effective than ATT alone.

Dzherelo, Lizorm and Svitanok are extracts from plants grown in Ukraine that have been used as food or folk medicine since time immemorial. Being derived from botanical sources and with established record of safety they have been approved by the Ministry of Health of Ukraine in 1997 as dietary supplements and as a functional food in 2006.

Over 9 million new cases of TB occur each year worldwide. In the United States alone, it is estimated that 10-15 million people are infected with the TB bacteria and 22,000 new cases occur each year. Tuberculosis is spread from person to person by breathing infected air during close contact. Thus, anyone can get TB.

Despite the overwhelming burden of TB, no new compounds were developed in last 40 years and current strains of TB are becoming resistant to existing drugs. Multidrug-resistant tuberculosis (MDR-TB) refers to organisms that are resistant to at least two of the first-line drugs, Izoniazid and Rifampicin. More recently, extensively (extremely) drug resistant tuberculosis (XDR-TB) has emerged which is resistant to three or more of the second-line treatment drugs. This emerging form of TB caused worldwide concern after recently reported outbreak in Kwazulu Natal province of South Africa where 52 of 53 patients with XDR-TB and HIV had died within 2 weeks from the time of diagnosis. Largely, because of HIV, a tremendous increase in the incidence of TB is seen today and when these two infections are presented in tandem they are more deadly than each one of them alone.

Scientific Director of Ekomed, Mr. Volodymyr Pylypchuk, commented: "Dzherelo and our other botanicals can be useful as immune adjuvants for therapy of tuberculosis and AIDS. What is important is that our study is the first ever study to show that one can treat successfully XDR TB - a condition which is commonly considered to be virtually incurable. In addition to medical problems Ekomed works on ecology projects. We have developed proprietary technologies that can potentially reverse global climate change and reduce greenhouse gas emissions, such as carbon dioxide, in ecologically friendly manner".

About Ekomed LLC
Founded in 1996, Ekomed is a privately-held company based in Kiev, Ukraine. The company is the leading ethnobotanical company that manufactures over 26 different multiherbal preparations for a variety of health disorders. For more details, please visit the company website at http://www.ekomed.com.ua

Media contact:
Volodymyr Pylypchuk
CEO and Scientific Director
Ekomed LLC
80-A Pravdy Avenue
pylypchuk @ bk.ru
http://www.ekomed.com.ua

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Volodymyr Pylypchuk
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