Double-blind, placebo-controlled, 1:1 randomized Phase III clinical trial of Immunoxel honey lozenges as an adjunct immunotherapy in 269 patients with pulmonary tuberculosis
Date
2016-11-21
Authors
Batbold, U.
Butov, Dmytro
Kutsyna, G.
Damdinpurev, N.
Grinishina, Elena
Mijiddorj, Otgonbayar
Kovolev, Mikola
Butova, Tetiana
Sandagdorj, M.
Zaitzeva, S.
Journal Title
Journal ISSN
Volume Title
Publisher
Future Medicine
Abstract
Aim: Safer and shorter antituberculosis treatment (ATT) regimens represent the
unmet medical need. Patients & methods: The patients were randomly assigned
into two arms: the first (n = 137) received once-daily sublingual honey lozenge
formulated with botanical immunomodulator Immunoxel and the second (n = 132)
received placebo lozenges along with conventional ATT. Immunoxel and placebo arms
were demographically similar: 102 versus 106 had drug-susceptible TB; 28 versus 20
multidrug-resistant TB (MDR-TB); 7 versus 7 extensively drug resistant TB (XDR-TB);
and 22 versus 20 TB-HIV. The primary end point was sputum smear conversion. Results:
After 1 month 87 out 132 (65.9%) of Immunoxel recipients became sputum smear
negative, whereas 32 out of 127 (25.2%) in placebo group had converted (p < 0.0001).
Sputum clearance produced by Immunoxel was equally effective across all forms of TB.
In the immunotherapy arm the average weight gain was 2 kg, but placebo recipients
gained only 0.6 kg. Immunoxel reduced TB-associated inflammation as evidenced
by defervescence and normalization of elevated leukocyte counts and erythrocyte
sedimentation rate. No adverse effects were seen at any time. The liver function
tests indicate that ATT-caused hepatotoxicity was counteracted by Immunoxel.
These results are in agreement with prior 20 trials of Immunoxel conducted over
the past 17 years. Conclusion: Immunoxel is affordable, safe, effective, fast-acting,
commercially available immunotherapeutic intervention to supplement conventional
TB chemotherapy.
Description
Keywords
DOT, Human immunodeficiency virus (HIV), HIV-TB, immunotherapy, MDR, Mycobacterium tuberculosis, XDR
Citation
Double-blind, placebo-controlled, 1:1 randomized Phase III clinical trial of Immunoxel honey lozenges as an adjunct immunotherapy in 269 patients with pulmonary tuberculosis / U. Batbold, D. O. Butov, G. A. Kutsyna, N. Damdinpurev, E. A. Grinishina, O. Mijiddorj, M. E. Kovolev, K. Baasanjav, T. S. Butova, M. Sandagdorj, O. Batbold, A. Tseveendorj, E. Chunt, S. I. Zaitzeva, H. L. Stepanenko, N. I. Makeeva, I. V. Mospan, V. S. Pylypchuk, J. L. Rowe, P. Nyasulu, V. Jirathitikal, A. I. Bain, M. G. Tarakanovskaya, A. S. Bourinbaiar // Immunotherapy. – 2017. – Vol. 9, № 1. – P. 13–24.