Immunoxel Honey Lozenges an Adjunct to Pulmonary Tuberculosis Treatment

by | Jul 8, 2019 | 2017, Lung Health

Written by Joyce Smith, BS. Immunoxel Honey Lozenges significantly improved tuberculosis in participating subjects after one month of treatment.

lung healthIncreasing poverty, drug resistance, and HIV co-infections have led to rampant tuberculosis (TB) in developing countries. 1 The authors of this study have conducted 20 clinical studies involving 1500 people with difficult to treat forms of TB and HIV. 2-5  Their preliminary Phase 11 study 6, using Honibe honey lozenges manufactured in Canada offered the best results, prompting them to conduct a double-blind placebo-controlled Phase III clinical trial 5 to validate the clinical benefits of these lozenges on 269 patients with pulmonary TB who were living in two high-burden countries: Mongolia and Ukraine. Patients were randomly assigned into two arms to receive daily for one month Immunoxel honey lozenges (n=137) or placebo lozenges along with conventional anti-tuberculosis therapy (ATT) (n=132). Immunoxel is an herbal immunomodulatory phytoconcentrate that was manufactured in Ukraine and shipped to Canada to be formulated into sublingual honey lozenges at 300 μl dose per lozenge. The Immunoxel and placebo arms were demographically similar: 102 participants versus 106 participants with drug-susceptible TB; 28 versus 20 with multidrug-resistant TB (MDR-TB); 7 versus 7 with extensively drug-resistant TB (XDR-TB); and 22 versus 20 with TB-HIV. Sputum smears were done pre- and post-treatment. The primary end point was the elimination of mycobacterium as detected by the conversion of pretreatment TB-infected sputum to post treatment TB free sputum.  The sputum smear conversion by microscopy was chosen over a culture-based method because of expediency and cost. 7

After one month of treatment, the following results were obtained:

  • The once-daily administration of Immunoxel honey lozenge along with first- or second-line TB drugs resulted in the clearance of Mycobacterium tuberculosis in sputum smears in 87 out of 132 (65.9%) of Immunoxel recipients versus 32 out of 127 (25.2%) in the placebo group.
  • Sputum conversion by Immunoxel occurred very fast (within one month of treatment) and was equally effective across all forms of TB, while in controls only drug susceptible TB (DS-TB) had the expected response rate (p<0.0001). The conversion rates were also not influenced by differences in gender, age and body weight.
  • Immunoxel reversed TB-associated wasting; the average weight gain was 2 kg versus 0.6 kg of placebo recipients. Weight gain was seen in 68.5 % versus 12.3% in both treatments arms, respectively (p<0.0001).
  • Immunoxel eliminated TB-associated fever in 63.4% of Immunoxel patients versus 28.6% of placebo recipients (p=0.002), and demonstrated a marked anti-inflammatory effect as noted by ESR (erythrocyte sedimentation rate) and leukocyte counts: the proportions of responders were 91 % Immunoxel versus 75% placebo (p=0.004) for ESR and 52.7% versus 26.5% for leukocytes (p=0.0003). Fever, cachexia, elevated leukocytes and ESR are parameters for gauging TB severity. 8
  • Immunoxel also counteracted the liver damage caused by anti-tuberculosis drugs. Immunoxel had no adverse effects and did not cause reactivation of TB.

These results concur with 20 prior trials of Immunoxel conducted over the past 17 years. Study limitations include budget restrictions that disallowed a long-term follow-up and limited the study to one month. However, Immunoxel is safe; it has not produced any adverse effects or caused reactivation of TB. It is also an effective, fast- acting, affordable, commercially available, and easy to administer immunotherapeutic intervention. Hopefully, the global emergence of drug resistant TB and TB-HIV will shift the empathsis from drug to immunotherapeutic approaches as an adjunct to conventional TB chemotherapy.

Source: Batbold, Uyanga, Dmytro O. Butov, Galyna A. Kutsyna, Narantsetseg Damdinpurev, Elena A. Grinishina, Otgonbayar Mijiddorj, Mikola E. Kovolev et al. “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.” Immunotherapy 9, no. 1 (2017): 13-24.

© 2017 Future Medicine Ltd

Posted July 8, 2019.

Joyce Smith, BS, is a degreed laboratory technologist. She received her bachelor of arts with a major in Chemistry and a minor in Biology from  the University of Saskatchewan and her internship through the University of Saskatchewan College of Medicine and the Royal University Hospital in Saskatoon, Saskatchewan. She currently resides in Bloomingdale, IL.

References:

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