Skip to main content
Top
Published in: Systematic Reviews 1/2021

Open Access 01-12-2021 | Tuberculosis | Research

Dzherelo (Immunoxel) as adjunctive therapy to standard antituberculosis treatment in patients with pulmonary tuberculosis: a systematic review and meta-analysis of clinical trials

Authors: Marcel Kitenge, Bessie Phiri, Sara M. Pheeha, Modupe Ogunrombi, Peter S. Nyasulu

Published in: Systematic Reviews | Issue 1/2021

Login to get access

Abstract

Background

Dzherelo (Immunoxel) is one of the few approved immunomodulators that has been shown to produce positive treatment outcomes in patients with tuberculosis (TB). The aim of this review was to assess the effectiveness of Immunoxel used as adjunct therapy with conventional anti-TB therapy for the treatment of pulmonary TB.

Methods

Comprehensive search was conducted in different major databases: PubMed (MEDLINE), EMBASE (OVID), Cochrane Central Register of Controlled Trials (CENTRAL), Scopus (Elsevier). We also searched Google Scholar along with trial registries and hand-searched the reference list of identified original research as well as review articles. Conference proceedings of relevant TB and lung disease annual conferences were also screened. Two independent authors extracted outcome data using a standardised extraction form. Relative risk (RR), mean difference (MD) and standardised mean difference (SMD) with a 95% confidence interval (CI) were used as measures of effect. We assessed certainty of evidence using GRADE.

Results

Six clinical trials, which met the criteria for the review, were identified, and these provided data for the review. Overall results from the six trials that compared antituberculosis treatment (ATT) alone versus ATT and Immunoxel, and ATT and placebo versus ATT and Immunoxel showed an increased number of patients becoming sputum-negative in the Immunoxel group (RR 3.19; 95% CI 2.44 to 4.17; 488 participants). There was also reduction in body temperature among patients receiving Immunoxel compared to ATT alone (MD −0.20, 95% CI −0.22 to −0.18, 345 participants). However, there were no differences in body weight changes across all the studies (MD 5.65; 95% CI −0.80 to 12.11; 382 participants).

Conclusion

Current evidence indicates that the use of Immunoxel as an adjunctive treatment in patients with pulmonary tuberculosis has the potential to enhance the efficacy of antituberculosis treatment. However, well-designed, conducted and adequately powered clinical trials are needed to establish the effectiveness of this adjunctive treatment.

Systematic review registration

PROSPERO registration number: CRD42019127823
Appendix
Available only for authorised users
Literature
4.
go back to reference Zulkifli Amin SPH. Promising herbals as adjunctive to standard antituberculosis therapy. Indian J Public Health. 2020;11(1):1–8. Zulkifli Amin SPH. Promising herbals as adjunctive to standard antituberculosis therapy. Indian J Public Health. 2020;11(1):1–8.
5.
go back to reference Batbold U, Butov DO, Kutsyna GA, Damdinpurev N, Grinishina EA, Mijiddorj O, 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. 2017;9(1):13–24. https://doi.org/10.2217/imt-2016-0079.CrossRefPubMed Batbold U, Butov DO, Kutsyna GA, Damdinpurev N, Grinishina EA, Mijiddorj O, 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. 2017;9(1):13–24. https://​doi.​org/​10.​2217/​imt-2016-0079.CrossRefPubMed
6.
go back to reference Arjanova OV, Prihoda ND, Yurchenko LV. Impact of adjunct immunotherapy with multi-herbal supplement Dzherelo (Immunoxel) on treatment outcomes in end-stage TB/HIV patients. J Antivirals. 2010;1(2):86–8. Arjanova OV, Prihoda ND, Yurchenko LV. Impact of adjunct immunotherapy with multi-herbal supplement Dzherelo (Immunoxel) on treatment outcomes in end-stage TB/HIV patients. J Antivirals. 2010;1(2):86–8.
10.
go back to reference RevMan. The Nordic Cochrane Centre, the Cochrane collaboration. Review Manager (RevMan). Version 5.3 Copenhagen. 2014. RevMan. The Nordic Cochrane Centre, the Cochrane collaboration. Review Manager (RevMan). Version 5.3 Copenhagen. 2014.
11.
go back to reference Cohen J. Statistical power analysis for the behavioural sciences. 2nd ed. Hillsdale: L. Erlbaum Associates; 1988. p. 567. Cohen J. Statistical power analysis for the behavioural sciences. 2nd ed. Hillsdale: L. Erlbaum Associates; 1988. p. 567.
12.
go back to reference Dijkers M. Introducing GRADE: a systematic approach to rating evidence in systematic reviews and to guideline development. KT Update. Austin, TX: SEDL, Center on Knowledge Translation for Disability and Rehabilitation Research. 2013;(1)5. Dijkers M. Introducing GRADE: a systematic approach to rating evidence in systematic reviews and to guideline development. KT Update. Austin, TX: SEDL, Center on Knowledge Translation for Disability and Rehabilitation Research. 2013;(1)5.
16.
go back to reference Zaitzeva SI, Matveeva SL, Gerasimova TG, Pashkov YN, Butov DA, Pylypchuk VS, et al. Efficacy and safety of phytoconcentrate Dzherelo (Immunoxel) in treatment of patients with multi-drug resistant TB (MDR-TB) in comparison to standard chemotherapy. Res J Med Sci. 2009;3:36–41. Zaitzeva SI, Matveeva SL, Gerasimova TG, Pashkov YN, Butov DA, Pylypchuk VS, et al. Efficacy and safety of phytoconcentrate Dzherelo (Immunoxel) in treatment of patients with multi-drug resistant TB (MDR-TB) in comparison to standard chemotherapy. Res J Med Sci. 2009;3:36–41.
17.
go back to reference Zulkifli A, Purnama H.S. Promising herbals as adjunctive to standard antituberculosis therapy. Indian J Public Heal Res Dev. 2017; 8 (2):220-225 Zulkifli A, Purnama H.S. Promising herbals as adjunctive to standard antituberculosis therapy. Indian J Public Heal Res Dev. 2017; 8 (2):220-225
18.
go back to reference Butov DA, Efremenko YV, Prihoda ND, Yurchenko LI, Sokolenko NI, Arjanova OV, et al. Adjunct immune therapy of first-diagnosed TB, relapsed TB, treatment-failed TB, multidrug-resistant TB and TB/HIV. Futur Med. 2012:687–95. Butov DA, Efremenko YV, Prihoda ND, Yurchenko LI, Sokolenko NI, Arjanova OV, et al. Adjunct immune therapy of first-diagnosed TB, relapsed TB, treatment-failed TB, multidrug-resistant TB and TB/HIV. Futur Med. 2012:687–95.
19.
go back to reference Nikolaeva LG, Maystat TV, Masyuk LA, Pylypchuk VS, Volyanskii YL, Kutsyna GA. Changes in CD4+ T-cells and HIV RNA resulting from combination of anti-TB therapy with Dzherelo in TB/HIV dually infected patients. Drug Des Devel Ther. 2009;2:87–93. Nikolaeva LG, Maystat TV, Masyuk LA, Pylypchuk VS, Volyanskii YL, Kutsyna GA. Changes in CD4+ T-cells and HIV RNA resulting from combination of anti-TB therapy with Dzherelo in TB/HIV dually infected patients. Drug Des Devel Ther. 2009;2:87–93.
20.
go back to reference Nikolaeva LG, Maystat TV, Pylypchuk VS, Volyanskii YL, Masyuk LA, Kutsyna GA. Effect of oral immunomodulator Dzherelo in TB/HIV co-infected patients receiving anti-tuberculosis therapy under DOTS. Int Immunopharmacol. 2009;8(6):845–51.CrossRef Nikolaeva LG, Maystat TV, Pylypchuk VS, Volyanskii YL, Masyuk LA, Kutsyna GA. Effect of oral immunomodulator Dzherelo in TB/HIV co-infected patients receiving anti-tuberculosis therapy under DOTS. Int Immunopharmacol. 2009;8(6):845–51.CrossRef
21.
go back to reference Prihoda ND, Arjanova OV, Yurchenko LV, Sokolenko NI, Vihrova LA, Pylypchuk VS, et al. Open label trial of adjuvant immunotherapy with Dzherelo, Svitanok and Lizorm, in MDR-TB, XDR-TB and TB/HIV co-infected patients receiving anti-tuberculosis therapy under DOT. J Med Plants Res. 2007;1:117–22. Prihoda ND, Arjanova OV, Yurchenko LV, Sokolenko NI, Vihrova LA, Pylypchuk VS, et al. Open label trial of adjuvant immunotherapy with Dzherelo, Svitanok and Lizorm, in MDR-TB, XDR-TB and TB/HIV co-infected patients receiving anti-tuberculosis therapy under DOT. J Med Plants Res. 2007;1:117–22.
22.
go back to reference Prihoda ND, Arjanova OV, Yurechenko LV, Sokolenko NI, Vihrova LA. Adjuvant immunotherapy of extensively drug resistant tuberculosis (XDR-TB) in Ukraine. Curr Res Tuberc. 2009;1(1):9–14.CrossRef Prihoda ND, Arjanova OV, Yurechenko LV, Sokolenko NI, Vihrova LA. Adjuvant immunotherapy of extensively drug resistant tuberculosis (XDR-TB) in Ukraine. Curr Res Tuberc. 2009;1(1):9–14.CrossRef
23.
go back to reference Prihoda ND, Arjanova OV, Yurchenko LV, Sokolenko NI, Vihrova LA, Pylypchuk VS, et al. Adjunct immunotherapy of tuberculosis in drug-resistant TB and TB/HIV co-infected patients. Int J Biomed Pharm Sci. 2008;2(1):59–64. Prihoda ND, Arjanova OV, Yurchenko LV, Sokolenko NI, Vihrova LA, Pylypchuk VS, et al. Adjunct immunotherapy of tuberculosis in drug-resistant TB and TB/HIV co-infected patients. Int J Biomed Pharm Sci. 2008;2(1):59–64.
26.
go back to reference Guyatt GH, Mills EJ, Elbourne D. In the era of systematic reviews, does the size of an individual trial still matter? PLoS Med. 2008;5(1):0003–5.CrossRef Guyatt GH, Mills EJ, Elbourne D. In the era of systematic reviews, does the size of an individual trial still matter? PLoS Med. 2008;5(1):0003–5.CrossRef
Metadata
Title
Dzherelo (Immunoxel) as adjunctive therapy to standard antituberculosis treatment in patients with pulmonary tuberculosis: a systematic review and meta-analysis of clinical trials
Authors
Marcel Kitenge
Bessie Phiri
Sara M. Pheeha
Modupe Ogunrombi
Peter S. Nyasulu
Publication date
01-12-2021
Publisher
BioMed Central
Published in
Systematic Reviews / Issue 1/2021
Electronic ISSN: 2046-4053
DOI
https://doi.org/10.1186/s13643-021-01698-2

Other articles of this Issue 1/2021

Systematic Reviews 1/2021 Go to the issue