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Efficacy and tolerability of propolis special extract gh 2002 as a lip balm against herpes labialis: a randomized, double-blind three-arm dose finding study

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DOI: 10.4236/health.2011.31010    5,574 Downloads   9,894 Views   Citations

ABSTRACT

A dose-finding study was performed with respect to the clinical applicability and tolerability of three different concentrations of propolis special extract GH 2002 in a lip balm (0.1%, 0.5% and 1%). The trial was designed as a double-blind, randomized dermatological study in 150 outpatients with Herpes labialis. The primary parameter was the duration in days until painless incrustation in 50% or 90% of the patients (observable in 121 patients). Secondary parameters were local pain (assessed on a visual analogue scale), itching, burning and tension/ swelling on a verbal rating scale, and tolerability. Visits were performed on days 2/3, 5/6 and 8/9. Best efficacy results with shortest healing time (3.4 and 5.4 days in the 50th and 90th percentile, respectively; p = 0.008 vs. 1% and 0.09 vs. 0.1%) and good tolerability were observed with the 0.5% concentration. All three concentrations achieved highly significant therapeutic results in comparison with baseline values (p < 0.0005) for all secondary parameters as early as day 2/3. Analgesia was the most prominent effect for the patients. Conclusion: The 0.5 % concentration of propolis special extract GH 2002 in a lip balm was found to have the best risk-benefit ratio for the treatment of Herpes labialis.

Conflicts of Interest

The authors declare no conflicts of interest.

Cite this paper

Holcová, S. and Hladiková, M. (2011) Efficacy and tolerability of propolis special extract gh 2002 as a lip balm against herpes labialis: a randomized, double-blind three-arm dose finding study. Health, 3, 49-55. doi: 10.4236/health.2011.31010.

References

[1] Patz, G. and Gross, G. (2006) Aciclovir creme bei lippenherpes. Dt Apoth Ztg, 145, 1653-1658.
[2] Spruance, S.L., Rea, T.L., Thoming, C., Tucker, R., Saltzman, R. and Boon, R. (1997) Penciclovir cream for the treatment of herpes simplex labialis. A randomized, multicenter, double-blind, placebo-controlled trial. Topical Penciclovir Collaborative Study Group, Journal of the American Medical Association, 277, 1374-1379.
[3] Spruance, S.L., Schnipper, L.E., Overall, J.C., Jr., Kern, E.R., Wester, B., Modlin, J., et al. (1982) Treatment of herpes simplex labialis with topical acyclovir in polyethylene glycol. Journal of Infectious Diseases, 146, 85-90.
[4] Spruance, S.L., Rea, T.L., Thoming, C., Tucker, R., Saltzman, R. and Boon, R. (1997) Penciclovir cream for the treatment of herpes simplex labialis. A randomized, multicenter, double-blind, placebo-controlled trial. Topical Penciclovir Collaborative Study Group. Journal of the American Medical Association, 277, 1374-1379.
[5] Spruance, S.L., Nett, R., Marbury, T., Wolff, R., Johnson, J. and Spaulding, T. (2002) Acyclovir cream for treatment of herpes simplex labialis: results of two randomized, double-blind, vehicle-controlled, multicenter clinical trials. Antimicrobial Agents and Chemotherapy, 46, 2238-2243. doi:10.1128/AAC.46.7.2238-2243.2002
[6] Fiddian, A.P. and Ivanyi, L. (1983) Topical acyclovir in the management of recurrent herpes labialis. British Journal of Dermatology, 109, 321-326. doi:10.1111/j.1365-2133.1983.tb03548.x
[7] Raborn, G.W., McGaw, W.T., Grace, M., Percy, J. and Samuels, S. (1989) Herpes labialis treatment with acyclovir 5% modified aqueous cream: a double-blind randomized trial. Oral Surgery, Oral Medicine, Oral Pathology, Oral Radiology, and Endodontology, 67, 676-679.
[8] Raborn, G.W., Martel, A.Y., Lassonde, M., Lewis, M.A., Boon, R. and Spruance, S.L. (2002) Effective treatment of herpes simplex labialis with penciclovir cream: Combined results of two trials. Journal of the American Dental Association, 133, 303-309.
[9] Boon, R., Goodman, J.J., Martinez, J., Marks, G.L., Gamble, M. and Welch, C. (2000) Penciclovir cream for the treatment of sunlight-induced herpes simplex labialis: a randomized, double-blind, placebo-controlled trial. Penciclovir Cream Herpes Labialis Study Group. Clinical Therapeutics, 22, 76-90. doi:10.1016/S0149-2918(00)87979-5
[10] Van Vloten, W.A., Swart, R.N. and Pot, F. (1983) Topical acyclovir therapy in patients with recurrent orofacial herpes simplex infections. Journal of Antimicrobial Chemotherapy, 12, 89-93.
[11] Morfin, F. and Thouvenot, D. (2003) Herpes simplex virus resistance to antiviral drugs. Journal of Clinical Virology, 26, 29-37. doi:10.1016/S1386-6532(02)00263-9
[12] Spruance, S.L., Schnipper, L.E., Overall, J.C., Jr., Kern, E.R., Wester, B., Modlin, J., et al. (1982) Treatment of herpes simplex labialis with topical acyclovir in polyethylene glycol. Journal of Infectious Diseases, 146, 85-90.
[13] Raborn, G.W., McGaw, W.T., Grace, M., Percy, J. and Samuels, S. (1989) Herpes labialis treatment with acyclovir 5% modified aqueous cream: a double-blind randomized trial. Oral Surgery, Oral Medicine, Oral Pathology, Oral Radiology, and Endodontology, 67, 676-679.
[14] Van Vloten, W.A., Swart, R.N. and Pot, F. (1983) Topical acyclovir therapy in patients with recurrent orofacial herpes simplex infections. Journal of Antimicrobial Chemotherapy, 12, 89-93.
[15] Scheller, S., Scaflarski, J., Tustanowski, J., Nolewajka, E. and Stojke, A. (1977) Biological properties and clinical applications of propolis. Arzneimittel-Forschung/Drug Research, 27, 105-111.
[16] Langner, E. and Schilcher, H. (1999) Propolis. Dt Apoth Ztg, 139, 3447-3458.
[17] Kujumgiev, A., Tsetkova, I., Serkedjieva, J., Bankova, V.S., Christov, R. and Popov, S. (1999) Antibacterial, antifungal and antiviral activity of propolis of different geographic origin. Journal of Ethnopharmacology, 64, 235-240. doi:10.1016/S0378-8741(98)00131-7
[18] Burdock, G.A. (1998) Review of the biological properties and toxicity of bee propolis (propolis). Food and Chemical Toxicology, 36, 347-363. doi:10.1016/S0278-6915(97)00145-2
[19] Castaldo, S. and Capasso, F. (2002) Propolis, an old remedy used in modern medicine. Fitoterapia, 73, S1-S6. doi:10.1016/S0367-326X(02)00185-5
[20] Castaldo, S. and Capasso, F. (2002) Propolis, an old remedy used in modern medicine. Fitoterapia, 73, S1-S6.
[21] Koo, H., Gomes, B.P., Rosalen, P.L., Ambrosano, G.M., Park, Y.K. and Cury, J.A. (2000) In vitro antimicrobial activity of propolis and Arnica montana against oral pathogens. Archives of Oral Biology, 45, 141-148. doi:10.1016/S0003-9969(99)00117-X
[22] Boyanova, L., Derejian, S., Koumanova, R., Katsarov, N., Gergova, G., Mitov, I., et al. (2003) Inhibition of helicobacter pylori growth in vitro by Bulgarian propolis: Preliminary report. Journal of Medical Microbiology, 52, 417-419. doi:10.1099/jmm.0.04895-0
[23] Cafarchia, C., De Laurentis, N., Milillo, M.A., Losacco, V. and Puccini, V. (1999) Antifungal activity of Apulia region propolis. Parassitologia, 41, 587-590.
[24] Borrelli, F., Maffia, P., Pinto, L., Ianaro, A., Russo, A., Capasso, F., et al. (2002) Phytochemical compounds involved in the anti-inflammatory effect of propolis extract. Fitoterapia, 73, S53-S63. doi:10.1016/S0367-326X(02)00191-0
[25] Amoros, M., Simoes, C.M.O., Girre, L., Sauvager, F. and Cormier, M. (1992) Synergistic effects of flavons and flavonols against Herpes simplex virus type I in cell culture. Comparison with the antiviral activity of propolis. Journal of Natural Products, 55, 1732-1740. doi:10.1021/np50090a003
[26] Amoros, M., Lourton, E., Boustie, Y., Girre, L., Sauvager, F. and Cormier, M. (1994) Comparison of the anti-Herpes simplex virus activities of propolis and 3-methyl- but-2-enyl caffeate. Journal of Natural Products, 57, 644-647. doi:10.1021/np50107a013
[27] Debiaggi, M., Tateo, F., Pagani L., Luinni, M. and Romero, E. (1990) Effects of propolis flavonoids on virus infectivity and replication. Microbiologica (Italia), 13, 207-213.
[28] K?nig, B. and Dustmann, H.J. (1988) Baumharze, Bienen und antivirale Chemotherapie. Naturwissenschaftliche Rundschau, 41, 43-53.
[29] Serkedjieva, J., Manolova, N. and Bankova, V.S. (1992) Anti-influenza virus effect of some propolis constituents and their analogues (esters of substituted cinnamic acids). Journal of Natural Products, 55, 294-297.
[30] doi:10.1021/np50081a003 Thiel, K.-D., Wutzler, P., Helbig, B., Kl?ckning, R., Spr?ssig, M. and Schweizer, H. (1984) Antivirale Wirksamkeit von enzymatisch und nicht-enzymatisch oxidierter Kaffee- und Hydrokaffees?ure gegenüber Herpesvirus hominis Typ 1 und Typ 2 in vitro. Pharmazie, 39, 781-782.
[31] Vynograd, S., Vynograd, I. and Soznowski, Z. (2000) A comparative multi-centre study of the efficacy of propolis, acyclovir and placebo in the treatment of genital herpes (HSV). Phytomedicine, 7, 1-6.
[32] K?nig, B. and Dustmann, H.J. (1985) The caffeoylics as a new family of natural antiviral compounds. Naturwissenschaften, 72, 659-661. doi:10.1007/BF00497441
[33] Nolkemper, S., Reichling, J., Sensch, K.H. and Schnitzler, P. (2010) Mechanism of herpes simplex virus type 2 suppression by propolis extracts. Phytomedicine, 17, 132-138. doi:10.1016/j.phymed.2009.07.006
[34] Schnitzler, P., Neuner, A., Nolkemper, S., Zundel, C., Nowack, H. and Sensch, K.H. (2010) Antiviral activity and mode of action of propolis extracts and selected compounds. Phytotherapy Research, 24, S20-S28.
[35] Boon, R., Goodman, J.J., Martinez, J., Marks, G.L., Gamble, M. and Welch, C. (2000) Penciclovir cream for the treatment of sunlight-induced herpes simplex labialis: a randomized, double-blind, placebo-controlled trial. Penciclovir Cream Herpes Labialis Study Group. Clinical Therapeutics, 22, 76-90.
[36] S. L. Spruance, T. L. Rea, C. Thoming, R. Tucker, R. Saltzman and R. Boon. “Penciclovir cream for the treatment of herpes simplex labialis. A randomized, multicenter, double-blind, placebo-controlled trial. Topical Penciclovir Collaborative Study Group”, JAMA, Vol. 277, 1997, pp. 1374-9.
[37] S. L. Spruance, R. Nett, T. Marbury, R. Wolff, J. Johnson and T. Spaulding. “Acyclovir cream for treatment of herpes simplex labialis: results of two randomized, double-blind, vehicle-controlled, multicenter clinical trials”, Antimicrob Agents Chemother, Vol. 46, 2002, pp. 2238-43.
[38] Saller, R., Buechi, S., Meyrat, R. and Schmidhauser, C. (2001) Combined herbal preparation for topical treatment of Herpes labialis. Forsch Komplementarmed Klass Naturheilkd, 8, 373-382. doi:10.1159/000057255
[39] S. Nolkemper, J. Reichling, K. H. Sensch and P. Schnitzler. “Mechanism of herpes simplex virus type 2 suppression by propolis extracts”, Phytomedicine, Vol. 17, 2010, pp. 132-8.
[40] S. L. Spruance, T. L. Rea, C. Thoming, R. Tucker, R. Saltzman and R. Boon. “Penciclovir cream for the treatment of herpes simplex labialis. A randomized, multicenter, double-blind, placebo-controlled trial. Topical Penciclovir Collaborative Study Group”, JAMA, Vol. 277, 1997, pp. 1374-9.
[41] S. L. Spruance, R. Nett, T. Marbury, R. Wolff, J. Johnson and T. Spaulding. “Acyclovir cream for treatment of herpes simplex labialis: results of two randomized, double-blind, vehicle-controlled, multicenter clinical trials”, Antimicrob Agents Chemother, Vol. 46, 2002, pp. 2238-43.
[42] S. L. Spruance, T. L. Rea, C. Thoming, R. Tucker, R. Saltzman and R. Boon. “Penciclovir cream for the treatment of herpes simplex labialis. A randomized, multicenter, double-blind, placebo-controlled trial. Topical Penciclovir Collaborative Study Group”, JAMA, Vol. 277, 1997, pp. 1374-9.
[43] R. Boon, J. J. Goodman, J. Martinez, G. L. Marks, M. Gamble and C. Welch. “Penciclovir cream for the treatment of sunlight-induced herpes simplex labialis: a randomized, double-blind, placebo-controlled trial. Penciclovir Cream Herpes Labialis Study Group”, Clin Ther, Vol. 22, 2000, pp. 76-90.

  
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