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Health  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

DOI: 10.4236/health.2011.31010, PP. 49-55

Keywords: Herpes labialis, propolis, lip balm, dose-finding study

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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.

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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