Background and objectivesThis controlled single-blind trial compared the efficacy of a lip balm with propolis special extract GH 2002 at a concentration of 0.5% in the treatment of episodes of herpes labialis with that of 5% aciclovir cream.MethodsPatients in the erythematous/papular stage were randomized: 189 patients were treated with propolis cream, 190 patients were treated with aciclovir cream (intention-to-treat population). Application was 5 times daily. The primary parameter was the difference in median time to complete encrustation or epithelialization of lesions. Secondary parameters were the development of typical herpes symptoms (eg, pain, burning and itching, tension, and swelling), the global assessment of efficacy, and the safety of application.ResultsThe predefined clinical situation was reached after a median of 4 days with propolis and after 5 days with aciclovir (P < 0.0001). Significant differences in favor of the study preparation were found with all secondary parameters and symptoms. No allergic reactions, local irritations, or other adverse events were observed.ConclusionsA formulation of 0.5% propolis GH 2002 extract lip balm was found to be superior in the treatment of episodes of herpes labialis over 5% aciclovir cream in patients in the papular/erythematous phase upon inclusion. EudraCT Registration No. 2006-001971-38.

The combination of levomenol and heparin proved to be significantly more efficacious in the treatment of pruritus and inflamed skin than the preparations of the single components.

Background: The aim of the clinical trial was to establish the contribution of propolis special extract GH 2002 as constituent of a lotion for the supportive treatment of Herpes zoster. Methods: 60 patients with diagnosed Herpes zoster were either treated with a propolis containing (n = 33) or an identical, but propolis-free lotion (n = 27) for 28 days, as an add-on therapy to oral antiviral treatment with aciclovir. Study parameters were the assessment of pain on a visual analogue scale, the assessment of the formation of new vesicles, and the safety of application of the preparation. Results: Improvement of pain was significantly better and quicker in the propolis lotion group (p < 0.001 at all visits). On day 3/4, the reduction of pain versus baseline was 54% versus 20% reduction in favour of propolis lotion. On day 14 the results were 80% versus 42% pain reduction. Healing of lesions was significantly quicker with the propolis-containing lotion: at visit 3 on day 7, 21% versus none of the patients showed a closed skin with or without crusting. After 14 days, the comparison showed 57.6% versus 25.9%. At least 50% of propolis-treated patients were lesion-free on day 14, versus day 28 in the control group (p = 0.013). The formation of new vesicles was also significantly suppressed. On day 3/4 the number of newly formed vesicles was 15 versus 25, on day seven the number of new vesicles was 4 versus 14 (p < 0.001). The advantage of propolis lotion was confirmed through the global assessment of efficacy by the physician, with 75.8 versus 33.3% "good" to "excellent" ratings already on day 3/4, 90.9 vs. 44.4% on day 7, and 100 vs. 74.1% on day 28 (p < 0.001). Skin tolerability was excellent, no allergic reactions, skin irritations or other adverse events were observed. Conclusion: The observations clinically confirm antiviral and anti-inflammatory effects of propolis special extract GH 2002 and at the same time demonstrate the benefits of the topical add-on to the systemic antiviral therapy of Herpes zoster.

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

ObjectiveThe safety of comfrey herbal cream application to broken skin is still a matter of regulatory debate. It was therefore examined in children with intact and with broken skin treated for blunt traumas and sports injuries, with the aim of collecting data for pharmacovigilance and clinical safety assessments.MethodsA total of 712 children (386 children with intact skin and 326 children with abrasions and superficial wounds) were openly treated for up to 2 weeks with 1–5 applications daily of comfrey herb cream after presenting for blunt traumas and sports accidents. The incidence rate of adverse events was calculated, next to a global assessment of treatment effects.ResultsNo adverse events occurred in the group of children with intact skin, and one intolerability reaction (burning and reddening) was observed after application to broken skin. The overall incidence rate of intolerability reactions per patient was calculated as 0.14% (95% CI 0.00–0.78%) and that of systemic adverse effects as 0.00% (95% CI 0.00–0.42%). Accordingly, the probability of the occurrence of local reactions and systemic adverse events is well below, which is one in 100 treated patients. The global assessment of effects corresponded to previously published experience.ConclusionThese studies confirm an excellent benefit-to-risk ratio for the application of comfrey herb cream in the treatment of blunt traumas and sports injuries in children with intact and with broken skin.