Expression of Concern to: Clinical study of Gene-Eden-VIR/Novirin in genital herpes: suppressive treatment safely decreases the duration of outbreaks in both severe and mild cases.

The Editor of this journal has published this Expression of Concern to alert readers that, following publication of the article [1], it came to light that there were undeclared competing interests that have a direct impact on the article and the strength of its findings. In addition, post publication peer review has indicated that the conclusions may not be supported by the results due to methodological flaws in the study. Pending further investigation of these concerns, further editorial action may be taken. The authors have not responded to any correspondence about this Expression of Concern.

Clinical Trial of Herbal Treatment Gene-Eden-VIR/Novirin in Oral Herpes.

BACKGROUND: Our previous articles showed that suppressive or preventive treatment with the herbal Gene-Eden-VIR/Novirin reduced the number and duration of genital herpes outbreaks with no adverse effects. These studies also revealed that the herbal Gene-Eden-VIR/Novirin is mostly superior to acyclovir, valacyclovir, and famciclovir drugs in genital herpes. This study tested the effect of Gene-Eden-VIR/Novirin in oral herpes (also called cold sores and fever blisters). METHODS: The framework of the study was a retrospective chart review. The study included 68 participants. The participants took 1 to 4 capsules per day over a period of 2 to 36 months. The study included 2 Food and Drug Administration-recommended controls: baseline and a no-treatment. RESULTS: Gene-Eden-VIR/Novirin was effective in 89.3% of participants. The treatment reduced the mean number of outbreaks per year from 6.0 and 3.6 in the control groups to 2.0 in the treatment group ( P < .0001 and P = .07, respectively). Gene-Eden-VIR/Novirin reduced the mean duration of outbreaks from 9.8 and 5.8 days in the control groups to 3.2 days in the treatment group ( P < .0001 and P = .02, respectively). There were no reports of adverse experiences. Gene-Eden-VIR/Novirin was compared to acyclovir and valacyclovir in 6 tests. In all tests, Gene-Eden-VIR/Novirin showed higher efficacy. Gene-Eden-VIR/Novirin also showed superior safety. CONCLUSIONS: This clinical study showed that suppressive or preventive treatment with the herbal Gene-Eden-VIR/Novirin reduced the number and duration of outbreaks in oral herpes without any adverse effects. The study also showed that the herbal Gene-Eden-VIR/Novirin had better clinical effects than acyclovir and valacyclovir, the leading drugs in the category. Based on these results, we recommend using the herbal Gene-Eden-VIR/Novirin as preventive treatment for oral herpes and, specifically, as an alternative to the acyclovir and valacyclovir drugs.

Human papillomavirus (HPV): systemic treatment with Gene-Eden-VIR/Novirin safely and effectively clears virus.

PURPOSE: This paper reports the results of a clinical study that tested the effect of systemic treatment with the botanical product Gene-Eden-VIR/Novirin on the clearance rate (also called time to clearance) of the human papillomavirus (HPV). The study compared the clearance rate in treated and untreated individuals suffering from a symptomatic HPV infection. The data on the untreated individuals were obtained by reverse engineering of the Kaplan-Meier figures in five published papers. MATERIALS AND METHODS: The study included 59 treated participants. All participants were suffering from a symptomatic HPV infection prior to the commencement of treatment. The treatment was one to four capsules of Gene-Eden-VIR/Novirin per day. The duration of treatment was 2-12 months. The study included five groups of external controls with diverse characteristics. RESULTS: The mean time to clearance in Gene-Eden-VIR/Novirin-treated individuals was 5.1 months or 151.5 days (95% CI: 4.2-5.9 months or 95% CI: 125.7-177.3 days, respectively). The median time to clearance was 3.5 months. The mean time to clearance in the five untreated groups ranged from 6.9 to 20.0 months (P<0.0001 for the difference between treatment group and each untreated group). Also, 100% of the participants in the treatment group were HPV free at the end of 12 months vs 53%, 52%, 65%, 20%, and 77% in the untreated control groups. The treated participants reported no adverse experiences. CONCLUSION: This clinical study has two major contributions. First, it showed that systemic treatment with the natural Gene-Eden-VIR/Novirin decreased the time to HPV clearance, increased the percentage of HPV-free individuals, and caused no adverse experiences in individuals suffering from a symptomatic HPV infection. Since there are no other systemic treatments for symptomatic HPV infections, this study presents highly valuable information on the clinical effects of the first treatment in this category. Second, the study presents a new method for conducting clinical studies that addresses one of the major deficiencies associated with the practice of the randomized controlled trial method.

Clinical study of Gene-Eden-VIR/Novirin in genital herpes: suppressive treatment safely decreases the duration of outbreaks in both severe and mild cases.

BACKGROUND: We conducted a clinical study that tested the effect of suppressive treatment with the botanical product Gene-Eden-VIR/Novirin on genital herpes. Our previous paper showed that the treatment decreased the number of genital herpes outbreaks without any side effects. It also showed that the clinical effects of Gene-Eden-VIR/Novirin are mostly better than those reported in the studies that tested acyclovir, valacyclovir, and famciclovir. The current paper reports the effect of suppressive treatment with Gene-Eden-VIR/Novirin on the duration of outbreaks, in severe and mild genital herpes cases. METHODS: The framework was a retrospective chart review. The population included 137 participants. The treatment was 1-4 capsules per day. The duration of treatment was 2-48 months. The study included three controls: baseline, no-treatment, and dose-response. RESULTS: The treatment decreased the duration of outbreaks in 87 % of participants and decreased the mean duration of outbreaks from 8.77 days and 6.7 days in the control groups to 2.87 days in the treatment group (P < 0.001, both groups). All participants reported no adverse experiences. CONCLUSIONS: This paper shows that suppressive treatment with Gene-Eden-VIR/Novirin decreased the duration of genital herpes outbreaks, in both severe and mild cases, without any side effects. Based on the results reported in this and our previous paper, we recommend suppressive treatment with Gene-Eden-VIR/Novirin as a natural alternative to both suppressive and episodic treatments with current drugs, in both severe and mild genital herpes cases. Trial registration ClinicalTrials.gov NCT02715752 Registered 17 March 2016 Retrospectively Registered.

Clinical study in genital herpes: natural Gene-Eden-VIR/Novirin versus acyclovir, valacyclovir, and famciclovir.

BACKGROUND: This paper reports the results of a clinical study that tested the effect of suppressive treatment with the botanical product Gene-Eden-VIR/Novirin on the number of genital herpes outbreaks. The results in this study were compared to those published in clinical studies of acyclovir, valacyclovir, and famciclovir. METHODS: The framework was a retrospective chart review. The population included 139 participants. The treatment was one to four capsules of Gene-Eden-VIR/Novirin per day. The duration of treatment was 2-48 months. The study included three controls recommended by the US Food and Drug Administration (FDA): baseline, no treatment, and dose response. RESULTS: The treatment decreased the number of outbreaks per year in 90.8% of the participants. The treatment also decreased the mean number of outbreaks per year from 7.27 and 5.5 in the control groups to 2.39 (P<0.0001 and P<0.001, respectively). The treated participants reported no adverse experiences. Out of the 15 tests that compared Gene-Eden-VIR/Novirin to the three drugs, Gene-Eden-VIR/Novirin had superior efficacy in eight tests, inferior efficacy in three tests, and comparable efficacy in four tests. Gene-Eden-VIR/Novirin also had superior safety. CONCLUSION: The clinical study showed that the natural Gene-Eden-VIR/Novirin decreases the number of genital herpes outbreaks without any side effects. The study also showed that the clinical effects reported in this study are mostly better than those reported in the reviewed studies of acyclovir, valacyclovir, and famciclovir.