Oleavicin White Paper
Review of the efficacy and safety of Oleavicin, a treatment for cold sores.
Terrance Owen, PhD, MBA
This paper reviews on the effectiveness and safety of the product, Oleavicin, as a treatment for cold sores which are caused by the virus, Herpes simplex I (“HSV-1”).
The marketing of Oleavicin focuses on the healing power of extracts from the leaves of the olive tree (“OLEx”) Olea europaea, which have been recorded since biblical times. Although no formal clinical studies have been conducted on the effectiveness and safety of Oleavicin, there is an abundance of anecdotal reports from uses of the product that attest to the validity of its claims.
A review of the scientific literature verifies the claims of the health benefits of OLEx, including the antimicrobial activity. OLEx is effective against HSV-1 which supports the claim that Oleavicin can be used to treat cold sores.
The anecdotal reports included no indications of side effects from the use of Oleavicin.
Also, every ingredient used in Oleavicin is listed in the compendium of natural products maintained by Health Canada and considered to be safe when used in the concentrations found in the product.
These observations lead to the conclusion that Oleavicin is safe to use as directed as a topical treatment for cold sores.
Competing products for the treatment of cold sores include topical and oral antiviral compounds, all of which have potentially serious side effects.
Docosonal reduces the healing time of cold sores by 18 hours when compared to treatment with a placebo. Users of Oleavicin report a 2 to 3 day reduction in the time required to resolve cold sores. Commercially available docosanol is significantly more expensive than Oleavicin.
It is concluded that Oleavicin is an effective natural product for the treatment of cold sores without the potential side effects of topical or oral antifungal agents or the expense of docosanol.
Review of the efficacy and safety of Oleavicin, a treatment for cold sores.
Oleavicin is a natural health product that is sold as a gel for the topical treatment of cold sores. It contains, among other ingredients, an extract from the leaves of the olive tree (“OLEx”), Olea europaea. Marketing of the product focuses on the healing properties of OLEx due to the historical use of the olive tree as a source of natural treatments to combat infectious micro-organisms, including bacteria, fungi and viruses.
Oleavicin is labelled as a “Cold sore/fever blister treatment”. Additional claims are made of relieving canker sores and dry, itchy skin and softening cold sores and the wounds caused by cold sores.
“Fever blisters” is another name cold sores which are caused by the virus, Herpes simplex I. Pray (2007) provides a review of the incidence and prevalence of HSV-1 infections in the USA and found that 600,000 new cases develop each year.
There is no cure for HSV-1, so an initial infection remains, without exception. This leads to an increase in prevalence of HSV-1 with the age of a given population group. For instance, the prevalence in young adults is 20% to 40%. Each year beyond age 29, another 1.5% of patients reportedly contract the infection, up to age 50. By age 70, the prevalence approaches 90%.
Canker sores may be the result of a virus infection or stress, hormonal fluctuations, food allergies, the menstrual cycle, vitamin or mineral deficiencies or an immune system problem. (Anon., 2016a) Anecdotal evidence has indicated that Oleavicin does provide relief for canker sores (Anon., 2016b) and it is registered for that purpose in the Health Canada natural products database (Anon. 2016c).
Historical use of the olive tree for medicinal purposes
Medicinal properties have been attributed to olive trees and other members of the Oleaceae family since biblical times (Frederickson, 2000). In lay articles, olive leaf extracts (“OLEx”) are reported to have anti-microbial activity that includes the ability to kill or inhibit bacteria, viruses, fungi and parasites (Bowden J, 2009).
These claims have been verified for anti-microbial activity in peer-reviewed scientific journals for bacteria (Markin et al., 2003), viruses (Micol et al., 2005) and fungi (Pereira et al., 2007).
Since the 1800s, the bitter component in olives was used in humans against malaria-induced fevers (Hamdi & & Castellon, 2005). In 1960, Panizzi and Oriente succeeded in isolating the phenolic compound, oleuropein (“Ole”), from this bitter fraction. The chemical structure of Ole was determined in 1970 by Inouye et al. and subsequent studies demonstrated that Ole and its hydrolysis product, elenolic acid, possessed anti-bacterial, anti-viral, and anti-fungal activities (Fleming et al., 1973; Renis, 1975; Martin et al., 2003; Hamdi & Castellon, 2005; Micol et al, 2005; Omar, 2010).
There is a lack of scientific papers that have tested OLEx or Ole as a topical treatment against Herpes viruses. However, the anecdotal evidence does provide evidence that Oleavicin is effective as a topical treatment for cold sores. Further, OLEx has been shown to have anti-viral activity against other viruses such as viral hemorrhagic septicemia rhabdovirus (VHSV) which affects wild and farmed salmon (Micol et al., 2005) and tomato yellow leaf curl disease (TYLCD) which affects tomato crops (Abdelkadar & Rifaat, 2016).
In addition to its anti-microbial properties, Omar (2010) has provided an extensive review of other pharmacological properties of Ole which are believed to be mostly due to its anti-oxidant properties (Al-Azzawie and Alhamdani, 2006) and include the following:
• anti-atherogenic (reduces the formation of fatty plaques in the arteries),
• anti-cancer agent,
• anti-aging agent,
• anti-rheumatic agent,
• skin protectant,
• neuroprotectant (helps to prevent nerve damage),
• hypo-glycemic (reduces blood sugar) and
• fever reduction.
These findings are published in peer-reviewed journals as referenced by Omar (2010) but, as of 2011, most studies were conducted in test tubes or animals. Few, if any formal clinical trials of Ole on humans have been conducted except for a study involving 232 people with high blood pressure who received treatment with OLEx and another commonly used medication with similar reductions in blood pressure seen in both groups (Susalit et al. 2011).
Antimicrobial activity of OLEx
Ole is known to have antimicrobial activity against bacteria and fungi (Fleming et al., 1973; Bisignano et al., 1999; Aziz et al., 1998; Furneri et al. 2002; Koruklouglu et al., 2008) and certain viruses (Ma et al. 2001).
However, Ma et al. (2001) found that Ole alone did not have any effect on HSV-1, the causative agent for cold sores. OLEx demonstrates activity against additional viruses (Micol et al., 2005; Abdelkader & Rifaat, 2016) but, other than anecdotal reports, no testing of OLEx against HSV-1 was found in the literature. The empirical observation that OLEx kills Herpes viruses is most likely due to other anti-viral ingredients found in OLEx (Erdohan & Turhan, 2011; Sato et al. 2007; Japón-Luján & Castro 2006; Japón-Luján & Castro 2007) which have been demonstrated to be effective against Herpes viruses, such as oleanolic acid (Jesus et al., 2015), verbascoside (Martins et al. 2009), apigenin-7glucoside (Todorov et al. 2014).
In addition to the antimicrobial properties of OLEx, Oleavicin contains additional ingredients that have well established antimicrobial properties.
• Aloe barbadensis (Aloe vera) leaf juice is an antibacterial and antifungal agent (Lawrence et al., 2009; Nejatzadeh-Barandozi, 2013; Kedarnath et al., 2013) that is also effective against HSV-1 and other viruses (Sydiskis et al., 1991)
• Glucose, glucose oxidase and lactoperoxidase act as a system to inhibit the viability of bacteria, fungi and viruses (Welk et al. 2009), including HSV-1 (Mikola et al. 1995). Glucose oxidase, using glucose as a substrate, generates hydrogen peroxide (H2O2) which is used by lactoperoxidase to generate the antimicrobial compounds, hypothiocyanite ion (OSCN-) and the corresponding acid, hypothiocyanous acid (HOSCN), from thiocyante ion (SCN-) which is present in saliva.
• Hypericum perforatum extract, also known as St. John’s wort, acts as an anti-inflammatory, anti-viral and anti-bacterial agent (Klemow et al, 2011) and one of its main ingredients, hypericin, is active against herpes viruses (Tang et al. 1990).
• Propolis extract is also highly effective against HSV-1 due to the presence of polyphenols, flavonoids and phenylcaboxylic acids (Schnitzler et al., 2010).
As stated above, the anti-microbial properties of OLEx and Ole are well known and documented through history but there are no known formal clinical studies on the effect of these materials on infectious diseases of humans nor have any clinical studies of Oleavicin been conducted.
However, there are anecdotal reports and endorsements on the website of the main distributor of Oleavicin, Amazon.com. As of September 18, 2016, there were 138 customer reviews posted on Amazon.com (Anon. 2016b) and Oleavicin received an average rating of 4.5 for the treatment of cold sores with 5 stars being the best rating. The respondents reported that Oleavicin reduced the healing time for cold sores by 2 to 3 days. No side effects were reported.
Eleven reviews were less than 4 stars for the following reasons:
• not better than other products for cold sores (5)
• tube empty or not full enough (3),
• cold sore gone before product arrived so, no opinion (2) and
• not better than other products for chapped lips, although that is not a stated use for the product (1).
Clearly, anecdotal evidence is not as powerful as double-blind, randomized, parallel and active-controlled clinical studies but, at this time, it provides evidence that Oleavicin reduces the healing time for cold sores.
As presented on the Health Canada website for natural products, the active ingredients of Oleavicin with weight to weight percentages are (Anon. 2016c):
• Allantoin (0.5%) which is an FDA-approved protectant to soften the skin to prevent cracking and also relieve dryness (Pray, 2007).
• Hypericum perforatum extract (0.5%), also known as St. John’s wort, acts as an anti-inflammatory, anti-viral and anti-bacterial agent and is active against herpes viruses, as discussed above.
• Olea europaea (Olive) fruit oil (0.15%) which has antimicrobial properties, as discussed above and is also included in the product to act as a preservative, stabilizer and emulsifier.
• Propolis extract (0.5%) is a mixture collected by honey bees from botanical sources for use as a sealant in hives, is active against bacteria, fungi and viruses, including HSV-1, as discussed above, and is also added to the product to assist in healing the open wound and preventing new infections.
Oleavicin also contains the following ingredients. The information below and the weight to weight percentages of each ingredient are provided in a patent for the treatment of Herpes and
cold sores (Makela & Makela, 2014) supplemented with additional literature references as deemed appropriate.
• Aloe barbadensis (aka Aloe vera) leaf juice (1-3%) is an antibacterial and antifungal agent that is also effective against HSV-1 and other viruses, as referenced above, which helps to prevent open wounds, cold sores, or herpes outbreaks from becoming further infected. Aloe vera is also a skin-conditioning agent (CRIEP, 2007).
• Carrageenan (0.1- 0.3%) is extracted from red seaweed and is used to thicken and gel the product.
• Glucose (<0.1%), glucose oxidase (<0.1%) and lactoperoxidase (<0.1%) act as a system to inhibit the viability of bacteria, fungi and viruses as discussed in more detail above.
• Glycerin (1-3%) helps to improve smoothness of the product and acts as a humectant which helps to retain water. Additionally, glycerin can penetrate the epidermis (Jiang et al, 2008) and act as a carrier to deliver other ingredients in the product into the skin
• Hydroxyethyl cellulose (1-3%) acts as a thickener and solvent.
• Menthol (0.12%) functions as a local anesthetic (Eccles, 1994) to help soothe the affected area and also demonstrates anti-bacterial activity (Freires et al. 2015).
• Olea europaea (Olive) leaf extract (0.1-0.3%) which has antimicrobial properties, as discussed above, and is also included in the product to act as a preservative, stabilizer and emulsifier.
• Panthenol (<0.1%) acts as a humectant, emollient, and moisturizer.
• Xanthan gum (1-3%) increases the viscosity of the product.
• Water is a solvent and makes up the remainder of the formulation
Oleavicin is registered in Canada with the Natural and Non-Prescription Health Products Directorate (NNHPD) under Product License NPN80061750 as, “An antiseptic and/or antimicrobial to help treat and heal minor skin wounds, cuts, burns and bruises. Temporarily protects and helps relieve minor skin irritation and itching of minor cuts, scrapes and burns. (Traditionally) used in Herbal Medicine to help relieve minor inflammations and sores or mucous membranes of the mouth (such as canker sores)” (Anon. 2016c).
The NNHPD allows the registration and sale of certain products without testing because the ingredients that are listed in a series of monographs and are known to be effective and safe. A search on the Health Canada website reveals that every ingredient in Oleavicin is classified as a natural product and safe for use within the concentrations that are used in the product (Anon, 2016d).
No side effects from the topical use of the ingredients in the concentrations present in Oleavicin are known but the possibility of an allergic reaction to one or more ingredients is possible. From the 138 anecdotal reports posted by users of Oleavicin, no side effects were reported (Anon. 2016b).
There are restrictions on use of Oleavicin to further reduce any risk to users which include the following warnings.
• Do not use if allergic to any ingredient in the product.
• Apply only to the infected areas.
• Do not use in or near the eyes.
• Do not share the product with anyone to avoid spreading infection.
• Stop using the product and seek medical help if the condition worsens or lasts more than 7 days.
• Keep out of reach of children.
• Consult a physician for use on children less than 2 years of age
Oleavicin is to be applied to the infected area 1 to 4 times per day for a period not to exceed 7 days.
Other treatments for HSV-1
Although not an exhaustive study of other treatments that are available for HSV-1 infections, a description of the main approaches follow.
Harmenberg et al, (2010) provide a review of common antiviral agents and observed the following. Limited but statistically significant results were shown with topical antivirals, such as acyclovir and penciclovir, which improved healing times by approximately 10%. Two orally administrated antivirals, valaciclovir and famciclovir, showed different results in phase 3 studies. Famciclovir showed improved healing times but no effect on prevention of lesions. Valaciclovir appeared to have a similar healing times compared to that of acyclovir cream and some effect on prevention of lesions.
A formulation of acyclovir/hydrocortisone showed further improvement in prevention of lesions, while retaining healing effectiveness. All of these drugs have potentially serious side effects that are identified in an online compendium of drug products (Anon. 2016e).
Sacks et al. (2001) completed two identical double-blind, placebo-controlled studies at a total of 21 sites on the use of 10% docosanol for the treatment of cold sores. Treatment was administered 5 times daily until healing occurred which means that the crust fell off spontaneously or there was no longer evidence of an active cold sore. The median time to healing in the 370 docosanol-treated patients was 4.1 days, 18 hours shorter than observed in the 367 placebo-treated patients Adverse experiences with docosanol were mild and similar to those with placebo.
Amazon.com sells Abreva for $16.49 per 0.07 ounce tube ($232.43/oz) compared to $12.49 for a 1.3 ounce tube of Oleavicin ($9.60/oz).
The shelf life of Oleavicin is 24 months.
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About the author
Dr. Terrance Owen has expertise in biochemistry, biotechnology, pharmaceuticals medical services. He obtained his BSc (Honours) in Biology from the University of Victoria in 1968, MSc in Biology from the University of New Brunswick in 1970, PhD in Zoology from the University of British Columbia in 1974 and MBA from Simon Fraser University in 1991. From 2000 to 2013, Dr. Owen was the President, CEO & a Director of ALDA Pharmaceuticals Corp. (Since renamed Vanc Pharmaceuticals Inc.), a company that focused on topical infection control with a patented anti-bacterial, anti-fungal and anti-viral formulation. From December, 1980 to April 2002, Dr. Owen was the President of Helix Biotech ULC, a laboratory providing DNA identity testing services for paternity, immigration and forensic cases. He was the President and a director of Helix BioPharma Corp., a pharmaceutical company, from July, 1995 to June, 1998. Dr. Owen is currently with Champion Pain Care Corporation, a medical services company as of October, 2013, first as the CEO and now the CFO.