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Herpes simplex - oral - Management
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How should I manage someone with cold sores?

When should I seek specialist advice for cold sores?

  • Seek specialist advice for managing immunocompromised individuals with cold sores.
  • Consider seeking specialist advice for pregnant women (particularly near term). Expert opinion differs as to whether this is necessary.
  • Neonatal herpes simplex infection is rare and may present with skin, eye and/or mouth symptoms. Seek specialist advice if this is suspected.
Basis for recommendation
  • CKS recommends seeking specialist advice on the management of immunocompromised people with cold sores and neonates with oral herpes simplex infection because of the increased risk of severe disease and complications in these groups [Arduino and Porter, 2006; BNF 54, 2007; Kimberlin, 2007; RCOG, 2007; Woo and Challacombe, 2007].
    • In immunocompromised individuals, recurrent herpes simplex virus (HSV) type 1 infection may be 'atypical', usually more extensive and aggressive than that of immunocompetent individuals, slow healing and extremely painful [Arduino and Porter, 2006]. Oral recrudescent HSV may lead to HSV viraemia and life-threatening disseminated disease [Woo and Challacombe, 2007].
    • In neonates, HSV infection is rare with a high morbidity (particularly if the central nervous system or multiple organs are affected) [RCOG, 2007]. Most cases occur as a result of direct contact with infected maternal secretions. Neonatal herpes can be localized to the skin, eye and/or mouth (SEM) which can progress to more severe disseminated disease. Treatment with intravenous aciclovir may be required for SEM infection [Kimberlin, 2007].
  • Pregnant women
    • There is a risk of HSV transmission to the neonate, particularly at child birth if the mother with cold sores is actively shedding the herpes simplex virus [RCOG, 2007].
    • Feedback from experts is divided whether specialist advice should be sought.

What self care advice can I give to someone with cold sores?

  • Reassure the person that the condition is self limiting and that lesions will heal without scarring.
  • Advise paracetamol or ibuprofen to relieve pain if required.
    • Topical anaesthetics or analgesics may relieve symptoms but there is little evidence to support their use.
  • Give advice to minimize transmission:
    • Avoid touching the lesions, other than when applying medication.
    • Wash hands with soap and water immediately after touching lesions.
    • Topical medications:
      • Should be dabbed on rather than rubbed in to minimize mechanical trauma to the lesions.
      • Should not be shared with others as this may spread infection.
    • Avoid kissing until the lesions have completely healed.
    • Do not share items that come into contact with lesion area (e.g. lipstick or lip gloss).
    • Avoid oral sex until all lesions are completely healed.
    • There is a risk of transmission to the eye if contact lenses become contaminated.
  • Inform that children with cold sores do not need to be excluded from nurseries and schools.
  • Advise the individual to seek medical advice if their condition deteriorates (e.g. lesion spreads, new lesions develop after initial outbreak, persistent fever, inability to eat) or no significant improvement is seen after 7 days.
Clarification / Additional information
  • The use of non-antiviral topical preparations to relieve symptoms (e.g. topical anaesthetics or analgesics) may be considered by people with cold sores but there is little evidence to support their use.
Basis for recommendation
  • These recommendations are based on expert opinion and advice issued by the Health Protection Agency (HPA) as most episodes of cold sores are generally mild and self limiting with spontaneous healing occurring over 7–10 days without scarring [Birek, 2000; Barbarash, 2001; Siegel, 2002; Spruance and Kriesel, 2002; HPA North West, 2005; HPA, 2006b; Gonsalves et al, 2007; Woo and Challacombe, 2007]. Treatment is primarily symptomatic [Birek, 2000; Siegel, 2002].
  • Cold sore lesions are generally self-limiting, starting to resolve within 7 days. Extensive or persistent lesions should raise the suspicion of immunosuppression [Birek, 2000; Spruance and Kriesel, 2002]. Expert feedback suggests reviewing the person if the condition deteriorates or no significant improvement is seen after 7 days.
  • Topical preparations for symptomatic relief:
    • A variety of these preparations are widely available to buy. However, CKS could find very little evidence from randomized controlled trials (RCTs) supporting their use.
      • Topical anaesthetics: evidence from a small double-blind placebo-controlled RCT (n = 72) found that topical tetracaine offer short term subjective relief (mainly for itch but not for pain) when initiated within 48 hours of cold sore lesion appearing [Kaminester et al, 1999]. No adverse reactions were reported for both groups. Lidocaine 5% ointment may be considered to relieve pain in oral lesions [BNF 54, 2007].
      • Topical analgesics: CKS found no double-blind RCTs supporting their use. Choline salicylate gel (Bonjela®) is licensed for use in adults and children over 16 years of age to relieve cold sore symptoms and may be sufficient for mildly painful lesions.
    • However, they may be considered by patients if they found them useful. They might help to relieve cold sore symptoms such as dryness, itching and pain [Barbarash, 2001].
    • Indirect evidence from double-blind RCTs have found even inert preparations can relieve symptoms by a direct or placebo effects [Shaw et al, 1985; Bodsworth et al, 2003].

Should I advise use of a topical antiviral to treat cold sores?

  • Advise that the benefits of topical antivirals (aciclovir or penciclovir) are small and require treatment to be initiated at the onset of symptoms (erythema or prodromal stage) before vesicles appear.
  • Reassure the individual that the cold sores will usually resolve within 7–10 days even without treatment.
  • If topical antiviral therapy is desired, remind the individual that:
    • Topical antivirals only affect the course of the current episode. They do not cure the individual or prevent future episodes of cold sores.
    • Treatment needs to be initiated at the onset of symptoms before vesicles appear.
    • Compliance with treatment is important, as antivirals need to be applied frequently for a minimum of 4–5 days.
    • Topical antivirals are widely available (without prescription) to treat future recurrences, if the individual finds them helpful. This can help to minimize the delay before starting treatment.
  • Seek specialist advice when managing people who are immunocompromised (including people with HIV) with cold sores.
Clarification / Additional information
Basis for recommendation
  • These recommendations are pragmatic advice, based on published expert review and evidence from randomized controlled trials (RCTs).
  • Most episodes of cold sores are generally mild and self limiting and can be treated symptomatically. For further information, see Self care advice
  • Mechanism of action:
  • Evidence from double-blind placebo-controlled RCTs involving topical antiviral creams (aciclovir 1% cream or penciclovir 1% cream) indicate that the benefits of topical treatment are small:
  • Timing of treatment:
    • In double-blind placebo-controlled RCTs, treatments with topical aciclovir or penciclovir were initiated within 1 hour of onset of signs or symptoms of a cold sore episode (erythema or prodromal stage) [Raborn, 1996; Spruance et al, 1997; Raborn et al, 2002; Spruance et al, 2002].
    • It is expected that the maximum clinical benefit from antiviral therapy is gained when treatment is started early because most viral replication occurs within the first 48 hours. Early initiation of antiviral therapy terminates virus replication and hence limits the subsequent epithelial damage responsible for the development of visible lesions [Esmann, 2001].

Should I consider prescribing an oral antiviral to treat cold sores?

  • For immunocompetent individuals, oral antivirals are not routinely indicated for the treatment of cold sores but may be indicated in severe episodes. However, the optimum timing and dose of oral antiviral treatment are uncertain. Consider seeking specialist advice (particularly for pregnant women — unlicensed use).
  • Seek specialist advice for people who are immunocompromised (including people with HIV).
Clarification / Additional information
Basis for recommendation
  • These recommendations are based on published expert review, evidence from randomized controlled trials (RCTs) and feedback from expert reviewers.
  • CKS does not recommend that oral antivirals should be used in immunocompetent individuals for mild-to-moderate episodes given the self-limiting nature of the disease, the limited benefits of oral antivirals, and that treatment needs to be initiated at the onset of prodromal symptoms (before the appearance of lesions).
    • Most episodes of cold sores are generally mild and self limiting and can be treated symptomatically. For further information, see Self care advice.
    • Evidence from double-blind placebo-controlled RCTs involving immunocompetent individuals indicate that [Raborn et al, 1987; Spruance et al, 1990b; Spruance et al, 2003; Spruance et al, 2006]:
      • Treatment with oral antivirals (aciclovir, valaciclovir, and famciclovir) does not appear to have an impact on the development of lesions, number of participants developing lesion pain, or the proportion of people with aborted lesions.
      • Oral antivirals can reduce the duration of a cold sore episode by 1.0–1.5 days when taken very early (typically within 1 hour of the onset of prodromal symptoms and before the appearance of any signs of cold sore lesions). Aciclovir taken at the papular lesion stage was found to have no effect on the duration of the episode and pain.
      • A reduction of 1.0–1.5 days in the duration of pain and lesion healing was only seen with higher dosage regimens of oral antivirals.
    • Timing of treatment
      • As for topical antivirals, it is expected that the maximum clinical benefit from antiviral therapy is gained when treatment is started early because most viral replication occurs within the first 48 hours. Early initiation of antiviral therapy terminates virus replication and hence limits the subsequent epithelial damage responsible for the development of visible lesions [Esmann, 2001].
  • However, they may be of most use in severe cases or in immunocompromised individuals at risk of developing further complications [Spruance et al, 1990b; Arduino and Porter, 2006; BNF 54, 2007; Woo and Challacombe, 2007].
  • Specialist advice should be sought for systemic treatment of herpes simplex infection in pregnancy [BNF 54, 2007]. Oral antivirals are not licensed for use in pregnancy.
  • Seek specialist advice when considering oral antiviral therapy in children.
    • There are no trials involving oral antivirals in those under 18 years of age for the treatment of cold sores [Woo and Challacombe, 2007].

What advice should I give about preventing cold sores recurring?

  • Minimize the impact of trigger factors:
    • Consider the use of sunblock lip balm (SPF 15 or greater) to help reduce outbreaks if sunlight is a potential trigger.
  • Inform the individual that prophylactic use of topical antivirals is ineffective.
  • Advise that, for immunocompetent people, the benefits of suppressive (continuous) therapy with oral antivirals are small and do not justify the routine use of long-term treatment. Episodic treatment might be preferred and more convenient (e.g. for those with 1–2 mild episodes per year).
  • For people with frequent or severe episodes, or for immunocompromised individuals (e.g. with HIV), prophylactic oral antiviral treatment may be helpful. Specialist advice should be sought.
Basis for recommendation
  • Minimize the impact of trigger factors:
    • In practice, trigger factors for cold sores are difficult to avoid or to modify (e.g. fatigue, psychological stress, trauma, and menstruation).
    • However, randomized controlled trials (RCTs) involving ultraviolet (UV) light induced cold sores indicate that sunblock may reduce recurrences if sunlight is a potential trigger factor [Worrall, 2006].
      • One small crossover RCT (n = 38) found sunblock (SPF 15) prevented lesions developing after UV exposure, while 71% of the placebo group developed lesions [Rooney et al, 1991]. Another small crossover RCT (n = 19) found a lower incidence of recurrence in the sunscreen group (5% recurrence) than placebo (58% recurrence) (p < 0.01) [Duteil et al, 1998].
  • Prophylactic use of oral antivirals:
    • There is limited evidence to support long-term prophylactic therapy in immunocompetent individuals. Treatment can increase the risk of systemic adverse effects. Compliance with therapy is important.
      • A small, double-blind placebo-controlled RCT indicated that aciclovir may delay the onset of cold sores. However the study was small (n = 22 healthy adults) and 18% of the aciclovir group dropped out due to adverse effects [Rooney et al, 1993].
      • The combined results of 2 double-blind RCTs (n = 98 healthy adults) found that prophylactic oral valaciclovir therapy delays recurrence of cold sores compared with placebo [Baker and Eisen, 2003]. However, it is uncertain if the populations of the two separate trials were matched. The study provides no details regarding randomization procedure, severity of recurrences and symptoms, and treatment compliance, nor any period effect.
    • There is little evidence to favour long-term suppressive (continuous) therapy over episodic (as required) treatment with oral antivirals:
      • CKS found one open-label, crossover RCT (76 adults enrolled but only 55 completed study) which found modest benefits with suppressive therapy (valaciclovir 1 g daily) compared with episodic treatment (valaciclovir 2 g twice daily, during attack) when treatments were taken for 6 months (mean number of cold sore episodes per 120 days of follow up: 0.49 episode for suppressive therapy vs. 1.1 for episodic therapy) [Gilbert, 2007]. However, the authors cautioned that results should be interpreted in the context of a significant period effect, which was not explained by the time of the year.
    • Prophylaxis regimens for patients who experience mild outbreaks 1 to 2 times a year are not recommended [Woo and Challacombe, 2007].
    • However, prophylactic therapy may be of use for those with frequent, severe episodes, or immunocompromised individuals who are at risk of developing severe complications [Arduino and Porter, 2006; Woo and Challacombe, 2007]. Specialist advice should be sought as the optimal timing and dose of treatment are uncertain and can vary in different situations [Arduino and Porter, 2006].
  • Prophylactic use of topical antivirals:
    • There is no good evidence to suggest that topical antivirals (aciclovir or penciclovir) can prevent or delay recurring cold sores.
      • Two small trials (n = 18 and n = 23) found no, or a modest, benefit with aciclovir compared with placebo [Fawcett et al, 1983; Gibson et al, 1986; Esmann, 2001].
      • One larger randomized, double-blind trial (undertaken in seven ski resorts, n = 191 treated) found no significant difference between topical aciclovir 5% cream and placebo in the number of people who experienced lesions during the treatment period [Raborn et al, 1997].
    • Given that frequent daily application is required, long-term continuous suppression with a topical antiviral preparation might be impractical [Esmann, 2001].

What advice should I give about treating further episodes of cold sores?

  • Offer self-care advice on how to manage future episodes symptomatically.
  • If treatment with a topical antiviral is desired, advise the individual that these should be applied at the onset of symptoms (erythema or prodromal stage) before vesicles appear. Inform the individual that the benefits might be small.
  • Seek specialist advice for immunocompromised individuals (including people with HIV).
Clarification / Additional information

How should I manage someone with gingivostomatitis?

  • Reassure the individual or parent that the disease is self limiting.
  • Treat symptomatically:
    • Offer paracetamol or ibuprofen to relieve pain and fever.
    • Encourage adequate fluid intake to avoid dehydration.
    • Avoid acidic or salty foods and consume cool, soft foods.
    • Consider offering topical benzydamine for additional pain relief.
    • Offer chlorhexidine mouthwash to help control secondary infections and to control plaque accumulation if brushing of teeth is painful.
    • The use of a lip barrier preparation (e.g. Vaseline®, Lypsyl®) may be useful to prevent lip adhesion.
  • Provide advice to minimize transmission:
    • Avoid touching the lesions, other than when applying lip barrier preparation.
    • Wash hands with soap and water immediately after touching lesions.
    • Avoid kissing until the lesions have completely healed.
    • Do not share items that come into contact with the lesion area (e.g. lipstick or lip gloss, or barrier lip cream).
    • Avoid oral sex until all lesions are completely healed.
  • Children with gingivostomatitis who are generally well do not need to be excluded from nurseries and schools.
  • Oral antivirals are not routinely indicated for the treatment of gingivostomatitis in immunocompetent individuals but may be indicated in severe episodes. However, the optimum timing and dose of oral antiviral treatment are uncertain. Consider seeking specialist advice.
  • Seek specialist advice if:
    • Symptoms are not improving after 5 days.
    • The affected person is pregnant, a neonate, or is immunocompromised.
  • Admit the person if they are unable to tolerate oral fluids and are at risk of becoming dehydrated. Intravenous fluids may be required.
Basis for recommendation
  • These recommendations are pragmatic advice, given that herpetic gingivostomatitis is a self-limiting disease (lasting from 7–14 days, and up to 3 weeks for severe lesions to heal) [Birek, 2000; Amir, 2001; Esmann, 2001; Sladden and Johnston, 2005; Arduino and Porter, 2006; Kolokotronis and Doumas, 2006; BNF 54, 2007].
  • Prevention of dehydration:
    • Drinking plenty of fluids should be encouraged, particularly in young children as they tend to avoid eating or drinking because of the pain.
    • The most common cause of morbidity following gingivostomatitis is dehydration, and in severe cases this may require hospital admission [Amir et al, 1997; Amir, 2001; Esmann, 2001; Kolokotronis and Doumas, 2006].
  • At risk groups:
    • CKS recommends seeking specialist advice on the management of oral herpes simplex infection in those who are pregnant or immunocompromised, or in neonates, because of the increased risk of severe disease and complications in these groups [Leflore et al, 2000; Scully and Felix, 2006; BNF 54, 2007; Kimberlin, 2007].
    • Herpetic gingivostomatitis generally runs its course within one to two weeks with mild lesions usually healing within 5–7 days [Birek, 2000; Kolokotronis and Doumas, 2006]. Expert feedback suggests that specialist advice should be sought if no improvement in symptoms is seen after 5 days.
  • The Health Protection Agency (HPA) does not recommend children with gingivostomatitis to be excluded from schools and nurseries [HPA, 2003].
  • Antiviral drugs:
    • Oral antiviral therapy might be of value, especially in severe infection, neonates, or immunocompromised people [Scully and Felix, 2006; BNF 54, 2007]. However, there is uncertainty regarding the optimal timing and dosage.
      • CKS found only three randomized controlled trials investigating the use of antiviral drugs in those with gingivostomatitis. All studies involved children.
      • The results suggested that aciclovir suspension may be effective in reducing the duration of symptoms of herpetic gingivostomatitis in young children, but the optimal timing and dose of antiviral therapy are uncertain [Amir, 2001; Esmann, 2001; Arduino and Porter, 2006].
      • It is expected that the maximum clinical benefit from antiviral therapy is gained when treatment is started early because most viral replication occurs within the first 48 hours. Early initiation of antiviral therapy terminates virus replication and hence limits the subsequent epithelial damage responsible for the development of visible lesions [Esmann, 2001].
    • Specialist advice should be sought for systemic treatment of herpes simplex infection in pregnancy [BNF 54, 2007].
  • Use of lip barrier cream:
    • Based on a case report, the use of lip barrier preparations is recommended as a simple measure to prevent adherence of the lips (labial adhesions). This is a rare and serious complication of gingivostomatitis which might require surgical intervention in severe cases [Thomas, 2007].
  • Doxycycline mouthwash:
    • Although recommended by the British National Formulary for the treatment of herpes infection in the mouth [BNF 54, 2007], CKS could not find any evidence to support this use.

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