Cochrane · intervention · CD006700

Acyclovir for treating primary herpetic gingivostomatitis

Cochrane Database of Systematic Reviews · 2008 · Cochrane Library

Full textEvery question was extracted from the full review (methods and results), not only its Summary of Findings table.
Questions
11
current version
GRADE rated
0
No studies
2
Included studies
2
as reported
No studies 2 · 18.2%Ungraded 9 · 81.8%Very low 0 · 0%Low 0 · 0%Moderate 0 · 0%High 0 · 0%

Ungraded means an effect was reported without a GRADE rating; it is not a gap. No studies means the review found nothing to answer the question. The six categories are a display order, not a score.

Review question

ElementPlanned (methods)Found (results)
PopulationChildren and young adults under 25 years with primary herpetic gingivostomatitis (PHG) with or without herpes labialis; diagnosis confirmed by clinical history and laboratory investigationChildren aged 1 to 6 years (Amir 1997b, n=72); children mean age 2 years, 11 boys and 9 girls (Ducoulombier 1988, n=20) (n=92 total)
InterventionSystemic oral acyclovir (any dose, frequency and duration of administration)Acyclovir suspension 15 mg/kg 5 times daily for 7 days (Amir 1997b); acyclovir tablets 5 per day for 5 days, dose unspecified (Ducoulombier 1988) (n=2)
ComparisonPlacebo or no treatmentPlacebo suspension (Amir 1997b); placebo tablets (Ducoulombier 1988) (n=2)
OutcomesDuration and time of healing of intraoral and extraoral lesions; Pain/discomfort; Difficulty in eating/drinking; Fever; Hospital admission; Quality of life; Patient or parental satisfaction; Direct costs; Adverse effectsOral lesions (n=2); Extraoral lesions (n=1); Pain/discomfort (n=1); Difficulty eating (n=2); Difficulty drinking (n=1); Fever (n=2); Hospital admission (n=1); Quality of life (n=0); Patient or parental satisfaction (n=1); Direct costs (n=0); Adverse effects (n=2)
Study designsRandomised controlled trials (RCTs)Randomised double-blind placebo-controlled trials (n=2)
TimingFrom time of administration of interventionAmir 1997b: examinations on days 0, 3, 6 and 8 (7-day treatment); Ducoulombier 1988: 5-day treatment

Search date: 2008-05. Databases: The Cochrane Oral Health Group's Trials Register; The Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE; EMBASE

Questions and results

Current version only

Systemic oral acyclovir vs Placebo or no treatment

Population: Children and young adults under 25 years with primary herpetic gingivostomatitis (with or without herpes labialis)
CD006700.PUB2 (current) · 11 questions
OutcomeEffectEvidenceStatus / GRADE
Number of individuals with oral lesions (8 days after administration); time to healing of oral lesions
8 days after administration
RR 0.10 [0.02, 0.38]1 study · 72 participantsUngraded
Number of individuals with drinking difficulties (8 days after administration); duration of drinking difficulties
8 days after administration
RR 0.11 [0.01, 0.83]1 study · 72 participantsUngraded
Number of individuals admitted to hospital after administration
After administration
RR 0.14 [0.01, 2.67]1 study · 72 participantsUngraded
Number of individuals who developed new extraoral lesions after administration; duration of extraoral lesions
After administration
RR 0.04 [0.00, 0.65]1 study · 72 participantsUngraded
Number of individuals with eating difficulties (8 days after administration); duration of eating difficulties
8 days after administration
RR 0.14 [0.03, 0.58]1 study · 72 participantsUngraded
Direct costs (medication, hospital bed days)
No data available in either included study.NRNo studies
Fever (duration; time to return to normal temperature)
Amir 1997b: fever disappeared significantly earlier with acyclovir (median 1 day) than placebo (median 3 days); difference in median (95% CI): From 72: 1 (0.0 to 2.0); From 61: 2 (0.8 to 3.2); reported as median, not…2 studiesUngraded
Patient or parental satisfaction (tolerance and acceptability of drug)
Amir 1997b: no data available. Ducoulombier 1988: tolerance and acceptability of the drug was described as satisfactory, but it was unclear how this was assessed by the trialists.1 studyUngraded
Adverse effects
Amir 1997b: two children in each group (2 vs 2) had mild gastrointestinal symptoms that resolved spontaneously after 24 to 48 hours without a change in study treatment. Ducoulombier 1988: no significant adverse effects…2 studiesUngraded
Quality of life (assessed by a validated questionnaire)
No data were available in either included study (Amir 1997b; Ducoulombier 1988).NRNo studies
Pain/discomfort (time to resolution of pain)
Amir 1997b: no data available. Ducoulombier 1988: time to resolution of pain, acyclovir (1 day=1, 2 days=1, 3 days=3, 4 days=3, 5 days=1, persistent=0) vs placebo (1 day=0, 2 days=0, 3 days=1, 4 days=2, 5 days=4,…1 study · 18 participantsUngraded

Systemic oral acyclovir vs Placebo or no treatment

Population: Children and young adults under 25 years with primary herpetic gingivostomatitis (with or without herpes labialis)
CD006700 · 11 questions
OutcomeEffectEvidenceStatus / GRADE
Difficulty in drinking (number with drinking difficulties)
Protocol primary outcome: difficulty in eating/drinking - time to resumption of normal feeding pattern.NRNo studies
Fever
Protocol primary outcome: fever.NRNo studies
Duration and time of healing of extraoral lesions; development of new extraoral lesions
Protocol primary outcome: duration and time of healing of all intraoral and extraoral lesions from time of administration of intervention.NRNo studies
Quality of life (assessed by a validated questionnaire)
Protocol secondary outcome: quality of life as assessed by a validated questionnaire.NRNo studies
Direct costs (medication, hospital bed days)
Protocol costs outcome: direct costs of medication, hospital bed days.NRNo studies
Duration and time of healing of intraoral (oral) lesions; number of individuals with oral lesions
Protocol primary outcome: duration and time of healing of all intraoral and extraoral lesions from time of administration of intervention; change in number of lesions and number of individuals with lesions.NRNo studies
Pain/discomfort (patient-assessed using any recognised validated pain scale)
Protocol primary outcome: pain/discomfort, patient-assessed using any recognised validated pain scale.NRNo studies
Patient or parental satisfaction (assessed by questionnaire)
Protocol secondary outcome: patient or parental satisfaction assessed by questionnaire.NRNo studies
Adverse effects
Protocol adverse effects outcome: any specific adverse effects related to any clinically diagnosed reactions to the active intervention.NRNo studies
Hospital admission (length of stay including intravenous rehydration; number admitted)
Protocol secondary outcome: hospital admission - length of stay to include intravenous (iv) rehydration.NRNo studies
Difficulty in eating (time to resumption of normal feeding pattern; number with eating difficulties)
Protocol primary outcome: difficulty in eating/drinking - time to resumption of normal feeding pattern.NRNo studies