Cochrane · intervention · CD006706
Interventions for the prevention and treatment of herpes simplex virus in patients being treated for cancer
Glenny, AM, Fernandez Mauleffinch, LM, Pavitt, S, et al. · Cochrane Database of Systematic Reviews · 2009 · Cochrane Library
Full textEvery question was extracted from the full review (methods and results), not only its Summary of Findings table.
Questions
22
current version
GRADE rated
0
No studies
9
Included studies
17
as reported
No studies 9 · 40.9%Ungraded 13 · 59.1%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
| Element | Planned (methods) | Found (results) |
|---|---|---|
| Population | Anyone receiving treatment for cancer. Trials were included if they recruited adults, children or both | Seventeen trials were included. Nine trials recruited adults only (age 15 to 84 years); the remainder recruited adults and children (age 2 to 79 years). One trial included patients with solid tumours (squamous cell carcinoma of the head and neck); the remainder recruited patients with haematological malignancies |
| Intervention | Any agent prescribed prophylactically or therapeutically for orofacial lesions caused by herpes simplex virus | Aciclovir oral administration (n=8); Aciclovir intravenous administration (n=3); Valaciclovir oral administration (n=3); Prostaglandin E oral administration (n=1) |
| Comparison | Placebo; No treatment; Any other active intervention | Placebo (n=12); Valaciclovir oral and intravenous administration (n=1); Aciclovir (n=1) |
| Outcomes | Prevention: Presence/absence of clinical/culture positive (with or without clinical symptoms) herpes simplex virus infections; Treatment: Time to complete healing of lesions; Duration of viral shedding; Recurrence of lesions; Time to relief of pain; Amount of analgesia; Days stay in hospital; Cost of oral care; Patient quality of life; Adverse effects | Presence/absence of HSV oral lesions (n=12); Viral isolates (n=11); Time to healing (n=2); Duration of viral shedding (n=2); Relief of pain (n=2); Cost of oral care (n=1); Adverse effects (n=11) |
| Study designs | Randomised controlled trials | RCT (n=17) |
| Timing | Not specified | Not specified |
Search date: 2008-11. Databases: Cochrane Oral Health Group's Trials Register; Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE (OVID) and MEDLINE Pre-indexed; EMBASE (OVID); CINAHL (OVID); CANCERLIT via PubMed; SIGLE; LILACS
Questions and results
Current version onlyProphylactic aciclovir (oral or intravenous) vs Placebo
Population: Patients being treated for cancer (predominantly haematological malignancies)
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Patient quality of life | None of the prophylactic aciclovir versus placebo trials reported on patient quality of life. For prevention or treatment, no trials reported on duration of hospital stay, amount of analgesia or patient quality of life. | 0 studies | No studies |
Viral isolates (HSV isolates identified, with or without clinical symptoms) | RR 0.17 [0.07, 0.37] | 9 studies · 511 participants | Ungraded |
Presence/absence of HSV oral lesions | RR 0.16 [0.08, 0.31] | 9 studies · 398 participants | Ungraded |
Recurrence of lesions | Recurrence of lesions was a planned secondary outcome; no included trial reported data for this outcome in the prophylactic aciclovir versus placebo comparison. | 0 studies | No studies |
Days stay in hospital | For prevention or treatment, no trials reported on duration of hospital stay, amount of analgesia or patient quality of life. | 0 studies | No studies |
Amount of analgesia | None of the prophylactic aciclovir versus placebo trials reported on amount of analgesia. For prevention or treatment, no trials reported on duration of hospital stay, amount of analgesia or patient quality of life. | 0 studies | No studies |
Adverse effects | Adverse effects were reported in nine trials. Diagnosis was by evaluation of clinical signs and symptoms (e.g. rash, neurological impairment) and by laboratory tests including renal and hepatic function. None of the… | 9 studies | Ungraded |
Prophylactic aciclovir (oral or intravenous) vs Prophylactic valaciclovir (oral)
Population: Patients being treated for cancer (predominantly haematological malignancies)
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Presence/absence of HSV oral lesions | RR 0.78 [0.26, 2.38] | 2 studies · 181 participants | Ungraded |
Cost of oral care | Only one trial reported on the cost of prophylaxis for HSV (Liesveld 2002). The reported mean pharmacy costs for those randomised to receive aciclovir were $1080 compared to $320 for those initially randomised to… | 1 study · 30 participants | Ungraded |
Prophylactic valaciclovir (lower dose) vs Prophylactic valaciclovir (higher dose)
Population: Patients being treated for cancer (acute leukaemia; chemotherapy or stem-cell transplantation)
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Adverse effects | One study reported adverse effects (Warkentin 2002). Twenty patients allocated to receive high dose valaciclovir reported adverse effects (42%); for the low dose group this number was 27 (52%). Adverse effects were… | 1 study · 100 participants | Ungraded |
Presence/absence of HSV oral lesions | RR 0.23 [0.05, 1.03] | 2 studies · 181 participants | Ungraded |
Viral isolates | Orlowski 2004: 182 throat swabs performed for patients receiving 500 mg of valaciclovir (n = 40) and 198 swabs for those receiving 1000 mg (n = 41); all of the cultures proved negative (1 trial, 81; not estimable). | 1 study · 81 participants | Ungraded |
Prophylactic prostaglandin E (oral) vs Placebo
Population: Patients being treated for cancer (leukaemia)
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Viral isolates | RR 1.87 [1.12, 3.14] | 1 study · 60 participants | Ungraded |
Aciclovir (oral or intravenous) for treatment vs Placebo
Population: Patients being treated for cancer with established oral HSV infection (bone marrow transplant recipients / immunocompromised)
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Relief of pain | Time to first decrease in pain was significantly shorter in favour of oral aciclovir (median 3 days versus 16 days, P = 0.04; Shepp 1985). Time to complete resolution of pain was shorter with oral aciclovir than… | 2 studies | Ungraded |
Recurrence of lesions | For the treatment comparison (aciclovir versus placebo), no data were available for recurrence of lesions, amount of analgesia, days of stay in hospital, cost of oral care or patient quality of life. | 0 studies | No studies |
Duration of viral shedding | Two studies. Statistically significant difference in median duration of virus shedding in favour of intravenous aciclovir (2.5 days versus 17.0 days, P = 0.0002; Meyers 1982) and oral aciclovir (2 days versus more than… | 2 studies | Ungraded |
Days stay in hospital | For the treatment comparison (aciclovir versus placebo), no data were available for recurrence of lesions, amount of analgesia, days of stay in hospital, cost of oral care or patient quality of life. | 0 studies | No studies |
Amount of analgesia | For the treatment comparison (aciclovir versus placebo), no data were available for recurrence of lesions, amount of analgesia, days of stay in hospital, cost of oral care or patient quality of life. | 0 studies | No studies |
Patient quality of life | For the treatment comparison (aciclovir versus placebo), no data were available for recurrence of lesions, amount of analgesia, days of stay in hospital, cost of oral care or patient quality of life. | 0 studies | No studies |
Time to complete healing of lesions | Two studies. Median time to total healing was shorter for patients receiving oral or intravenous aciclovir than placebo: median of 8 days versus 21 days, P = 0.01 (Shepp 1985); 13.9 days versus 20.7 days, P = 0.08… | 2 studies | Ungraded |
Adverse effects | Adverse effects were assessed in both studies. For intravenous aciclovir the most commonly reported adverse effect was a reaction at the injection site (8 (16%) aciclovir versus 3 (7%) placebo; all patients, n = 97);… | 2 studies | Ungraded |
Cost of oral care | For the treatment comparison (aciclovir versus placebo), no data were available for recurrence of lesions, amount of analgesia, days of stay in hospital, cost of oral care or patient quality of life. | 0 studies | No studies |
Any agent prescribed prophylactically for orofacial lesions caused by herpes simplex virus vs Placebo, no treatment, or any other active intervention
Population: Anyone receiving treatment for cancer (adults, children, or both)
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Outcome NR | Protocol-stage planned comparison (prevention). Primary null hypothesis: there is no difference in the proportion of patients developing culture positive HSV lesions during cancer treatment. Planned outcomes:… | 0 studies | No studies |
Any agent prescribed therapeutically for orofacial lesions caused by herpes simplex virus vs Placebo, no treatment, or any other active intervention
Population: Anyone receiving treatment for cancer (adults, children, or both)
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Outcome NR | Protocol-stage planned comparison (treatment). Primary null hypothesis: there is no difference in the proportion of patients achieving complete healing of HSV lesions during cancer treatment. Planned outcomes: time to… | 0 studies | No studies |