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Health related quality of life in genital herpes: a pilot comparison of measures.

BACKGROUND: Genital herpes (GH) is a common sexually transmitted infection. Novel tools for the control of GH (for example, tests and vaccines) are emerging, but optimal assessment of the cost effectiveness of such interventions requires scaled, preference based estimates of the impact of GH on health related quality of life. METHODS: We provided self administered interviews to 39 individuals with recurrent GH recruited from an STD clinic and a GH support group in southern Ontario, Canada. Health preference estimates were generated using visual analogue scales (VAS), a time-tradeoff approach (TTO) and the Health Utilities Index Mark-II (HUI-II). Quality of life was also assessed with the Recurrent Genital Herpes Quality of Life scale (RGHQoL). RESULTS: Average (SD) health values for asymptomatic and symptomatic genital herpes were 0.89 (0.21) and 0.89 (0.22) using TTO, and 0.76 (0.30) and 0.71 (0.30) using VAS. Health utility estimates generated with HUI-II for transient symptomatic and asymptomatic health states were 0.93 (0.08) and 0.80 (0.16). Log transformed health value estimates exhibited convergent validity when compared to RGHQoL, as did health utility estimates for symptomatic GH. Utility scores for symptomatic GH increased (improved) with increasing age; no other subject characteristic was predictive of preference weights. CONCLUSIONS: Preference based measures of health related quality of life can be elicited with relative ease in the context of genital herpes, and preference weights are correlated with quality of life scores generated using the RGHQoL. Generation of preference weights will permit direct comparison of the economic attractiveness of herpes prevention interventions with that of other commonly available health interventions.

Adult↗

National survey of diagnostic services for genital herpes.

OBJECTIVE: To investigate the provision of diagnostic services for genital herpes simplex virus (HSV) infection in the United Kingdom. METHODS: National survey of laboratories providing diagnostic services for genital herpes. RESULTS: Completed questionnaires were returned from 25/32 (78%) laboratories participating in the Clinical Virology Network, including seven in London, 12 in the rest of England, one in Wales, four in Scotland, and one in Northern Ireland. Virus culture was the diagnostic method of choice in 20/25 (80%) laboratories; 5/25 (20%) routinely used HSV DNA detection by polymerase chain reaction (PCR). HSV PCR for DNA detection in cerebrospinal fluid (CSF) was available in 17/25 (68%) laboratories. Typing of isolates (HSV-1 or HSV-2) was performed routinely in 22/25 (88%) laboratories. Only 2/25 (8%) laboratories offered HSV type specific serology, although an additional 12/25 (48%) referred requests elsewhere. Consistent with this finding, the number of HSV type specific antibody tests referred to the Health Protection Agency increased by nearly fivefold between 1997 and 2003. CONCLUSIONS: Virus culture remains the preferred diagnostic method for genital herpes, despite evidence indicating that its sensitivity is suboptimal compared to PCR. As HSV PCR is widely available for testing of CSF, it is recommended that clinicians and virologists discuss ways to implement PCR testing of genital swabs, thus enabling greater diagnostic accuracy. A call is made for studies to assess the use of HSV type specific serology in genitourinary medicine (GUM) settings, now that rapid and validated assays have become available and guidelines have been issues to provide recommendations on their use.

Diagnostic Services↗

Topical acyclovir in the treatment of initial genital herpes.

In a double-blind randomised placebo-controlled trial of topical acyclovir in initial (first episode) genital herpes 18 patients received acyclovir ointment and 22 matching placebo ointment. Acyclovir significantly reduced the duration of viral shedding from external and all genital lesions, the duration of vesicles, the time to crusting, the time to complete healing of external and all genital lesions, new lesion formation, and the duration of pain, itching, and all symptoms combined for all patients. In female patients alone the time to crusting was not significantly different and the duration of pain only approached significance but the effects were otherwise the same as for all patients. No patients reported any adverse effects of treatment. Topical acyclovir is well tolerated and effective in treating initial genital herpes.

Acyclovir↗

Genital herpes: an increasing problem?

Over the past 10 years there has been a pronounced increase in the number of cases of genital herpes seen in sexually transmitted disease (STD) clinics in the United Kingdom. The reporting system, however, does not differentiate between primary and recurrent infections, and consequently any increase in the number of patients reattending clinics with recurrent genital herpes would falsely inflate the statistics. A study of cases of herpes seen in the department of genitourinary medicine of this hospital in the two years 1972 and 1982 is presented. It showed that the proportion of patients attending with recurrent herpes had increased from 18% in 1972 to 31% in 1982. As a result of this, the 68% increase between 1972 and 1982 in the total number of cases of herpes seen in the clinic overestimates the real increase in the size of the problem, which is closer to 40%, based upon cases of primary herpes only. Modifications to the national recording system are necessary to overcome the problems highlighted by this study. These modifications could include classifying each case of genital herpes as primary, recurrent, or recurrent but not previously recorded, which would provide a more accurate picture of the size of the problem of genital herpes in the population.

Female↗

Human papillomavirus DNA in the urogenital tracts of men with gonorrhoea, penile warts or genital dermatoses.

OBJECTIVE: To assess the presence of human papillomavirus (HPV) DNA in urethral and urine specimens from men with and without sexually transmitted diseases. DESIGN: Prospective study. SETTING: Two London departments of genitourinary medicine PATIENTS: 100 men with urethral gonorrhoea, 31 men with penile warts and 37 men with genital dermatoses. METHODS: Urethral and urine specimens were taken, HPV DNA extracted and then amplified using the polymerase chain reaction. HPV types 6, 11, 16, 18, 31 and 33 were identified using Southern blotting followed by hybridisation. RESULTS: HPV DNA was detected in 18-31% of urethral swab specimens and in 0-14% of urine specimens. Men with penile warts had HPV detected in urethral swabs more often than did men in the other two clinical groups. "High risk" HPV types were found in 71-83% of swab specimens and in 73-80% of urine specimens containing HPV DNA. CONCLUSIONS: HPV is present in the urogenital tracts of men with gonorrhoea, penile warts and with genital dermatoses. In men with urethral gonorrhoea, detection of HPV in urethral specimens is not related to the number of sexual partners, condom usage, racial origin or past history of genital warts. HPV DNA in the urethral swab and urine specimens may represent different aspects of the epidemiology of HPV in the male genital tract. The preponderance of HPV types 16 and 18 in all three groups of men may be relevant to the concept of the "high risk male".

Adolescent↗

A prospective study of the psychological impact on patients with a first episode of genital herpes.

OBJECTIVES: To assess the psychological impact of first episode of genital herpes, and to determine whether this changes over time. SETTING AND SUBJECTS: The Departments of Genitourinary Medicine (GUM), and Dermatology, Middlesex Hospital London. The study group consisted of patients attending the department of GUM with a clinically proven first episode of genital herpes. Two control groups were recruited; firstly patients without herpes attending the GUM Department and secondly patients attending the Dermatology Department out patients with chronic dermatoses. METHODS: Patients and controls completed an 87 item, self-administered psychological questionnaire at 3 monthly intervals for a year. The questionnaire consisted of the General Health Questionnaire (GHQ); the Hospital Anxiety and Depression Questionnaire (HADQ); Illness Attitude Scales and Illness Concern. Patients were also asked questions about their sexual behaviour. RESULTS: Ninety one patients (68 women, 23 men) with genital herpes, 61 GUM controls (42 women, 19 men) and 56 dermatology controls (36 women, 20 men) participated. There were no statistically significant demographic differences between patients and controls. At first visit the proportion of patients classified as "cases" by the GHQ (GHQ cases) were similar for primary herpes patients 62% (56/91) and Dermatology controls 52% (29/56) while a significantly smaller proportion of GUM controls 34% (21/61) were classified as GHQ cases. The primary herpes group were significantly more concerned about their illness than either the GUM controls or the Dermatology controls (p < 0.002). The proportion of primary herpes patients classified as "cases" by the GHQ reduced significantly over the initial three month period with 67% of patients classified as "cases" at their first visit becoming "noncases" after three months (p < 0.0001). Also 50% of those classified as "cases" at first visit by the HADQ become "noncases" after the initial three months (p = 0.007). The illness concern scores also decreased significantly from visit one to visit two (means 14.7 vs. 12.3; p < 0.0001). CONCLUSION: The diagnosis of a first episode of genital herpes has a profound emotional effect on patients. If they do not have recurrent episodes, their emotional state improves. For those who do have recurrences, the level of anxiety and concern remains as high as at the time of their first diagnosis. Clinicians must be sensitive to the emotional impact such a diagnosis may bring.

Adult↗

Influence of genital infection on cervical cytology.

OBJECTIVE: To ascertain whether the presence of genital infection adversely affects smear quality. METHOD: A prospective study of all patients having cytology performed. The presence of genital infection was recorded and compared with the smear result. RESULTS: The presence of genital infection was not associated with inadequate cytology. Inflammatory changes were found in association with symptomatic candidiasis, trichomoniasis, Chlamydia trachomatis infection, primary herpes simplex, and the finding of 21-30 polymorphs per high power field (averaged over 10 fields) on cervical samples. Inadequate cytology was significantly associated with the smear taker. CONCLUSION: The presence of genital infection at the time of cytology does not increase the rates of inadequacy, and opportunistic cytology should not be deferred as the patient may default from further appointments.

Adolescent↗

Management of women with recurrent genital herpes in pregnancy in Australia.

OBJECTIVE: To document clinical practice for the management of recurrent genital herpes in pregnant women in Australia. DESIGN AND PARTICIPANTS: A questionnaire to all doctors associated with the Royal Australian College of Obstetricians and Gynaecologists. MAIN OUTCOME MEASURES: Policies for antenatal herpes screening, circumstances in which delivery by caesarean section was considered appropriate, and the use of aciclovir during pregnancy. The results were analysed by college status, sex, and whether the doctor worked in a public or private facility. RESULTS: 2855 (67.3%) obstetricians returned questionnaires. 696 (34.3%) stated that their hospital had a policy for managing recurrent genital herpes in pregnancy: 44.5% examined the genitalia and 33.8% took cultures during pregnancy. Fellows were more likely to examine the genitalia (87% v 37%, p < 0.001), and more likely to perform antenatal viral cultures than members (75% v 30%, p < 0.001). Doctors working at private hospitals were significantly more likely to take viral cultures than doctors in public hospitals (39% v 33% p < 0.05). Doctors were asked to consider five scenarios and judge whether caesarean section would be appropriate. 96% considered that a caesarean section was appropriate in women with active herpes at the onset of labour. In the case of a recurrence of genital HSV at the time of presentation with ruptured membranes longer than 4 hours, diplomats (79%) were significantly more likely to recommend a caesarean section than fellows (64%), members (63%), or trainees (49%) (all p < or = 0.001). Where there were positive viral cultures before the onset of labour fellows (45%) were more likely than members (29%) (p = 0.005), males (62%) were more likely than females (55%) (p = 0.03), and doctors working in private hospitals (69%) were more likely than those in the public sector (54%) (p < 0.001) to recommend caesarean section. CONCLUSION: There is considerable divergence of opinion regarding the appropriate management of recurrent genital herpes in pregnancy. The implementation of management guidelines would provide consistency of care.

Acyclovir↗

Impact of suppressive antiviral therapy on the health related quality of life of patients with recurrent genital herpes infection.

OBJECTIVE: To investigate whether suppressive antiviral therapy improves health related quality of life in patients with recurrent genital herpes. METHODS: Health related quality of life was measured using the disease specific recurrent genital herpes quality of life questionnaire (RGHQoL) as part of a randomized, double blind, 52 week, placebo controlled, dose ranging study of once and twice daily valaciclovir or aciclovir for the suppression of recurrent genital herpes in patients with six or more recurrences per year. RESULTS: Of 1479 participants, 1349 patients completed the baseline questionnaire. There were no significant baseline differences in RGHQoL score between any of the treatment groups. After 3 months there were significantly greater improvements in mean RGHQoL scores for all active treatment groups compared with placebo (p < 0.05). Mean RGHQoL score improvements from baseline remained significantly higher in the active treatment groups than in the placebo group after 6 and 12 months, indicating that the improved health related quality of life in patients receiving suppressive antiviral therapy was sustained over a prolonged period of time. CONCLUSION: Suppressive antiviral therapy is an effective strategy for improving the quality of life of patients with recurrent genital herpes. These improvements in quality of life are sustained over time, thus enhancing the clinical benefit in the long term management of this condition.

Acyclovir↗

Genital herpes: general practitioners' knowledge and opinions.

OBJECTIVES: To evaluate GPs' knowledge about genital herpes, especially recent information and to assess their attitudes towards serotesting. METHODS: GPs working in Coventry and the surrounding area were asked to complete an anonymous questionnaire. RESULTS: 70% of GPs (183 out of 261) responded to the questionnaire. Overall, 56% of the questions were answered correctly. 73% of participants knew that source partners in most transmission events are unaware of their infection and 77% were aware that patients shed the virus and transmit it even in the absence of clinical signs. As many as 43% did not know that the majority of infected individuals are unaware of their infection and 44% only knew that most transmission occurs during periods of asymptomatic shedding. Only 53% were aware that the proportion of genital herpes caused by HSV-1 is not decreasing. The majority (78%) supported the availability of its serotesting. CONCLUSIONS: This study demonstrates the lack of knowledge, among studied GPs, in some areas about genital herpes, especially recent information and indicates the need for more education about the condition. Most GPs in the study support the availability of genital herpes serotesting, although more studies need to be done before the wide availability of this testing.

Antibodies, Viral↗

Epidemiology and natural history of human papillomavirus infections in the female genital tract.

Human papillomavirus (HPV) is the most common newly diagnosed sexually transmitted infection in the United States. Although the majority of sexually active adults will be infected with HPV at least once in their lives, it is sexually active women less than 25 years of age who consistently have the highest rates of infection. Besides youth and gender, common risk factors for HPV infection and clinical sequelae of infection include high number of sexual partners and coinfection with Chlamydia trachomatis or herpes simplex virus. Most HPV infections are cleared by the immune system and do not result in clinical complications. Clinical sequelae in cases of low-risk HPV infection consist of genital warts, and clinical manifestations of high-risk HPV infection include abnormal Pap test results, low-grade squamous intraepithelial lesions (LSIL), high-grade squamous intraepithelial lesions (HSIL), and cervical cancer. LSIL, HSIL, and cervical cancer carry significant morbidity and/or mortality; genital warts and abnormal Pap test results are often significant sources of psychosocial distress. Currently, there are neither effective means of preventing HPV transmission nor cures for clinical manifestations: infection can only be prevented via complete sexual abstinence, while treatment for clinical sequelae such as genital warts and cytologic abnormalities consists of removing the problematic cells and watching for recurrence; this method consumes significant health care resources and is costly. New prophylactic HPV vaccines promise to dramatically reduce the incidence of HPV infection, genital warts, and cytologic abnormalities.

Adolescent↗

Female genital warts: global trends and treatments.

The increasing incidence of human papillomavirus (HPV) infection and HPV-associated conditions such as genital warts in women is a global concern. Genital warts are a clinical manifestation of HPV types 6 and 11, and are estimated to affect 1% of sexually active adults aged between 15 and 49. HPV infection is also strongly associated with cervical cancer, and is prevalent in as many as 99% of cases. The psychological stress of having genital warts is often greater than the morbidity of the disease, and therefore successful treatment is crucial. Current treatments are patient-applied and provider-administered therapies. Imiquimod 5% cream, a patient-applied therapy, is an efficacious treatment with tolerable side-effects and a low recurrence rate, and has the potential to be an effective strategy for the management of genital warts.

Adjuvants, Immunologic↗

Acyclovir suppression to prevent recurrent genital herpes at delivery.

OBJECTIVE: To determine if suppressive acyclovir near term decreased the frequency of clinical recurrences at delivery in women with recurrent genital herpes simplex virus (HSV) infection. METHODS: We conducted a prospective, double-blind, randomized trial in 234 women with recurrent genital herpes. Women with genital infection of any frequency were enrolled. Patients received either suppressive oral acyclovir 400 mg three times daily or an identical placebo after 36 weeks' gestation. Clinical lesions were identified, and HSV cultures were obtained at delivery. The frequencies of clinical and subclinical HSV recurrences at delivery were evaluated. RESULTS: Six percent of patients treated with acyclovir, and 14% of patients treated with placebo had clinical HSV at delivery (p = 0.046). No patients in the acyclovir group had positive HSV cultures, compared with 6% of placebo-treated patients (p = 0.029). There was no significant difference in subclinical HSV shedding in the acyclovir group (0%) compared with the placebo-treated group (3%) (p = 0.102). CONCLUSIONS: Suppressive acyclovir therapy significantly decreased the incidence of clinical genital herpes and the overall incidence of HSV excretion at delivery in patients with previous herpes infection.

Acyclovir↗

Recurrent genital infection in the guinea pig: differences between herpes simplex types 1 and 2.

Recurrence rates of genital infections are significantly higher for herpes simplex virus (HSV) type 2 than HSV type 1. Reasons for this difference are not known. In this report, multiple strains of HSV-1 and HSV-2 were evaluated in the guinea-pig model. HSV-2 strains showed significantly higher genital lesion recurrence than HSV-1, including HSV-1 McKrae strain which is highly recurrent in ocular infections. HSV-2 strains were also associated with more frequent asymptomatic vaginal virus shedding. Further study showed that HSV-1 strains replicated as well as HSV-2 in both the genital tract and the nervous system during acute infection. In addition, no difference was detected between HSV-1 and HSV-2 in nervous system latency. Thus, a number of possible explanations for the observed difference in genital herpes recurrence rates were examined and excluded.

Acute Disease↗

Human leukocyte interferon-alpha in cream for the treatment of genital herpes in Asian males. A placebo-controlled, double-blind study.

BACKGROUND: Genital herpes simplex virus infection, a sexually transmitted disease, is the commonest cause of ulcerative genital infections among the young and adult population. The recurrent nature of the disease, possible cause of cervical dysplasia and neonatal herpes are the primary concern associated with this infection. OBJECTIVE: The purpose of this double-blind, placebo-controlled study was to evaluate the clinical efficacy and tolerance of human leukocyte inferon-alpha in hydrophilic cream (2x10(6)IU/g) to cure patients afflicted with first episodes of genital herpes. METHODS: Patients (n = 60), aged 18-40 years (mean: 22.8) with culture-confirmed diagnosis of herpes simplex genitalis, harboring 751 lesions (mean: 12.5) were randomly allocated to two parallel groups (active/placebo). Patients entered the study within 7 days (mean:4.2) of the onset of lesions. Each patient received a precoded 40-gram tube with instructions to apply the trial medication (at home) on their lesions thrice daily for 5 consecutive days (max. 15 topical applications/week). To assess the clinical efficacy patients were examined twice a week. A completely reepithelized lesion with persistent erythema was evaluated as healed or cured. Patients cured during the subsequent treatment period were spared further therapy and were requested to visit us as scheduled for recurrence control. As for the remaining patients, the same course was continued further (max. 4 weeks active treatment). The study was scheduled for 16 weeks, with 20 months of follow-up (on a monthly basis). RESULTS: The treatment was well tolerated by all the patients. Patients treated with leukocyte interferon-alpha cream had a significantly shorter mean duration of healing than placebo recipients, 5.9 versus 15 days (p < 0.01), as well as the number of cured patients, 24/30 (80%) versus 5/30 (17%; p < 0.001), with mild and nonobjective complaints of drug-related adverse symptoms; there were no dropouts. Five of the cured patients (5/29, 17%) showed recurrence after 22 months. CONCLUSIONS: The results substantiate that human leukocyte interferon-alpha (2 x 10(6) IU/g) in hydrophilic cream is more efficacious than placebo and testify that the regimen can be considered a home-based reliable treatment to cure first episodes of genital herpes in males.

Administration, Cutaneous↗

Human leukocyte interferon-alpha versus podophyllotoxin in cream for the treatment of genital warts in males. A placebo-controlled, double-blind, comparative study.

BACKGROUND: The incidence of overt genital warts, a common sexually transmitted disease of high prevalence, has been on the rise for the last few years. The infection is caused by several types of human papillomaviruses (HPVs), some of which have been accepted as a factor in the pathogenesis of genital squamous-cell carcinomas. OBJECTIVE: The aim of this double-blind, placebo-controlled study was to compare and evidence differences in clinical efficacy and tolerance between human leukocyte interferon-alpha (2 x 10(6) IU/g) and podophyllotoxin (0.5%), incorporated in a hydrophilic cream base to cure genital warts in Asian males. METHODS: Sixty patients, circumcised, who ranged in age from 18 to 40 years (mean 25.0), diagnosed with the evidence of penoscopy and HPV DNA (Southern dot blot) as harboring 396 lesions (mean 6.6), were randomized to three parallel groups. Each subject was allocated a precoded tube (40 g) containing one of two trial preparations or matching placebo for 3 days' (consecutive) usage, thrice daily. The study lasted 16 weeks with 4 weeks of active treatment. The patients were examined on a weekly basis, and a clinically and HPV-DNA-confirmed total regression of lesions was recorded as cured. Patients cured during the treatment were spared further therapy and were requested to visit us as scheduled for poststudy follow-up. RESULTS: Findings indicated that patients treated with leukocyte interferon-alpha cream had shown comparatively better results than the podophyllotoxin-treated group (90 vs. 55%, p < 0.0285) or the placebo group (15%). Mild and transient localized erythema (8.3%), burning sensation (6.6%) and transitory increase in body temperature (> 38 degrees C; 6.6%) were the most frequent adverse symptoms with no dropout. The study was followed up for 1 year, and out of 32/60 (53.3%) cured patients 3 had a relapse after 10 months. CONCLUSION: Leukocyte interferon-alpha (2 x 10(6) IU/g) has shown comparatively better results than 0.5% podophyllotoxin and placebo in a hydrophilic cream base, thus leukocyte interferon-alpha in cream may provide an alternative and effective regimen to treat genital warts in males.

Administration, Topical↗

Genital warts do not respond to systemic recombinant interferon alfa-2a treatment during cannabis consumption.

The case of a 22-year-old man suffering from genital warts is described. The lesions responded completely to recombinant interferon alfa-2a only after discontinuation of cannabis consumption. Cannabis was detected using the enzyme immunoassay/1-trans-tetrahydrocannabinoid method in urine. Southern blotting of frozen genital wart biopsy material revealed papillomavirus type 11 DNA, the amount of which increased significantly during interferon treatment. The final clearing of lesions after discontinuation of cannabis consumption implicates that the drug-induced impairment of cellular immunity was reversible. It is concluded that drug abuse and especially cannabis consumption may play some role in the world-wide increase in genital papillomavirus disease and in the high number of recalcitrant courses of genital warts.

Adult↗

Psychiatric aspects of male genital self-mutilation.

From the beginning of the century to this day 57 cases of male genital self-mutilation have been reported in the English literature. In German publications we found 5 case descriptions. Although no precise data are available on the prevalence of male genital self-mutilation, such acts are presumably much more frequent than the small number of published cases would suggest. In the literature several features are regarded as risk factors for self-mutilation, such as e.g. homosexual or transsexual tendencies, repudiation of the male genitals, absence of a competent male for identification during childhood, feeling of guilt for sexual offences, and self-injury in the anamnesis. The most frequent diagnoses are schizophrenia and affective psychosis; alcohol intoxication was diagnosed in about one-fourth of the cases published. In the present paper we summarize data from the literature on epidemiology, psychopathology, psychodynamic and sociocultural factors in male genital automutilation and we describe 2 new cases of self-castration in which several of the risk factors described above were observed. We conclude that although it is difficult to estimate the risk of self-castration in view of the heterogeneity of the respective patient groups, the danger of such deeds should be kept in mind if the above factors are present.

Adult↗