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PubMed1992

[Human papillomavirus infection of the uterine cervix in immune suppressed women after kidney transplantation].

In 23 women, who had immunosuppressive therapy following renal transplantation, routine cytology and colposcopy were performed. Colposcopically directed punch biopsies were taken from the most suspect area. If no pathologic finding was evident during colposcopy a random sample was taken from the transformation zone. Histology revealed condylomatous lesions in seven cases. In two of the lesions, a CIN II was detected. To each woman with a renal allograft and therefore immunosuppressive therapy, two cases were matched for age, parity, and histological finding as a control group. Human papillomavirus (HPV) detection was performed by in-situ hybridisation. HPV infection rate in women with renal allografts was higher in biopsy specimens with condylomatous lesion (86%), as well as in tissue without condylomatous lesions (25%), compared to controls (56% and 9%). The high prevalence of cervical dysplasia and high HPV infection rate in women with immunosuppressive therapy, indicates the need for accurate and regular cytologic and colposcopic examinations in these patients.

Adolescent↗
PubMed2000

A population-based five-year follow-up study of cervical human papillomavirus infection.

OBJECTIVE: The purpose of this study was to determine the long-term tendency for cervical human papillomavirus infections to persist in the general population. STUDY DESIGN: From 500 women who participated in a 1991 population-based survey, 90 healthy women with normal results of cytologic examination (women with human papillomavirus deoxyribonucleic acid detected and age-matched control women without human papillomavirus deoxyribonucleic acid detected) were interviewed and examined 5 years later colposcopically, cytologically, and with human papillomavirus serologic testing and human papillomavirus deoxyribonucleic acid testing by polymerase chain reaction with 2 different consensus primer pairs (MY09 and MY11 and GP5(+) and GP6(+)), type-specific polymerase chain reaction, and deoxyribonucleic acid sequencing. RESULTS: The 5-year human papillomavirus clearance rate was 92%. Only human papillomavirus type 16 infections persisted. Colposcopic impression of grade 2 cervical intraepithelial neoplasia was associated with persistent human papillomavirus 16 infection (P <.03). Human papillomavirus detection was associated with sexual history. Human papillomavirus type was the only determinant of human papillomavirus persistence. CONCLUSION: The high clearance rates in a population-based setting with a 5-year follow-up period imply that inclusion of human papillomavirus deoxyribonucleic acid testing in population-based cervical screening programs should target persistent infection.

Adult↗
PubMed2001

Residency training in colposcopy: a survey of program directors in obstetrics and gynecology and family practice.

OBJECTIVE: Our goal was to identify how colposcopy is being taught to residents in obstetrics and gynecology and family practice programs and to see if the program directors think their residents receive sufficient clinical exposure to be adequately trained in colposcopy. STUDY DESIGN: A 30-question survey was sent to all obstetrics and gynecology and family practice residency program directors. The survey included questions about the didactic nature of the colposcopy curriculum, the type of supervision, how resident skills are evaluated, estimates of the numbers and types of patients evaluated, the numbers and types of procedures being done by each resident, and the program director's perception of residents' competence in colposcopy. RESULTS: The overall response rate was 485 of 752 program directors (64.5%). Significantly fewer family practice than obstetrics and gynecology program directors thought they had adequate numbers of colposcopy patients to train their residents. By their program directors' estimates, 86% of family practice residents evaluate 10 or fewer patients with high-grade lesions (versus 16.5% of obstetrics and gynecology residents); 51.4% evaluate 10 patients or fewer with low-grade lesions (versus 6.7% of obstetrics and gynecology residents), and 40.6% evaluate 10 patients or fewer with atypical squamous cells of undetermined significance (versus 3% of obstetrics and gynecology residents). Experience with vulvar disease is also limited. Program directors thought their residents' colposcopy skills were roughly comparable with their general obstetrics and gynecology skills. CONCLUSIONS: It is possible that many program directors underestimate the number of colposcopic examinations required to achieve and maintain colposcopic skills. Many training programs have insufficient clinical volume to properly train residents in colposcopy.

Colposcopy↗
PubMed2002

Baseline inaccuracy rates for the comparison of cervical biopsy to loop electrosurgical excision histopathologic diagnoses.

OBJECTIVE: The purpose of this study was to quantify the baseline inaccuracies in histopathologic diagnosis between colposcopically directed cervical biopsies and loop electrosurgical excision procedure specimens. STUDY DESIGN: A retrospective review was made of cervical biopsies and loop electrosurgical excision procedure pairs (n = 448) that were performed at the University of Arizona between 1992 and 2000. Agreement was assessed by kappa statistics and Spearman rho coefficients. Subgroup analysis was performed (n = 139) to assess pairs with significant inaccuracy between biopsy and loop electrosurgical excision procedure, when these were performed within 28 days of each other. RESULTS: Eighty-one percent agreement was found between cervical biopsy and loop electrosurgical excision procedure histopathologic diagnoses, when compared to within 1 degree (kappa, 0.73; P <.0001). A discrepancy that would be attributed to regression or progression was found: mild biopsy (regression, none by definition; progression, 4%), moderate biopsy (regression, 9%; progression, 0%), and severe biopsy (regression, 26%; progression, 0%). CONCLUSION: Even when colposcopically directed cervical biopsy correlates strongly with loop electrosurgical excision procedure histopathologic diagnosis, there is a definable percentage of patients for whom there is a discrepancy between these 2 diagnoses. This discrepancy represents an inherent inaccuracy of the diagnostic testing modality and should not be interpreted as progression or regression of disease.

Biopsy↗
PubMed2003

The effect of time interval between referral and colposcopy on detection of human papillomavirus DNA and on outcome of biopsy.

OBJECTIVE: This study was undertaken to assess the effect of the time interval between referral cytology and the outcome of colposcopically directed biopsy in relation to human papillomavirus (HPV) DNA detected by polymerase chain reaction in women referred after abnormal Papanicolaou (Pap) smears. STUDY DESIGN: The study enrolled 453 women who were referred for colposcopic examination after two Pap smears were reported as atypical squamous cells of undetermined significance (ASCUS) or low-grade intraepithelial lesions (LSIL) and 553 women who were referred with a single smear reported as high-grade squamous intraepithelial lesions (HSIL). RESULTS: The results in both patient groups were evaluated in time intervals of 60 days or more, 61 to 120 days, and more than 120 days between referral and colposcopy. A higher proportion of white women than African American women and Hispanic women were seen within 60 days after referral in both referral groups. Women of all race/ethnic backgrounds referred with HSIL were seen within 60 days in a significantly larger proportion than women referred with ASCUS/LSIL. Women referred with ASCUS/LSIL had an increasing frequency of negative HPV findings with the prolonged time intervals. In women referred with a single smear of HSIL, there was a significantly decreasing trend over time in detection of low-risk and unidentified types of HPV and an increasing trend of HPV DNA negative results. CONCLUSION: The frequency of high-risk HPV DNA was similar in patients referred with ASCUS/LSIL or HSIL. In both referral groups, there was a time-dependent increase of negative biopsy results and a decreased frequency of low-risk HPV or of unidentified HPV types. This suggests that the initial abnormality on the Pap smear associated with other than high-risk HPV types may regress over time. The presence of high-risk HPV DNA does not predict the actual histologically verifiable tissue changes but indicates a lower probability of negative biopsy results in all time intervals between referral and biopsy.

Adult↗
PubMed2003

Results of a randomized trial on the management of cytology interpretations of atypical squamous cells of undetermined significance.

OBJECTIVE: This study was undertaken to compare alternative strategies for the initial management of a cytologic diagnosis of atypical squamous cells of undetermined significance (ASCUS). STUDY DESIGN: A total of 3488 women with a community-based ASCUS interpretation were randomly assigned to immediate colposcopy, triage that was based on enrollment HPV DNA testing and liquid-based cytology at a colposcopy referral threshold of high-grade squamous intraepithelial lesion (HSIL), or conservative management based on repeat cytology at a referral threshold of HSIL. All arms included 2 years of semiannual follow-up and colposcopy at exit. Loop electrosurgical excision procedure was offered to women with histologic diagnoses of cervical intraepithelial neoplasia (CIN) grade 2 or 3 at any visit or persistent CIN grade 1 at exit. The study end point was 2-year cumulative diagnosis of CIN grade 3. RESULTS: The 2-year cumulative diagnosis of CIN grade 3 was 8% to 9% in all study arms. The immediate colposcopy strategy yielded 53.6% sensitivity for cumulative cases of CIN grade 3 diagnosed over 2 years. The human papillomavirus (HPV) triage strategy referred 55.6% of women and detected 72.3% of cumulative cases of CIN grade 3. A conservative management strategy of repeat cytology at the HSIL threshold referred 12.3% of women while detecting 54.6% of cumulative CIN grade 3. To compare triage tests, we re-estimated the performance of HPV and cytology in successfully referring women with underlying CIN grade 3 (ie, ignoring the insensitivity we discovered in colposcopically directed biopsies). A single enrollment HPV test identified 92.4% of the women diagnosed with CIN grade 3. Serial cytology, even at an ASCUS threshold, would have required two visits to achieve similar sensitivity (95.4%) and would have referred 67.1% to colposcopy. CONCLUSION: HPV triage is at least as sensitive as immediate colposcopy for detecting CIN grade 3 and refers about half as many women to colposcopy. Follow-up that used repeat cytology is sensitive at an ASCUS referral threshold but requires two follow-up visits and ultimately more colposcopic examinations than HPV triage.

Adolescent↗
PubMed2003

Prospective follow-up suggests similar risk of subsequent cervical intraepithelial neoplasia grade 2 or 3 among women with cervical intraepithelial neoplasia grade 1 or negative colposcopy and directed biopsy.

OBJECTIVE: The purpose of this study was to determine the risk of cumulative cervical intraepithelial neoplasia (CIN) grade 2 or 3 according to initial colposcopy and directed biopsy results among women with low-grade squamous intraepithelial lesions (LSIL) or human papillomavirus (HPV) DNA positive atypical squamous cells of undetermined significance (ASCUS). STUDY DESIGN: A 2-year follow-up of 897 cases of LSIL and 1193 cases of HPV DNA positive ASCUS from the ASCUS/LSIL Triage Study was used to simulate American Society for Colposcopy and Cervical Pathology Consensus Conference recommendations. Women with CIN grade 1 or less were followed up for 2 years by semiannual cytologic examination, with universal exit colposcopy. The clinical end point was a cumulative clinical center histologic diagnosis of CIN grade 2 or 3. RESULTS: The cumulative risk of CIN grade 2 or 3 was equivalent for LSIL (27.6%) and HPV positive ASCUS (26.7%). After excluding the women with a diagnosis of CIN grade 2 or 3 at initial colposcopy and directed biopsy (17.9%), the remaining women were at nearly identical risk for subsequent CIN grade 2 or 3 regardless of initial colposcopy result (completely negative colposcopy-11.3%; negative colposcopically directed biopsy-11.7%; and CIN grade 1 biopsy-13.0%). CONCLUSION: LSIL and HPV positive ASCUS are clinically equivalent. Initial colposcopic detection of obviously prevalent CIN grade 2 or 3 reduces risk. However, for the remaining women who have CIN grade 1 or less on colposcopy and directed biopsy, the risk for subsequent CIN grade 2 or 3 (whether missed, prevalent, or truly incident) is approximately 12% over 2 years. This risk does not vary meaningfully by initial distinction of histologic CIN grade 1 from negative colposcopy and biopsy.

Adolescent↗
PubMed2003

Patient distress and satisfaction with optical spectroscopy in cervical dysplasia detection.

OBJECTIVE: The aim of this investigation was to evaluate the impact of optical spectroscopy, a new approach for the detection of cervical dysplasia, on patient well-being and satisfaction. STUDY DESIGN: Patient distress and satisfaction with optical spectroscopy compared with the Papanicolaou test and colposcopically directed biopsy were measured in a volunteer sample of 314 women with no history of abnormal Papanicolaou test findings. RESULTS: Participants reported significantly less pain and anxiety (P<.001) during optical spectroscopy than during the Papanicolaou test or colposcopically directed biopsy. Generally, participants found spectroscopy equal to the Papanicolaou test and to biopsy on a variety of questions that measured satisfaction. There were statistically significant differences between spectroscopy and the Papanicolaou test or biopsy on issues such as the discomfort and fear caused by the test, the amount of time taken, the room lighting, and perceptions of accuracy. CONCLUSION: That patients reported less distress during spectroscopy than during a Papanicolaou test, colposcopy, or biopsy suggests the possibility of improved adherence to cervical cancer screening and follow-up in settings in which it is used.

Adult↗
PubMed2006

Current issues in the use of colposcopy for examination of sexual assault victims.

Colposcopic examination is considered the gold standard in child sexual abuse evaluations in Australia. However, there remain contentious issues with its use, especially in adult victims, which we sought to address by a review of the literature. Colposcopy has been shown to be a sensitive and acceptable tool for detection of anogenital abnormalities in children. The significance of some genital findings remains controversial, especially when images are interpreted by inexperienced clinicians. Its use in adult assessments is hampered by a lack of comparative studies on colposcopically detected genital injuries in adults following consensual v. non-consensual sexual intercourse. Further research is urgently needed before the use of colposcopy can be routinely recommended for adult victims.

Adult↗
PubMed1994

In vivo diagnosis of cervical intraepithelial neoplasia using 337-nm-excited laser-induced fluorescence.

Laser-induced fluorescence at 337-nm excitation was used in vivo to differentiate neoplastic [cervical intraepithelial neoplasia (CIN)], nonneoplastic abnormal (inflammation and human papilloma viral infection), and normal cervical tissues. A colposcope (low-magnification microscope used to view the cervix with reflected light) was used to identify 66 normal and 49 abnormal (5 inflammation, 21 human papilloma virus infection, and 23 CIN) sites on the cervix in 28 patients. These sites were then interrogated spectroscopically. A two-stage algorithm was developed to diagnose CIN. The first stage differentiated histologically abnormal tissues from colposcopically normal tissues with a sensitivity, specificity, and positive predictive value of 92%, 90%, and 88%, respectively. The second stage differentiated preneoplastic and neoplastic tissues from nonneoplastic abnormal tissues with a sensitivity, specificity, and positive predictive value of 87%, 73%, and 74%, respectively. Spectroscopic differences were consistent with a decrease in the absolute contribution of collagen fluorescence, an increase in the absolute contribution of oxyhemoglobin attenuation, and an increase in the relative contribution of reduced nicotinamide dinucleotide phosphate [NAD(P)H] fluorescence as tissue progresses from normal to abnormal in the same patient. These results suggest that in vivo fluorescence spectroscopy of the cervix can be used to diagnose CIN at colposcopy.

Cervix Uteri↗
PubMed2006

Management and course of histologically verified cervical carcinoma in situ during pregnancy.

BACKGROUND: To study the rate of regression and progression into invasive disease of patients with histologically proven carcinoma in situ of the uterine cervix during pregnancy. METHODS: Prospective observation of all pregnant women with biopsy-proven carcinoma in situ of the uterine cervix, gained by colposcopic guided biopsy from 1996 to 2004 and correlation with the route of delivery and cytologic and histologic postpartum findings. RESULTS: Eighty-three patients with histologically verified carcinoma in situ during pregnancy were treated conservatively. Two patients were lost to follow-up, one patient had an abortion, and three are still pregnant. The study population of 77 patients were followed for a median of 140 days before delivery. Postpartum regression rate was 34.2%, two patients had a diagnosis of microinvasive cervical cancer on the postpartum cone biopsy, and persistent carcinoma in situ was found postpartum in 63.1% of patients. No difference was seen for the route of delivery. Both patients with microinvasive carcinoma were delivered by primary cesarean section and are disease-free after 24 and 38 months, respectively. CONCLUSIONS: We recommend conservative management for women with carcinoma in situ of the uterine cervix. We found no difference for the route of delivery regarding postpartum regression and recommend a postpartum evaluation after the puerperium. Colposcopic guided biopsy should rule out an invasive process during pregnancy. Cesarean section as the mode of delivery should be considered, if invasion is suspected.

Adolescent↗
PubMed2005

p16(INK4a) as a complementary marker of high-grade intraepithelial lesions of the uterine cervix. I: Experience with squamous lesions in 189 consecutive cervical biopsies.

AIM: To test the usefulness of p16(INK4a) immunostaining for improving the diagnostic accuracy of cervical punch biopsies referred to a routine laboratory setting during the investigation of women with abnormal Papanicolaou smears. METHODS: A total of 188 consecutive and unselected colposcopically directed cervical biopsies and a single contemporaneous cervical polyp were accessioned prospectively over a 3-month period, step-serially sectioned and examined by H&E and immunostained for p16(INK4a). The clinical context, results of concurrent Papanicolaou smears/ThinPrep slides and Digene hybrid capture tests for high-risk human papillomavirus (HPV) subtypes, as well as follow-up cervical smears/ThinPrep, biopsies and loop excisions of transformation zones or cone biopsies were all correlated with the morphological and immunohistochemical findings. RESULTS: Seventy-seven biopsies (40.7%) displayed a high-grade squamous intraepithelial lesion (HGSIL; cervical intraepithelial neoplasia [CIN] 2-3), 27 (14.3%) showed a low grade squamous intraepithelial lesion (HPV +/- CIN1) and 85 (45%) showed a range of non-dysplastic (inflammatory or reactive) changes. Diffuse strong parabasal immunostaining for p16(INK4a), suggestive of integrated high-risk HPV DNA into the host genome, was observed in 81 biopsies (42.9%, including the cervical polyp) and correlated (>90%) with HGSIL in the H&E sections. Only one case revealed irreconcilable discordance between the histological features and this strong parabasal immunostaining pattern. Focal and weaker midzonal or superficial p16(INK4a) immunostaining, suggestive of episomal HPV infection, was noted in 19 biopsies (10%) and these biopsies exhibited a range of histological changes but predominantly low grade squamous intraepithelial lesion (LGSIL). No staining of the squamous epithelium was seen in 89 biopsies (47.1%). Again, only one case revealed irreconcilable discordance between the histological features and this negative immunostaining pattern. On review of all cases where discordant results were noted between the H&E appearances and expected p16(INK4a) immunostaining, we found 26 cases (13.7%) in which this discordance prompted justifiable modification of the original diagnosis. CONCLUSIONS: Thus, within a routine diagnostic laboratory, p16(INK4a) immunostaining appears to be a very useful adjunctive test in the examination of colposcopically directed cervical biopsies, in the diagnostic cascade of women investigated for abnormal Papanicolaou smears. It is possible, as further data accumulate concerning the importance of integration of high-risk HPV DNA into the host cell genome and the reliability with which this can be identified by p16(INK4a) immunostaining, that this will become the diagnostic 'lesion of interest', replacing the subjective histological grading of cervical dysplasia, in the management of such patients; i.e., the discriminatory watershed between continued surveillance and active intervention.

Biomarkers, Tumor↗
PubMed1999

A comparative study of the assessment of cervical intraepithelial neoplasia in women having large loop excision of the transformation zone.

Findings on Papanicolaou (Pap) smear and colposcopically directed punch biopsy show discrepancies when compared with findings on loop excision specimens and this situation creates management problems. We performed a comparative assessment of cervical intraepithelial neoplasia (CIN) in 100 consecutive women who had large loop excision of the transformation zone (LLETZ) with a view to developing a local protocol that would be safe, avoid delay and minimise over-treatment. Agreement between Pap smear and LLETZ was 62% with 21% overcall and 17% undercall at Pap smear; there was no significant correlation (Spearman's rank correlation coefficient 0.17 P > 0.05). The agreement between punch biopsy and LLETZ was 61% with 25% overcall and 15% undercall at punch biopsy; there was a slight agreement over chance (kappa=0.20) and there was a weak but significant correlation (Spearman's rank correlation coefficient=0.26; P = 0.047). Colposcopic impression of 'highly abnormal'lesions agreed with high grade lesions on LLETZ in 83% of cases. The problem of undercall suggests that defaulters with apparent low grade dyskaryosis need to be pursued to colposcopy as vigorously as defaulters with high grade dyskaryosis. The lack of significant correlation between cervical cytology and LLETZ finding suggests that the smear-to-colposcopy waiting interval should not be strictly based on the degree of dyskaryosis.

Journal Article↗
PubMed2001

'See and treat' at colposcopy--achieving the standard.

The National Health Service Cervical Screening Programme has issued quality standards for the colposcopy service nationally. One standard is that for women who undergo treatment at their first colposcopy clinic visit, 90% should have proven cervical intra-epithelial neoplasia (CIN) on histology. We have assessed data from a teaching hospital colposcopy clinic over a 9-year period to assess the criteria that should be satisfied in order to achieve this target. We propose that only those women with severe dyskaryosis on the referral smear and a colposcopic appearance of CIN 2 or 3, or those in whom the colposcopic appearance suggests CIN 3 with any grade of dyskaryosis undergo treatment at their first visit.

Journal Article↗
PubMed1989

Management of the abnormal Papanicolaou smear.

Since 1943, Papanicolaou (Pap) smears have been widely used to screen for cervical cancer. Over the past 25 years, new understanding of the natural history of cervical epithelial neoplasia has defined the existence and importance of dysplasia, also termed cervical intraepithelial neoplasia (CIN), and more recently, its probable link to human papilloma virus (HPV). Inflammatory atypia (IA) is a common cytological diagnosis whose significance is less understood. Current gynecological opinion strongly supports a practice of colposcopic evaluation for all women with cytology showing any degree of CIN. Data from studies in our health service and elsewhere establish that 15% to 30% of patients with IA will have CIN if evaluated by colposcopy. Although clinicians may choose to follow such patients with repeated Pap smears, there are strong arguments for offering colposcopic evaluation to patients with IA. Potential problems with false-positive cervical biopsy reports, however, may limit the utility of colposcopy in patients with IA cytology.

Carcinoma in Situ↗
PubMed2004

IL-10 promoter nt -1082A/G polymorphism and human papillomavirus infection in cytologic abnormalities of the uterine cervix.

The role of A/G polymorphism at nucleotide -1082 in the interleukin-10 (IL-10) promoter was assessed by following the disease course of 253 patients who had had a routine diagnostic Hybrid Capture human papillomavirus (HPV) test because of cytologic or colposcopic abnormalities of the uterine cervix. At baseline, 97 (78%) of the 125 high-risk HPV-positive and 83 (65%) of the 128 HPV-negative patients had equivocal cytologic atypia classified as P3 by the Papanicolaou classification, and the rest of the patients had mild colposcopic atypia with cytologic results of no oncogenic significance. In the high-risk HPV-infected patients, the frequency distribution of the nt -1082 genotypes (A/A: 28%; A/G: 52%; G/G: 20%) did not differ significantly from that in the controls (A/A: 25%; A/G: 51%; G/G: 24%; p = 0.70). On the other hand, the nt -1082 G allele tended to decrease susceptibility to equivocal cytologic atypia unrelated to HPV infection (A/G: OR = 0.56 [95% CI: 0.31-1.02], G/G: OR = 0.27 [95% CI: 0.11-0.63], p for trend = 0.05). With respect to the development of high-grade cervical intraepithelial neoplasia (CIN), the established risk factors, such as high-risk HPV infection (RR = 104.6, 95% CI: 14.2-769.9) and cytologic atypia (RR = 9.6, 95% CI: 2.34-39.7) but not the various nt -1082 genotypes (A/A: reference; A/G: RR = 1.11 [95% CI: 0.59-2.08]; G/G: RR = 0.62 [95% CI: 0.25-1.50]) were found to increase the risk for high-grade CIN. In conclusion, the nt -1082 polymorphism had no influence on the early phase of cervical carcinogenesis but may determine different susceptibilities to cervical abnormalities unrelated to HPV infection.

Adenine↗
PubMed1995

Etiologies for non-correlating cervical cytologies and biopsies.

To investigate the etiologies for discrepancies between cervicovaginal smear and corresponding cervical biopsy results, 615 patients with cytologic diagnoses of dysplasia or malignancy during 1 year were reviewed. Sixty-nine patients (11%) were identified in which the cytologic and histologic diagnoses differed. Utilizing an algorithm developed for the study, these cases were assigned an etiologic category for discrepancy: colposcopic biopsy or cytologic sampling, cytologic screening, histotechnical processing, histologic or cytologic interpretation. The most common cause for a discrepancy was colposcopic biopsy sampling (36 cases, 51%). There were nine errors (13%) in biopsy interpretation, with seven underdiagnoses and two overdiagnoses. Eight errors (11%) in cytologic interpretation occurred with half of these representing underdiagnoses. The other causes for discrepancy were less common--cytologic sampling (6 cases), histotechnical processing (3 cases), cytologic screening (2 cases), and a combination of factors (5 cases). Use of this algorithm allows laboratories to identify problem areas and design specific corrective protocols to improve diagnostic accuracy and patient care.

Algorithms↗
PubMed1995

Frequent use of menfegol spermicidal vaginal foaming tablets associated with a high incidence of genital lesions.

Menfegol is a spermicide with in vitro activity against human immunodeficiency virus (HIV). A randomized placebo-controlled safety study covered the use of menfegol foaming tablets for 14 days at increasing frequencies of insertion by 125 prostitutes in Dakar, Senegal. The frequencies of colposcopically diagnosed genital lesions were 5.0%, 11.8%, 27.8%, 49.7%, and 29.4% among menfegol recipients when tablets were used once every other day or 1, 2, 4, or 8 times a day, respectively (P < .05). Among placebo recipients, frequencies were 11.1% and 23.5% when tablets were used < 8 times daily and 8 times daily, respectively. There was no association between subjective genital symptoms and the incidence of colposcopically detected lesions. The high incidence of genital lesions when menfegol foaming tablets were used more than once daily suggests that their frequent use should not be recommended to prevent HIV transmission. In use at low frequency, the tablets' toxicity might be balanced by anti-HIV properties. Safety studies on vaginal microbicides should use objective methods, such as colposcopy, to assess the incidence of lesions.

Adult↗