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The sociodemographic characteristics, clinical profile and treatment records of anogenital warts in Eastern Uttar Pradesh--retrospective evaluation from treatment records at a tertiary centre.

INTRODUCTION

Anogenital Human Papillomavirus (HPV) is the most frequent sexually transmitted viral infection in the world, which can result in malignant cancers or benign skin and mucosal tumors including Anogenital Warts (AGWs). [1] AGWs are categorized as a clinical anogenital HPV infection, because they manifest as visible lesions, namely as single or multiple papules on the vulva, perineum, perianal area, vagina, cervix, penis, anus, scrotum and urethra. [1]

Clinical symptoms may include pruritus, burning, vaginal discharge and bleeding.Pl Four distinct subtypes of AGWs have been described: condylomata acuminata (Pointed warts), flat/macular lesions, papular and keratotic lesions. [1] The first two sub-types are mainly found on moist, non-keratinized epithelia, while the latter two usually present on keratinized epidermis. [1] AGWs are also often referred to as genital warts, condylomata acuminata or genital verruca, although strictly speaking the first two terms are subsets of the anogenital category.

HPV 6 and 11 account for the majority of AGW cases. [1,3-5] AGWs are highly infectious; approximately 65% of individuals with an infected partner develop AGWs within 3 weeks and 8 months. [6] In rare cases, AGWs can be associated with malignant lesions, namely Buschke-Lowenstein tumors. [5] Recent prospective studies reported that the median time between infection with HPV types 6 or 11 and the development of AGWs was 11 to 12 months among males. [7,8] and 5 to 6 months among young females. [9] Although, there are no severe health complications or mortality associated with AGWs, there are significant psychosocial issues which often ensue. [10,11]

Treatment options include patient-applied (Home-based) chemical treatments (Podofilox, imiquimod), physician-applied (Office-based) chemical treatments (Podophyllin, trichloroacetic acid, interferon, green tea extract. [12]) and ablative treatments (Cryotherapy, surgical removal, laser treatment). [13-16] The main limitation of current therapies is the high recurrence rate after initial remission. [15,17,18] The quadrivalent HPV vaccine demonstrated high efficacy in preventing the onset of HPV 6/11-related AGWs in both males. [19] and females. [20]

Although, AGWs rank among the most frequent Sexually Transmitted Diseases (STD). [21,22] the epidemiology and of AGWs is not well characterized. In order to implement measures of prophylaxis, to increase awareness among people for the anogenital warts it is important to assess the extent of the infection in the area and various socio-demographic variables affecting the spreadability of disease in the concerned area. There is relative paucity of data in Eastern UP, which necessitated this study.

METHODS

All patients who had the diagnosis of anogenital warts in 5 years period, i.e. from 2009-2013 confirmed at the tertiary centre in Eastern UP by clinical or histopathological methods had their medical records examined retrospectively. Detailed medical records of patients with sexually transmitted diseases including anogenital warts are maintained at the separate STI clinic (Sexually Transmitted Infection Clinic) of the tertiary referral centres. The records had a mention of the age, sex, locality of infected patients and phone numbers (For the provision of contact tracing of the patients), educational level, employment status, month of diagnosis, sexual orientation, number of sex partners a patient is indulged with, duration of infection, site of warts, type of warts, treatment given and duration of treatment given to the patients which were noted. Other sexually transmitted diseases found in these patients were also noted.

We also attempted to interview every patient by telephone to find out if they had any clinical recurrences for which treatment was sought elsewhere.

Statistical analysis was done to compare the outcomes of the main modalities of treatment for anogenital warts during the study period.

RESULTS

A total of 640 patients were reported with the diagnosis of anogenital warts at the STI (Sexually Transmitted Infections) Clinic in the referral centre of the Eastern UP area. Sociodemographic parameters of patients

Maximum burden of the disease was in the patients of age group 25-35 years with 193/640 (30.2%] patients in the category followed by those in age group 35-45 yrs. with 168/640 (26.3%] patients (Table 1], Majority (67.5%] of the patients were male (Table 2], majority (58.6%] belonged to rural areas (Table 3]; 47.3% patients were either uneducated or had a low educational level (Table 4]. Marital status of patients is shown in Table 5. Of the employed patients, 40% were labourers (Tables 6, 7]. Sexual activity and sexual orientation of patients is shown in Tables 8, 9; 478/548 (74.7%] accepted on the fact of their positive history of contact (Table 10]; 29.8% patients accepted that their mode of acquisition was through contact with commercial sex workers (Table 11]. Mean duration of warts before approach for treatment was 2-4 months (Table 12]. Majority of male patients had penile warts (51.4%) and majority of female patients had warts on the post fourchette (41.3%), the site of maximum coital friction (Tables 13, 14). Most of the patients recorded from the area had condyloma accuminata (41.5%) (Table 15); 83.8% patients accepted the fact of never adapting the means of safe sexual practices (Table 16); 59.5% patients had more than 1 sexual partners (Table 17); 20% of patients had records of other STD's as well, majority being HIV and herpes (Tables 18,19).

The prevalence as from the treatment records came out to be lower than the reported nationwide prevalence. The difference noted may be on account of study methodology of treatment records rather than routine genital examination and active surveillance of patients, which would be a better estimate of the prevalence of disease in the area. The difference especially of lower prevalence of anogenital warts in the female patients from the records could be accounted by the fact of hidden and asymptomatic carriage of infection in the cervical or anal mucosa without coming to patient's knowledge. This could only come into light by routine genital examination of suspected patients through routine cervical smear. Further reluctance and shame on the part of female patients could also defer them from coming to the treatment centres.

The illiteracy and unprotected sexual intercourse of majority of patients brought into light the lack of awareness and knowledge among the people about HPV and genital warts. This was especially seen with adolescent age group where >60% denied any knowledge of HPV before acquiring the infection. There is a great need to fill this knowledge gap, especially in adolescent population to bring down prevalence of disease in the area.

Treatment

One of the following treatment modalities was given to the patients:

1. 5% Imiquimod cream was applied to the lesions and then advised to apply it every alternate day by themselves for duration of 6 weeks.

2. Topical 20% Podophyllin lotion was applied to the lesion once weekly under supervision and the same treatment was repeated for 6 weeks.

352/640(55%) patients were treated with topical 20% podophyllin cream and 288/640 patients(45%) were treated with 5% topical imiquimod cream (Table 20); 238/352 (67.6%) patients treated with podophyllin showed complete healing of lesion in comparison to 32.3% patients treated with 5% imiquimod showing complete response (Table 21). Table 22 shows time taken for complete healing of lesions with different modalities of treatment. We also attempted to interview every patient by telephone to find out if they had any clinical recurrences for which treatment was sought elsewhere (Table 23).

Overall recurrence was seen in 36.3% patients.

Statistical analysis of results was done (Table 25). On applying Fisher test to the results p value comes out to be 0.005, which is <0.05. Hence, the difference obtained was statistically significant and podophyllin 20% is better treatment of genital warts than imiquimod 5%.

DISCUSSION

Although non-life threatening, even low-risk HPV-type infections such as anogenital warts carry a substantial psychosocial and economic burden. Stressors include the shame and embarrassment related to diagnosis as well as the inconvenience and discomfort of treatment and the fear of recurrence and transmission.

The literature suggests that anogenital warts are widespread and the prevalence depends on study methodology and higher rates may be reported from passive surveillance of patients. Results presented in this study are from treatment based surveillance at the referral centre and offer a first insight into HPV prevalence in a sample of population from Eastern UP that has not been previously considered and render these findings useful for further investigation in population-based studies from Eastern Uttar Pradesh to further elucidate the epidemiology of this disease in the respective population.

The association with other sexually transmitted diseases in 20.1% of cases is characteristic and underlines the importance of adequate screening. The retrospective nature of this study makes it difficult to obtain accurate information regarding the incubation period of warts.

The treatment of warts continues to be problematical. In my study podophyllin (20%) proved to be a much better treatment modality than imiquimod (5%) for the treatment of genital warts. As of yet there is little evidence to suggest that a single therapy can prove as the gold standard for treatment. We achieved complete remission in only 51.7% patients with the best possible treatment options available presently. Recurrence was observed in 36.3% patients, which is too high a variable. Current treatment options focus predominantly on removal of the external wart rather than attacking the underlying viral infection and have thus proven somewhat inadequate in achieving effective long-term results.

In the data reported by the general practitioners and in the data reported by the hospitals at national level, the cases of anogenital warts are seen more frequent in females. In contradiction, in our study from the Dermato-venereological Department at the tertiary centre, there was a majority of males. It is possible that the females with HPV infection have a bigger addressability to gynaecologists and also that they have asymptomatic infection. The HPV infection seems to be more frequent in the rural areas, but this situation is created by the unsafe sexual habits in these areas and perhaps lack of awareness among people in these areas.

Perhaps the low prevalence of infection seen through our study is also demonstrating the low frequency of patients with anogenital warts presenting for dermato-venereological consult. The untreated patients are at risk to develop complications and also are responsible for the spread of the infection. These cases represent a public health concern and HPV medical information (e.g. leaflets for patients, internet announcements) must be spread in the general population.

A reliable electronic system for reporting the HPV cases would permit also contact notification and would decrease the total number of infected persons.

The general costs involved in the management of HPV patients is high due to: (i) the recurrence of the disease, (ii) its complications (e.g. cervical cancer), (iii) asymptomatic viral shedding and (iv) increasing number of new cases.

The logical step to reduce these costs is to increase the awareness of the public on this disease. Our study proved that in the case of HPV infected patients, there is a big discrepancy between data collected by dermato-venereologists in tertiary referral unit in the Eastern UP area and the national data records. Those reports need to use the same coding system. An improved electronic system for medical data collection may bring to light the real situation and would permit the identification of needed steps to reduce the incidence of the HPV infection and its comorbidities in the respective area. The high incidence of HPV infection in young persons living in rural areas, revealed by our study, supports the importance of awareness messages that must be transmitted with high priority to this group: firstly, the risk they have by engaging unprotected intercourse and secondly the benefits of the vaccination for both girls and boys.

REFERENCES

[1.] Gross G, Pfister H. Role of human papillomavirus in penile cancer, penile intraepithelial squamous cell neoplasias and in genital warts. Med Microbiol Immunol (Berl] 2004;193:35-44. doi: 10.1007/s00430-003-0181-2. [PubMed] [Cross Ref]

[2.] Insinga RP, Dasbach EJ, Myers ER. The health and economic burden of genital warts in a set of private health plans in the United States. Clin Infect Dis. 2003;36:1397-1403. doi: 10.1086/375074. [PubMed] [Cross Ref]

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[5.] Giuliano AR, Tortolero-Luna G, Ferrer E, et al. Epidemiology of human papillomavirus infection in men, cancers other than cervical and benign conditions. Vaccine. 2008;26(Suppl 10]:K17-K28. [PMC free article] [PubMed]

[6.] Lacey CJ, Lowndes CM, Shah KV. Chapter 4: Burden and management of non-cancerous HPV-related conditions: HPV-6/11 disease. Vaccine. 2006;24(Suppl 3]:35-41. [PubMed]

[7.] Arima Y, Winer RL, Feng Q, et al. Development of genital warts after incident detection of human papillomavirus infection in young men. J Infect Dis. 2010;202:1181-1184. doi: 10.1086/656368. [PubMed] [Cross Ref]

[8.] Anic GM, Lee JH, Stockwell H, et al. Incidence and human papillomavirus (HPV] type distribution of genital warts in a multinational cohort of men: The HPV in men study. J Infect Dis. 2011;204:1886-1892. doi: 10.1093/infdis/jir652. [PMC free article] [PubMed] [Cross Ref]

[9.] Garland SM, Steben M, Sings HL, et al. Natural history of genital warts: analysis of the placebo arm of 2 randomized phase III trials of a quadrivalent human papillomavirus (Types 6, 11, 16 and 18] vaccine. J Infect Dis. 2009;199:805-814. doi: 10.1086/597071. [PubMed] [Cross Ref]

[10.] Graziottin A, Serafini A. HPV infection in women: psychosexual impact of genital warts and intraepithelial lesions. J Sex Med. 2009;6:633-645. doi: 10.1111/j.l7436109.2008.01151.x. [PubMed] [Cross Ref]

[11.] Maw RD, Reitano M, Roy M. An international survey of patients with genital warts: perceptions regarding treatment and impact on lifestyle. Int J STD AIDS. 1998;9:571-578. doi: 10.1258/0956462981921143. [PubMed] [Cross Ref]

[12.] Tzellos TG, Sardeli C, Lallas A, et al. Efficacy, safety and tolerability of green tea catechins in the treatment of external anogenital warts: a systematic review and metaanalysis. J Eur Acad Dermatol Venereol. 2011;25:345-353. doi: 10.1111/j. 1468-3083.2010.03796.x. [PubMed] [Cross Ref]

[13.] Kodner CM, Nasraty S. Management of genital warts. Am Fam Physician. 2004;70:2335-2342. [PubMed]

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[16.] Scheinfeld N, Lehman DS. An evidence-based review of medical and surgical treatments of genital warts. Dermatol Online J. 2006;12:5. [PubMed]

[17.] Centers for Disease Control and Prevention. Sexually Transmitted Diseases Treatment Guidelines. MMWR. 2006;55(No. RR-ll]:62-67.

[18.] Wiley DJ, Douglas J, Beutner K, et al. External genital warts: diagnosis, treatment and prevention. Clin Infect Dis. 2002;35(Suppl 2]:S210-S224. [PubMed]

[19.] Giuliano AR, Palefsky JM, Goldstone S, et al. Efficacy of quadrivalent HPV vaccine against HPV infection and disease in males. N Engl J Med. 2011;364:401-411. doi: 10.1056/NEJMoa0909537. [PMC free article] [PubMed] [Cross Ref]

[20.] Munoz N, Kjaer SK, Sigurdsson K, et al. Impact of human papillomavirus (HPV]-6/ll/16/18 vaccine on all HPV-associated genital diseases in young women. J Natl Cancer Inst. 2010;102:325-339. doi: 10.1093/jnci/djp534. [PubMed] [Cross Ref]

[21.] Johnston A, Fernando D, MacBride-Stewart G. Sexually transmitted infections in New Zealand in 2003. N Z Med J. 2005;118:U1347. [PubMed]

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Harleen Chhachhi (1), Anil Kumar Gupta (2), Santosh Kumar Singh (3), Rakesh Kumar Patel (4), Pawan Kumar Patels, Raj Kumar (6), Avnish Kumar (7)

(1) 3rd Year Junior Resident, Department of Dermatology, BRD Medical College, Gorakhpur.

(2) Associate Professor, Department of Dermatology, BRD Medical College, Gorakhpur.

(3) Associate Professor, Department of Dermatology, BRD Medical College, Gorakhpur.

(4) 3rd Year Junior Resident, Department of Dermatology, BRD Medical College, Gorakhpur.

(5) 3rd Year Junior Resident, Department of Dermatology, BRD Medical College, Gorakhpur.

(6) 3rd Year Junior Resident, Department of Dermatology, BRD Medical College, Gorakhpur.

(7) Senior Resident, Department of Paediatrics, BRD Medical College, Gorakhpur.

Financial or Other, Competing Interest: None. Submission 22-12-2015, Peer Review 21-01-2016, Acceptance 27-01-2016, Published 09-02-2016.

Corresponding Author:

Dr. Harleen Chhachhi, 26, Paras Ram Nagar, West Shivaji Nagar, (Near Dr. Maria School), Shahganj, Agra-282010.

E-mail: drharieenchhachhi@gmail.com

DOI: 10.14260/jemds/2016/112
Table 1: Age distribution of patients

AGE (IN YEARS)    NUMBER OF PATIENTS
                       (n=640)

13-25 YRS                112
25-35 YRS                193
35-45 YRS                168
45-55 YRS                 97
55-65 YRS                 70

Table 2: Sex distribution of patients

Males          Females

432(67.5%)    208(32.5%)

Table 3: Locality (Rural/Urban) of patients

Rural Area                  Urban Area

375 patients (58.6%)   265 patients (41.4%)

Table 4: Educational status of patients

Educational Level        No. of Patients

Illiterate            206 patients (32.2%)
<10th std.            97 patients (15.15%)
10th-12th std.        100 patients (15.6%)
Graduate              173 patients (27.03%)
Post Graduate          64 patients (10.0%)

Table 5: Marital status of Patients

Married                   Unmarried

410 patients (64%)    230 patients (36%)

Table 6: Employment status of patients

Employed                    Unemployed

444 patients (69.4%)   196 patients (30.6%)

Table 7: Profession of employed patients

Profession       No. of patients (n=444)

Labourers         178 patients (40.09%)
Truck drivers      52 patients (11.7%)
Defence            23 patients (5.2%)
White collars     114 patients (25.67%)
Other              77 patients (17.3%)

Table 8: Sexual activity of patients

Sexually active         Sexually inactive

548 patients (85.6%)   92 patients (14.4%)

Table 9: Sexual orientation of sexually active patients (n=548)

Heterosexual               Homosexual

482 patients (87.9%)   66 patients (12.1%)

Table 10: History of contact in sexually active patients (n=548)

Positive                     Negative

478 patients (87.2%)   70 patients (12.8%)

Table 11: Source of exposure in patients
with positive contact history (n=478)

Commercial                    Others
Sex Workers

146 patients (30.5%)   332 patients (69.5%)

Table 12: Duration of illness in months

Duration of Illness      No. of Patients
(In months)                  (n=640)

<2 months              178 patients (27.8%)
2-4 months             284 patients (44.4%)
4-6 months             100 patients (15.6%)
6-7 months             78 patients (12.2%)

Table 13: Genital area involved in male patients

                           Number of Male
Area Involved             Patients (n=432)

Penis (Incl glans,          222 (51.4%)
prepuce, penile shaft)
Scrotum                      62 (14.4%)
Perineum                     31 (7.2%)
Perianal                     35 (8.1%)
Mixed                         82 (19%)

Table 14: Genital area involved infernale patients

Area Involved           Number of Patients
                             (n=208)

Labia                       42 (20.2%)
Posterior fourchette        86 (41.3%)
Perineum                    35 (16.8%)
Perianal                    15 (7.2%)
Mixed                       30 (14.4%)

Table 15: Types of anogenital warts

Type of Warts          Number of
                    Patients (n=640)

Plane warts            72 (11.3%)
Filiform warts        196 (30.6%)
Accuminate warts      266 (41.5%)
Verrucal warts        106 (16.6%)

Table 16: Protective barrier usage in sexually active patients-(n=548)

Patients using condoms   Patients not using condoms

89 patients (16.2%)             459 (83.8%)

Table 17: Number of sexual partners of patients (n=548)

1 partner                    >1 partner

222 patients (40.5%)    326 patients (59.5%)

Table 18: History of other STD in sexually active patients (n=548)

Other STD's Present           Absent

110 (20.1% patients)   438 (79.9% patients)

Table 19: Other STD records of patients

Other STD Present    Number of Patients (n=110)

HIV                              42
Herpes genitalis                 32
Trichomonas                      18
Hepatitis B                      09
Scabies                          09

Table 20: Treatment modality used

Podophyllin 20%     Imiquimod 5%

352 patients        288 patients

Table 21: Patients completely healed with the treatment

Treatment      Completely Cured Patients

Podophyllin    238/352 (67.6%) patients
Imiquimod       93/288 (32.3%) patients

Table 22: Time period for complete clearance
of warts in the respective treatment groups

                  2wks          4wks           6wks

Podophyllin    39 patients   90 patients   109 patients
Imiquimod      21 patients   30 patients   42 patients

Table 23: Recurrence in patients with complete
clearance of anogenital warts

Podophyllin                 Imiquimod

92 patients (38.6%)    28 patients (30.1%)

Table 24: Treatment of patients with incomplete
clearance of aenital warts

                                  PATIENTS WITH
TREATMENT GIVEN            INCOMPLETE CLEARANCE (n=26)

RADIOFREQUENCY ABLATION            178 (57.6%)
CRYO                                40(12.9%)
MIXED                              93 (30.1%)

Table 25: Statistical analysis of results

Drugs          Cured   Uncured   Total   Cure Rate

Imiquimod       93       195      288      32.3%
Podophyllin     238      114      352     67.65%
Total           331      309      640
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Title Annotation:Original Article
Author:Chhachhi, Harleen; Gupta, Anil Kumar; Singh, Santosh Kumar; Patel, Rakesh Kumar; Patel, Pawan Kumar;
Publication:Journal of Evolution of Medical and Dental Sciences
Article Type:Clinical report
Date:Feb 11, 2016
Words:3476
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