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Mushtaq et al.

IJAVMS Vol. 3, Issue 1, 2009:43-48

Comparative Therapeutic Efficacy of Permethrin, Benzyl benzoate and Sulfur in the treatment of Scabies Patients Muhammad Mushtaq, 1Muhammad.A.Khan, *Muhammad Younus, *Muhammad K. Shahzad, Muhammad Tariq, Roubina Kausar Departments of Epidemiology and Public Health, and *Pathology University of Veterinary and Animal Sciences Lahore Pakistan 1 Corresponding Author, email: dratharkhan@yahoo.com Accepted: 12 Oct 2009 Abstract This study was designed to evaluate the comparative therapeutic efficacy and side effects of permethrin cream/lotion (5%), benzyl benzoate lotion (25%), and sulfur (10%), after one, three, and three days application at bed time in the treatment of patients of scabies. Sample size n=120 were randomly divided into 3 groups designated as A,B and C comprising of 40 individuals in each group patients in groups A,B and C were treated with permethrin, benzyl benzoate, and sulfur after one, three and three days treatment applications respectively. Severity of Lesions significantly decreased with permethrin after once a week treatment as compared to benzyl benzoate and sulfur, while pruritus was significantly reduced with permethrin as compared to benzyl benzoate and sulfur treatment after one, three and three treatment applications once a week respectively. Permethrin 5% proved to be very reliable but expensive and exhibited very few side effects when applied once at bed time. Benzyl benzoate lotion (25%) is cheap and effective but requires application on more than 1 day (3 days applications). The numbers of irritations and post scabious eczematous reactions were increased after benzyl benzoate treatment. Sulfur (10%) is the oldest anti scabietic in use and common in various preparations appears to be effective, is very cheap, safe but stains clothing and requires application on 3 successive days. On the basis of above mention parameters permethrin (5%, once for 8-14 hours) finds to be effective, well tolerated and safe but expensive, proved to be the drug of choice followed by benzyl benzoate and sulfur in scabietic patients. Key Words: Efficacy, Scabies, Scabies Drug Therapy Introduction Scabies is a common public health problem with an estimated global prevalence of three hundred millions and the annual incidence of scabies being three million, the disease burden on the developing countries justifies this study in Lahore Pakistan.[1],[2] The Muslim physician Avenzoar described the Itch mite (Acarus Scabiei) in the twelve century de Gordon living in the thirteen century devoted a Manuscript to it. Several centuries later (1687). Bonomo described the parasite and Wichmann wrote a monograph on the disease (1978). Hebra demonstrated the etiological relationship between Sarcoptes scabiei and scabies. [3] Scabies is due to a mite that burrows into deep skin layers. The female mite deposits eggs. The eggs mature into adult mites in about 3 weeks. The mites are only 0.1mm in diameter and, therefore, can only be seen under a microscope. Scratching allows the mites and eggs to collect under the fingernails. They are then frequently spread to different sites of the body by further scratching.[4] Microscopic sized mites produce scabies. This disease is found in all age groups and in all areas of the world. The mites burrow into the skin. They produce an identified pattern of distribution. Scabies is contagious from person to person (by shared clothing or bed linen). It can also spread from one site to another in the same person. Scabies are found on the skin of the finger webs, and folds under the arms, breasts, elbows, genitals and buttocks.[4]

Mushtaq et al.,

IJAVMS Vol. 3, Issue 1, 2009:43-48

Diagnosis a) Clinical The main symptom is itch, which usually develops 2-6 weeks after infestation. In a reinfected person the itch recurs within 1-4 days. Examination reveals characteristics silvery lines with a mean length of 0.5cm, which may be seen in the skin where the mites have burrowed. Typical sites include between fingers and on the sides of the hands and feet, on wrists, extensor surface of the elbow, female nipples, penis and scrotum, anterior axillary folds. Hypersensitivity to mites may induce urticarial papules or nodules, especially in the genital area. Eczema and impetigo are consequences of itch.

b) Microscopic examination Direct microscopic examination of a potassium hydroxide mount of a scaperficial epidermal skin sample (skin snip) obtained with a scalpel from the end of a burrow.[5]

Management a) Information, explanation and advice for the patient Patients should be advised to avoid close contact until they and their sexual partners have completed treatment and follow-up. Patients should be given a detailed explanation of their infestation together with clear written information.

b) Indications for therapy Characteristics clinical findings High-risk contacts: persons with protected or frequent skin contact (e.g. via the hands) should be treated whether or not they have symptoms. Low-risk contacts: persons with indirect contact (e.g. via bedding) [5]

Sarcoptes scabies gains its importance by making the host morbid by making the host morbid by its lesions, immense pruritus, high infectivity, frequent relapses, and persistence of symptoms for many days even after eradication and resistance to the routine treatment. [6] Treatment of scabies has changed from old to modern medicine, from sulfur to permethrin. [7] Current treatment of scabies comprises of topical antiscabetics, applied all over the body for a specified contact period. [1] Research has been attempted to find the best antiscabetic focusing on efficacy and safety data. [8] Population being commonly affected by scabies, masses has poor affordability for the most efficacious antiscabetic. Hence, it was decided to study and compare three antiscabetics - the most commonly used benzyl benzoate, the currently considered medicine of choice permethrin, and the oldest sulfur. Aim To provide better and improved treatment option for scabies based on efficacy, and safety profile. To study the different available treatment modalities in scabies. To compare efficacy and safety of three treatment modalities and suggest the best intervention for cure. Materials and Methods Study design This was a prospective, randomized, parallel, no crossover, comparative, controlled clinical trial, conducted

Mushtaq et al.,

IJAVMS Vol. 3, Issue 1, 2009:43-48

in patients attending the OPD of Skin and Venereal Disease Private Clinic of Union Council no. 70 of Lahore, Pakistan from 1st Jan to 31st oct, 2009. Dermatologist diagnosed patients of scabies were approached with request to participate in the trial with a detailed information sheet. Diagnosis of the disease was based on history, clinical signs and microscopic examination. Selection criteria Inclusion criteria Newly diagnosed patients of scabies, of either gender, above 5 years of age, willing to participate, and give written informed consent. The patients had to satisfy at least three out of the five criteria viz. history of contact with a scabies patient, complaint of nocturnal itching, history of involvement of family members, presence of classical burrows on clinical examination, and presence of typical scabetic lesions like papules, nodules, or vesicles. Exclusion criteria Pregnant or lactating women; women of child bearing age or planning for conception in near future. Participants with abnormal liver and kidney functions, nervous system disorders, and psychiatric illnesses. Participants with history of diabetes mellitus, hypertension, or chronic infectious diseases. Participants taking any concurrent medication for other illness. Participants with any other associated skin disease, which could alter the picture of scabies. Known/suspected immunocompromised individuals, having scabies with atypical presentations like crusted scabies Participants who had taken any antiscabetic treatment in the preceding week. Noncompliant participants were excluded. Medication along with printed handouts of "do's" in the local vernacular language was given. During their second visit, those participants who failed to answer correctly the method of application followed by them and the treatment of fomite were considered as noncompliant. Participants were first treated for the secondary infection, if present, with Cephradine 500 mg three times daily for 5-7 days/Amoxicillin 500 mg 6 hourly for 5-7 days or with Azithromycin 500 mg once daily for three days, as per clinical judgment of the senior dermatologist and subsequently included in the trial. The demographic data of the participants like age, gender, occupation, education, and marital status were collected in the case record form (CRF) by the principle investigator (PI). At each visit the participant was examined by two doctors, a dermatologist and the PI. The enrolled 120 participants were divided into three groups A, B, and C according to random allocation number generated through computer and provided with any one of the chosen four therapeutic interventions. Interventions Benzyl benzoate 25% lotion to be applied and left overnight to the whole body below neck for three consecutive nights. Permethrin 5% cream to be applied once to the whole body below neck and left overnight. Sulfur 10% is the oldest antiscabietic, to be applied and left overnight to the whole body below neck for three consecutive nights. Participants on intervention were advised to take bath with warm water before application of medication and on subsequent morning. Participants were advised not to use or mix any other treatment including any antipruritic or antihistamine. Participants were also reinforced with the about treatment of family members and other close contacts during each visit Method of evaluation The participants were recalled after one week for follow-up evaluation. The same intervention was repeated if there were no signs of improvement. The participants were followed up for two weeks for cure rate, adverse drug reaction (ADR) monitoring, and post intervention observation. Because of the known safety of all the three interventions, no laboratory examinations were advised. The follow-up was stopped after two weeks, subject to achievement of one of the three endpoints - participant defined as completely cured,

Mushtaq et al.,

IJAVMS Vol. 3, Issue 1, 2009:43-48

participant who developed severe ADR, or participant who was not cured two weeks post intervention follow up. For efficacy Cure During the one week post intervention follow up, both the doctors examined each participant. The participants who did not have any new lesions were considered as cured. Papules, vesicles, and classical burrows were considered as new lesions suggestive of live parasite. The cured participants were prescribed antihistamine for symptomatic treatment of remaining pruritus and the uncured participants were prescribed to repeat intervention along with antihistamine. All the cured as well as uncured participants were again called after one week for the follow-up examination and recording of the parameters. Pruritus Before Treatment Yes 40 No 0 Pruritus After Treatment (One Week) Yes 9 No 31 p-value=0.000

40 0 30 10

40 0 32 8

Pruritus All participants were followed up for one week post intervention, for improvement of pruritus. Antipruritic medicines, if needed, were prescribed only after this. After one week follow up, each participant was asked to quote 0/25/50/75/100%, on the visual analogue scale (VAS) about the percent of remaining pruritus, considering the pruritus at first visit as 100%. Thus, pruritus was observed for only one week post intervention. On each visit, the participants were asked for occurrence of any ADR. Data was entered and analyzed through SPSS version 13, Chi-square test was used to see the association between the treatment group and severity of lesions at 1st and 2nd week. Results Living status - Majority of the participants was from 10-35 years age group, showing the usual trend of scabies [8]. Most of the participants had at least primary education. This confirms their literacy and ability to understand the written instructions provided to them. The distribution of typical scabies lesions over different body parts was variable. To enumerate the important ones, pubic region lead with followed by abdomen, wrists, and web space affliction, and cubital region. Considering pruritus as presenting symptom, the medication which alleviates it has greater acceptance in clinical practice. It was observed that permethrin qualifies for this, decrease in pruritus at the end of one week. At the end of two-week treatment, this finding was almost finished because of the use of antihistamine in group A, as compared to groups B and C, the severity of lesions and pruritus persists after one and two weeks of treatment as shown in the tables. Discussion Patients in group A showed 98% cure at the end of two weeks of treatment. Some previous studies have shown the same results [8] [9] [10] [11]. as compared to groups B and C which showed severity of lesions and pruritus after two weeks of treatment. In our study, neither patients nor investigators noted any Adverse Drug Reactions as seen in other studies.[10] [12] [13] [14] Finding the best option Karthikeyan et al , gave definition for an ideal antiscabetic, as that, which is effective against adult and egg, easily applicable, nonsensitizing, nonirritating, nontoxic, and economical. [7] . Johnston et al, opined that the treatment selected should be determined by local epidemiology of resistance, drug toxicity, and particularly in underdeveloped countries, cost and availability. [15]. Chosidow et al , have admitted that optimal therapy for classic scabies is not certain[6]. Currently, permethrin is commonly recommended as the drug of choice.

Mushtaq et al.,

IJAVMS Vol. 3, Issue 1, 2009:43-48

Conclusion: We concluded from the study that each patient of scabies should be treated with permethrin topically once a week after that followed by an antihistamine for pruritus if needed for one week only. References 1. First nations and Inuit health committee, Canadian pediatric society. Scabies management. Pediatr Child Health 2001; 6:775-7. [Accessed on 2007 Mar 20]. Available from http://www.cps.ca/english/statements/II/ii01-01.htm 2. Scabies [online]. [accessed on 2007 Apr 12] [8 pages]. Available from: http://www.stanford.edu/class/humbio103/ParaSites2004/Scabies/Scabies%20Home.htm 3. Beeson, B.B. 1999, Acarus Scabiei: A study of its history. Publishers J.B. Lippincott Company, Philadelphia and Toronto: 294. 4. http://www.prlog.org/10432643-healthy-life-identifying-scabies.html 5. Argenziano G, Fabbrocini G, Delfino M. Epiluminescence microscopy: a new approach to in vivo detection of Sarcoptes scabiei. Arch Dermatol 1997;133:751-3. 6. Chosidow O. Scabies. N Engl J Med 2006; 354:1718-27. [Accessed on 2007 Mar 20]. Available from: http://content.nejm.org/cgi /content/short/354/16/1718. 7. Karthikeyan K. Treatment of scabies: Newer perspectives. Postgrad Med J 2005; 81:7-10. [Accessed on 2007 Mar 20]. Available from: http://pmj.bmj.com/cgi/reprint/81/951/7.pdf. 8. Strong M, Johnstone PW. Interventions for treating scabies. Cochrane Database of Systematic Reviews 2007, Art.No:CD000320. DOI: 10.1002/14651858. CD000320.pub2. [Accessed on 12 Aug 2007]; 3: pp1-43. 9. McCarthy JS, Kemp DJ, Walton SF, Currie BJ. Scabies: More than just an irritation. Postgrad Med J 2004;80:382-7. [accessed on 2007 May 26]. Available from: http://pmj.bmj.com/cgi/reprint/80/945/382 10. Usha V, Nair TV. A comparative study of oral ivermectin and topical permethrin cream in the treatment of scabies. J Am Acad Dermatol 2000;42:236-40 11. Das S, Chatterjee T, Banerji G, Biswas I. Evaluation of the commonest site, demographic profile and most effective therapy in scabies. Indian J Dermatol 2006;51:186-8. [cited 2007 Oct 23]. Available from: http://www.e-ijd.org/text.asp?2006/51/3/186/27981 12. Fawcett RS. Ivermectin use in scabies. Am Fam Physician 2003;68:1089-92. [accessed on 2007 1. Mar 20]. Available from: http://www.aafp.org/afp/20030915/1089.pdf. 2. Zargari O, Golchai J, Sobhani A, Dehpour AR, Sadr-Ashkevari S, Alizadeh N, et al. Comparison of the efficacy of topical 1% lindane vs 5% permethrin in scabies: A randomized, double-blind study. Indian J Dermatol Venerol Leprol 2006;72:33-6. [accessed on 2007 May 26]. Available from: http://www.ijdvl.com/temp /ijdvl72133_090759.pdf. 3. Meinking TL, Taplin D, Hermida JL, Pardo R, Kerdel FA. The treatment of scabies with ivermectin. N Engl J Med 1995; 333:26-30. [Accessed on 2007 Mar 20]. Available from: http://content.nejm.org/cgi/reprint/333/1/26.pdf. 4. Johnston G, Sladden M. Scabies: Diagnosis and treatment. BMJ 2005;331:619-22. [Accessed on 2007 Apr 9]. Available from: http://www.bmj.com/cgi/reprint/331/7517/619.

Mushtaq et al.,

IJAVMS Vol. 3, Issue 1, 2009:43-48

GROUP-A

Permethrin (n=40) Age Distribution 5-14 12 17 15-24 18 9 25-34 10 10 >35 5 4 Gender Male 25 22 Female 15 18 Distribution of Lesions Pubic Region 32 27 Abdomen 4 6 Wrists 2 3 Web Spaces 2 3 Cubital Region 0 1 Educational Level Primary 18 22 Middle 3 5 Secondary 2 3 Higher Secondary 3 3 Bachelor 1 0 Illiterate 13 7 Socioeconomic Status Lower Class 30 24 Middle Class 8 10 Upper Class 2 6 Severity of Lesions before Treatment Mild 24 19 Moderate 12 15 Severe 4 6 Severity of Lesions with Respect to Treatment (After One Week) Mild 2 10 Moderate 4 3 Severe 1 5 p-value=0.03 Changes in Severity of Lesions with Respect to Treatment (After Two Weeks) Mild 0 4 Moderate 2 1 Severe 0 2 p-value=0.02

GROUP-B Benzyl benzoate (n=40)

GROUP-C Sulfur (n=40) 19 11 5 5 17 23 21 11 4 3 1 20 1 5 5 0 9 32 6 2 21 11 8 19 2 4

10 1 2

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