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Ivermectin Versus Benzyl Benzoate Applied Once Or Twice to Treat

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Ivermectin Versus Benzyl Benzoate Applied Once Or Twice to Treat Ivermectin versus benzyl benzoate applied once or twice to treat human scabies in Dakar, Senegal: a randomized controlled trial Fatimata Ly,a Eric Caumes,b Cheick Ahmet Tidiane Ndaw,c Bassirou Ndiaye d & Antoine Mahé a Objective To compare the effectiveness of oral ivermectin (IV) and two different modalities of topical benzyl benzoate (BB) for treating scabies in a community setting. Methods The trial included patients aged 5–65 years with scabies who attended the dermatology department at the Institut d’Hygiène Sociale in Dakar, Senegal. The randomized, open trial considered three treatments: a single application of 12.5% BB over 24 hours (BB1 group), two applications of BB, each over 24 hours (BB2 group), and oral IV, 150–200 µg/kg (IV group). The primary endpoint was the disappearance of skin lesions and itching at day 14. If necessary, treatment was repeated and patients were evaluated until cured. Results were analysed on an intention-to-treat basis. A pre-planned intermediate analysis was carried out after the BB1, BB2 and IV groups had recruited 68, 48 and 65 patients, respectively. Findings At day 14, 33 patients (68.8%) in the BB2 group were cured versus 37 (54.4%) in the BB1 group and 16 (24.6%) in the IV group (P < 10 –6). Bacterial superinfection occurred more often in the IV group than in the BB1 and BB2 groups combined (28% versus 7.8%, respectively; P = 0.006). At day 28, 46 patients (95.8%) in the BB2 group were cured versus 52 (76.5%) in the BB1 group and 28 (43.1%) in the IV group (P < 10 –5). These clear findings prompted early study cessation. Conclusion Topical BB was clearly more effective than oral IV for treating scabies in a Senegalese community. الرتجمة العربية لهذه الخالصة يف نهاية النص الكامل لهذه املقالة. .Une traduction en français de ce résumé figure à la fin de l’article. Al final del artículo se facilita una traducción al español Introduction Methods Scabies is a globally occurring ectoparasitic infection whose Patients were included if they presented to the Institut burden has been estimated to be as high as 300 million cases d’Hygiène Sociale in Dakar, Senegal, and satisfied the follow- per year.1 In developing countries, scabies is a significant ing criteria: they were aged between 5 and 65 years; they were public health problem because it is highly prevalent and experiencing itching that involved at least three distinct sites complications are frequent. It is one of the main reasons for on the body and had lesions that were characteristic of scabies consultations in non-specialized primary health-care centres.2 (i.e. vesicles, papules, nodules or pustules) on at least three Children appear to be more commonly affected and are at a sites of predilection for scabies (i.e. the interdigital folds of the significant risk of streptococcal superinfection, which may hands, the elbows, the wrists, the buttocks, the axillary folds, be complicated by acute glomerulonephrititis.3 In addition, the nipple areolas in women and the male external genitalia), a recent study performed in the Gambia showed that skin as assessed by a trained health-care worker; 6 and they were lesions associated with scabies were the leading portal of willing to participate in the study. entry for organisms that cause septicaemia in infants aged Patients were excluded if they satisfied any of the follow- 3 months or less.4 ing exclusion criteria: there was doubt about the diagnosis Several topical treatments are effective: permethrin, lin- of scabies; pruritus due to insect bites was present; the case dane and benzyl benzoate (BB), with the last being consid- patient or a member of his or her family had chickenpox; or ered the treatment of choice in most parts of Africa. On the the patient had been treated for scabies less than 1 month other hand, oral ivermectin (IV) has also been shown to be before the consultation; was under 5 years or over 65 years effective, but the optimal number of courses is still a matter of age; weighed less than 15 kg; was pregnant or breastfeed- of some controversy. A recent meta-analysis5 reported that, to ing; was a women who used bleaching products for cosmetic date, there is no conclusive evidence that oral IV is superior purposes; had crusted scabies; had a general condition such as to topical preparations for treating common scabies in the diabetes, high blood pressure or cardiovascular or neurological community setting. disease; or lived outside of the Dakar district. An HIV test We conducted a randomized controlled trial in Dakar, was not required either before or after inclusion. Senegal, to compare three modalities of treatment for scabies A parasitological examination was performed by low- (i.e. oral IV and two forms of application of BB) with the power microscopy for each patient included in the trial. Skin aim of determining the most suitable treatment regimen in scrapings were taken from each interdigital space in the hands our setting. and from the most clinically affected locations elsewhere. a Service de Dermatologie/Infections Sexuellement Transmissibles, Institut d’Hygiène Sociale, Dakar, Senegal. b Maladies Infectieuses et Tropicales, Hôpital Pitié-Salpêtrière, Paris, France. c Unité de Recherche sur le Paludisme, Institut de Recherche pour le Développement, Dakar, Senegal. d Service de Dermatologie, Hôpital Aristide le Dantec, Dakar, Senegal. Correspondence to Fatimata Ly (e-mail: [email protected]). (Submitted: 26 February 2008 – Revised version received: 11 July 2008 – Accepted: 21 August 2008 – Published online: 18 March 2009 ) 424 Bull World Health Organ 2009;87:424–430 | doi:10.2471/BLT.08.052308 Research Fatimata Ly et al. Treatment of human scabies in Senegal The scrapings were placed in a drop Fig. 1. Flowchart of a randomized trial comparing one or two applications of BB of 10% potassium hydroxide solution versus IV in the treatment of scabies, Dakar, Senegal on a glass slide and examined for the presence of Sarcoptes scabiei (i.e. adult Patients consulting forms), eggs or faecal pellets. Negative the trial institution findings on parasitological examination (n = 2001) Not eligible did not imply exclusion from the trial. (n = 1242) Eligible Setting (n = 759) Senegal is a sub-Saharan country with 11 million inhabitants, and its capital, Patients screened Dakar, has approximately 2 million (n = 455) inhabitants. The per capita gross na- tional income is US$ 700. Forty per cent of the population lives in cities. Patients randomized (n = 181) The literacy rate is 50.4% in women and 72.8% in men. Fifty-seven per cent of the population is under 20 years of a b c 7 Group BB1 Group BB2 Group IV age. The prevalence of HIV infection (n = 68) (n = 48) (n = 65) in the general adult population is esti- mated to be 0.8%.8 Our unit is one of only two services that provide specialist dermatology care in Dakar. Lost to follow-up Lost to follow-up Lost to follow-up (n = 8) (n = 0) (n = 11) Interventions A randomized, controlled, non-blinded trial was carried out to compare three At day 14 At day 14 At day 14 scabies treatments: a single oral dose 60 patients remaining 48 patients remaining 54 patients remaining of 150–200 µg/kg of IV taken on an Cured (n = 37) Cured (n = 33) Cured (n = 16) Poor compliance (n = 17) Poor compliance (n = 12) Poor compliance (n = 3) empty stomach (IV group); one ap- plication of 12.5% BB, which was not removed for 24 hours, administered Lost to follow-up Lost to follow-up Lost to follow-up over the whole body except the head (n = 2) (n = 0) (n = 1) (BB1 group); and two such applications of 12.5% BB separated by 24 hours (BB2 group). To reproduce conditions At day 28 At day 28 At day 28 found in the real world (i.e. a pragmatic 21 patients remaining 15 patients remaining 37 patients remaining Cured (n = 15) Cured (n = 13) Cured (n = 12) trial), the investigators did not super- vise compliance with any regimen. IV was manufactured by Merck, Sharp At day 35 At day 35 At day 35 and Dohme-Chibret and was provided 6 patients remaining 2 patients remaining 25 patients remaining by the Senegalese national programme for controlling onchocerciasis. The ex- BB, benzyl benzoate; IV, ivermectin. piry dates of the different drugs were a Group that received one application of benzyl benzoate. checked. b Group that received two applications of benzyl benzoate. c Group that received ivermectin. Randomization A random number table was used to 400, distributed as follows: 150 in the given was applied again. If treatment allocate treatment, with equilibration IV group, 150 in the BB1 group and failure was noted at day 28, patients in of asymmetries between the three treat- 100 in the BB2 group. Any member of either the IV or BB1 group were sched- ment arms being carried out for every a patient’s family who was included in uled to be switched to two applications 40 patients. There was no provision for the trial received the same treatment as of BB, and those in the BB2 group were double-blinding. The study sample size the index case. switched to IV. was calculated based on the assump- At day 7, any patient who had Systematic cleaning of clothes and tion that the difference in effectiveness clearly worsened was again given the bedding was recommended. If a pa- between the treatment arms was less same treatment as the week before. If at tient had a patent skin superinfection, than 15%. The chosen significance day 7 no change was noted or the pa- an oral antibiotic (i.e.
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