Berkale Hina Kedokteren Vor. 41, No. 3, September 2009: 157-163 The effectiveness of rivanol tampon’ compared with burowi tampon in acute diffuse otitis externa | Wayan Marthana Kedel, Edhie Samodra, Bambang Udji Djoko Rianto Ear, Nose, and Throat Department, Faculty of Medicine, Gadjah Mada University/Dr. Sardjito Hospital Yogyakarta ABSTRACT | Wayon Macthans Kec, Edhie Samosa, Bambang Uji Djoko Ranta The atteceveness of ivanal tamport compared ‘with borow! tampon in acute diffuse obtis externa /ADOE] patents ‘Background: Acute diffuse ots exteens (ADOE is one of the commen diseases in ENT Department, Dr. Sota Hosp wth the faquancy of 9-125. The most commen mlccoorganism found ie Psaudomangs aorypiose. Infection usualy oceurts ater taking a bath, washing har, ond scratching tha axtemalanr canal. Troatmant of acute citfuse ‘lls oxterne which consists of topical preparations, We, antibotes end antintlammation tarpon oF eat op, Is Tolatvely expensive. A rtionsle, Noh recover rate, chesp, and esa found preparation 's read, Gurow solution i ona of the recommended weatment, butt is sss popula. ‘Objective: The goal ofthe study waa fo know the effectiveness of Rlvanof ‘tampon compared with Burowi tampon in acute cifuse otis extere ‘Mathode: & randomized single blind controled tal ACT) ws performed atthe outpatient lnc of ENT Oapanmant ‘of Dr Serato Gonerel Hosetal Yooyakare. Sixty-five subjacts whe were diagnosed as ADOE who met incision ‘rteria wore randomiy allocated ite two groups, tht is, Rienel” group anc Burow! group. The ear canal was ‘lesnad, and then fivsno"tampan or Burowi tarhpon wes Sopled. Evaluation was performed on day 3 and S. Primary outcome was the racovery rete, and secondary outcomes were adverse reaction and marginal cost: atfectveness Results: Of 65 subjects, 33 were allocated into Rivanct” group and 32 were-alloceted into Burowi group. The racovary rate in Rivanel” group was 75.4%, whiten Burow groups was 49.39%. The tforence in recovery rato ‘between the two groups wer stetatcaly sigaiicane (pr 0,018: AR 4. 360; 95% CI 1.226-15,442), Adverse ronetion In Rivanot group was dampness ond soggy feeling in tha ear canal (1.6%, whi n tho Burowi group the adverse ‘vents were ein and buent sensation lt the ear canal (3.16), but thay coUkd be oleeted and disappeared on day 6. ‘Analyste on marginal cost-etfectiveness showed thatthe cost 1 cure ane acute diffu ats extane patont with ‘RvanoFtarngon wes Rp 1.000. ‘Concluslon:Fivana” tampon was morectinically etfective and more cost-effective than Burowi tampon for acute due otis extoma testment, Key words: acute dittuse otis extoros, Rivano®, Burowi, cliniesl and cost effectiveness ABSTRAK ‘Bolakang; Otkis oksterne dius akut merupakan salah satu penyakit yang seing itemukan di Baglan THT, ‘Rumah Seki Or. Saraito, Yogyakarta, dangan trokuersi sebesar 9-12%. Mikroatganigms yang tersering dtemukan deah Pseudomonas aeroginess.Iieks basanys trad stelan mand, karamas, dan menggaru hang telnga War. ‘Terap ovis eksterne dive kut berupa prepara tplkal yang teri dar antibictke dan tampon antinfiamas atau {eles tinge, adalah reatt mahal Dperkan prepara yang ational, menimbuken kesembuhan yang tog, murah, ddan madah didapat, Tampon lautan Butawl merupacan ssh eat tovepl yang donlrkan wtap! Karena poplar Tuan: Tuue peelion aeloh mengetahKoetektivan tampon Rivet banding mean Burn pas ot tome dfs ou. | Wayan Martane Kea, Eat, Nose, ana Thvoat Deparment SUP Gr Sueitercdty of Matcine Oedah Mage Uoworsky, Voovekats 157Borkole imu Kedokteran, Volume 41, No. 3, September 2009: 187-163 ‘Motoda -Diakukan til kontrol buta acak di Polikinik Bagion THT Rumah Sakit Or. Sardto, Vopyakasta Lime pulah ‘nam eubjok dengan diagnosis ote media ekstarna akut yang merenuh kites hlus diigkasikan ecora 'andom Gengon kompurar ke dalam 2 Kelompok, yaitu: kelompok RivanoT dan kalorpok Burowi. Saluran her talnge tibersinken. dap kemudian ober tampon Rivanof atau Burow, Evalussi dlakukan pada hal ke-3 dan 6 Luaran, betel argh hasan dan Skane ren ak bak don acloktvan bays mera eat Da 6 suyek, 33 masuk dalam Kelompok Rivano” dan 32 dalam kelompok Suro. Angks kasembuhan pada kelomock Fivanot adakah 75.4%, sodangkan pade ketompoBuowi 49.2%, Okemuken porbedaan barmatina tara a kel pok tp ~ 0,088, RF'4,350, dan IK 86% 1,225; 18,442). Efak kurang bak pada kolompck Rivano”adalah “dampness end soggy teeting” 7 pada Vang tenga (1.5%), sedengken peda kelompck Burowi adalah rasaiyeti dan panes di tang tliga (3,1) tetpi ef ta depot tolears don manghieng pada ha kalina. Analisis keefoktvan Biava marginal menunjukken bahwe untuk manyembuhkan satu pasien dengan cts eksterna cifus akut dongan ivan” ada Rp 1.000,— ‘Simputa : tampon Aivenot dar ogi Minis mauoun bisya lebih etektifdaripada okstorna dfs ak, INTRODUCTION Acute diffuse otitis extema (ADOE) is ear inflammation affecting the skin of external ear canal, characterized by ear pain, hearing loss, and tinnitus. According to Mawson, acute diffuse otitis externa isthe infection of the whole external ear canal with ‘the symptoms of irritation, otorrhes, uncomfortable sensation, and swelling. "? Other researcher defines acute diffuse otitis extema as the infection of superficial skin of external ear canal, outer layer of tympanic membrane, and auricula, with symptom of itching, sensation pain when masticating or ‘opening the mouth, fever, and hearing loss, and ‘objective signs of hyperemia, edeme, and debris or pus in extemal ear canal. The signs and symptoms are difficult to differentiate with early stage of ‘malignant otitis externa. Diffuse otitis externa consists of 3 stages: 1) pre-inflammatory phase, 2) acute inflammatory stage, and 3) chronic stage. Other author classifies diffuse otitis externa into acute, subacute, and chronic ‘stages.!* Acute diffuse otitis extema i the most brevolent otitis extema commonly found in hot climate and high humidity areas. Acute diffuse otitis externa is also referred to as hot weather ear, Singapote ear, Hongkong ear, and swimmer's ear 2674 At the end of 19% century and at the beginning ‘of 20" century, there were many reports of otitis cextera cases. Gill found 5-40% paticnts with otitis externa. Johnston reported that a third of ENT examinations in South America showed otitis ‘extema, and he also reported that in the examinations, ‘of 70,000 soldiers in 1946 showed that 9.3% of 8,432! outpatients and 8.1% of 2,382 inpatients had 158 pon Burowi untuk rep os otitis externa, Conley reported 4.3% of 2,290 inpatients of Army Air Force Medical Manual had otitis extema.”® Raza e/al, inENT Polyctinic of Singleton Wales Hospital found almost 10% ofthe whole poputation +had ever suffered from ADOE in their life, Similar ‘event was reported by Tiemey ef al. who found around 240 cases per year, 30% needed follow-up, ‘and there was 1 ADOE patient out of 6 patients who visited the clinic. Pond reported that from 14,389 patients who came to Emergency Unit of Royal Victoria Eye and Ear Hospital, 20% suffered from new cases of ADOF and 44% were patients who came for reexamination for ADOBE." ‘The frequency of ADOE in teaching hospital in Indonesia, such as in Karyadi Hospital in 1974- 1978, out of 57,289 patients there were 8.09% ADOE patients; in Dr. Soetomo Hospital in 1975+ 1978, out of 88,166 patients there were 8.88% ADOE patients; in Sumber Waras Hospital in 1980- 1982, out of 51,540 patients there were 8.05% ADOE patients; in Dr, Sardjito Hospital in 1990, ‘out of 21,189 patients there were 14.70% ADOE patients. Ih the last five years (1998-2002), the frequency of patients with ADOE in Dr. Sardjito Hospital was 8,54-12.35%. The infection of external ear canal skin is usualty caused by aerobe bacteria, such as Pseudomonas sp., Staphylococcus aureus, Escherichia coli.*! Tobing conducted a study ‘on 50 patients of ADOE, and culture showed that the most common bacteria was Pseudomonas (48%), followed by Proteus (18%), Coliform (16%), Klebsiella (10%), and Staphylococcus (10%). This is consistent with the study by Slack who foundede! et ol, The effectiveness of rivanol tampon” compared with burow! tampon in acute ltfuse otitis externe patients that the most common bacteria was Pseudomonas, {followed by Proteus and Coliform, while yeast was rare Until recently, the management of ADOE patients is variable among experts; drugs used in the treatment are also variable. Zainuddin studied the use of 10% chloramphenicol tampon and cat érop in ADOE patients, and found that in 73 subjects of ADOE patients, the use of tampon gave 89.48% recovery rate compared with the use of ear drop (76.47%), with average recurrence rate of 31.0 days in tampon group compared to 5.08 days inear drop soup.” ‘Antara studied the use of chloramphenicol, acetate acid, and boric acid antiseptics, given with tampon, on 103 ADOE patients, and found that there ‘was no significant difference between the three rugs. The recovery rate in chloramphenicol group was 91%, in acetic acid group was 88%, and in boric acid group was 91%, with the average recovery uration of 3 days."” Other research by Pond on the use of Sofradex®tampon compared with Soframycin® ear drop in 94 ADOE patients found that the recovery rate in tampon group was 70%, while in ear drop gTOUp was 64%." Yaniv etal. compared the use of powder containing antibiotics, steroid, and antifungal (oxytetracyline, polymyxin B sulphate, nystatin, and dexamethasone) and Dex-Otic® ear dcop in 67 ADOE patients, and found thet recurrence occurred in average of 7 days with recovery rate of 74% in powder group and 40% in ear drop group.!? ‘Theuse of topical antibiotics has to be cautious because of allergic reaction and microorganism resistance. Long use of antibiotics may cause fungal superinfection? In several big hospitals, the use of Burowi tampon as the first line reatment on ADOE patients gives satisfactory result, Burowi solution is an astringent, which absorbs water from tissue, causing the tissue constriction. Burowi solution has small antiseptic effect and not long-lasting. Simple and cheap treatment like Rivanol® antiseptic is seldom used for ADOE, whereas itis ‘available in Puskesmas and moreover Rivanol has Jong-lasting effect. An in vitro study by Masroh showed that Rivanol® solution was effective (98.4294) as antiseptic for Pseudomonas aeruginosa in the concentration of 0.01." Rivanol* solution was active in alkaline pH by binding bacterial anion with Rivanol® cation to form an undissociated and stable salt, itis also effective as antibacterial 22 Theeffectivity of this drug in acute diffuse otitis ‘extema hasnotbeen studied yet. Therefore, a study ‘on the effectivity of this drug will be done in the treatment of ADOE. The objective of this study was to find out the difference of the effectivity of Rivanol? tampon and Burowi tampon in the treatment of ADOE. METHOD This was a randomized single-blind controlled trial, which compered 2 types of drugs, ie. Rivanol? and Burowi. The first group was given Rivanol® and the second group was given Burowi tampon. ‘The recovery rate and variables that may affect the recovery rate were analyzed, ‘The subjects were ADOE patients in inpatient clinic of ENT Department of Dr. Sardjito Hospital ‘who met the inclusion and exclusion criteria. Block randomization was conducted to balance the distribution of variable characteristics in the treatment and contro! groups. Inclusion criteria were: 1) edema, hyperemia, laceration, and otorthea in extemal ear canal, while the tympanic membrane was still intact, pain was felt when the tragus was pressed or the auricula was moved, 2) age of 6 years old or more, 3) had not received any local or systemic antibiotics, analgeties, and antiinflammatory drugs in the last 2, weeks, 4) not allergic to Rivanol® and Burowi, 5) agreed to join the study after reading informed consent. Exclusion criteria were: 1) perforated tympanic. ‘membrane, 2) total edema in external ear canal, so ‘that the antiseptic tampon could not be applied, 3) hhad diabetes mellitus, 4) KOH test showed positive of yeast. Far canal of the subject was cleaned from debris and secretion. The researcher explained to the subjects about the procedure of the research, the drugs and their doses, when the evaluation would ‘be conducted, and what will be observed until the end of the study (day 5), and the side effeet of the rugs. 159Borksle tim Kedokteran, Volume 41, No. 3, Septombor 2009: 157-163 Subjects were given ear drop applied to tampon, ‘which in turn was applied into ear canal. Drug was, ‘given 3 times 3 drops daily. First evaluation was ‘conducted on day 3, and the last evaluation was ‘conducted on day 5. Statistical analysis used was X? test, Fisher's exact test, Mentel-Haenzel X? test, logisticregression analysis, and ttest. Cost-effectivencss of each drug RESULTS AND DISCUSSION Sixty eight out of 75 ADOE patients met the ‘nolusion criteria, and the remaining 7 were exchided from the study complete the program, two subjects ‘were from Burowi group, and 1 from Rivano!® group, ‘The youngest subject was 7 years old, while the oldest was 60 years old. The average age was 30.7 years old. TABLE 1 showed distribution and was calculated. characteristics of research subjects. ‘TABLE |. Characteristics of research subjects TTT i 20%) a(%) Pate ‘Age (yrs oid) pare 13) 200) tis.6 BBN) 9033) een 938) 9033) 0997 8-84 346) 6092) 2 ss 365) 365) 1 Ss 263) i169 ‘Gender * Male 16246 64g) 0550 + Female 17063) 16e49) earl iva Elementary seb! 369) 9038) Jor hk sboo! 365, 2.) + Senior high schoo! 1929.2) 16 (24.6) 0.354 + Academy 1s) 5 + Grade 50) $7) 2 pongraune 15 : 346) 4(62) 285) 169 i169) dass O94 4062) 602) 39 204) - 26) 25085) 264400) : 602) 103) : s Hs) 99 . - 1s) . 105) 103) 2 Safey match 105) - + Delnoteeatch : Tier Takings bath . 145) Washing ba 26.1) : 0261 Sern the a cand 306462) nary = Unknown 105 : 160Redel ot ol, The effectiveness of rivanot tempon" compared with burowi tempon in acute cltfuse otis extema pationts ‘There were no statistical significant differences in terms of subject characteristics based on age, gender, educational level, employment, trigger, instrument used to scratch the ear canal, and the affected ear side. First evaluation of recovery on day 3 showed that 20 subjects (30.8%) in Rivanol® group were cured and 13 subjects (20.0%) were not cured yet, while in Burowi group, there were 12 subjects (18.5%) who were cured and 20 subjects (30.8%) who were not cured yet. The difference was not statistically significant (X?, p 0.053). Second evaluation at day 5 showed that 29 subjects (44.69%) in Rivanol® group were cured and 4 subjects (6.2%) were not cured yet, while in Burowi group, there ‘were 20 subjects (30.8%) who were cured and 12 subjects (18.5%) who were not cured yet, The difference was statistically significant (X?, p<0.05) (TABLE 2). ‘TABLE 2, First and second clinica evaluation of treatment result in both reatment groups n Rivanel” _ Burowi Evaluation Recovery bwom _p value Cured 70 G08) 1218.5) 1 Not cued 13200) 2030.) 8 Cured 29446) 200308) 2 Nor cured 1(8s) 0018 Acute diffuse otitis externa is superficial skin infection with treatment principle of cleaning the discharge/debris regularly and giving topical drugs. Ear tampon use may direcily inhibit and stop the growth of pathogenic mieroo ‘anism in the ear canal by pressing on canal skin st face and lengthy drug contact. Amdt? suggested thas the recovery depends ‘on the duration of drug coritact with ear canal skin surface, compared with ear drop use that will be decreased in absorption 15-60 minutes after application, so that ear tampon use is clearly more beneficial ‘The other function of tampon use is to inhibit patient from manipulating the affected ear, in order to accelerate healing. Histologically, thin ear canal skin may facilitate drag diffusion, not only because ofthe chemical effect, but also mechanically caused by the pressure from ear tampon. ‘The result of treatment on day 3 showed 12.3% difference between recovery of the two groups, but the difference was not statistically significant. This is consistent with a study by Suharyono.* Based on a study by Basjrah and Zuraidah, the recovery Tate of Burowi was between 50-68%, and the study showed 49.3% cure rate. An in vitro study by Mastoh showed 98.42% efficacy of Rivanol® solution as antiseptic for acute diffusc otitis externa with 75.4% recovery rate, From this study, there ‘was 26.1% difference between cure rates compared to Rivanol® group.” Rivanol gave best result because it was an antiseptic for gram positive and negative bacteria, and also yeast. Aside of the attachment between ‘Rivanol*cation with bacterial anion, Rivanol® also attaches the nucleic acid of bacteria or yeast, inhibiting the DNA synthesis of bacteria and yeast, ‘causing the change in mutation in protein synthesis reference. Average recovery day of Rivanol® group was 4.1 days, while in Burowi group was 4.9 days, and it was statistically different, This result showed a significant difference betweca recovery day in both treatment groups where Rivanol® caused healing faster than Burowi (TABLE 3). TABLE 3. Average recovery day in exch tearment sop Group NORBERT vate Rivanol™ 412 Bue: 490 0.046 Result of the study by Zainuddin showed healing time for ADOE was in average of 6 days, it was different with the result of the study by Antara, which was 3.4.3.7 days. The result was almost 161Bertola limu Kedokteran, Volume 41, No. 3, September 2009: 187-163 similar with the study by Basjrah which showed an average of 3.39 days with Burowi.""2* In this study, Rivanol® tampon gave faster recovery, because Rivanol® as antiseptic acted in alkaline condition, and was a wide-spectrum antiseptic, so that it was effective to be used in ADOE patients. Burowi ‘exhibits an astringent effect by absorbing water from. ear canal and does not inhibit the growth of micro- ‘organism directly ‘The side effect in Rivanol®group occurred in 1 (1.596) suibject at the end of the study, in the form. of dampness and soggy feeling in the ear, but they could be tolerated by the patient. In Burowi group, the side effect was stinging sensation in 2 (3.1%) subjects, but the symptom was mild and could be tolerated by the patients, Cost calculation revealed that to cure an ADOE patient with Rivanol® tampon needed only Rp 1000,- CONCLUSION ‘The use of Rivanot® tampon was clinically effective and cost-effective compared to Burowi tampon for acute diffuse external otitis patients. REFERENCES 1, GocdhillVExtemat en diseases, Ear Diseases, Deafness, and Dizziness New York: Harper & Row Publishers, 1979: 268.91 2 Mawson SR. Infections. Disease of The Ear 3° ed, London: aiden and Momaay td, 1974: 233-49, 3. Cohen D, Friedman P. The diagnosis rtria of malignant ‘extemal obs. J Laryngol Orel 1987;101:216-21, 4. Browning GG Aetiopshalogy of illarematory conditions Of the extemal and middle ea. In: Seott-Brown’s (Otolaryngology Sed. Vat 3, Keer AG (od), Buterworthe Heinemann 1997: 31-3333. 5. Senturia BH, Pathogenesis of diffuse extemal otitis and ‘otomycoss. 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