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SJIF Impact Factor 3.628 ejpmr, 2016,3(9), 282-286. Research Article EUROPEAN JOURNAL OF PHARMACEUTICAL European Journal of Pharmaceutical and Medical Research ISSN 3294-3211 AND MEDICAL RESEARCH Qadir et al. www.ejpmr.com EJPMR EPIDEMIOLOGY, CLINICAL CHARACTERISTICS, AND MAGNITUDE OF ECONOMIC BURDEN OF EAR WAX IN KASHMIR. Dr. Waseem Qadir*, Dr. Omar Shafi, Dr. Manzoor Malik and Dr. Sajad M. Qazi India. *Correspondence for Author: Dr. Waseem Qadir India. Article Received on 28/06/2016 Article Revised on 18/07/2016 Article Accepted on 08/08/2016 ABSTRACT Background and Aim: Ear wax impaction is a common condition worldwide with varied presentations. This study is aimed to document the epidemiology, clinical characteristics and magnitude of economic burden in Kashmir, a subtropical region with harsh winter. Materials and methods: A retrospective analysis of hospital records of ear wax clearance for a period of two years was done to note the prevalence, and demographic profile of patients presenting with ear wax. A prospective analysis was done on 240 serial patients to note the presenting complaint, duration of symptoms, and type of wax, laterality, and history of any predisposing factors. Complete ear examination was done and findings were documented in a premade proforma. The cost incurred in clearing the ear wax was calculated. Results: Out of 1,80,000 patients visiting OPD for a period of 2 years, a total of 12473 patients underwent clearance of ear wax. A prevalence of 6.5% was found. The ages ranged from 5 to 90 years. The highest number of patients affected were in the age group of 21 to 40 years amounting to 1546(49.40%) followed by 3769 patients (39%) from 41 to 60 years. The number of patients differed over different months. The average number of patients seen from March to August was significantly higher than from September to February. The average per annum cost of managing ear wax impaction amounted to 3816,000 Rupees ($56955). On prospectively analyzing 240 patients of different age groups, 45.41% patients described their presenting symptoms as fullness of ear(s), 30.83% patients complained of otalgia and 22.5% of patients complained of decreased hearing. Of the 187 patients with a unilateral symptoms, 108 (57.75%) had bilateral impacted ear wax. The most common predisposing factors identified was rinsing with soap in 98 followed by ear bud usage in 80 patients. Conclusion: Ear wax is a fairly common condition that can be diagnosed and managed by general practioners. Ear buds remain a preventable predisposing factor. KEYWORDS: Ear wax, burden, Kashmir. INTRODUCTION Ear wax, also referred to as cerumen auris, is a mixture of secretions from ceruminous and pilosebaceous glands located within the outer one-third of EAC, together with desquamated epithelium, dust and other foreign debris. It is composed of mainly 60% desquamated cells, 12–20% saturated and unsaturated long‑chain fatty acid and 6– 9% cholesterol.[1-4] Due to its sticky nature it acts as a lubricant, entraps dust and foreign bodies and also possesses antimicrobial activities due to fatty acids, lysozymes and low pH.[5, 6, 7] It gets dried up and falls out of the external auditory canal with the trapped particles by conveyor belt process of epithelial migration assisted by jaw movement during chewing and talking.[8, 9] There are genetically and racially determined differences in the physical characteristics of cerumen that vary in appearance and consistency and may be associated with immunoglobulin and lysozyme content.[10] Most Caucasians and Negroes have the so-called 'wet' phenotype, with moist, pale, honey-colored cerumen that www.ejpmr.com sticks to the otoscope. In contrast, mongoloid races tend to have grey, granular and brittle cerumen (the 'dry' phenotype). Wet wax has lower concentrations of immunoglobulin’s and lysozymes, but a higher lipid content than the dry variety. Cerumen type is determined by two autosomal alleles, the wet allele being dominant.[11, 12] Ear wax is normally extruded naturally. However, it may accumulate and occlude the canal of one or both ears. Earwax is said to be impacted when its accumulation in the external auditory canal is symptomatic or prevent assessment of the canal and eardrum or both. Impacted earwax causes discomfort such as irritation, fullness, decreased hearing. Earache, noise in the ear, chronic cough and dizziness.[13,14,15] necessitating removal. Wax can be removed from the ear by ceruminolytics, syringing, suction or hooking it out under direct vision. The habit of self-cleaning ears by pointed objects, ear canal abnormalities, excess sebum production are some of the predisposing factors for wax impaction. Earwax impaction is one of the most common ear pathology treated in the otolaryngological clinic 282 Qadir et al. European Journal of Pharmaceutical and Medical Research worldwide, in the USA, about 6% of the population suffer from impacted cerumen with 150 000 ear wax removals take place each week. In the UK, some 2.3 million people suffer cerumen (‘ear wax’) problems serious enough to warrant management, with approximately 4 million ears syringed annually. [16, 17] Little research has been done on the magnitude and characteristics of ear wax in a sub-tropical region like Kashmir. This study is aimed at noting the epidemiology, clinical presentation, predisposing factors for ear wax impaction and the magnitude of this condition and its economic burden on the population in Kashmir. MATERIALS AND METHODS This study was done in the SMHS hospital associated with GMC Srinagar the capital of Kashmir province a sub-tropical area with particularly harsh winter. This hospital is a tertiary care center catering to needs of 5 main districts. This study was done in the OPD of ENT & HNS. A retrospective analysis of data of patients who underwent wax removal by syringing or other methods was done for a period of 2 years ranging from May 2013 to May 2015. The demographic data which included age, gender, month of visit and residence was collected. A prospective observational study for a study group of 240 serial patients which included 60 each of patients from age groups 0 to15 years, 15 t0 25 years, 25 to 60 years, and more than 60 years was done. The presenting complaint, duration of symptoms, type of wax, laterality and history of any predisposing factors was recorded in a premade proforma. A complete ear examination and otoscopic examination was done. Patients with history of ear discharge, any previous ear surgery, suspected EAC cholesteatoma and bilateral asymptomatic ears and ear clearance by methods other than ear syringing were excluded from the prospective study. All the patients were treated by wax softeners ear drops for duration of 5 days and ear wax was removed by syringing with normal saline after proper temperature control. Patients presenting with otalgia and positive tragal test were treated by antibiotics before using ceruminolytic agents. RESULTS In a retrospective analysis of Hospital records, it was noted that a total of 12473 patients underwent clearance of ear wax. The total number of patients visiting the OPD during this period is 180,000. The prevalence of the ear wax in our study was 6.93%. the number of males was 6426(52%) and number of females was 6047 (48%) with no significant difference in prevalence between male and female population. The age range varied from 5 months to 90 years. The number varied according to the age as shown in table 1. The highest number of patients affected were in the age group of 21 to 40 years amounting to 1546(49.40%) followed by 3769 patients (39%) from 41 to 60 years. The extremes of ages amounted to only 8% of our study. The number of patients differed over different months. The average number of patients seen from March to August was significantly higher than from September to February as shown in the fig 1.The www.ejpmr.com approximate cost incurred per month was Rs 318,00. And average per annum cost amounted to3816,000 rupees ($56955) as described in table TABLE 2.We prospectively analyzed 240 patients of ear wax 60 each from 0 to15 years, 15 t0 25 years, 25 to 60 years and more than 60 years with 109 males and 131 females. The presenting complaints is as shown in FIG 2. 45.41% patients described their presenting symptoms as fullness of ear(s), 30.83% patients complained of otalgia and 22.5% of patients complained of decreased hearing. 103 patients complained of symptoms in their right ear, 84 patients complained of left ear symptoms and 53 patients complained of bilateral symptoms. Of the 187 patients with a unilateral symptoms, 108 (57.75%) had bilateral presence impacted ear wax. The most common predisposing factors identified was Ear bud usage in 80 patients, rinsing with soap in 98, hirsute canal in 25, narrow canal in 10 patients, use of hearing aid in 5 patients. No probable causes could be identified in 50 patients as shown in table 3. The relation of type of ear wax with presenting symptoms, duration of presentation age, gender and recurrence is as shown in Table 4. No significant difference could be found between duration of presentation and type of ear wax. There were a total of 71 patients who had underwent ear syringing more than once in their life time. 40 patients were undergoing it for second time. As shown in figure 2 a total of 49 patients complained of some form of complication. 30 patient’s complained of vertigo which was self-limiting. 15 cases presented with otitis externa and were treated with analgesics and local antibiotics. 3 patients developed ear perforation. One case developed malignant otitis externa. On investigation patient had undiagnosed diabetes mellitus of unknown duration. The patient was admitted and treated by injectable antibiotics. Table 1: Age Range Distribution Of Study Group Age range Number Percentage 0-10 481 3.85% 11 --20 1546 12.30% 21-40 6167 49.40% 41-60 3769 30.20% 61-80 510 4.08% Total 12473 283 Qadir et al. European Journal of Pharmaceutical and Medical Research prevalence of ear wax in our study is least in 3.85% up to 10 years. Approximately half of our patients (49.40%) were in the age group of 21 to 40 years. The prevalence noted in elderly patients is 4.08% which is less than in other studies which can be explained by the decrease in cerumen production with age. The decrease may also be due to recall bias. The older patients tend to reveal their age lower. The number of patients seen in a particular month showed a pattern in our study. The number of patients is least during winter months and gradually rises in spring and mid-summer and least in autumn. The pattern is largely due to harvest season, decreased activity, decreased bathing frequency in winter. Fig 2 Presenting Complaints Of Patients TABLE 2 predisposing factors predisposing factor Frequency Ear bud usage 80 Rinsing with soap 98 Use of hearing aid 5 Hirsute canal 25 Narrow canal 10 Dermatosis 5 No cause identified 50 perecentage 33.33% 40.83% 2.08% 10.21% 4.16% 2.085 20.83% DISCUSSION Ear wax is a common otological problem in people of all age groups. Earwax impaction is one of the most common ear pathology treated in the otorhynolaryngological clinic worldwide, in the USA, about 6% of the population suffer from impacted cerumen with 150 000 ear wax removals take place each week. Many studies from Europe put the prevalence of ear wax between 2 to 6%. A few studies from African continent put the prevalence from 10 to 20%.[18] The prevalence also varies between different age groups. The prevalence of cerumen impaction varies greatly, approximately 10% of the children, 5% of normal healthy adults, up to 57% of older patients in nursing homes and 36% of patients with mental retardation.[19] The prevalence in our study is 6.92% and is largely comparable with rest of the world. The age wise www.ejpmr.com Ear wax is seems innocuous but due to sheer magnitude of this condition and cost of its management it is a sizable burden on the resources of health care systems all over the world including the developed nations. To calculate the direct cost on health care we included the cost of skilled manpower involved, the cost of commodities utilized and patient cost incurred in visiting a doctor to remove the ear wax. The approximate cost incurred per month was ₹ 31800. And average per annum cost amounted to ₹3816000 ($56955) as described in table. In a study done in Oman the average cost incurred calculated was $20 per patient and total estimated cost in population amounting to staggering $3.6 million.[20] Of the 250 patients of the prospective arm of study, majority of patients (61) complained of unilateral symptoms. 103 patients has symptomatic ear wax on right side and only 84 on left side, Ibiam Fa[21] in their study found that bilateral ear affection by wax was twice as common as either right or left ear presence of wax accounting for 60.1% of all cases seen. Zeba et al [22] in their study also found that bilateral ear impaction was commoner than either right or left ear affectation. Patients seek treatment for cerumen impaction for a host of symptoms. Pain, itching, sensation of fullness, tinnitus, odor, drainage, cough and dizziness have all been reported. In our study most common symptom is sensation of fullness, followed by otalgia and decreased hearing. Complete occlusion can result in significant hearing loss.[23] Hearing loss can range from 5 to 40 dB depending on the degree of occlusion of the canal with cerumen.[24] The most common predisposing factors identified was Ear bud usage in 80 patients, rinsing with soap in 98, hirsute canal in 25, narrow canal in 10 patients, use of hearing aid in 5 patients. No probable causes could be identified in 50 patients. Waheed Atilade[25] in their study reveals 74.4% of participants cleaning their ears by cotton tipped swab and other object. This could be explained by 72.5% of the participants, who believed that earwax is harmful and 87.4% believe it is dirt or dust. Cotton tipped swabs and other object used may push earwax further into the canal and potentially foiling the natural earwax removal phenomenon and causing earwax impaction.[26][27] 284 Qadir et al. European Journal of Pharmaceutical and Medical Research All 250 patients underwent syringing with water after proper temperature control. A total of 49 patients complained of some form of complication. 30 patient’s complained of vertigo which was self-limiting. 15 cases presented with otitis externa and were treated with analgesics and local antibiotics. 3 patients developed tympanic membrane perforation. One case developed malignant otitis externa. Sorenson has assessed the pressure developed during routine ear syringing and found it safe for normal ears. But he did note that it may present a risk of perforation when the tympanic membrane is atrophic.[28] Commonly reported significant complications are perforation (0.2% in Pavlidis series) and vertigo (0.2% in Pavlidis series)[29] Sharp et al estimated that only 1 in 1000 episodes of aural irrigation resulted in a complication significantly severe to require specialist referral.[24], Similarly, Bird asserts that major complications occur in 1 in 1000 ears syringed.[30] Roland et al reported a total of six adverse events in 74 patients who had cerumen removed with cerumenolytics followed by aural irrigation.[31] All were minor (3 puritis, 1 dermatitis, 1 vertigo, 1 discomfort) and resolved spontaneously. Tympanic membrane perforation with serious injury to the middle and inner ear is rare but has been reported on a number of occasions. Bapat et al[32] have reported fracture of the stapedial footplate with subsequent profound neurosensory hearing loss following aural irrigation using an ear syringe, and Dinsdale et al have reported a similar complication resulting in profound deafness following the use of an oral jet irrigator. In our study we report one case of malignant otitis externa in a 72 year old female with previously unknown diabetes mellitus. Patient required admission and treatment with intravenous antibiotics and insulin for control of raised blood glucose. CONCLUSION We conclude that though an innocuous disease ear wax impaction is a burden on health care. In our study the young productive age groups from 20-60 years were more commonly affected and each visit to hospital amounted to a work day loss. A sudden Fullness of ear following bathing and decreased hearing were most common symptoms of presentation. The prevalence of ear wax was seen to increase after winter months probably due to decrease in bathing frequency and limited transportation. A significant proportion of patients were in the habit of using ear buds. Treatment of ear wax by ceruminolytic followed by syringing is quite safe. Ear wax can be diagnosed and managed by general practitioners at peripheral hospitals to reduce the burden on tertiary care ORL centers. BIBLIOGRAPHY 1. Brand-Auraban A, Kopito L, Shwachman H. Chemical analysis of some inorganic elements in cerumen from patients with cystic fibrosis. J Invest Dermatol, 1972; 58: 14-15. www.ejpmr.com 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. El-Ghazzawi EF, Talaat M, Mandour MA, Arafa SA. The ceruminous glands in chronic suppurative otitis media. J Laryngol Otol, 1979; 93: 785-91. Stránský K, Valterová I, Kofroňová E, Urbanová K, Zarevúcka M, Wimmer Z. Non‑polar lipid components of human cerumen. Lipids, 2011; 46: 781‑8. 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Arch Otolaryngol Head Neck Surg, 2004; 130: 1175–7. 31. Bapat U, Nia J, Bance M. Severe audiovestibular loss following ear syringing for wax removal. J Laryngol Otol, 2001; 115: 410–1. 32. Dinsdale RC, Roland PS, Manning SC, et al. Catastrophic otologic injury from oral jet irrigation of the external auditory canal. Laryngoscope, 1991; 101: 75–8. www.ejpmr.com 286