To Study the Burden and Risk Factors for Chronic Suppurative Otitis Media in a Population of Sikkim, India: A Hospital Based Study

Abstract

Chronic suppurative otitis media (CSOM) denotes a chronic inflammation of the middle ear and mastoid mucosa in which the tympanic membrane is not intact and discharge is present (Verhoeff et al. in Int J Pediatr Otorhinolaryngol 70:1-12, 2006). The risk factors for the development of CSOM have not been clearly established in the available literature. Risk factors of COM include low socioeconomic status, malnutrition, high number of children in the household, family history, and passive exposure to smoking (Lasisi et al. in Int J Pediatr Otorhinolaryngol 71:1549–1554, 2007). The effects of various host and environmental factors have not been well defined. There are very few studies to assess the risk factors and disease burden in the community. The study aims to estimate the disease burden of CSOM in the state of Sikkim which would help in effective treatment and control of the disease. This study which is the first of its kind in Sikkim would help us in identification of risk factors which could be present in the Sikkimese population and this could be attributed to ethnic as well as unique geographical factors of this place. Observational study where all Sikkimese patients reporting to ENT with ENT complaints were included after taking consent, The information was noted in a specific questionnaire and all patient were subjected to Otoscopic examination. Analyses using SPSS 17.00. A total of 497 subjects had participated in the study and all the relevant data has been categorized and tabulated according to the requirements of the study.

Introduction

Otitis media (OM) is among the most frequent infections in populations throughout the world. Chronic suppurative otitis media (CSOM) denotes a chronic inflammation of the middle ear and mastoid mucosa in which the tympanic membrane is not intact and discharge is present [1]. While acute otitis media (AOM) mainly causes fever, pain and general malaise, chronic suppurative otitis media (CSOM) may cause long-term problems in the form of intermittent or permanent purulent ear discharge and hearing loss. CSOM is the result of recurrent episodes of acute otitis media and is often characterized by a persistent discharge from the middle ear through a tympanic perforation. It is an important cause of preventable hearing loss, particularly in the developing world and is a major disease entity in the field of otolaryngology. It often requires expensive treatment and ear surgery, and can induce severe or fatal complications such as mastoiditis, facial nerve palsy, labyrinthitis, petrositis, brain abscess, meningitis, and thrombophlebitis. It also decreases patients’ quality of life.

A history of at least 2 weeks of persistent ear discharge should alert primary health workers to the problem; if the ear could be dry mopped well enough to see the eardrum, then the diagnosis of CSOM can be confirmed by visualization of the perforation in the tympanic membrane. To help identify the disease at an early stage without unduly increasing the number of unnecessary referrals to specialists, the questions that health workers should ask and the procedures for visualizing the eardrum must be refined, standardized, and validated.

Review of global burden of disease from otitis media The 1993 World Development Report [2] estimated that about 5.12 million disability-adjusted life-years (DALYs) were lost from otitis media, 91% of which comes from the developing world. This was later scaled down in 1996 to 2.163 million DALYs [3], 94% of which still comes from the developing world. India and Sub-Saharan Africa (SSA) account for most deaths and years of life lost and DALYs from otitis media [4]. Prevalence surveys, which vary widely in disease definition, sampling methods, and methodologic quality, show that the global burden of illness from CSOM involves 65–330 million individuals with draining ears, 60% of whom (39–200 million) suffer from significant hearing impairment. Over 90% of the burden is borne by countries in the South-east Asia, among the South-East Asian countries, prevalence rates in Thailand ranged from 0.9 to 4.7% while the Indian prevalence of 7.8% is high. Therefore, CSOM is a major public-health problem, and India is one of the countries with high-prevalence where urgent attention is needed [4].

The risk factors for the development of CSOM have not been clearly established in the available literature. The disease is less common than AOM and well-designed prospective cohorts that correlate pre-existing conditions with the incidence of CSOM are lacking [5]. Much of what we know is based on studies of the predisposing factors to AOM, which the authors have extrapolated to CSOM. This is based on the observation that recurrent AOM may predispose to CSOM [6]. Another compelling piece of evidence is the decline of CSOM in the antibiotic era, suggesting that treatment of acute infections like AOM prevents progression to the chronic forms [7, 8]. However, the risk factors for AOM and CSOM may still be different from each other [9] and the associations are not consistent among studies [10]. The multifactorial nature of otitis media must be stressed. Risk factors of COM include low socioeconomic status, malnutrition, high number of children in the household, family history, and passive exposure to smoking [11]. Inadequate antibiotic treatment, frequent upper respiratory tract infections, nasal disease [12], and poor living conditions with poor access to medical care [13] are also related to the development of CSOM. Moreover, the effects of various host and environmental factors have not been well defined.

The morbidity and mortality associated with CSOM is a really a challenge for health care systems. Surprisingly, there are very few studies done in India to know the burden of disease on the society. This study which is the first of its kind in Sikkim would help us in identification of other risk factors which could be present in the Sikkimese population and this could be attributed to ethnic as well as unique geographical factors of this place. Further, the study also aims to estimate the disease burden of CSOM in the state of Sikkim which would help in effective treatment and control of the disease.

Aims and Objectives

1. To assess the burden of chronic suppurative otitis media in a population of Sikkim.

2. To evaluate the risk factors of chronic suppurative otitis media in a population of Sikki

Materials and Methods

Study Type

Observational study.

Study Setting

The present study will be conducted in the Department of ENT and Head and Neck Surgery, Central Referral Hospital, Sikkim Manipal Institute of Medical Sciences, 5th Mile, Tadong, Gangtok, Sikkim.

Study Period

Three months period.

Sample Size

All the patients attending ENT OPD in this period of 3 months will be included in the study.

Study Population

Includes patients belonging to a population of Sikkim (All persons currently staying in Sikkim for a period of more than 5 years now and above 10 years of age). All patients reporting to ENT OPD who are diagnosed with chronic suppurative otitis media will be included in the study and the burden of CSOM will be assessed. All patients reporting to ENT OPD without chronic suppurative otitis media, but with some other ENT problems shall be compared with those suffering from active ear disease to evaluate various risk factors of CSOM.

Data Collection

After obtaining the informed written consent the patient presenting to ENT Out Patient Department of the Central Referral Hospital was included in the study.

The Burden of chronic suppurative otitis media and its relation with risk factors will be noted with the help of a questionnaire, clinical examination is performed with the help of a hand held otoscope and the result obtained is analysed.

Inclusion Criteria

• Agree to give a voluntary consent.

• All patients suffering from ENT problems.

• Patients belonging to a population of Sikkim.

• Patients who are currently staying in Sikkim for a period of more than 5 years now and above 10 years of age

Exclusion Criteria

• Person who deny giving a voluntary consent.

• Patients below the age of 10 years and who have stayed in Sikkim for less than 5 years.

The data obtained is sorted and categorised on the basis of different parameters of the questionnaire and clinical findings. The information is compiled and analysed by using SPSS version 16.00. The 'p' value will be obtained using chi-square test and the results will be depicted in the form of tables and charts.

Results

A total of 497 subjects had participated in the study and all the relevant data has been categorized and tabulated according to the requirements of the study as follows:

The above tabulated data categorizes all the participants of the study irrespective of the participant suffering from CSOM or not. This is for a better idea about the sociodemographic description of the study population owing to the prospect of the study being conducted for the first time in a hilly region of India (Table 1).

Table 1.

Baseline characteristics of the population studied

Variables	n = 497	%
Gender
Male	202	40.64
Female	295	59.35
Age group
10–20	80	16.09
20–30	187	37.62
30–40	192	38.63
40–50	8	1.60
50–60	2	0.40
> 60	28	5.63
Occupation
Unemployed	253	50.90
Unskilled worker	2	0.40
Semiskilled worker	9	1.81
Skilled worker	41	8.24
Clerical/shop/farm	123	24.74
Semi professional	36	7.24
professional	33	6.63
Religion
Hindu	315	63.38
Muslim	35	7.04
Buddhist	147	29.57
Stay in Sikkim
10–20	80	16.09
20–30	187	37.62
30–40	192	38.63
40–50	8	1.60
50–60	2	0.40
> 60	28	5.63
Marital status
Married	287	57.74
Unmarried	210	42.25
Address
East Sikkim	414	83.29
West Sikkim	1	0.20
North Sikkim	25	5.03
South Sikkim	51	10.26
Outstation	6	1.20
Literacy status
Illiterate	27	5.43
Middle school	4	0.80
High school	1	0.20
Intermediate	312	62.77
Graduate	68	13.68
Professional	85	17.10
SES
Lower class	7	1.40
Upper class	263	52.91
Lower middle	59	11.87
Upper Middle	147	29.57
Upper class	21	5.83
Smoking
Yes	98	19.71
No	399	80.28
BMI
Underweight	7	1.40
Normal weight	330	66.39
Over weight	153	30.78
Obesity class 1	7	1.40

Following is the tabulated data categorizing various parameters exclusively for the cases of CSOM:

Gender distribution of the patients were 74(43.52%) males and 96(56.47%) females (Table 2).

Table 2.

Distribution of cases

Sex	No. of cases	%
Male	74	43.52
Female	96	56.47
Total	170

Out of 497 subjects participating in the study, a total of 170 subjects were found to be suffering from CSOM. Therefore, disease burden in the above study sample was found to be 34.20%.

125(73.52%) patients were below 30 years age, with maximum number of patients between 20–30 years of age and 45(26.44%) were from above 30yrs (Table 3).

Table 3.

Showing age distribution and years of stay in Sikkim

Age (in years) and years of stay	No. of cases	%
10–20	28	16.47
20–30	97	57.05
30–40	23	13.52
40–50	8	4.70
50–60	2	1.17
> 60	12	7.05
Total	170

The risk factor associated with 170 cases of chronic suppurative otitis media were low socioeconomic status and poor living conditions with overcrowding and poor ventilation, Smoking (both active and passive), indoor air pollution and head bath without proper ear plugs. It has been seen that constant exposure to loud noises have also increased the risk of development of the disease. Diseases associated with chronic suppurative otitis media were Upper respiratory tract infection including nasal and throat problems and GERD respectively. It has been seen that poor compliance to medication and treatment is also an important risk factor for progression of the disease (Table 4).

Table 4.

Sociodemographic correlates associated with CSOM

	Cases N1 = 170 (%)	Controls N2 = 327(%)	x2, df, p
Socio demographic correlates
1. Presence of nasal problems (blocked/running/ allergy etc.)			x2 = 5.9, df = 3, p = 0.118
Yes	68	128
No	102	199
2. Presence of history of URTI			x2 = 21.407, df = 1, p = 0.000*
Yes	73	75
No	97	252
3. Socioeconomic status			x2 = 67.429, df = 4, p = 0.000*
Lower class	0	7
Upper lower	106	157
Lower middle	40	19
Upper middle	20	127
Upper class	4	17
4. Presence of throat problems			x2 = 23.440, df = 1, p = 0.0001*
Yes	61	193
No	108	134
5. Presence of GERD			x2 = 18.352, df = 1, p = 0.0001*
Yes	5	52
No	164	275
6. Seasonal variation of ear symptoms			x2 = 2.289, df = 1, p = 0.000*
Yes	96	0
No	74	327
7. Seasonal variation			x2 = 2.289, df = 2, p = 0.000*
Summer	22	0
Winter	74	0
No relation	74	327
8. Exposure to loud noise			x2 = 14.658, df = 1, p = 0.000*
Present	4	42
Absent	166	285
9. Head bath without ear plug			x2 = 1.1189, df = 1, p = 0.000*
Yes	104	318
No	65	9
10. Smoking (active)			x2 = 1.695, df = 1, p = 0.119
Yes	39	59
No	131	268
11. Frequency of smoking			x2 = 1.186, df = 3, p = 0.611
1–5/day	8	13
6–10/day	30	45
> 10/day	1	1
none	131	268
12. Passive smoking/indoor air pollution			x2 = 1.146, df = 1, p = 0.000*
Yes	120	70
No	50	257
13. Habit of alcohol consumption			x2 = 0.110, df = 1, p = 0.729
Yes	37	67
No	133	260
14. Cleaning ear with stick or bud (unhygienic practices)			x2 = 0.386, df = 1, p = 0.531
Yes	51	90
No	118	237
15. Exposure to pets at home			x2 = 0.76, df = 1, p = 0.783
Present	30	61
Absent	140	266
16. Ventilation at each room			x2 = 11.471, df = 2, p = 0.0003*
Absent	3	0
Adequate ventilated	53	140
Well ventilated	114	187
Socio demographic correlates
17. Compliance of treatment			x2 = 11.830, df = 1, p = 0.000*
Yes	57	64
No	113	263
18. Presence of overcrowding			x2 = 1.643, df = 2, p = 0.000*
1–2/room	131	60
2–4/room	28	155
> 4/room	11	112
19. Presence of cross ventilation			x2 = 46.666, df = 1, p = 0.000*
Yes	129	143
No	41	184
20. BMI			x2 = 17.170, df = 3, p = 0.001*
Underweight	2	5
Normal	101	229
Overweight	60	93
Obesity	7	0

*Represent p value significance

Discussion

CSOM is a major public-health problem, and India is one of the countries with high-prevalence where urgent attention is needed and a reason of serious concern, particularly in children, because it may have long-term effects on early communication, language development, auditory processing, educational process, and physiological and cognitive development [4].

Out of 170 cases of chronic suppurative otitis media, Gender distribution of the patients were found to be 74(43.52%) males and 96(56.47%) females (Table 2). Thus, in our study more number of females were found to be affected than the males This observation was parallel with the findings of few authors [14, 15] and in contrast with other studies where significant male predominance have been seen [16, 17]. As this study involved, a random selection of cases the predominance of female patients over male may be only an incidental finding. Moreover, no knowledge of anatomical differences in the ear structures of male and female has been reported in this study on simple clinical examination or with examination with a hand held otoscope.

We found that the CSOM was more prevalent below third decade of life and accounted for 125(73.52%) of cases, with maximum number of patients between 20 and 30 years of age (Table 3). This finding corroborates well with the observations made by other studies [14, 17–20]. High-prevalence of CSOM in may be attributed to the fact to being prone to upper respiratory tract infections (URTIs). Furthermore, cold weather due to the geographical location of Sikkim in the Himalayan belt pre-disposes the inhabitants more to URTI almost throughout the year, with more frequency during winter (Table 4; seasonal variation) [21, 22].

Furthermore, we wanted to analyse which state of Sikkim has the maximum number of cases and it was found that maximum number of cases were seen to be reported from the east district of the state 89(53.35%), followed by North Sikkim 63(37.05%). The higher number of cases from these two districts can be explained to the geographical location and the higher altitude which in turn is responsible to colder temperatures throughout the year. Due to lack of earlier studies in this region, corroborative data to support the statistics could not be found.

High incidence of CSOM among the patients who have participated in the study was associated with risk factors as shown in Table 5. Poor living conditions were associated with maximum patients 131(77.05%) and they mostly belonged to lower socioeconomic groups. This observation is parallel with other studies [23, 24]. Diseases associated with chronic suppurative otitis media were Upper respiratory tract infection 73(42.94%), including nasal problems and allergy 68(40%) and throat problems 61(35.88%) and GERD (2.94%) respectively. These findings were closely supported by different workers [25–27]. Poor hygiene and unorthodox approach to treatment like use of unconventional ear drops and concoctions such as oil and honey into the middle-ear may initiate the proliferation of opportunistic pathogens leading to blockage of Eustachian tube, further aggravating the situation.

Table 5.

summary of risk factors associated with CSOM

Factors	No. of cases (n = 170) (%)	No. of controls (n = 327) (%)
URTI	73 (42.94)	75 (22.93)
Nasal problems/allergy	68 (40)	128 (39.14)
Throat problems	61 (35.88)	193 (59.02)
GERD	5 (2.94)	52 (15.90)
Low SES	106 (62.35)	164 (50.15)
Smoking/indoor air pollution	120 (70.58)	70 (21.40)
Head bath	104 (62.17)	318 (97.24)
Poor living conditions	131 (77.05)	112 (34.25)
Exposure to loud noises	4 (2.35)	42 (12.84)
Non compliance to treatment	113	66.47

Conclusion

Chronic suppurative otitis media has become public health importance in the present days in developing countries like India. It is well known disease of multiple etiology and its recurrence and persistence. Irregular, haphazard and indiscriminate use of antibiotics has precipitated the emergence of multi resistant bacteria. Recurrent upper respiratory infection, low socioeconomic status, lack of awareness and ignorance, bathing in contaminated dirty water, foreign body are contributing factors for developing CSOM in the present era.

Research on burden of chronic suppurative otitis media and its risk factors has not been undertaken so far and the prevalence of chronic suppurative otitis media is quite high in this region. This study about burden and risk factor in Sikkim will help us to cater a remedial message to the general population and to eventually promote the awareness about chronic suppurative otitis media in Sikkim.

Author’s Contribution

SPK: conceived the idea of the study and guide for conduct of the study, participated in its design and coordination, performed the statistical analysis and helped to draft the manuscript. SP, RD: On the spot data collection and drafting the manuscript, assisted in statistical analysis of the data.

Funding

The study was approved as a project under Endowment fund as a part of TMA Pai Research Fund 2018–19, Sikkim, India during March 2018 towards research development at MBBS level to MBBS student Miss Sampriti Paul. Dr. Santosh Prasad Kesari was the research guide and technical advisors. The funding agency has encouraged the researchers to go ahead with the publication of this project report and there is no conflict of interest of any kind.

Declarations

Conflict of interest

There are no potential, perceived, or real competing and/or conflicts of interest among authors regarding the article and therefore have nothing to declare.

Ethical Approval

Both the authors have seen and approved the final version of the manuscript and it is not currently under active consideration for publication elsewhere, has not been accepted for publication, nor has it been published earlier, in full or in part. Both the authors have been personally and actively involved in substantive work leading to the report, and will hold themselves jointly and individually responsible for its content.