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Syed et al., Int J Med Res Health Sci. 2015;4(4):740-743

Available online at: www.ijmrhs.com DOI: 10.5958/2319-5886.2015.00144.7

Research article Open Access

HIV/AIDS KNOWLEDGE AND PATTERNS OF SEXUAL BEHAVIOR AMONG ADULT

SLUM DWELLERS IN MUMBAI, INDIA

Saba Syed1, Sukhdas Gangam

2

INTRODUCTION

HIV/AIDS was first identified in India in 1986[1]

when

serological testing found that 10 of 102 female sexworkers in Chennai were HIV positive. In the face of

increasing numbers of people being identified with HIV,

the Government of India (GOI) established the National

AIDS Committee (NAC) and in 1992, the National AIDS

Control Organization (NACO).[1]

In India, currently 2.1

million people are living with HIV.[2]

The four high

prevalence states Andhra Pradesh, Maharashtra,

Karnataka, Tamil Nadu account for 55% of all HIV

infections in the country[3]

In National AIDS Control Programme (NACP IV);

prevention is the mainstay of the strategic response to

HIV/AIDS in India as 99% population of the country is

uninfected; prevention strategies include expanding IEC

services for (a) general population and (b) high risk groups

with a focus on behaviour change and demand

generation. Among the general population, women, youth

and adolescents are seen as most vulnerable. Also, lack

of access to correct information can pose a possible

barrier in HIV/AIDS prevention programmes. Interventions

for general population are about raising their awareness of

HIV. Awareness raising brings behaviour change.

Changing knowledge, attitudes and behaviour as a

prevention strategy of HIV/AIDS thus is a key thrust area

of the National AIDS Control Programme. Through this

route the programme aims to reach out to 80 percent of the high risk groups and 95 percent of the young people.[4]

In metropolitan cities; the rising rate of urbanization and

the accompanying disproportionate growth in theproportion of poor city residents pose new challenges for

health care in urban slums. They may start sexual

intercourse at earlier ages, have more sexual partners,

and are less likely than other city residents to know of or

adopt preventive measures against contracting Sexually

Transmitted Infections/Reproductive Tract Infections

STIs/RTIs and HIV/AIDS[5]

. Mumbai, the most populous

city in India is unique in having a huge migrant population;

largely young as it offers opportunities for all to earn a

living. Slums too are a ubiquitous feature of Mumbai’s

geographical landscape. Socio-economic determinants

that make a person vulnerable also increase the risk of

exposure to HIV. People inhabiting slums have low

awareness and are more vulnerable to RTI/STIs and

HIV/AIDS[5]

. As HIV infection is entirely preventable

through awareness raising about its occurrence and

spread, it is very significant in protecting the people from

the epidemic. Thus, the present study was planned to

assess HIV/AIDS knowledge and sexual behaviour,

reported symptoms of STI/RTI’s along with the socio

demographic profile of adult population of urban slum

dwellers. Information regarding age at first sexual

intercourse, reasons for not using condoms during

intercourse may give insights into novel approaches of

applying HIV/AIDS prevention strategies.

ARTICLE INFO

Received: 4th Apr 2015

Revised: 23rd May 2015

Accepted: 29th Jun 2015

Authors details: 1 Assistant Professor,

Department of Community Medicine,

Apollo Institute of Medical Sciences and

Research, Mumbai, Maharashtra, India2 Assosicate Professor, Department of

Community Medicine, Apollo Institute of

Medical Sciences and Research,

Mumbai, Maharashtra, India

Corresponding author: Saba Syed

Apollo Institute of Medical Sciences and

Research, Mumbai, Maharashtra, India

Mumbai, Maharashtra, India

Email: [email protected]

Keywords: HIV/AIDS Knowledge, Sexualbehaviour, Slum dwellers

ABSTRACT

Background: In India, currently 2.1 million people are living with HIV.

Prevention is the mainstay of the strategic response to HIV/AIDS in India.

Awareness rising brings behaviour change. People inhabiting slums have low

awareness and are more vulnerable to RTI/STIs and HIV/AIDS. Aims: To

assess HIV/AIDS knowledge, sexual behaviour, reported symptoms of

STI/RTI’s along with the socio demographic profile of adult population of

urban slum dwellers. Methods: A cross sectional, qualitative study. The study

area, chosen by convenience sampling was an urban slum located in M East

Ward of Greater Mumbai. The study was finally conducted with 104

participants. Results: The mean age of surveyed participants was 23.5yrs

and nearly 38(40%) of participants were illiterate Age at first sexualintercourse among the study participants was between 12-16 years for

23(22.10%) participants. Among study participants; 30(29%) of participants

do not have any knowledge about prevention and transmission of HIV/AIDS.

Conclusions: Urban slum residents in Mumbai have knowledge gap

regarding HIV/AIDS transmission and prevention. Initiation of sexual

intercourse is at an early age, a high percentage report symptoms of

STI/RTIs.


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MATERIAL AND METHODS

Study design: It was a cross sectional, qualitative study.

Ethical approval & Consent: Approval from institutional

ethics committee (IEC) was obtained prior to initiation of

the study. Informed verbal consent of the participants

was taken after explaining to them that the

information revealed by them would be kept strictly

confidential and those who gave consent were enrolled as

study participants

Mumbai is divided into administrative zones and wards.

The study area, chosen by convenience sampling was an

urban slum located in M East Ward of Greater Mumbai. It

has a population of approximately one lakh, which is

predominantly migrant. Inhabitants of the slum reside in

dwellings in multiple lanes, parallel to each other.

Sampling technique: By systematic random sampling

technique initially, ten lanes were selected by choosing

every fifth lane of the study area. All dwellings in the

selected lane were enlisted; following which every fifth

household was selected, until the number of study

participants equalled ten in each lane. Locked houseswere excluded and the next fifth house on the list was

selected.

Inclusion criteria: Individuals with chronological age

eighteen years and above; residing in these households

were eligible to be enrolled as study participants.

Sample size: Assuming HIV prevalence of between

0.25%- 0.3% in general population; the required sample

size was calculated to be 104 using formula [s=4 PQ/ E2].

Study was finally conducted with 104 participants.

Methodology

A self designed, semi- structured questionnaire was

prepared comprising questions pertaining to the

demographic and socioeconomic Profile, their knowledge

regarding HIV /AIDS prevention and transmission,

misconceptions regarding HIV/AIDS transmission. It also

included questions on age at first sexual intercourse,

reported symptoms of Sexually Transmitted Infections

(STIs) /Reproductive Tract Infections (RTIs) and means of

protection of themselves from an intimate partner who has

symptoms of STI/RTIs and their sexual Practices. All

participants reporting symptoms of STI/RTI were referred

to the nearest health care centre. Socioeconomic

classification of study participants was done using B. G

Prasad’s classification.[6]

A pilot study was carried out

prior to the final study with thirty participants to test theaccuracy and completeness of the questionnaire

Data collection was done by administration of the

questionnaire through personal interviews and in depth

discussions with the participants.

Statistical analysis: Data was collated and qualitative

data analysis (frequencies & percentages) done by using

MS Excel.

RESULTS

Table 1 depicts the demographic profile of study

participants. The mean age of study participants was

23.5yrs .Table 2 depicts knowledge regarding HIV/AIDS

prevention & transmission among study participants and

30(29%) of participants do not have any knowledge about

prevention and transmission of HIV/AIDS. Table 3 depicts

Misconceptions Regarding HIV/AIDS transmission. Table

4 shows Reported symptoms of STI/RTIs in study

participants.

Age at first sexual intercourse among the study

participants was between 12-16 years for 23(22.10%)

participants and between 17-21yrs for 62(59.60%)

participants whereas it was between 22-26 yrs for

14(13.50%) participants and in 4(3.84%) participants it

was between 27-31 yrs. Partner during first sexual

intercourse for 85(81.20%) participants was their spouse,

for 2(1.9%) it was an acquaintance, for 5(7.14%) male

participants it was a commercial sex worker, for 3(2.88%)

partner was a relative and for 8 (7.70%) male participants

it was their intimate partners. Regarding condom usage

during first sexual intercourse; only 3(2.90%) participants

had used a condom and 100(96.20%) had not used a

condom. Among the reasons for not using condoms,

9(8.70%) revealed they had no knowledge of how to use acondom, 6 (5.8%) revealed that a condom was not

available at that time, two revealed that they did not feel it

was required.

Regarding means of protection of themselves from an

intimate partner who has symptoms of STI/RTIs,

31(29.80%) said they would insist on condom usage is

preferable, 17(16.30%) said refusal for intercourse and

9(8.70%) participants said they would take treatment for

the symptoms, whereas 47(45.20%) did not know how

they would protect themselves if their partner had

symptoms of STI/RTIs.

Table 1: Demographic profile of study participants:

Demographic factors Number (%)

Gender Male 70 67.30

Female 34 32.70

Age group(yrs) 21-25 15 14.80

26-30 33 32.91

31-35 25 24.82

36-40 17 16.81

41-45 12 10.76

Educational

status

Illiterate 40 38.50

Primary 12 11.50

Secondary 48 46.20

H. Secondary 2

1.90

Graduate 2 1.90

Marital status Married 4 3.80

Unmarried 97 93.30

Separated 2 1.92

Widow 1 0.96

B.G.Prasad

Socioeconomic

Classification

a)Class I 3 2.88

b)Class II 38 36.53

c)Class III 46 44.23

d)Class IV 17 16.30


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Table 2: Knowledge regarding HIV/AIDS prevention & transmission among study participants

Knowledge of regarding HIV/AIDS Prevention and transmission Yes No Don’t know

Is HIV/AIDS Curable 14(13.5%) 45(43.30%) 45(43.30%)

HIV/AIDS Prevented By Consistent Condom Use 81(77.90%) 2(1.90%) 21(20.20%)

HIV/AIDS Prevented By Single Uninfected Sexual Partner 84(80.80%) 0(0.00%) 20(19.20%)

HIV/AIDS Prevented By Sterilized Needles And Syringes 75(72.10%) 1(0.96%) 28(26.90%)

HIV/AIDS Prevented By Blood/Blood Products Tested For HIV 76(73.10%) 0(0.00%) 28(26.90%)

HIV/AIDS transmission can occur By Sexual Intercourse Without A

Condom 84(80.80%) 0(0.00%) 20(19.20%)

HIV/AIDS transmission can occur by Infected blood/blood products 77(74.00%) 0(0.00%) 27(26.00%)

HIV/AIDS transmission can occur By Needles Syringes Infected With HIV 75(72.10%) 1(0.96%) 28(26.92%)

HIV/AIDS transmission can occur from Mother To Child During

Pregnancy 65(62.50%) 7(6.70%) 32(30.80%)

HIV/AIDS transmission can occur from Mother To Child During delivery 48(46.20%) 12(11.50%) 44(42.30%)

HIV/AIDS transmission can occur from Mother To Child through breast

milk 52(50.00%) 9(8.70%) 43(41.30%)

Table 3 Misconceptions Regarding HIV/AIDS

transmission

Misconceptions Regarding HIV/AIDS transmission

Yes (%) No (%)

Don’tknow

(%)

Person Get Infected By

Kissing On The Mouth 22(21.2) 16(15.4) 66(63.5)

Person Get Infected

By Mosquito Bites 23(22.1) 34(32.7) 47(45.2)

Person Get Infected By

Sharing A Common

Toilet 12(11.5) 39(37.5) 53(51)

Person Get Infected

By Bug Bites 15(14.4) 38(36.5) 51(49)

Table 4: Reported symptoms of STI/RTIs in studyparticipants

Reported Symptoms of STI/RTIs No. (%)

Urethral discharge 22 (31.42%)

Burning Micturition 42 (41.20%)

Genital ulcers 8 (7.69%)

Itching In Genital Area 33 (32.40%)

Inguinal Lymph nodes 17 (16.70%)

Chronic Lower Abdominal Pain 9 (8.80%)

Vaginal Discharge 21(61.76%)

DISCUSSION

The education status of study participants shows that

nearly 38(40%) of participants were illiterate, and only

4(3.84%) had studied beyond secondary school. Lack of

formal education may be one of possible causes of

migrating to Mumbai and it may influence sexual

behaviour choices. In National Behavioural Surveillance

Survey, 2006 carried out by NACO, it was seen that level

of awareness about HIV / AIDS was lower in illiterates

(45.8%) as compared to primary (77.7%), middle (91.6%),

secondary and higher secondary (98.2%) and graduate

and above (99.8%).[7]

As seen in table 2; by studying responses regarding the

existence of a cure for AIDS, 13.4% of participants thought

there is a cure for HIV/AIDS at present; almost similar to

12% and 14 % participants seen in other studies.[8, 9]

A

considerable knowledge gap is seen among study

participants as 30(29%) of participants do not have anyknowledge about prevention and transmission of

HIV/AIDS. Similarly in a study[10]

in 13 states of India, low

rates of knowledge and awareness were reported more

among rural women. This could be associated with lack of

formal education and media exposure. A study done

among slum-dwellers in another metropolitan city of India[11]

showed 67% males and 55% females were aware of

the sexual mode of transmission, as compared to 84% in

our study population.

About one fifth of the study population had misconceptions

regarding HIV/AIDS transmission as seen in table 3. Only

23% of participants in our study thought AIDS could

spread through mosquito bites, as compared to45% malesand 62% females in the above study.

[11]

Since Information education and communication (IEC)

strategies are important as components of behaviour

change in HIV/AIDS prevention among the general

population; possible interventional areas to address the

knowledge gap could be consistent involvement of visual

and print media, health education at each level of their

interaction with the formal health system along with

involvement of informal health care providers (unqualified

practitioners). Health education through all the above

channels may also dispel misconceptions regarding

HIV/AIDS transmission and act also aid in reducing stigmaand discrimination against people living with

HIV/AIDS(PLHA) in families and general population.

Age at first sexual intercourse was less than 21 years for

85(81.70%) of participants which includes the 12-16 years

age group in 23(22.10%) participants, similarly is also

seen in other studies.[12]

This observation may lead to

suggestion of initiation of sex education/family life

education both in formal and informal setups at an earlier

age group possibly at eight to nine years of age. In

informal setups; for out of school children different

strategies may have to be explored for e.g. peer

facilitators, adolescent groups for girls etc.

On exploring the reasons for not using condoms, 9(8.70%)

revealed they had no knowledge of how to use a condom,

indicating further strengthening of IEC and health


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education component. Cultural beliefs might moderate the

way in which STI/HIV is perceived and therefore

addressed in that particular context.[13]

Addressing risky

sexual practices such as early sexual debut is one

strategy which could lead to lower risk for RTI/STIs and

HIV/AIDS among slum dwellers.

Reported symptoms of STI were seen in both males

(31.4%) and females (61.76%), compared to a study in

Nigeria[14] where 27% of males and 10% of females

reported symptoms of STI/RTIs .Women are more

vulnerable to RTI/STIs. Out of 47(45.20%) study

participants who did not know how they would protect

themselves if their partner had symptoms of STI/RTIs, 30

(88.23%) were women. Teaching assertiveness skills in

sexual and reproductive health areas for women in slums

can an important interventional area.

Lack of awareness of symptoms of STI/RTIs coupled with

less priority given to women and their health could be

possible reasons for high reported prevalence seen in

women participants.

CONCLUSION

Urban slum residents in Mumbai have knowledge gap

regarding HIV/AIDS transmission and prevention. Initiation

of sexual intercourse is at an early age, they report

symptoms of STI/RTI and are making unsafe sexual

behavioural choices. These findings highlight the need to

possibly treat slum residents as a sub-population

vulnerable to reproductive health problems and may

require allocation of more/special innovatively packaged

resources for interventions in slums. At individual level, the

interventions would focus on behaviour change; aimed at

HIV / AIDS prevention and at community level they may

focus on raising awareness and reducing stigma regarding

both STI/RTI and HIV/AIDS, thus empowering

communities in fighting the battle against HIV/AIDS.

ACKNOWLEDGMENT: Nil

Conflict of Interest: Nil

REFERENCES

1. International Institute for Population Sciences (IIPS)

and Macro International. 2007. National Family Health

Survey (NFHS-3), 2005–06: India: Volume I. Mumbai:

IIPS.

2. AIDS control program. http://www.naco.gov.in/

NACO/National_AIDS_Control_Program/Prevention_

Strategies/ [Last accessed on March30 2015]

3. http://www.unaids.org/en/regionscountries/countries/i

ndia[Last accessed on February 28 2015]

4. http://www.worldbank.org/en/news/feature/2012/07/10

/hiv-aids-india[Last accessed on March30 2015]

5. Madise N. J. Are slum dwellers at heightened risk of

HIV infection than other urban residents? Evidence

from population-based HIV prevalence surveys in

Kenya. Health Place. 2012;18(5): 1144–152.

6. K. Park, Epidemiology of Communicable Diseases,

Parks Textbook of Preventive and Social Medicine,

22ndedition M/S Banarasidas Bhanot publishers;2013;

399-05.

7. National Behavioral Surveillance Survey – General

population. National AIDS Control Organization,

Ministry of Health and Family Welfare, Government of

India. 2006;36:108

8. Unnikrishnan B, Mithra PP, T R, B R. Awareness and

attitude of the general public towards HIV/AIDS in

Coastal Karnataka. Indian J Community

Med. 2010;35:142–6.

9. Sobhan K, Kumar TS, Kumar GS, Ravikanth R,

Adarsha S, Mohammad AS, et al. HIV and AIDS:

Awareness and attitudes among males in a rural

population. Indian J Community Med 2004;29:141 -2.

10. Balk D, Lahiri S. Awareness and knowledge of AIDS

among Indian women: Evidence from 13 States.

Health Transit Rev. 1997; 7:421-65

11. Kalasagar M, Sivapathasundharam B, Einstein T,

Bertin A. AIDS′s awareness in an Indian metropolitan

slum dweller: A KAP (knowledge, attitude, practice)

study. Indian J Dent Res 2006;17:66-9.

12. Zulu E, Dodoo F, Ezeh A. Sexual risk-taking in theslums of Nairobi, Kenya, 1993–98. Population

Studies. 2002;56(3):311–23

13. UNESCO UNAIDS: Handbook appropriate

communication for behavior change:

Information/Education/Communication. A cultural

approach to HIV/AIDS Prevention and

Care.2001. http://unesdoc.unesco.org/images/0012/0

01255/125589e.pdf.

14. Adedimeji AA, Omololu FO, Odutolu O. HIV risk

perception and constraints to protective behaviour

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Health, Popu & Nutri.2007; 13(2):146–57.


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Phatak et al., Int J Med Res Health Sci. 2015;4(4):744-748



COST ANALYSIS OF LONG ESTABLISHED AND NEWER ORAL ANTIEPILEPTIC

DRUGS AVAILABLE IN THE INDIAN MARKET

*Phatak Abhishek M1, Hotwani Jitendra H

2, DeshmukhKiran R

3, Panchal Sagar S

1, Naik Madhura S

1

INTRODUCTION

Epilepsy is a chronic non-communicable disorder of the

brain that affects people of all ages often interfering with

education and employment. Epilepsy is defined by

International League Against Epilepsy (ILAE) as a

condition characterized by recurrent (two or more)

epileptic seizures, unprovoked by any immediate

identified cause.[1]

According to the World Health

Organization (WHO), of the 50 million people with

epilepsy worldwide, 80% reside in developing countries.[2]

It is estimated that there are more than 10 million persons

with epilepsy in India. Its prevalence is about 1% in Indian

population.[3]

The prevalence is higher in the rural (1.9%)

compared to urban population (0.6%).[4,5]

The estimated

burden of epilepsy using the disability adjusted life years

(DALYs) accounts for 1% of the total burden of disease in

the world, excluding that due to social stigma and

isolation, which further add to the disease burden.[6]

In many developing countries, people with epilepsy do not

receive appropriate treatment for their condition, a

phenomenon called treatment gap (TG), which is defined

as the number of people with active epilepsy not on

treatment (diagnostic and therapeutic) or on inadequatetreatment, expressed as a percentage of the total number

with active epilepsy.[7]

The magnitude of epilepsy

treatment gap in India ranges from 22% among urban,

middle-income people to 90% in rural India.[8]

In order to reduce this gap in the context of limited

resources, it would be necessary to specify the important

causes of gap for a particular community and the most

cost-effective resource

for a particular situation.[9,10-12]

The Indian pharma market

size is expected to grow to US$ 85 billion by 2020. The

growth in Indian domestic market will be on back of

increasing consumer spending, rapid urbanization, and

raising healthcare insurance and so on.[13]

The cost of drug plays a crucial role in patients care

especially in developing countries and constitutes an

essential part of rational drug prescription. In recent years

more emphasis has been given on cost effective practice

which should be adopted by clinicians. Cost of drugs is an

important factor influencing compliance with treatment.[14]

The epileptic seizures are a common disorder for which

patients have to take medication for a prolonged period,

sometimes even life-long. It is necessary for the clinicians

to prescribe most effective, appropriate and economical

treatment regimen available.Estimation of the economic burden of epilepsy is of pivotal

relevance to enable a rational distribution of healthcare

resources. Being one of the common brain disorders with

ABSTRACT

Background: Large number of pharmaceutical companies manufactures

antiepileptic drugs in India. The price variations among the marketed drugs are

wide. Aims: The present study was aimed to find the cost of different oral

antiepileptic drugs available in Indian market as monotherapy, combination

therapy and number of manufacturing companies for each, to evaluate

difference in cost of different brands of same dosage of same active drug by

calculating percentage variation of cost. Methods and Materials: Cost of a drug

being manufactured by different companies, in the same strength and dosage

forms was obtained from “Indian Drug Review” Vol. XXI, Issue No.4, 2014 and

“Current Index of Medical Specialties” July-October 2014. The difference in the

maximum and minimum price of the same drug manufactured by different

pharmaceutical companies and percentage variation in price was calculated.

Results: The percentage price variation noted of long-established drugs was –

Phenytoin (50mg): 140%, Carbamazepine (100mg): 1033%, Phenobarbital

(30mg) : 730%, Valproic acid (300mg) : 420%. Newer drugs –Levetiracetam

(250mg): 75%, Lamotrigine (25mg): 66%, Topiramate (50mg): 108%,

Zonisamide (100mg): 19%. Combination drugs – Phenobarbital + Phenytoin

(30+100) mg: 354.55%. Conclusion: The percentage price variation of different

brands of the same commonly used long-established oral antiepileptic drug

manufactured in India is very wide. The formulation or brand of Antiepileptic

drugs (AEDs) should preferably not be changed since variations in

bioavailability or different pharmacokinetic profiles may increase the potential for

reduced effect or excessive side effects. Hence, manufacturing companies

should aim to decrease the price variation while maintaining the therapeutic

efficacy.

ARTICLE INFO

Received: 2nd May 2015Revised : 14th July 2015Accepted: 29th July 2015

Authors details: 1Third Year Junior Resident, 2 Associate Professor, 3SecondYear Junior Resident, Department of Pharmacology, Topiwala NationalMedical College and B. Y. L. Nair Charitable Hospital, Mumbai Central,Mumbai, Maharashtra, India

Corresponding author: Phatak Abhishek M.

Topiwala National Medical College and

B. Y. L. Nair Charitable Hospital,

Mumbai Central, Maharashtra, India


Keywords: Therapeutic drug

monitoring, Bioavailability,

Carbamazepine, Topiramate. Treatment

gap


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varying etiologies, which can present at any age, requiring

prompt therapy and with the aim to promote rational

pharmacotherapy we decided to study the cost of different

brands of antiepileptic drugs available in Indian market.

MATERIALS AND METHODS

Study design: This was an analytical study.

Exclusion criteria: The drug formulation being

manufactured by only one company was excluded.The study was conducted by the Department of

Pharmacology, Topiwala National Medical College &

B.Y.L. Nair Charitable Hospital, Mumbai.

Methodology: Price in Indian rupees (INR) of oral

antiepileptic drugs manufactured by different

pharmaceutical companies in India, in the same strength

was obtained from “Indian Drug Review” (IDR) Vol. XXI,

Issue No.4, 2014 and “Current Index of Medical

Specialties”(CIMS)(15)

July-October 2014. The prices of 18

oral antiepileptic drugs (16 single and 2 combinations),

available in 56 different formulations were analyzed.

Cost of the oral antiepileptic drug formulation was

calculated for an average of 10 tablets as the number of tablets available per strip varied. Difference in the

maximum and minimum price of the same drug

formulation manufactured by different pharmaceutical

companies and percentage variation in price was

calculated.

Percentage cost variation was calculated as follows:[14]

%CV= Price of most expensive brand– least expensive brand × 100

Price of least expensive brand

(CV= Cost variation)Statistical analysis: Findings of our study were

expressed as absolute numbers as well as percentage.

RESULTS

Table 1 shows variation in cost of long - established oral

antiepileptic drugs used as a single drug therapy. The

percentage variation noted in the cost was -

Carbamazepine (100 mg): 1033%, Phenobarbital (30 mg):

730%, Valproic acid (300 mg): 420%, Divalproax sodium

(500 mg): 378% and Diazepam (5 mg): 374%.

Table 2 shows variation in cost of oral antiepileptic drugs

used in combination. The percentage variation noted in

the cost was Sodium valproate + Valproic acid (333+145

mg): 76.67%, Phenobarbital + Phenytoin (30+100 mg):

354.55%.

Table 3 shows variation in cost of newer oral antiepilepticdrugs used as single drug therapy. The percentage

variation noted in the cost was - Pregabalin (75 mg):

143%, Topiramate (50 mg): 108%, Levetiracetam(250

mg): 75%, Oxcarbazepine (150 mg): 59%.

Table 1: Price variation in long-established oral antiepileptic drugs

Drug Formulation Doses(mg) No.of Manuf.Companies

Minimum price(INR)

Maximum price(INR)

% Pricevariation

Carbamazepine 4 100 13 6.18 70.00 1033

200 22 11.17 120.00 974

300 5 18.24 28.28 55

400 11 24.24 37.71 56

Phenytoin 3 50 3 7.49 18.00 140

100 9 8.36 21.10 152300 2 50.19 56.66 13

Phenobarbitone 2 30 3 4.95 41.08 730

60 3 8.25 28.02 240Divalproexsodium

7 125 7 17.00 30.30 78250 21 24.00 84.00 250

500 25 32.00 153.00 378

750 9 85.00 106.05 25

1000 6 99.00 115.00 16

200 3 29.50 35.00 19

300 3 41.00 55.00 34

Valproic acid 3 200 15 19.50 42.00 115300 8 25.90 56.00 420

500 9 39.90 93.00 133Diazepam 3 2 3 12.65 20.20 60

5 9 7.00 33.21 37410 8 11.75 40.85 248

Lorazepam 2 1 11 7.80 30.00 285

2 10 10.59 35.00 230

Clonazepam 4 0.25 9 7.00 16.25 132

0.5 23 9.63 45.00 367

1 13 12.50 37.00 1962 16 31.68 67.00 111

Clobazam 3 5 9 23.00 53.52 133

10 9 43.00 106.37 147

20 4 79.90 146.00 83


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INR: Indian rupees. The prices of 18 oral antiepileptic drugs (16 single and 2 combinations), available in 56 different

formulations were analyzed.

Table 2: Price variation among combination therapy

Drug Formulation Doses

(mg)

No of Manufa.

Companies

Minimum

price (INR)

Maximum price

(INR)

% Price

variation

Na valproate+

valproic acid

2 200+87 7 36.50 62.50 71.23

333+145 7 60.00 106.00 76.67Phenobarbital+

phenytoin

1 30+100 3 6.60 30.00 354.55

INR: Indian rupees, Na: sodium

Table 3: Price variation in newer oral antiepileptic drugs

Drug Formulation Doses

(mg)

No. of

Manufacturing

Companies

Minimum price

(INR)

Maximum price

(INR)

% Price

variation

Lamotrigine 3 25 4 30.00 50.00 66

50 7 54.50 90.00 65

100 7 98.00 158.00 61

Gabapentin 3 100 3 36.20 44.00 22

300 10 98.75 131.00 33

400 5 119.50 152.00 27

Pregabalin 3 50 2 58.20 59.00 1

75 17 56.83 138.00 143

150 14 114.14 169.00 48

Topiramate 3 25 4 19.00 38.00 100

50 4 36.00 75.00 108

100 2 108.00 158.00 46

Levetiracetam 4 250 5 55.00 96.00 75

500 5 110.00 189.00 72

750 4 168.00 280.00 67

1000 2 290.00 360.00 24

Zonisamide 2 50 2 57.00 59.40 4

100 3 87.79 104.70 19

Oxcarbazepine 4 150 11 26.39 42.00 59

300 12 48.33 75.00 55

450 2 110.00 120.00 9

600 10 90.00 134.00 49

INR: Indian rupees

DISCUSSION

The epilepsies are a spectrum of brain disorders rangingfrom mild, benign forms to severe, life-threatening and

disabling ones. Epilepsies can occur in children, adults

and the elderly, as well as following brain trauma, stroke,

and brain tumors. There is lack of sufficient data in India

comparing the cost of the same antiepileptic drug sold

under different brand names by different pharmaceutical

companies.[15]

The drug prices available in CIMS and IDR were

compared as they are one of the available sources of

drug information that are updated on a regular basis.

In our study, we have found that there were 56

formulations of antiepileptic drugs of which 31 were of

long-established antiepileptic drugs, 22 of newer and 3 of

combination drugs. So it is not practically possible for any

health care provider to remember the prices of all thesebrands.

Variations in costs were found to be significant. The ones

with significant variations were the cost of the brands of

Carbamazepine 100mg varied from Rs.6.18 to Rs.70.00;

Phenobarbital 30mg varied from Rs.4.95 to Rs.41.08.

Valproicacid 300mg cost varied from Rs.25.90 to Rs.

56.00. Among newer antiepileptics, Pregabalin 75mg

varied from Rs.56.83 to Rs. 138.00; Topiramate 50 mg

cost varied from Rs. 36.00 to Rs. 75.00. Among the

combination therapy, Phenobarbital + Phenytoin (30

mg+100 mg) showed maximum price variation i.e.

354.55%.

Thus, in our study of cost-analysis of various anti-epileptic

brands, it has been observed that there is substantial

variation in the cost of different brands of same generic


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drugs. Anand Krishnan, Ritvik, DebashishChowdhary

(2007) have also observed a lot of variation in the cost of

anti-epileptic drugs.[16]

Findings of our study is similar to

their studies. The intrabrand comparison of newer anti-

epileptic drugs also showed wide variation in the cost. Our

study is in agreement with the study of Beghi, Ettore, et al

(2008) as they have noticed a higher cost of newer anti-

epileptic drugs.[17]

The reasons for this price variation could be as follows- [18]

1. Government regulations and pricing policies

2. The existing market structure of the pharmaceutical

industry

3. Industry costs

Drugs are the mainstay of treatment for epilepsy, and are

effective for most patients. It is switching from brand-

name to generic antiepileptic or from one generic

antiepileptic to another that should be avoided in clinical

practice, since subtle differences in bioavailability may

disturb optimal degree of seizure control to which the

patient was previously successfully titrated.[19]

Even using

a parent compound, antiepileptic medication levels canfluctuate if the product source has changed, resulting in

toxicity.[20]

In this regard, therapeutic drug monitoring

becomes essential specially for phenytoin since it has

narrow therapeutic index. It is vital therefore those

patients should receive the same brand consistently to

avoid loss of control.

In India, a large number of patients are not covered under

any individual or government medical insurance. Hence,

the patients have to purchase the prescribed drugs by

themselves. These wide variations in the prices of

different formulations of the same drug have severe

economic implications on the Indian Population.

The Government of India has unveiled ’Pharma Vision2020’ aimed at making India a global leader in end-to-end

drug manufacture. It has reduced approval time for new

facilities to boost investments. Further, the government

has also put in place mechanisms such as the Drug Price

Control Order (DPCO) and the National Pharmaceutical

Pricing Authority (NPPA) to address the issue of

affordability and availability of medicines.

There are few antiepileptic drugs included in The National

list of essential medicines but still there are many drugs

especially the newer antiepileptic drugs such as

oxcarbazepine, topiramate etc. having better safety,

efficacy profile but not included in the list.

[21-24]

Limitations of this study: Being sources of information

were limited to IDR and CIMS. There are various other

brands which are marketed in India but not published in

the above mentioned sources. Also we have not

assessed the prices of parenteral preparations.

CONCLUSION

The percentage price variation of different brands of the

same antiepileptic drug manufactured in India is very

wide. Considering the prevalence of epilepsy especially in

rural India where there are limited resources and poverty,

providing a broad overview of available antiepileptic drugs

and their prices is of utmost importance.There should be

education programs and marketing strategies so that

prescribers can select proper medication for their patients

which is cost-effective, tolerable as well as efficacious in

accordance to the principles of rational pharmacotherapy.

Acknowledgment: We Acknowledge Department of

Pharmacology and Central library, Topiwala National

Medical College & B.Y.L. Nair Charitable Hospital,

Mumbai, for their support.

Source of Support: Nil

Conflict of Interest: NoneREFERENCES

1. Hauser WA, Kurland LT. The epidemiology of

epilepsy in Rochester, Minnesota. Epilepsia. 1975;

16:1-66.

2. WHO. Neurological Disorders: Public Health

Challenges. Geneva: World Health Organization;

2006.

3. Sridharan R, Murthy BN. Prevalence and pattern of

epilepsy in India. Epilepsia. 1999; 40:631-636.

4. Leonardi M, Ustun TB. The global burden of epilepsy.

Epilepsia. 2002; 43(6):21-25.5. Pahl K, de Boer HM. Epilepsy and rights. Atlas:

Epilepsy Care in the World. Geneva: WHO; 2005:72-

73.

6. Jain S, Satishchandra P. Epilepsy: A Comprehensive

Textbook. . In: Engel J Jr, Pedley TA, editors. New

York: Cambridge University Press, Lippincott

Williams and Wilkins; 2008. pp. 2885-2889.

7. Meinardi H, Scott RA, Reis R, Sander JW. ILAE

Commission on the Developing World. The treatment

gap in epilepsy: The current situation and ways

forward. Epilepsia. 2001; 42:136-149.

8. Meyer AC, Dua T, Ma J, Saxena S, Birbeck G. Global

disparities in the epilepsy treatment gap: Asystematic review. Bull World Health Organ. 2010;

88:260-266.

9. Bharucha NE, Bharucha EP, Bharucha AE, Bhise

AV, Schoenberg BS. Prevalence of epilepsy in the

Parsi community of Bombay. Epilepsia. 1988;

29:111-115.

10. Koul R, Razdan S, Motta A. Prevalence and pattern

of epilepsy (Lath/Mirgi/Laran) in rural Kashmir, India.

Epilepsia. 1988; 29:116-122.

11. Mani KS. Epidemiology of epilepsy in Karnataka,

India. Neurosci Today. 1997; 1:167-74.

12. Pal DK. Methodological issues in assessing riskfactors for epilepsy in an epidemiologic study in India.

Neurology. 1999; 53:2058-2063.

13. Consolidated FDI Policy, Department of Industrial

Policy & Promotion (DIPP), Press Information Bureau

(PIB), Media Reports, Pharmaceuticals Export

Promotion Council. Available from

[accessed on 25 April, 2015]

14. Ravi Shankar P, Subish P, Bhandari RB, Mishra P,

Saha AC. Ambiguous pricing of topical

dermatological products: A survey of brands from two

South Asian countries. Journal of Pakistan

Association of Dermatologists. 2006; 16:134-140


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15. Jadhav NB, Bhosale MS, Adhav CV. Cost analysis

study of oral antidiabetic drugs available in Indian

market. Int J Med Res Health Sci. 2013; 2(1): 63-69.

16. Sridharan R. Epidemiology of epilepsy. Current

Science. 2002; 82:664-670.

17. Goel D, Agarwal A, Dhanai JS, Semval VD, Mehrotra

V, Saxena V, et al. Comprehensive rural epilepsy

surveillance programme in Uttarakhand state of India.

Neurol India. 2009; 57:355-356.18. Banerjee TK, Ray BK, Das SK, Hazra A, Ghosal MK,

Chaudhuri A, et al. A longitudinal study of epilepsy in

Kolkota, India. Epilepsia. 2010; 51:2384-2391.

19. Jancovic SM, Ignjatovic RD, Is bioavailability altered

in generic versus brand anticonvulsants? Expert

Opinion on Drug Metabolism Toxicology. 2015;

11(3):329-332.

20. Patel V, Cordato DJ, Dias M, Beran RG, Changed

constitution without change in brand name--the risk of

generics in epilepsy. Epilepsy Research. 2012; 98(2-

3):269-272.

21. National Pharmaceutical Pricing Authority,Government of India. Available at

http://www.nppaindia.nic.in/

DPCO2013.pdf.[Accessed on 18 April 2015].

22. National Pharmaceutical Pricing Authority,

Government of India, Current Price list. Available at

http://www.nppaindia.nic.in/ceiling/press28april14/so1

156e-28-4-14.html.[Accessed 18 April 2015].

23. National List of Essential Medicines of India.

Available at: http://www.mohfw.nic.in/WriteReadData/

l892s/7364497513National%20List%20of%20Essenti

al%20Medicine,%202011.pdf.[Accessed 18 April

2015].

24. Rang HP, Ritter JM, Flower RJ, Henderson G,

Rang& Dales Pharmacology. 7th

edition, Elsevier

Churchill Livingstone, Spain; 2012, pp. 540-552.


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Saaka et al., Int J Med Res Health Sci. 2015;4(4):749-755



ROLE OF DIETARY DIVERSITY IN ENSURING ADEQUATE HAEMATOLOGICALSTATUS DURING PREGNANCY

Mahama Saaka1

Abdulai Abdul Rauf 2

INTRODUCTION

In most developing countries maternal under nutrition

including micronutrient deficiencies is a leading cause of

maternal and child mortality and morbidity[1]. Anaemia in

particular is one of the most prevalent public health

problems in Ghana. Anaemia is defined as a condition in

which the number and size of red blood cells or

haemoglobin concentration falls below an established cut

-off, consequently impairing the capacity of the blood to

transport oxygen around the body[2]

. According to recent

estimates, anaemia affects 60.0% pregnant women in

developing countries including Ghana and about 7.0 % of

cases are severe[3,4]

.

The aetiological factors responsible for anaemia in

pregnancy are multiple and their relative contributions are

said to vary by geographical area and by season[5]

. Admittedly, several predisposing factors contribute to

anaemia among pregnant women and these include socio-

demographic, socio-economic status, multiparity, short

inter-pregnancy intervals and nutritional factors[6]

. The

relative importance of each of these varies from place to

place. In the Northern Region of Ghana, where anaemia is

of public health significance, very little is documented

regarding the role maternal dietary factors contribute to

haematological status. The role of diet on blood

biomarkers may be significant, but evidence of the

magnitude of this benefit is limited.

An understanding of association between dietary diversity

and haematological status may be complicated by other

factors including malarial infection and household socio-

economic status. This study sought to determine the

independent contribution of dietary diversity to

haematological status of pregnant women whilst

controlling for potential confounding factors. We

hypothesized that diversified diets during pregnancy would

be associated with better haematological status compared

to nutrient-poor diets.

MATERIAL AND METHODS

Study design: This study was analytical cross-sectional

design from January- March 2013.

Sample size: 307 was calculated using single population

proportion formula assuming the prevalence of all types of

anaemia among pregnant women in Northern Region was

estimated as 73.0 %[7]

, confidence interval 95%, margin

of error 5.0 %. Systematic random sampling procedurewas used to select the study participants. The attendance

list of the women who sought ante-natal care services

served as the sampling frame.

Ethical approval: The protocol for this study was

approved by the School of Medicine and Health Sciences,

University for Development Studies. Informed consent was

obtained from all study participants. Information about

objective of the study, procedures, potential risks, and

benefits was given to mothers before they were enrolled to

the study. Their full right to refuse participation was

explained. Written informed consent was obtained from

each mother/caregiver.Inclusion criteria: The study population comprised

pregnant women who sought antenatal care at four major

ABSTRACTIntroduction: Though nutrition is a key input to blood formation, little is

known about the extent maternal dietary quality contributes to the

haematological status of pregnant women in Northern Region of Ghana.

Objective: The aim of this study was to assess the independent

contribution of dietary diversity to haematological status of pregnant women

whilst controlling for potential confounding factors including malarial

infection. Methods: A cross-sectional study design was used on a sample

of 307 pregnant women in their third trimester. A structured questionnaire

was used to collect socio-demographic characteristics, obstetric and dietary

data related to anaemia. Overall dietary quality was assessed using the

dietary diversity score. Haemoglobin concentration (Hb) was measured

using portable HemoCueR Hb 301 system. Predictors of anaemia were

estimated using multiple linear regression analysis. Results: The mean Hb

was 10.8±1.4 g/dl and prevalence of anaemia (Hb


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hospitals in Tamale Metropolis of the Northern region of

Ghana.

Data Collection; The study participants were recruited in

their third trimester (34-36 weeks gestation). Study

participants were then interviewed face-to-face by the

investigators. A pre-tested questionnaire was used to

collect information including haemoglobin concentration,

blood pressure, weight, maternal age, parity, gestational

age, level of education and occupation of the women,

history of malarial infection in the index pregnancy (self-

reported fever or laboratory-tested), presence of any

chronic illnesses, and prophylactic medications received

during pregnancy. Standard procedures were followed for

the recording of blood pressure and weight.

Independent and dependent variables

The main outcome variable for this study was the

prevalence of anaemia (Hb less than 11 g /dl). The

independent variables for this study were maternal, child

and household characteristics including antenatal care

(ANC) attendance, malarial infection, maternal dietary

intake. A brief description of main independent and dependent

variables is as follows:

Diagnosis of anaemia : Haemoglobin concentration

levels were measured in late pregnancy (gestational age

≥34 weeks) using a portable haemoglobinometer made by

HemoCue® Hb301. Capillary blood was collected from

participants using a finger prick method under sterile

conditions. The first drop of blood was wiped away using

alcohol sterile wipes, and the next drop was placed into

the Hemocue curvette for immediate testing of

haemoglobin. Women were classified as anaemic if they

had a haemoglobin concentration less than 11 g/dL.

Anaemia was further classified as mild (9.0-10.9 g/dL),

moderate (7.0-8.9 g/dL) or severe (


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mothers was 27.2±4.0 years which ranged from 18 to 38

years. Majority (75.2%) of the respondents were Muslims.

Majority, 245 (79.8%), of the respondents were married

and (47.9 %) of the mothers had no formal education at

all. Petty trading was common among the mothers and

most of the participants (67.1%) were multigravida (Table

1).

Table 1: Sample Characteristics (N =307)

Frequency (n) Percentage (%)

Religion

Islam 231 75.2

Christianity 76 24.8

Classification of occupation

None 97 31.6

Petty trader 108 35.2

Farmer 72 23.5

Civil Servant 30 9.8

Tribe

Dagomba 180 58.6

Gonja 36 11.7

Mamprusi 34 11.1

Nanumba 28 9.1

Akan 12 3.9Others 17 5.5

Education level of mother

None 147 47.9

Primary 41 13.4

JSS/Middle 50 16.3

Secondary 47 15.3

Tertiary 22 7.2

Marital status

Single 62 20.2

Married 245 79.8

Gravidity

Primigravida 32 10.4

Secundigravida 69 22.5Multigravida 206 67.1Magnitude of Anaemia: The mean hemoglobin level was

about 10.8±1.4 g/dL which ranged from 7.3 g/dL to

14.3 g/dL. The prevalence of anaemia was 46.3%. In

terms of severity, mild anaemia was 34.9 %, moderate

anaemia was 11.4 % but there were no cases of severe

anaemia.

Factors Associated with Anemia: Bivariate analyses

were performed to assess association of socio-

demographic and other maternal factors with child anemia

(Table 2). There was an inverse relationship between the

prevalence of anaemia and the level of education of the

women. This means the proportion of anaemic womendecreased with increased in the level of education.

Anaemia was significantly more common in women of

lower household wealth index. As maternal 7-day dietary

diversity increased, the prevalence of anaemia decreased.

As the number of sulfadoxine-pyrimethamine (SP) doses

increased the prevalence of malaria decreased.

Dietary Diversity and Food Group Frequency

Consumption

In late pregnancy, the minimum dietary diversity (that is,

proportion of women who receive foods from 5 or more

food groups in seven days was 85.5 %. The mean dietary

diversity score (DDS) from 11 food groups was 9.1±1.4.

The mean food group frequency of consumption (past 7

days) was 15.0±2.8. The minimum and maximum of the

food group frequency of consumption index scores were

6.0 and 22 respectively. More than half of the pregnant

women (52.8%) were on low diversified diet as measured

by DDS over a period of one week. A significant proportion

of the pregnant women rarely consumed dairy products

and eggs though over 80 % of consumed cereals and

roots & tubers on a daily basis (Table 3).

Table 2a: Bivariate Analysis of predictors of anaemia

among pregnant women

Characteristic

N Anaemia

No n (%)

Yes n (%)

Teststatistic

Maternal Education

None 147 78 (53.1) 69(46.9) χ =15.2p= .001Low 91 36 (39.6) 55(60.4)

High 63 45 (71.4) 18(28.6)Religion of mother

Islam 227 110(48.5) 117(51.5) χ = 7.1p=.008Christianity 74 49 (66.2) 25(33.8)

Marital status

Single 60 23 (38.3) 37(61.7)

Married 241 136(56.4 ) 105(43.6) χ = 6.3p=.012

Malarial infection

None 45 30 (66.7) 15 (33.3) =14.5p=0.0011-2 times 223 121(54.3) 102(45.7)

3-4 times 33 8 (24.2) 25 (75.8)

Maternal 7-day dietary diversity

Low 162 71 (43.8) 91 (56.2) χ =11.4p=.001

High 139 88 (63.3) 51 (36.7)

Table 2b: Bivariate Analysis of predictors of anaemia

among pregnant women

Characteristic

N Anaemia

No

n (%)

Yes

n (%)

Teststatistic

Household wealth index

Low 160 71 (44.4) 89 (55.6) χ = 9.7

p =

0.002High 141

88 (62.4) 53 (37.6)

ANC visit


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3 doses 111 65 (58.6) 46(41.4) 0.012

Table 3: Food groups consumption frequency in the past week (n= 307)

Frequency of foods consumption in the past week (% of women)

Type of food Usually every day 4 to 6 times per week 1- 3 times per week Never/rarely

Meat 58.0 34.2 7.2 0.7

Poultry 2.3 19.2 50.8 27.7

Liver 14.3 43.0 53.8 6.8

Fish 18.6 30.6 41.7 9.1Cereals 97.1 2.3 0.7 0.0

Roots & tubers 84.7 11.7 1.3 2.3

Legumes 58.0 34.9 7.1 0.0

Dairy products 2.0 22.8 45.0 30.2

Eggs 4.2 16.3 39.4 40.1Fruits 22.5 30.6 36.2 10.7

Green leafy vegetables 37.5 44.6 14.3 3.6

Table 4: Determinants of Hb in the third trimester of pregnancy

Model StandardizedCoefficients

Sig. 95.0% Confidence Intervalfor (β)

CollinearityStatistics

Beta (β) Lower Bound Upper Bound Tolerance VIF

(Constant) 7)

0.239


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past research that showed a high prevalence of anaemia

among women in Northern Ghana[7,17,18]

.

Most of the women in this study had anaemia of mild to

moderate severity with no case being severely anaemic.

These findings are similar to the findings from other

studies in which 47.5 % of women aged 15-49 years had

some form of anaemia[17]

.

Dietary diversity and haematological status: The

results of this study showed that high maternal dietary

diversity was associated with reduced risk of anaemia and

so nutritional factors may be important. This finding is

consistent with that of similar studies carried out

elsewhere in India, where low dietary intake of multiple

micronutrients, but higher intakes of nutrients that inhibit

iron absorption such as calcium and phosphorus, may

help explain high rates of maternal anaemia[19]

.

It has earlier been reported that some pregnant women do

restrict dietary intake in order to have smaller babies, and

therefore easier deliveries[20,21]

. In Ethiopia, women with

restrictive dietary habits were reported of 39 % higher risk

of anaemia compared to those without restrictive dietary

behavior [22]

and where maternal dietary diversity wasprotective of pregnancy anaemia

[23,24]. Studies conducted

in Pakistan and Turkey also reported that consumption of

fruit two or more times per week is associated with a

decreased risk of anemia[25,26]

.

Diet is an important factor for anaemia, as some eating

patterns or habits may predispose individuals to a higher

risk for developing anaemia. For example, high fibre diets

can inhibit the absorption of iron; low fat diets can equally

inhibit iron absorption since fat is needed for iron

absorption, high tea and coffee consumption but without

vitamin C intake inhibits iron absorption. Poor dietary

diversity leads to deficiency of minerals and vitamins

which may increase bio-availability of iron then affects Iron

status[27]

.

Dietary diversity is considered to be a key indicator for

assessing the access, utilization, and quality of diet of

individuals or household[28]

. Individual dietary diversity

scores have been shown to indicate adequate nutrient

intake through diet and it can be used as a proxy indicator

for measuring nutrient adequacy among pregnant females[29]

.

A pregnant woman’s diet that lacks diversity is most likely

to be deficient in essential nutrients and as a result the

foetus will not be provided the nutrition it requires to have

a healthy growth[30]

. Women’s dietary behaviours andintake during pregnancy are strongly influenced by

different cultural practices, myths and taboos[31,32]

.

During pregnancy, dietary energy and nutrient

requirements are generally increased to support increased

maternal metabolism, blood volume and red cell mass

expansion, and the delivery of nutrients to the fetus. Key

nutrients including folate, iron, zinc, calcium, vitamin D,

and essential fatty acids function to promote red blood cell

production, enzyme activity, bone development, and brain

development. Poor maternal dietary quality may thus have

serious implications for anaemia during pregnancy[33]

.

Haematinics, particularly iron contributes to the rise in

serum erythropoietin which often decreases during

pregnancy. Deficiency of these essential haematinics

arising from increased requirements and inadequate

intake may have far reaching effects on both mother and

foetus.

Parity, gravidity and haematological status: On the

average, increased parity was associated with decreased

Hb concentration. It is generally believed that anaemia in

pregnancy increases with rising parity, due to repeated

drain on iron stores[34]

. However, the association between

high parity and anaemia in pregnancy is not unequivocal.

While some studies show high parity increases risk[35,36]

,

others show no increased risk [19].

However, the prevalence of anaemia decreased with

gravidity, ranging from 75% among primigravidae to 43.7

% among multigravidae.

ANC attendance and anaemia: The content of ANC

services received and early initiation were found to be

associated with lower odds of having anaemia in the third

trimester. The percentage of women with anaemia was

lowest among those that booked for antenatal care in the

first trimester. This finding is in agreement with findings of

Komolafe et al.[4]

and Bukar et al.[37]

in Nigeria. The

positive contribution of early initiation of ANC attendance

to haematological status is probably due to the benefitsassociated with ANC. For example, women who initiate

ANC visits early are more likely to benefit from

prophylactic measures against malarial infection, iron and

folic acid supplementation and that of nutrition and health

education. There is an increased foetal demand for

haematopoietic factors as pregnancy progresses and so

women who will not avail themselves to health services

early enough may suffer the consequences of increased

demand for nutrients. Such women are also more likely to

take advantage of accessing health services to treat any

underlying maternal diseases and untreated anaemia in

early pregnancy that are likely to worsen in the course of

pregnancy.

Limitation of the study: This study was hospital based

and as such may not be truly reflective of the situation in

the district due to selection bias. Pregnant women utilizing

the health institutions are also more likely to be educated,

of higher socioeconomic status than the typical pregnant

woman in the community.

Dietary diversity was assessed based on responses

obtained from participants (e.g. dietary recall) during the

pregnancy and this depended on memory and their ability

to recall accurately. Recall bias could not be ruled out

completely. However, methods used in assessing dietary

diversity are useful for ranking individuals but do notnecessarily permit exact assessments of absolute nutrient

intake.

The study also relied partly on secondary data about

participants recorded by health professionals during the

pregnancy. Therefore any error in measurements,

readings or recordings of these parameters and indices

will reflect in the results. However with the level of

professionalism of health workers in the institutions

involved in the study, this is expected to be minimal. The

cross-sectional study design used to collect data also

makes it difficult to demonstrate cause-and-effect

relationships.

CONCLUSION


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In the present study, there was statistically significant

association between maternal DDS and anaemia in

pregnancy. The content of ANC, as well as dietary

diversity of women had positive effect on Hb in the third

trimester and so women should be educated on the need

for improved quality diets as well as quality and content

of ANC services in the health facilities.

The study findings suggest the need to strengthen

interventions that focus on improving the consumption of

diversified foods particularly during pregnancy.

Additionally, anaemia was higher with increased parity

levels and among women who initiated ANC late. This

implies the need to target interventions to these vulnerable

groups of women.

ACKNOWLEDGMENT

The authors wish to express their profound gratitude to all

the study participants. We are also grateful to the

administrators and midwives of Tamale Teaching Hospital,

Tamale West Hospital, Tamale Central Hospital and SDA

Hospital for granting us permission to interview thepregnant women admitted in their labour wards.


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Murali et al., Int J Med Res Health Sci. 2015;4(4):756-759



CLINICAL PATTERN AND EFFECT OF CO-MORBIDITIES IN THE ETIOPATHOGENESIS

OF INCISIONAL HERNIAS

*Murali U¹, Thakre N D²

INTRODUCTION

Incisional hernia is a problem of magnitude. It is also a

socioeconomic problem. For the individual patient

incisional hernia is an unexpected and hindering

complication, which can influence daily life in such a

manner that he or she could be consider disabled.

Repeated admissions and operations have a major impact

on the patient. When subsequent hernia repair does not

solve the problem, but results in recurrence or

complications, a patient’s quality of life may be seriously

affected.

Incisional hernia occurs in about 2-19% of patients after

various incisions[1, 2, 3, 4]

. When the scar has a defect, the

abdominal contents may start protruding through it, due to

intra-abdominal pressure. Certain conditions like chronic

cough, chronic constipation, urinary obstruction, obesity,

pulmonary disease, repeated pregnancies and post-

operative abdominal distension may further increase the

pressure unwantedly and increase the chance of incisionalhernia

[5, 6]. Wound infection is probably an important risk

factor for the development of incisional hernia[7]

and

wound dehiscence[8, 1, 2]

. In spite of all precautions during

surgery and meticulous repairs to cure them, a number of

cases of incisional hernias are being reported with failures

of repairs leading to “Recurrent incisional hernia”.

Therefore, prevention of incisional hernia is warranted.

Our aim was to study the aetiopathogenesis and effects of

co-morbidities on the clinical course of incisional hernias

and repair.

MATERIALS & METHODS

Study design: It was a cross sectional, Descriptive study

Locus of study: The study carried out in patients of

Jawaharlal Nehru Hospital (JNH), Rose Belle, Mauritius

between December 2010 to September 2012.

Sample size: A total number of 38 cases were studied.

Inclusion criteria: All patients of both genders aged

above 25 years with incisional hernia who came to JNH

were included in this study.

Exclusion criteria: Patients with recurrent inguinal hernia

were excluded as they were categorized as primarily

hernias of different aetiopathology.

Ethics: The protocol and proforma for collection of data as

well for the study was approved by the ethical committee.

Methodology:

Detailed history pertaining to the surgery which later on

led to the incisional hernia was recorded; more stress was

laid on the predisposing factors and co-morbidities at the

time of operation. Thorough work up of all patients

included a complete physical examination, weight inkilograms, height in meters, size of defect and

investigations like haemogram, X-ray chest, ECG, renal

profile and echocardiography.

Patients were evaluated for co-morbidities like asthma,

chronic obstructive pulmonary diseases (COPD), diabetes

mellitus (DM), morbid obesity, hypertension (HTN) and

malignancies at the time of first operation. Body mass

index (BMI) at the time of previous operation which led to

incisional hernia was also recorded.

Out of 38 patients in this study 22 patients were operated

and hernia repaired. These patients were studied for their

postoperative recovery and complications. Special

emphasis was laid on the date of the operation which led

to hernia formation and the actual date when the patient

detected hernia. These dates gave information about the

ABSTRACT

Background: Incisional hernia is a common iatrogenic complication of

abdominal surgery and is a cause of unwanted morbidity. The study was

reported for the first time from Republic of Mauritius. Aims & Objectives: The

objective of the study was to analyze the clinical pattern and effect of co-

morbidities on the clinical course of incisional hernias and repair. Methods: The

study is a cross sectional study conducted at a tertiary care hospital for over 22

months. 38 patients with incisional hernia were studied with special emphasis

laid on the predisposing factors and co-morbidities at the time of hernia repair.

Results: In this study the incidence of incisional hernia was prevalent in females

and occurrence was 3 times more than males. All hernias in females were the

result of a gynaecological operation. 68% (26 out of 38 patients studied) of

hernias were reported within 2 years of gynaecological operation. Majority of

patients presented with swelling and pain related to scar. Twenty two out of thirty eight were operated and hernia repaired. Obesity was found to be the

most important factor when the effects of co-morbidities were studied. Fifteen

out of thirty eight (39.47%) patients came under the category of morbidly obese.

Conclusion: In patients with recurrent hernia control of obesity and other co-

morbidities before the attempt to repair hernia can be decisive.

ARTICLE INFO

Received: 11th May 2015Revised : 2nd Jun 2015Accepted: 23rd Jul 2015

Authors details:1,2

Department of

General Surgery, D Y Patil Medical

College, Mauritius

Corresponding author: Murali U

Department of General Surgery, D Y

Patil Medical College, Mauritius


Keywords: Incisional hernia,

Complications, Co-morbidity, Obesity .


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exact time period between surgery and the hernia. In most

of the cases the information related to the type of previous

surgery and methods of closure adopted were also traced

from their earlier records.

Statistical analysis: Data was analyzed using descriptive

statistical principles (like mean, proportions and

percentages) with SPSS 19 Package analyzed and

different findings were compared with the available

literature and discussed.

RESULTS

Out of 38 patients in the study, 29 patients were female

while 9 were male. The age group of the patients varied

from 29 to 82 years. Incidence was highest in the age

group ranging from 50 to 70 years. Regarding the

occupation of patients, out of 29 females majority of them

(22) were house-wives.

Most of the patients (15) presented with swelling, followed

by pain and swelling in about 11 of them, pain alone in 9

cases and rest (3) with associated symptoms of

constipation. Only two out of 38 came with features

suggestive of intestinal obstruction. Incisional hernia was

more common after midline incision (76.31%). Out of the

38 patients studied the commonest incisions responsible,

for the hernia were infra umbilical midline (16) and supra

umbilical midline (13) (Table – 1).

Lower segment caesarean section (LSCS) was the

commonest operation responsible for the incisional hernia

in 18 cases of this study followed by emergency

laparotomy (Table – 1). The dimension of the defect was

studied in only 30 patients. The commonest defect size

was 12 sq. cm. observed in 7 followed by 8 sq.cm in 6 out

of 30 patients studied (Table – 1). The time period

between the appearance of hernia and the operation

responsible for it showed that 26 out of 38 patients

reported about their hernia within 2 years of operation

(68.42%) (Table – 2).

Morbid obesity was the commonest co-morbidity amongst

the patients (15) studied followed by hypertension in 14

patients (Table – 3). Out of the 38 patients studied, 28

(73.68%) patients were obese (BMI over 25 kg/m2). Out of

these 28 patients, 15 came under the category of morbidly

obese with 3 in class III (BMI over 40 kg/m2), 4 in class II

(BMI over 35 kg/m2) and 8 in class I (BMI over 30 kg/m2).

Out of 38 patients, 22 were operated and repair of hernia

carried out. There was no recurrence or complicationsobserved in our study. There was no mortality.

Table 1: Operations and Incisions causing hernia with Defect sizes

Operation No. of cases Incision No. of cases Defect size No. of cases

LSCS 18 McBurney 2 2 sq.cm 3

Cholecystectomy 3 Kocher’s 2 2.25sq.cm 1

Hysterectomy 2 Infra umbilical transverse 2 4 sq.cm 4

Appendicectomy 2 Infra umbilical midline 16 6 sq.cm 5

Expl. Laparotomy 7 Supra umbilical midline 13 8 sq.cm 6

Laparotomy 1 Supra umbilical transverse 1 12 sq.cm 7

Umbilical hernia 4 Lumbar 1 15 sq.cm 2

Nephrolithotomy 1 Para median 1 24 sq.cm 2

Table 2: Onset of hernia

Time interval Number of cases

0 to 6 months 9

6 months to 1 year 8

1 year to 2 year 9

2 year to 3 year 1

3 year to 4 year 3

4 year to 5 year 3

5 years onwards 5

Table 3: Types of Co-morbidities

Co-morbidities Number of

cases

Percentage

Diabetes mellitus 7 18.42

Hypertension 14 36.84

Morbid obesity 15 39.47

Ischaemic heart disease 4 10.52

Hyperthyroidism 1 2.63

Bronchial asthma 4 10.52

Neurological disorder 2 5.36

Malignant disease 1 2.63

DISCUSSION

38 cases of incisional hernia admitted in JNH, Rose Belle,

Mauritius for treatment were included in this study

between December 2010 to September 2012. The mean

age of patients of incisional hernia in our study was 56.02

years. Ellis et al[9]

in their study observed a mean age of

49.4 years. The youngest patient in our study was 29

years and the oldest was 82 years. The sex ratio of

incisional hernia among the cases studied was 1:3 (M: F),

showing a female preponderance. This can be attributed

to the laxity of abdominal muscles due to multiple

pregnancies and an increased incidence of obesity in

females. Most of the women were housewives which show

that incisional hernias were more common in women.

Thirty nine percent (39.4%) of patients presented with

abdominal swelling without any complaint of pain or

discomfort due to hernia. Two patients (5.26%) presentedwith complication, i.e. one with acute intestinal obstruction

which needed an exploratory laparotomy with resection

and anastomosis of small bowel for gangrene and repair

of hernia. The other was a sub-acute case of intestinal

obstruction, treated conservatively and hernia repair done

later on. This can be compared with Mudge and Hughes[4]

series (14%).

In our study 42.1% of incisional hernia occurred in midline

infra umbilical incisions. This may be because of following

features:

1. Intra-abdominal hydrostatic pressure is higher in

lower abdomen compared to upper abdomen, in erect

position i.e. 20cm of water and 8cm of water

respectively.

2. Absence of posterior rectus sheath below the arcuate

line.


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Midline infra umbilical incisions were used mainly in

females for LSCS and abdominal hysterectomy, which

have poor abdominal wall musculature. This can be

comparable with that of Goel and Dubey[10]

studies

(44.6%).

Fifty two percent of cases (52%) occurred following

gynaecological procedures (abdominal hysterectomy and

LSCS). Suhas and Rigved[11]

in their studies noted 68%

incidence and other studies[10]

noted 28.76% incidence

following gynaecological procedures. Higher incidence in

our study similar to studies[11]

may be because most of

these procedures were done through lower midline

incisions.

In our study 23.68% of patients developed incisional

hernia within 6 months of previous surgery. These early

hernias can be attributed to a possibly faulty technique of

repair. 21.05% of patients developed within 6-12 months.

23.68% of patients developed within 12-24 months.

31.57% of patients developed incisional hernia after 2

years of the previous surgery. All the hernias which were

reported by patients within 2 years come under the

category of early incisional hernia, the defect must havestarted at the initial phase of healing but was detected little

later. Most studies showed incidence within a year of

follow-up of patients except for studies of Ellis et al[9]

which showed an incidence of 5.8% for a follow-up period

of 2.5 – 5.5 years in 363 patients, similar to present study.

Considering the dimension of defect in 30 patients, 23.3%

of patients were found to have hernia defect of up to 12

sq. cm. While most others showed a defect size of 2sq.cm

to 8 sq. cm. Previous studies[1]

show that the size of the

fascial defect should dictate the selection of the most

appropriate method of hernia repair.

One patient with diabetes mellitus developed an

intractable infection which needed removal of the mesh. It

is one of the most dreaded complications, as it adds to the

morbidity and leads to recurrent hernia invariably. 11

patients (28.9%) in this study had history of multiple

attempts of repair. This can be compared with Ellis et al[12]

series (25%). Co-morbidities which were encountered in

the patients were namely obesity (15) , hypertension (14),

diabetes mellitus (7), ischaemic heart disease , bronchial

asthma (4 each) and neurological disorder (2). One of the

patients had hyperthyroidism and one patient had colonic

malignancy. Out of all above conditions, morbid obesity

(39.47%) was the commonest co-morbidity in the patients

studied. This can be compared to the results reported byNikhil et al (40%)

[13].

In our study Body mass index (BMI) of more than 30 was

considered as morbid obesity. 15 out of 38 patients were

morbidly obese with BMI of more than 30. In this study 11

patients with recurrent incisional hernia formed a major

group. Out of these 11 patients 6 (54%) were morbidly

obese with BMI of more than 40 (Morbid obesity class III).

Hernia repair was carried out in 22 cases. The types of

repair done were polypropylene mesh repair in 12 patients

and anatomical repair in 10 patients. Non-absorbable

suture material was used to close the fascial layer. In our

study no complications or recurrences were observed.

This can be compared to Usher [14] who reported zero

percent recurrence in 48 patients who were treated by

polypropylene mesh repair. Certain studies show

recurrence rates up to 43% after anatomical suture repair

and 24% after mesh repair [15]

. Thus the recurrence rate

varies in different studies but all studies favor mesh repair

to decrease the rate of recurrence. The merit of our study

was that there was no mortality.

CONCLUSION

Thirty eight cases of Incisional hernias were studied with

respect to its clinical pattern aspects, effects of its co-

morbidities and efficacy of its repair. The following

conclusions were drawn: Obesity with deposition of fat in

the lower abdomen is an important factor in causation of

recurrent hernia. Operation for an incisional hernia should

be undertaken after reduction of body weight. The use of

midline incision should be restricted, to operations in

which unlimited access to abdominal cavity is necessarily

required. Non absorbable suture material should be used

for repair of facial layer. All co-morbidities should be

corrected before a planned operation.

ACKNOWLEDGEMENTS

We wish to express our thanks to Dr.R.K.Sharma, Dean,

Padmashree Dr. D. Y. Patil Medical College, Mauritius for

his support and encouragement. We are thankful to our

earlier HOD, Dr. Sanjay. M. Date for his contribution to

research article. We also thank Dr.S. L. Bodhankar for his

assistance in the preparation of manuscript.


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