|Year : 2021 | Volume
| Issue : 9 | Page : 1307-1312
Prevalence and Pattern of Self-medication with Alternative Medicine: Treatment-switch Analysis in Oral Submucous Fibrosis Patients
SM Gondivkar1, SC Sarode2, AR Gadbail3, RS Gondivkar4, GS Sarode2, S Patil5, RN Gaikwad6, M Yuwanati7
1 Department of Oral Medicine and Radiology, Government Dental College and Hospital, Nagpur, Maharashtra State, India
2 Department of Oral Pathology and Microbiology, Dr. D.Y. Patil Dental College and Hospital, Dr. D.Y. Patil Vidyapeeth, Pune, Maharashtra State, India
3 Department of Dentistry, Indira Gandhi Government Medical College and Hospital, Nagpur, Maharashtra State, India
4 Independent Researcher Dental Surgeon, Aarti Regency, Mahalakshmi Nagar, Manewada Road, Nagpur, Maharashtra State, India
5 Department of Maxillofacial Surgery and Dia gnostic Sciences, Division of Oral Pathology, College of Dentistry, Jazan University, Jazan, Kingdom of Saudi Arabia
6 Department of Community Dentistry and Oral Epidemiology, College of Dentistry, Qassim University, Buraydah, Kingdom of Saudi Arabia
7 Department of Oral Pathology and Microbiology, Saveetha Dental College and Hospitals, Saveetha Institute of Medical and Technical Sciences, Saveetha, University, Chennai, India
|Date of Submission||08-Sep-2020|
|Date of Acceptance||14-Jan-2021|
|Date of Web Publication||16-Sep-2021|
Dr. S C Sarode
Department of Oral Pathology and Microbiology, Dr. D.Y. Patil Dental College and Hospital, Dr. D.Y. Patil Vidyapeeth, Sant-Tukaram Nagar, Pimpri, Pune, Maharashtra - 411018
Source of Support: None, Conflict of Interest: None
| Abstract|| |
Aim: The aim of this study was to investigate prevalence and pattern of self-medication with alternative medicine (ALM) among oral submucous fibrosis (OSF) patients with emphasis on treatment-switch analysis. Methods: A total of 115 OSF patients were recruited and subjected to scientifically validated questionnaire. Two groups were identified: S-ALM: patients who have previously received modern medicinal treatment but switched to ALM; and DN-ALM: patients who started ALM from De Novo. Results: A total of 37 (32.18%) patients reported use of the ALM at some point of time. Twenty-five (67.56%) switched to ALM, whereas 12 (32.43%) patients used ALM from De Novo. The pattern of switching to ALM in short period was significantly prevalent in patients with advanced stages (stage III and IV) as compared to early stages (stage I and II) of OSF. Clarified butter, glycerin, and honey were the most commonly used ALM in both the groups. The most common reasons for switching to ALM were the cost of treatment (32.00%), longer duration of medicinal treatment (24.00%) and ineffectiveness of the medications (24.00%). Conclusions: ALM usage is common in OSMF patients with significant percentage of patient switched from modern medicine to ALM. Therapeutic efficacy of ALM in OSF needs exploration in future.
Keywords: Oral submucous fibrosis, premalignant disorder, self-medication
|How to cite this article:|
Gondivkar S M, Sarode S C, Gadbail A R, Gondivkar R S, Sarode G S, Patil S, Gaikwad R N, Yuwanati M. Prevalence and Pattern of Self-medication with Alternative Medicine: Treatment-switch Analysis in Oral Submucous Fibrosis Patients. Niger J Clin Pract 2021;24:1307-12
|How to cite this URL:|
Gondivkar S M, Sarode S C, Gadbail A R, Gondivkar R S, Sarode G S, Patil S, Gaikwad R N, Yuwanati M. Prevalence and Pattern of Self-medication with Alternative Medicine: Treatment-switch Analysis in Oral Submucous Fibrosis Patients. Niger J Clin Pract [serial online] 2021 [cited 2022 Nov 29];24:1307-12. Available from: https://www.njcponline.com/text.asp?2021/24/9/1307/325917
| Introduction|| |
In a quest for recovery from diseases, self-medication is the most commonly seen phenomenon. Main sources of self-medication are relatives, friends, social media, and pharmacists who not only provide medicines but also the information about drug's use., Especially in developing countries, factors such as lack of access to health care, physician fees, time constraint, lack of trust on physician, inadequate implementation of drug laws have been shown to influence self-medication behavior.,, Self-medication is an important public health problem and is practiced globally with higher prevalence rate in India 79% followed by Pakistan 84%, Saudi Arabia 78% and Nigeria 67%
Intriguingly, one of the practices for self-medication is consumption of non-conventional drugs or drugs associated with alternative medicine (ALM). Various reasons associated with it could be attributed to a need for self-empowerment regarding healthcare, a feeling of dissatisfaction with and distrust of conventional medicine, and individual values and beliefs.,
Oral submucous fibrosis (OSF) is an insidious chronic disease caused mainly due to chewing betel quid. The major concern about OSF is the increasing prevalence of the disease and high malignant transformation rate. OSF is mainly characterized by fibrosis of the oral mucosa and burning sensation and over the period of time, fibrosis causes progressive reduction in the mouth opening. Limited mouth opening and burning sensation are the two most important symptoms presented by the patients during therapeutic consultation.,
OSF is associated with significant disturbance in the quality of life and mainly functional domain is affected quite frequently.,, Due to chronic nature, OSF takes longer time to respond to the medicinal treatment prescribed by the oral healthcare professionals and needs frequent follow-ups. Hence, it is quite conceivable to expect patient's non-compliance to the prescribed treatment and switching over to ALM especially in patients residing in places with sparse oral/dental healthcare facilities. Moreover, OSF is most commonly reported in lower socioeconomic strata (SES), and hence it is also hypothesized that patients might prefer self-medications over costly dental healthcare professional's consultation.
With this view in mind, this study was designed to investigate the prevalence and pattern of self-medication with alternative medicine among OSF patients with special emphasis on treatment-switch analysis.
| Materials and Methods|| |
A questionnaire based cross-sectional study was conducted at the Out Patient Department of Oral Medicine and Radiology, Government Dental College and Hospital, Nagpur, India. Ethics approval was obtained from institutional ethics committee of Government Dental College and Hospital, Nagpur, India. (Ref no. GDCHN/22/19, dated 01/01/2019). A total of 115 OSF patients participated in the study during a period of February 2019 to October 2019. Patients were diagnosed based on the following clinical criteria: intolerance to hot and spicy foods, pale oral mucosa, palpable fibrotic bands, and chronic, progressive trismus. The patients giving history of any relevant systemic or local illness were excluded from the study. The grading of the OSF was performed according to classification suggested by Lai et al. The SES of reported OSF patients was determined by the modified Kuppuswamy's SES scale.
To retrieve the history of usage of self-medications with ALM by OSF patients, a questionnaire was developed. The questionnaire was gone through the external and internal validity before its actual application in the study. (Supplementary file 1).
The obtained data were subjected to statistical analysis using Statistical Package for the Social Sciences, version 17.0. Descriptive statistics were carried out. The Chi-square test, Mann–Whitney U test, and Spearman rank correlation test, wherever appropriate, were used to calculate the P value. The level of statistical significance was at P < 0.05.
| Results|| |
Of total 115 patients, 105 were males and 10 were females with male-to-female ratio of 10.5:1. The age of the patients ranged from 18 to 65 years with mean of 31.4 years. More than half of the patients (55.6%) belonged to lower SES followed by middle (40%) and upper SES (5%). Maximum patients were reported in stage III (34.7%), followed by stage IV (26.08%), II (21.7%) and I (17.3%). Of 115 patients, 78 (67.8%) were undergoing conventional medicinal treatment as prescribed by their oral healthcare physicians while 37 (32.1%) reported use of the ALM at some point of time [Table 1].
|Table 1: Demographic details of included oral submucous fibrosis patients|
Click here to view
Based on results obtained from the questionnaire analysis of 37 OSF patients undertaking ALM, two groups were identified. A first group included patients who had previously received treatment from the oral healthcare professionals but switched to ALM (S-ALM). Second group comprised patients who started ALM from De Novo (DN-ALM).
Patients with switch to alternative medicine (S-ALM)
Out of 37 patients, 25 (67.5%) had switched to the ALM after receiving conventional treatment from oral healthcare professionals. The most commonly adopted ALM was clarified butter (n = 11, 44%) and glycerin (n = 11, 44%) [Table 2]. Cost of the treatment (32%), longer duration of the medicinal treatment (24%) and ineffectiveness of the medicines advised by oral healthcare professionals (24%) were reported to be the most common reasons for switching over to ALM [Table 3].
|Table 2: Details of alternative medicines used by included oral submucous fibr osis patients|
Click here to view
|Table 3: Reasons for switch over to self-medication with alternative medicine from conventional medication|
Click here to view
The mean duration for switching over to ALM after obtaining conventional treatment from oral healthcare professional was 3.3 ± 1.4 months. The shortest duration for such switch was shown by stage III patients (2.3 ± 0.9 months) followed by stage IV (3.1 ± 0.8 months),. Mainly, this switch to ALM was found to be prevalent in stage III (n = 11) and stage IV (n = 7) patients [Table 4].
|Table 4: Details of duration for switching to alternative medicines after obtaining conventional treatment for oral submucous fibrosis from oral health professional|
Click here to view
The main sources of knowledge for use of ALM were noticed to be relatives (40%) and friends (28%) followed by social media (20%). Only 12% patients had history of true ALM [Table 5]. As per results of the questionnaire, about 15% patients of this group reported transient relief from oral ulcerations and burning sensation of oral mucosa to some extent.
|Table 5: Oral submucous fibrosis patients' source of knowledge about use of alternative medicine|
Click here to view
Patients with De novo alternative medicine (DN-ALM)
Amongst 37 patients who were on ALM, 12 (32.4%) started ALM from de novo. DN-ALM group showed more patients with stage I OSF (n = 5) followed by stage II (n = 4) and III (n = 3). Similar to S-ALM group, clarified butter (50%) and glycerin (41.6%) were most commonly used DN-ALM [Table 2]. The results of the questionnaire revealed that the cause for self-medication with ALM was self-driven for almost 50% of the patients followed by relative (25%) [Table 5]. Interestingly, few patients of DN-ALM group experienced relief from oral ulcerations and burning sensation of oral mucosa after application of ALM.
Overall, the use of self-medication with ALM was more prevalent in stage III OSF patients [14 (37.8%)] and the most commonly reported ALM were clarified butter [17 (45%)] and glycerin [16 (43%)]. The relatives (43.2%) and friends (27.02%) were the main sources of information for use of ALM.
Relationship between and SES and use of ALM
It was noticed that majority of the patients who used ALM were in lower SES (n = 28; 75.6%) and none in upper SES used ALM during treatment. Statistically significant differences (P = 0.008) and correlation (P = 0.002) in SES was obtained between conventional and ALM group [Table 6].
|Table 6: Relation between socioeconomic status and use of alternative medicines in oral submucous fibr osis patients|
Click here to view
| Discussion|| |
For chronic disorders, self-medication with traditional drugs is very common practice in Indian population. Old beliefs and customs are the major driving source for consumption of non-conventional medicines. OSF is one of such chronic disorders where treatment response with modern allopathic medicines usually takes time to show results and hence, patients likely to show non-compliance and switching over to ALM. In this study, of 115 OSF patients, about one-third (32.1%) employed the ALM at some point of time. While 21.7% patients reported switch to the ALM after receiving conventional treatment from oral healthcare professionals, 10.4% patients reported to have used ALM from de novo.
In moderately advanced and advanced stages, OSF is characterized by dreadful signs and symptoms. Patients especially reports for the consultation with manifestations such as limited mouth opening and burning sensation. Limited mouth opening is caused due to the cross-linking and increased deposition of collagen in the stroma, which once occurred is very difficult to reverse by conventional medicinal treatment. Burning sensation of the oral mucosa is attributed to the atrophic epithelium and vesiculations, which again is not completely relieved by conventional medicinal treatment. Hence, especially in advanced stages, we observed more number of patients in S-ALM group as early stages symptoms are more tolerable. In tune with this, the main reason for such switch in advanced stages was cost of the treatment, longer duration of the treatment and ineffectiveness of the conventional treatment. However, chronic illness (20%) was the least common reason for the switch in overall grades of OSF. Moreover, in accordance, we observed significantly less duration for the switch over to ALM in advanced stages as compared to early stages of OSF.
In this study, it was observed that clarified butter, glycerin, and honey were used for the relief of OSF symptoms especially burning sensation of the oral mucosa. Clarified butter, glycerin, and honey are the integral part of traditional Indian folk medicine for use in various diseases. Ancient scripts of Ayurveda have mentioned various uses of these ingredients such as anti-inflammatory, healing, antioxidant, anti-carcinogenic actions, etc., However, these agents lack any documented scientific evidences for their aforementioned actions. This information has passed from generation to generations in the Indian population. Hence, perhaps this could be the reason for their use in OSF treatment as ALM. Till date, there is no literature published on the use of clarified butter, glycerin, and honey in OSF treatment. Since OSF is fibrotic disorder associated with chronic inflammation and production of various cytokines, it is envisaged that the therapeutic effect seen in OSF after usage of these natural agents could be attributed to their anti-inflammatory nature.
OSF is commonly reported in the lower SES group of patients. Due to lack of awareness of the disease and cost of the long-standing treatment, OSF patients usually prefer the self-medications suggested by the peers. In accordance, this study revealed a large number of patients of S-ALM and DN-ALM groups implemented ALM as per suggestions of their relatives and friends. Intriguingly, few patients using ALM experienced temporary relief of their symptoms including burning sensation of the oral mucosa. It is well-known fact that early intervention with conventional medicinal treatment along with discontinuation of habit in the initial stages of OSF can revert back the OSF state to normal condition. In contrast, discontinuation of the conventional treatment at any stages of OSF not only worsens the signs and symptoms but more importantly also increases the possibility of OSF progression to malignant transformation. In this study, more than three-fourth of the 37 patients who employed ALM at any point of time belonged to lower SES. It might be possible that physician's fees, mistrust on the oral healthcare physician, frequent visits, and cost of the long-standing conventional treatment might have forced these lower SES patients to use other, relatively economic ALM.
In this study, we reported male preponderance with male-to-female ratio of 10.5:1. Moreover, age of the patients ranged from 18 to 65 years with mean of 31.4 years. This corresponds with the increased prevalence of Ghutka chewing habit among the young male population of India. These data are in accordance with the previously published literature.,
Restricted study population (central India) is the major limitation of this study. Other regions might have practice of different ALM and hence nation-wide multi-centric study is warranted in this direction. Due to the cross-sectional observational nature of the study, it was not possible to confidently comment on the potency of ALM (clarified butter, glycerin, and honey). Future randomized controlled trials are needed in this direction to ensure its efficacy.
| Conclusions|| |
Usage of scientifically unproven self-medications with ALM by OSF patients presents an alarming situation for oral healthcare providers and needs appropriate intervention. We recommend future studies with larger sample size to find out the usage of ALM, if any, in OSF management and reasons behind such practices. Moreover, outcome analysis of ALM practices could help in understanding the therapeutic efficacy of various drugs.
Financial support and sponsorship
The author received no specific funding for this work.
Conflicts of interest
All the authors associated with present manuscript declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Supplementary file 1: Questionnaire used in this study to elicit the response.
1. Are you aware of your mouth condition?
A. Yes B. No C. Don't know
2. Are you aware about the treatment options for your mouth condition?
A. Yes B. No C. Don't know
3. Did you visit dental healthcare professional for treatment of your mouth condition?
A. Yes B. No
4. Have you used medications advised by dental healthcare professional?
A. Yes B. No
5. For how long did you use medications advised by dental healthcare professional?
A. 1 month B. 2 months C. 3 months D. 4 months E. any other
6. Did you feel the treatment was adequate?
A. Yes B. No C. Don't know
7. Have you completed the treatment advised by dental healthcare professional?
A. Yes B. No
8. Were you satisfied with the treatment you underwent?
A. Yes B. No
9. Why have you not completed the treatment advised by dental healthcare professional?
A. Cost B. Long duration C. Chronic illness D. Ineffectiveness E. any other
10. Did you try medications for your mouth condition on your own?
A. Yes B. No
11. Of the following, which ingredients you used on your own for treatment of your symptoms?
A. Glycerine B. Lime
C. Honey D. Clove oil
E. Clarified butter F. Any other
12. For how long did you used self-medication drug opted by you in question 11?
A. 1 months B. 2 months
C. 3 months D. 4 months e. any other
13. Have you received relief from the self-medication drug opted by you in question 11?
A. Yes B. No C. Don't know
14. What type of relief you got from the self-medication drug opted by you in question 11?
A. Burning sensation B. Ulcerations
B. C. Pain D. Mouth opening E. Any other
15. Were you satisfied with the self-medication drug opted by you in question 11?
A. yes B. No C. Don't know
16. Have you noticed any side effects of self-medication drug opted by you in question 11?
A. Yes B. No
17. What were the side effects of self-medication drug opted by you in question 11?
A. Allergy B. GI irritation
C. Mucosal pigmentation D. Any other
18. Who suggested self-medication drug opted by you in question 11?
A. Friends B. Relatives C. On own D. Social media E. Any other
| References|| |
Agbor M, Azodo C. Selfmedication for oral health problems in Cameroon. Int Dent J 2011;61:204-9.
Loyola Filho AI, LimaCosta MF. Bambuí project: A qualitative approach to selfmedication. Cad Saude Publica 2004;20:1661-9.
Gualano M, Bert F, Passi S, Stillo M, Galis V, Manzoli L, et al
. Use of self medication among adolescents: A systematic review and metaanalysis. Eur J Public Health 2014;25:444-50.
Sharma A, Oommen S, Topno I, Saya RP. Perceptions and practices of selfmedication in healthcare and nonhealthcare university students in South India. J Basic Clin Physiol Pharmacol 2015;26:633-40.
Sahebi L, Vahidi R. Self-medication and storage of drugs at home among the clients of drugstores in Tabriz. Curr Drug Saf 2009;4:107-12.
Kumar N, Kanchan T, Unnikrishnan B. Perceptions and practices of selfmedication among medical students in coastal South India. PLoS One 2013;8:e72247.
Al Rasheed A, Umar Yagoub U, Alkhashan H, Abdelhay O, Alawwad A, Al Aboud A, et al
. Prevalence and predictors of selfmedication with antibiotics in Al Wazarat Health Center, Riyadh City, KSA. Biomed Res Int 2016;2016:3916874.
Oshikoya K, Senbanjo I, Njokanma O. Self-medication for infants with colic in Lagos, Nigeria. BMC Pediatr 2009;9:9.
Pagán JA, Pauly MV. Access to conventional medical care and the use of complementary and alternative medicine. Health Aff (Millwood) 2005;24:255-62.
Ho TF, Rowland-Seymour A, Frankel ES, Li SQ, Mao JJ. Generational differences in complementary and alternative medicine (CAM) use in the context of chronic diseases and pain: Baby boomers versus the silent generation. J Am Board Fam Med 2014;27:465-73.
Van der Waal I. Potentially malignant disorders of the oral and oropharyngeal mucosa; terminology, classification and present concepts of management. Oral Oncol 2009;45:317-23.
Wang YY, Tail YH, Wang WC, Chen CY, Kao YH, Chen YK, et al
. Malignant transformation in 5071 Southern Taiwanese patients with potentially malignant oral mucosal disorders. BMC Oral Health 2014;14:99.
Gondivkar SM, Bhowate RR, Gadbail AR, Gaikwad RN, Gondivkar RS, Sarode SC, et al
. Development and validation of oral health-related quality of life measure in oral submucous fibrosis. Oral Dis 2018;24:1020-8.
Gondivkar SM, Bhowate RR, Gadbail AR, Gondivkar RS, Sarode SC, Sarode GS, et al
. Impact of oral submucous fibrosis on oral health-related quality of life: A condition-specific OHRQoL-OSF instrument analysis. Oral Dis 2018;24:1442-8.
Gondivkar SM, Bhowate RR, Gadbail AR, Gondivkar RS, Sarode SC. Impact of socioeconomic inequalities on quality of life in oral submucous fibrosis patients. Future Oncol 2019;15:875-83.
Gadbail AR, Dande R, Sarode SC, Gondivkar S, Belekar L, Mankar-Gadbail M, et al
. Patients with oral submucous fibrosis who visit dental hospitals have nonspecific chief complaints. Trans Res Oral Oncol 2019;4:1-6.
Kerr AR, Warnakulasuriya S, Mighell AJ, Dietrich T, Nasser M, Rimal J, et al
. A systematic review of medical interventions for oral submucous fibrosis and future research opportunities. Oral Dis 2011;17:42-57.
Lai DR, Chen HR, Lin LM, Huang YL, Tsai CC. Clinical evaluation of different treatment methods for oral submucous fibrosis. A 10-year experience with 150 cases. J Oral Pathol Med 1995;24:402-6.
Singh T, Sharma S, Nagesh S. Socio-economic status scales updated for 2017. Int J Res Med Sci 2017;5:3264-7.
Rashid M, Chhabra M, Kashyap A, Undela K, Gudi SK. Prevalence and predictors of self-medication practices in India: A systematic literature review and meta-analysis. Curr Clin Pharmacol 2020;15:90-101.
Mukherjee PK, Harwansh RK, Bahadur S, Banerjee S, Kar A, Chanda J, et al
. Development of Ayurveda-Tradition to trend. J Ethnopharmacol 2017;197:10-24.
Gondivkar SM, Bhowate RR, Gadbail AR, Sarode SC, Gondivkar RS, Yuwanati M, et al
. Quality of life related “patient reported outcome measures” in oral submucous fibrosis patients. J Contemp Dent Pract 2018;19:331-8.
Arakeri G, Rai KK, Hunasgi S, Merkx MAW, Gao S, Brennan PA. Oral submucous fibrosis: An update on current theories of pathogenesis. J Oral Pathol Med 2017;46:406-12.
Sarode SC, Sarode GS. Burning sensation in oral submucous fibrosis and its possible association with mucin secreted by affected minor salivary glands. Oral Oncol 2013;49:e16-7.
Kotian S, Bhat K, Pai S, Nayak J, Souza A, Gourisheti K, et al
. The role of natural medicines on wound healing: A biomechanical, histological, biochemical and molecular study. Ethiop J Health Sci 2018;28:759-70.
Arakeri G, Rai KK, Boraks G, Patil SG, Aljabab AS, Merkx MAW, et al
. Current protocols in the management of oral submucous fibrosis: An update. J Oral Pathol Med 2017;46:418-23.
Hazarey VK, Erlewad DM, Mundhe KA, Ughade SN. Oral submucous fibrosis: Study of 1000 cases from central India. J Oral Pathol Med 2007;36:12-7.
Ranganathan K, Devi MU, Joshua E, Kirankumar K, Saraswathi TR. Oral submucous fibrosis: A case-control study in Chennai, South India. J Oral Pathol Med 2004;33:274-7.
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6]