Comparison of the Pattern, Efficacy, and Tolerability of Self-Medicated Drugs in Primary Dysmenorrhea: a Questionnaire Based Survey

Short Communication

Comparison of the pattern, efficacy, and tolerability of self- medicated drugs in primary dysmenorrhea: A questionnaire based survey

Ramya Sugumar, Vasundara Krishnaiah, Gokul Shetty Channaveera1, Shilpa Mruthyunjaya2

ABSTRACT

Department of Pharmacology, Objective: To compare the pattern, efficacy, and tolerability of self-medicated drugs Kempegowda Institute of Medical and to assess the adequacy of their dose in primary dysmenorrhea (PD). Sciences, Bangalore, 1Jagadguru Materials and Methods: A survey using a self-developed, validated, objective, and Jayadeva Murugarajendra Medical structured questionnaire as a tool was conducted among subjects with PD. Statistical College, Davangere, 2Physiology, analysis was carried out using Chi-square test and ANOVA with post-hoc Tuckey’s test. Mysore Medical College, Mysore, Results: Out of 641 respondents, 42% were self-medicated. The pattern of drugs used Karnataka, India was: Dicyclomine, an unknown drug, mefenamic acid, mefenamic acid + dicyclomine, and metamizole by 35%, 29%, 26%, 9%, and 1% of respondents, respectively. Mefenamic Received: 24-04-2011 acid + dicyclomine, the combination was the most efficacious in comparison to other Revised: 05-08-2012 Accepted: 30-12-2012 drugs in moderate to severe dysmenorrhea. There was better tolerability with mefenamic acid + dicyclomine group compared to other drugs. Sub-therapeutic doses were used Correspondence to: by 86% of self-medicating respondents. Dr. Ramya Sugumar, Conclusions: The prevailing self-medication practices were inappropriate in a E-mail: drramya.sugumar@gmail. substantial proportion of women with inadequate knowledge regarding appropriate com drug choice, therapeutic doses, and their associated side effects.

KEY WORDS: Efficacy, primary dysmenorrhea, self-medication, survey, tolerability

Introduction suprapubic pain and may be accompanied by lumbosacral backache, pain radiating down the anterior thigh, nausea, Primary dysmenorrhea (PD), a common gynaecological vomiting, diarrhea, and rarely syncopal attack.[1] disorder affecting nearly 50% of menstruating women, is The mainstay of treatment includes various classes of non- characterized by painful menstruation in the absence of any steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, underlying pelvic pathology.[1,2] It is mostly confined to the mefenamic acid, naproxen, ketoprofen, and celecoxib.[4] adolescent age group, appearing within 6-12 months after Hormonal therapy in the form of oral contraceptive pills (OCPs) menarche and coinciding with the onset of regular ovulatory cycles. The prevalence is particularly high among adolescents to inhibit ovulation and to decrease endometrial proliferation (50-70%) disrupting educational and social life, leading to school and PG synthesis is particularly useful in patients with severe absenteeism and loss of labor.[3] PD. Other hormonal agents used are medroxyprogesterone Dysmenorrhea results from increased prostaglandins (PGs), acetate, levonorgestrel-releasing intrauterine devices (IUDs), [5] which induce intense uterine contractions, decrease uterine and GnRH analogues like leuprolide acetate. blood flow, and increase peripheral nerve hypersensitivity, Self-medication is defined as the use of medication by a resulting in pain. Clinical presentation of PD consists of colicky patient on his own initiative or on the advice of a pharmacist or a layperson instead of consulting a medical practitioner.[6] Self- [7] Access this article online medication for PD is common with an incidence of 38-80%. Quick Response Code: With extensive accessibility to over-the-counter drugs for PD, Website: www.ijp-online.com there exists lack of awareness regarding appropriate choice of DOI: 10.4103/0253-7613.108312 drugs and adequate therapeutic dose.[8,9] However, to the best of our knowledge the published data regarding self-medication for PD in India is found lacking and yet to be established and hence the present study was undertaken to evaluate the existing self-medication pattern, to compare

180 Indian Journal of Pharmacology | April 2013 | Vol 45 | Issue 2 Sugumar, et al.: Self-medication practices for primary dysmenorrhea the efficacy, adequacy, and tolerability of self-medicated Sixty three percent reported missing of school/work for 2 - 7 drugs in PD. days/month. The most commonly associated symptoms which were overlapping included nausea/vomiting (76%) followed by Materials and Methods headache (63%), sweating (39%), diarrhea (38%), dizziness We conducted a survey in various educational institutions (36%), loss of appetite (35%), and fainting (28%). in and around Bangalore from January 2011 to June 2011 with Among 641 respondents, 42% (n = 269) resorted to self- prior approval from Institutional Ethics Committee. medication, 53% followed non pharmacological methods, The inclusion criteria were females aged between and only 5% took physician-prescribed medication. The data 18- 30 years, with regular menstrual cycle, with at least four obtained from self-medicating respondents was considered painful menstrual cycles during the preceding six months, for the study. prior normal abdomino-pelvic scan, if available, and willing Self-medication was practiced by 27% nursing, 56% medical, to give written informed consent. Exclusion criteria included 36% agricultural, 47% engineering, 66% pharmacy, 47% dental, women <18 years or > 30 years of age, history of irregular and 40% of physiotherapy students. Pharmacy and medical menstrual cycle, with <4 painful menstrual cycles during the students significantly resorted to self-medication in comparison preceding six months, not willing to give written informed to respondents of other professions (P = 0.0001). consent, subjects receiving concomitant medications Self-medication was initiated by physician/nurse, pharmacist including antipsychotics, antidepressants, sedative hypnotics, and relatives/self in 41%, 8%, and 51%, respectively. The antispasmodics, corticosteroids, taking physician prescribed existing pattern of self-medication was as follows: Dicyclomine, medications, resorting to only non-pharmacological measures, an unknown drug, mefenamic acid, mefenamic acid + incomplete questionnaires, and with no available normal dicyclomine, and metamizole in 35%, 29%, 26%, 9%, and 1% of abdomino-pelvic scan. The verbal multidimensional scoring respondents, respectively. Severity of dysmenorrhea among system was used for assessment of dysmenorrhea severity.[7] respondents was as follows: 23% mild, 45% moderate, and 32% The survey questionnaire was pre-validated for reliability severe. The pattern of self-medication in relation to severity coefficient by initially administering it to a sample of 40 women of dysmenorrhea was assessed [Table 1]. The prevalence of across different professions and strata of society. self-medication was more in respondents with moderate and Following data was collected: Demographic characteristics, severe dysmenorrhea (86%, P = 0.0001). In respondents with menstrual history including age at menarche, severity and mild dysmenorrhea, the least commonly used was mefenamic duration of dysmenorrhea, number of days missed at work/class acid + dicyclomine. Dicyclomine, mefenamic acid were used due to dysmenorrhea and associated symptoms, and details of more frequently, while 37% consumed an unknown drug. In self-medication including pattern, adequacy of dose, efficacy respondents with moderate dysmenorrhea, most commonly (based on verbal rating scale), and tolerability. used was dicyclomine followed by mefenamic acid, mefenamic Statistical analysis was done using SPSS version 19. The acid + dicyclomine, metamizole, while 32% took an unknown characteristics of demographic and menstrual pain and self- drug. In respondents with severe dysmenorrhea, metamizole medication patterns were described using descriptive statistics. was most commonly used followed in descending order by The association of self-medication pattern and severity of pain mefenamic acid + dicyclomine, mefenamic acid, unknown drug, was analysed using ANOVA and post-hoc Tuckey’s test. The and dicyclomine. The severity of dysmenorrhea did not influence efficacy and tolerability assessment was done using Chi- square the pattern of self-medication [Table 1, P > 0.05]. test; P values were calculated, with P < 0.05 considered The efficacy of the self-medicated drugs was assessed statistically significant. with respect to dysmenorrhea severity based on the verbal rating scale [Table 2]. In mild dysmenorrhea – mefenamic acid, Results dicyclomine, mefenamic acid + dicyclomine, and unknown The mean age and mean age at menarche of 641 respondents drug were equally efficacious (P = 0.7960). In moderate and was 23.5 ± 2.5 years and 12.6 ± 1.6 years, respectively. The severe dysmenorrhea, mefenamic acid + dicyclomine was survey included respondents studying in various professions perceived to be more efficacious compared to other drugs like nursing 28%, medical 26%, agricultural sciences 21%, [Table 2, P = 0.0006, P = 0.0403]. The daily dose adequacy engineering 7%, pharmacy 6%, dental 5%, and physiotherapy 7%. of self-medicated drugs was calculated and compared with The mean duration of dysmenorrhea was 2.2 ± 0.5 days/month. standard recommended daily dose for that medication.[10,11]

Table 1:

Comparison of severity of dysmenorrhea & pattern of self medication (n = 269)

Dysmenorrhea Mefenamic acid Dicyclomine Mefenamic acid + Metamizole Unknown drug P* severity (n = 70) % (n = 95) % dicyclomine (n = 23) % (n = 3) % (n = 78) % Mild 23 16 13 0 37 1.71 Moderate 46 58 35 33 32 0.65 Severe 31 26 52 67 31 1.06 *One-way ANOVA with post-hoc Tuckey’s test

Indian Journal of Pharmacology | April 2013 | Vol 45 | Issue 2 181 Sugumar, et al.: Self-medication practices for primary dysmenorrhea

Table 2:

Pain relief assessment based on verbal rating scale (n = 269)

Dysmenorrhea Degree of Mefenamic acid Dicyclomine Mefenamic acid + Metamizole Unknown drug P* severity pain relief (n = 70) % (n = 95) % dicyclomine (n = 3) % (n = 78) % (subjective) (n = 23) % Mild Complete 31 40 33 0 32 0.7960 Fair amount 38 20 0 0 34 Incomplete 31 40 67 0 34 Moderate Complete 81 36 88 0 36 0.0006 Fair amount 13 24 12 0 32 Incomplete 6 40 0 100 32 Severe Complete 45 32 83 50 29 0.0403 Fair amount 45 36 8 50 33 Incomplete 10 32 8 0 38 *Chi-square test

Eighty six percent, 5%, and 9% respondents consumed <99%, Figure 1: Comparison of dose adequacy of self medicated drugs with 100%, and >101% of maximum daily doses of self-medicated their standard recommended daily dose* (n = 191). *Not assessed for drugs, respectively [Figure 1]. The most commonly associated respondents taking unknown drugs. side effects were nausea (72%), followed by abdominal pain (27%), headache (27%), and dizziness (16%). Mefenamic acid + 100 s dicyclomine was better tolerated than other drugs (P = 0.0001). 90 80 Discussion 70 60 of respondent It is inferred from our study that the prevalence of self- 50 medication is significant among the pharmacy and medical 40 30 students with similar results from previous studies, probably Percentage 20 due to better awareness of self-medication and greater access 10 [12] 0 to drug information during their curriculum. Similar to < 99% 100%>101% various other studies, majority reported missing school/work, Percentage of maximum daily dose implicating a negative impact on quality of life with substantial social, economical, and educational consequences.[13] Fifty three percent respondents used non-pharmacological measures other drugs [Table 2].[11] Mefenamic acid, a NSAID, relieves such as acupressure, massage, topical heat/cooling therapy, PD primarily by suppressing endometrial prostaglandin (PG) exercises which are found to be generally less effective and often production, thus alleviating cramps and restoring normal [9,14,15] harmful. In majority of women (51%), self-medication was uterine activity.[13] It is also found to decrease the volume [15,16] initiated by self/relatives, akin to previous studies. Reasons of menstrual flow and relieve PG-induced symptoms like like lack of initiative to seek medical help, inaccessibility headache, bloating, diarrhea, and breast tenderness.[18,19] In to medical care, dysmenorrhea considered as insignificant addition, it is also reported to have direct analgesic action on physiological menstrual pain, lack of time to approach physician Central Nervous System (CNS) mediated by interactions with as majority of the respondents were students, confidence in self/ descending serotonergic pathways, together with modulation relatives regarding drug choice based on their prior experience, of neurotransmission at glycine or N-methyl-D-aspartate economical and convenient access to non-pharmacological receptors independent of cyclo-oxygenase inhibition.[20] In PD, measures, and readily available OTC drugs may be attributed which is spasmodic in nature, the combination of mefenamic to the existing above self-medication practices followed by acid with dicyclomine is likely to be synergistic [Table 2].[21] majority of women. Majority of the women consumed dicyclomine alone which Our study showed that majority of women with moderate was less efficacious in moderate and severe dysmenorrhea to severe dysmenorrhea resorted to self-medication probably [Table 2], as a non PG synthesis inhibitor was chosen for its due to increased burden of morbidity associated with it antispasmodic effect. It probably reflects the lack of awareness necessitating the need for self-medication.[17] These results regarding appropriate drug choice. Similar results in the were similar to previous studies.[9,17] Though dicyclomine past have shown that women rely on medications whose was the most commonly used, there existed no statistically efficacy in reducing dysmenorrhea is not known.[22] In mild significant association between self-medication pattern and dysmenorrhea, all drugs were equally efficacious probably severity of dysmenorrhea which is similar to the results of a due to self-limiting physiological nature of dysmenorrhea. One pre-existing study [Table 1].[9] In our study, mefenamic acid+ percent respondents used metamizole which is associated with dicyclomine was found to be more effective in reducing agranulocytosis. Seventy eight percent respondents were not moderate and severe dysmenorrhea when compared to aware of the name of the drug. This ignorant unsafe act carries

182 Indian Journal of Pharmacology | April 2013 | Vol 45 | Issue 2 Sugumar, et al.: Self-medication practices for primary dysmenorrhea serious implications like harm to the patient and a constant risk Zeiger R, editors. Current Medical Diagnosis and Treatment. 49th ed. New of medication error. Majority of the respondents (86%) used York: McGraw Hill Lange; 2010. p. 655-86. the medications at considerably less than the recommended 5. Sanfilippo J, Erb T. Evaluation and management of dysmenorrhea in adolescents. Clin Obstet Gynecol 2008;51:257-67. therapeutic dose with comparable observations from past 6. World Health Organisation: Guidelines for the regulatory assessment of studies; probably due to lack of awareness of appropriate dose medicinal products for use in self-medication. Available from: http://apps.who. [Figure 1].[8,9] Nine percent of respondents used more than int/medicinedocs/pdf/s2218e/s2218e.pdf. 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