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