International Journal of Research in Pharmacology & Pharmacotherapeutics

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1 International Journal of Research in Pharmacology & Pharmacotherapeutics ISSN Print: IJRPP Vol 3 Issue 1 Jan - Mar ISSN Online: Journal Home page: Research article Open Access A prospective study of the pattern of drug use in primary dysmenorrhea in a tertiary care hospital Ramya Sugumar* 1, Vasundara Krishniah 2, Suvarna 2, H.P.Pundarikaksha 2, Prathap.B 1, Gladius Jennifer H 1. 1 Karpaga Vinayaga Institute of Medical Sciences, Madurantakam, Kanchipuram District, Tamil Nadu, India Kempegowda Institute of Medical Sciences, Bangalore, Karnataka, India *Corresponding author: Ramya Sugumar. address : drramya.sugumar@gmail.com Aim To study the pattern of drug use in primary dysmenorrhea in a tertiary care hospital. Materials and Methods This prospective study of nine months duration was carried in Obstetrics and Gynecology OPD, in a tertiary care teaching hospital among 100 patients with PD. The analysis was done for the pattern of drug use, prescribing frequency of individual drug, to evaluate association between severity of dysmenorrhea and prescription pattern and adequacy of prescription details. Results The mean age of the patients was ± 4.5 years. Majority (61%) of patients experienced severe dysmenorrhea. Mefenamic acid with dicyclomine combination was most frequently (72%) prescribed, followed by mefenamic acid alone (16%) and diclofenac (12%) and none were prescribed hormonal preparations. Although majority (43%) of the patients with severe dysmenorrhea were prescribed mefenamic acid with dicyclomine combination, the severity of dysmenorrhea did not influence the prescription pattern and choice of drug (p>.05). Instructions regarding dose, frequency and duration of drug administration were present in the prescriptions. Conclusion In our present study, NSAIDs and their combination with antispasmodics were prescribed most frequently. Majority of the drugs were prescribed by their brand names. Instructions regarding the prophylactic benefit of NSAIDs were not present in the prescriptions. Keywords: Drug use study, NSAIDS, Primary dysmenorrhea, Tertiary care hospital. INTRODUCTION Primary dysmenorrhea (PD) is a common gynecological disorder characterized by painful menstruation in the absence of any underlying pelvic pathology. 1,2 Its prevalence (71.9%) among adolescent girls is particularly high. 3 The medical, social and economic consequence of PD are ~ 80~

2 substantial causing interference with daily activities, disruption of educational and social life leading to school absenteeism and loss of labour. 3 Prostaglandins (PGs) have a well recognized pathophysiological role in PD by inducing intense uterine contractions, decreasing uterine blood flow, increasing peripheral nerve hypersensitivity and resulting in pain. Patients with PD usually present with colicky suprapubic pain, nausea, vomiting, diarrhea and rarely syncopal attacks. 1 The pharmacological measures for PD include various non-steroidal anti-inflammatory drugs (NSAIDs), antispasmodics and hormonal therapy. NSAIDs which are PG synthesis inhibitors form the main stay of treatment. Among them the most commonly used are ibuprofen, mefenamic acid, naproxen, ketoprofen, celecoxib, diclofenac. 4 Hormonal therapy in the form of oral contraceptive pills (OCPs) are reserved for patients with suboptimal or lack of response to NSAIDs. Medroxy progesterone acetate, levonorgestral releasing intra uterine device and leuprolide are the other hormonal agents that may be used. 5 PD being a common gynecological disorder requires adequate treatment failing which it may be responsible for the silent suffering among young women. 6 However, there is no unanimity or universally accepted and standardized guidelines regarding the choice of drug therapy, criteria for selection, the dose, frequency and duration of administration. Hence the present study is taken up to study the pattern of drug use in PD. MATERIALS & METHODS Study design A prospective observational study. Study duration Nine months from March 2012 November 2012 Study subjects 100 consecutive patients attending Obstetrics & Gynecology OPD, KIMS Hospital and Research Centre, Bangalore and diagnosed as PD by the gynecologist. Study procedure The study was conducted after prior approval from Institutional Ethics Committee. The data from 100 patients fulfilling the inclusion and exclusion criteria were recorded and analyzed. For each patient, demographic data, menstrual history (including onset, duration and severity of dysmenorrhea and its associated symptoms), prescription details including name of drug, dose, route and frequency of administration, and also prescription by generic or brand names were documented on a case record form. Inclusion criteria Data of patients with PD between years of age and with regular menstrual cycle (28±7 days). Exclusion criteria Data of patients with underlying pelvic pathology (abnormal USG) indicating secondary dysmenorrhea. Statistical analysis was done using SPSS version The characteristics of demographic details, dysmenorrhea and drug prescription patterns were described using descriptive statistics. The association of prescription pattern and severity of pain was analyzed using Chi square test (p<.05 considered statistically significant). RESULTS Total of 100 prescriptions of patients with PD were analyzed. Their mean age and mean age at menarche was ± 4.5 and 12.8 ±1.7 years respectively. The age distribution of the patients is given in Table 1. Majority (93%) of them were from urban background. Dysmenorrhea was experienced on 1 st day of menstrual flow by majority (76%) of patients, 1 day before menstrual flow in 13% patients, 2 days before menstrual flow in 6% patients and >2 days before menstrual flow in 5% patients. Mean duration of dysmenorrhea was 2.2 days with 74% of patients experiencing pain in the first 2-3 days of menstrual cycle. Figure 1 shows the severity of dysmenorrhea among the patients which was categorized using verbal multi dimentional scoring system. 7 The drug prescribing pattern was as follows: A majority (72%) of patients were prescribed a combination of mefenamic acid (250mg) + dicyclomine (10mg) (MA + Di) t.i.d, followed by mefenamic acid (250mg) (MA) t.i.d in 16% and diclofenac (50mg) (D) in 12% patients respectively. Among the patients with severe dysmenorrhea 42% were prescribed MA+Di, 10% ~ 81~

3 MA, and 9% were prescribed D. Among those with moderate dysmenorrhea 29% were prescribed MA + Di, 6% MA and 3% patients were prescribed D. One percent patients with mild dysmenorrhea were prescribed MA + Di (Table 2). There was no statistically significant relationship between drug prescription and severity of dysmenorrhea (p>.05) (Table 2). DISCUSSION Though PD is common in adolescents, in our study only 27% belonged to adolescent age group (12-19 years) (Table 1). This may probably be due to lack of awareness regarding existing medical treatment for dysmenorrhea, practice of non-pharmacological methods and prevalence of self medication practice in them. 8,9,10,11,12 The mean age at menarche was 12.8 years which was akin to the previous studies. 13,14,15 Majority (93%) of the patients were from urban background and only 7% were from rural, indicative of better awareness and accessibility to institutional health care facilities among the urban population. With respect to onset of dysmenorrhea, in our study majority (76%) of the patients experienced it on 1 st day of menstrual flow which is similar to the results of previous studies. 16 The mean duration of dysmenorrhea was 2.2 days and majority(74%) of patients experienced pain on 1 st 2-3 days of menstrual cycle which is in accordance with previous study and probably because PG levels are highest during first two days of menses. 6 The prescribing pattern for PD included mefenamic acid with dicyclomine combination (most commonly prescribed), mefenamic acid alone and diclofenac which are among the most commonly preferred drugs for PD. 4 None of the patients were prescribed OCPs as they are indicated only when there is suboptimal or lack of response to NSAIDs and when contraception is required in addition to pain relief. 5 The severity of dysmenorrhea did not influence the prescribing pattern indicating that severity of pain was not taken as a criteria for choice of drug in PD (p>.05, Table 2). Most of the drugs were prescribed by their brand names which may undermine the essential drug concept. Instructions to the patients regarding dose, frequency and duration of drug administration were present in all prescriptions but prophylactic analgesic benefit of NSAIDs (that they can be taken 1-2 days before the onset of menstruation) was not present. If advice is given to the patients with severe dysmenorrhea to take NSAIDs prophylactically the burden of pain and its consequences can be reduced substantially. To conclude, the drug prescription pattern for PD included NSAIDs and antispasmodics which were prescribed irrespective of the severity of pain. The results of this study along with other extensive drug utilization studies on primary dysmenorrhea will be helpful in the future for the appropriate and efficient treatment and thereby decrease the social and economic consequences associated with it. Table 1. Age distribution of patients Age group % of patients (yrs) Total 100 Mean±SD 22.3±4.5 ~ 82~

4 Percentage (%) Ramya sugumar et al / Int. J. of Res. in Pharmacology & Pharmacotherapeutics Vol-3(1) 2014 [80-84] Figure 1: Dysmenorrhea severity based on verbal multidimensional scoring system Mild Moderate Severe Dysmenorrhea severity Table: 2 Pattern of drug prescription and severity of dysmenorrhea Dysmenorrhea severity MA MA + Di D Mild Modearte Severe Total p* >.05 *Chi square test REFERENCES [1] Ropkin AJ, Howe NC. Pelvic pain and dysmenorrhea. In: Berek JS, editor. Novak s Gynecology. 14 th ed. Philadelphia: Lippincot Williams & Wilkins; p [2] Umland EM, Weinstein LC, Buchanan C. Menstruation related disorders. In Dipiro JT, Talbert RL, Yee GC, Matzke GR, Wells BG, Posey LW, editors. Pharmacotherapy a pathophysiologic approach. 7 th ed. New York: McGraw Hill; p [3] Agarwal AK, Agarwal A. A study of dysmenorrhea during menstruation in adolescent girls. India J Community Med 2010;35: [4] Mackay HT. Dysmenorrhea. In: McPhee ST, Papadakis MA, Gonzales R, Zeiger R, editors. Current Medical Diagnosis and Treatment. 49th ed. New York:McGraw Hill Lange; p [5] Sanfilippo J, Erb T. Evaluation and management of dysmenorrhea in adolescents. Clin Obstet Gynecol 2008;51: [6] Esimai OA, Omoniyi Esan GO. Awareness of menstrual abnormality amongst college students in urban area of Ile-Ife, Osun state, Nigeria. Indian Journal of Community Medicine 2010;35(1):63-6. [7] Andersch B, Milsom I. An epidemiological study among young women with dysmenorrhea. Am J Obstet Gynecol 1982;144: [8] Kolhe S, Deb S. Dysmenorrhea. Obstetrics, Gynecology and Reproductive Medicine 2011 Nov; 21(11): ~ 83~

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