Comparison between ibuprofen and paracetamol in primary dysmenorrhea

Abstract

Background: Primary dysmenorrhea refers to the symptom of painful menstruation in the absence of identifiable pelvic or uterus pathology. Initial presentation usually occurs in adolescence and early adulthood. Medications used to treat primary dysmenorrhea include anti-inflammatory drugs, principally, ibuprofen and paracetamol. So far there has been no comparison of effectiveness and security profile between the two pharmaceutical substances. Objectives: Purpose of this prospective randomized crossover study was to compare the effectiveness and safety profile between those two pharmaceutical substances. Methods: In this clinical trial, 100 young women were included. The inclusion criteria was: a) age between 18–25 years old, b) no present or previous pelvic pathology, based on their medical history and an ultrasound examination which was performed in the 3–6th day of their menstrual circle, a month before the clinical trial. Vaginal discharge examination and also Papanicolaou test were held to exclude relevant pathology of the genital system. Participants were assessed and divided in two groups. The duration of the study was two months. The first group received ibuprofen for the first month and paracetamol for the second month while the second group received them vice versa (cross-over trial). Both groups filled in a questionnaire in regard to how they responded to each therapy. In addition, the security profile of the pharmaceutical drugs was compared as also their effect to the characteristics of menstruation and their probable side-effects. All participants filled in a questionnaire before the assignment into groups. For the comparison of the results, the 10% of the women with not painful menstruation, steadily every month, were removed and paired-samples t-test was used. Results: Ibuprofen has been proven as a safe and more effective therapeutic option than paracetamol in all parameters, when treating women with primary dysmenorrhea. After the administration of analgesics for the two following months, the comparison and statistical analysis of the new questionnaires revealed that, when Ibuprofen was compared to Paracetamol, the analgesic effectiveness was 98,9 and 91,1% respectively. Ibuprofen provided a maximum pain relief in 30 minutes – 53,3% of participants –when Paracetamol demonstrated the maximum pain relief in 60 minutes (64,4%). The pain was decreased “moderate” with the use of Paracetamol (37,8%) and “totally” with Ibuprofen (58,9%). The duration of analgesia with Ibuprofen was 4–8 hours –73,3% of participants– compared to 1–4 hours with Paracetamol (57,4%). Daily activity has been remarkably improved with the use of Ibuprofen (62%) compared to Paracetamol (only 9%). After the administration of Paracetamol 4% of the women appeared side-effects and none of the women appeared with the use of Ibuprofen. All the above results were statistically significant. Conclusions: Ibuprofen provides a significantly improved quality of life when compared to Paracetamol and no side effects have been noticed.