Analgesia with ibuprofen arginate versus conventional ibuprofen for patients with dysmenorrhea: a crossover trial

Abstract

Background: Dysmenorrhea produces painful abdominal cramps that can disrupt the personal lives and productivity of women.Objective: The aim of this study was to compare the analgesic efficacy, including onset and duration of pain relief, peak effect, and total effect, and tolerability of ibuprofen arginate with those of conventional ibuprofen in patients with moderate to severe pain associated with primary dysmenorrhea.Methods: Patients were administered a single dose of ibuprofen arginate (200 or 400 mg), conventional ibuprofen (200 or 400 mg), or placebo during each of 5 menstrual cycles in a single-center, double-blind, randomized, doubledummy, 5-cycle, crossover study. Patients recorded their pain intensity and pain relief at regularly scheduled intervals (10,20, 30, 40, 50, 60, and 90 minutes and 2, 3, 4, 5, and 6 hours) after taking the study medication, and all study observations were recorded in a patient diary. Pain intensity was rated using the following 4-point categoric rating scale: 0 ϭ none, 1 ϭ mild, 2 ϭ moderate, and 3 ϭ severe. Pain relief was rated on a 5-point scale as 0 ϭ none, 1 ϭ a little, 2 ϭ some, 3 ϭ a lot, and 4 ϭ complete relief. Tolerability of ibuprofen arginate was based on a comparison of the incidence of spontaneously reported adverse events in each of the treatment groups.Results: One hundred four patients entered the study. Of these, 81.7% were white; the mean (SD) age was 27.5 (5.0) years. A total of 65.4% of patients reported moderate pain from dysmenorrhea, and the remaining 34.6% reported severe pain; 20.2% of patients did not complete the study. The median time to achieve meaningful pain relief was ϳ30 minutes faster with ibuprofen arginate 400 mg than with either dose of conventional ibuprofen. Tolerability was similar across all treatments.Conclusions: In this study population of patients experiencing acute pain as a result of primary dysmenorrhea, ibuprofen arginate was associated with 327CURRENT THERAPEUTIC RESEARCH effective, tolerable analgesia and a more rapid onset of action than conventional ibuprofen. The faster onset of analgesia may have a role in clinical practice in treating women with dysmenorrhea. A faster onset of action may be important to women whose personal relationships, productivity, or ability to sleep is being adversely affected by pain. (Curr Ther Res Clin Exp. 2003;64:327-337)

Ultrasound‐guided high‐intensity focused ultrasound treatment for abdominal wall endometriosis: a retrospective study

“…The size of the nodule ranged from 1.0 to 5.0 cm (median of 2.4 cm). According to the four-category scale of Mehlisch for reporting dysmenorrhea pain (no pain, mild pain, moderate pain and severe pain), 7 mild pain appeared in 16 patients, moderate pain in 15 patients, and severe pain in one patient (Table 1).…”

The Effects of Fish Oil Capsules and Vitamin B1 Tablets on Duration and Severity of Dysmenorrhea in Students of High School in Urmia-Iran

“…Complementary therapies like massage, aromatherapy, and heating or cooling therapy have been practiced for many years ( Durain, 2004 ). Usually, non-steroidal anti-inflammatory drugs (NSAIDs) are used for its treatment ( Mehlisch, Ardia, & Pallotta, 2003 ).…”

Specific Physiological Responses in Women with Severe Primary Dysmenorrhea during the Menstrual Cycle

“…In other studies on dysmenorrhea, pains have been relieved with various treatment approaches that include non-steroidal anti-inflammatory drugs (Namavar Jahromi et al, 2003;Mehlisch et al, 2003;Milsom et al, 2002), oral contraception (Milsom and Andersch, 1984;Davis and Westhoff, 2001;Callejo et al, 2003), acupuncture (Helms, 1987;Habek et al, 2003), transcutaneous electrical nerve stimulation (Dawood and Ramos, 1990;Kaplan et al, 1997), and microwave diathermy treatment (Vance et al, 1996). However, results of these treatments were subjective.…”