Abstract
ObjectivePreliminary evaluation of efficacy and safety of uzara use in treatment of moderate and severe primary dysmenorrhea in comparison to ibuprofen.Materials and MethodsThis randomized, comparative two way cross-over study comprised 60 single female students at Faculty of Medicine, Ain Shams University, Egypt, aged 19–28 years with moderate (n = 46) or severe (n = 14) primary dysmenorrhea. Participants were randomized to take either uzara (80 mg/8 hours for two doses, then 40 mg/8 hours) then ibuprofen (400 mg/6 hours) in two subsequent cycles or vice versa. The pain intensity, using VAS, was recorded immediately before taking the medication (0 hour) and after 4, 12, 24, 48–60, 96–120 hours. Main outcome measures included effectiveness of pain relief defined as drop of VAS to 3 or less, patient's global evaluation of the drug, absence from school, the use of a rescue medication, and, in those who continued the treatment, the pain intensity difference (PID) at different points after start of medication and its sum (SPID).ResultsUzara was comparably effective to ibuprofen (78.3% vs. 86.7% of cycles; respectively), with comparable rates of effectiveness on global evaluation (being around 50% for either drug), and rates of school absences (11.7% vs. 13.3%; respectively). The need for rescue medication was different (18.3% and 10%; respectively), albeit with no statistical significance. The means of PID at different time points and SPID were comparable, with significantly lower average mean of VAS scores compared to that felt with no medication (1.6 vs. 6.8, p<0.001). Side effects were less with uzara than ibuprofen (0% vs. 8.3%, p<0.05).ConclusionsUzara might be as effective as ibuprofen in management of primary dysmenorrhea but with less side effects. These findings need to be confirmed by a properly designed trial with a larger sample size.Trial RegistrationCurrent Controlled Trials ISRCTN25618258
Highlights
Primary dysmenorrhea is a common gynecological problem [1,2,3]
Uzara might be as effective as ibuprofen in management of primary dysmenorrhea but with less side effects
The combined oral contraceptives pills (COCPs), which act by decreasing menstrual fluid volume and prostaglandin production have been advocated to treat primary dysmenorrhea, there is insufficient evidence for pain relief with their use [6]
Summary
Primary dysmenorrhea is a common gynecological problem [1,2,3]. Nonsteroidal anti-inflammatory drugs (NSAIDs) are well established as first-line therapy. Common side effects are nausea, vomiting, dyspepsia and diarrhea; with less common serious ones [4]. They act by suppressing the production of endometrial prostaglandins [2]. They are significantly more effective in relieving pain when compared to placebo or paracetamol. They have an overall treatment failure rate of approximately 25%. The combined oral contraceptives pills (COCPs), which act by decreasing menstrual fluid volume and prostaglandin production have been advocated to treat primary dysmenorrhea, there is insufficient evidence for pain relief with their use [6]. Other alternative therapeutic modalities include acupuncture [7], transcutaneous electrical nerve stimulation (TENS) [8], laparoscopic presacral neurectomy [9], spinal manipulation [10], behavioral interventions [11], Zingiber officinale R. rhizomes (ginger) [12], and herbal and dietary therapies (including magnesium, vitamin B6, vitamin B1, vitamin E, omega fatty acids, and Japanese herbal combination) [13]
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