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Efficacy and Safety of Adjunctive Nifedipine with Acetaminophen in Primary Dysmenorrhea: A Randomized Clinical Trial
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Farnaz Rezaie1    , Zeinab Hemati2 , Roya Mardani2 , Yousef Moradi3 |
1- Student Research Committee, Kurdistan University of Medical Sciences Sanandaj, Iran.
2- Department of Gynecology and Obstetrics, School of Medicine, Kurdistan University of Medical Sciences, Sanandaj, Iran
3- Social Determinants of Health Research Center, Research Institute for Health Development, Kurdistan University of Medical Sciences, Sanandaj, Iran. , Yousfmoradi211@yahoo.com |
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Abstract: (32 Views) |
Background and Aim: Primary dysmenorrhea is a common gynecological condition characterized by recurrent cramping menstrual pain in the absence of pelvic pathology. Although nonsteroidal anti-inflammatory drugs (NSAIDs) are widely used, inadequate pain relief in some patients highlights the need for adjunctive therapies. This study aimed to evaluate the efficacy and safety of nifedipine as an adjunct to acetaminophen in women with primary dysmenorrhea.
Materials and Methods: In this randomized, double-blind clinical trial conducted in Sanandaj, Iran (2024), 110 women aged 18–35 years with primary dysmenorrhea were randomly assigned in a 1:1 ratio to either the intervention or control group. The intervention group received nifedipine (10 mg) plus acetaminophen (325 mg), while the control group received acetaminophen (325 mg) alone. At the onset of menstrual pain, participants took one dose of the assigned regimen. If adequate relief was not achieved after 30 minutes or if pain recurred, the same dose was repeated every 12 hours for up to 48 hours during each menstrual cycle. The intervention was continued for three consecutive cycles. Primary outcomes included pain intensity (VAS), quality of life (SF-12), physical activity (PPAQ), and adverse events. Data were analyzed using repeated-measures ANCOVA adjusted for baseline covariates.
Results: All participants completed the study. Pain intensity was significantly lower in the nifedipine plus acetaminophen group compared with the acetaminophen-only group across all three cycles (Cycle 1: P = 0.017; Cycle 2: P = 0.007; Cycle 3: P < 0.0001). Quality of life and physical activity levels improved significantly in the intervention group (P < 0.0001). Adverse events were more frequent in the nifedipine group (OR = 10.02; 95% CI: 2.91–34.50; P < 0.001); however, they were mild and transient.
Conclusion: Adjunctive nifedipine combined with acetaminophen significantly reduced menstrual pain and improved functional outcomes compared with acetaminophen alone. Although mild adverse events were more common in the combination group, the treatment was generally well tolerated.
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| Keywords: Nifedipine, Primary Dysmenorrhea, Pain Intensity, Quality of Life, Clinical Trial, Randomization |
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Type of Study: Original Research |
Subject:
Medicine - Obstetrics and Gynecology
Received: 2025/10/10 | Accepted: 2026/05/23
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