Background and aims: Osteoporosis is one of the most common metabolic bone diseases with systemic involvement of the body skeleton. The Peganum harmala seed contains high amounts of carboline alkaloids, which have been shown to have positive effects on bone formation in animal studies. In the present study, the effect of an oral capsule of P. harmala seed on bone density was evaluated in menopausal women prone to osteoporosis.
Methods: In this randomized controlled clinical trial, 100 women referring to the orthopedic clinic with a diagnosis of osteoporosis were included and divided into the intervention group treated with calcium D (500 mg) twice a day, Osteofos (70 mg) per week, and P. harmala (500 mg) twice‐a‐day, and the control group treated with calcium D and Osteofos. Before and three months after the intervention, patients were evaluated for osteoporosis using bone densitometry. Finally, independent t-test, paired t-test, and repeated measures ANOVA were used for statistical analysis.
Results: The mean bone mineral density (BMD) of the femur before and after the intervention showed significant improvements in the intervention and control groups (P<0.001). The mean differences in BMD before and after the intervention were significant in both control and intervention groups with higher improvements in the intervention group (P<0.001). Although the mean BMD of the spine before the intervention was not significantly different between the two groups (P=0.167), it was better in the intervention group after the intervention (P=0.030).
Conclusion: The findings of the present study confirmed the beneficial effects of P. harmala on osteoporosis while the lack of any changes in liver enzymes.