Effect of Magnesium Sulfate Added to Tincture of Opium and Buprenorphine on Pain and Quality of Life in Women with Dysmenorrhea: A Prospective, Randomized, Double-blind, Placebo-controlled Trial

Document Type : Original Article


1 Department of Psychology, School of Humanities, University of Science and Culture AND Preventative Gynecology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran

2 Department of Midwifery, School of Medicine, Qom Branch, Islamic Azad University, Qom, Iran

3 Bijan Center for Substance Abuse Treatment, Tehran, Iran

4 Department of Psychology, Kish International Branch, Islamic Azad University, Kish, Iran

5 Department of Health Psychology, North Tehran Branch, Islamic Azad University, Tehran, Iran

6 Department of Psychology, School of Psychology, Tonekabon Branch, Islamic Azad University, Tonekabon, Iran

7 Department of Food Science and Technology, School of Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran

8 Preventative Gynecology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran


Background: Adding magnesium sulfate (MgSO4) to opioid receptor agonists increases the opioid analgesic
effects via blocking this receptor. The current study aimed to evaluate the effectiveness of adding MgSO4 to
tincture of opium (TOP) and buprenorphine (BUP) on pain and quality of life (QOL).
Methods: In prospective, randomized, double-blind, placebo-controlled clinical trial, one hundred and
sixty-three women with secondary dysmenorrhea caused by endometriosis were selected using a respondentdriven sampling (RDS) and assigned into six groups using block randomization. Patients received 50 mg/kg
MgSO4 in 100 ml saline by micro set in six monthly menstrual periods and completed the visual analogue
scale (VAS) and QOL Questionnaire (QOLQ). Data were analyzed by repeated measures analysis of variance
(ANOVA) and hierarchical regression.
Findings: The primary outcomes showed that pain scores in magnesium (MAG) + opium tincture (OT)
[F = 5.7(1,162), P = 0.004] and MAG+ BUP [F = 4.5(1,162), P = 0.006] groups showed a significant decrease
compared with control group. Also, QOL scores in MAG + OT [F = 4.8(1,162), P = 0.005] and MAG + BUP
[F = 5.9(1,162), P = 0.003] showed a significant increase. However, there was no significant difference
between the two groups (P = 0.140) and the changes did not persist until follow-up (P = 0.810). Secondary
outcomes indicated that the low scores of the two components of QOL including physical and psychological
components were predictors of pain (P = 0.011, Beta > 3.09).
Conclusion: Simultaneous use of MAG with opioids is associated with pain reduction and the improvement of
QOL. However, this hypothesis requires careful handling in a randomized controlled trial