Volume 18, Issue 1 (4-2024)
Qom Univ Med Sci J 2024, 18(1): 412-425 |
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Ethics code: IR.IAU.DAMGHAN.REC.1399.003
Clinical trials code: IRCT20151228025732N62
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Shokravian M, Miladi-Gorji H, Shajiee H, Ghorbani R, Mazinani M. Effect of Raha Herbal Syrup on Craving Severity and Serum Cortisol Level of Men With Opiate Use Disorder Under Opium Tincture Maintenance Therapy: A Randomized Clinical Trial. Qom Univ Med Sci J 2024; 18 (1) : 2786.1
URL: http://journal.muq.ac.ir/article-1-3625-en.html
URL: http://journal.muq.ac.ir/article-1-3625-en.html
1- Department of Biology, Faculty of Science, Damghan Branch, Islamic Azad University, Damghan, Iran.
2- Research Center of Physiology, Semnan University of Medical Sciences, Semnan, Iran. ,miladi331@yahoo.com
3- Social Determinants of Health Research Center, Semnan University of Medical Sciences, Semnan, Iran.
4- Sina Addiction Treatment Center, Semnan, Iran.
2- Research Center of Physiology, Semnan University of Medical Sciences, Semnan, Iran. ,
3- Social Determinants of Health Research Center, Semnan University of Medical Sciences, Semnan, Iran.
4- Sina Addiction Treatment Center, Semnan, Iran.
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Introduction
Opioid addiction causes complicated behavioural changes (dependence, tolerance, and sensitivity), which may eventually lead to relapse even after long periods of abstinence. Opium Tincture (OT) is used widely as an alternative treatment in Iran. However, according to studies, the use of OT alone for the treatment of opioid addiction, especially in case of psychological dependence, is still a subject of debate. The use of OT in addicts reduced the severity of physical dependence to some extent, but a relapse occurred after abstinence. It seems that combined treatments using OT and medicine can be more effective than OT alone. One of proposed herbal medicines in this filed is called Raha syrup (Isfahan, Iran). Previous studies have shown that the active ingredients in this syrup can effectively treat morphine dependence. Given the beneficial effects of the active compounds in Raha syrup on, this study aimed to investigate the effect of Raha syrup on craving and serum cortisol level in patients with opioid use disorder (OUD) under maintenance therapy with OT.
Methods
This is a randomized controlled clinical trial using a pre-test/post-test design. Of 107 men with OUD under OT maintenance therapy assessed for eligibility, 23 declined to participate and 14 did not match the criteria. Finally, 70 patients met all inclusion criteria. Since eight patients showed little motivation to continue participation, they were excluded. The final number of samples was 62. They were randomly divided into two groups of OT (n=30 ), and OT+Raha syrup (n=32). Both groups completed the desire for drug questionnaire before and after the treatment. Venous blood samples were taken from patients after 8 hours of fasting before and after the treatment to measure serum cortisol levels. The normality of quantitative variables was determined by the Shapiro-Wilk test. Comparison between two groups was done using Chi-square test, Fisher’s exact test, Mann-Whitney U test, Student’s t-test and paired t-test if needed. The statistical significance level was set at 0.05.
Results
After intervention, the momentary assessment showed that craving intensity score in the OT+Raha syrup group decreased by 8.72, while the OT group showed a decrease by 1.77. This reduction in mean score was significantly different between the two groups (P<0.001). Moreover, after the intervention, the mean serum cortisol level in the OT+Raha syrup group decreased by 1.09, while the OT group showed a decrease by 0.01, but it was significantly different.
Conclusion
The craving intensity for opioid decreased in men received OT alone or in combination with Raha syrup, where the group received combined treatment showed more reduction, and there is a significant difference between the two groups. However, there is no significant difference in cortisol levels between the two groups. Therefore, the use of Raha syrup with OT may be beneficial for the management of abstinence from opioid.
Ethical Considerations
Compliance with ethical guidelines
The present study was approved by the Ethics Committee of Damghan Branch, Islamic Azad University (Code: IR.IAU.DAMGHAN.REC.1399.003) and registered in Iran Clinical Trials (ID: IRCT20151228025732N62).
Funding
The present article was extracted from the PhD dissertation of Mrs Monireh Shokravian, approved by Department of Biology, Faculty of Science, Damghan Branch, Islamic Azad University, Damghan, Iran.
Authors contributions
All authors equally contributed to preparing this article.
Conflicts of interest
The authors declared no conflict of interest.
Acknowledgments
All the staff of Sinai Semnan De-addiction Center are appreciated and thanked for their cooperation in this study.
Opioid addiction causes complicated behavioural changes (dependence, tolerance, and sensitivity), which may eventually lead to relapse even after long periods of abstinence. Opium Tincture (OT) is used widely as an alternative treatment in Iran. However, according to studies, the use of OT alone for the treatment of opioid addiction, especially in case of psychological dependence, is still a subject of debate. The use of OT in addicts reduced the severity of physical dependence to some extent, but a relapse occurred after abstinence. It seems that combined treatments using OT and medicine can be more effective than OT alone. One of proposed herbal medicines in this filed is called Raha syrup (Isfahan, Iran). Previous studies have shown that the active ingredients in this syrup can effectively treat morphine dependence. Given the beneficial effects of the active compounds in Raha syrup on, this study aimed to investigate the effect of Raha syrup on craving and serum cortisol level in patients with opioid use disorder (OUD) under maintenance therapy with OT.
Methods
This is a randomized controlled clinical trial using a pre-test/post-test design. Of 107 men with OUD under OT maintenance therapy assessed for eligibility, 23 declined to participate and 14 did not match the criteria. Finally, 70 patients met all inclusion criteria. Since eight patients showed little motivation to continue participation, they were excluded. The final number of samples was 62. They were randomly divided into two groups of OT (n=30 ), and OT+Raha syrup (n=32). Both groups completed the desire for drug questionnaire before and after the treatment. Venous blood samples were taken from patients after 8 hours of fasting before and after the treatment to measure serum cortisol levels. The normality of quantitative variables was determined by the Shapiro-Wilk test. Comparison between two groups was done using Chi-square test, Fisher’s exact test, Mann-Whitney U test, Student’s t-test and paired t-test if needed. The statistical significance level was set at 0.05.
Results
After intervention, the momentary assessment showed that craving intensity score in the OT+Raha syrup group decreased by 8.72, while the OT group showed a decrease by 1.77. This reduction in mean score was significantly different between the two groups (P<0.001). Moreover, after the intervention, the mean serum cortisol level in the OT+Raha syrup group decreased by 1.09, while the OT group showed a decrease by 0.01, but it was significantly different.
Conclusion
The craving intensity for opioid decreased in men received OT alone or in combination with Raha syrup, where the group received combined treatment showed more reduction, and there is a significant difference between the two groups. However, there is no significant difference in cortisol levels between the two groups. Therefore, the use of Raha syrup with OT may be beneficial for the management of abstinence from opioid.
Ethical Considerations
Compliance with ethical guidelines
The present study was approved by the Ethics Committee of Damghan Branch, Islamic Azad University (Code: IR.IAU.DAMGHAN.REC.1399.003) and registered in Iran Clinical Trials (ID: IRCT20151228025732N62).
Funding
The present article was extracted from the PhD dissertation of Mrs Monireh Shokravian, approved by Department of Biology, Faculty of Science, Damghan Branch, Islamic Azad University, Damghan, Iran.
Authors contributions
All authors equally contributed to preparing this article.
Conflicts of interest
The authors declared no conflict of interest.
Acknowledgments
All the staff of Sinai Semnan De-addiction Center are appreciated and thanked for their cooperation in this study.
Type of Study: Original Article |
Subject:
فیزیولوژی
Received: 2022/12/9 | Accepted: 2023/10/25 | Published: 2024/04/29
Received: 2022/12/9 | Accepted: 2023/10/25 | Published: 2024/04/29
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