The effects of Berberis vulgaris L. root extract on the opiate withdrawal syndrome and psychological factors: a randomized double-blind clinical trial

Fatemeh Dabaghzadeh; Fariba Sharififar; Amir-Mohammad Ahmadzadeh; Somayyeh Karami-Mohajeri

doi:10.1515/jbcpp-2020-0327

Article

The effects of Berberis vulgaris L. root extract on the opiate withdrawal syndrome and psychological factors: a randomized double-blind clinical trial

Fatemeh Dabaghzadeh , Fariba Sharififar , Amir-Mohammad Ahmadzadeh and Somayyeh Karami-Mohajeri

Published/Copyright: June 21, 2021

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From the journal Journal of Basic and Clinical Physiology and Pharmacology Volume 34 Issue 4

Abstract

Objectives

In this clinical trial, the effect of aqueous extract of Berberis vulgaris L. was investigated on opiate withdrawal syndrome, depression, anxiety, stress, and sleep quality in opioid addicts which were under methadone maintenance therapy.

Methods

For this purpose, 52 opiate addicts were randomly selected of whom 28 received 500 mg capsules of B. vulgaris extract (treatment) and the rest received 500 mg of starch capsules (placebo), twice daily for 4 weeks. Signs and symptoms of opiate withdrawal syndrome, depression, anxiety, stress, and sleep quality were assessed through Clinical Opiate Withdrawal Scale (COWS), Pittsburgh Sleep Quality Inventory (PSQI) and Depression Anxiety Stress Scales-21 (DASS-21) questionnaires at baseline and after 7, 14, and 28 days of receiving intervention.

Results

Signs and symptoms of opiate withdrawal syndrome were significantly improved in those who received the extract for 1 month compared to the placebo group. However, there were no significant differences in depression, anxiety, stress, and sleep quality scores in the treatment group compared to those in the placebo group.

Conclusions

The extract of B. vulgaris root as a traditional herbal product in combination with methadone could improve the symptoms and signs of opiate withdrawal.

Keywords: anxiety; berberine; Berberis vulgaris L.; depression; opioid withdrawal; sleep quality; stress

Corresponding author: Somayyeh Karami-Mohajeri, PhD in Toxicology, Pharm D, Pharmaceutics Research Center, Institute of Neuropharmacology, Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman 7616913555, Iran, Phone: + 98 34 31325001, Fax: + 98 34 31325003, E-mail: s_karami@kmu.ac.ir

Acknowledgments

The authors wish to thank Ehsan Mehrabi-Kermani for the English editing of the paper.

Research funding: None declared.
Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.
Competing interests: Authors state no conflict of interest.
Informed consent: Informed consent was obtained from all individuals included in this study.
Ethical approval: This study was approved by the ethics committee of Kerman University of Medical Sciences with the identification code of IR.KMU.REC.1397.205. Also, this clinical trial was registered in the Iranian Registry of Clinical Trial with identity number IRCT20180114038356N3. All participants in this study read and signed a written consent form. Patient information remained confidential and at each stage of the project, patients were allowed to discontinue their cooperation without worrying about the impact of this decision on their treatment process.

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Received: 2020-10-29

Accepted: 2021-04-15

Published Online: 2021-06-21

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Articles in the same Issue

https://doi.org/10.1515/jbcpp-2020-0327

Keywords for this article

anxiety; berberine; Berberis vulgaris L.; depression; opioid withdrawal; sleep quality; stress