Efficacy and safety of Sophora alopecuroides var. alopecuroides seed extract for opioid detoxification: A randomized, double‐blind, and placebo‐controlled clinical trial

The seeds of Sophora alopecuroides L. var. alopecuroides (S. alopecuroides) have alleviated morphine withdrawal in mice. Therefore, in this study, the alkaloid composition of S. alopecuroides extract was determined by gas chromatography (GC) and gas chromatography–mass spectrometry (GC–MS) analysis....

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Veröffentlicht in:Phytotherapy research 2020-05, Vol.34 (5), p.1108-1113
Hauptverfasser: Kianbakht, Saeed, Hajiaghaee, Reza, Akhondzadeh, Shahin
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description The seeds of Sophora alopecuroides L. var. alopecuroides (S. alopecuroides) have alleviated morphine withdrawal in mice. Therefore, in this study, the alkaloid composition of S. alopecuroides extract was determined by gas chromatography (GC) and gas chromatography–mass spectrometry (GC–MS) analysis. Moreover, 50 abstinent opium addicts consumed three 400 mg extract capsules once daily and 50 other patients took placebo for 8 days. At the baseline and days 3 and 8, the clinical opiate withdrawal scale (COWS) was used to assess withdrawal symptoms. At the baseline and Day 8, the patients' blood levels of serum glutamate oxaloacetate transferase; serum glutamate pyruvate transferase; alkaline phosphatase; total, direct, and indirect bilirubins; creatinine and blood urea nitrogen; complete blood count; and prothrombine time were measured. The groups' parameter values were also compared. Sophocarpine, matrine, and sophoramine were the major alkaloids constituting, respectively, 32.85, 26.55, and 6.91% of the extract. The extract decreased the COWS score at Days 3 and 8 significantly compared with the placebo (p < .001). The extract did not significantly affect the blood parameters' values compared with the placebo (p > .05). There was no adverse drug effect. In conclusion, the extract reduces the acute opioid withdrawal symptoms and seems to have good safety and tolerability.
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Therefore, in this study, the alkaloid composition of S. alopecuroides extract was determined by gas chromatography (GC) and gas chromatography–mass spectrometry (GC–MS) analysis. Moreover, 50 abstinent opium addicts consumed three 400 mg extract capsules once daily and 50 other patients took placebo for 8 days. At the baseline and days 3 and 8, the clinical opiate withdrawal scale (COWS) was used to assess withdrawal symptoms. At the baseline and Day 8, the patients' blood levels of serum glutamate oxaloacetate transferase; serum glutamate pyruvate transferase; alkaline phosphatase; total, direct, and indirect bilirubins; creatinine and blood urea nitrogen; complete blood count; and prothrombine time were measured. The groups' parameter values were also compared. Sophocarpine, matrine, and sophoramine were the major alkaloids constituting, respectively, 32.85, 26.55, and 6.91% of the extract. The extract decreased the COWS score at Days 3 and 8 significantly compared with the placebo (p &lt; .001). The extract did not significantly affect the blood parameters' values compared with the placebo (p &gt; .05). There was no adverse drug effect. 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Therefore, in this study, the alkaloid composition of S. alopecuroides extract was determined by gas chromatography (GC) and gas chromatography–mass spectrometry (GC–MS) analysis. Moreover, 50 abstinent opium addicts consumed three 400 mg extract capsules once daily and 50 other patients took placebo for 8 days. At the baseline and days 3 and 8, the clinical opiate withdrawal scale (COWS) was used to assess withdrawal symptoms. At the baseline and Day 8, the patients' blood levels of serum glutamate oxaloacetate transferase; serum glutamate pyruvate transferase; alkaline phosphatase; total, direct, and indirect bilirubins; creatinine and blood urea nitrogen; complete blood count; and prothrombine time were measured. The groups' parameter values were also compared. Sophocarpine, matrine, and sophoramine were the major alkaloids constituting, respectively, 32.85, 26.55, and 6.91% of the extract. The extract decreased the COWS score at Days 3 and 8 significantly compared with the placebo (p &lt; .001). The extract did not significantly affect the blood parameters' values compared with the placebo (p &gt; .05). There was no adverse drug effect. 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The extract decreased the COWS score at Days 3 and 8 significantly compared with the placebo (p &lt; .001). The extract did not significantly affect the blood parameters' values compared with the placebo (p &gt; .05). There was no adverse drug effect. In conclusion, the extract reduces the acute opioid withdrawal symptoms and seems to have good safety and tolerability.</abstract><cop>England</cop><pub>Wiley Subscription Services, Inc</pub><pmid>31793731</pmid><doi>10.1002/ptr.6578</doi><tpages>6</tpages><orcidid>https://orcid.org/0000-0002-2086-248X</orcidid></addata></record>
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subjects Addicts
Alkaline phosphatase
Alkaloids
Blood
Blood levels
Cattle
Chromatography
Clinical trials
Creatinine
Detoxification
Double-blind studies
Drug abuse
Drug withdrawal
Gas chromatography
Mass spectrometry
Mass spectroscopy
Morphine
Narcotics
opioid
Opioids
Parameters
Pyruvic acid
Safety
Seeds
Sophora alopecuroides
Urea
Withdrawal
title Efficacy and safety of Sophora alopecuroides var. alopecuroides seed extract for opioid detoxification: A randomized, double‐blind, and placebo‐controlled clinical trial
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