ASF (a Compound of Traditional Chinese Medicine) in the treatment of patients with alcohol dependence: Study protocol of a randomized, double-blinded, placebo-controlled clinical trial
Alcohol dependence is one of the biggest problems facing public health worldwide. Currently, it is an under-diagnosed and under-treated disease. Even when given treatments for addiction withdrawal, over 2/3 of patients who have undergone abstinence-oriented treatment will relapse in the first year....
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| Veröffentlicht in: | Medicine (Baltimore) 2020-12, Vol.99 (52), p.e23899-e23899 |
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| creator | Liang, Xianting Hu, Xiaoyu Zhang, Xia Fu, Hongfang |
| description | Alcohol dependence is one of the biggest problems facing public health worldwide. Currently, it is an under-diagnosed and under-treated disease. Even when given treatments for addiction withdrawal, over 2/3 of patients who have undergone abstinence-oriented treatment will relapse in the first year. Therefore, it is necessary to find an efficacious way to prevent and treat alcohol dependence. ASF (a Compound of Traditional Chinese Medicine) has proven to inhibit the formation and expression of ethanol-induced behavioral sensitization and the development of conditioned place preference in mice. As an empirical prescription for abstinence from alcohol, ASF has long been used in clinical patients. However, the effect of ASF in humans has not yet been investigated. The purpose of this study is to evaluate the efficacy of ASF for patients with alcohol dependence.
The effect of ASF will be studied in a randomized, double-blinded, placebo-controlled clinical trial. 82 outpatients and inpatients will be recruited and randomly assigned to treatment with either ASF or placebo for 6 weeks as a complement to cognitive behavioural therapy. The primary endpoints are the changes in the average daily alcohol consumption of the 2 groups before and after treatment and comparison of the scores of the psychological craving self-rating scale during the courses of treatment of 2 groups. The secondary endpoints include abstinence rates of the 2 groups during the follow-up period, days without consumption, and changes of Short Form Health Survey (SF-36) scores in 2 groups before and after therapy.
This study is the first randomized controlled trial to investigate ASF in the treatment of alcohol dependence. ASF is likely to be a new and effective drug for the treatment of alcohol dependence developed from natural products with a low incidence of side effects or toxicity.
Registry number: ChiCTR2000039397. |
| doi_str_mv | 10.1097/MD.0000000000023899 |
| format | Article |
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The effect of ASF will be studied in a randomized, double-blinded, placebo-controlled clinical trial. 82 outpatients and inpatients will be recruited and randomly assigned to treatment with either ASF or placebo for 6 weeks as a complement to cognitive behavioural therapy. The primary endpoints are the changes in the average daily alcohol consumption of the 2 groups before and after treatment and comparison of the scores of the psychological craving self-rating scale during the courses of treatment of 2 groups. The secondary endpoints include abstinence rates of the 2 groups during the follow-up period, days without consumption, and changes of Short Form Health Survey (SF-36) scores in 2 groups before and after therapy.
This study is the first randomized controlled trial to investigate ASF in the treatment of alcohol dependence. ASF is likely to be a new and effective drug for the treatment of alcohol dependence developed from natural products with a low incidence of side effects or toxicity.
Registry number: ChiCTR2000039397.</description><identifier>ISSN: 0025-7974</identifier><identifier>EISSN: 1536-5964</identifier><identifier>DOI: 10.1097/MD.0000000000023899</identifier><identifier>PMID: 33350787</identifier><language>eng</language><publisher>United States: Lippincott Williams & Wilkins</publisher><subject>Adult ; Alcohol Abstinence - psychology ; Alcohol Abstinence - statistics & numerical data ; Alcoholism - psychology ; Alcoholism - therapy ; Craving - drug effects ; Diagnostic Self Evaluation ; Double-Blind Method ; Drugs, Chinese Herbal - administration & dosage ; Epimedium ; Female ; Humans ; Male ; Medicine, Chinese Traditional - methods ; Outcome and Process Assessment, Health Care ; Randomized Controlled Trials as Topic ; Study Protocol Clinical Trial ; Ziziphus</subject><ispartof>Medicine (Baltimore), 2020-12, Vol.99 (52), p.e23899-e23899</ispartof><rights>Lippincott Williams & Wilkins</rights><rights>Copyright © 2020 the Author(s). Published by Wolters Kluwer Health, Inc.</rights><rights>Copyright © 2020 the Author(s). Published by Wolters Kluwer Health, Inc. 2020</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c3559-7457dca07a65d5a4e338bb6d80281e9ad494fbbdcacdb8d8631c9927311192453</cites><orcidid>0000-0002-6980-6673</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7769360/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7769360/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,860,881,27903,27904,53769,53771</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33350787$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Liang, Xianting</creatorcontrib><creatorcontrib>Hu, Xiaoyu</creatorcontrib><creatorcontrib>Zhang, Xia</creatorcontrib><creatorcontrib>Fu, Hongfang</creatorcontrib><title>ASF (a Compound of Traditional Chinese Medicine) in the treatment of patients with alcohol dependence: Study protocol of a randomized, double-blinded, placebo-controlled clinical trial</title><title>Medicine (Baltimore)</title><addtitle>Medicine (Baltimore)</addtitle><description>Alcohol dependence is one of the biggest problems facing public health worldwide. Currently, it is an under-diagnosed and under-treated disease. Even when given treatments for addiction withdrawal, over 2/3 of patients who have undergone abstinence-oriented treatment will relapse in the first year. Therefore, it is necessary to find an efficacious way to prevent and treat alcohol dependence. ASF (a Compound of Traditional Chinese Medicine) has proven to inhibit the formation and expression of ethanol-induced behavioral sensitization and the development of conditioned place preference in mice. As an empirical prescription for abstinence from alcohol, ASF has long been used in clinical patients. However, the effect of ASF in humans has not yet been investigated. The purpose of this study is to evaluate the efficacy of ASF for patients with alcohol dependence.
The effect of ASF will be studied in a randomized, double-blinded, placebo-controlled clinical trial. 82 outpatients and inpatients will be recruited and randomly assigned to treatment with either ASF or placebo for 6 weeks as a complement to cognitive behavioural therapy. The primary endpoints are the changes in the average daily alcohol consumption of the 2 groups before and after treatment and comparison of the scores of the psychological craving self-rating scale during the courses of treatment of 2 groups. The secondary endpoints include abstinence rates of the 2 groups during the follow-up period, days without consumption, and changes of Short Form Health Survey (SF-36) scores in 2 groups before and after therapy.
This study is the first randomized controlled trial to investigate ASF in the treatment of alcohol dependence. ASF is likely to be a new and effective drug for the treatment of alcohol dependence developed from natural products with a low incidence of side effects or toxicity.
Registry number: ChiCTR2000039397.</description><subject>Adult</subject><subject>Alcohol Abstinence - psychology</subject><subject>Alcohol Abstinence - statistics & numerical data</subject><subject>Alcoholism - psychology</subject><subject>Alcoholism - therapy</subject><subject>Craving - drug effects</subject><subject>Diagnostic Self Evaluation</subject><subject>Double-Blind Method</subject><subject>Drugs, Chinese Herbal - administration & dosage</subject><subject>Epimedium</subject><subject>Female</subject><subject>Humans</subject><subject>Male</subject><subject>Medicine, Chinese Traditional - methods</subject><subject>Outcome and Process Assessment, Health Care</subject><subject>Randomized Controlled Trials as Topic</subject><subject>Study Protocol Clinical Trial</subject><subject>Ziziphus</subject><issn>0025-7974</issn><issn>1536-5964</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpdUctu1DAUtRCIDoUvQEJegkSKn3HMolI1pYDUEYuWdeTYd4jBY0eOw6h8GZ-Hy0B5eON773n4Wgehp5ScUKLVq835CflzGO-0vodWVPK2kboV99GqTmWjtBJH6NE8fyaEcsXEQ3TEOZdEdWqFvp9dXeDnBq_TbkpLdDht8XU2zhefogl4PfoIM-ANOG9r-QL7iMsIuGQwZQex3ComU3wtZ7z3ZcQm2DSmgB1MEB1EC6_xVVncDZ5yKslWqGoMzia6tPPfwL3ELi1DgGYIvipqPwVjYUiNTbHkFAI4bCvmbd2pZG_CY_Rga8IMT37dx-jjxZvr9bvm8sPb9-uzy8ZyKXWjhFTOGqJMK500AjjvhqF1HWEdBW2c0GI7DJVi3dC5ruXUas0Up5RqJiQ_RqcH32kZduBs_WY2oZ-y35l80yfj-3-R6Mf-U_raK9Vq3pJqwA8GNqd5zrC901LS3wbZb877_4Osqmd_P3un-Z1cJYgDYZ9CgTx_Ccsecj-CCWX86SeVZg0jjFDGBGnqpC70AyZorSQ</recordid><startdate>20201224</startdate><enddate>20201224</enddate><creator>Liang, Xianting</creator><creator>Hu, Xiaoyu</creator><creator>Zhang, Xia</creator><creator>Fu, Hongfang</creator><general>Lippincott Williams & Wilkins</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0002-6980-6673</orcidid></search><sort><creationdate>20201224</creationdate><title>ASF (a Compound of Traditional Chinese Medicine) in the treatment of patients with alcohol dependence: Study protocol of a randomized, double-blinded, placebo-controlled clinical trial</title><author>Liang, Xianting ; Hu, Xiaoyu ; Zhang, Xia ; Fu, Hongfang</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3559-7457dca07a65d5a4e338bb6d80281e9ad494fbbdcacdb8d8631c9927311192453</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Adult</topic><topic>Alcohol Abstinence - psychology</topic><topic>Alcohol Abstinence - statistics & numerical data</topic><topic>Alcoholism - psychology</topic><topic>Alcoholism - therapy</topic><topic>Craving - drug effects</topic><topic>Diagnostic Self Evaluation</topic><topic>Double-Blind Method</topic><topic>Drugs, Chinese Herbal - administration & dosage</topic><topic>Epimedium</topic><topic>Female</topic><topic>Humans</topic><topic>Male</topic><topic>Medicine, Chinese Traditional - methods</topic><topic>Outcome and Process Assessment, Health Care</topic><topic>Randomized Controlled Trials as Topic</topic><topic>Study Protocol Clinical Trial</topic><topic>Ziziphus</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Liang, Xianting</creatorcontrib><creatorcontrib>Hu, Xiaoyu</creatorcontrib><creatorcontrib>Zhang, Xia</creatorcontrib><creatorcontrib>Fu, Hongfang</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Medicine (Baltimore)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Liang, Xianting</au><au>Hu, Xiaoyu</au><au>Zhang, Xia</au><au>Fu, Hongfang</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>ASF (a Compound of Traditional Chinese Medicine) in the treatment of patients with alcohol dependence: Study protocol of a randomized, double-blinded, placebo-controlled clinical trial</atitle><jtitle>Medicine (Baltimore)</jtitle><addtitle>Medicine (Baltimore)</addtitle><date>2020-12-24</date><risdate>2020</risdate><volume>99</volume><issue>52</issue><spage>e23899</spage><epage>e23899</epage><pages>e23899-e23899</pages><issn>0025-7974</issn><eissn>1536-5964</eissn><abstract>Alcohol dependence is one of the biggest problems facing public health worldwide. Currently, it is an under-diagnosed and under-treated disease. Even when given treatments for addiction withdrawal, over 2/3 of patients who have undergone abstinence-oriented treatment will relapse in the first year. Therefore, it is necessary to find an efficacious way to prevent and treat alcohol dependence. ASF (a Compound of Traditional Chinese Medicine) has proven to inhibit the formation and expression of ethanol-induced behavioral sensitization and the development of conditioned place preference in mice. As an empirical prescription for abstinence from alcohol, ASF has long been used in clinical patients. However, the effect of ASF in humans has not yet been investigated. The purpose of this study is to evaluate the efficacy of ASF for patients with alcohol dependence.
The effect of ASF will be studied in a randomized, double-blinded, placebo-controlled clinical trial. 82 outpatients and inpatients will be recruited and randomly assigned to treatment with either ASF or placebo for 6 weeks as a complement to cognitive behavioural therapy. The primary endpoints are the changes in the average daily alcohol consumption of the 2 groups before and after treatment and comparison of the scores of the psychological craving self-rating scale during the courses of treatment of 2 groups. The secondary endpoints include abstinence rates of the 2 groups during the follow-up period, days without consumption, and changes of Short Form Health Survey (SF-36) scores in 2 groups before and after therapy.
This study is the first randomized controlled trial to investigate ASF in the treatment of alcohol dependence. ASF is likely to be a new and effective drug for the treatment of alcohol dependence developed from natural products with a low incidence of side effects or toxicity.
Registry number: ChiCTR2000039397.</abstract><cop>United States</cop><pub>Lippincott Williams & Wilkins</pub><pmid>33350787</pmid><doi>10.1097/MD.0000000000023899</doi><orcidid>https://orcid.org/0000-0002-6980-6673</orcidid><oa>free_for_read</oa></addata></record> |
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| source | MEDLINE; DOAJ Directory of Open Access Journals; IngentaConnect Open Access; PubMed Central; Alma/SFX Local Collection; EZB Electronic Journals Library; Wolters Kluwer Open Access |
| subjects | Adult Alcohol Abstinence - psychology Alcohol Abstinence - statistics & numerical data Alcoholism - psychology Alcoholism - therapy Craving - drug effects Diagnostic Self Evaluation Double-Blind Method Drugs, Chinese Herbal - administration & dosage Epimedium Female Humans Male Medicine, Chinese Traditional - methods Outcome and Process Assessment, Health Care Randomized Controlled Trials as Topic Study Protocol Clinical Trial Ziziphus |
| title | ASF (a Compound of Traditional Chinese Medicine) in the treatment of patients with alcohol dependence: Study protocol of a randomized, double-blinded, placebo-controlled clinical trial |
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