Efficacy and Safety of Mulberry Twig Alkaloids Tablet for Treatment of Type 2 Diabetes: A Randomized, Double-Blind, Placebo-Controlled Multicenter Clinical Study
Objective To assess the efficacy and safety of mulberry twig alkaloids (Sangzhi alkaloids, SZ-A) for treatment of type 2 diabetes in a randomized, double-blind, placebo-controlled multicenter clinical trial. Methods A total of 200 patients were randomized to receive SZ-A ( n =100) or placebo ( n =10...
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| Veröffentlicht in: | Chinese journal of integrative medicine 2022-04, Vol.28 (4), p.304-311 |
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| container_title | Chinese journal of integrative medicine |
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| creator | Qu, Ling Liang, Xiao-chun Tian, Guo-qing Zhang, Gai-li Wu, Qun-li Huang, Xiu-mei Cui, Ya-zhong Liu, Yu-ling Shen, Zhu-fang Ma, Guo-qing Lu, Hao Li, Yi Jiang, Hong Yang, Xi-yan Zhang, Guang-de Yang, Chen-hua |
| description | Objective
To assess the efficacy and safety of mulberry twig alkaloids (Sangzhi alkaloids, SZ-A) for treatment of type 2 diabetes in a randomized, double-blind, placebo-controlled multicenter clinical trial.
Methods
A total of 200 patients were randomized to receive SZ-A (
n
=100) or placebo (
n
=100) for 16 weeks. The data analysis system for electronic data capture clinical trial central randomization system was used for randomization and dispensing of drugs. The primary outcome was the change in glycosylated hemoglobin (HbA1c) level. The secondary outcome included the proportions of cases with HbA1c |
| doi_str_mv | 10.1007/s11655-021-2885-9 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2621658730</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2621658730</sourcerecordid><originalsourceid>FETCH-LOGICAL-c344t-4b80f33876ee52f80a1aa6692461ebb29fa93b22f2e5bd1ebee1ba468b5f10ef3</originalsourceid><addsrcrecordid>eNp9kc9uFSEUxonR2D_6AG4MSxdigRmYGXfX29Y2qdHYcU1g5tBQmeEWmJjxbXxTubm1S1cc4Pd9nMOH0BtGPzBKm7PEmBSCUM4Ib1tBumfomHVdRWhN-fNSy4aXmokjdJLSPaWikVS8REeVoHXLa3qM_lxY6wY9rFjPI77VFvKKg8VfFm8gxhX3v9wd3vif2gc3Jtxr4yFjGyLuI-g8wZz3fL_uAHN87rSBDOkj3uDvxTFM7jeM7_F5WIqOfPJuLrtvXg9gAtmGOcfgPYz797IbihlEvC1U6cnj27yM6yv0wmqf4PXjeop-XF702yty8_Xz9XZzQ4aqrjOpTUttVbWNBBDctlQzraXseC0ZGMM7q7vKcG45CDOWIwBmdC1bIyyjYKtT9O7gu4vhYYGU1eTSAN7rGcKSFJe8_HbbVLSg7IAOMaQUwapddJOOq2JU7ZNRh2RUSUbtk1Fd0bx9tF_MBOOT4l8UBeAHIJWr-Q6iug9LnMvI_3H9C3ALmq8</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2621658730</pqid></control><display><type>article</type><title>Efficacy and Safety of Mulberry Twig Alkaloids Tablet for Treatment of Type 2 Diabetes: A Randomized, Double-Blind, Placebo-Controlled Multicenter Clinical Study</title><source>SpringerNature Journals</source><source>Alma/SFX Local Collection</source><creator>Qu, Ling ; Liang, Xiao-chun ; Tian, Guo-qing ; Zhang, Gai-li ; Wu, Qun-li ; Huang, Xiu-mei ; Cui, Ya-zhong ; Liu, Yu-ling ; Shen, Zhu-fang ; Ma, Guo-qing ; Lu, Hao ; Li, Yi ; Jiang, Hong ; Yang, Xi-yan ; Zhang, Guang-de ; Yang, Chen-hua</creator><creatorcontrib>Qu, Ling ; Liang, Xiao-chun ; Tian, Guo-qing ; Zhang, Gai-li ; Wu, Qun-li ; Huang, Xiu-mei ; Cui, Ya-zhong ; Liu, Yu-ling ; Shen, Zhu-fang ; Ma, Guo-qing ; Lu, Hao ; Li, Yi ; Jiang, Hong ; Yang, Xi-yan ; Zhang, Guang-de ; Yang, Chen-hua</creatorcontrib><description>Objective
To assess the efficacy and safety of mulberry twig alkaloids (Sangzhi alkaloids, SZ-A) for treatment of type 2 diabetes in a randomized, double-blind, placebo-controlled multicenter clinical trial.
Methods
A total of 200 patients were randomized to receive SZ-A (
n
=100) or placebo (
n
=100) for 16 weeks. The data analysis system for electronic data capture clinical trial central randomization system was used for randomization and dispensing of drugs. The primary outcome was the change in glycosylated hemoglobin (HbA1c) level. The secondary outcome included the proportions of cases with HbA1c <7.0% and HbA1c <6.5%, fasting blood glucose (FBG), postprandial blood glucose (PBG), area under curve for the PBG (AUC
0-2h
), body weight, and body mass index (BMI). Adverse events (AEs), severe adverse events (SAEs), treatment-related adverse events (TAEs), gastrointestinal disorders (GDs), blood pressure, routine blood tests, and liver and kidney function were monitored.
Results
Compared with baseline, the change of HbA1c at week 16 was −0.80% (95% CI: −0.98% to −0.62%) and −0.09% (95% CI: −0.27% to 0.09%) in SZ-A group and placebo group, respectively. The proportion of patients with HbA1c <7% and <6.5% was higher in the SZ-A group than in the placebo group (46.8%
vs
. 21.6% and 29.9%
vs
. 10.8%). The observed values and changes in FBG, 1 h-PBG, 2 h-PBG, and AUC
0-2h
differed significantly between groups (
P
<0.001), but differences were not significant in body weight and BMI (
P
>0.05). The incidence rates of AEs, TAEs, and GDs differed significantly between groups (
P
=0.010,
P
=0.005, and
P
=0.006, respectively), whereas the incidence rates of SAEs showed no significant differences between groups (
P
=1.000).
Conclusion
SZ-A are effective and safe for treatment of type 2 diabetes. The protocol was registered in
http://www.chictr.org.cn/showproj.aspx?proj=60117
(ChiCTR2000038550)</description><identifier>ISSN: 1672-0415</identifier><identifier>EISSN: 1993-0402</identifier><identifier>DOI: 10.1007/s11655-021-2885-9</identifier><identifier>PMID: 35048240</identifier><language>eng</language><publisher>Singapore: Springer Singapore</publisher><subject>Medicine ; Medicine & Public Health ; Original Article</subject><ispartof>Chinese journal of integrative medicine, 2022-04, Vol.28 (4), p.304-311</ispartof><rights>The Chinese Journal of Integrated Traditional and Western Medicine Press and Springer-Verlag GmbH Germany, part of Springer Nature 2022</rights><rights>2022. The Chinese Journal of Integrated Traditional and Western Medicine Press and Springer-Verlag GmbH Germany, part of Springer Nature.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c344t-4b80f33876ee52f80a1aa6692461ebb29fa93b22f2e5bd1ebee1ba468b5f10ef3</citedby><cites>FETCH-LOGICAL-c344t-4b80f33876ee52f80a1aa6692461ebb29fa93b22f2e5bd1ebee1ba468b5f10ef3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s11655-021-2885-9$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s11655-021-2885-9$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,780,784,27924,27925,41488,42557,51319</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/35048240$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Qu, Ling</creatorcontrib><creatorcontrib>Liang, Xiao-chun</creatorcontrib><creatorcontrib>Tian, Guo-qing</creatorcontrib><creatorcontrib>Zhang, Gai-li</creatorcontrib><creatorcontrib>Wu, Qun-li</creatorcontrib><creatorcontrib>Huang, Xiu-mei</creatorcontrib><creatorcontrib>Cui, Ya-zhong</creatorcontrib><creatorcontrib>Liu, Yu-ling</creatorcontrib><creatorcontrib>Shen, Zhu-fang</creatorcontrib><creatorcontrib>Ma, Guo-qing</creatorcontrib><creatorcontrib>Lu, Hao</creatorcontrib><creatorcontrib>Li, Yi</creatorcontrib><creatorcontrib>Jiang, Hong</creatorcontrib><creatorcontrib>Yang, Xi-yan</creatorcontrib><creatorcontrib>Zhang, Guang-de</creatorcontrib><creatorcontrib>Yang, Chen-hua</creatorcontrib><title>Efficacy and Safety of Mulberry Twig Alkaloids Tablet for Treatment of Type 2 Diabetes: A Randomized, Double-Blind, Placebo-Controlled Multicenter Clinical Study</title><title>Chinese journal of integrative medicine</title><addtitle>Chin. J. Integr. Med</addtitle><addtitle>Chin J Integr Med</addtitle><description>Objective
To assess the efficacy and safety of mulberry twig alkaloids (Sangzhi alkaloids, SZ-A) for treatment of type 2 diabetes in a randomized, double-blind, placebo-controlled multicenter clinical trial.
Methods
A total of 200 patients were randomized to receive SZ-A (
n
=100) or placebo (
n
=100) for 16 weeks. The data analysis system for electronic data capture clinical trial central randomization system was used for randomization and dispensing of drugs. The primary outcome was the change in glycosylated hemoglobin (HbA1c) level. The secondary outcome included the proportions of cases with HbA1c <7.0% and HbA1c <6.5%, fasting blood glucose (FBG), postprandial blood glucose (PBG), area under curve for the PBG (AUC
0-2h
), body weight, and body mass index (BMI). Adverse events (AEs), severe adverse events (SAEs), treatment-related adverse events (TAEs), gastrointestinal disorders (GDs), blood pressure, routine blood tests, and liver and kidney function were monitored.
Results
Compared with baseline, the change of HbA1c at week 16 was −0.80% (95% CI: −0.98% to −0.62%) and −0.09% (95% CI: −0.27% to 0.09%) in SZ-A group and placebo group, respectively. The proportion of patients with HbA1c <7% and <6.5% was higher in the SZ-A group than in the placebo group (46.8%
vs
. 21.6% and 29.9%
vs
. 10.8%). The observed values and changes in FBG, 1 h-PBG, 2 h-PBG, and AUC
0-2h
differed significantly between groups (
P
<0.001), but differences were not significant in body weight and BMI (
P
>0.05). The incidence rates of AEs, TAEs, and GDs differed significantly between groups (
P
=0.010,
P
=0.005, and
P
=0.006, respectively), whereas the incidence rates of SAEs showed no significant differences between groups (
P
=1.000).
Conclusion
SZ-A are effective and safe for treatment of type 2 diabetes. The protocol was registered in
http://www.chictr.org.cn/showproj.aspx?proj=60117
(ChiCTR2000038550)</description><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Original Article</subject><issn>1672-0415</issn><issn>1993-0402</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><recordid>eNp9kc9uFSEUxonR2D_6AG4MSxdigRmYGXfX29Y2qdHYcU1g5tBQmeEWmJjxbXxTubm1S1cc4Pd9nMOH0BtGPzBKm7PEmBSCUM4Ib1tBumfomHVdRWhN-fNSy4aXmokjdJLSPaWikVS8REeVoHXLa3qM_lxY6wY9rFjPI77VFvKKg8VfFm8gxhX3v9wd3vif2gc3Jtxr4yFjGyLuI-g8wZz3fL_uAHN87rSBDOkj3uDvxTFM7jeM7_F5WIqOfPJuLrtvXg9gAtmGOcfgPYz797IbihlEvC1U6cnj27yM6yv0wmqf4PXjeop-XF702yty8_Xz9XZzQ4aqrjOpTUttVbWNBBDctlQzraXseC0ZGMM7q7vKcG45CDOWIwBmdC1bIyyjYKtT9O7gu4vhYYGU1eTSAN7rGcKSFJe8_HbbVLSg7IAOMaQUwapddJOOq2JU7ZNRh2RUSUbtk1Fd0bx9tF_MBOOT4l8UBeAHIJWr-Q6iug9LnMvI_3H9C3ALmq8</recordid><startdate>20220401</startdate><enddate>20220401</enddate><creator>Qu, Ling</creator><creator>Liang, Xiao-chun</creator><creator>Tian, Guo-qing</creator><creator>Zhang, Gai-li</creator><creator>Wu, Qun-li</creator><creator>Huang, Xiu-mei</creator><creator>Cui, Ya-zhong</creator><creator>Liu, Yu-ling</creator><creator>Shen, Zhu-fang</creator><creator>Ma, Guo-qing</creator><creator>Lu, Hao</creator><creator>Li, Yi</creator><creator>Jiang, Hong</creator><creator>Yang, Xi-yan</creator><creator>Zhang, Guang-de</creator><creator>Yang, Chen-hua</creator><general>Springer Singapore</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20220401</creationdate><title>Efficacy and Safety of Mulberry Twig Alkaloids Tablet for Treatment of Type 2 Diabetes: A Randomized, Double-Blind, Placebo-Controlled Multicenter Clinical Study</title><author>Qu, Ling ; Liang, Xiao-chun ; Tian, Guo-qing ; Zhang, Gai-li ; Wu, Qun-li ; Huang, Xiu-mei ; Cui, Ya-zhong ; Liu, Yu-ling ; Shen, Zhu-fang ; Ma, Guo-qing ; Lu, Hao ; Li, Yi ; Jiang, Hong ; Yang, Xi-yan ; Zhang, Guang-de ; Yang, Chen-hua</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c344t-4b80f33876ee52f80a1aa6692461ebb29fa93b22f2e5bd1ebee1ba468b5f10ef3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Original Article</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Qu, Ling</creatorcontrib><creatorcontrib>Liang, Xiao-chun</creatorcontrib><creatorcontrib>Tian, Guo-qing</creatorcontrib><creatorcontrib>Zhang, Gai-li</creatorcontrib><creatorcontrib>Wu, Qun-li</creatorcontrib><creatorcontrib>Huang, Xiu-mei</creatorcontrib><creatorcontrib>Cui, Ya-zhong</creatorcontrib><creatorcontrib>Liu, Yu-ling</creatorcontrib><creatorcontrib>Shen, Zhu-fang</creatorcontrib><creatorcontrib>Ma, Guo-qing</creatorcontrib><creatorcontrib>Lu, Hao</creatorcontrib><creatorcontrib>Li, Yi</creatorcontrib><creatorcontrib>Jiang, Hong</creatorcontrib><creatorcontrib>Yang, Xi-yan</creatorcontrib><creatorcontrib>Zhang, Guang-de</creatorcontrib><creatorcontrib>Yang, Chen-hua</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Chinese journal of integrative medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Qu, Ling</au><au>Liang, Xiao-chun</au><au>Tian, Guo-qing</au><au>Zhang, Gai-li</au><au>Wu, Qun-li</au><au>Huang, Xiu-mei</au><au>Cui, Ya-zhong</au><au>Liu, Yu-ling</au><au>Shen, Zhu-fang</au><au>Ma, Guo-qing</au><au>Lu, Hao</au><au>Li, Yi</au><au>Jiang, Hong</au><au>Yang, Xi-yan</au><au>Zhang, Guang-de</au><au>Yang, Chen-hua</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy and Safety of Mulberry Twig Alkaloids Tablet for Treatment of Type 2 Diabetes: A Randomized, Double-Blind, Placebo-Controlled Multicenter Clinical Study</atitle><jtitle>Chinese journal of integrative medicine</jtitle><stitle>Chin. J. Integr. Med</stitle><addtitle>Chin J Integr Med</addtitle><date>2022-04-01</date><risdate>2022</risdate><volume>28</volume><issue>4</issue><spage>304</spage><epage>311</epage><pages>304-311</pages><issn>1672-0415</issn><eissn>1993-0402</eissn><abstract>Objective
To assess the efficacy and safety of mulberry twig alkaloids (Sangzhi alkaloids, SZ-A) for treatment of type 2 diabetes in a randomized, double-blind, placebo-controlled multicenter clinical trial.
Methods
A total of 200 patients were randomized to receive SZ-A (
n
=100) or placebo (
n
=100) for 16 weeks. The data analysis system for electronic data capture clinical trial central randomization system was used for randomization and dispensing of drugs. The primary outcome was the change in glycosylated hemoglobin (HbA1c) level. The secondary outcome included the proportions of cases with HbA1c <7.0% and HbA1c <6.5%, fasting blood glucose (FBG), postprandial blood glucose (PBG), area under curve for the PBG (AUC
0-2h
), body weight, and body mass index (BMI). Adverse events (AEs), severe adverse events (SAEs), treatment-related adverse events (TAEs), gastrointestinal disorders (GDs), blood pressure, routine blood tests, and liver and kidney function were monitored.
Results
Compared with baseline, the change of HbA1c at week 16 was −0.80% (95% CI: −0.98% to −0.62%) and −0.09% (95% CI: −0.27% to 0.09%) in SZ-A group and placebo group, respectively. The proportion of patients with HbA1c <7% and <6.5% was higher in the SZ-A group than in the placebo group (46.8%
vs
. 21.6% and 29.9%
vs
. 10.8%). The observed values and changes in FBG, 1 h-PBG, 2 h-PBG, and AUC
0-2h
differed significantly between groups (
P
<0.001), but differences were not significant in body weight and BMI (
P
>0.05). The incidence rates of AEs, TAEs, and GDs differed significantly between groups (
P
=0.010,
P
=0.005, and
P
=0.006, respectively), whereas the incidence rates of SAEs showed no significant differences between groups (
P
=1.000).
Conclusion
SZ-A are effective and safe for treatment of type 2 diabetes. The protocol was registered in
http://www.chictr.org.cn/showproj.aspx?proj=60117
(ChiCTR2000038550)</abstract><cop>Singapore</cop><pub>Springer Singapore</pub><pmid>35048240</pmid><doi>10.1007/s11655-021-2885-9</doi><tpages>8</tpages></addata></record> |
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| identifier | ISSN: 1672-0415 |
| ispartof | Chinese journal of integrative medicine, 2022-04, Vol.28 (4), p.304-311 |
| issn | 1672-0415 1993-0402 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_2621658730 |
| source | SpringerNature Journals; Alma/SFX Local Collection |
| subjects | Medicine Medicine & Public Health Original Article |
| title | Efficacy and Safety of Mulberry Twig Alkaloids Tablet for Treatment of Type 2 Diabetes: A Randomized, Double-Blind, Placebo-Controlled Multicenter Clinical Study |
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