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  1. Article ; Online: Gut microbiome alterations in colitis rats after moxibustion at bilateral Tianshu acupoints.

    Qi, Qin / Liu, Ya-Nan / Lv, Si-Yi / Wu, Huan-Gan / Zhang, Lin-Shuang / Cao, Zhan / Liu, Hui-Rong / Wang, Xiao-Mei / Wu, Lu-Yi

    BMC gastroenterology

    2022  Volume 22, Issue 1, Page(s) 62

    Abstract: ... in the moxibustion and normal rats with moxibustion groups were treated with moxibustion at Tianshu (bilateral, ST25 ...

    Abstract Background: The pathogenesis of ulcerative colitis (UC) is closely related to the gut microbiota. Moxibustion has been used to improve the inflammation and gastrointestinal dysfunctions in gastrointestinal disorders such as UC. In this study, we investigated whether moxibustion could improve the gut microbial dysbiosis induced by dextran sulphate sodium.
    Methods: Twenty-five male rats were randomly assigned into five groups. The UC rat model was established by administering DSS solution. The rats in the moxibustion and normal rats with moxibustion groups were treated with moxibustion at Tianshu (bilateral, ST25) points, and the mesalazine group rats were treated with mesalazine once daily for 7 consecutive days. Disease activity index (DAI) and haematoxylin and eosin staining were used to evaluate the effect of moxibustion. Gut microbiota profiling was conducted by metagenomic high throughput sequencing technology. The gut microbiota composition, diversity and function were analyzed and compared using metagenomics methodologies.
    Results: The DAI scores and histopathology scores in the moxibustion and mesalazine groups were significantly decreased compared with the UC group (P < 0.01). Moxibustion treatment increased abundance levels of Bacteroidetes, Actinobacteria, Ascomycota, Synergistetes and decreased abundance of Firmicutes, Proteobacteria. At the genus level, the abundance of Bacteroides, Bacteroides_bacterium_M7, Prevotella, Bacteroidales_bacterium_H2, were increased and Bacteroides_bacterium_H3, Parabacteroides, Porphyromonas, Alistipes, Parasutterella were decreased in the UC group in comparsion with those in the NG group. Moxibustion increased the abundance of Bacteroides and Bacteroides_bacterium_H3 and decreased Bacteroides_bacterium_M7, Prevotella, Bacteroidales_bacterium_H2. In UC group, the specie Bacteroides_massiliensis was negatively (P < 0.05) correlated with IL-23, Bacteroides_eggerthii_CAG109 and Bacteroides_eggerthii were negatively (P < 0.05) correlated with TGF-β. And the species Prevotella_sp_CAG1031 and Bacteroides_bacterium_H2 were significant positively (P < 0.05) correlated with IL-23. In addition, compare with the normal group, genes involved in certain metabolic pathways, such as energy production and conversion, amino acid transport and metabolism, carbohydrate transport and metabolism, were under-represented in the UC group, and these changes in the metabolic pathways could be reversed by moxibustion treatment and mesalazine treatment.
    Conclusions: Our findings suggest that moxibustion treatment may protect the host from mucosal inflammation by modulating the intestinal microbiota community.
    MeSH term(s) Acupuncture Points ; Animals ; Colitis/chemically induced ; Colitis/therapy ; Colitis, Ulcerative/therapy ; Dextran Sulfate ; Disease Models, Animal ; Gastrointestinal Microbiome ; Male ; Moxibustion ; Rats
    Chemical Substances Dextran Sulfate (9042-14-2)
    Language English
    Publishing date 2022-02-12
    Publishing country England
    Document type Journal Article
    ZDB-ID 2041351-8
    ISSN 1471-230X ; 1471-230X
    ISSN (online) 1471-230X
    ISSN 1471-230X
    DOI 10.1186/s12876-022-02115-1
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article: [Effects of moxibustion at "Tianshu"(ST25) and "Shangjuxu" (ST37) on colonic metabolites and inflammatory factors in rats with Crohn's disease].

    He, Hao-Long / Zhang, Guo-Shan / Xiao, Shan-Feng / Liu, Hong-Hua / Zhong, Huan / Chang, Xiao-Rong / Liu, Qiong / Liu, Mi

    Zhen ci yan jiu = Acupuncture research

    2023  Volume 48, Issue 8, Page(s) 736–745

    Abstract: Objective: To observe the effects of moxibustion at "Tianshu"(ST25) and "Shangjuxu"(ST37 ...

    Abstract Objective: To observe the effects of moxibustion at "Tianshu"(ST25) and "Shangjuxu"(ST37) on the colonic metabolites and inflammatory factors in rats with Crohn's disease(CD), so as to explore the mechanisms of moxibustion in protecting colon of CD rats based on metabolomics.
    Methods: Twelve rats were first randomly selected from 36 male SD rats as a normal group(NG). The CD model was induced by 2, 4, 6 trinitrobenzene sulfonic acid(TNBS) enema on the rest 24 rats. After successful modeling, rats were randomly divided into model(TNBS) and moxibustion(TNBS+MOX) groups(
    Results: After modeling, compared with the NG group, the body weight of the rats in the TNBS group was significantly decreased(
    Conclusion: The mechanism of moxibustion at ST25 and ST37 for CD may be related to improving colon metabolic disorder state by regulating multiple metabolic metabolites and metabolic pathways, and reducing the level of inflammatory factors, so as to maintain intestinal immune homeostasis.
    MeSH term(s) Animals ; Male ; Rats ; Betaine ; Body Weight ; Colon ; Crohn Disease/therapy ; Hypoxanthines ; Isoleucine ; Leucine ; Lysine ; Moxibustion ; Rats, Sprague-Dawley ; Tumor Necrosis Factor-alpha/genetics
    Chemical Substances Betaine (3SCV180C9W) ; Hypoxanthines ; Isoleucine (04Y7590D77) ; Leucine (GMW67QNF9C) ; Lysine (K3Z4F929H6) ; Tumor Necrosis Factor-alpha
    Language Chinese
    Publishing date 2023-08-24
    Publishing country China
    Document type English Abstract ; Journal Article
    ZDB-ID 1283179-7
    ISSN 1000-0607
    ISSN 1000-0607
    DOI 10.13702/j.1000⁃0607.20221276
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article: [Effect of deep needling "Tianshu" (ST25) on colonic motility in rats with slow transit constipation].

    Lü, Qi / Sun, Yu-Pei / Zhang, Xin / Zhang, Xuan-Ping / Xu, Xiao-Kang / Gao, Fei / Sun, Yan-Hui

    Zhen ci yan jiu = Acupuncture research

    2023  Volume 48, Issue 7, Page(s) 643–649

    Abstract: Objective: To observe the effect of acupuncture of "Tianshu"(ST25) at different depths on colonic ... EA (2 Hz, 2 mA) was applied to "Tianshu"(ST25), with the acupuncture needle inserted to a depth of 3 ...

    Abstract Objective: To observe the effect of acupuncture of "Tianshu"(ST25) at different depths on colonic transportation function, expressions of colonic substance P (SP) and interstitial cells of Cajal (ICC) in rats with slow transit constipation (STC), so as to explore its mechanisms underlying improvement of STC..
    Methods: Fifty male Wistar rats were selected and randomly divided into control,STC model,conventional acupuncture,deep needling group 1 and deep needling group 2 groups,with 10 rats in each group.The STC model was established by gavage of 1 mg/mL compound diphenoxylate suspension (10 mg/kg), once every other day for 21 days, and rats of the control group were given the same dose of distilled water by gavage.EA (2 Hz, 2 mA) was applied to "Tianshu"(ST25), with the acupuncture needle inserted to a depth of 3 mm for rats of the conventional acupuncture group, 4.5 mm for those of deep needling group 1, and 10 mm for those of the deep needling group 2. The acupuncture needle was twirled for 1 min, then retained for 15 min each time, once a day for 15 consecutive days.Following modeling, rats of the 4 groups and the control group received gavage of active carbon 2 mL (100 g/L) for observing the excretion time of the first black stool grain to assess the intestinal transit function. The colonic myoelectric activities (frequency and amplitude) were recorded by using BIOPAC multichannel physiograph. The immunoactivity of SP and c-kit (a transmembrane protein kinase for identification of ICC) of colonic musculature was detected by immunohistochemistry.
    Results: Compared with the control group,the time of excretion of the first black stool grain, and the amplitude of colonic electromyogram (EMG) were significantly increased (
    Conclusion: Deep needling at ST25 at depth of 4.5 mm and 10 mm,especially at depth of 10 mm,has a significant effect in promoting gut motility to ameliorate constipation in rats with STC, which may be related to its function in up-regulating the expressions of SP and ICC activity.
    MeSH term(s) Animals ; Male ; Rats ; Acupuncture Points ; Colon ; Constipation/genetics ; Constipation/therapy ; Defecation ; Proto-Oncogene Proteins c-kit/genetics ; Rats, Wistar ; Substance P/genetics
    Chemical Substances Proto-Oncogene Proteins c-kit (EC 2.7.10.1) ; Substance P (33507-63-0)
    Language Chinese
    Publishing date 2023-06-27
    Publishing country China
    Document type English Abstract ; Journal Article
    ZDB-ID 1283179-7
    ISSN 1000-0607
    ISSN 1000-0607
    DOI 10.13702/j.1000-0607.20220588
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: Treatment of migraines with Tianshu capsule

    Shengyuan Yu / Ye Ran / Wei Xiao / Wenjing Tang / Jianjun Zhao / Wei Chen / Huikui Zhuang / Cun Ouyang / Hai Lin / Dequan Liu / Tongjun Chen / Hui Huang / Baoshen Wang / Yanlei Hao / Zhongrui Yan / Shike Zhao / Yanling Wang / Jinjun Ni / Chaodong Wang /
    Wentao Ding / Guoqian Li / Jianhua Cao / Shujuan Tian

    BMC Complementary and Alternative Medicine, Vol 19, Iss 1, Pp 1-

    a multi-center, double-blind, randomized, placebo-controlled clinical trial

    2019  Volume 9

    Abstract: Abstract Background Tianshu capsule (TSC), a formula of traditional Chinese medicine, has been ...

    Abstract Abstract Background Tianshu capsule (TSC), a formula of traditional Chinese medicine, has been widely used in clinical practice for prophylactic treatment of headaches in China. However, former clinical trials of TSC were small, and lack of a standard set of diagnostic criteria to enroll patients. The study was conducted to re-evaluate the efficacy and safety of TSC post-marketing in an extending number of migraineurs who have diagnosed migraine with the International Classification of Headache Disorders, 3rd edition (beta version, ICHD-3β). Methods The study was a double-blind, randomized, placebo-controlled clinical trial that conducted at 20 clinical centers in China. At enrollment, patients between 18 and 65 years of age diagnosed with migraine were assigned to receive either TSC (4.08 g, three times daily) or a matched placebo according to a randomization protocol. The primary endpoint was a relative reduction of 50% or more in the frequency of headache attacks. The secondary outcomes included a reduction in the incidence of headache, the visual analogue scale of headache attacks, days of acute analgesic usage, and percentage of patients with a decrease of 50% or more in headache severity. Accompanying symptoms were also assessed. Results One thousand migraine patients were initially enrolled in the study, and 919 of them completed the trial. Following the 12-week treatment, significant improvement was observed in the TSC group concerning both primary and secondary outcomes. After therapy discontinuation, the gap between the TSC group and the placebo group in efficacy outcomes continued to increase. There were no severe adverse effects. Conclusions TSC is an effective, well-tolerated medicine for prophylactic treatment of migraine, and still have prophylactic effect after medicine discontinuation. Trial registration ClinicalTrials.gov Identifier: NCT02035111; Data of registration: 2014-01-10.
    Keywords Tianshu capsule ; Migraine ; Herbal medicine ; Multicenter ; Randomized controlled trial ; Other systems of medicine ; RZ201-999
    Subject code 610
    Language English
    Publishing date 2019-12-01T00:00:00Z
    Publisher BMC
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  5. Article: [Effect of electroacupuncture at "Zusanli" (ST36) and "Tianshu" (ST25) on intestinal function and autonomic nerve balance in rats with irritable bowel syndrome].

    Wang, Zheng-Wen / Chen, Bi-Wei / Chen, Shao-Zong / Zhang, Li-Li / Sun, Hong-Wei / Chang, Xiao-Li

    Zhen ci yan jiu = Acupuncture research

    2023  Volume 48, Issue 2, Page(s) 165–171

    Abstract: Objective: To study whether electroacupuncture (EA) of "Zusanli" (ST36) combined with "Tianshu ...

    Abstract Objective: To study whether electroacupuncture (EA) of "Zusanli" (ST36) combined with "Tianshu" (ST25) has a synergistic effect in regulating the colonic function and autonomic nerve balance in rats with irritable bowel syndrome (IBS).
    Methods: Male Wistar rats were randomly divided into control, model, EA-ST36, and EA-ST36+ST25 groups, with 14 rats in each group. The IBS model was established by using water avoidance stress method. The visceral hypersensitivity was measured using the abdominal wall retraction reflex (AWR). The rectus abdominis electromyogram (EMG), intestinal electrical activity, and electrocardiogram (ECG) were recorded using a PowerLab data acquisition and analysis system. The contents of serum cAMP and cGMP were determined by ELISA, the expression levels of colonic tyrosine hydroxylase (TH) and choline acetyl-transferase (ChAT) proteins were determined by immunofluorescence staining and Western blot, respectively.
    Results: Compared with the control group, the model group had an evident increase in the levels of AWR, LF, LF/HF, ChAT protein expression, cAMP and cGMP contents and cAMP/cGMP ratio (
    Conclusion: EA of both ST36 and ST36+ST25 can relieve visceral pain, and reduce sympathetic activity to improve autonomic nerve balance, but without apparent synergistic effect between EA-ST36 and EA-ST25 in rats with IBS.
    MeSH term(s) Male ; Rats ; Animals ; Irritable Bowel Syndrome ; Rats, Wistar ; Electroacupuncture ; Defecation ; Autonomic Pathways ; Cyclic GMP
    Chemical Substances Cyclic GMP (H2D2X058MU)
    Language Chinese
    Publishing date 2023-02-28
    Publishing country China
    Document type English Abstract ; Journal Article
    ZDB-ID 1283179-7
    ISSN 1000-0607
    ISSN 1000-0607
    DOI 10.13702/j.1000-0607.20211324
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. Article: [Real time release testing of disintegration time of uncoated Tianshu Tablets].

    Xia, Chun-Yan / Xu, Bing / Xu, Fang-Fang / Zhang, Xin / Wang, Qing / DU, Hui / Bao, Le-Wei / Wang, Zhen-Zhong / Qiao, Yan-Jiang / Xiao, Wei

    Zhongguo Zhong yao za zhi = Zhongguo zhongyao zazhi = China journal of Chinese materia medica

    2020  Volume 45, Issue 2, Page(s) 250–258

    Abstract: ... of Tianshu tablets was established on the basis of the concept of quality by design(QbD), in order to improve ... a foundation for the implementation of intelligent control strategy of the key process of Tianshu Tablets. ...

    Abstract In this paper, a real time release testing(RTRT) model for predicting the disintegration time of Tianshu tablets was established on the basis of the concept of quality by design(QbD), in order to improve the quality controllability of the production process. First, 49 batches of raw materials and intermediates were collected. Afterwards, the physical quality attributes of all materials were comprehensively characterized. The partial least square(PLS) regression model was established with the 72 physical quality attributes of raw materials and intermediates as input and the disintegration time(DT) of uncoated tablets as output. Then, the variable screening was carried out based on the variable importance in the projection(VIP) indexes. Moisture content of raw materials(%HR), tapped density of wet masses(D_c), hygroscopicity of dry granules(%H), moisture content of milling granules(%HR) and Carr's index of mixed granules(IC) were determined as the potential critical material attributes(pCMAs). According to the effects of interactions of pCMAs on the performance of the prediction model, it was finally determined that the wet masses' D_c and the dry granules'%H were critical material attributes(CMAs). A RTRT model of the disintegration time prediction was established as DT=34.09+2×D_c+3.59×%H-5.29×%H×D_c,with R~2 equaling to 0.901 7 and the adjusted R~2 equaling to 0.893 3. The average relative prediction error of validation set for the RTRT model was 3.69%. The control limits of the CMAs were determined as 0.55 g·cm~(-3)<D_c<0.63 g·cm~(-3) and 4.77<%H<7.59 according to the design space. The RTRT model of the disintegration time reflects the understanding of the process system, and lays a foundation for the implementation of intelligent control strategy of the key process of <mark>Tianshu Tablets.
    MeSH term(s) Drug Compounding ; Drug Liberation ; Drugs, Chinese Herbal/chemistry ; Least-Squares Analysis ; Solubility ; Tablets
    Chemical Substances Drugs, Chinese Herbal ; Tablets
    Language Chinese
    Publishing date 2020-04-01
    Publishing country China
    Document type Journal Article
    ZDB-ID 1004649-5
    ISSN 1001-5302 ; 0254-0029
    ISSN 1001-5302 ; 0254-0029
    DOI 10.19540/j.cnki.cjcmm.20191219.303
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  7. Article: [Effect of electroacupuncture of "Tianshu"(ST25) at different frequencies on electromyography and immunoactivity of SP and VIP of colon in rats with slow transit constipation].

    Cui, Meng-Xiao / Sun, Yu-Pei / Li, Xiao-Feng / Zhang, Xuan-Ping / Xu, Xiao-Kang / Gao, Fei / Sun, Yan-Hui / Zhang, Xin

    Zhen ci yan jiu = Acupuncture research

    2022  Volume 47, Issue 8, Page(s) 710–714

    Abstract: Objective: To observe the effect of electroacupuncture (EA) of bilateral "Tianshu"(ST25 ...

    Abstract Objective: To observe the effect of electroacupuncture (EA) of bilateral "Tianshu"(ST25) at different frequencies on the first black stool discharge time, colonic electromyography (EMG) and immunoactivity of vasoactive intestinal peptide (VIP) and substance P (SP) in the colon tissue in rats with slow transit constipation (STC), so as to choose a better stimulating frequency in the treatment of STC.
    Methods: A total of 50 male Wistar rats were randomized into control, model, 2 Hz-EA, 100 Hz- EA, and 2 Hz/100 Hz-EA groups, with 10 rats in each group. The STC model was established by intraperitoneal injection of compound diphenoxylate suspension fluid (10 mg/kg). EA was applied to bilateral ST25 for 30 min, once a day for 14 consecutive days. The discharge time for the first black stool was recorded after gavage of mixed suspension fluid of active carbon (2 mL) for assessing the gastrointestinal motility. The colonic EMG was recorded by using a pair of silver electrodes and bioelectric amplifier. The expression of SP and VIP in the colonic tissue was detected by immunohistochemistry.
    Results: Following mode-ling, the colonic EMG amplitude, the discharge time for the first black stool and VIP immunoactivity were significantly increased (
    Conclusion: EA can accelerate colonic EMG activities, which may be associated with its functions in down-regulating VIP immunoactivity and up-regulating SP immunoactivity in the colonic tissues. The therapeutic effects of 2 Hz/100 Hz-EA and 2 Hz-EA are better than that of 100 Hz-EA.
    MeSH term(s) Acupuncture Points ; Animals ; Colon ; Constipation ; Electroacupuncture ; Electromyography ; Male ; Rats ; Rats, Wistar ; Substance P ; Vasoactive Intestinal Peptide
    Chemical Substances Substance P (33507-63-0) ; Vasoactive Intestinal Peptide (37221-79-7)
    Language Chinese
    Publishing date 2022-08-27
    Publishing country China
    Document type Journal Article
    ZDB-ID 1283179-7
    ISSN 1000-0607
    ISSN 1000-0607
    DOI 10.13702/j.1000-0607.20210638
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  8. Article: [Evaluate effects of different drying methods on quality of Tianshu capsule on substance basis].

    Zhang, Meng-Ting / Bi, Yu-An / Zhang, Xin / Xu, Gui-Hong / Huang, Wen-Zhe / Wang, Zhen-Zhong / Xiao, Wei

    Zhongguo Zhong yao za zhi = Zhongguo zhongyao zazhi = China journal of Chinese materia medica

    2017  Volume 42, Issue 18, Page(s) 3537–3545

    Abstract: To investigate the effect of hot air circulation drying and spray drying on the quality of Tianshu ... of Tianshu capsules for the first time, and the main chemical constituents were identified by UPLC-Q-TOF-MS ... MS. A total of 62 compounds were identified in this method, 21 of which were reported in Tianshu ...

    Abstract To investigate the effect of hot air circulation drying and spray drying on the quality of Tianshu capsule from the view point of chemical compositions. UPLC-DAD was used to establish the fingerprint of Tianshu capsules for the first time, and the main chemical constituents were identified by UPLC-Q-TOF-MS/MS. A total of 62 compounds were identified in this method, 21 of which were reported in Tianshu capsules for the first time. The results showed that there were no significant differences in the identification of the chemical constituents types between these two methods, but the contents of some constituents were different. The common patterns generated by the 10 batches of hot air cycle drying samples were used as the control fingerprint, and the similarity of the spray drying samples fingerprints was 0.877, with high similarity of the fingerprints between these two methods. UPLC-DAD combined with UPLC-Q-TOF-MS/MS technology was used for the first time to evaluate the chemical constituents of Tianshu capsule rapidly, comprehensively and accurately, providing technical support for the quality evaluation of Tianshu capsule.
    MeSH term(s) Chromatography, High Pressure Liquid ; Desiccation/methods ; Drugs, Chinese Herbal/chemistry ; Quality Control ; Tandem Mass Spectrometry ; Technology, Pharmaceutical/methods
    Chemical Substances Drugs, Chinese Herbal
    Language Chinese
    Publishing date 2017-12-06
    Publishing country China
    Document type Journal Article
    ZDB-ID 1004649-5
    ISSN 1001-5302 ; 0254-0029
    ISSN 1001-5302 ; 0254-0029
    DOI 10.19540/j.cnki.cjcmm.20170719.005
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  9. Article: [Comparison of effects of electroacupuncture at "Tianshu" (ST25) and "Dachangshu" (BL25) on intestinal sensitivity and expression of muscarinic M

    Ji, Mao-Xian / Guo, Meng-Wei / Gao, Yu-Shan / Lan, Ying / Wang, Shan / Wang, Yi-Fan / Qin, Ying / Zhang, Hong-Lin / Ren, Xiao-Xuan

    Zhen ci yan jiu = Acupuncture research

    2019  Volume 44, Issue 4, Page(s) 264–269

    Abstract: Objective: To observe and compare the effect of electroacupuncture (EA) of "Tianshu" (ST25) and ...

    Abstract Objective: To observe and compare the effect of electroacupuncture (EA) of "Tianshu" (ST25) and "Dachangshu" (BL25) on intestinal sensitivity and the expression of M
    Methods: Forty newborn Wistar rats were randomly divided into blank control, model, ST25 and BL25 groups (
    Results: After modeling, the latency was obviously shortened, the number and peak-peak values of contraction waves of intestine were significantly increased, and the immunoactivity of M
    Conclusion: EA at ST25 and BL25 can reduce the intestinal sensitivity in IBS rats, which is probably associated with its effects in down-regulating the expression of M
    MeSH term(s) Acupuncture Points ; Animals ; Cholinergic Agents ; Electroacupuncture ; Irritable Bowel Syndrome ; Maternal Deprivation ; Muscarine ; Rats ; Rats, Sprague-Dawley ; Rats, Wistar ; Receptors, Serotonin, 5-HT3 ; Serotonin
    Chemical Substances Cholinergic Agents ; Receptors, Serotonin, 5-HT3 ; Serotonin (333DO1RDJY) ; Muscarine (7T101UWZ5W)
    Language Chinese
    Publishing date 2019-05-06
    Publishing country China
    Document type Comparative Study ; Journal Article
    ZDB-ID 1283179-7
    ISSN 1000-0607
    ISSN 1000-0607
    DOI 10.13702/j.1000-0607.180764
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  10. Article ; Online: Treatment of migraines with Tianshu capsule: a multi-center, double-blind, randomized, placebo-controlled clinical trial.

    Yu, Shengyuan / Ran, Ye / Xiao, Wei / Tang, Wenjing / Zhao, Jianjun / Chen, Wei / Zhuang, Huikui / Ouyang, Cun / Lin, Hai / Liu, Dequan / Chen, Tongjun / Huang, Hui / Wang, Baoshen / Hao, Yanlei / Yan, Zhongrui / Zhao, Shike / Wang, Yanling / Ni, Jinjun / Wang, Chaodong /
    Ding, Wentao / Li, Guoqian / Cao, Jianhua / Tian, Shujuan

    BMC complementary and alternative medicine

    2019  Volume 19, Issue 1, Page(s) 370

    Abstract: Background: Tianshu capsule (TSC), a formula of traditional Chinese medicine, has been widely used ...

    Abstract Background: Tianshu capsule (TSC), a formula of traditional Chinese medicine, has been widely used in clinical practice for prophylactic treatment of headaches in China. However, former clinical trials of TSC were small, and lack of a standard set of diagnostic criteria to enroll patients. The study was conducted to re-evaluate the efficacy and safety of TSC post-marketing in an extending number of migraineurs who have diagnosed migraine with the International Classification of Headache Disorders, 3rd edition (beta version, ICHD-3β).
    Methods: The study was a double-blind, randomized, placebo-controlled clinical trial that conducted at 20 clinical centers in China. At enrollment, patients between 18 and 65 years of age diagnosed with migraine were assigned to receive either TSC (4.08 g, three times daily) or a matched placebo according to a randomization protocol. The primary endpoint was a relative reduction of 50% or more in the frequency of headache attacks. The secondary outcomes included a reduction in the incidence of headache, the visual analogue scale of headache attacks, days of acute analgesic usage, and percentage of patients with a decrease of 50% or more in headache severity. Accompanying symptoms were also assessed.
    Results: One thousand migraine patients were initially enrolled in the study, and 919 of them completed the trial. Following the 12-week treatment, significant improvement was observed in the TSC group concerning both primary and secondary outcomes. After therapy discontinuation, the gap between the TSC group and the placebo group in efficacy outcomes continued to increase. There were no severe adverse effects.
    Conclusions: TSC is an effective, well-tolerated medicine for prophylactic treatment of migraine, and still have prophylactic effect after medicine discontinuation.
    Trial registration: ClinicalTrials.gov Identifier: NCT02035111; Data of registration: 2014-01-10.
    MeSH term(s) Adult ; Analgesics/adverse effects ; Analgesics/therapeutic use ; Double-Blind Method ; Drugs, Chinese Herbal/adverse effects ; Drugs, Chinese Herbal/therapeutic use ; Female ; Humans ; Male ; Middle Aged ; Migraine Disorders/drug therapy ; Treatment Outcome
    Chemical Substances Analgesics ; Drugs, Chinese Herbal
    Language English
    Publishing date 2019-12-16
    Publishing country England
    Document type Journal Article ; Multicenter Study ; Randomized Controlled Trial
    ZDB-ID 2050429-9
    ISSN 1472-6882 ; 1472-6882
    ISSN (online) 1472-6882
    ISSN 1472-6882
    DOI 10.1186/s12906-019-2775-2
    Database MEDical Literature Analysis and Retrieval System OnLINE

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