Evidence map›Paper›PMID 31842860›Full record

Trial reportBMC complementary and alternative medicine2019

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

Shengyuan Yu, Ye Ran, Wei Xiao, Wenjing Tang, Jianjun Zhao, Wei Chen, Huikui Zhuang, Cun Ouyang, Hai Lin, Dequan Liu and 13 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC complementary and alternative medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02035111 (To Evaluate the Safety and the Efficacy of Tianshu Capsule Treating Migraine in a Randomized, Placebo-Controlled, Double-blind, Multicenter Study.), which is not on this map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
0.7field-weighted citation impact, top 29% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02035111 phase4completednot on this map

To Evaluate the Safety and the Efficacy of Tianshu Capsule Treating Migraine in a Randomized, Placebo-Controlled, Double-blind, Multicenter Study.

TypeinterventionalSponsorJiangsu Kanion Pharmaceutical Co., LtdRan2014 to 2015Enrolled947ConditionsMigraineArmsTianshu capsule, Sugar pill
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 19 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. The Effectiveness ofEvidence-based complementary and alternative medicine : eCAM · 2021
    Article
  9. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

23 authors at 17 institutions in 1 country.

Shengyuan YuDepartment of Neurology, Chinese PLA General Hospital, Fuxing Road 28, Haidian District, Beijing, 100853, China. yusy1963@126.com.
Ye RanDepartment of Neurology, Chinese PLA General Hospital, Fuxing Road 28, Haidian District, Beijing, 100853, China.
Wei XiaoState Key Laboratory of New-tech for Chinese Medicine Pharmaceutical Process, Lianyungang, 222001, China.
Wenjing TangDepartment of Neurology, Chinese PLA General Hospital, Fuxing Road 28, Haidian District, Beijing, 100853, China.
Jianjun ZhaoAffiliated Hospital of Changchun University of Tradition Chinese Medicine, Changchun, Jilin, China.
Wei ChenBrain Hospital of Jilin province, Changchun, China.
Huikui ZhuangSecond Affiliated Hospital of Shandong University of Tradition Chinese Medicine, Jinan, Shandong, China.
Cun OuyangWuhan Sixth Hospital, Wuhan, Hubei, China.
Hai LinXi'an Hospital of Tradition Chinese Medicine, Xi'an, Shaanxi, China.
Dequan LiuLangfang Tradition Chinese Medicine Hospital, Langfang, Hebei, China.
Tongjun ChenTangshan Tradition Chinese Medicine Hospital, Tangshan, Hebei, China.
Hui HuangHuaibei People's Hospital, Huaibei, Anhui, China.
Baoshen WangLuohe Hospital of Chinese Medicine, Luohe, Henan, China.
Yanlei HaoAffiliation Hospital of Jining Medical University, Jining, Shandong, China.
Zhongrui YanJining No.1 People's Hospital, Jining, Shandong, China.
Shike ZhaoJi'nan Municipal Hospital of Traditional Chinese Medicine, Ji'nan, Shandong, China.
Yanling WangCangzhou People's Hospital, Cangzhou, Hebei, China.
Jinjun NiKaifeng Hospital of Tradition Chinese Medicine, Kaifeng, Henan, China.
Chaodong WangSanming First Hospital, SanMing, Fujian, China.
Wentao DingGuang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
Guoqian LiQuanzhou First Hospital, Quanzhou, Fujian, China.
Jianhua CaoYiyang Central Hospital, Yiyang, Hunan, China.
Shujuan TianThe 260th Hospital of PLA, Shijiazhuang, Hebei, China.
Chinese PLA General Hospital · CNAffiliated Hospital of Jining Medical University · CNBrain Hospital of Jilin · CNChinese Academy of Medical Sciences & Peking Union Medical College · CNFirst Hospital of Shijiazhuang · CNHuaibei Normal University · CNJining First People's Hospital · CNKaifeng City Children's Hospital · CNLuohe Medical College · CNPeople's Hospital of Cangzhou · CNSecond Hospital of Shandong University · CNShaanxi Provincial Hospital of Traditional Chinese Medicine · CNTangshan People's Hospital · CNThe Affiliated Hospital to Changchun University of Chinese Medicine · CNThe First Hospital of Kunming · CNWuhan Sixth Hospital · CNYichang Central People's Hospital · CN

Funding

Beijing Science and Technology Project Z161100002616013National Scientific Research Fund of China 81671077"One Hundred Advantage Projects" Fund of Chinese PLA General Hospital YS201414
6 · The paper itself

Abstract

backgroundTianshu 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).

methodsThe 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.

resultsOne 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.

conclusionsTSC is an effective, well-tolerated medicine for prophylactic treatment of migraine, and still have prophylactic effect after medicine discontinuation.

trial registrationClinicalTrials.gov Identifier: NCT02035111; Data of registration: 2014-01-10.

Indexed as

AdultAnalgesicsDouble-Blind MethodDrugs, Chinese HerbalFemaleHumansMaleMiddle AgedMigraine DisordersTreatment OutcomeAnalgesicsDrugs, Chinese HerbalHerbal medicineMigraineMulticenterRandomized controlled trialTianshu capsule

Identifiers

PMID31842860
PMCPMC6915862
OpenAlexW2996586790

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.