PMID- 31553228
OWN - NLM
STAT- MEDLINE
DCOM- 20200121
LR  - 20200121
IS  - 1557-7708 (Electronic)
IS  - 1075-5535 (Linking)
VI  - 25
IP  - 12
DP  - 2019 Dec
TI  - Efficacy and Safety of Toutongning Capsule in Patients with Migraine: A 
      Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial.
PG  - 1215-1224
LID - 10.1089/acm.2018.0500 [doi]
AB  - Objective: Toutongning (TTN) capsule, a Chinese patent medicine, is used as a 
      prophylactic treatment for migraine. The present study was conducted as a 
      postmarketing evaluation of the efficacy and safety of TTN capsule. Design: A 
      randomized, double-blind, placebo-controlled trial. Location: Patients recruited 
      from 14 medical centers in China from May 2014 to August 2015. Subjects: Patients 
      between 18 and 65 years of age with a diagnosis of migraine. Interventions: The 
      patients were randomly assigned to receive either TTN (1200 mg, three times 
      daily) or a matched placebo (1:1) for 4 weeks. Outcome measures: The primary 
      outcome measured was a minimum 50% reduction in the frequency of headaches from 
      the 4-week baseline period to the last 4 weeks of the 12-week trial. Secondary 
      outcomes included duration, days, and visual analog score of headache attack, 
      interval between headache attacks, usage of acute analgesics, and score on the 
      Headache Impact Test-6. In addition, all patients were evaluated for adverse 
      events (AEs). Results: This study initially enrolled 400 patients; a total of 378 
      participants completed the experiment while fulfilling all study requirements. 
      TTN had a superior effect compared with the placebo on both the primary and 
      secondary outcome measures without any serious AEs or unexpected side effects. 
      Conclusion: TTN can effectively prevent the occurrence of migraine headaches and 
      is well-tolerated and safe. TTN may exhibit a persistent therapeutic effect even 
      after cessation of use. Trial Registration number: ChiCTR-IPR-15007058.
FAU - Yu, Shengyuan
AU  - Yu S
AD  - Department of Neurology, Chinese PLA General Hospital, Beijing, P.R. China.
FAU - Ran, Ye
AU  - Ran Y
AD  - Department of Neurology, Chinese PLA General Hospital, Beijing, P.R. China.
FAU - Wan, Qi
AU  - Wan Q
AD  - Department of Neurology, Jiangsu Province Hospital, Nanjing, P.R. China.
FAU - Yang, Xiaosu
AU  - Yang X
AD  - Department of Neurology, Xiangya Hospital Central South University, Changsha, 
      P.R. China.
FAU - Chen, Huisheng
AU  - Chen H
AD  - Department of Neurology, The General Hospital of Shenyang Military, Shenyang, 
      P.R. China.
FAU - Wang, Hebo
AU  - Wang H
AD  - Department of Neurology, Hebei General Hospital, Shijiazhuang, P.R. China.
FAU - Hu, Xueqiang
AU  - Hu X
AD  - Department of Neurology, The Third Affiliated Hospital, Sun Yat-Sen University, 
      Guangzhou, P.R. China.
FAU - Mao, Shanping
AU  - Mao S
AD  - Department of Neurology, Hubei General Hospital, Wuhan, P.R. China.
FAU - Yu, Tingming
AU  - Yu T
AD  - Department of Neurology, The Second Hospital of Jilin University, Changchun, P.R. 
      China.
FAU - Luo, Guogang
AU  - Luo G
AD  - Department of Neurology, The First Affiliated Hospital of Xi'an Jiaotong 
      University, Xi'an, P.R. China.
FAU - Gao, Xuguang
AU  - Gao X
AD  - Department of Neurology, Peking University People's Hospital, Beijing, P.R. 
      China.
FAU - Li, Xin
AU  - Li X
AD  - Department of Neurology, The Second Hospital of Tianjin Medical University, 
      Tianjin, P.R. China.
FAU - Zhou, Muke
AU  - Zhou M
AD  - Department of Neurology, West China Hospital, Sichuan University, Chengdu, P.R. 
      China.
FAU - Li, Yu
AU  - Li Y
AD  - Department of Neurology, Fuling Center Hospital of Chongqing City, Chongqing, 
      P.R. China.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20190925
PL  - United States
TA  - J Altern Complement Med
JT  - Journal of alternative and complementary medicine (New York, N.Y.)
JID - 9508124
RN  - 0 (Drugs, Chinese Herbal)
SB  - IM
MH  - Adult
MH  - Double-Blind Method
MH  - Drugs, Chinese Herbal/*adverse effects/*therapeutic use
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Migraine Disorders/*drug therapy/epidemiology
MH  - Treatment Outcome
MH  - Vital Signs
OTO - NOTNLM
OT  - Toutongning capsule
OT  - herbal medicine
OT  - migraine
OT  - multicenter study
OT  - randomized controlled trial
EDAT- 2019/09/26 06:00
MHDA- 2020/01/22 06:00
CRDT- 2019/09/26 06:00
PHST- 2019/09/26 06:00 [pubmed]
PHST- 2020/01/22 06:00 [medline]
PHST- 2019/09/26 06:00 [entrez]
AID - 10.1089/acm.2018.0500 [doi]
PST - ppublish
SO  - J Altern Complement Med. 2019 Dec;25(12):1215-1224. doi: 10.1089/acm.2018.0500. 
      Epub 2019 Sep 25.