Efficacy and Safety of Toutongning Capsule in Patients with Migraine: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial.

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.

[Study on regulation mechanism of Toutongning capsule through TNF signaling pathway in treatment of migraine based on systems pharmacology method].

Toutongning capsule (TTNC) is a traditional Chinese medicine(TCM) with good effect for treating migraine in clinical application. In this paper, a systems pharmacology method was carried out to study the TNF mechanism of the TTNC on the migraine. First, the ingredients for TTNC were collected from TCM databases, and ADME properties prediction was firstly applied to screen out the active compounds of TTNC. Then, the target searching and identification was performed by using CSDT model, and the targets were mapped to the migraine disease to determine the active targets through some common databases like TTD. To obtain the targets related with TNF signaling pathway, KEGG pathway analysis was performed by DAVID online analysis tool. Finally, the "herbs-compounds-targets" network was built by Cytoscape software. According to the results of degree and betweenness in the network, the key active compounds and targets were determined to explore the TNF mechanism for TTNC. Results showed that 19 active compounds and 8 targets played a crucial role in the treatment of migraine by TNF pathway for TTNC. This work provided a new perspective to deepen the understanding of the TNF signaling pathway mechanism in migraine treatment by TTNC, and may provide a necessary theoretical basis for the determination of effective markers and the clinical research of this medicine.

Study on regulation mechanism of Toutongning capsule through TNF signaling pathway in treatment of migraine based on systems pharmacology method / 中国中药杂志

Toutongning capsule (TTNC) is a traditional Chinese medicine(TCM) with good effect for treating migraine in clinical application. In this paper, a systems pharmacology method was carried out to study the TNF mechanism of the TTNC on the migraine. First, the ingredients for TTNC were collected from TCM databases, and ADME properties prediction was firstly applied to screen out the active compounds of TTNC. Then, the target searching and identification was performed by using CSDT model, and the targets were mapped to the migraine disease to determine the active targets through some common databases like TTD. To obtain the targets related with TNF signaling pathway, KEGG pathway analysis was performed by DAVID online analysis tool. Finally, the "herbs-compounds-targets" network was built by Cytoscape software. According to the results of degree and betweenness in the network, the key active compounds and targets were determined to explore the TNF mechanism for TTNC. Results showed that 19 active compounds and 8 targets played a crucial role in the treatment of migraine by TNF pathway for TTNC. This work provided a new perspective to deepen the understanding of the TNF signaling pathway mechanism in migraine treatment by TTNC, and may provide a necessary theoretical basis for the determination of effective markers and the clinical research of this medicine.

Observation of the efficacy of Toutongning capsule combined with nimodipine in the treatment of 76 patients with primary vascular headache / 中国基层医药

Objective To explore the clinical efficacy of Toutongning capsule combined with nimodipine in the treatment of 76 patients with primary vascular headache.Methods 76 patients with primary vascular headache were selected as the research subjects.According to the different surgery,the patients were randomly divided into control group (n =38) and observation group (n =38).The control group was given compound Danshen injection,while the observation group was given Toutongning capsule combined with nimodipine.The efficacy,the peak systolic velocity(Vs) and pulsatility index(PI) of each vessel,the time of stopping pain,recurrence rate and adverse reaction were compared between the two groups.Results The total effective rate of the observation group was 94.74％,which was higher than 84.21％ of the control group,the difference was statistically significant (x2 =4.785,P ＜ 0.05).The MCA,ACA,BA,VA value of Vs and PI,the time of stopping pain and recurrence rate in the observation group were better than those in the control group (t =5.385,6.834,7.407,6.651,4.032,5.716,6.203,5.016,4.785,x2 =5.473,all P ＜ 0.05).There were no significant differences between the two groups in PCA value of Vs and PI and adverse reaction(t =0.283,0.037,x2 =0.314,all P ＜ 0.05).Conclusion Toutongning capsule combined with nimodipine in the treatment of primary vascular headache has high application value and significant effect,and it can promote cerebral circulation,blood flow,time of stopping pain and recurrence rate,so it is worthy of clinical popularization and application.

Effect of Toutongning capsule for treatment of headache with stroke-associated risk factors / 重庆医学

Objective To investigate the effect of Toutongning capsule for treatment of headache with stroke-associated risk fac-tors .Methods 60 cases of headache patients with stroke-associated risk factors were selected and divided into the treatment group and the control group ,30 cases in each group .The treatment group were given conventional therapy plus Toutongning capsule while the control group were given conventional therapy only .Results After 4 weeks ,the remission rate of treatment group was 93% and that of the control group was 63% .The attack frequency ,duration and degree between the two groups showed statistically signifi-cant difference(P<0 .05) .Conclusion Additional Toutongning capsule has a better effect for treatment of headache with stroke-as-sociated risk factors.