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.

Functional alterations of pain processing pathway in migraine patients with cutaneous allodynia.

OBJECTIVE: Cutaneous allodynia (CA) is a characteristic of central sensitization, predicting migraine progression, and poor response to therapy. The present study aimed to find out the cerebral functional alterations related to the establishment of central sensitization in migraineurs using functional magnetic resonance imaging (fMRI). DESIGN: The experiment was performed in 15 migraineurs with Cutaneous allodynia (MWCA) and 19 patients without Cutaneous allodynia (MWoCA) in the interictal phase, and 20 matched healthy controls. Blood oxygen level dependent-fMRI was applied in all subjects when they were given transcutaneous electrical nerve stimulation at the left medial forearm, achieving to a predetermined level of pain sensation (i.e., visual analogue scale [VAS] = 40). Contrast images were then produced to determine whether this disorders present functional changes in the brain during pain processing. RESULTS: Demographic and headache characteristics were balanced between groups. The contrast images of both migraine groups comparing to healthy controls exhibited weaker activation of various brain regions (e.g., cerebellum and insulae), which might be relevant to the pathophysiological procedure of migraine. The direct comparison between the two migraine groups revealed that activation in the dorsal pons and contralateral (right) inferior parietal lobule of MWCA subjects were significantly lower than it in MWoCA ones. CONCLUSIONS: The interictal dysfunction of pain processing pathway may be responsible for (at least relevant to) central sensitization in migraine patients, via abnormal modulations of nociceptive transmission.

Radix/rhizoma notoginseng extract (sanchitongtshu) for ischemic stroke: a randomized controlled study.

Agents of sanchi have been widely used as a complementary medicine for stroke in China. Sanchitongshu is a new Chinese patent medicine extracted from sanchi which has stronger anti-platelet activity than other agents of sanchi. Our aim was to investigate the synergistic action of low dose of aspirin combined with sanchitongshu capsule in the treatment of patients with light and moderate ischemic stroke in acute and subacute stages. This was a multi-center, double-blinded, randomized controlled clinical trial conducted in four hospitals in China from July 2004 to 2006. 140 patients of ischemic stroke in anterior cerebral circulation within 30 days of onset were enrolled. Participants were assigned either to receive aspirin (50mg per day) and sanchitongshu capsule (200mg three times a day) or aspirin (50mg per day) and placebo capsule. Low dose of aspirin combined with sanchitongshu capsule significantly ameliorated neurological deficit (increased score of ESS: t=-5.02, p<0.0001) and activities of daily living (increased score of BI: t=-2.4, p=0.0178) after treatment compared with aspirin alone. Adverse reaction which occurred equally in both arms, was light to moderate and disappeared without special treatment. Sanchitongshu capsule, as a complementary medicine to aspirin, was effective in improving outcomes after ischemic stroke. It was a safe drug in our trial.

Acupuncture for Bell's palsy.

BACKGROUND: Bell's palsy or idiopathic facial palsy is an acute facial paralysis due to inflammation of the facial nerve. A number of studies published in China have suggested acupuncture is beneficial for facial palsy. OBJECTIVES: The objective of this review was to examine the efficacy of acupuncture in hastening recovery and reducing long-term morbidity from Bell's palsy. SEARCH STRATEGY: We updated the searches of the Cochrane Neuromuscular Disease Group Trials Specialized Register (24 May 2010), The Cochrane Central Register of Controlled Trials (CENTRAL) (Issue 2, 2010), MEDLINE (January 1966 to May 2010), EMBASE (January 1980 to May 2010), AMED (January 1985 to May 2010), LILACS (from January 1982 to May 2010) and the Chinese Biomedical Retrieval System (January 1978 to May 2010) for randomised controlled trials using 'Bell's palsy' and its synonyms, 'idiopathic facial paralysis' or 'facial palsy' as well as search terms including 'acupuncture'. Chinese journals in which we thought we might find randomised controlled trials relevant to our study were handsearched. We reviewed the bibliographies of the randomised trials and contacted the authors and known experts in the field to identify additional published or unpublished data. SELECTION CRITERIA: We included all randomised controlled trials involving acupuncture by needle insertion in the treatment of Bell's palsy irrespective of any language restrictions. DATA COLLECTION AND ANALYSIS: Two review authors identified potential articles from the literature search, extracted data and assessed quality of each trial independently. All disagreements were resolved by discussion between the review authors. MAIN RESULTS: The literature search and handsearching identified 49 potentially relevant articles. Of these, six RCTs were included involving 537 participants with Bell's palsy. Two more possible trials were identified in the update than the previous version of this systematic review, but both were excluded because they were not real RCTs. Of the six included trials, five used acupuncture while the other one used acupuncture combined with drugs. No trial reported on the outcomes specified for this review. Harmful side effects were not reported in any of the trials. Poor quality caused by flaws in study design or reporting (including uncertain method of randomisation, allocation concealment and blinding) and clinical differences between trials prevented reliable conclusions about the efficacy of acupuncture. AUTHORS' CONCLUSIONS: The quality of the included trials was inadequate to allow any conclusion about the efficacy of acupuncture. More research with high quality trials is needed.

Acupuncture for Bell's palsy.

OBJECTIVES: The objectives of this study were to examine the efficacy of acupuncture in hastening recovery and reducing long-term morbidity from Bell's palsy. METHODS: We searched the Cochrane Neuromuscular Disease Group Trials Register, MEDLINE (January 1966-April 2006), EMBASE (January 1980-April 2006), LILACS (January 1982-April 2006), and the Chinese Biomedical Retrieval System (January 1978-April 2006) for randomized controlled trials using "Bell's palsy" and its synonyms, "idiopathic facial paralysis" or "facial palsy" as well as search terms including "acupuncture." Chinese journals in which we thought we might find randomized controlled trials or controlled clinical trials relevant to our study were hand searched. We reviewed the bibliographies of the randomized trials and contacted the authors and known experts in the field to identify additional published or unpublished data. We included all randomized or quasi-randomized controlled trials involving acupuncture in the treatment of Bell's palsy, irrespective of any language restrictions. Two review authors identified potential articles from the literature search and extracted data independently using a data extraction form. The assessment of methodological quality included allocation concealment, patient blinding, differences at baseline of the experimental groups, and completeness of follow-up. Two (2) review authors assessed quality independently. All disagreements were resolved by discussion between the review authors. RESULTS: Six (6) studies including a total of 537 participants met the inclusion criteria. Five (5) of them used acupuncture while another one used acupuncture combined with drugs. No trials reported on the outcomes specified for this review. Harmful side-effects were not reported in any of the trials. Flaws in study design or reporting (particularly uncertain allocation concealment and substantial loss to follow-up) and clinical differences between trials prevented conclusions about the efficacy of acupuncture. CONCLUSIONS: The quality of the included trials was inadequate to allow any conclusion about the efficacy of acupuncture. More research with high-quality trials is needed.

Sanchi for acute ischaemic stroke.

BACKGROUND: Currently very few drugs are supported for routine use for acute ischaemic stroke. Sanchi is one of the most widely used herbal medicines for ischaemic stroke in China. OBJECTIVES: To assess the effectiveness and safety of sanchi in the treatment of acute ischaemic stroke. SEARCH STRATEGY: We searched the Cochrane Stroke Group Trials Register (last searched January 2008), the Chinese Stroke Trials Register (searched February 2007), the Cochrane Complementary Medicine Field trials register (searched February 2007), the Chinese Cochrane Centre Controlled Trials Register (last searched February 2007). We also searched the Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 1, 2007), MEDLINE (1966 to February 2007), EMBASE (1980 to February 2007), CINAHL (1982 to February 2007), AMED (1985 to February 2007), CNKI (1979 to February 2007), CBM-disc (1979 to February 2007), Chinese scientific periodical database of VIP INFORMATION (1989 to February 2007), Wanfang Data (1982 to February 2007), CISCOM (1980 to February 2007), and TCMLARS (1984 to February 2007). SELECTION CRITERIA: Randomised controlled trials comparing sanchi with placebo or no treatment for acute ischaemic stroke within 30 days of onset. DATA COLLECTION AND ANALYSIS: Two review authors extracted data and assessed trial quality. MAIN RESULTS: Eight trials involving 660 participants were included. Seven of the eight studies were of poor quality. Follow-up time was less than one month in six trials. Only two trials provided data for the number of participants who were dead or dependent at the end of 28 days of treatment, indicating a significantly lower rate of death and dependency in the sanchi group than in the control group (relative risk (RR) 0.63, 95% confidence interval (Cl) 0.45 to 0.88). One trial reported higher Barthel index scores in the sanchi group. Pooled analysis of seven trials indicated that sanchi might improve neurological deficit more than control with a significant difference (RR 0.29, 95%Cl 0.18 to 0.47). The total case fatality rate was lower than 1% indicating that participants probably had mild strokes. Few adverse events were reported. Data were limited in respect of stroke recurrence and quality of life. AUTHORS' CONCLUSIONS: Sanchi appears to be beneficial and safe for acute ischaemic stroke in this review, but the small sample and inferior quality of studies prevented a definite conclusion. More well-designed randomised controlled trials are required.