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

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.

Efficacy and Safety of Oral Chinese Herbal Medicine for Migraine: A Systematic Review and Meta-Analyses Using Robust Variance Estimation Model

“…Six RCTs reported outcomes at the end of the 4-week follow-up phase (26,27,31,34,39,41). Fourteen RCTs reported data on the primary outcome measure (migraine frequency) at the EoT (25-29, 31, 34, 35, 37, 39-42) and six reported this at the EoFU (26,27,31,(39)(40)(41). The number of RCTs that reported secondary outcomes such as migraine days, pain VAS/NRS, migraine duration, frequency of acute medication, and the response rate was <10.…”

“…The methodological quality of included RCTs was assessed using the Cochrane Collaboration risk of bias tool and presented in Figure 2. Regarding the random sequence generation, 11 RCTs were assessed as "low risk" for performing adequate randomization (25,26,28,31,32,(36)(37)(38)(39)(40)(41), the remaining seven RCTs were "unclear" due to lack of information (27,29,30,(33)(34)(35)42). Six RCTs depicted the allocation concealment method and were assessed as "low risk" for this domain (26,28,(37)(38)(39)(40), the remaining 12 studies were evaluated as "unclear" due to the absence of relevant information.…”

Efficacy and Safety of Chuanxiong Qingnao Granule in Patients with Migraine: A Randomized, Double-Blind, Placebo-Controlled Trial

“…Before this study, there were many similar types of research on the treatment and prevention of migraine in TCM, with pros and cons. A multicenter double-blind, randomized, placebo-controlled clinical trial demonstrated that Tianshu capsule (TSC), a formula of traditional Chinese medicine, could decrease the frequency and days of migraine and improve related symptoms with good safety [ 24 ]. In this trial, primary and second outcomes included only the directly related indicators of headache, such as headache frequency, VAS, and number of onset days, while evaluation of mood, sleep status, quality of life, and disability status was lacking.…”

Migraine patients visiting Chinese medicine hospital: Protocol for a prospective, registry-based, real-world observational cohort study

“…Chinese herbal medicine (CHM), which is often prescribed to migraine patients in China [25], has gained clinical research evidence as an effective alternative or complementary therapy for migraine in recent years. However, most of the existing evidence has been generated from randomised controlled trials (RCTs) [26][27][28][29][30] and RCT-based systematic reviews [31][32][33][34]. Under controlled settings, RCTs usually apply strict selection criteria and provide unified treatments to all participants [35].…”