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

Abstract

Background: Tianshu 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).

Methods: The 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.

Results: One 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.

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

Trial registration: ClinicalTrials.gov Identifier: NCT02035111; Data of registration: 2014-01-10.

Keywords: Herbal medicine; Migraine; Multicenter; Randomized controlled trial; Tianshu capsule.

Conflict of interest statement

Author Dr. Wei Xiao hold shares in Kanion Pharmaceutical Company. Other authors declare that they have no competing interests. Kanion Pharmaceutical Company manufactured the intervention products for the study. However, Kanion Pharmaceutical Company had no role in the design, implementation, analysis, or publication of the trial.

Figures

Fig. 1

Primary and secondary outcome measures in the full analysis set (FAS). a: Percentage of patients with ≥50% reduction in frequency of headache; b: Frequency of headache; c: Severity of headache; d: Usage of acute analgesics; e: Percentage of patients with ≥50% reduction in severity of headache. The percentage of patients with ≥50% reduction in frequency of headache (a) increased gradually in the TSC group and was significantly different from the placebo group at week 8 (***P < 0.001). The frequency of headache (b) in the TSC group was significantly lower than in the placebo group after 8 weeks of treatment (***P < 0.001). The severity of headache (c) and usage of acute analgesics (d) were significantly lower in the TSC group than those in the placebo group after 4 weeks of treatment (***P < 0.001). The percentage of patients with ≥50% reduction in headache severity (e) was significantly increased in the TSC group compared with the placebo group after 8 weeks of treatment (***P < 0.001)