| BackgroundsMigraine is a kind of recurrent and throbbing headache, which generally break out unilaterally, and often accompanywith nausea and vomiting.Before the onset of headache, a few visual, sensory signs and motor disorders may occur, and some patients can have a family history.In China, the prevalence of migraine is about 9.3%. The morbidityof migraine is high, and patients of migraine confront a heavy burden. Additionally, migraine with aura is a risk factor of ischemic stroke and cerebral white matter lesions.Patientsof migraine have a lower living quality than other people.The prevention and treatment of migraine have aroused wide attention in the medical community.Moreover, treatment for headache through Chinese medicine has a long history,witha wealth of clinical experience.The investigation on Zhengtian capsules curing migraine is a part of the randomized double-blind, multicenter study of Zhengtian capsules curing migraine in control with flunarizine. The study is one of the projects of’Major Drug Discovery’ in China. Based on theguidelines for migraine clinical researches, a prospective, randomized, double-blind, double layered block modeling, positive drug controlled multicenter clinical research program has been designed.ObjectivesWe aimed to further investigate the adaptation syndromes for Zhengtian caplsule curing migraine, and then evaluate the clinical efficacy and safety of Zhengtian caplsule during the catabatic period of migraine.MethodsThis research adopts the multicenter, prospective, block randomized, double-blind, double simulation, positive medicine contrast design, usingexperimental drugs compared with positive drug.It’s also a noninferiority design. Zhengtian capsulesarereformed from Zhengtian pills.Because early literature about theZhengtian capsules reported less, so determination ofthe test sample refer to the Zhengtian pills.We mainly collected patients by means of outpatient service and advertising, in strict accordance with the random Numbers table. All patients included firstly signed informed consent, and then undergone the physical and chemical inspection, patients who conform to the standars finally enter into the group.The experimental grouptook Zhengtian capsules by day, every time 2 grain (0.45 g/grain),3 times a day, after meals.At the same time,the control grouptookflunarizinewith dose of 5 mg, and once every night, every time 2 grain (0.45 g/grain),3 times a day, after meals.All the patients were interviewed on the day of enrollment, at the baseline periodof 4 weeks, after treatment of 4 weeks,8 weeks, and 12 weeks, and after after drug withdrawal of 4 weeks. We used the SAS9.2 statistical package for statistical analysis.All of the statistical tests adopted bilateral inspection. The difference is statistically significanton the threshold of P< 0.05, or highly significant statistical significant of P< 0.01.Main curative effect is evaluated by thefrequency rate of headache reducing by half. The secondary efficacy index is thenumbers, days, degree, and duration of headache, outcome assessment scale (PRO) migraine patients reported, the number and quantity of using analgesics, and weight, etc.ResultsMain outcomes:at the 4th week to 12th week after treatment, the frequency of of headache reducing by halfdecreased in two groups of patients.At the 12th week after treatment, the group of flunarizine had a lower frequency of of headache reducing by halfdecreased than the Zhengtian capsules group (P= 0.0087). At the 4th week offollow-up, the frequency of of headache reducing by halfdecreased in two groups of patients, and the group of flunarizine had a lower frequency of of headache reducing by halfdecreased than the Zhengtian capsules group (P=0.0005). The Zhengtian capsules and flunarizine all can redulce the frequency of of headache reducing by half.The effect was significant at 12th week after treatment, andthe Zhengtian capsuleswere superior to flunarizine, and were lighter at the 4th weekthan at the 12th week offollow-up, and Zhengtian capsules were superior to flunarizine. At the 4th week after treatment, and 8th week after treatment, the non inferior effect analysis showed that the Zhengtian capsules is not short of flunarizine. At the 12th week after treatment, and 4th week of follow-up, the non inferior effect analysis showed that the Zhengtian capsules is not short of flunarizine. The Zhengtian capsules were superior to flunarizine on thelong curative effect in the treatment of migraine (12 weeks of treatment and follow-up of 4 weeks).The clinical adaptation syndromes of Zhengtian capsules:Zhengtian capsules were superior to flunarizine on in the treatment of migraine wind syndrome. Patients ofmigraines wind syndrome, with the use of Zhengtian capsules had a higher frequency of of headache reducing by halfthan flunarizine (p< 0.05). The Zhengtian capsules group had a lower PRO scale score than those of flunarizine (p< 0.05). The Zhengtian capsules were superior to flunarizine on the long curative effect in the treatment of migraine.For patients with migraine of phlegm dampness syndromes, the Zhengtian capsules grouphad a higher frequency of of headache reducing by halfthan flunarizine (p< 0.05). At the 8th week, 12th week after treatment, and the 4th week of follow-up, the two groups had no difference on on the overall level of and changes relative to the baseline of the half headache frequency rate, number of headache days, headache, headache duration, number of using analgesics, and PRO rating scale, etc. (all p> 0.05).That indicates thatin the treatment of migraine phlegm dampness syndromes, the Zhengtian capsules were superior toflunarizine on the short-term curative effect, and on thelong-term curative effect were similar to the latter.For patients with migraine belong to blood stasis, blood deficiency syndrome and Yang deficiency syndrome, the two groups had no difference on the overall level of and changes relative to the baseline of the half headache frequency rate, number of headache days, headache, headache duration, to use of the number of analgesics, PRO rating scale, etc. at the4 th week,8th week,12th week after treatment, and the 4th week of follow-up (all p> 0.05).The Zhengtian capsules were similar toflunarizine on the short-term curative effect, and the long-term curative effect compaired with flunarizine.For patients with migraine belong to a hot syndrome, at the 4th week of follow-up, the flunarizine group had a higher PRO rating scale total score than the Zhengtian capsules group, the difference was statistically significant. At the 12th week of treatment, flunarizine group had higher decrease amplitude on the headache frequency than the Zhengtian capsules group, the difference was statistically significant. The two groups had no difference on the overall level of and changes relative to the baseline of the half headache frequency rate, number of headache days, the headache frequency, headache duration, to use of the number of analgesics, etc. at the4 th week,8th weekafter treatment, and the 4th week of follow-up (all p> 0.05). For patients with migraine belong to a hot syndrome, the Zhengtian capsules were similar toflunarizine on the short-term curative effect compaired with flunarizine, and the long-term curative effect needed be further researched.For patients with migraine belong to the wind syndromes, or the phlegm dampness syndromes, the Zhengtian capsules were superior to flunarizine, on the long-term curative effect for the wind syndrome(at the 4th week of follow-up after withdrawal), and on the short-term curative effectfor phlegm dampness syndromes (at the4th week after treatment).At the 4th week of follow-up, the Zhengtian capsules were better on treating migraine belong to the wind syndromesthan treating other syndromes based on the frequency of of headache reducing by half.ConclusionsThe Zhengtian capsules and flunarizine are all effective improving the diseases and syndromes in patients with migraine.1. The Zhengtian capsules were better on treating migraine belong to the wind syndromesthan treating other syndromes. For patients with migraine belong to the wind syndromes, or the phlegm dampness syndromes, the Zhengtian capsules were superior to flunarizine, on the long-term curative effect for the wind syndrome(at the 4th week of follow-up after withdrawal), and on the short-term curative effect for phlegm dampness syndromes (at the4th week after treatment). That indicated that the advantage of TCM syndrome using Zhengtian capsules.2. The Zhengtian capsules were superior to flunarizine, on the long-term curative effect (at the 12th week after treatment and at the 4th week of follow-up). Zhengtian capsules can improve the mental state of patients with migraine, and have a better perform on the evaluation scale (PRO)and SF-36 scale.Taht indicates Zhengtian capsules can improve the mental health, the patient’s physical health, and the patient’s quality of life, which embodies the comprehensive effect of the treatment of disease. |
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