| Objectives To observe the clinical efficacy,safety and possible mechanism of Tibetan medicine Rannasangpei(RNSP)in the migraine patients at high altitude.Methods In this study,a randomized,double-blind,and positive drug control study was conducted to observe the efficacy and safety of Tibetan medicine Rannasangpei in the treatment of migraine.From December 2016 to September 2017,selecting 80 patients with migraine from the Department of Neurology,Qinghai Provincial People's Hospital(2260m above sea level),randomly selected 40 patients for treatment group and 40 patients for control group according to the random number table method.The treatment group was given oral Tibetan medicine Rannasangpei(0.33g/grain),2 tablets each time,taken once a night before going to bed;the control group was given oral flunarizine hydrochloride capsules(5mg/grain),each time 2 Granules,taken once a night before going to bed.All subjects were unable to take any other analgesic drugs during the observation period and began to fill in a headache diary(see Appendix 1)on time after enrollment,and recorded clinical symptoms such as attack times,pain extent,lasting time and accompanied symptoms of headache are used for clinical efficacy evaluation before treatment and after treatment of 4 and 8 weeks.At the same time,fasting blood was collected before treatment and on the 8th week after treatment.Enzyme-linked immunosorbent assay(ELISA)was used to detect serum 5-hydroxytryptamine(5-HT)and brain-derived neurotrophic factor(BDNF)in two groups of patients.The course of treatment for both groups was 8 weeks.Follow-up was conducted after treatment of 4 and 8 weeks,including clinical changes in headache symptoms and adverse reactions during patient medication.Results 1.Before treatment,the treatment group had no statistically significant differences in the gender,age,duration,nationality,illness,and headache symptom scores(including attack times,pain extent,lasting time and accompanied symptoms of headache)between the Tibetan medicine Rannasangpei treatment group and the flunarizine control group(P>0.05);2.Comparison of pain scores after treatment:(1)Comparison of Tibetan medicine Rannasangpei treatment groups: Compared with before treatment and after taking Tibetan medicine Rannasangpei for 4 weekends,the headache symptom scores of the Tibetan medicine Rannasangpei decreased significantly after 8 weeks,and the differences were statistically significant.Significance(P<0.05);(2)Comparison between flunarizine control groups: Compared with before treatment,the symptom scores of headache at the 4th and 8th week of flunarizine use were significantly lower,and the differences were statistically significant(P<0.05);Compared with flunarizine at the end of the 4th week,the number of headache attacks and headache scores decreased significantly after 8 weeks of flunarizine administration(P<0.05);(3)Comparison between Tibetan medicine Rannasangpei treatment and flunarizine control groups: Treatment with the flunarizine control group At the end of the 4 weeks,there was no significant difference in the scores of headache symptoms in the Tibetan medicine Rannasangpei treatment group for 4 weeks(P>0.05).Compared with the flunarizine control group,there was a statistically significant difference in headache symptom scores in the Tibetan medicine Rannasangpei treatment group at 8 weeks after treatment.(P<0.05);3.The overall evaluation of efficacy: The total efficacy rate of flunarizine in the control group was 74.4% for 8 weeks,and the total effective rate was 85.0% in the treatment group for the use of the Tibetan medicine Rannasangpei for 8 weeks.The difference in total effective rate between the two groups was statistically significant(P<0.05);4.Serum levels of 5-HT and BDNF in the two groups were compared:(1)Compared with before treatment between the groups,the serum 5-HT and BDNF levels were all significantly increased after 8 weeks of treatment in the both groups,with statistical significancally(P<0.05);(2)The serum 5-HT and BDNF levels in the RNSP treatment group for 8 weeks were higher than those in the control group of Flunarizine treatment,with statistical significancally(P<0.05);5.Safety analysis: The incidence of adverse reactions in the 8 weeks of flunarizine in the control group was 8.7%,and 5% in the treatment group after taking Rannasangpei in the 8 weeks.The incidence of adverse reactions in the two groups was analyzed by Fisher's exact test.There was no significant difference between the two groups(P>0.05).There was no significant difference in blood routine and liver and kidney function between the two groups before and after treatment(P>0.05).Conclusions 1.RNSP can significantly reduce migraine attacks,reduce headaches,shorten headache duration,and reduce accompanying symptoms;2.RNSP has the same curative effect as Flunarizine at the 4th week of treatment of migraine.The curative effect is better than Flunarizine at 8 weeks and has high safety and no effect on liver and kidney function;3.RNSP can significantly increase serum 5-HT and BDNF levels in migraine patients,which may be one of the mechanisms of action for headaches in migraine patients. |
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