A Randomized Clinical Study On The Preventive Treatment Of Chronic Migraine With Botulinum Toxin Type A

Aim:To compare the efficacy and safety of repeated injection of low dose botulinum toxin type A(BTX-A)with fixed sites plus pain points and high dose BTX-A with fixed sites as prophylactic treatment of chronic migraine(CM).Methods:A total of 117 CM patients were randomly recruited into low dose BTX-A(50 U)group(group A),high-dose(155U)group(group B)and control(saline)group(group C).Patient information was collected before treatment and after treatment at different time points:4 weeks,8 weeks,12 weeks,16 weeks,20 weeks,24 weeks,including headache frequency,headache days,VAS score,HIT-6 score,the percent of patients who used over-dosage drugs and adverse effects.Results:No significant difference was found in demographic data and baseline headache measures among three groups before treatment.Compared to baseline,Headache related indexes of patients in all groups were improved from 4 weeks after treatment(p<0.01).Headache frequency of both group A and B was significantly lower than group C from 8 weeks after treatment(p<0.01).Headache days of both group A and B were lower than group C from 12 weeks after treatment(p<0.01).Both VAS score and HIT-6 score of group A and B were lower than group C after treatment(VAS score p<0.05,HIT-6 score p<0.01).The percentage of acute drug overdose in A and B groups was significantly lower than group C at the 16 and 20weeks after treatment(p<0.01)..The incidence of adverse reactions was about 12.0%(14/117).Adverse reaction rate in group A were significantly lower than B(p<0.01).Conclusions:Repeated injection of low dose BTX-A with fixed sites plus pain points is as effective as high dose BTX-A with fixed sites,and its adverse effects are significantly less than the latter.Therefore,we recommend this repeated low dose injection of BTX-A for regular treatment of CM.