Literature search results
According to the retrieval strategy, a total of 259 English literatures were obtained. After reading the topic, abstract and full text, 4 items of RCT14-17 were included. The process of literature retrieval and screening is shown in Figure 1, and the basic characteristics of the included studies are shown in Table 1. The studies included in this system review were randomized, double-blind and multicenter clinical trials. ITT analysis was used to analyze the effectiveness indicators. The specific methods of generating random sequences are described, and the allocation and concealment are all interactive voice response systems. The number of people who quit and lose visits are reported, and the quality of the study is high.
Risk of Bias
We judged a high proportion of the trials to have low risk of bias for sequence generation (100%), and low risk of bias for allocation concealment (100%), complete outcome reporting (100%), blinding of participants and personnel (100%), and outcome assessment (100%) ,but other bias is unclear(100%)(Figure 2,3). Overall,4 trials13-16 were judged to be of low risk.Supplementary Figure 2 and 3 summarizes the reasons for the risk of bias judgment decisions.
Primary Outcomes
Percentage of Participants Reporting Pain Freedom (PF)
Compared with placebo, ubrogepant was found to be statistically significantly associated with a reduction in percentage of participants reporting pain freedom (PF), RR=1.99,95%CI:1.51~2.63,P<0.00001. (Supplementary Figure 4).
Percentage of Participants With Pain Relief (PR)
Compared with placebo, ubrogepant was found to be statistically significantly associated with a reduction in percentage of participants with pain relief (PR), RR=1.31,95%CI:1.20~1.42,P<0.00001. (Supplementary Figure 5).
Secondary Outcomes
Percentage of Participants With Sustained Pain Freedom (SPF)
Compared with placebo, ubrogepant was found to be statistically significantly associated with a reduction in percentage of participants with sustained pain freedom (SPF), RR=1.31,95%CI:1.18~1.45,P<0.00001. (Supplementary Figure 6).
Percentage of Participants With Sustained Pain Relief (SPR)
Compared with placebo, ubrogepant was found to be statistically significantly associated with a reduction in percentage of participants with sustained pain relief (SPR), RR=1.63,95%CI:1.46~1.82,P<0.00001. (Supplementary Figure 7).
Tolerability
Phonophobia is sensitivity to sound
Compared with placebo, ubrogepant was found to be statistically significantly associated with a reduction in percentage of participants with the absence of phonophobia in sound, RR=1.22,95%CI:1.15~1.29,P<0.00001. (Supplementary Figure 8).
Photophobia is sensitivity to light
Compared with placebo, ubrogepant was found to be statistically significantly associated with a reduction in percentage of participants with the absence of phonophobia in light, RR=1.32,95%CI:1.22~1.42,P<0.00001. (Supplementary Figure 9).
Absence of Nausea
Compared with placebo, ubrogepant was found to be statistically significantly associated with a reduction in percentage of participants with absence of nausea, RR=1.16,95%CI:1.05~1.27,P=0.002. (Supplementary Figure 10).