头痛解郁通络方治疗肝气郁滞、痰瘀阻络型偏头痛随机对照研究OA

Objective To observe the clinical efficacy and safety of the Toutong Jieyu Tongluo Formula(TJTF)in treating migraine with liver qi stagnation,phlegm and blood stasis obstructing collaterals.Methods A total of 460 patients diagnosed with migraine of the liver qi stagnation,phlegm and blood stasis obstructing collaterals were randomly assigned into a control group and a treatment group,with 230 patients in each group.The control group received flunarizine hydrochloride capsules,while the treatment group was given the TJTF,with both groups treated continuously for 8 weeks.The frequency of headache,headache index,Chinese Medicine(CM)syndrome scores and clinical efficacy,headache accompanying symptom scores,analgesic usage,and adverse reactions were compared before treatment,4 weeks,8 weeks after treatment between the two groups.Results Totally 12 patients dropped out from the control group and 10 from the treatment group,resulting in 438 patients completing the trial and being included in the statistical analysis.Compared with before treatment,both groups demonstrated a reduction in the frequency of headache,headache index,Visual Analogue Scale(VAS)score,CM syndrome scores,and analgesic usage at both 4 and 8 weeks after treatment(P＜0.01),the scores for headache accompanying symptoms decreased significantly at 8 weeks after treatment(P＜0.01),with results at 8 weeks being superior to those at 4 weeks(P＜0.01).When compared to the control group at the same time points,the treatment group exhibited lower frequency of headache,headache index,VAS scores,CM syndrome scores,headache accompanying symptom scores,and analgesic usage at both 4 and 8 weeks(P＜0.01).Furthermore,the treatment group showed higher cure+marked improvement rate and total effective rates for headache index and CM syndrome scores after 8 weeks of treatment(P＜0.01,P＜0.05).No severe adverse reactions were reported in either group.Conclusion The TJTF exhibits clear clinical efficacy and a low incidence of adverse reactions.ITMCTR(No.ITMCTR2025002493)