Modified Banxia Baizhu Tianmatang Combined with Acupuncture for Migraine (Wind-phlegm Upset Syndrome) Observe / 中国实验方剂学杂志

Objective:To observe theclinical efficacy of modified Banxia Baizhu Tianmatang combined with acupuncture on migraine with wind phlegm disturbance syndrome， and the regulatory effect on neurovasoactive peptide and vascular endothelial activator. Method:Two hundred and fifty patients were randomly divided into control group （75 cases） and observation group （75 cases）. Patients in Two group got acupuncture for 6 times， 1 time/day， after a day of rest， they got placebogranules of Banxia Baizhu Tianmatang， 10 g/time， 2 times/day. Patients in observation group got Banxia Baizhu Tianmatang， 1 dose/day， and also the same acupuncture with the therapyof control group. And the treatment lasted for 4 weeks. At the half， 1^st， 2^nd， 6^th， 12^th， 24^th， and 48^th hour after treatment， VAS were scored， rate of pain relief within 6， 12， and 24 hours， disappearance rate and recurrence rate of pain within 72 hours， migraine attack times， headache duration and headache degree before 4 weeks of treatment， during the treatment and after the treatment were recorded. Before and after treatment， accompanying symptoms， wind phlegm disturbance syndrome， headache impact test version-6 （HIT-6） and the migraine disability assessment questionnaire （MIDAS） were scored. And levels of calcitonin gene-related peptide （CGRP）， nitric oxide （NO）， endothelin-1 （ET-1）， pituitary adenylate cyclase activating peptide （PACAP）， S100B protein， substance P（SP）， von Willebrand factor （vWF） and fibrinogen （FIB） were detected. And safety was evaluated. Result:VAS in two groups decreased at different time points （<italic>P<</italic>0.01）， and VAS in observation group at 6^th， 12^th， 24^thand 48^th hour after treatment were lower than those in control group （<italic>P<</italic>0.01）. The rate of pain relief in observation group at 6^th and 12^th hours after treatment and the disappearance rate of pain at 72^th hour were 67.14%（47/70）， 87.14% （61/70） and 92.86% （65/70）， which were higher than 50.00% （34/68）， 70.59% （48/68） and 79.41% （54/68） in control group. The recurrence rate of pain in observation group was 21.43% （15/70）， which was lower than 39.71% （27/68） in control group （<italic>P<</italic>0.05）. During the treatment and drug withdrawal， times of migraine attack， headache duration and headache degree were all less than those in control group （<italic>P<</italic>0.01）. Scores of accompanying symptoms， wind phlegm disturbance syndrome， HIT-6 and MIDAS were all lower than those in control group （<italic>P<</italic>0.01）. The clinical effect was better than that in control group （<italic>Z</italic>=2.106， <italic>P<</italic>0.05）. Levels of CGRP， PACAP， S100B protein， SP， ET-1， vWF and FIB were lower than those in control group， while level of NO was higher than control group （<italic>P<</italic>0.01）. Conclusion:Modified Banxia Baizhu Tianmatang combined with acupuncture had a better instant analgesic effect， with a significant effect on continuing analgesia and reducing headache recurrence. It can also alleviate migraine symptoms and accompanying symptoms， andreduce the impact of migraine on daily life and the degree of disability. Its mechanism may be related to the regulation of neurovasoactive peptides and vascular endothelial substances. It is worth for further study.