Abstract
Objective
To study the efficacy of modified Wuzhuyu Decoction Granule (加减吴茱萸汤颗粒, MWDG) in the treatment of migraine patients with cold and stasis obstructing meridian syndrome.
Methods
This study was a randomized, double-blind, placebo-controlled trial. A total of 78 migraine patients with cold and stasis obstructing meridian syndrome were recruited and randomly assigned by a ratio of 2:1 into a treatment group (51 cases) and a placebo group (27 cases). Patients in the treatment group were treated with MWDG while placebo granules were applied in the control group. The treatment course lasted for 12 weeks with a follow-up of 4 weeks. The primary outcome measures included frequency and days of migraine attacks and the secondary outcome measures were analgesics consumption and visual analogue scale (VAS) scores. All outcome assessments were conducted respectively at baseline, the 4th, 8th and 12th week, and the end of follow-up.
Results
In the treatment group, significant decrease in frequency of migraine attacks were observed since the 4th week and that of analgesics consumption since the 8th week (both P<0.05). While, in the placebo group, significant decrease in frequency of migraine attacks were observed since the 8th week and that of analgesics consumption since the 12th week (both P<0.05). No significant decrease in days of migraine attacks and VAS scores of migraine pain were observed in both groups. Between the two groups, there were significant differences in VAS scores and intensity of pain appeared in the 8th week (P<0.05). However, no significant differences were found in days and frequency of migraine attacks and analgesics consumption (P>0.05).
Conclusions
MWDG was probably effective in the treatment of migraine especially for alleviating pain intensity. Furthermore, MWDG could reduce the frequency of migraine attacks and analgesics consumption sooner than the placebo.
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Acknowledgments
The authors gratefully thank Prof. He LY and statistician Yan SY of the China Academy of Chinese Medical Sciences for valuable comments on the study design and statistical analysis. The authors also appreciate the approval of GR Pharmaceutical Co. Ltd. for medication supply. Finally, the authors deeply thank Zhao JJ, Gong HY, Zhang SQ, Lin AJ, Yang WM and Li T of the other hospitals for participating and collecting data in this study.
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Liu, Hw., Zou, Yh., Cao, Kg. et al. Efficacy of Modified Wuzhuyu Decoction Granule (加减吴茱萸汤 颗粒剂) for Migraine Patients with Cold and Stasis Obstructing Meridian Syndrome: A Randomized, Double-Blind, Placebo-Controlled Trial. Chin. J. Integr. Med. 24, 409–414 (2018). https://doi.org/10.1007/s11655-017-2547-5
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DOI: https://doi.org/10.1007/s11655-017-2547-5