Abstract
Objective
To compare the clinical effects of thick-needle therapy (TNT) and acupuncture therapy (AT) on patients with Bell’s palsy (BP) at the recovery stage.
Methods
A total of 146 eligible participants from 3 hospitals in China were randomized into the TNT group (73 cases) and the AT group (73 cases) using a central randomization. Both groups received Western medicine thrice a day for 4 weeks. Moreover, patients in the TNT group received subcutaneous insertion of a thick needle into Shendao (GV 11) acupoint, while patients in the AT group received AT at acupoints of Cuanzhu (BL 2), Yangbai (GB 14), Dicang (ST 4), **aguan (ST 7), Jiache (ST 6), Yingxiang (LI 20) and Hegu (LI 4), 4 times a week, for 4 weeks. Both groups received 2 follow-up visits, which were arranged at 1 month and 3 months after treatment, respectively. The primary outcome measure was House-Brackmann Facial Nerve Grading System (HBFNGS) grade. And the clinical recovery rates of both groups were evaluated according to the HBFNGS grades after treatment. The secondary outcome measures included the facial disability index (FDI) and electroneurogram (EnoG). The adverse events were observed and recorded in both groups.
Results
Three cases withdrew from the trial, 2 in the TNT group and 1 in the AT group. There was no signifificant difference in the clinical recovery rates between the TNT and AT groups after 4-week treatment [40.85% (29/71) vs. 34.72% (25/72), P>0.05]. At the 2nd follow-up visit, more patients in the TNT group showed reduced HBFNGS grades than those in the AT group (P<0.01). No significant difference was observed between the two groups in FDI score, EnoG latency and maximum amplitude ratio at all time points (all P>0.05).
Conclusion
The clinical effect of TNT was equivalent to that of AT in patients with BP at recovery stage, while the post-treatment effect of TNT was superior to that of AT. (Registration No. ChiCTR-INR-16008409)
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Acknowledgment
We thank the Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences for its supervision and support on protocol implementation and safety control of the trial. We are grateful to CLINDA Soft Co., Ltd. for their statistical management. We also extend our gratitude to the First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou Traditional Chinese Medical Hospital and the Second Affiliated Hospital of Zhejiang University School of Medicine for their kind assistance and collaboration.
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Xuan LH, Wang YP and Shang HC designed the trial. Yu BY and Wan YJ drafted the manuscript. Zhao C and Wang LY collected data and performed statistical processing. All authors read and approved the final manuscript.
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Supported by the Scientific Research Special Fund of Traditional Chinese Medicine Industry (No. 201507006-01)
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Yu, By., Wang, Yp., Shang, Hc. et al. Effect of Thick-Needle Therapy in Patients with Bell’s Palsy at Recovery Stage: A Multi-center Randomized Controlled Trial. Chin. J. Integr. Med. 26, 455–461 (2020). https://doi.org/10.1007/s11655-020-3081-z
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DOI: https://doi.org/10.1007/s11655-020-3081-z