Objective:

2

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:

2

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)

Xiaguan (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:

2

Three cases withdrew from the trial

2 in the TNT group and 1 in the AT group. There was no significant 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:

2

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)