Objective To explore the clinical effectiveness and safety of acupuncture combined with Huafeng Elixir（化风丹） in treating peripheral facial paralysis（PFP） of wind-cold type. Methods Seventy-four patients with wind-cold type PFP were randomly divided into acupuncture group and combination（acupuncture plus medicine） group with 37 cases in each group. Both groups were given acupuncture

and oral Huafeng Elixir was additionally administered in combination group with 0.72 g each time

three times daily; medication was stopped for six days after 18 days of administration; the treatment duration was eight weeks. The House-Brackmann（H-B） facial nerve function grading score

facial disability index（FDI） score（including physical function score and social function score）

and traditional Chinese medicine（TCM） symptom score were compared between groups before treatment and after 4 and 8 weeks of treatment; the clinical effectiveness was evaluated

and the occurrence of adverse events was recorded. Results A total of 69 patients were finally analyzed

including 35 patients in the combination group and 34 in the acupuncture group. After 4-week treatment

the cure rate was 62.86% and the total effective rate was 91.43% in the combination group

while those in the acupuncture group were 47.06% and 82.35%

respectively. After 8-week treatment

the cure rate and total effective rate were 88.57% and 97.14% in the combination group while those were 64.71% and 88.24% in the acupuncture group. The 8-week results of cure rate and total effectiveness rate were significantly higher than 4-week results（P<0.05 or P<0.01）

and cure rate of both 4-week and 8-week were significantly higher in the combination group than in acupuncture group（P<0.05）. In terms of the H-B facial nerve function

patients in the combination group were mainly grade Ⅰ and Ⅱ after 4-week treatment and grade I after 8-week treatment

while those in the acupuncture group were mainly grade Ⅰ

Ⅱ and Ⅲ after 4-week treatment and grade Ⅰ and Ⅱ after 8-week treatment. Physical function score of both 4-week and 8-week treatment were higher

while social function score and TCM symptom score were lower than those before treatment（P<0.01）. The combination group had higher physical function score and lower TCM symptom score than acupuncture group both after 4-week and 8-week treatment（P<0.05）. Thirty-one cases were cured in the combination group with mean treatment duration of 31.13±1.71 days

and 22 cases were cured in the acupuncture group with duration of 36.91±2.85 days; the treatment duration for cured cases was significantly reduced in the the combination group compared to acupuncture group（P<0.05）. The incidence of adverse events was 5.7% in the combination group

which was not significantly different with 5.9% in the acupuncture group（P>0.05）. Conclusion Acupuncture combined with Huafeng Elixir is better than acupuncture alone in improving facial nerve function and clinical symptoms

reducing treatment duration and increasing social function for the treatment of wind-cold type PFP

and the treatment is safe.