Clinical study on tongyan spray for post-stroke dysphagia patients: a randomized controlled trial

Abstract

Objective: To observe the effectiveness and safety of Tongyan spray composed of Chinese medicine for post-stroke dysphagia patients.

Method: One hundred and twenty-two post-stroke dysphagia patients were randomly assigned to the treatment group (61 cases) and the control group (61 cases). Basic treatment was given to both groups, with Tongyan spray additionally used in oropharynx for the treatment group, and the placebo used for the control group. After 28-day treatment, the clinical effect and safety were evaluated according to the standard swallowing assessment (SSA) scale.

Results: One patient dropped out in each group, and 120 patients reached the final analysis of the study. The total effective rate for the treatment group was 71.7% (43/60), higher than 46.7% (28/60) in the control group (P<0.05), and the improvement on SSA scores of the two groups were significantly different after treatment (P<0.05). For grade 1 dysphagia patients (completely depending on nasogastric tube), the effective rate of the treatment group was 40.9% (9/22), and 12.5% (2/16) of the control group, without significant difference (P>0.05), while the improvement of SSA score was significantly different between the two groups after treatment (P<0.05). For grade 2-3 dysphagia patients (oral and nasogastric tube feeding), the total effective rate of the treatment group was 89.5% (34/38), higher than 59.1% (26/44) in the control group (P<0.05), and also the improvement on SSA scores was significantly different between the two groups after treatment (P<0.05).

Conclusion: Tongyan spray was an effective and safe method for post-stroke dysphagia patients.