[Study on integrated Chinese and Western therapy and criterion for efficacy evaluation of gastroesophageal reflux disease--a clinical observation on 116 cases].

OBJECTIVE

To explore the criterion for efficacy evaluation of gastroesophageal reflux diseases (GERD) and the effect of treatment with integrated Chinese and Western medicine.

METHODS

One hundred and sixteen patients of GERD were randomly assigned to two groups, group A treated with Western medicine and group B with integrated Chinese and Western medicine. Changes of symptoms, TCM syndromes, and endoscopic picture were observed before and after treatment. And the condition of recurrence was also inspected.

RESULTS

The total effective rate was 84.5% and 67.2% in group A and B respectively. The long-term efficacy was better in group B than that in group A (P < 0.05), while there was no significant difference in short-term efficacy between the two groups. But the recurrence happened in both groups after withdrawal of treatment. The recurrence rate was significantly higher in patients of deficiency syndrome type and coexistence of deficiency and excess syndrome type than that in those of excess syndrome type (P < 0.05), and it was also higher in those whose pathogenesis was associated with mental factor (P < 0.05). In the other 20 patients the treatment was sustained for 10.4 +/- 11.4 months on average. There were 69.0% of the patients with normal esophagus mucosa shown by endoscope examination, and the pathological changes were not coincident with the symptoms and prognosis.

CONCLUSIONS

Basically, no case of GERD could be cured, so, it is supposed that the item of "cure" in the criteria of therapeutic efficacy evaluation is advisably made over to "clinical control" or "obvious efficacy", and add an item of "no change" in the criterion. The importance of endoscopic picture for efficacy evaluation is doubtful and needs to be further discussed.