Objective  To observe the efficacy and safety of tandospirone in treating patients with functional dyspepsia(FD) co-morbid with anxiety.

  Methods  Thirty-one patients diagnosed with FD co-morbid with anxiety and failed to respond to routine therapy were recruited from the outpatient clinic of gastroenterology in Peking Union Medical College Hospital during the period of March 2012 to December 2013. The patients were treated with tandospirone citrate tablets 10 mg thrice a day for 4 weeks. FD symptom scores before treatment, after 2-week treatment and after 4-week treatment were compared. The Zung anxiety and depression self-rating scales (SAS and SDS), Hamilton anxiety and depression scales (HAMA and HAMD), quality of life questionnaire (SF-36), and liquid nutrient load test results after 4-week treatments were compared with those before treatment to evaluate the efficacy of tandospirone treatment. Adverse reactions were recorded.

  Results  The total symptom scores 2 weeks and 4 weeks after treatment were 8.48±5.96 and 7.39±5.463, both significantly lower than that prior to treatment (10.45±5.66; P=0.002, 0.020). Compared with before treatment, the discomfort after meal and early satiety symptom scores decreased significantly after 2-week and 4-week treatment (all P < 0.05). The SAS, HAMA and HAMD scores declined significantly after 4-week treatment compared with pre-treatment score (P=0.028, 0.002, 0.000). SF-36 indicated significantly improved physiological function, body pain and total health condition after 4-week treatment (P=0.033, 0.022, 0.041). The threshold volume and satiety volume in liquid nutrient load test showed no significant change after treatment (P=0.285, 0.532). During treatment, there were adverse reactions in 5 patients (16.1%, e.g. rash and pruritus) and one case withdrew from the therapy.

  Conclusion  Tandospirone is effective and safe in treating functional dyspepsia patients with anxiety, offering an option when routine therapy fails.