Efficacy of the 5-HT1A agonist tandospirone citrate in improving symptoms of patients with functional dyspepsia: a randomized controlled trial.
OBJECTIVE
Functional dyspepsia (FD) is a common condition in the general population; however, its treatment remains a challenge. The aim of this study was to examine the efficacy of tandospirone citrate, a new partial agonist of the 5-hydroxytryptamine 1A (5-HT1A) receptor, in improving the symptoms of patients with FD.


METHODS
In this double-blind, placebo-controlled, multicenter study, FD patients were randomized to treatment with 10 mg t.i.d. tandospirone citrate or to placebo for 4 weeks. The primary end point was change in abdominal symptom scores. The difference in the proportion of responders (a total abdominal symptom score of 0 or 1) was also assessed. The quality-of-life questionnaire, the SF-8, and a psychological test questionnaire, the State-Trait Anxiety Inventory (STAI), were completed at baseline and at weekly intervals.


RESULTS
Data were available for 144 patients: 73 for tandospirone and 71 for placebo. Improvements in total abdominal scores were significantly larger with tandospirone than placebo at weeks 1, 2, and 4. Significantly greater improvements in the tandospirone group were observed in upper abdominal pain (P=0.02) and discomfort (P=0.002) at week 4. The proportion of responders was significantly greater in the active treatment arm at weeks 3 (P=0.017) and 4 (P=0.0016). Significant improvements in STAI (P<0.0001) were reported in both arms, as well as in the majority of questions in the SF-8 (P=0.04). No serious adverse events were reported, with similar rates in both study arms.


CONCLUSIONS
Despite a considerable placebo effect, the benefits of tandospirone were shown in terms of improvement in abdominal symptom scores.
Miwa
Hiroto
H
Division of Upper Gastroenterology, Department of Internal Medicine, Hyogo College of Medicine, Hyogo, Japan. miwahgi@hyo-med.ac.jp
Nagahara
A
A
Tominaga
K
K
Yokoyama
T
T
Sawada
Y
Y
Inoue
K
K
Ashida
Kiyoshi
K
Fukuchi
T
T
Hojo
M
M
Yamashita
H
H
Tomita
T
T
Hori
K
K
Oshima
T
T
D000328:Adult; D000704:Analysis of Variance; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004415:Dyspepsia / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D005260:Female; D006801:Humans; D054833:Isoindoles / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D010879:Piperazines / Q000008:administration & dosage* / Q000009:adverse effects; D011336:Probability; D011743:Pyrimidines / Q000008:administration & dosage* / Q000009:adverse effects; D011788:Quality of Life; D012016:Reference Values; D018570:Risk Assessment; D017366:Serotonin Receptor Agonists / Q000008:administration & dosage* / Q000009:adverse effects; D012720:Severity of Illness Index; D013315:Stress, Psychological; D016896:Treatment Outcome
D054833:Isoindoles; D010879:Piperazines; D011743:Pyrimidines; D017366:Serotonin Receptor Agonists; C055267:tandospirone