Fig. 1Patients of the study.
Fig. 2Changes of the diabetes bowel symptom questionnaire (DBSQ) scores before and after rebamipide treatment (Tx). aP<0.05.
Fig. 3Comparisons of the diabetes bowel symptom questionnaire (DBSQ) score before and after rebamipide treatment (Tx), with respect to (A) sex, (B) age, (C) duration of mellitus duration (DM), (D) glycosylated hemoglobin (HbA1c) level, and (E) body mass index (BMI). Paired t-test for paired values.
Table 1Inclusion and exclusion criteria of patients
Inclusion criteria |
Age ≥18 and ≤80 |
Presence of informed consent |
Presence of atypical gastrointestinal (GI) symptom(s), such as dyspepsia, nausea, abdominal distension, heartburn, irritable bowel symptom, and abdominal pain. |
Glycosylated hemoglobin level ≤10% |
No recent changes in administration of drugs associated with GI symptomsa
|
Proton pump inhibitor, H2 blocker, and all other kinds of antacids |
Prokinetics, such as metoclopramide, domperidone, and mosapride |
Exclusion criteria |
Non-communicable patients |
Psychotic patients who are unable to cooperate |
Severe cardiovascular disease |
Myocardial infarction within 3 months |
History of cerebral infarct or significant cardiovascular disease |
Uncontrolled hypertension (systolic blood pressure ≥180 mm Hg and/or diastolic blood pressure ≥100 mm Hg) |
Severe renal disease |
Severe liver disease |
Severe pulmonary disease |
Presence of organic GI disorder identified by the judgment of clinician |
History of severe acute complications of diabetes mellitus |
i.e., diabetic ketoacidosis or hyperglycemic hyperosmolar syndrome |
Diabetic foot lesion that needs immediate treatment |
Cancer patients with ongoing treatment |
Pregnancy or breastfeeding women |
Hypersensitivity to rebamipide |
Enrollment to other study within 30 days |
History of drug or alcohol abuse |
Absence of informed consent |
Unable to carry out the study based on the judgment of clinician |
Table 2Baseline clinical characteristics of patients
Characteristic |
Overall (n=105) |
Age, yr |
65.0±7.8 |
Male sex |
26 (24.8) |
Diabetes mellitus duration, yr |
14.7±9.1 |
Weight, kg |
61.0±8.1 |
Height, cm |
170.4±141.4 |
Body mass index, kg/m2
|
25.0±3.0 |
Abdominal circumference, cm |
84.6±9.4 |
Alcohol |
|
Never |
80 (76.2) |
Ex-drinker |
2 (1.9) |
Current drinker |
23 (21.9) |
Smoking |
|
Never |
85 (81.0) |
Ex-smoker |
14 (13.3) |
Current smoker |
6 (21.9) |
Medication |
|
Oral hypoglycemic agents |
|
Sulfonylurea |
56 (53.3) |
Metformin |
55 (52.4) |
Thiazolidinedione |
2 (1.9) |
Others |
51 (48.6) |
Antihypertensive agents |
|
Angiotensin-converting enzyme inhibitor |
0 |
Angiotensin II receptor blocker |
55 (52.4) |
β-Adrenergic blockers |
7 (6.7) |
Calcium channel blocker |
50 (47.6) |
Diuretics |
9 (8.6) |
Others |
4 (3.8) |
Lipid-lowering agents |
|
Statin |
54 (51.4) |
Fibrate |
4 (3.8) |
Others |
9 (8.6) |
Antiplatelet agents |
|
Aspirin |
4 (3.8) |
Cilostazol |
4 (3.8) |
Clopidogrel |
68 (64.8) |
Others |
30 (28.6) |
Past medical history |
|
Hypertension |
81 (77.1) |
Dyslipidemia |
78 (74.3) |
Angina pectoris |
13 (12.4) |
Myocardial infarction |
2 (1.9) |
Cerebrovascular disease |
12 (11.4) |
Others |
87 (82.9) |
Systolic blood pressure, mm Hg |
126.8±13.9 |
Diastolic blood pressure, mm Hg |
73.4±9.5 |
White blood cell, 103/µL |
6.12±1.77 |
Hemoglobin, g/dL |
12.9±1.1 |
Hematocrit, % |
38.7±3.1 |
Platelet, 103/µL |
277.0±81.6 |
Glycosylated hemoglobin, % |
6.97±0.82 |
Blood urea nitrogen, mg/dL |
15.38±5.06 |
Creatinine, mg/dL |
0.71±0.22 |
Aspartate aminotransferase, IU/L |
22.63±7.20 |
Alanine aminotransferase, IU/L |
21.26±9.12 |