Skip to main content
. 2020 Feb 18;40(2):BSR20191260. doi: 10.1042/BSR20191260

Table 1. The detailed inclusion and exclusion criteria for the present study.

Inclusion criteria
(1) Patients diagnosed with Type 2 diabetes (following the WHO diabetes diagnosis and typing standard (1999) diagnostic criteria).
(2) Moderate and mild depression (light depression), depression and recurrent depression with non-psychotic symptoms (light depression, depression with non-psychotic symptoms, following diagnostic criteria of 10th edition of 1992 WHO International Classification of diseases – mental and behavioral disorders).
(3) Score more than 8 points, less than 35 points according to Hamilton Depression Scale (HAMD, 24 versions); accord with the diagnostic criteria of imbalance of heart and kidney in traditional Chinese medicine.
(4) Adult patient over 18 years of age.
(5) Glycated hemoglobin was less than or equal to 8%.
(6) No antidepressants and psychotropic drugs were used within 2 weeks.
(7) The patient had self-knowledge ability and correctly understood the questionnaire content, and written informed consent was obtained from the patients before the study
Exclusion criteria
(1) Patients with acute complications of diabetes, including diabetic ketoacidosis, diabetic hyperosmolar nonketotic coma, hypoglycemia coma or severe unconscious hypoglycemia, etc.; or severe chronic diabetic complications.
(2) Patients with heart failure, unstable angina pectoris, severe arrhythmia, myocardial infarction in the past 12 months; blood pressure SBP>180mmHg or DBP>100mmHg.
(3) Patients with a history of liver disease such as cirrhosis, hepatitis B, or hepatitis C (except for carriers), or AST or ALT 2. 5 times higher than the normal upper limit.
(4) Patients with renal disease or clinically diagnosed history of renal insufficiency, serum creatinine greater than 1.5 mg/dl (132.6 mol/l) and the clearance rate of endogenous creatinine less than 50 ml/min.
(5) Patients who suffered from acute or chronic pancreatitis, or had pancreatic injury for any reason, had blood amylase levels above the normal limit.
(6) Patients were suffering from upper gastrointestinal ulcers, history of bleeding and gastric retention due to gastrointestinal surgery or pyloric obstruction.
(7) Patients with other endocrine system diseases, such as hyperthyroidism, hypercortisolism and so on.
(8) Patients with severe mental symptoms other than depression or family history of mental disorders and mental disorders of family history.
(9) There were stress factors such as trauma, infection, surgery, fever and history of glucocorticoid use in the last 3 months.
(10) No clear history and typical clinical manifestations of HPA axis dysfunction (centripetal obesity, full moon face, buffalo back, skin purple pattern, etc.)
(11) Pregnant women, breast-feeding women, women of childbearing age who did not take effective contraception or plan to conceive during the trial period, whose results of urine HCG test show positive.
(12) Patients with perimenopausal syndrome.
(13) Patients with that curative effects and safety judgment was affected by data under-collection or unable to judge.