Outcomes
T2D, thirst, fatigue, constipation, polyuria, dry mouth
HEAT, SECONDARY, DRY MOUTH
The primary outcomes were the standard-reaching rates of blood glucose, including HbA1c (HbA1c < 6.5%, < 7%), FBG (< 7 mmol/L), and 2hPG (< 10mmol/L, 11.1 mmol/L) in the two groups after 12 weeks of treatment. The secondary outcomes were symptom disappearance rate, symptom improvement rate, efficacy of single symptom, and total symptom score. During this 12-week study period, all the subjects received a clinical symptom evaluation at 0, 4, 8, and 12 weeks. The assessed symptoms were nine common symptoms of patients with T2D, including thirst, fatigue, increased eating with rapid hungering, polyuria, dry mouth, spontaneous sweating, night sweat, vexing heat in the chest, palms, and soles, and constipation. The efficacy of a single symptom was marked as disappearance, improvement, and ineffective. It was scored according to the severity of symptoms. None, mild, moderate, and severe of the thirst and fatigue symptoms were scored 0, 2, 4, and 6, respectively, and of the other seven symptoms were scored 0, 1, 2, and 3, respectively. The cumulative score of the nine symptoms was the total symptom score. A correlation analysis between symptom improvement (change of the total symptom score) and HbA1c was also evaluated.