Patients
In this trial, a total of 186 participants, assigned to 94 in the placebo group and 92 in the Jinlida group, completed the study. The mean HbA1c (%), FBG, 2hPG, body weight, and BMI in the Jinlida and placebo groups was no statistically significant difference in the baseline data. Demographic information of patients has been reported previously [10].
Standard-reaching Rate Of Blood Glucose
The standard-reaching rate of HbA1c (<6.5%, <7%) was 25%, 34.8% in the treatment group when compared to 14.9%, 23.4% in the control group, respectively. The standard-reaching rate of FBG (<7mmol/l), was 34.8% in the treatment group when compared to 23.4% in the control group. The standard-reaching rate of 2HPG (<10mmol/l, <11.1 mmol/l) was 32.6%, 10.6%, when compared to 39.1%, 18.1%, respectively. Standard-reaching rate of blood glucose exhibited a statistically significant difference in standard-reaching rate of HbA1c (<6.5%), and standard-reaching rate of 2hPG (<10mmol/l, 11.1mmol/l) in the treatment group (P <0.05). Although standard-reaching rate of HbA1c <7% (P =0.06) and standard-reaching rate of FBG <7.0mmol/l (P =0.079) in the treatment group did not a significant difference in the treatment group, the standard-reaching rate of tendency is markable (Table 1).
Table 1
Standard-reaching outcomes from baseline in patients after receiving a treatment group or control group for 12 weeks.
Standard-reaching outcomes
|
Treatment group
|
Placebo group
|
P value
|
HbA1c < 6.5%
|
25.0%
|
14.9%
|
0.046
|
HbA1c < 7.0%
|
34.8%
|
23.4%
|
0.06
|
2HPG < 10.0 mmol/l
|
32.6%
|
10.6%
|
0.001
|
2HPG < 11.1 mmol/l
|
39.1%
|
18.1%
|
0.000
|
FBG < 7.0 mmol/l
|
34.8%
|
23.4%
|
0.079
|
Symptom Disappearance Rate
All the symptom disappearance rate has an upward trend. However, only five of nine symptoms exhibited a statistical change difference in the treatment group, including hunger, polyuria, dry mouth, sweating and dysphoria in chestpalms-soles, compared to that in the control group. (P < 0.05; Figure 1C, D, E, F, and H). Especially for sweating symptom, comparing the treatment group to the control group after the intervention, the symptom exhibited a significant difference in the treatment group at just week 4 with a faster rate of clinical improvement than another symptom. (P<0.05; Figure 1F).
Symptom Improvement Rate
Comparing the treatment group to the control group after 12 weeks’ intervention, all the symptom exhibited a statistically significant difference in symptom improvement rate in the treatment group. (P < 0.05; Figure 2). Four of nine symptoms exhibited a significant difference in the treatment group at 8 weeks including thirsty, polyuria, dry mouth and dysphoria in chestpalms-soles, compared to that in the control group. (P < 0.05; Figure 2A, D, E, and H). Sweeting symptom in the treatment group achieved a statistically significant difference at week 4. (P < 0.05; Figure 2F). Notably, though night-sweat symptom achieved a statistically significant difference at week 4 and week 12, it did not exhibit a significant difference at week 8. (P < 0.05; Figure 2G).
Total Symptom Score
Comparison with pre-treatment, total symptom score was statistically significant in both groups in week 4, week 8, week 12. (P < 0.05; Figure 3A). The mean change in total symptom score from baseline to week 12 was -5.45 score in the treatment group, when compared to -2.38 score in the control group (P = 0.023; Figure 3B).
Efficiency Of Single Symptom
Nine kinds of symptoms were assessed by this work including thirsty, fatigue, hunger, polyuria, dry mouth, night-sweat, dysphoria in chenstplms-soles and constipation. Every symptom was evaluated as ineffective, improvement and disappeared. All the symptom exhibited a change difference, comparing the treatment group to the control group after 12 weeks of continuous intervention. (P< 0.05; Figure 4).
Correlation Of Symptom Improvement And Hba1c
Pearson correlation was applied to analyze the correlation between symptom effective and HbA1c. No significant correlations were noted between total symptom score and HbA1c, comparing the treatment group to the control group after 12 weeks of continuous intervention. Correlation coefficients are 0.13 and P value is 0.072. (Figure 5).