| 1. ObjectiveTo evaluate the efficacy and safety of transcutaneous electrical point stimulation for type 2 diabetes mellitus(T2DM) by a single-blind concurrent randomized controlled trial, to provide the evidence for clinical practice and basis for future research.2. Methods2.1 Diagnosis CriteriaThe diagnostic criteria of T2DM by the expert committee of World Health Organization(WHO) in 1999 was adopted. They were fasting plasma glucose (FPG) ≥7.0mmol/L(126mg/dl), or the 2 hours plasma glucose(2hPG) in oral glucose toleranee test (OGTT)≥11.1 mmol/L(200mg/dl), or randomized plasma glucose≥ 11.1 mmol/L. Inclusive, exclusive, rej ective and dropping criteria were strictly formulated.2.2 Inclusion criteria(1) Voluntarily participating in this experiment and signing the informed consent.(2) With age between 18-72 years.(3) Patients with type 2 diabetic patients who comply with WHO standards.(4) Patients who did not use insulin.(5) Patients without serious liver or kidney damage, cardiovascular or cerebrovascular disease (angina, myocardial infarction, multiple cerebral infarction, cerebral hemorrhage, etc.), malignant tumor, severe mental illness and other serious diseases.(6)HbAlc ≤ 8.5.(7) Patients with good compliance.2.3 Exclusion criteria(1) Patients with type 2 diabetic patients but do not meet the WHO standards.(2) With age<18 or age> 72 years.(3) Pregnant or lactating women.(4) Patients with serious liver or kidney damage, cardiovascular and cerebrovascular diseases (angina, myocardial infarction, multiple cerebral infarction, cerebral hemorrhage, etc.), malignant tumor, serious mental illness, chronic alcohol poisoning, etc..(5) Patients with skin ulcers and severe peripheral vascular diseases or infections.(6) Patients with high blood pressure (systolic blood pressure ≥ 170 mmHg or diastolic blood pressure ≥ to 95).(7) Patients using insulin.(8) HbAlc> 8.5.(9) Patients unwilling to cooperate with doctors, including those who do not accept the treatment and cannot cooperate with the treatment.If the patient is consistent with any of the above, the study cannot participate in this study.2.4 Drop out standard(1) Patients with serious adverse events, serious complications, etc., should not continue to accept the test.(2) For various other reasons, the course of treatment failed to end the test.(3) Patients who are unwilling to continue to accept the trial in the course of the medication, self quit.(4) Cases with incomplete information, unable to determine the efficacy.When the above situation occurs, the test should be stopped immediately and the reasons for the suspension and rejection of the records shall be recorded in detail.2.5 Subjects2.5.1 Knowledge education for diabetesDiabetes 2 knowledge education and training for all enrolled patients, including the performance and complications of hazards, emotion regulation, rational and individualized diabetes diet to control weight and obesity, physical exercise, blood glucose self-monitoring, response when the blood sugar is low, less smoking, less drinking and so on.2.5.2 Grouping:One hundred and eight subjects who matched the inclusive criteria were randomly divided into three groups, a treatment group with 36 cases transcutaneously electrically stimulated at bilateral Zusanli(ST 36), Sanyinjiao(SP 6), Pishu(BL 20), Shenshu(BL 23) and electrically stimulated at the vagus acupoint in auricular concha, a body acupoint group with 36 cases transcutaneously electrically stimulated at bilateral Zusanli(ST 36), Sanyinjiao(SP 6), Pishu(BL 20) and Shenshu(BL 23), an auricular point group with 36 cases electrically stimulated at the vagus acupoint in auricular concha.2.5.3 Treatment Methods1ã€Body acupoints were transcutaneously electrically stimulated with dorsal decubitus at bilateral Zusanli(ST 36), Sanyinjiao(SP 6), Pishu(BL 20), Shenshu(BL 23) after acupoints conventional disinfection. Huatuo Electronic Acupuncture Treatment Instrument of SDZ-V type produced by Suzhou Medical Products Factory Ltd.Co. was adopted with disperse-dense wave, electric current less than 50mA, pulse length of 0.2ms±30%, frequency of 20Hz to the degree that patients could tolerate without pain,30 minutes each time,3 times a week for continuous 4 weeks.2ã€Auricular Vagus Stimulator(AVNS) of Huatuo type TNS-200 produced by Suzhou Medical Products Factory Ltd.Co. was applied. It was appropriate with continuous wave, electric current of 1mA, pulse frequency of 20Hz, pulse length less than 1ms to the degree that patients could tolerate without pain,30 minutes each time,3 times a week for continuous 4 weeks.2.6 Observation Index and Time Point2.6.1 Indexes of Clinical Therapeutic EvaluationThe age, gender, Body Mass Index (BMI) and other basic data of the subjects were observed and recorded, as well as the FPG,2hPG, Glycated Hemoglobin(HbAlc) and Chinese medicine symptom classification quantization table before and after the 4-week treatment, and in the 2nd month follow-up. 2.6.2 Safety IndexesBlood Pressure, respiration frequency, heart rate, body temperature.2.7. Data Process and Statistical AnalysisStatistical software of spssl9.0 were used to analyze the data.3 Results There were 90 T2DM subjects completed the trial.3.1 Hypoglycemic Effect3.1.1 Comparison among groups The FPG efficacy after 4 weeks’ treatment and in the follow-up after 2 months were (1.74±1.64) and (1.38±1.38) mmol/L in the treatment group, which were not statistically different from (1.58±1.36) and (1.27±2.45) mmol/L in the body acupoint group, and had no statistical difference compared with (1.67±1.21) and (1.29±1.43) mmol/L in the auricular point group (all P>0.05).There was no statistical significance between the body group and the auricular point group as well(P>0.05).The 2hPG effect after 4 weeks’ treatment and in the follow-up after 2 months were (5.19±2.21) and (4.84±2.21) mmol/L in the treatment group, which were statistically decreased compared with (3.28±3.21)and(2.95±2.97)mmol/L in the body acupoint group (P<0.05), and were obviously different from (3.44±2.41) and(3.33±2.23) mmol/L in the auricular point group(P> 0.05).And there was no statistical significance between the body acupoint group and the auricular point group(P>0.05).The HbAlc effect after the 2nd month follow-up was (0.25±0.26) in the treatment group, which was decreased obviously than (0.09±0.28) in the body acupoints group (P<0.05) and (0.06±0.21) in the auricular point group(P< 0.05).But there was no statistical significance between the body acupoint group and the auricular point group(P>0.05).3.1.2 Comparison within groupsIn the treatment group, FPG in the 4th week of (5.93±0.74) was decreased than (7.68±1.76) before treatment (P<0.05), but compared with (6.29±1.04) in the 2nd month follow-up there was no apparent difference(P>0.05).The FPG in the 2nd month was (6.29±1.04), which was obviously decreased than (7.68±1.76) before treatment (P<0.05). The 2hPG of (8.60±1.20) in 4 weeks was reduced apparently compared with that of (13.79±2.11) before enrolling (P<0.05), but was not different from (8.94±1.56) in the 2nd month follow-up obviously (P> 0.05).The FPG in the 2nd month follow-up of (8.94±1.56) was apparently decreased than (13.79±2.11) before treatment (P<0.05).The HbAlc in the 2nd month follow-up was (7.00±0.72), which was statistically different from (7.25 ±0.73) before treatment (P<0.05)In the body acupoint group, FPG in the 4th week of (6.59±0.97) was decreased than (8.17±1.74) before treatment (P<0.05), but compared with (6.90±1.17) in the 2nd month follow-up there was no apparent difference (P>0.05).The FPG in the 2nd month was (6.90±1.17), which was obviously decreased than (8.17± 1.74) before treatment (P<0.05).The 2hPG of (9.03±1.77) in 4 weeks was reduced apparently compared with that of (12.30±2.4) before enrolling (P< 0.05), but was not different from (9.35±2.21) in the 2nd month follow-up obviously (P>0.05).The 2hPG in the 2nd month follow-up of (9.35±2.21) was apparently decreased than (12.30±2.4) before treatment (P< 0.05).The HbAlc in the 2nd month follow-up was (7.26±0.78), which was statistically different from (7.36±0.75) before treatment (P<0.05)In the auricular point group, FPG in the 4th week of (6.69±1.09) was decreased than (8.36±1.87) before treatment (P<0.05), and compared with (7.07±1.19) in the 2nd month follow-up it was decreased apparently (P<0.05).The FPG in the 2nd month was (7.07±1.19), which was obviously decreased than (6.69±1.09) before treatment (P< 0.05). The 2hPG of (10.00±3.49) in 4 weeks was reduced apparently compared with that of (13.42±2.75) before enrolling (P< 0.05), but was not different from (10.10±2.79) in the 2nd month follow-up obviously (P> 0.05).The 2hPG in the 2nd month follow-up of (10.10±2.79) was apparently decreased than (13.42±2.75) before treatment (P<0.05).The HbAlc in the 2nd month follow-up was (7.21±0.69), which was not statistically different from (7.27±0.67) before treatment (P>0.05)3.1.3 Frequency variationThe FPG and 2hPG excellently decreased numbers in the treatment group were 24 and 22, which were better than 12 and 14 in the body acupoint group and 10 and 11in the auricular point group(P<0.05).The efficetive rates of reducing FPG and 2hPG in the treatment group were 86.67% and 96.67% respectively.3.2 TCM symptoms scores3.2.1 Comparison among groupsThe TCM symptoms scores after 4 weeks’ treatment and in the follow-up after 2 months were (21.10±9.99) and (20.93±10.62) in the treatment group, which were statistically different from (15.10±6.86) and (14.47±7.33) in the body acupoint group (P<0.05), and had statistical difference compared with (16.33±8.19) and (15.97±10.65) in the auricular point group (P< 0.05).There was no statistical significance between the body group and the auricular point group (P>0.05).3.2.2 Comparison within groupIn the treatment group, the TCM symptoms score after 4 weeks’treatment was (6.60±3.49), which was obviously decreased than (27.70±11.62) before treatment (P<0.05), but compared with (6.67±3.14) in the 2nd month follow-up there was no apparent difference (P>0.05).The score in the 2nd month follow-up was apparently reduced than that before treatment (P<0.05)In the body acupoint group, the TCM symptoms score after 4 weeks’ treatment was (8.23±5.57), which was obviously decreased than (23.33±5.82) before treatment (P<0.05), but compared with (8.87±5.86) in the 2nd month follow-up there was no apparent difference (P>0.05).The score in the 2nd month follow-up was apparently reduced than that before treatment (P<0.05)In the auricular point group, the TCM symptoms score after 4 weeks’ treatment was (9.90±6.50), which was obviously decreased than (26.23±12.05) before treatment (P<0.05), but compared with (10.27±6.07) in the 2nd month follow-up there was no apparent difference (P>0.05).The score in the 2nd month follow-up was apparently reduced than that before treatment (P< 0.05)3.3 Safety IndexIn the treatment group, the systolic pressureafter treatment (123.17±9.87 mmHg) was decreased than (127.27±11.13 mmHg) before treatment (P<0.05)It showed no statistical significance in heart rate, breath frequency and body temperature and diastolic pressure in all groups before and after treatment for subjects who completed the trial(P>0.05).The safety was rated as Level2.4 Conclusions(1) Transcutaneous electrical stimulating at body acupoints and auricular points could reduce the blood glucose before and after food and glycated hemoglobin, and improve the clinical symptoms, especially for blood glucose after food.(2) Transcutaneous electrical stimulating at both body acupoints and auricular points is not significantly different from simple body acupoints or auricular points for the blood glucose before food, but after treatment and in the 2-month follow-up it is better than simple body acupoints and simple auricular points for reducing the blood glucose after food, glycated hemoglobin and symptoms scores.(3) Transcutaneous electrical stimulating at body acupoints and auricular points is effective and safe for type 2 diabetes mellitus. |
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