| 1. ObjectiveTo evaluate the effectiveness and safety of intervention for IGT patients by auricular vagus nerve stimulation through a single-blind and randomized controlled trial, thereby providing the evidence and basis for the clinical practice and future research concurrently.2. Method2.1 Diagnosis CriteriaThe definition of IGT by the expert committee of the World Health Organization (WHO) and the International Diabetes Federation (IDF) in 1999:fasting plasma glucose (FPG)<7.0 mmol/L (126 mg/dl); and 2 hours after ingesting 75g of glucose, the Oral Glucose Tolerance Test (OGTT) resulting in plasma glucose (2hPG) =7.8mmol/L(140 mg/dl) but<11.1mmol/L(200 mg/dl). Inclusive, exclusive, eliminative, as well as rejective criteria were strictly formulated.2.2 Grouping and Treatment Method2.2.1 Grouping:72 IGT subjects who fulfilled the inclusive criteria were randomly divided into two groups, while we enrolled 30 subjects into blank control group simultaneously.Auricular vagus nerve stimulation (ATVNS):36 cases, stimulating the auricular concha vagus acupoints by electric acupuncture;Auricular non-vagus nerve stimulation (ANVNS):36 cases, stimulating the auricular non-vagus nerve area on the middle point(s) of auricle edge by electric acupuncture.Blank control (BC):30 cases with no treatments.2.2.2 Treatment MethodsThe treatment lasts for 12 weeks, twice a day,20 minutes each time, by using the auricular vagus stimulator (Huatuo Auricular Vagus Stimulator, model TENS-200, produced by Suzhou Medical Products Factory Ltd. Co.) with 1mA output currency, 20Hz pulse frequency and=1ms pulse width, slightly adjusted individually according to the pain tolerance of each subject.2.3 Observation Indexes and Time Points2.3.1 Indexes of Clinical Therapeutic Evaluation Recorded the age, gender and other basic data of the subjects, examined the BMI, FPG,2hPG and HbAlc individually, before and after the 12-week treatment, and the FPG and 2hPG at the 6th weeks as well.2.3.2 Safety IndexesBlood pressure, respiration frequency, heart rate, body temperature.2.4 Data Process and Statistical AnalysisDatabase establishment:A database, for recording and managing the electronic data, made by Microsoft Excel, would be used for the final statistical analysis. Input the same data into two databases for accuracy comparison and corrected them by referring to the original data in CRF if there were discrepancies.3 RESULTSThere were 102 IGT subjects enrolled at the beginning and 2 people dropped off during the treatment. Finally 100 subjects finished the treatment.3.1 Blood Glucose3.1.1 Comparison among groupsThe different effect values of FPG, in ATVNS [(0.32±0.65); (0.48±0.58) mmol/L, respectively] decreased more markedly than that of BC[(-0.19±0.70); (-0.42±1.11) mmol/L, respectively] (P<0.01) before and after the 6week and 12week treatments. ANVNS(0.09±0.81 mmol/L) decreased more markedly than that in BC (P< 0.01) before and after the 12week treatments.The different effect values of 2hPG in ATVNS [(2.39±1.87); (2.19±1.48) mmol/L, respectively]and ANVNS [(1.10±1.73); (1.16±1.56) mmol/L, respectively] decreased more obviously than those in BC (P<0.01), ATVNS decreased more obviously than that in ANVNS (P<0.05) before and after the 6w and 12w treatments respectively.The different effect values of HbAlc in ATVNS (0.17±0.34%) and ANVNS (0.13±0.49%) decreased more obviously than those in BC (-0.14±0.37%) (P< 0.01 and P<0.05 respectively) before and after the 12w treatments.3.1.2 Comparison within groupsATVNS:It showed significant decrease(P<0.01)by comparing the mean level of the FPG and 2hPG [(6.21±0.60); (9.71±1.14) mmol/L, respectively] before, during and after the 12week treatments [(5.89±0.77),(5.73±0.63); (7.32±1.76),(7.52±1.35) mmol/L, respectively]; The HbAlc (6.32±0.53%) shows the same after the 12week treatments(6.15±0.44%).ANVNS:It showed significant decrease(P<0.01)by comparing the mean level of the 2hPG (9.11±1.21 mmol/L) both before and after the 6w and 12w treatments [(8.01±1.58); (7.95±1.44) mmol/L], but the mean value, which the normal value is 7.8mmol/L. BC:It showed a rising trend (P>0.05) by comparing the mean level of the FPG (6.44±0.27 mmol/L) and HbAlc (6.16±0.35%) before and after the 12week treatments(6.93±1.22 mmol/L); (6.30±0.58%).3.1.3 Frequency variationIt shows statistical significance (P<0.05) by comparing the frequency variation of FPG (25 cases) and 2hPG(34 cases) after the 12week treatments between ATVNS to BC (10; 11 cases).The effective rate of reducing FPG and 2hPG by stimulating the auricular vagus nerve and non-vagus were 85.71%,82.85% and 62.86%,80.00% respectively.3.2 BMI3.2.1 Comparison among groupsIt showed no statistical significance (P>0.05) by comparing the different effect values of BMI in all groups after the 12w treatments.3.2.2 Comparison within groupsIt showed no statistical significance (P<0.01 and P<0.05, respectively) by comparing the mean level of the BMI in ATVNS (24.40±3.42 Kg/m2) and ANVNS (24.12±2.73 Kg/m2) before and after the 12week treatments [(23.90±3.22); (23.87±2.73) Kg/m2, respectively].3.3 TCM symptoms score and syndrome types3.3.1 Comparison among groupsThe decrease of the different effect values of TCM symptoms score in ATVNS (5.11±8.71) and ANVNS (5.77±7.66) were more obvious than those in BC (1.43± 5.10) (P<0.05) after the 12w treatments.After the 12w treatments, it shows ATVNS (12 cases) was more obvious than BC (2 cases) (P<0.01)through the comparison of the normal TCM physique ratio among all groups, and it shows significant conversion of the normal TCM physique in ATVNS (1 cases) (P<0.05) after the 12w treatments (12 cases).3.3.2 Comparison within groupIt proves the significant effects on symptoms improving by stimulating the auricular concha vagus and auricular margin non-vagus by the obvious decrease (P< 0.01) in the comparison of the TCM symptoms scores in ATVNS (18.94±10.90) and ANVNS (19.89±12.19) after the 12week treatments [(13.83±11.82); (14.11±9.38), respectively].3.4 Safety IndexThe abnormal ratio of systolic pressure in ATVNS (123.66±14.34 mmHg) decreased after the 12w treatments (118.60±13.53 mmHg) (P<0.05). It showed no statistical significance(P>0.05) by comparing the difference in heart rate, breath frequency and body temperature in all groups before and after the 12w treatments. The safety-rate was rated as Level 2.4 Conclusions1) The treatment could reduce the blood glucose, HbAlc, BMI, systolic pressure, and improve the symptoms, and the 2hPG by stimulating the auricular vagus nerve.2) The treamtment could reduce the blood glucose, HbAlc and improve the symptoms by stimulating on the auricular non-vagus nerve.3) The treatment showed superior effect on reducing 2hPG comparing with the auricular non-vagus nerve. And effect on reducing blood glucose, BMI, HbAlc and improving symptoms through stimulating the auricular vagus nerve, comparing with the blank control.4) Blood glucose and HbAlc on BC elevated, ins subjects without any intervention after 12 weeks.5) Vagus nerve Elctrostimulation is a new and safety treatment of improving the metabolism of glucose and preventing DM of auricular vagus nerve stimulation. |
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