| ObjectiveThis randomized controlled clinical trial intended to observe the clinical effect of combination Back-Shu Front-mu & Yuan-(source) Luo-(connecting) pionts Method in treating deficiency syndrome of gastric ulcer. Based on the previous research of the tutor, by randomized controlled study and simultaneously multidisciplinary observation, we objectively assessed the clinical effect and safety about the combination of Back-Shu Front-mu & Yuan-(source) Luo-(connecting) pionts Method in treating deficiency syndrome of gastric ulcer. Looking forward to further standardize the clinical effect of Deficiency Syndrome of gastric ulcer and get better social benefits. To establish an essential/necessary system and provide rigorous scientific reaearch data for Chinese medicine clinical research on Gastric ulcer prevention and treatment, as well as new drug development.In this study, adopting Back-Shu Front-mu & Yuan-(source) Luo-(connecting) pionts Method to study these two acupoints methods and compare with ordinary acupuncture acupoints by detecting certain objective indicators to observe the effect of acupoints, and attempt to explain its mechanism.MethodsStudy objects were patients from Taiwan GuangSheng Chinese Medicine Clinic. Patients with Gastric ulcer mostly had abdominal pain occurred in upper abdomen, like dull or stabbing pain, sometimes like stending or burning pain;It may radiate into the small of the back. Unregular diet, tiredness, nervousness, or sudden change in the climate may cause abdominal pain to happen, accompanied by sour regurgitation/acid regurgitation, belching, nausea or vomiting. Fecal occult blood test was positive or negative. Gastroscopy showed ulcer. Patients with gastric ulcer were required to do biopsy or exfoliative cells to exclude Canceration. Western gastric ulcer diagnostic criteria was as follows (refer to Internal medicine Sixth Edition edited by Ye Rengao. Traditional chinese deficiency syndrome of ulcer diagnostic criteria was:main symptoms:①dull stomachache, likes being pressed and warmed;②it Occures or even gets worse when cold or tiredness;③severe pain when empty stomach, less pain while eating, distention after eating;④tongue is pale and tender with teeth marks in edges and thin white coating, the pulse is deep thin or slow. Secondary symptoms:①lack of strenth, tiredness dislike talking;②cold body and limbs;③loose stools;④vomit clear saliva.In this study, a total of 83 cases of qualified volunteers, the test group (test group) 46 cases, male 30 and female 16; the control group (control group) 37 cases, male 24 and female 13. They were all outpatients. Equally randomized controlled test with 83 qualified volunteers that met the criteria,divided them into test group(Back-Shu Front-mu & Yuan-(source) Luo-(connecting) pionts group) and control group (conventional acupoints group). Allocation of specific random was designated to the clinical study researchers, by operating SAS (Statistical Analysis System) software to get the random number, and making random distribution of cards, adding sealed envelopes, card number and serial number of the same. According to the order of Patients entry who had passed into this trial, opening the same number of envelopes to give patients treatment stated group by card in envelopes. Random number tables for preservation are in accordance with the requirements. According to "Medical institutions of higher learning materials·Acupuncture" edited by Qiu Maoliang, Method of selecting points:Back-Shu & Front-mu points group with main points:RN12, BL21;Yuan-(source) & Luo-(connecting) points group, mian point:ST42, SP4 (both sides). Conventional acupoints group with main piont:ST36, PC6, RN13;matched pionts:severe stomachache ST34, cold stomach apply moxibustion to Rnl2, abdominal distension ST25, sour regurgitation/acid regurgitation LR3, lack of strength RN6. Alternate to use the above points. Methods of acupuncture:use 75% ethanol to sterilize the skin, select 1 inch or 1.5 inch needleof the Huatuo brand, after needling and getting Qi,select the equally reinforcing and reducing method at all points, remain the needles for 30 minutes, once a day,5 times for a course of the treatment, each 2 days off between treatments, a total of 9 courses. During the trial period, the other therapeutic drugs were not allowed to be used. The Course of treatment for 2 months. Once every other day,5 times for a course, 2 days off between each course of treatment. After 9 courses (i. e.2 months), had gastroscope rechecked.Effect standard/indicator:Clinical cure:the main and secondary symptoms disappeared. Ulcer was basically healed in gastroscope. Excellence/Markedly effective:the main and secondary symptoms were significantly improved, or individual main symptoms improved slightly, but the other main symptoms had disappeared. Ulcer lesions were improved in gastroscope. Effective:main and secondary symptoms were improved, or main symptoms had not improved, but all the minor symptoms had disappeared. Ulcer lesions had no change in gastroscope. Ineffective/Void:main and secondary symptoms were not improved. After the clinical study, clinical data was promptly collected, entered into the computer, then set a database and managed the data. Using EpiData 3.0 software to operate data entry. After the treatment, using statistical software to analyze and compare the overall clinical effect, clinical symptoms and signs effect, to have an objective evaluation on clinical effect and its safety. Statistical methods:categorical data using Chi-Square test, ranked data using two-samples compared Wilcoxon rank sum test (adjusted), compare means of two samples using T-test or Wilcoxon rank sum test, before and after itself using paired-samples T-test or Wilcoxon paired rank sum test. Statistics calculated by using statistical software SPSS17.0 to complete statistical analysis.ResultsIn this study, a total of 83 cases of qualified volunteers, the test group 46 cases, male 30 and female 16; the control group 37 cases, male 24 and female 13.Testing the comparability of the two groups:the age composition, gender distribution, recurrent pathogenetic condition,the recent occurrence of disease, stomachache time (minute/day), the extent of abdominal pain, frequency of upper abdominal pain, abdomen likes being pressed & heated.frequency of pain reduction after eating, abdominal stabbing pain, vague pain, frequency of accompaied pain in both costal part, there was no statistically significant difference(P>0.05). Before treatment, the two groups main symptoms of sour regurgitation, nausea, belching, abdominal distension, frequency of less ingestion, there was no statistically significant difference(P>0.05).Comparing the main symptoms of tasteless, bitter taste of mouth, firm stools, frequency of tiredness in both groups before treatment, There was no significant difference (P<0.05). Comparing ulcer area of the two groups before treatment, there was no statistically significant difference (P>0.05). Comparing the number of ulcers of two groups before treatment, there was no statistically significant difference (P>0.05). Comparing ulcer stage of the two groups before treatment, there was no statistically significant difference (P>0.05). Comparing texture and coating of tongue, pulse in the two groups before treatment, there was statistically significant difference. Comparing the detection of HP in the two groups before treatment, there was no statistically significant difference (P>0.05).In summary, comparing sex, age, duration, syndrome of TCM, entity and the nature of abdominal pain, frequency, extent, ulcer area, ulcer stage, the number of ulcers, tongue demonstration, pulse and other major symptoms (except for loose stools), gastroscopy results in the two group before treatment, here was no statistically significant difference (P>0.05), meaning that the above factors between the two groups has homogeneity and the test was comparable between test group and control group.Effect comparison:comparing Chinese medicine syndromes of two groups, the clinical curative rate of the test group was 56.52%, markedly effective rate was 21.74%, markedly effective and clinical curative rate was 77.2% in total;clinical curative rate of control group was 29.73%, markedly effective rate was 37.84%, markedly effective and clinical curative rate was 67.5% in total. The total effect of Chinese medicine syndromes of two groups, there was statistically significant difference (P<0.05). Improvement of abdominal pain before and after treatment between the two group, there was statistically significant difference (P<0.05).After treatment, comparing the disappearance rate of sour regurgitation/acid regurgitation, nausea, belching, less ingestion, abdominal distension, tasteless, bitter taste of mouth, loose stools, firm stools, tiredness and other main clinical symptoms and signs, there was no statistically significant difference (P>0.05). Comparing effect of gastroscopy in test group, the clinical curative rate was 52.17%, markedly effective rate was 21.74%, markedly effective and clinical curative rate was 73.8% in total; in control group, clinical curative rate was 32.43%, markedly effective rate was 37.84%, markedly effective and clinical curative rate was 70.2% in total. Comparing Gastroscopy effects of gastric ulcer, there was no statistically significant difference (P>0.05) between the two groups. After treatment, Comparing reducing time of stomachache (minutes/day), there was no statistically significant difference (P>0.05).Safety Testing:the test group were detected 46 cases of blood before and after the treatment, and the results showed no abnormal changes.The test group were detected 46 cases of stool before treatment and after the treatment,and the results showed no abnormal changes. the test group were detected 46 cases of urine before treatment and after the treatment, and the results showed no abnormal changes. The test group were detected 46 cases of liver function(GPT)/renal function (BUN) before and after the treatment, and the results showed no abnormal changes. The test group were detected 46 cases of ECG before treatment, rechecked 44 cases after treatment, and the results showed no abnormal changes.The control group were detected 37 cases of blood before and after the treatment, and the results showed no abnormal changes. The control group were detected 37 cases of stool before treatment and after the treatment, and the results showed no abnormal changes. The control group were detected 37 cases of urine before treatment and after the treatment,and the results showed no abnormal changes.The control group were detected 37 cases of liver function(GPT)/renal function (BUN) before and after the treatment, and the results showed no abnormal changes. The control group were detected 37 cases of ECG before and after the treatment, and the results showed no abnormal changes.Observation on adverse events in this trial, the test group and control group of blood, urine and stool regular test,liver function (GPT), renal function (BUN), ECG and other test results before and after treatment,no obvious damage was found.ConclusionThis clinical trial adopted randomized controlled test methods, a total of 83 patients/qualified subjects/qualified volunteers,46 cases in test group,37 cases in control group. Safety testing showed that blood, urine and stool regular test, liver and kidney function, ECG were normal before treatment and no abnormal changes after treatment, indicating that the clinical application of this therapy was safe.Testing the comparability between the two groups before treatment in sex, age, duration, syndrome of TCM, entity and the main symptoms was in a good equitability. No obvious adverse reactions were found during the course of treatment.In this study, patients with gastric ulcer received this treatment had a deficiency and cold syndrome. The effect of syndrome of TCM:the total effective rate was 96.5% in test group,83.78% in control group, there was statistically significant difference(P<0.05);total effect of gastroscopy:the total effective rate was 86.96% in test group, and 83.78% in contaol group, there was statistically significant difference (P<0.05). The effect of Chinese medicine syndromes between the two groups, there was statistically significant difference(P<0.05).The test group was better than the control group in clinical effect.This test was in strict accordance with the implementation of clinical trials, observing through randomized controlled test method, as far as possible to avoid bias possibly brought by observers or volunteers, so the result had better objectivity and authenticity.To sum up, this treatment for deficiency and cold syndrome of gastric ulcer has a better effect and more security.
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