A Randomized Controlled Study Of Electroacupuncture On Benign Prostatic Hyperplasia And MRS For Electroacupuncture Intervention

Background:benign prostate hyperplasia (BPH) is a common disease of the urinary system amongst adult males, causing urinary disorders such as frequent urination, urinary urgency and nocturia. Other problems include progressive difficulty in initiating a urine stream, decreased strength of urine stream and urinary intermittency. Abdominal and perineal distension, heaviness or dragging sensation, and lumbago may also accompany the abovementioned symptoms. In serious cases, acute urinary retention or upper urinary tract disorders may be present. By the age of 50, the prevalence of BPH could reach an estimated 50% of the male population. BPH takes a toll on the mental and physical state of the afflicted patient, severely compromising their quality of life. Given the rising awareness and demand for an effective treatment for BPH, there is a pressing need for increased research on BPH to address this issue.Using acupuncture in the clinical treatment of BPH have already been very common, however additional improvement and validation of an effective method would facilitate its widespread clinical applications. Progressive advances in magnetic resonance spectroscopy(MRS) techniques provides an opportunity for its application in appraising the clinical efficacy of BPH and investigating the mechanism behind BPH. This study aimed at the BPH of the Chinese and Western medicine research present situation of the BPH patients to carry out the clinical randomized controlled study and the MRS experimental study of electroacupuncture related group points.1 Clinical ResearchObjective:A comparison of the treatment efficacy of electrostimulation of Zhongji (CV3) and Qugu (CV2) acupoint, against enteric administration of tamulosin hydrochloride sustained release capsules on BPH was conducted. Concurrently, to guide future clinical correlatkion between syndrome and symptom during treatment, observations of Traditional Chinese Medicine (TCM) syndromes and symptoms in BPH patients were made. Analysis of the relationship between estrogen and androgen hormones and BPH symptom indices, as well as any changes in hormone levels in the control and experimental groups before and after treatment, in order to establish the feasibility and scientific basis for use of electrostimulation of acupoints in the treatment of BPH.Methods:In a 6 week randomized controlled trial, subjects were randomly assigned into two groups, the experimental group (26 subjects) and the control group (24 subjects). In the experimental group, electrostimulation of the Zhongji and Qugu acupoing was used in the treatment of BPH. In the control group, tamulosin hydrochloride sustained release capsules was enterically administered. Assessments conducted before and after treatment were the International Prostate Symptom Score (IPSS), Quality of life (QOL), Maximal urinary flow rate (Qmax), Post-void residual volume (PVR), Prostate volume (PV), Prostatespecific antigen (PSA), Estrodiol (E2), Testosterone (T), Liver and Kidney functions, routine urine test and International Index of Erectile Function (IIEF5). Before their random assignment into one of the 2 groups, subjects were also interviewed for their general information and Body mass index (BMI). Further information was acquired revolving around the 4 basic diagnostic methods of TCM, for future determination of their syndrome.SPSS22.0 software was used for the statistical analysis of the experimental data. Statistical techniques used were descriptive analysis, T-test, ANOVA, Rank sum test, analysis of correlation etc.The first experiment involves comparison of the efficacy and safety indices between the experimental group using acupuncture and the control group using the oral medicine. The second experiment involves differentiation of subjects into 2 groups according to their deficiency or excess syndrome and conducting a comparison between the respective clinical indices of each group. A comparison of the treatment efficacy indices before and after treatment for both groups was also carried out. The third experiment involved correlation analysis of subject’s pre-treatment T、E2、E2/T levels and age with their other clinical indices, while simultaneously conducting a comparison between the pre-and post-treatment T、 E2、 E2/T levels for both the experimental and control groups.Results: ① IPSS overall scoring for the experimental group was significantly lower after treatment (P<0.01). IPSS sub items scoring for the experimental group showed no significant difference after treatment (P>0.05). All remaining IPSS sub items scoring showed some difference after treatment (P<0.05). Comparing the pre and post treatment values between the 2 groups, the IPSS overall scoring between the experimental and control group showed significant difference (P<0.01). There was no significant difference in IPSS sub item 3,6 scoring between the experimental and control group. All remaining IPSS sub items scoring between the experimental and control groups showed some difference (P<0.05).② QOL scoring for the experimental group was significantly lower after treatment (P<0.01). Comparing the pre and post treatment values between the 2 groups, the experimental group had a better QOL score than the control group (P<0.05). ③ There was no significant difference in Qmax, PVR and PV of the experimental group after treatment (P>0.05).④ There was no significant difference in the IIEF5 scoring after treatment for both the experimental and control groups (P>0.05). There was no irregularities or changes in the kidney and liver functions as well as the routine urine test before and after treatment, however a minority of the control group reported dizziness after administration of tamulosin. ⑤ Before treatment, TCM differentiation into the deficient syndrome and excess syndrome showed that there was a difference in the PV between the 2 groups (P<0.05). The average PV of the excess syndrome group was greater than that of the deficient syndrome group. IPSS overall scoring, sub items scoring, QOL scoring, PV, Qmax and PVR showed no significant difference before and after electrostimulation of acupoints for both the deficient and excess syndrome (P>0.05). ⑥ Before treatment, there was a positive correlation between T, E2, age, PV and the IPSS sub item 3,7 scoring. E2 and PSA antigen showed a positive correlation E2/T showed a negative correlation with Qmax. There was a positive correlation between age and PVR, IPSS sub item 4,7. There was a negative correlation between age and IPSS sub item 5. The change in T after electrostimulation of acupoint showed a positive correlation with BMI. ⑦ Post treatment T, E2 and E2/T values had no significant changes from the pre treatment values for the experimental group (P>0.05). In the control group, the was a difference in the E2/T values before and after treatment (P<0.05). Comparing between the experimental and control group, there was no difference in the variation of the T, E2 and E2/T values (P>0.05).Conclusion: ① Electrostimulation of acupoints resulted in significant improvement to the subject’s quality of life, satisfactorily alleviating lower urinary tract symptoms. Acupuncture treatment for short term alleviation of voiding symptoms was significantly more effective than enteric administration of tamsulosin hydrochloride sustained release capsules. Acupuncture treatment did not elicit any significant improvement in urinary intermittency, and had no advantages over tamulosin. However, acupuncture treatment was better than tamulosin at improving the Qmax of subject. Aside from possible orthostatic hypotension during the initial administration of tamulosin, both methods of treatment were found to be safe. ② On average, subjects with the excess syndrome had a greater PV than subjects with the deficient syndrome, and there was no difference in efficacy between the subjects with excess and deficient syndrome when undergoing electrostimulation of the acupoints. Zhongji and Qugu may be used as the main acupoints for clinical treatment of BPH. ③ Enteric administration of tamilosin was able to intrease E2/T values, electro stimulation of acupoints had no significant impact on estrogen and androgen hormone levels. However, amongst the subjects in the experimental group, those with higher BMI were found to have greater decrease in T levels after treatment. There is a definite correlation between estrogen/androgen hormone levels, age, PV, Qmax and BPH symptoms. Changes in hormone levels played an important role in the progression of BPH symptoms. ④ Subjects of a younger age were more likely to present with urinary tract blockage symptoms, whereas subjects of an older age were more likely to present with urinary tract irritation symptoms.2 Experimental StudyObjective:Observation via MRS imaging of the effect of acupoint electrostimulation on hyperplastic prostate tissue metabolism, and investigate the mechanism behind the reversal of prostatic hyperplasia.Methods:Experiment 1:3 subjects with no BPH history were examined with MRS, focusing on a the spectral form in each of the central and peripheral zones and observing for spectroscopic images, Cit peak, Cho peak and (Cho+Cre)/Cit value. Experiment 2:3 subjects from the control group were selected and examined with MRS before and after treatment, focusing on a the spectral form in each of the central and peripheral zones and observing for spectroscopic images, Cit peak, Cho peak and (Cho+Cre)/Cit value. Experiment 3:3 subjects from the experimental group were selected and examined with MRS before and after treatment, focusing on a the spectral form in each of the central and peripheral zones and observing for spectroscopic images, Cit peak, Cho peak and (Cho+Cre)/Cit value.Results:① In experiment 1,3 subjects with normal peripheral zone prostatic tissue had Cit peak at 2.6ppm, with some presenting as elevated double peaks. Cho peak was at 3.2ppm, a portion of which merged with Cre peaks. The (Cho+Cre)/Cit average value for the central and peripheral zones were 0.35 and 0.57 respectively. ② In experiment 2, spectroscopic analysis of the central zones in the 3 subjects from the control group showed decrease in the Cit peak and (Cho+Cre)/Cit value. In the peripheral zone, (Cho+Cre)/Cit vlue was elevated to varying extents.③ In experiment 3, spectroscopic analysis of the central zones in the 3 subjects from the experimental group showed varying extents of elevation of the Cit peak, Cho peak and (Cho+Cre)/Cit value. In one subject, the peripheral zone Cit peak, Cho peak and (Cho+Cre)/Cit value showed varying extents of reduction.Conclusion: ①The MRS of a normal prostate should reveal higher Cit peaks in the peripheral zone than in the central zone. In the same position spectral form, Cit peaks should be higher than Cho peaks. The (Cho+Cre)/Cit value in both central and peripheral zone should be smaller than 1. ②Enteric administration of tamsulosin hydrochloride sustained release capsules is able to elicit changes in the metabolism of the central zone of the prostate, suggesting a possible mechanism for suppression of the hyperplastic growth of the gland and alleviation of symptoms. However there was no observed effect on the metabolism of the peripheral zone. ③ Electro stimulation of acupoint did not demonstrate any observable changes in metabolism to suppress hyperplastic growth of the central zone, but may have suppressive effects on hyperplasia on the peripheral zone tissue.3 Innovation① In this research, Zhongji and Qugu acupoints were used in tandem along with electrostimulation to treat BPH and its efficacy evaluated. At the same time, a comparison was conducted on the efficacies of electrostimulation of acupoints on BPH, matching the syndrome and its clinical symptoms. ② In this research, MRS examination was used in the evaluation of the treatment efficacies for BPH, using a self-controlled case series to investigate the metabolic changes after electro stimulation of acupoint.