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Effectiveness and safety of electroacupuncture and its cotreatment with electronic moxibustion in the treatment of patients with moderate benign prostatic hyperplasia using alpha blocker: Study protocol for an assessor-blinded, randomized controlled clinical trial.

ABSTRACT: BACKGROUND:Benign prostatic hyperplasia (BPH) is a medical condition that affects the quality of life by causing lower urinary tract symptoms (LUTS) in 40% to 70% of men aged ?60 years. Medication treatment is primarily recommended for patients with BPH if their symptom score based on the International Prostate Symptom score (IPSS) is above the moderate level. However, electroacupuncture (EA) and electronic moxibustion (EM), one of the most recent complementary and alternative treatments, are suggested as adjuvant treatments in the improvement of LUTS caused by BPH with respect to the limitations of medication treatments, such as side effects or no improvement in LUTS despite treatment. Therefore, this study aimed to evaluate the effectiveness and safety of EA and its cotreatment with EM for the improvement of LUTS in patients diagnosed with BPH using an alpha blocker but with moderate symptoms on the basis of IPSS. METHODS/DESIGN:This protocol is a 2-arm parallel-design, randomized, controlled assessor-blinded clinical trial. Seventy-eight patients diagnosed with BPH are randomized to one of the following groups: [EA and its cotreatment with EM + alpha blocker group] and [alpha blocker group]. [EA and its cotreatment with EM + alpha blocker group] continues to use the previously prescribed alpha blocker and visits the study institution 3 times a week for 6 weeks to receive the cotreatment of EA and EM. [Alpha blocker group] continues to use the previously prescribed alpha blocker for 6 weeks. To evaluate the effectiveness of the EA and its cotreatment with EM, the followings are measured: total score of the IPSS, IPSS quality of life assessment, EuroQol-Five dimension, maximum and average urinary flow rate (Qmax and Qave), and prostate size at the baseline, 3rd, 6th, and 12th weeks. The primary effectiveness endpoint measures the average change in the total score of the IPSS at the 6th week. Side effects are recorded at each visit. DISCUSSION:The results of this study are expected to provide useful information on the effectiveness and safety of the EA and its cotreatment with EM for patients with BPH with regard to the improvements in LUTS. TRIAL REGISTRATION:Clinical Research Information Service of Republic of Korea (CRIS-KCT0004411), October 31, 2019.

SUBMITTER: Kim HB

PROVIDER: S-EPMC7220246 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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Effectiveness and safety of electroacupuncture and its cotreatment with electronic moxibustion in the treatment of patients with moderate benign prostatic hyperplasia using alpha blocker: Study protocol for an assessor-blinded, randomized controlled clinical trial.

Kim Hyo Bin HB Kim Young Il YI Jeon Ju Hyun JH Kim Eunseok E Kim Jin Youp JY Kwon Ojin O Choi Young Eun YE Yang Changsop C Han Chang-Hyun CH

Medicine 20200401 15

<h4>Background</h4>Benign prostatic hyperplasia (BPH) is a medical condition that affects the quality of life by causing lower urinary tract symptoms (LUTS) in 40% to 70% of men aged ≥60 years. Medication treatment is primarily recommended for patients with BPH if their symptom score based on the International Prostate Symptom score (IPSS) is above the moderate level. However, electroacupuncture (EA) and electronic moxibustion (EM), one of the most recent complementary and alternative treatments ...[more]

PMID: 32282720

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Project description:BackgroundBenign prostatic hyperplasia (BPH) is a disease that affects the quality of life by causing lower urinary tract symptoms (LUTS) in men. Electroacupuncture (EA) and moxibustion therapy have been suggested as an adjunct therapy for improving LUTS in patients with BPH, but clinical studies evaluating the effectiveness of EA and its cotreatment with electronic moxibustion (EM) in patients who have been prescribed alpha blockers have yet to be reported. Therefore, this study aimed to evaluate the effectiveness and safety of EA and EM.MethodsTwenty-eight patients diagnosed with BPH were randomized to treatment group (TG, n = 14) or control group (CG, n = 14). The TG continued to use the previously prescribed alpha blocker and received the cotreatment of EA and EM 3 times a week for 6 weeks. The CG continued to use the previously prescribed alpha blocker alone for 6 weeks. The primary outcome was the mean change in the international prostate symptom score (IPSS) from baseline to week 6. The secondary outcomes were IPSS at week 3 and 12, clinical relevance, IPSS life satisfaction, EuroQol-Five dimensions, average urinary flow rate, maximum urinary flow rate, and prostate volume.ResultsThe IPSS decreased at all time points with a statistically significant difference between the 2 groups (3W: P = .0313; 6W: P = .0010; 12W: P = .0304). Based on the minimal clinically important difference (MCID, 3 points), there were significant differences between the TG and the CG at week 3, 6, and 12 (3W: P = .0461; 6W: P = .0123; 12W: P = .0216). Significant group × week interaction effects were found for the IPSS score (P = .0018), as determined from analyses using repeated measures analysis of variance. There were no significant differences between the 2 groups in IPSS life satisfaction, EuroQol-Five dimensions, average urinary flow rate, maximum urinary flow rate, and prostate volume.ConclusionEA and its cotreatment with EM might have a beneficial effect as an adjunct therapy in improving LUTS in patients with BPH. Large-scale randomized controlled trials are warranted to confirm the effectiveness and safety of EA and its cotreatment with EM.

Project description:BackgroundMale lower urinary tract symptoms (LUTS) occur in more than half of men above 50 years of age. LUTS were traditionally attributed to benign prostatic hyperplasia (BPH) and therefore the clinical terminology often uses LUTS and BPH interchangeably. More recently, LUTS were also linked to fibrogenic and inflammatory processes. We tested whether osteopontin (OPN), a proinflammatory and profibrotic molecule, is increased in symptomatic BPH. We also tested whether prostate epithelial and stromal cells secrete OPN in response to proinflammatory stimuli and identified downstream targets of OPN in prostate stromal cells.MethodsImmunohistochemistry was performed on prostate sections obtained from the transition zone of patients who underwent surgery (Holmium laser enucleation of the prostate) to relieve LUTS (surgical BPH, S-BPH) or patients who underwent radical prostatectomy to remove low-grade prostate cancer (incidental BPH, I-BPH). Images of stained tissue sections were captured with a Nuance Multispectral Imaging System and histoscore, as a measure of OPN staining intensity, was determined with inForm software. OPN protein abundance was determined by Western blot analysis. The ability of prostate cells to secrete osteopontin in response to IL-1β and TGF-β1 was determined in stromal (BHPrS-1) and epithelial (NHPrE-1 and BHPrE-1) cells by enzyme-linked immunosorbent assay. Quantitative polymerase chain reaction was used to measure gene expression changes in these cells in response to OPN.ResultsOPN immunostaining and protein levels were more abundant in S-BPH than I-BPH. Staining was distributed across all cell types with the highest levels in epithelial cells. Multiple OPN protein variants were identified in immortalized prostate stromal and epithelial cells. TGF-β1 stimulated OPN secretion by NHPrE-1 cells and both IL-1β and TGF-β1 stimulated OPN secretion by BHPrS-1 cells. Interestingly, recombinant OPN increased the mRNA expression of CXCL1, CXCL2, CXCL8, PTGS2, and IL6 in BHPrS-1, but not in epithelial cell lines.ConclusionsOPN is more abundant in prostates of men with S-BPH compared to men with I-BPH. OPN secretion is stimulated by proinflammatory cytokines, and OPN acts directly on stromal cells to drive the synthesis of proinflammatory mRNAs. Pharmacological manipulation of prostatic OPN may have the potential to reduce LUTS by inhibiting both inflammatory and fibrotic pathways.

Dataset Information

Effectiveness and safety of electroacupuncture and its cotreatment with electronic moxibustion in the treatment of patients with moderate benign prostatic hyperplasia using alpha blocker: Study protocol for an assessor-blinded, randomized controlled clinical trial.

Publications

Effectiveness and safety of electroacupuncture and its cotreatment with electronic moxibustion in the treatment of patients with moderate benign prostatic hyperplasia using alpha blocker: Study protocol for an assessor-blinded, randomized controlled clinical trial.

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