ArticleTranslational andrology and urology2021
A randomized placebo-controlled study: Phellodendron Bawei tablets combined with standard management can improve storage symptoms, sleep quality, and medication compliance in patients with benign prostatic hyperplasia compared to placebo with standard management.
Article in Translational andrology and urology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
3 citing papers in PubMed, 1 synthesis or guideline pooled it, 5 citations in OpenAlex.
- The Therapeutic Impact of Plant-Based and Nutritional Supplements on Anxiety, Depressive Symptoms and Sleep Quality among Adults and Elderly: A Systematic Review of the Literature.International journal of environmental research and public health · 2023Pooled it
- Impact of Fixed-Dose Combination Versus Single-Component Therapy for Benign Prostatic Hyperplasia-Related Urinary Symptoms on Persistence, Adherence, and Satisfaction in a Real-Life Setting.Pharmaceuticals (Basel, Switzerland) · 2025Article
- Article
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Authors and funding
8 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundBenign prostatic hyperplasia (BPH) is a common micturition disorder in middle-aged and elderly males, and it is one of the most common urology-related diseases worldwide. However, standard therapeutic drugs (α1-receptor blockers + 5α reductase inhibitors) do not provide anti-inflammatory or anti-infective effects. The Phellodendron Bawei tablet is a proprietary Chinese medicine with anti-inflammatory and anti-infective effects. Here, we analyzed whether the combination of standard therapeutic drugs and Phellodendron Bawei tablets has more advantages than placebo with standard management in improving the lower urinary tract symptoms (LUTs), sleep quality, sexual function, and medication compliance in patients with BPH.
methodsThis study was a prospective, double-blind, single-center, 6-month clinical trial in patients with BPH. Male patients, 45-75 years old, a history of moderate-to-severe BPH/LUTs for more than 6 months, moderate-to-severe LUTs [International Prostate Symptom Score (IPSS) ≥8], maximum urine flow rate (Qmax) of <15 mL/s, and prostate volume (PV) of >30 mL. All patients were randomly divided into two cohorts at baseline. The standard management (SM) group was treated with tamsulosin + finasteride + placebo, while the experimental group was treated with tamsulosin + finasteride + Phellodendron Bawei tablets. The clinical indicators were as follows: Age, body mass index (BMI), blood prostate-specific antigen (PSA), PV, Qmax, IPSS; IPSS voiding subscore (IPSS-V), IPSS storage subscore (IPSS-S), and IPSS quality of life (IPSS-QOL)], five-item version of the International Index of Erectile Function (IEFF-5) score, Athens Insomnia Scale (AIS) score, and the Medication Adherence Questionnaire (MAQ). And adverse drug reactions were observed. Student's
resultsWe randomly divided 120 patients into two groups, with 60 patients in each group, and a total of 105 patients completed the study. IPSS-S (P=0.027) and AIS scores (P<0.001) improved more significantly in the Phellodendron Bawei tablets + SM group, and the MAQ score in this group was lower (P=0.003).
conclusionsPhellodendron Bawei tablets combined with α1-receptor blockers and 5α-reductase inhibitors can improve lower urinary tract symptoms associated with urine storage, sleep quality, and medication compliance in patients with benign prostatic hyperplasia compared to placebo with standard management.
trial registrationChinese Clinical Trial Registry ChiCTR2100046463.
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