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The efficacy and safety of Serenoa repens extract for the treatment of patients with chronic prostatitis/chronic pelvic pain syndrome: a multicenter, randomized, double-blind, placebo-controlled trial.
World J Urol. 2021 Jan 16 [Online ahead of print]WJ

Abstract

PURPOSE

To perform a placebo-controlled trial to evaluate the efficacy and safety of Serenoa repens extract (SRE) for the treatment of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS).

METHODS

We conducted a double-blind, randomized, placebo-controlled, multicenter, clinical phase 4 study of 221 patients with CP/CPPS across 11 centers. Participants were randomly assigned in a 2:1 ratio to receive SRE or placebo for 12 weeks. The primary efficacy endpoint was the change in total score on the National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI). Secondary efficacy endpoints included improvements within each domain of NIH-CPSI, clinical response rate, and International Index of Erectile Function 5 items (IIEF-5).

RESULTS

In total, 226 patients were enrolled and randomized between January 2017 and June 2018. Of these 221 patients were included in the intent-to-treat analysis: 148 in the SRE group and 73 patients in the placebo group. Compared to the placebo, SRE led to statistically significant improvements in the NIH-CPSI total score and sub-scores. The significant improvements of NIH-CPSI scores were established after 2 weeks from the first dose, and continued to the end of the treatment. Furthermore, a significantly higher rate of patients achieved a clinical response in the SRE group compared with that in the placebo group (73.0% vs 32.9%, P < 0.0001). Only minor adverse events were observed across the entire study population.

CONCLUSIONS

SRE was effective, safe, and clinically superior to placebo for the treatment of CP/CPPS. ChiCTR-IPR-16010196, December 21, 2016 retrospectively registered.

Authors+Show Affiliations

Department of Urology, Peking University First Hospital, The Institute of Urology, Peking University, National Urological Cancer Center, Beijing, 100034, China. Beijing Key Laboratory of Urogenital Diseases (Male) Molecular Diagnosis and Treatment Center, Beijing, China.Minimally Invasive Tumor Therapies Center, Beijing Hospital, National Center of Gerontology, Beijing, China. Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, China.Department of Urology, Huashan Hospital of Fudan University, Shanghai, China.Department of Urology, Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.Department of Urology, The Second Affiliated Hospital, Soochow University, Suzhou, China.Department of Urology, Beijing Tongren Hospital, Capital Medical University, Beijing, China.Department of Urology, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, Guangdong, China.Department of Urology, Beijing Hospital, Beijing, China.Department of Urology, Beijing Friendship Hospital, Capital Medical University, Beijing, China.Department of Urology, Changzhou No. 2 People's Hospital Affiliated to Nanjing Medical University, Changzhou, Jiangsu, China.Department of Urology, Zhongda Hospital, Southeast University, Nanjing, 210000, Jiangsu, China. mingchen6308@163.com.Department of Urology, Peking University First Hospital, The Institute of Urology, Peking University, National Urological Cancer Center, Beijing, 100034, China. zhoulqmail@sina.com. Beijing Key Laboratory of Urogenital Diseases (Male) Molecular Diagnosis and Treatment Center, Beijing, China. zhoulqmail@sina.com.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

33452912

Citation

Zhang, Kai, et al. "The Efficacy and Safety of Serenoa Repens Extract for the Treatment of Patients With Chronic Prostatitis/chronic Pelvic Pain Syndrome: a Multicenter, Randomized, Double-blind, Placebo-controlled Trial." World Journal of Urology, 2021.
Zhang K, Guo RQ, Chen SW, et al. The efficacy and safety of Serenoa repens extract for the treatment of patients with chronic prostatitis/chronic pelvic pain syndrome: a multicenter, randomized, double-blind, placebo-controlled trial. World J Urol. 2021.
Zhang, K., Guo, R. Q., Chen, S. W., Chen, B., Xue, X. B., Chen, S., Huang, J., Liu, M., Tian, Y., Zuo, L., Chen, M., & Zhou, L. Q. (2021). The efficacy and safety of Serenoa repens extract for the treatment of patients with chronic prostatitis/chronic pelvic pain syndrome: a multicenter, randomized, double-blind, placebo-controlled trial. World Journal of Urology. https://doi.org/10.1007/s00345-020-03577-2
Zhang K, et al. The Efficacy and Safety of Serenoa Repens Extract for the Treatment of Patients With Chronic Prostatitis/chronic Pelvic Pain Syndrome: a Multicenter, Randomized, Double-blind, Placebo-controlled Trial. World J Urol. 2021 Jan 16; PubMed PMID: 33452912.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The efficacy and safety of Serenoa repens extract for the treatment of patients with chronic prostatitis/chronic pelvic pain syndrome: a multicenter, randomized, double-blind, placebo-controlled trial. AU - Zhang,Kai, AU - Guo,Run-Qi, AU - Chen,Shan-Wen, AU - Chen,Bin, AU - Xue,Xin-Bo, AU - Chen,Shan, AU - Huang,Jian, AU - Liu,Ming, AU - Tian,Ye, AU - Zuo,Li, AU - Chen,Ming, AU - Zhou,Li-Qun, Y1 - 2021/01/16/ PY - 2020/09/30/received PY - 2020/12/19/accepted PY - 2021/1/16/entrez PY - 2021/1/17/pubmed PY - 2021/1/17/medline KW - Chronic pelvic pain syndrome KW - Chronic prostatitis KW - Efficacy KW - Safety KW - Serenoa repens JF - World journal of urology JO - World J Urol N2 - PURPOSE: To perform a placebo-controlled trial to evaluate the efficacy and safety of Serenoa repens extract (SRE) for the treatment of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). METHODS: We conducted a double-blind, randomized, placebo-controlled, multicenter, clinical phase 4 study of 221 patients with CP/CPPS across 11 centers. Participants were randomly assigned in a 2:1 ratio to receive SRE or placebo for 12 weeks. The primary efficacy endpoint was the change in total score on the National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI). Secondary efficacy endpoints included improvements within each domain of NIH-CPSI, clinical response rate, and International Index of Erectile Function 5 items (IIEF-5). RESULTS: In total, 226 patients were enrolled and randomized between January 2017 and June 2018. Of these 221 patients were included in the intent-to-treat analysis: 148 in the SRE group and 73 patients in the placebo group. Compared to the placebo, SRE led to statistically significant improvements in the NIH-CPSI total score and sub-scores. The significant improvements of NIH-CPSI scores were established after 2 weeks from the first dose, and continued to the end of the treatment. Furthermore, a significantly higher rate of patients achieved a clinical response in the SRE group compared with that in the placebo group (73.0% vs 32.9%, P < 0.0001). Only minor adverse events were observed across the entire study population. CONCLUSIONS: SRE was effective, safe, and clinically superior to placebo for the treatment of CP/CPPS. ChiCTR-IPR-16010196, December 21, 2016 retrospectively registered. SN - 1433-8726 UR - https://www.unboundmedicine.com/medline/citation/33452912/The_efficacy_and_safety_of_Serenoa_repens_extract_for_the_treatment_of_patients_with_chronic_prostatitis/chronic_pelvic_pain_syndrome:_a_multicenter,_randomized,_double-blind,_placebo-controlled_trial. L2 - https://dx.doi.org/10.1007/s00345-020-03577-2 DB - PRIME DP - Unbound Medicine ER -
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