Open AccessEffect of fire needle therapy on mild-moderate benign prostatic hyperplasia
Author(s) -
Tao Zhang,
Yun-Qing Xun,
Bin Li,
Guiling Wang,
Linpeng Wang,
Lian-Cheng Jia,
Weiguang Li,
Xuemei Liu,
Huilin Liu,
Jing Sun
Publication year - 2020
Publication title -
medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.59
H-Index - 148
eISSN - 1536-5964
pISSN - 0025-7974
DOI - 10.1097/md.0000000000020376
Subject(s) - medicine , lower urinary tract symptoms , tolerability , watchful waiting , international prostate symptom score , adverse effect , prostate , randomized controlled trial , benign prostatic hyperplasia (bph) , prospective cohort study , hyperplasia , clinical trial , urology , surgery , prostate cancer , cancer
Background: Benign prostatic hyperplasia (BPH) is the most common non-cancerous disease of the prostate and leads to lower urinary tract symptoms in middle-aged and elderly males. Fire needle therapy could improve the lower urinary tract symptoms associated with mild-moderate BPH in clinical practice. The aim of the present pilot study is to assess the preliminary effects of fire needle therapy on mild-moderate BPH. Methods: The present study is a prospective parallel randomized controlled pilot trial. A total of 60 eligible participants will be randomly assigned to a treatment or control group at a 1:1 ratio. The treatment group will receive fire needle therapy and the control group will receive watchful waiting with lifestyle advice and education regarding BPH. Participants will receive intervention for 4 weeks, with a follow-up period of 4 additional weeks. Adverse events will be recorded to assess the safety and tolerability of fire needle therapy for mild-moderate BPH. The primary outcome will be the change in the International Prostate Symptom Score. The secondary outcomes will include the change in the mean number of nightly urinations, the maximum urinary flow rate, the average flow rate, and the prostate volume as measured by a B-mode ultrasound device. All outcome measures will be observed at baseline and at 4 and 8 weeks following the beginning of treatment. Discussion: The present study will provide evidence of the preliminary effects of fire needle therapy on mild-moderate BPH and indicate an optimal sample size for future studies.