title: Moxibustion as an adjuvant for benign prostatic hyperplasia with lower urinary tract symptoms: a protocol for a parallel-group, randomised, controlled pilot trial.
abstract: BACKGROUND
  This study aims to explore the feasibility of using moxibustion as a supplementary intervention and to assess the sample size for verifying the effectiveness and safety of integrative treatment involving moxibustion compared with conventional treatment for patients with benign prostatic hyperplasia accompanying moderate to severe lower urinary tract symptoms.
  
  
  METHODS
  A total of 60 patients diagnosed with benign prostatic hyperplasia by a urologist based on prostate size, prostate-specific antigen and clinical symptoms will participate of their own free will; urologists will monitor the patients and evaluate their symptoms. The patients will be randomised to either a conventional group or an integrative group with a 1:1 allocation according to computer-generated random numbers concealed in opaque, sealed, sequentially numbered envelopes. Watchful waiting or oral medication including α blocker, 5α-reductase inhibitors or antimuscarinic drugs will be offered as conventional treatment. Integrative treatment will include moxibustion therapy in addition to the conventional treatment. The moxibustion therapy will be conducted twice a week for 4 weeks on the bilateral acupoints SP6, LR3 and CV4 by a qualified Korean medical doctor. The primary outcome will be the International Prostate Symptom Score (IPSS) after eight sessions. The secondary outcomes will be the post-void residual urine volume, the maximum urinary flow rate, IPSS, the results of a Short-Form 36-Question Health Survey after 12 weeks, and the patients' global impression of changes at each visit.
  
  
  BACKGROUND
  Written informed consent will be obtained from all participants. This study was approved by the institutional review boards of both Pusan National University Yangsan Hospital and Pusan National University Korean Medicine Hospital. The trial results will be disseminated through open-access journals and conferences.
  
  
  BACKGROUND
  NCT02051036.
authors.affiliation: Department of Internal Medicine, Pusan National University Korean Medicine Hospital, Yangsan, South Korea Department of Korean Medicine, School of Korean Medicine, Pusan National University, Yangsan, South Korea.
authors.forename: Hye-Yoon
authors.initials: HY
authors.lastname: Lee
authors.affiliation: Department of Urology, Pusan National University Yangsan Hospital, Yangsan, South Korea Department of Urology, Pusan National University School of Medicine, Yangsan, South Korea.
authors.forename: Jong-Kil
authors.initials: JK
authors.lastname: Nam
authors.affiliation: Department of Urology, Pusan National University Yangsan Hospital, Yangsan, South Korea Department of Urology, Pusan National University School of Medicine, Yangsan, South Korea.
authors.forename: Sang-Don
authors.initials: SD
authors.lastname: Lee
authors.affiliation: Department of Urology, Pusan National University Yangsan Hospital, Yangsan, South Korea Department of Urology, Pusan National University School of Medicine, Yangsan, South Korea.
authors.forename: Dong-Hoon
authors.initials: DH
authors.lastname: Lee
authors.affiliation: Department of Urology, Pusan National University Yangsan Hospital, Yangsan, South Korea Department of Urology, Pusan National University School of Medicine, Yangsan, South Korea.
authors.forename: Ji-Yeon
authors.initials: JY
authors.lastname: Han
authors.affiliation: Department of Internal Medicine, Pusan National University Korean Medicine Hospital, Yangsan, South Korea Division of Clinical Medicine, School of Korean Medicine, Pusan National University, Yangsan, South Korea.
authors.forename: Young-Ju
authors.initials: YJ
authors.lastname: Yun
authors.affiliation: Department of Internal Medicine, Pusan National University Korean Medicine Hospital, Yangsan, South Korea Department of Korean Medical Science, School of Korean Medicine, Pusan National University, Yangsan, South Korea.
authors.forename: Ji-Hye
authors.initials: JH
authors.lastname: Lee
authors.affiliation: Department of Internal Medicine, Pusan National University Korean Medicine Hospital, Yangsan, South Korea Department of Korean Medicine, School of Korean Medicine, Pusan National University, Yangsan, South Korea.
authors.forename: Hye-Lim
authors.initials: HL
authors.lastname: Park
authors.affiliation: Department of Internal Medicine, Pusan National University Korean Medicine Hospital, Yangsan, South Korea Division of Clinical Medicine, School of Korean Medicine, Pusan National University, Yangsan, South Korea.
authors.forename: Seong-Ha
authors.initials: SH
authors.lastname: Park
authors.affiliation: Department of Internal Medicine, Pusan National University Korean Medicine Hospital, Yangsan, South Korea Division of Clinical Medicine, School of Korean Medicine, Pusan National University, Yangsan, South Korea.
authors.forename: Jung-Nam
authors.initials: JN
authors.lastname: Kwon
mesh_terms: D015669:Acupuncture Points; D000328:Adult; D000368:Aged; D002985:Clinical Protocols; D003131:Combined Modality Therapy / Q000379:methods; D005240:Feasibility Studies; D006801:Humans; D059411:Lower Urinary Tract Symptoms / Q000209:etiology / Q000503:physiopathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009071:Moxibustion / Q000379:methods; D010865:Pilot Projects; D015995:Prevalence; D011470:Prostatic Hyperplasia / Q000150:complications / Q000503:physiopathology / Q000628:therapy*; D056910:Republic of Korea / Q000453:epidemiology; D012107:Research Design; D016896:Treatment Outcome; D014554:Urination
keywords: integrative medicine; lower urinary tract symptoms; moxibustion