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Efficacy and Safety of Electroacupuncture and Acupuncture in Postmenopausal Women with Overactive Bladder; a Pilot Study of Randomized Clinical Controlled Trial

폐경 여성의 과민성 방광에 대한 전침 치료와 침 치료의 유효성과 안전성 평가 ; 무작위 대조군 예비 임상시험

  • Nam, Eun-Young (Dept of Korean Obstetrics & Gynecology, Dong-Incheon Gachon University Gil Korean Medicine Hospital) ;
  • Jung, Seung-Hyun (Dept. of Korean Internal Medicine, Bundang Dong-Guk University Korean Medicine Hospital) ;
  • Bae, In-Suk (Dept. of Korean Internal Medicine, Bundang Dong-Guk University Korean Medicine Hospital) ;
  • Choi, Su-Ji (Dept of Korean Medicine Obstetrics & Gynecology, Ilsan Dong-Guk University Korean Medicine Hospital) ;
  • Kim, Dong-Il (Dept of Korean Medicine Obstetrics & Gynecology, Ilsan Dong-Guk University Korean Medicine Hospital)
  • 남은영 (가천대학교 동인천부속길한방병원 한방부인과) ;
  • 정승현 (동국대학교 한의과대학 분당한방병원 한방내과) ;
  • 배인숙 (동국대학교 한의과대학 분당한방병원 한방내과) ;
  • 최수지 (동국대학교 한의과대학 일산한방병원 여성의학과) ;
  • 김동일 (동국대학교 한의과대학 일산한방병원 여성의학과)
  • Received : 2018.01.26
  • Accepted : 2018.02.14
  • Published : 2018.02.23

Abstract

Objectives: The purpose of this pilot study was to examine the feasibility of recruiting women into a clinical trial designed to examine the effects of acupuncture and electroacupuncture in treating overactive bladder (OAB) in menopause women. We tried to determine if there was preliminary evidence to suggest that acupuncture may be effective in reducing OAB symptoms and improving disease-specific quality of life. We also tried to determine the appropriate treatment duration of OAB, with safety of performing acupuncture and electroacupuncture treatment. Methods: This study was a randomized clinical trial. 7 menopause women were randomly assigned to a electroacupuncture group (EA group) (n=4) or acupuncture group (AC group) (n=3) and received electroacupuncture or acupuncture treatment twice a week (16 sessions) in 8 weeks, and follow up assessment was performed after the end of treatment. Overactive Bladder Symptom Score (OABSS), 3-day bladder diary, and King's Health Questionnaire (KHQ) were performed 4 times (at baseline (visit 0), the middle of treatment (visit 8), after the end of treatment (visit 16), and at 4 weeks of follow-up (visit 17)) and analyzed. 2 subjects were dropped out, and finally 5 subjects completed the study. Statistical analysis was performed using SPSS 18.0 for window program. Results: There was an significant improvement in night-time frequency after the treatment (visit 17) in PP (Per-protocol) group analysis (p=0.042). In additional ITT (Inter-to-treat) group analysis, the OABSS (p=0.042) and night-time frequency (p=p=0.017) were improved significantly after the treatment (visit 17). But there was no significant difference of KHQ before and after the treatment. Also there was no significant difference between EA and AC group after the treatment (visit 16, 17). Conclusions: The results of this pilot study suggested that it was feasible to recruit subjects and perform the study procedures, after reconstructing several details of study protocol in performing further clinical trial.

Keywords

References

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