Lee Hye-Yoon, Yun Young-Ju, Choi Jun-Yong, Hong Jin-Woo, Lee In, Park Seong-Ha, Kwon Jung-Nam
Pusan National University Korean Medicine Hospital School of Korean medicine, Pusan National University, Republic of Korea.
Medicine (Baltimore). 2018 Aug;97(34):e12016. doi: 10.1097/MD.0000000000012016.
This study aimed to evaluate trial feasibility and explore the potential efficacy and safety of moxibustion in the treatment of overactive bladder (OAB).
A randomized, controlled, cross-over, assessor blinded design was used. This study was conducted in an outpatient department of a university hospital in Republic of Korea. The overall study period was 8 weeks. Participants were randomly allotted to either Group A or Group B. Group A participants underwent 8 to 12 sessions of moxibustion with behavioral training during the first 4 weeks, while the Group B participants received behavioral training only. Over the next 4 weeks, the treatment offered to the 2 groups was reversed (Group A participants received behavioral training only, while Group B participants underwent the moxibustion session with behavioral training). The OAB-validated 8-question awareness tool (OAB-V8), OAB symptom scores (OABSS), visual analog scale (VAS) for lower urinary tract symptoms, and frequency voiding chart were used to assess outcomes. For analysis, we used effect size, measured as Hedge's g, to present descriptive results indicating the actual difference between the groups.
Compared to that in Group B, the Hedge's g of OAB-V8 for the former 4 weeks in Group A was -0.248, that of OABSS was -1.531, and that of VAS was -0.713. During the latter 4 weeks, Group B showed similar effect with g = 0.465, 1.207, and 0.427 for OAB-V8, OABSS, and VAS, respectively, compared to Group A. The portion of nocturnal voiding volume decreased (g = -0965), the mean voiding volume increased (g = 0.690), and the voiding frequency decreased (g = -0.498) with moxibustion.
Moxibustion might be considered as an alternative for OAB. A full-sized randomized controlled trial may be feasible with minimal modification in outcome measures and comparator population.
This clinical trial has been registered on clinicaltrials.gov (NCT02271607).
本研究旨在评估试验的可行性，并探讨艾灸治疗膀胱过度活动症（OAB）的潜在疗效和安全性。
采用随机、对照、交叉、评估者盲法设计。本研究在韩国一所大学医院的门诊进行。整个研究期为8周。参与者被随机分配到A组或B组。A组参与者在最初4周接受8至12次艾灸并进行行为训练，而B组参与者仅接受行为训练。在接下来的4周里，两组的治疗方式互换（A组参与者仅接受行为训练，而B组参与者接受艾灸并进行行为训练）。使用膀胱过度活动症验证的8题认知工具（OAB-V8）、OAB症状评分（OABSS）、下尿路症状视觉模拟量表（VAS）和排尿频率图表来评估结果。为了进行分析，我们使用效应量（以Hedge's g衡量）来呈现描述性结果，表明两组之间的实际差异。
与B组相比，A组前4周OAB-V8的Hedge's g为-0.248，OABSS为-1.531，VAS为-0.713。在后4周，与A组相比，B组在OAB-V8、OABSS和VAS方面的效应量分别为g = 0.465、1.207和0.427。艾灸使夜间排尿量比例降低（g = -0.965），平均排尿量增加（g = 0.690），排尿频率降低（g = -0.498）。
艾灸可被视为治疗OAB的一种替代方法。在对结局指标和对照人群进行最小程度修改的情况下，开展一项全规模的随机对照试验可能是可行的。
本临床试验已在clinicaltrials.gov上注册（NCT02271607）。
