School of Nursing, University of Pittsburgh, 440 Victoria Bldg, 3500 Victoria St, Pittsburgh, PA 15261, USA.
J Wound Ostomy Continence Nurs. 2009 Nov-Dec;36(6):661-70. doi: 10.1097/WON.0b013e3181bd82dd.
The propose of this pilot study was to examine the feasibility of recruiting women into a clinical trial designed to examine the efficacy of acupuncture in treating urge and mixed urinary incontinence (UI) and the feasibility of performing the planned study procedures. We also sought to determine if there was preliminary evidence to suggest that acupuncture may be effective in reducing UI and improving general health-related and disease-specific quality of life and if a sham acupuncture needle is an effective placebo intervention.
This pilot study was a double-blinded, randomized, clinical trial. Subjects were randomly assigned to a true or sham (placebo control) acupuncture group. Both true and sham acupuncture treatments were performed twice a week for 6 weeks. All subjects were evaluated at the completion of the 6-week intervention and 4 weeks later.
The sample consisted of 9 women between the ages of 44 and 66 years with urge or mixed urge and stress UI at least twice a week for a minimum of 3 months.
Subjects completed a 1-week bladder diary at baseline and at 1 and 4 weeks postacupuncture to assess the impact of acupuncture on incontinence episodes. Quality of life was measured at baseline and at 1 and 4 weeks postacupuncture using the Medical Outcomes Short-Form (general health- related quality of life) and the Incontinence Impact Questionnaire and Urogenital Distress Inventory (incontinence-specific quality of life).
It was feasible to recruit subjects and perform the planned study procedures. Subjects randomized to the true acupuncture group had a mean 63.30% (median = 65.99%) reduction in daytime accidents/day at 1 week postacupuncture and 67.47% reduction (median = 75.76%) at 4 weeks postacupuncture. In contrast, the mean reduction in daytime accidents was 18.88% (median = 19.64%) at 1 week and 16.67% (median = 0%) at 4 weeks post-sham acupuncture. There were no significant group differences in changes in the scores on the quality-of-life measures. Subjects' perceptions about whether they had received the true or sham acupuncture were not significantly better than one would expect by chance.
The findings of this pilot study support the need for additional research examining the efficacy of acupuncture in the treatment of UI in women, the feasibility of performing study procedures, and the use of a sham needle as placebo in acupuncture studies.
本初步研究旨在探讨招募女性参与旨在研究针灸治疗急迫性和混合性尿失禁（UI）疗效的临床试验的可行性，以及实施计划研究程序的可行性。我们还试图确定是否有初步证据表明针灸可能有效减少 UI 并改善一般健康相关和疾病特异性生活质量，以及假针灸针是否是有效的安慰剂干预措施。
本初步研究是一项双盲、随机临床试验。受试者被随机分配到真针灸组或假（安慰剂对照）针灸组。真和假针灸治疗均每周进行两次，共 6 周。所有受试者在 6 周干预结束后和 4 周后进行评估。
样本包括 9 名年龄在 44 岁至 66 岁之间的女性，她们每周至少有两次急迫性或急迫性和压力性混合性 UI，持续至少 3 个月。
受试者在基线和针灸后 1 周和 4 周完成为期 1 周的膀胱日记，以评估针灸对失禁发作的影响。使用医疗结局短期表格（一般健康相关生活质量）和尿失禁影响问卷和泌尿生殖窘迫量表（尿失禁特异性生活质量）在基线和针灸后 1 周和 4 周测量生活质量。
招募受试者和实施计划研究程序是可行的。随机分配到真针灸组的受试者在针灸后 1 周时白天意外次数减少了 63.30%（中位数=65.99%），4 周时减少了 67.47%（中位数=75.76%）。相比之下，假针灸组在针灸后 1 周时白天意外次数减少了 18.88%（中位数=19.64%），4 周时减少了 16.67%（中位数=0%）。两组在生活质量测量评分变化方面没有显著差异。受试者对他们是否接受了真或假针灸的看法并不明显优于随机猜测。
本初步研究结果支持需要进一步研究针灸治疗女性 UI 的疗效、进行研究程序的可行性，以及在针灸研究中使用假针作为安慰剂。
