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Assistant Professor, Department of Family and Community Medicine, Penn State College of Medicine, State College
Dr. Baker reports no financial relationships relevant to this field of study.
SYNOPSIS: Following six weeks of every other day treatment, women treated with electroacupuncture in the sacral region reported less urinary incontinence than women receiving sham acupuncture in the same region.
SOURCE: Liu Z, Liu Y, Xu H, et al. Effect of electroacupuncture on urinary leakage among women with stress urinary incontinence: A randomized clinical trial. JAMA 2017;317:2493-2501.
Liu et al studied the effects of acupuncture on stress urinary incontinence, recognizing that there are few adequate therapies for this prevalent condition and the overall psychological effects of this problem can be far reaching in a woman’s life.1,2 In a randomized, clinical trial at 12 hospital sites, the authors enrolled 504 women and assigned them in a 1:1 ratio (in blocks of six women at each trial site) to real or sham acupuncture. The women were not compensated for their participation. Participants were 40 to 75 years of age. They were recruited through posters and newspaper advertisements and reported involuntary leakage on effort, exertion, sneezing, or coughing that ceased as the stress ended. Inclusion in the participation group required an incontinence pad weight gain of > 1 g in a one-hour pad test. The participants were told to void two hours prior to testing; on arrival, they wore a pre-weighed pad, drank 500 mL of water in 15 minutes, and then performed strenuous activity (going up and down stairs, walking, running, bending over to pick up coins, coughing, etc.).3 The weight of the wet pad was then compared to the weight of the dry pad.
The researchers excluded those who had urge, overflow, or mixed incontinence; vaginal prolapse greater than degree two; intercurrent urinary tract infection; pregnant; significant cardiac, hepatic, central nervous system, or psychiatric disease; limited mobility; metal allergy, or needle phobia.4
Preparations were made to mimic real acupuncture in the sham group. Sham acupuncture was accomplished through “pragmatic placebo needles” placed at sham points, 20 mm from the real acupoint, and lateral to the line consistent with the bladder meridian. Liu et al developed the use of pragmatic placebo needles and found them to be useful in previous research.5 Pragmatic placebo needles are blunt acupuncture needles, shielded on the working end from the patient’s sight with a 5 mm polyethylene foam collar that allows the needle to stand straight without skin penetration by adhesive on the collar.5 No skin penetration, electrical stimulation, or needle manipulation was used for the sham group, but the same equipment setup, including electrical stimulation equipment and set, was used. At weeks 3 and 6, participants at two sites were asked to guess whether they were receiving sham or real acupuncture. The results of the two groups in the patient blinding analysis at the two intervals were similar as described below.
All participants received their blinded treatment three times a week for six weeks. The electroacupuncture was performed at two points bilaterally along the bladder meridian, BL-33 and BL-35, found in the sacral area. (See Figure 1.) As a component of ideal acupuncture therapy, de qi (soreness, heaviness, numbness at the site of insertion) was obtained. The needle handles of each side (BL-33 and BL-35) were stimulated at a continuous wave of 50 Hz and a current intensity of 1-5 mA. Electroacupuncture treatments lasted 30 minutes.
The sham acupuncture participants were treated with a placebo needle placed 20 mm (1 cun, a functional measurement of distance used in acupuncture) lateral to the locations of real BL-33 and BL-35 points. (See Figure 1.) All procedures for the two groups were identical, but no skin penetration, electricity output, or needle manipulation were used on the sham group. All participants of the trial were treated separately to prevent communication.
The primary outcome to be measured was change in urine leakage measured by the one-hour pad test at six weeks’ intervention. Three groups were preplanned for sub-analysis: mild leakage of 1.1-9.9 g urine in one hour, moderate leakage of 10-49.9 g in one hour, and severe leakage of ≥ 50 g in one hour.6 Although there is controversy surrounding the reproducibility of the test,7 the one-hour pad test was performed at baseline, two weeks, and six weeks as a measurement of incontinence. It was chosen for measurement, as it was the only incontinence test with a standardized protocol.8
A number of secondary outcomes were measured, including change in urine leakage from baseline at two weeks; 72-hour urinary incontinence episodes measured by bladder diary at various points in the study (weeks 1-6, weeks 15-18, and weeks 27-30); the number of incontinence pads used reported in the 72-hour diaries; participant-reported severity of their stress urinary incontinence (mild, moderate, or severe); and the participants’ self-evaluation of therapeutic help (no help, little help, medium help, and great help) at weeks 1-6, 7-18, and 19-30.
Adverse events were documented throughout the trial. Hematoma and fatigue occurred in 1.6% of the electroacupuncture group and 2% of the sham group.
The primary outcome was analyzed according to intention-to-treat principles. A sample size of 144 participants per group was estimated to provide 90% power to detect between-group differences of 1 g of urine measured in the one-hour pad test, but the groups were enlarged to 250 participants to compensate for a potential 20% loss to follow-up. The results of the six-week trial showed that despite the time commitment needed to undergo 18 acupuncture treatments, a reduction in incontinence and an improvement in quality of life could be obtained by this modality. (See Table 1 and Table 2.)
As to the primary outcome, the mean urine leakage in the electroacupuncture group, measured by the one-hour pad test, was 18.4 g (95% confidence interval [CI], 15.5-21.4 g) at baseline and 8.2 g (95% CI, 6.3-10.0 g) at week 6, while the sham group measured a mean of 19.1 g (95% CI, 15.6-22.7 g) at baseline and 16.8 g (95% CI, 13.5-20.1 g) at week 6. The electroacupuncture group had a greater reduction in the amount of urine leakage at week 6 (mean, -9.9 g) than the sham group (-2.6 g), with a difference of 7.4 g (95% CI, 4.8-10.0 g; P < 0.001). Similar results were observed at week 2. At week 6, greater success was found in decreasing urine incontinence by at least 50% in the electroacupuncture group (64.6%) compared with the sham group (21.7%).
At weeks 6, 18, and 30, the electroacupuncture group self-reported scores of symptom severity and evaluation of the effects of their treatment as more improved than the sham group. No difference was found between the two groups in the number of pads per week used to help control the episodes of incontinence. At week 3 of treatment, 31 of 41 (75.6%) participants receiving acupuncture guessed that they were receiving acupuncture, while 29 of 42 (69.0%) sham procedure participants thought they were receiving acupuncture as well. At week 6, 32 of 42 (78%) participants in the electroacupuncture group and 25 of 39 (64.1%) participants in the sham group believed they were receiving acupuncture.
The authors acknowledged that the study involved many limitations, including the use of fixed block randomization, allowing prediction of treatment bias at centers, and the assessment of blinding of participants at only two centers. They did not reassess the amount of urine leakage at the 24-week follow-up, and they did not pre-define a “meaningful difference” in the use of the one-hour pad test.
The authors presented valid arguments for the comparability of their technique to other methods of stress urinary incontinence treatment. They compared their acupuncture results to cited articles in the field showing that they provided similar results to pelvic floor strengthening and duloxetine prescription for decreases in 72-hour incontinence episodes and the proportion of participants with at least a 50% reduction in mean 72-hour incontinence episodes. Satisfaction rates for acupuncture treatment and pelvic floor muscle training were noted to be similar.
Options for treating stress incontinence in women are varied, yet often are not very effective. Behaviors have been modified, drugs consumed, and surgeries endured, without arriving at a distinct set of treatments that are reliable to use universally.9 Through a series of studies, Liu et al attempted to show that acupuncture may be considered among the therapies showing promise as an option to help women with this common and inconvenient disorder.
Previous attempts at reviewing non-acupuncture forms of electrostimulation as treatment for stress urinary incontinence produced little in the way of conclusions, citing low quality of evidence in the literature.10 Most recently, the Cochrane review group found that too little adequate research exists to make conclusions regarding acupuncture treatment for stress urinary incontinence.11 Liu et al took measures to ensure that their data would be acceptable (group size, effect size, and power) as an acupuncture trial (data on guessing whether a participant received real acupuncture and the use of a sham group). Previously, they demonstrated that the use of a pragmatic placebo needle, placed in acupuncture points without skin penetration and shielded visually from Chinese participants, could be perceived to be real. The Chinese are very aware of acupuncture treatments and how they should feel and appear, thus making the pragmatic placebo needle a very good tool in blinding patients from real acupuncture.5
In the same JAMA issue, Wang criticized the study by taking issue with his perception that traditional Chinese medicine (TCM) diagnostic criteria were not used for the ultimate acupuncture treatment, as historically, acupuncture treatment is based on a TCM diagnosis. He noted that the quality of acupuncturists was not ensured and that the number of incontinence pads remained relatively constant throughout the trial.12 Liu et al responded in kind, noting that their previous study was the basis of this trial and that the uniqueness of their point selection (stimulating the third sacral nerve inferior gluteal nerves) was congruent with TCM theory that all acupuncturists were required to attend training prior to their involvement in the trial.13
The use of acupoints is not unique to TCM therapy or eastern medicine practices. Urologists treat overactive bladder successfully with electrical stimulation. The technique involves repeated “stimulation of the tibial nerve.”14,15 The two stimulation points used in this procedure by urologists are similar to the electroacupuncture of points of kidney-6 (KI-6) and kidney-7 (KI-7) found near the medial ankle area.
This study is not an end, but an important beginning. Liu et al successfully tested a different approach to help women with urinary stress incontinence. By adhering to the current rigors of research review standards, they have opened the door to uncovering further treatment options and directions for stress urinary incontinence. They also have shown that acupuncture research can be accomplished in a complete and acceptable fashion. Women can now use further alternatives to the current palate of treatment options in this common disorder.
Financial Disclosure: Integrative Medicine Alert’s Executive Editor David Kiefer, MD; Peer Reviewer Suhani Bora, MD; AHC Media Executive Editor Leslie Coplin; Editor Jonathan Springston; and Editorial Group Manager Terrey L. Hatcher report no financial relationships relevant to this field of study.