Effectiveness and safety of moxibustion for alleviating symptoms of overactive bladder: A prospective, randomized controlled, crossover-design, pilot study

Hye-Yoon Lee, Young-Ju Yun, Jun-Yong Choi, Jin-Woo Hong, In Lee, Seong-Ha Park, Jung-Nam Kwon, Hye-Yoon Lee, Young-Ju Yun, Jun-Yong Choi, Jin-Woo Hong, In Lee, Seong-Ha Park, Jung-Nam Kwon

Abstract

Background: This study aimed to evaluate trial feasibility and explore the potential efficacy and safety of moxibustion in the treatment of overactive bladder (OAB).

Method: 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.

Results: 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.

Conclusions: 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.

Other information: This clinical trial has been registered on clinicaltrials.gov (NCT02271607).

Conflict of interest statement

The authors have no funding and no conflicts of interest to disclose.

Figures

Figure 1
Figure 1
Location of the acupuncture points. (A) The location of CV4; (B) the location of SP6 and LR3; (C) an apparatus type moxibustion (Haitnim device with moxa pillar); (D) an indirect moxibustion stick (Kanghwa mini-moxa).
Figure 2
Figure 2
Treatment courses of each group.

References

    1. Haylen BT, De Ridder D, Freeman RM, et al. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Int Urogynecol J 2010;21:5–26.
    1. Abrams P, Cardozo L, Fall M, et al. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn 2002;21:167–78.
    1. Lee YS, Lee KS, Jung JH, et al. Prevalence of overactive bladder, urinary incontinence, and lower urinary tract symptoms: results of Korean EPIC study. World J Urol 2011;29:185–90.
    1. Gill SS, Mamdani M, Rochon PA. Management of overactive bladder. N Engl J Med 2004;350:2213.
    1. Gormley EA, Lightner DJ, Burgio KL, et al. Diagnosis and treatment of overactive bladder (non-neurogenic) in adults: AUA/SUFU guideline. J Urol 2012;188:2455–63.
    1. de Groat WC. A neurologic basis for the overactive bladder. Urology 1997;50:36–52.
    1. Lee KS, Lee YS. Overactive bladder. Korean J Urol 2007;48:1191–208.
    1. Maguire T, Doshani A, Mayne C, et al. Patients’ experience and expectations of conservative management strategies, anti-muscarinics and treatment with intravesical onabotulinum toxin for overactive bladder–a qualitative interview study. Int J Urol Nurs 2016;10:68–77.
    1. Coyne KS, Sexton CC, Irwin DE, et al. The impact of overactive bladder, incontinence and other lower urinary tract symptoms on quality of life, work productivity, sexuality and emotional well-being in men and women: results from the EPIC study. BJU Int 2008;101:1388–95.
    1. Liberman JN, Hunt TL, Stewart WF, et al. Health-related quality of life among adults with symptoms of overactive bladder: results from a US community-based survey. Urology 2001;57:1044–50.
    1. Milsom I, Abrams P, Cardozo L, et al. How widespread are the symptoms of an overactive bladder and how are they managed? A population-based prevalence study. BJU Int 2001;87:760–6.
    1. Korean Acupuncture & Moxibustion Society Textbook Compilation Committee. The Acupuncture and Moxibustion Medicine. Paju, Gyeongi, South Korea: Jipmoon; 2008.
    1. Kim KM. A literature study of acupuncture and moxibustion therapy in the [the Urine] section (in the Naegyeong Chapter) of [Dong-Ui-Bo-Gam]. J Daejeon Oriental Med 2010;19:129–42.
    1. Jung SY, Kim DI. Retrospective study on overactive bladder. J Oriental Obstetr Gynecol 2009;22:169–84.
    1. Yun SP, Jung WS, Park SU, et al. Effects of moxibustion on the recovery of post-stroke urinary symptoms. Am J Chin Med 2007;35:947–54.
    1. Yu Y, Kang J. Clinical studies on treatment of chronic prostatitis with acupuncture and mild moxibustion. J Tradit Chin Med 2005;25:177–81.
    1. Zheng H, Wang S, Shang J, et al. Study on acupuncture and moxibustion therapy for female urethral syndrome. J Tradit Chin Med 1998;18:122–7.
    1. Zhou RX, Yan J. Treatment of poststroke urinary incontinence with acupuncture and moxibustion, microwave and pelvic floor muscle exercise: analysis of 106 cases. Chin J Clin Rehab 2006;10:155–7.
    1. Kitakoji H, Terasaki T, Honjo H, et al. Effect of acupuncture on the overactive bladder. Nihon Hinyokika Gakkai Zasshi 1995;86:1514–9.
    1. Zhang J, Cheng W, Cai M. Effects of electroacupuncture on overactive bladder refractory to anticholinergics: a single-blind randomised controlled trial. Acupunct Med 2015;33:368–74.
    1. Yang L, Wang Y, Mo Q, et al. A comparative study of electroacupuncture at Zhongliao (BL33) and other acupoints for overactive bladder symptoms. Front Med 2017;11:129–36.
    1. Chung IM, Kim YS, Sung YH, et al. Effects of acupuncture on abdominal leak point pressure and c-Fos expression in the brain of rats with stress urinary incontinence. Neurosci Lett 2008;439:18–23.
    1. Kavia RBC, Dasgupta R, Fowler CJ. Functional imaging and the central control of the bladder. J Comp Neurol 2005;493:27–32.
    1. Dinis P, Charrua A, Avelino A, et al. Intravesical resiniferatoxin decreases spinal c-fos expression and increases bladder volume to reflex micturition in rats with chronic inflamed urinary bladders. BJU Int 2004;94:153–7.
    1. Kavia RB, Dasgupta R, Fowler CJ. Functional imaging and the central control of the bladder. J Comp Neurol 2005;493:27–32.
    1. Yuan Z, He C, Yan S, et al. Acupuncture for overactive bladder in female adult: a randomized controlled trial. World J Urol 2015;33:1303–8.
    1. Aydogmus Y, Sunay M, Arslan H, et al. Acupuncture versus solifenacin for treatment of overactive bladder and its correlation with urine nerve growth factor levels: a randomized, placebo-controlled clinical trial. Urol Int 2014;93:437–43.
    1. MacPherson H, Altman DG, Hammerschlag R, et al. Revised standards for reporting interventions in clinical trials of acupuncture (STRICTA): extending the CONSORT statement. J Evidence Based Med 2010;3:140–55.
    1. Acquadro C, Kopp Z, Coyne KS, et al. Translating overactive bladder questionnaires in 14 languages. Urology 2006;67:536–40.
    1. Coyne KS, Zyczynski T, Margolis MK, et al. Validation of an overactive bladder awareness tool for use in primary care settings. Adv Ther 2005;22:381–94.
    1. Coyne K, Revicki D, Hunt T, et al. Psychometric validation of an overactive bladder symptom and health-related quality of life questionnaire: the OAB-q. Qual Life Res 2002;11:563–74.
    1. Homma Y, Yoshida M, Seki N, et al. Symptom assessment tool for overactive bladder syndrome—overactive bladder symptom score. Urology 2006;68:318–23.
    1. Blaivas JG, Panagopoulos G, Weiss JP, et al. Validation of the overactive bladder symptom score. J Urol 2007;178:543–7.
    1. Jeong SJ, Homma Y, Oh SJ. Korean version of the overactive bladder symptom score questionnaire: translation and linguistic validation. Int Neurourol J 2011;15:135–42.
    1. Miller MD, Ferris DG. Measurement of subjective phenomena in primary care research: the Visual Analogue Scale. Fam Pract Res J 1993.
    1. Siltberg H, Larsson G, Victor A. Frequency/volume chart: the basic tool for investigating urinary symptoms. Acta Obstet Gynecol Scand Suppl 1997;166:24–7.
    1. Larsson G, Abrams P, Victor A. The frequency/volume chart in detrusor instability. Neurourol Urodyn 1991;10:533–43.
    1. Jones BF, Plassmann P. Digital infrared thermal imaging of human skin. IEEE Eng Med Biol Mag 2002;21:41–8.
    1. Noh SH, Lee BR, Yim YK. Single and triple moxibustion with large, indirect moxa induced differential effects on skin temperature and blood perfusion in healthy human subjects: counterevidence to a previous report. Complement Ther Med 2014;22:311–9.
    1. Whitehead AL, Julious SA, Cooper CL, et al. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res 2015;25:1057–73.
    1. Lancaster GA, Dodd S, Williamson PR. Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract 2004;10:307–12.
    1. Nahm FS. Understanding effect sizes. Hanyang Med Rev 2015;35:40–3.
    1. Olejnik S, Algina J. Measures of effect size for comparative studies: applications, interpretations, and limitations. Contemp Educ Psychol 2000;25:241–86.
    1. Hedges LV. Distribution theory for Glass's estimator of effect size and related estimators. J Edu Stat 1981;6:107–28.
    1. Cohen J. Statistical Power Analysis for the Behavioral Sciences. 1988;Hillsdale, NJ: Lawrence Earlbaum Associates, 20–26.
    1. Sawilowsky SS. New effect size rules of thumb. J Mod Appl Stat Methods 2009;8:597–9.
    1. Thabane L, Ma J, Chu R, et al. A tutorial on pilot studies: the what, why and how. BMC Med Res Methodol 2010;10:1.
    1. Homma Y. Development and validity of the Overactive Bladder Symptom Score (OABSS). Jpn J Urol 2005;96:182.
    1. Song FJ, Jiang SH, Zheng SL, et al. Electroacupuncture for post-stroke urinary incontinence: a multi-center randomized controlled study. Zhongguo Zhen Jiu 2013;33:769–73.
    1. Weiss JP, Blaivas JG, Stember DS, et al. Nocturia in Adults: Etiology. Neurourol Urodyn 1998;17:467–72.
    1. van Kerrebroeck P, Abrams P, Chaikin D, et al. The standardisation of terminology in nocturia: report from the standardisation sub-committee of the International Continence Society. Neurourol Urodyn 2002;21:179–83.
    1. Chen YL, Feng WJ, Zhang XL. Parkinson's disease combined with overactive bladder syndrome treated with acupuncture and medication. Zhongguo Zhen Jiu 2012;32:215–8.
    1. Choi JB, Kim YB, Kim BT, et al. Analysis of heart rate variability in female patients with overactive bladder. Urology 2005;65:1109–12.
    1. Park KS, Lee JM, Lee CH, et al. Correlation between heart rate variability and urine analysis of women with urinary disturbance. J Orient Obst Gynecol 2011;24:74–86.
    1. Kleiger R, Stein P, Bosner M, et al. Time domain measurements of heart rate variability. Cardiol Clin 1992;10:487–98.
    1. Lee KU, Na YG, Travis DM, et al. Alterations in voiding frequency and cystometry in the clomipramine induced model of endogenous depression and reversal with fluoxetine. J Urol 2003;170:2067–71.
    1. Park SM, Lee SH, Jung JC, et al. Effect of moxibustion treatment on UPDRS and heart rate variability in idiopathic Parkinson's disease patients. J Korean Oriental Med 2005;26:176–81.
    1. Chang Y, Liu YP, Liu CF. The effect on serotonin and MDA levels in depressed patients with insomnia when far-infrared rays are applied to acupoints. Am J Chin Med 2009;37:837–42.
    1. Son HM, Kim DH, Kim E, et al. A qualitative study of the experiences of patients with knee osteoarthritis undergoing moxibustion. Acupunct Med 2013;31:39–44.
    1. Emmons SL, Otto L. Acupuncture for overactive bladder: a randomized controlled trial. Obstet Gynecol 2005;106:138–43.
    1. Hrobjartsson A, Gotzsche PC. Placebo interventions for all clinical conditions. Cochrane Database Syst Rev 2010. 448.
    1. Digesu GA, Khullar V, Cardozo L, et al. Overactive bladder symptoms: do we need urodynamics? Neurourol Urodyn 2003;22:105–8.

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