Efficacy of electroacupuncture at Zhongliao point (BL33) for mild and moderate benign prostatic hyperplasia: study protocol for a randomized controlled trial

Yang Wang, Zhishun Liu, Jinna Yu, Yulong Ding, Xuan Liu, Yang Wang, Zhishun Liu, Jinna Yu, Yulong Ding, Xuan Liu

Abstract

Background: Acu-point specificity is a key issue in acupuncture. To date there has not been any satisfactory trial which can ratify the specific effect of acupuncture. This trial will evaluate the specific effect of BL33 for mild and moderate benign prostatic hyperplasia (BPH) on the basis of its effectiveness. The non-specific effect will be excluded and the therapeutic effect will be evaluated.

Method: This is a double-blinded randomized controlled trial. 100 Patients will be randomly allocated into the treatment group (n = 50) and the control group (n = 50). The treatment group receives needling at BL33 and the control group receives needling at non-point. The needling depth, angle, direction, achievement of De Qi and parameters of electroacupuncture are exactly the same in both groups. The primary outcome measure is reduction of international prostate symptom score (IPSS) at the 6th week and the secondary outcome measures are reduction of bladder residual urine, increase in maximum urinary flow rate at the 6th week and reduction of IPSS at the 18th week.

Discussion: This trial will assess the specific therapeutic effect of electroacupuncture at BL33 for mild and moderate BPH.

Trial registration: Protocol Registration System of Clinical Trials.gov NCT01218243.

Figures

Figure 1
Figure 1
Flow chart of the trial.
Figure 2
Figure 2
BL33 and non-point used in the trial.
Figure 3
Figure 3
Effects of BL33 acupuncture and non-point acupuncture of this trial.

References

    1. Linde K, Allais G, Brinkhaus B, Acupuncture for migraine prophylaxis. Cochrane Database Syst Rev. 2009 (issue 1).
    1. Linde K, Allais G, Brinkhaus B, Acupuncture for tension-type headache. Cochrane Database Syst Rev. 2009 (issue 1).
    1. Ezzo JM, Richardson MA, Vickers A, Acupuncture-point stimulation for chemotherapy-induced nausea or vomiting. Cochrane Database Syst Rev. 2006 (issue 2).
    1. Campbell A. Point specificity of acupuncture in the light of recent clinical and imaging studies. ACUPUNCTURE IN MEDICINE. 2006;24(3):118–122. doi: 10.1136/aim.24.3.118.
    1. Linde K, Streng A, Jurgens S, Hoppe A, Brinkhaus B, Witt C. et al.Acupuncture for patients with migraine: a randomized controlled trial. JAMA. 2005;293(17):2118–25. doi: 10.1001/jama.293.17.2118.
    1. Melchart D, Streng A, Hoppe A, Brinkhaus B, Witt C, Wagenpfeil S. et al.Acupuncture in patients with tension-type headache: randomised controlled trial. BMJ. 2005;331(7513):376–82. doi: 10.1136/bmj.38512.405440.8F.
    1. Witt C, Brinkhaus B, Jena S, Linde K, Streng A, Wagenpfeil S. et al.Acupuncture in patients with osteoarthritis of the knee: a randomised trial. Lancet. 2005;366(9480):136–43. doi: 10.1016/S0140-6736(05)66871-7.
    1. Scharf H-P, Mansmann U, Streitberger K, Witte S, Kramer J, Maier C. et al.Acupuncture and knee osteoarthritis: a three-armed randomized trial. Ann Intern Med. 2006;145(1):12–20.
    1. Goldman N, Chen M, Fujita T. et al.Adenosine A1 receptors mediate local anti-nociceptive effects of acupuncture. Nature neuroscience. 2010;13(7):883–888. doi: 10.1038/nn.2562.
    1. Shuran J, Zhongsuan H. Specific effect of acupuncture at ST36 for visceral pain. Acupuncture Reaearch. 1987;1:73–76.
    1. Cheng K, Han Y. Study on the Specificity of Effects of Acupuncture of Different Acupoints in Reducing Gentamycin Induced Ototoxicity in Guinea-pigs. Acupuncture Reaearch. 2004;29(3):204–208.
    1. Xu B, Yu X, Chen C. et al.Relationship Between Efficacy of Electroacupuncture and Electroacupuncture Stimulation of Different Acupoints and Different Tissue Layers of Acupoint Area in Hypotension plus Bradycardia Rats. Acupuncture Reaearch. 2010;35(6):422–428.
    1. Yang T, Zhang XQ, Feng YW. et al.Efficacy of Electroacupuncture in Treating 93 Patients with Benign Prostatic Hyperplasia. Chinese Journal of Integrated Traditional and Western Medicine. 2008;28(11):998–1000.
    1. Yang T, Liu Z, Zhang XQ. et al.Evaluation on therapeutic effects of electro acupuncture for benign prostatic hyperplasia: A prospective randomized controlled study. Chinese Journal of Rehabilitation Medicine. 2008;23(11):1028–1031.
    1. Ding Y, Yu J, Liu Z. A pilot trial of point speciality using electroacupuncture at Zhongliao point for benign prostatic hyperplasia. Journal of Clinical Acupuncture and Moxibustion. in press .
    1. Chapple C R, Montorsi F, Teuvo T LJ. et al.Silodosin therapy for lower urinary tract symptoms in men with Suspected Benign Prostatic Hyperplasia: Results of an International, Randomized, Double-Blind, Placebo- and Active-Controlled Clinical Trial Performed in Europe. European Urology. 2011;59:342–352. doi: 10.1016/j.eururo.2010.10.046.
    1. Yu HJ, Lin A, Yang SD, Non-inferiority of silodosin to tamsulosin in treating patients with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) BJU INTERNATIONAL. 2011, doi: 10.1111/j.1464-410X.2011.10233.x.
    1. Wang J. Clinical Epidemiology-design, measurement and evaluation. 2. Shanghai: Shanghai Science and Technology Press; 2001. pp. 141–142.
    1. Xie H. Huangdi Neijing. Puslishing House of Ancient chinese medical books; 2001.
    1. Li L, Qin W, Bai L. et al.Exploring vision-related acupuncture point specificity with multivoxel pattern analysis. Magnetic Resonance Imaging. 2010;28(3):380–387. doi: 10.1016/j.mri.2009.11.009.

Source: PubMed

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