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Study protocol
Huazheng Liang
Shanghai Fourth People's Hospital affiliated to Tongji University School of Medicine
Corresponding Author
ORCiD: https://orcid.org/0000-0001-9097-7357
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background
Combined acupuncture and moxibustion have shown benefits for a variety of illnesses. However, few studies have reported the therapeutic effect of this combined therapy for benign prostatic hyperplasia. Here, we report the study protocol of a randomized controlled clinical trial investigating the therapeutic effect of this combined therapy by comparing with the effect of conventional medical treatments.
Methods
A single-center, two-arm designed, randomized controlled clinical trial will commence in Shanghai Fourth People’s Hospital, China. Two hundred participants with moderate to severe benign prostatic hyperplasia will be recruited and assigned to the combined therapy group and the conventional western medicine group in a ratio of 1:1. They will be treated for 18 weeks and assessed after 8- and 18-weeks treatment. The primary outcome is the International prostate symptom score (IPSS), the Aging Male Symptoms score (AMS); secondary outcomes include constitution in Chinese Medicine Questionnaire (CCMQ), post-voiding residual urine volume, maximum flow rate (Qmax) and average flow rate (Qave), voided volume (VV), voiding time and time to maximum flow, the change of urgency/24 h, the change of voiding frequency/24 h, the change of nocturnal frequency/24 h, the change of urge urinary incontinence frequency/24 h.
Discussion
The result of this trial will confirm whether combined acupuncture and moxibustion is effective in managing benign prostatic hyperplasia as well as the superiority of inferiority of this therapy to conventional medical treatments.
Trial registration:
chictr.org.cn, ID: ChiCTR2000030504/ChiMCTR2000003082.
Keywords
acupuncture, moxibustion, combined therapy, conventional medical treatment, benign prostatic hyperplasia, study protocol
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This preprint is under consideration at Trials. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Study protocol
Huazheng Liang
Shanghai Fourth People's Hospital affiliated to Tongji University School of Medicine
Corresponding Author
ORCiD: https://orcid.org/0000-0001-9097-7357
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Under Review
Version 1
Posted 13 May, 2020
No community comments so far
Editor assigned
On 06 Jun, 2020
Submission checks complete
On 12 May, 2020
First submitted
On 05 Apr, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background
Combined acupuncture and moxibustion have shown benefits for a variety of illnesses. However, few studies have reported the therapeutic effect of this combined therapy for benign prostatic hyperplasia. Here, we report the study protocol of a randomized controlled clinical trial investigating the therapeutic effect of this combined therapy by comparing with the effect of conventional medical treatments.
Methods
A single-center, two-arm designed, randomized controlled clinical trial will commence in Shanghai Fourth People’s Hospital, China. Two hundred participants with moderate to severe benign prostatic hyperplasia will be recruited and assigned to the combined therapy group and the conventional western medicine group in a ratio of 1:1. They will be treated for 18 weeks and assessed after 8- and 18-weeks treatment. The primary outcome is the International prostate symptom score (IPSS), the Aging Male Symptoms score (AMS); secondary outcomes include constitution in Chinese Medicine Questionnaire (CCMQ), post-voiding residual urine volume, maximum flow rate (Qmax) and average flow rate (Qave), voided volume (VV), voiding time and time to maximum flow, the change of urgency/24 h, the change of voiding frequency/24 h, the change of nocturnal frequency/24 h, the change of urge urinary incontinence frequency/24 h.
Discussion
The result of this trial will confirm whether combined acupuncture and moxibustion is effective in managing benign prostatic hyperplasia as well as the superiority of inferiority of this therapy to conventional medical treatments.
Trial registration:
chictr.org.cn, ID: ChiCTR2000030504/ChiMCTR2000003082.
Figure 1
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