Effect of additional acupuncture to pelvic floor exercise on urinary incontinence: A randomized controlled trial.

AIMS: To investigate the additional benefit of acupuncture to pelvic floor exercise (PFE) on the improvement of urinary incontinence (UI) and quality of life (QoL) in women. METHODS: This was a single-blinded randomized controlled trial in a tertiary university hospital. Women with UI in various severity and types were randomized to receive either a weekly course of acupuncture with PFE or PFE alone for 6 weeks and then followed up for 24 weeks in every 6 weeks. Investigators were blinded to group allocation in pre- and postintervention assessments. Primary outcome was subjective changes of UI symptoms at 24 weeks. Secondary outcomes were episodes and severity of UI from bladder diary, severity by Visual Analogue Scale, and QoL scores by validated Chinese short-form of Urogenital Distress Inventory (UDI-6) and Incontinence Impact Questionnaire (IIQ-7). RESULTS: One hundred seventy-nine women were screened while 137 were randomized. Significant subjective improvement in UI symptoms was demonstrated at all follow-up, latest at 24 weeks (odds ratio [OR]: 2.29, 95% confidence Interval [CI]: 1.02-5.12, respectively), with reduced episodes and severity of UI after (p < 0.05), and a trend of improvement in IIQ-7 score (p = 0.05). No major adverse events occurred. History of 2 years or longer duration of UI symptoms was associated with lower effectiveness of acupuncture (OR: 0.08, 95% CI: 0.01-0.68).

A double-blinded, randomized placebo-controlled trial on the effect of traditional Chinese medicine formula Wuzi Yanzong pill on improving semen qualities in men with suboptimal parameters.

BACKGROUND: In Hong Kong, one of six couples is affected by subfertility problems. Male infertility contributes to half of the infertility cases. In male infertility, there is no effective treatment for patients with idiopathic infertility/poor semen parameters. Recent meta-analysis results suggest that a traditional Chinese medicine (TCM) formula - Wuzi Yanzong pill - showed a curative effect on male fertility. However, the heterogeneity of the studies could not draw a definitive conclusion on the therapeutic effect of this formula. The aim of this study is to conduct a well-designed randomized controlled trial to investigate the effect of TCM formula Wuzi Yanzong pill on improving semen qualities in men with suboptimal parameters. METHODS: This study is a double-blinded, randomized placebo-controlled trial conducted in a public hospital in Hong Kong. Participants will be randomized, using computer-generated random numbers, with a 1:1 ratio to either the Wuzi Yanzong pill formula group or the placebo group. Both groups will be administered the drugs for 12 weeks. Participants will have a total of four visits for their semen and blood assessments for a 6-month period, and we will follow up for another 6 months to record their conception outcome. The primary outcome is to compare the total motile sperm count, natural conception rate, and pregnancy outcome to those under placebo treatment. Secondary objectives are sperm functions and assisted reproductive technology outcome. DISCUSSION: To date, there are no studies using the disclosed Wuzi Yanzong formula or double-blinded, randomized trials. The Wuzi Yanzong TCM formula may provide a good clinical solution for subfertile males for which contemporary western medicine has no cure. Therefore, a well-designed randomized trial for evaluating the effect of Wuzi Yanzong TCM formula is urgently needed. TRIAL REGISTRATION: Chinese Clinical Trial Registry (ChiCTR), ChiCTR-INR-17010790 . Registered on 27 February 2017. Centre for Clinical Research and Biostatistics - Clinical Trials Registry, CUHK_CCRB00548 . Registered on 27 February 2017.