Study design, materials and methods
A parallel group, single blind, randomized controlled trial was conducted in a tertiary urogynecology center for 24 weeks. Women presented with UI and diagnosed to be ‘kidney asthenia’ by traditional Chinese medicine (TCM) assessment were randomized to have acupuncture and PFE (acupuncture group) or PFE only (control group). Non-Chinese, aged under 18, women who were pregnant or planning for pregnancy within the study period were excluded. Women with uncontrolled diabetes or hypertension or cardiovascular diseases, with history of pelvic floor injury, radiation or pelvic organ prolapses were also excluded. Written consent was obtained. Urinary Distress Inventory (UDI-6) and Incontinence Impact questionnaires (IIQ-7), Visual Analogue Score (VAS) of severity of UI, 3-days bladder diary were collected at baseline. All women received an educational class on drinking and voiding habit and PFE at baseline. Randomization was conducted in 1:1 ratio. Ethical approval was obtained from institution.
In control group, women attended PFE training sessions at 6 weeks and 12 weeks. In acupuncture group, in addition to the same training sessions, women attended a weekly acupuncture session for six weeks (from week 1 to 6) by a registered Traditional Chinese Medicine (TCM) practitioner. Each session lasted for 20 minutes and the acupuncture points were chosen based on the previous literature: Shenshu (BL-23), Pangguanshu (BL-28), Ciliao (BL-32) and Zhongliao (BL-33), Guanyuan (REN-4), Henggu (KID-11), Qihai (REN-6), Sanyinjiao (SP-6), Zusanli (ST-36).
The primary outcome was the subjective outcome of UI at 12 and 24 weeks after treatment. Secondary outcomes included the urinary symptoms and QoL assessment by UDI-6, IIQ-7, VAS of UI severity, bladder diary at 12 and 24 weeks, any adverse event from acupuncture and the compliance of PFE in both groups.
The sample size calculation was based on the assumption that 50% of women in the control group and an addition of 25% in the acupuncture group would have improvement in their UI. The alpha level was set at 0.05 and power at 80. We assumed 15% women would be excluded after TCM assessment and a drop out rate of 20%, 85 subjects per group and a total of 170 subjects would be needed. Intention to treat analysis was carried out.
Results
179 women were approached, 19 refused study and 23 were excluded after TCM assessment, leaving 137 women were randomized (69 in acupuncture group and 68 in control group) (Table 1). 63 (91.3%) women in acupuncture group and 59 (86.8%) in control group completed the follow up at 24 weeks. The primary and secondary outcomes were presented as in Table 2. The subjective improvement rate was significantly higher in acupuncture group (68.3% vs 47.1%, p<0.01) at 12 weeks but was not significant (79.4% vs 62.8%, p=0.13) at 24 weeks. There was a tendency of more improvement in the QoL and VAS score of UI severity in acupuncture group; however, they did not reach the statistical significance. There was no significant difference in the compliance of PFE in both groups. Nine (13%) women had minor complaint of numbness (4), persistent pain (2), bruises (2) or tiredness (1) after received acupuncture.
Interpretation of results
More women in acupuncture group had subjective improvement in their UI symptoms after 12 weeks. The QoL scores were reduced in both acupuncture group and controls group at 12 weeks; however, there was no significant difference between two groups. At 24 weeks, more women in acupuncture group had subjective improvement in their UI symptoms, but it was not statistically significant. There was no major adverse event in women received acupuncture, only 13% reported minor discomfort.