Effectiveness and safety of electroacupuncture and manual acupuncture in postmenopausal women with overactive bladder: a multicenter, randomized, controlled, parallel clinical trial.

BACKGROUND

Overactive bladder (OAB) is a common disease in menopausal women that can negatively affect a patient's quality of life and cause high stress levels. Despite several studies of the effects of electroacupuncture (EA) and manual acupuncture (MA) on OAB, to our knowledge, there has been no direct comparison between EA and MA for postmenopausal OAB in a single trial. The object of this study was to evaluate the effectiveness and safety of EA at two frequencies (2 and 16 Hz) and MA for OAB in postmenopausal women.

METHODS

In this multicenter, randomized, controlled, parallel clinical trial, 147 participants were allocated randomly to 16 Hz EA, 2 Hz EA or MA groups in a 1:1:1 ratio. All participants received EA or MA twice a week for 6 weeks at CV3, CV4, GV20 and bilateral KI3 and SP6. The EA groups also received electrical stimulation at 2 or 16 Hz at CV3/CV4 and KI3/SP6. A total of 140 participants completed 6 weeks of treatment with 16 Hz EA (n = 48), 2 Hz EA (n = 46) or MA (n = 46) and were followed-up after 4 weeks. The primary outcome measurement was the change in the number of micturitions per 24 hours (averaged over 3 days) from baseline to week 6. Secondary outcome measures included daytime and nocturnal micturitions per 24 h, total number of urinary urgency and urge urinary incontinence (UUI) episodes over 3 days, overactive bladder symptom score (OABSS) and King's Health Questionnaire (KHQ) score.

RESULTS

The primary outcome did not significantly differ between groups (p = 0.160). Of all secondary outcomes, there was a significant difference only in total urinary urgency, which was reduced in 2 Hz EA versus MA groups (-9.9 ± 10.37 vs -4.3 ± 7.21, p = 0.012). Otherwise, there were no significant differences between groups. There were no serious adverse events reported during the treatment period. When symptoms were re-evaluated at week 10 (4 weeks post-treatment), most scores were similar to week 6 but there remained no significant differences between groups.

CONCLUSION

There were no significant differences between 2 Hz EA, 16 Hz EA and MA for the treatment of OAB-related symptoms in postmenopausal women, except for a tentative finding that 2 Hz EA may reduce the number of urinary urgency episodes compared to MA (secondary outcome without correction for multiple testing).

TRIAL REGISTRATION NUMBER: KCT0003912 (Clinical Research Information Service).