Inspired by Liu et al. Mayo Clin Proc 2019.
Another huge trial from the team at the China Academy of Chinese Medical Sciences in Beijing. This follows on from two previous large multicentre trials,[2,3] both of which I have reported on in this blog:
Having established specific effects of electroacupuncture (EA) in stress urinary incontinence (SUI), this team has gone on very quickly to perform a large non-inferiority trial in mixed urinary incontinence (MUI) against the established conventional treatment: pelvic floor muscle training (PFMT) plus solifenacin. The latter drug is an antimuscarinic agent, that is an inhibitor of the neurotransmitter acetylcholine at its muscarinic receptors (mostly found in smooth muscle – the ones in skeletal muscle are called nicotinic receptors). It has been shown to reduce the frequency of urinary incontinence episodes in women with MUI, but its use can be limited by common side effects including dry mouth, dry eyes and constipation.
Technically speaking it was non-inferior, but this merely reflects a statistical choice in the methods. It is easier (requires less statistical power) to demonstrate non-inferiority than it is to demonstrate equivalence. It sounds odd when you say it, doesn’t it, but equivalence requires you to prove something is not better and not worse, whereas non-inferiority only requires a one-sided test…
The EA protocol used in this trial was similar to that I described in the previous blog: https://bmas.blog/2018/10/11/ea-for-stress-urinary-incontinence/
The frequency used was mixed 10/50Hz. It was described as ‘spare-dense’ in both the protocol and the paper itself. I guess this was intended to read ‘sparse’ rather than ‘spare’, and thus be the same as dense-dispersed, which we always refer to in the wrong order as we write the lower frequency first. The previous paper described a continuous wave at 50Hz. There was also a minor inconsistency in the lower end of the intensity range – I will try to clarify that and report back.
The sticking point for Western practice might be the number of treatment sessions: 3 per week for 12 weeks, and no real possibility of self-treatment with this sort of needling location. On the positive side, the effect lasted at least 24 weeks, and the benefit was certainly well into the range of clinical relevance. Readers should note that clinical relevance here is correctly measured as the change from baseline, not in the way often performed (by NICE Guideline Development Groups for example) as a between group difference.
So perhaps this is something for future development. We will need many more practitioners trained and bigger infrastructure in our health services to be able to provide this intensity of treatment equitably for the whole population.
In case some of you are thinking you might not like needles placed 50-60mm deep either side of your coccyx, the EA protocol in this trial achieved high rates of satisfaction than the PFMT plus solifenacin ;-).
- Liu B, Liu Y, Qin Z, et al. Electroacupuncture Versus Pelvic Floor Muscle Training Plus Solifenacin for Women With Mixed Urinary Incontinence: A Randomized Noninferiority Trial. Mayo Clin Proc 2019;94:54–65. doi:10.1016/j.mayocp.2018.07.021
- Liu Z, Yan S, Wu J, et al. Acupuncture for Chronic Severe Functional Constipation: A Randomized Trial. Ann Intern Med 2016;165:761–9. doi:10.7326/M15-3118
- Liu Z, Liu Y, Xu H, et al. Effect of Electroacupuncture on Urinary Leakage Among Women With Stress Urinary Incontinence: A Randomized Clinical Trial. JAMA 2017;317:2493–501. doi:10.1001/jama.2017.7220