Inspired by Sun et al 2021.[1]
CP – chronic prostatitis
key to acronyms
CPPS – chronic pelvic pain syndrome
RCT – randomised controlled trial
IF – impact factor
NIH-CPSI – National Institute of Health Chronic Prostatitis Symptom Index
MA – manual acupuncture
MCID – minimal clinically important difference
SUI – stress urinary incontinence
This is another huge trial organised by the China Academy of Chinese Medical Sciences. It is a parallel two-arm RCT with 220 patients in each arm, so 440 men in total were randomised. The trial was performed across 10 centres in China, and it was published online on the 17th of August in Annals of Internal Medicine (IF 25.391).
The inclusion criteria were at least 3 months of pelvic pain in the previous 6 months with no evidence of infection, age between 18 and 50, and a score of at least 15 on the NIH-CPSI.
NIH-CPSI is a 9-item questionnaire
The NIH-CPSI is a 9-item questionnaire with domains for pain, urinary symptoms, and quality of life impact.[2] The total score (of the scoring version used in this trial) ranges from 0 to 43.
Patients were randomised to either MA or sham MA and received 20 sessions of 30 minutes over an 8-week treatment period. They were then followed up for a further 24 weeks.
The MA involved 4 bilateral points: BL23, BL33, BL35 & SP6. 50–60mm needles were used at BL33 and BL35, and the angulations were inferomedial at BL33 (presumably to enter the sacral foramen at S3), and superolateral at BL35 (presumably to avoid the rectum).
The sham MA involved superficial needling (2–3mm depth), just lateral (10–15mm) to the standard point locations.
The primary outcome was the responder rate – defined by a 6-point reduction in the NIH-CPSI.
At 8 weeks and 32 weeks the responder rate in the MA group was 60.6% respectively. The equivalent figures for the sham MA group were 36.8% and 38.3%. Adjusted mean differences in the NIH-CPSI from baseline at 32 weeks were -7.4 in the MA group and -4.9 in the sham group. A reduction of 4 points on this scale has been used in the past as an MCID, although the Cochrane reviews used a 6-point reduction from baseline.[3,4]
The effect of acupuncture just exceeds the MCID
The effect of acupuncture appears to be relatively modest, just exceeding the MCID, and the difference over sham is small but statistically significant.
I was pleased to see that the authors were not forced to say something like the superiority of real acupuncture over sham was not clinically important.
Overall, this is a very comprehensive and well written report of a large multicentre sham controlled RCT from China. My only real concern was whether the Chinese participants would be convinced enough by the superficial needling. As you would expect for such a trial, there was a formal blinding assessment, and over 60% of those receiving sham MA thought they had received the real treatment. Only 6% guessed correctly they were in the sham MA group, and just over 30% were unsure. The equivalent percentages for the real MA group were 72.3, 0.5 and 27.2. The 0.5 represents one robust individual who thought he had received sham MA despite having 60mm needles inserted either side of his coccyx, up under the sacrotuberous ligament. We are not told the gauge of these needles, but these were likely to be at least 0.30mm in diameter.
Judging by what this group has done in the past with SUI, I suspect there might be a non-inferiority trial against α-blockers in the pipeline.
References
1 Sun Y, Liu Y, Liu B, et al. Efficacy of Acupuncture for Chronic Prostatitis/Chronic Pelvic Pain Syndrome : A Randomized Trial. Ann Intern Med Published Online First: 17 August 2021. doi:10.7326/M21-1814
2 Litwin MS, McNaughton-Collins M, Fowler FJ, et al. The National Institutes of Health chronic prostatitis symptom index: development and validation of a new outcome measure. Chronic Prostatitis Collaborative Research Network. J Urol 1999;162:369–75. doi:10.1016/s0022-5347(05)68562-x
3 Franco JV, Turk T, Jung JH, et al. Non-pharmacological interventions for treating chronic prostatitis/chronic pelvic pain syndrome. Cochrane Database Syst Rev 2018;5:CD012551. doi:10.1002/14651858.CD012551.pub3
4 Franco JVA, Turk T, Jung JH, et al. Pharmacological interventions for treating chronic prostatitis/chronic pelvic pain syndrome: a Cochrane systematic review. BJU Int 2020;125:490–6. doi:10.1111/bju.14988
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