Inspired by Zhao et al 2024.[1]
The Rome IV diagnostic criteria were used to evaluate patients with suspected refractory IBS.
IBS – irritable bowel syndrome
RCT – randomised controlled trial
MA – manual acupuncture
IBS-SSS – IBS symptom severity scale– key to acronyms
This is a multicentre RCT from China (Beijing and Chengdu) with 2 parallel arms (n=170) examining the efficacy of acupuncture in refractory IBS.
The treatment phase consisted of 12 sessions of either MA or sham over 4 weeks. The points used in the acupuncture group were ST25, ST36, ST37, PC6 bilaterally. The sham was superficial off-point needling with no stimulation.
The primary outcome was the IBS-SSS,[2] which is a relatively simple 5-point scale using VAS-like measures from 0 to 100%, which means that the score can range from 0 to 500. Less than 75 is within the normal range, and the baseline for the population recruited in this trial was ~250, which would be categorised as moderate to severe IBS.
The mean reduction in the IBS-SSS score at 4 weeks (end of treatment phase) was 140 in the acupuncture group and 64 in the sham group (p<0.001). The difference between groups was still highly significant at 8 weeks (4 weeks after the end of treatment).
In both groups ~50% of patients had a ‘significant’ expectation of success and blinding was achieved after the first session of acupuncture but not after the 12 session. At the latter stage 86% of the acupuncture group guessed their allocation correctly, but only 5% of the sham group guessed correctly with most not knowing or guessing they were in the acupuncture group. We have discussed the problem of timing of the blinding assessment in trials of acupuncture previously.[3] Successful interventions are more likely to unblind the active treatment group by the end of the treatment phase because the patients improve on average.
The vast majority of the patients in this trial were in the IBS diarrhoea subgroup, so little can be said about IBS constipation or IBS mixed subgroups from the results of this trial, although the 10 patients in the IBS mixed subgroup did improve significantly more with real acupuncture than the sham.
By the end of the trial (4 weeks treatment and 4 weeks follow-up), the acupuncture group achieved a mean IBS-SSS of 106.6, which is well into the mild IBS range. It leaves me wondering whether or not a more prolonged course of treatment might achieve symptomatic cure of the condition.
The protocol is straightforward, and some patient may be able to self-treat with the appropriate training. I have not considered this before for IBS, so this paper would potentially change my practice in this regard.
References
1 Zhao J, Zheng H, Wang X, et al. Efficacy of acupuncture in refractory irritable bowel syndrome patients: a randomized controlled trial. Front Med. Published Online First: 3 July 2024. doi: 10.1007/s11684-024-1073-7
2 Francis CY, Morris J, Whorwell PJ. The irritable bowel severity scoring system: a simple method of monitoring irritable bowel syndrome and its progress. Aliment Pharmacol Ther. 1997;11:395–402. doi: 10.1046/j.1365-2036.1997.142318000.x
3 Usichenko TI, Cummings M. Appropriate times to measure the credibility of blinding in placebo-controlled acupuncture trials. Acupunct Med. 2024;42:52–3. doi: 10.1177/09645284231210579
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