The main paper this week was an obvious choice as it is a big clinical trial published in a mainstream general medicine journal. Currently the paper has not surfaced on PubMed, although it is published online. I was tipped off by an email from the journal editor as I had been one of the reviewers.
Annals of Internal Medicine
I am pleased to say that we published the pilot study in Acupuncture in Medicine,[2] which led up to this definitive multicentre clinical trial.[1] Note that we only published it in early February! I remember considering highlighting it at the time, but it didn’t make the cut. Well, it does now!
PDS – postprandial distress syndrome
The papers are on postprandial distress syndrome (PDS) the most common subclassification of functional dyspepsia (FD). The pilot study randomised 42 patients and the larger trial, just published, randomised 278. The populations both met the Rome IV criteria for PDS, and had normal gastroscopy findings within the previous year. Both used a parallel arm, sham controlled design, providing 12 sessions of acupuncture or sham over 4 weeks. The points were local to symptoms: CV17, CV12, CV6, ST25; in the limbs: ST36, SP4, PC6; and on the head: GV20. The larger trial also allowed the addition of an optional point guided by the TCM syndrome pattern: LR3, SP3 or ST44.
The sham was superficial needling at non-classical sites using the same needles but only inserting them 2-3mm, with no manipulation. It is always brave to use needling in the sham group, but the Chinese often manage to create enough of a difference. This could be because the standard manual needling is a lot stronger on average in China. One advantage of using gentle superficial needling in the sham group is the avoidance of having to use devices for non-penetrating needles in the real acupuncture group. These may degrade the real acupuncture effect.[3]
The response rate at the end of the 4 weeks treatment was 83.0% in the acupuncture group and 51.6% in the sham group. This difference was maintained after a further 3 months follow-up.[1]
Blinding was tested after the first and 6th session, and there was no difference between the groups – 70 to 80% guessed they had real acupuncture in both real and sham groups at both time points.
On reviewing some large drug trials, a responder rate of 50% seems quite large, and whilst the outcomes are similar (a 7-point patient reported scale), they are not directly comparable.[4,5] It seems safer to simply look at the difference over placebo or sham in this situation as Yang et al do in their discussion – something I do not favour as it assumes sham is no different to a drug placebo.
On the subject of drugs in upper GI symptoms, it was a paper from 2007 that first made me take the potential role of acupuncture more seriously.[6] This paper took 30 patients with refractory heartburn, aka gastro-oesophageal reflux disease, GORD or GERD, depending on whether you prefer an ‘o’ at the start of your oesophagus or not. These patients had symptoms despite taking a standard dose of a PPI (proton pump inhibitor). They were randomised to double the dose or add acupuncture to the standard dose. The acupuncture group received 10 sessions over 4 weeks, and the protocol used standard points: CV17, CV12, ST36, SP9, LR3, PC6. The acupuncture group improved significantly, and the double-dose PPI group were really unchanged after 4 weeks.
Those of us who trained in the 80’s or earlier know what a huge impact cimetidine and ranitidine (H2 receptor antagonists) had on rates of gastric surgery. Over my time as a medical student at Leeds I saw a transition of surgical techniques for ulcer disease ending with the highly selective vagotomy, and then they all disappeared, almost overnight, when cimetidine was introduced. The PPIs were simply the next stage in this drug revolution and were so rapidly effective that we even used them diagnostically in acute settings in the community. But like so many areas of modern healthcare, this short-term efficacy did not translate to a long-term solution for patients with GORD symptoms, and the commercial pressures from industry did nothing to help find a solution – they urged us to try the latest drug or to double the dose. It should have been obvious that this was not going to be a long-term solution, rather like drugs are not the solution to insulin resistance and type 2 diabetes.
The long-term solutions nearly always lie in lifestyle choices, and perhaps acupuncture is one way of transitioning from the passive treatment to the active engagement in personal health.
References
1 Yang J, Wang L, Zou X, et al. Effect of Acupuncture for Postprandial Distress Syndrome. Ann Int Med Published Online First: 2020. doi:10.7326/M19-2880
2 Tu J-F, Yang J-W, Wang L-Q, et al. Acupuncture for postprandial distress syndrome: a randomized controlled pilot trial. Acupunct Med Published Online First: 7 February 2020. doi:10.1177/0964528419900911
3 Kim T-H, Lee MS, Alraek T, et al. Acupuncture in sham device controlled trials may not be as effective as acupuncture in the real world: a preliminary network meta-analysis of studies of acupuncture for hot flashes in menopausal women. Acupunct Med 2019;:acupmed2018011671. doi:10.1136/acupmed-2018-011671
4 Van Zanten SV, Armstrong D, Chiba N, et al. Esomeprazole 40 mg once a day in patients with functional dyspepsia: The randomized, placebo-controlled ‘ENTER’ trial. Am J Gastroenterol 2006;101:2096–106. doi:10.1111/j.1572-0241.2006.00751.x
5 Vakil N, Laine L, Talley NJ, et al. Tegaserod treatment for dysmotility-like functional dyspepsia: Results of two randomized, controlled trials. Am J Gastroenterol 2008;103:1906–19. doi:10.1111/j.1572-0241.2008.01953.x
6 Dickman R, Schiff E, Holland A, et al. Clinical trial: acupuncture vs. doubling the proton pump inhibitor dose in refractory heartburn. Aliment Pharmacol Ther 2007;26:1333–44. doi:10.1111/j.1365-2036.2007.03520.x
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