Acupuncture non-inferior to NRT

Inspired by Wang et al Chest 2018.[1]

Photo by David Yanutama on Unsplash.

I am a bit slow to comment on this paper that was published nearly a year ago. This morning a colleague from Madrid asked my opinion on an earnest letter dismissing the research.[2] I had a quick look over both and thought the original paper was indeed worth highlighting. The earnest letter was also rather amusing since it clearly demonstrated that the authors had not actually read the paper properly.

I have to confess to being somewhat surprised that acupuncture was not inferior to nicotine replacement therapy (NRT), but the trial appears to have been well conducted and reported. It was a 3-arm open trial pitting body acupuncture against NRT, controlled by a third active arm receiving auricular acupressure. The acupuncture was performed twice a week for 8 weeks and comprised 30 minutes sessions including electroacupuncture (EA) to LU7 and ST36, as well as manual acupuncture (MA) to GV20, LI4, SP3, LR3, Yintang, plus PC6 if certain symptoms were present. The auricular acupressure involved applying vaccaria seeds to 6 or 7 points and pressing each of them for 1 minute (presumably on both ears). The sessions lasted 30 minutes and were performed twice a week for 8 weeks. Patients were instructed to press each of the points for 20 seconds every 1-2 hours at home or whenever they got a craving. The NRT group received patches to be applied each day for 8 weeks.

The primary outcome was carbon monoxide-confirmed 24 hour point abstinence rate at 24 weeks post quit date. 300 participants were enrolled, and 195 completed the trial. So this was a 35% dropout rate – high but not unusual in trials of smoking cessation.

At 24 weeks the abstinence rates in the acupuncture, NRT and auricular groups was 43%, 44% and 30% respectively. Both acupuncture and NRT were significantly superior to auricular acupressure.

So what was the fuss from the earnest letter?

First the title was suitably cryptic for pretentious sceptics:

Acupuncture and Smoking Cessation? One Swallow Doesn’t Make a Summer!

[2]

What does that mean exactly? Perhaps it is an acknowledgement of a positive trial for acupuncture, ie the one swallow. So one positive result does not mean it is really effective, ie it is really summer when you see one swallow. This seems to be an acknowledgement that it is indeed a positive result for acupuncture, yet the following text of the letter suggests something different.

Braillon and Ernst (B&E) make 5 points following the assertion:

The trial in question has numerous serious flaws.

[2]

B&E 1: The sample was too small for a meaningful assessment of therapeutic safety.[2]

MC response: The protocol involved needling limb points and scalp points so there was little risk of trauma to viscera – the most common of the serious adverse effects of acupuncture. We can gauge other risks from the huge survey performed in Germany as part of the Modellvorhaben Akupunktur.[3,4] The authors report 2 adverse events in both acupuncture and NRT groups. There is little more to add here except that the trial was not designed to assess safety, it was an non-inferiority trial.

B&E 2: Patients were not blinded and the repeated acupuncture sessions (twice per week for 8 weeks) provided extra attention, which is bound to affect the outcomes of the study.[2]

MC response: The active control group received exactly the same level of attention, yet acupuncture was significantly superior. Did you actually read the methods section EE?

B&E 3: Attrition rates were unacceptably high and showed pronounced group differences.[2]

MC response: Yes there were significantly more dropouts in the acupuncture group, but the primary outcome was an intention to treat analysis (ITT), and dropouts were all assumed to be smoking (ie not abstinant). Therefore a higher dropout rate is not an advantage to acupuncture in this trial.

B&E 4: The nicotine dose of 14-mg patches was too low; 21mg is the usual dose for this population, ideally combined with oral forms (both lozenges or spray). Using an underdosed comparator must inevitably produce a false-positive result for acupuncture.[2]

MC response: Oh dear I think you skimmed the methods section! The participants were given 21mg/d for 4 weeks if they smoked >20 cigarettes a day. The dose was then tapered, as you might do to wean someone off an addictive substance. Not unreasonable I think.

B&E 5: The authors claim they had no conflicts of interest, which does not tally with the fact that the trial was funded by the ‘Special Scientific Research Fund of Traditional Chinese Medicine Profession of China.’[2]

MC response: The following text is prominent under the title of the paper online and in pdf – on behalf of the Chinese Acupuncture for Tobacco Cessation Research Team. This affiliation is not hidden, and it is not necessarily a conflict of interest. The authors are unlikely to gain financially from acupuncture being used for smoking cessation. Do you imagine that academics writing papers of this quality spend their spare time performing acupuncture in smoking cessation clinics? I think not!

Well, should I write all this to the journal? It is a bit late now perhaps. But it nicely illustrates the sort of slapdash critical EBM (evidence-based medicine) approach. You don’t need to read the paper properly, you can fire out the same old lines… not big enough, not blinded, too many dropouts etc etc. I hope I have illustrated how a proper look at the paper dismisses all of this sloppy nonsense from characters like EE and co, who clearly do not actually read the papers they try to discredit.

References

1         Wang Y, Liu Z, Wu Y, et al. Efficacy of Acupuncture Is Noninferior to Nicotine Replacement Therapy for Tobacco Cessation: Results of a Prospective, Randomized, Active-Controlled Open-Label Trial. Chest 2018;153:680–8. doi:10.1016/j.chest.2017.11.015

2         Braillon A, Ernst E. Acupuncture and Smoking Cessation? One Swallow Doesn’t Make a Summer! Chest 2018;153:1516. doi:10.1016/j.chest.2017.12.029

3         Witt CM, Pach D, Brinkhaus B, et al. Safety of Acupuncture: Results of a Prospective Observational Study with 229,230 Patients and Introduction of a Medical Information and Consent Form. Forsch Komplementmed 2009;16:91–7. doi:10.1159/000209315

4         Cummings M. Modellvorhaben Akupunktur–a summary of the ART, ARC and GERAC trials. Acupunct Med 2009;27:26–30. doi:10.1136/aim.2008.000281


Declaration of interests MC