Stimulated by Sato et al 2026.[1]
BMS – burning mouth syndrome
RCT – randomised controlled trial
IF – impact factor
ACUSAR – acupuncture for seasonal allergic rhinitis
ARC – acupuncture in routine care (part of the Modellvorhaben Akupunktur)
BDI-II – Beck Depression Inventory II
VAS – visual analogue scale
ANOVA – analysis of variance– key to acronyms
This is the first RCT of acupuncture in burning mouth syndrome (BMS) that I am aware of… I guess it is the first in the English language anyway. It is a small parallel-arm sham controlled trial (n=40) based in Germany and published in the European Archives of Oto-Rhino-Laryngology (IF 2.2). I do not recall coming across this journal before, so I thought I would investigate and was astounded to read on the journal website that it was first published in the 19th century – 1864 to be precise. The journal was published in German (principally) for over a century before changing to English-only in 1990 (presumably to comply with contemporary biomedical publishing norms).
The lead author of this paper is from Tokyo, so presumably he was attached to the University Hospital of Dresden, where the study took place for a research degree or sabbatical. The patients were recruited from the ENT department between 2013 and 2016 (so it has taken a while to get this study reported – I have emailed the corresponding author to ask why).
The acupuncture involved 10 sessions of 30 minutes performed once or twice a week. The protocol involved 1 midline point (CV23) and 10 bilateral points – 3 in the ear, 4 in the arm (LI11, HT7, SI3, HT9), 2 in the leg (ST36, LR3), and 1 on the back (BL17).
The ‘Very Point’ technique popularised by Jochen Gleditsch (JG) was used to find the points, although it is not clear whether this applied to all the points or only the ear points. It would have been quite time-consuming to use the technique for every point. JG was a fan of ear acupuncture and the ‘Very Point’ technique involves finding very precise reactive points through tenderness and a reflex vascular signal. The latter was first described by Paul Nogier – a 20th century French physician widely credited as the father of modern auriculotherapy.
The sham was a penetrating off-point version, rather like the shams used in the Modellvorhaben Akupunktur. The points were copied from the ACUSAR study,[2,3] which itself followed the ARC study on allergic rhinitis (which was part of the Modellvorhaben Akupunktur).[4] The report does not detail the sham needling but the protocol of the ACUSAR study advises the use of short fine needles (20mm or less) and subcutaneous insertion with no stimulation of de qi (typical needling sensation in deep soma).[2]
There was no primary outcome identified in the trial and 8 different outcomes were listed. These were (in order of listing) the Beck Depression Inventory II (BDI-II), the Zerssen mood scale questionnaire, VAS of burning mouth and tongue pain (morning, noon, and evening), psychophysical olfactory testing (using Sniffin’ Sticks for odour recognition), taste test (using taste sprays and taste strips), electrogustometry (a form of electrical threshold testing for the tongue – front and back), salivary pH, and salivary quantification (by weighing dental rolls after 5 minutes in the mouth).
The VAS of burning mouth pain reduced from a baseline mean of just over 4 to 2.4 in the verum acupuncture group. The sham group mean stayed just over 4. This difference was significant (repeated measures ANOVA p=0.001). Time of day did not influence the result (the change with acupuncture treatment), but symptoms were significantly worse in the evening (p<0.001).
There were trends suggesting changes in some of the other outcome measures (including the BDI-II), but these did not make it to between group differences with statistical significance. Remember there were only 20 patients in each arm of the trial, which runs the risk of type II statistical errors for any outcomes with wide distributions, not to mention trials with needling in both arms.
They were probably lucky to get a significant result in VAS burning mouth pain considering the small groups and the penetrating sham. I wonder to what degree CV23 played a role in that difference. I would have liked to see a few more points close to the mouth (ST7, ST6) or in the segments for the head and neck (GB20, GB21), but the ear points may have played a positive role here as well.
Addendum
The lead author (Hitomi Sato) replied just after I had posted this blog. Concerning the late publication, he explained that he just did not have time to prepare the manuscript earlier than this… He must be a busy chap! He also confirmed that the JG technique was used in finding all points, but they used tenderness alone rather than the patient’s pulse. I can confirm that this was the method I had seen demonstrated by Dominik Irnich some years ago too.
References
1 Sato H, Gunkel K, Tödtmann N, et al. Efficacy of acupuncture in burning mouth syndrome: A placebo-controlled trial. Eur Arch Otorhinolaryngol. Published Online First: 21 January 2026. doi: 10.1007/s00405-025-10001-1
2 Brinkhaus B, Witt CM, Ortiz M, et al. Acupuncture in seasonal allergic rhinitis (ACUSAR)–design and protocol of a randomised controlled multi-centre trial. Forsch Komplementarmed. 2010;17:95–102. doi: 10.1159/000303012
3 Brinkhaus B, Ortiz M, Witt CM, et al. Acupuncture in Patients With Seasonal Allergic Rhinitis. Ann Intern Med. 2013;158:225. doi: 10.7326/0003-4819-158-4-201302190-00002
4 Witt CM, Reinhold T, Jena S, et al. Cost-effectiveness of acupuncture in women and men with allergic rhinitis: a randomized controlled study in usual care. Am J Epidemiol. 2009;169:562–71. doi: 10.1093/aje/kwn370
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