Umezaki 2016

Methods	Parallel RCT
Participants	Country of study: USA Setting: not reported Condition: burning mouth syndrome Prior management details: not reported n = 26 Age mean (SD): active group 63.36 (10.78) years, sham group 64.42 (8.35) years Duration of symptoms, mean (SD): active group 61.57 (32.10) months, sham group 65.58 (55.52) Gender distribution: active group 93% F, sham group 92% F
Interventions	Stimulation type: rTMS Stimulation parameters: frequency 10 Hz; coil orientation not specified, 100% RMT, number of trains 10; duration of trains 5 s; ITI 10 s; total number of pulses 3000 Stimulation location: L DLPFC Number of treatments: 10 x 1 daily on work days Control type: sham coil ‐ same sound and appearance and sensory cues
Outcomes	Primary: pain NRS anchors 0 = no pain, 10 = extreme amount When taken: end of stimulation and 15, 30, 60 days after start of treatment Secondary: AEs
Notes	Funding source: no information provided COI: no information provided
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: “Patients who met all inclusion criteria were randomly assigned to one of two groups – one given active and the other sham stimulation – using a web‐based randomization generator”
Allocation concealment (selection bias)	Unclear risk	Comment: allocation concealment procedures not reported
Adequate blinding of participants?	Low risk	Comment: sham controls for all aspects of stimulation Quote: “The coil used in the sham group was the same configuration as that used with the real group but shielded so that actual stimulation does not occur. All subjects had ECT electrodes placed under the TMS coil. For those receiving active TMS, the electrodes were disconnected, such that there was no current flowing through during stimulation. In contrast, the electrodes were connected during sham, so participants received a small electrical stimulation through the electrodes, precisely when the TMS was being triggered.” “Ten of 12 (83%) patients in the real group and 4 of 8 (50%) patients in the sham group thought that they were in the real group. There was no significant difference for the belief of the allocated group between two groups (χ2 = 2.54,1, NS), suggesting that blinding for the subjects in this study was kept. The high percentage of correct guessing in the active group is concerning. However, when asked why they guessed the way they did, it was based on whether they had BMS symptom reduction. If this occurred, then they guessed the active group. There were no instances of patient unblinding.”
Adequate blinding of assessors?	High risk	Comment: assessor was not blinded to group allocation
Incomplete outcome data (attrition bias) All outcomes	High risk	Comment: 2/14 (14%) randomised did not receive active stim, 4/12 (33%) randomised to sham did not receive sham. Excluded from the analysis
Selective reporting (reporting bias)	High risk	Comment: pain intensity data only presented in graphical form without numeric point estimates/precision estimates
Study Size	High risk	Comment: combined n = 26 (per protocol = 20)
Study duration	Unclear risk	Comment: 7‐week follow‐up
Other bias	Low risk	Comment: no other risks of bias detected