Umezaki 2016.
Methods | Single‐centre, placebo‐controlled, single‐blinded parallel RCT |
Participants | 26 BMS patients
Mean age 63.9 years (SD 9.56) Sex: 24F:2M (F92%:M8%) Inclusion/exclusion and diagnostic criteria appropriate |
Interventions |
Intervention category: Electromagnetic radiation Group 1: (n = 14) High‐frequency transcranial magnetic stimulation (TMS): 10 daily sessions (1 session p/day for 5 days, 2 days untreated and then a further 5 days of 1 session p/day) totalling 30,000 single‐pulse stimulations at 10 Hz (MagVenture MagPro x100 Stimulator ‐ MagVenture Inc., Denmark; Cool‐B65 A/P figure 8 coil, positioned over left dorsolateral prefrontal cortex (DLPFC) at medial frontal 10‐20 system EEG‐electrode location (F3); unconnected ECT electrodes placed under coil ‐ Natus Neurology, Middleton, Wisconsin) Group 2: (n = 12) Placebo: 10 daily sessions (1 session p/day for 5 days, 2 days untreated and then a further 5 days of 1 session p/day) totalling 30,000 single‐pulse stimulations (MagVenture MagPro x100 Stimulator ‐ MagVenture Inc., Denmark; shielded Cool‐B65 A/P figure 8 coil, positioned over left DLPFC at location F3; connected ECT electrodes placed under coil to stimulate when TMS was triggered ‐ Natus Neurology, Middleton, Wisconsin) Duration: 2 months |
Outcomes |
Outcomes not of interest to this review
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Source of funding | Not reported |
Notes | No numbers (tables 1‐3), means or SDs (text and figures 2‐3) associated with the study's results were available in the published study paper. Until this information is obtained we are unable to incorporate this study within our analyses Quotation: "SSRIs were prescribed for around 40% of the patients, but these did not adequately relieve the BMS pain. Although 30% of the patients had a prior history of depression, none currently met diagnostic criteria for depression" Comment: Unclear if SSRIs were prescribed before the trial commenced, or during the trial as a co‐intervention SES: Not reported Conflict of interests: Not reported Data analysis: Per‐protocol (according to Figure 1). 6 participants did not complete the assigned intervention duration due to competing commitments which allowed them to attend only 2 sessions (of 10 scheduled) each. Group 1: 2 patients abandoned study; Group 2: 4 patients left study |
BMS = burning mouth syndrome; F = female; M = male; QoL = quality of life; RCT = randomised controlled trial; SD = standard deviation; SES = socioeconomic status; SSRIs = selective serotonin reuptake inhibitors; VAS = visual analogue scale.