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. 2016 Nov 18;2016(11):CD002779. doi: 10.1002/14651858.CD002779.pub3

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
  • Pain intensity at baseline, daily during days 1‐14, follow‐up at day 15, 1 month and 2 months (assessed by VAS)

  • Functional impairment at baseline, days 8 and 15, 1 month and 2 months (assessed by Short Form McGill Pain Questionnaire (SFMPQ); Brief Pain Inventory (BPI); Patient Health Questionnaire (PHQ‐9); Patients' Global Impression of Change (PGIC); Clinical Global Impression for global improvement scale (CGI‐I))

  • Adverse effects


Outcomes not of interest to this review
  • Patients' assumed treatment group (TMS or placebo; assessed at end of treatment)

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.