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Lack of efficacy of alpha‐lipoic acid in burning mouth syndrome: A double‐blind, randomized, placebo‐controlled study
Author(s) -
Carbone Mario,
Pentenero Monica,
Carrozzo Marco,
Ippolito Alessio,
Gandolfo Sergio
Publication year - 2009
Publication title -
european journal of pain
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.305
H-Index - 109
eISSN - 1532-2149
pISSN - 1090-3801
DOI - 10.1016/j.ejpain.2008.06.004
Subject(s) - medicine , placebo , visual analogue scale , burning mouth syndrome , randomized controlled trial , mcgill pain questionnaire , placebo controlled study , double blind , anesthesia , physical therapy , alternative medicine , pathology
Background : A systematic review from the Cochrane Collaboration stated that alpha‐lipoic acid (ALA) may help in the management of burning mouth syndrome (BMS). Because all of the data on ALA came from a single group, it has been stressed that its effectiveness should be reproduced in other populations. Aim : A double‐blind, randomized, placebo‐controlled study, including two test groups (Group A and Group B) and one control group (Group C), was carried out to evaluate the efficacy of systemic ALA (400mg) and ALA (400mg) plus vitamins in the treatment of BMS. Methods : Sixty‐six patients (54 females and 12 males) were included in an 8‐week trial. Symptoms were evaluated by using a visual analogue scale (VAS) and the McGill Pain Questionnaire (MPQ) at 0, 2, 4, 8 and 16 weeks. Results : Fifty‐two patients (43 females and 9 males, aged 67.3±11.9 years) completed the study. All three groups had significant reductions in the VAS score and in the mixed affective/evaluative subscale of the MPQ; the responders’ rate (at least 50% improvement in the VAS score) was about 30%. No significant differences were observed among the groups either in the response rate or in the mean latency of the therapeutic effect. Conclusions : The fairly high placebo effect observed is very similar to data obtained from patients affected by atypical facial pain. This study failed to support a role for ALA in the treatment of BMS, and further investigations are needed to identify the cause of BMS in order to develop efficacious therapies.