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ALA and Burning Mouth Syndrome

Burning Mouth Syndrome

There are no definitive therapies for BMS (50).. According to published data, ALA is reportedly one of the most effective drugs in the management of BMS. However, to date, there is no clear consensus  as many variables such as mood disorders appear to decrease effectiveness when co-existing with BMS (51).

Femiano et al. have published most of the studies that examine the efficacy of ALA in the management of BMS (22-26). They use a dose of 600 mgr/day with a follow up around 30 days in their studies, as our study. Their results have been quite effective for ALA in order to improve symptoms, very similar in general compared with our results. There are some differences to consider that we point below.

In their first study (52), they carried out an open trial of 42 patients to compare ALA treatment (600 mg/day) over placebo. In the study group, none of the patients worsened, similar to our study. 24% presented no changes and 76% reported some level of improvement. However, statistical analysis was not conducted, the sample size was small, and treatment duration was only one month.

Femiano and Scully (53) evaluated ALA at a dose of 600 mg/day in a 60-patient double-blind placebo controlled study. 97% of the patients reported some improvement with ALA, 3% showed no changes in symptomatology, and none of the patients reported worsening of symptoms. These results were statistically significant in favour of ALA. Similarly to our study, not a single patient treated with ALA worsened; but the results obtained with ALA (97% improvement) were higher than our own results. We must also highlight the important placebo effect obtained (40%).

In 2002, Femiano et al. (54) compared ALA with other products (Bethanechol 5mg/8 hours, Lactoperoxidase and 3% Xylitol). Administration of ALA showed statistically significant results.

Femiano et al. (55) in 2003 conducted an open trial of 192 patients divided into four groups: one undergoing cognitive therapy (CT), one treated with ALA (600mg/day), one combining CT and ALA, and one with placebo. The ALA group and the ALA + CT group showed statistically significant improvement compared to CT alone and the placebo group.

In 2004, Femiano et al. (56) studied the efficacy of ALA in patients treated with and without anxiolytics. Although the latter group displayed more significant results, these were not statistically significant. In 2011, López-D’Alessandro and Escovich verified the efficacy of ALA (600 mg/day) in conjunction with gamma-amino butyric acid (GABA) over placebo over a two-month period. The combination ALA + GABA proved to be the most effective according to patients’ perceptions (57).

Other authors have used ALA in higher concentrations. In 2008, Carbone et al. (58) conducted a 60-patient double-blind study to evaluate the efficacy of pure ALA 800 mg/day over ALA 800 mg/day supplemented with a vitamin complex, and in comparison with placebo. The 3 groups showed a reduction in symptoms, but with no statistical significance. López-Jornet et al. (59) used the same concentration of ALA over placebo and equally found that both groups improved, yet with no statistically significant differences.

Finally, Cavalcanti et al. (60), in their crossover trial comparing the efficacy of ALA (600mg/day) over placebo, found a reduction in symptoms in both groups. The rate of this reduction was higher in the first month than in the second month of treatment.

ALA appears to have benefits in the management of BMS, yet the results supporting its efficacy is inconclusive. Further studies, with a higher number of patients, are, therefore, needed.

Variables such as depression, long-term evolution and symptom intensity make it less likely for ALA patients to improve. This fact, together with the importance of the placebo effect, suggests the need to assess the psychological and/or psychiatric implications that may require multidisciplinary treatments.

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