Botulinum toxin in the treatment of orofacial tardive dyskinesia: A single blind study

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Abstract

Objective

Orofacial tardive dyskinesia (OTD) is difficult to treat and Botulinium Toxin A (BTA) may be an option.

Methods

In a single blind (raters were blind) study (N = 12, duration 33 weeks) OTD was treated with Botulinum Toxin A in three consecutive sessions with increasing dosages. The severity was measured with the Abnormal Involuntary Movement Scale (AIMS).

Results

Overall there was a non-significant reduction in the severity of OTD (p = 0.15). However, in the patients with no change in their antipsychotic medication (N = 8) the reduction was significant (p = 0.035). After the study, 50% of the patients preferred to continue the Botulinum Toxin A treatment.

Conclusion

BTA was well tolerated and showed a non-significant improvement for OTD. A larger double blind study is warranted.

Introduction

Tardive dyskinesia (TD) is a serious, potentially irreversible side effect and its average prevalence in patients on long term antipsychotic treatment with first generation antipsychotics can be estimated around 30% (Jankovic, 1995). Most frequent is the orofacial form of tardive dyskinesia (OTD), accounting for approximately 80% of TD cases (Rapaport et al., 2000). OTD may cause physical problems such as disturbances in speech articulation and eating. It often leads to psychological distress. There are only a few albeit restricted approaches to treat TD, such as L-dopa, tiapride, vitamin E (Soares and McGrath, 1999). The efficacy of Botulinum Toxin A (BTA) in dystonia is well established (Costa et al., 2005a, Costa et al., 2005b). Based on several case reports and one open clinical trial, BTA may also be effective in the treatment of OTD (Rapaport et al., 2000, Truong et al., 1990, Yasufuku-Takano et al., 1995, Van Harten and Hovestadt, 2006). Therefore, we conducted a single blind study to evaluate the hypothesis that botulinum toxin can reduce the severity of OTD.

Section snippets

Methods

Clinicians treating chronically mentally ill patients at the Parnassia Psychiatric Institute in The Hague were asked to refer patients with orofacial tardive dyskinesia for the study.

Results

Of the 15 patients referred to the study, 12 (8 males and 4 females) with a mean age of 51 years (S.D. 8.8 and range 34–60 years) fulfilled the inclusion criteria. Table 1 shows demographic and clinical data. Diagnostically eight patients had schizophrenia, one schizoaffective disorder, one bipolar disorder, one an organic psychosyndrome and one mental retardation. The mean total dosage of the third treatment session was 72.8 Mu (range 40–80). The inter-rate reliability of the 2 blind raters of

Discussion

This first single blind study of Botulinium Toxin A as a treatment for orofacial tardive dyskinesia showed a non-significant tendency for improvement in the group as a whole. Given the long duration of the study (> 8 months) and the severity of the population, psychotic relapses were likely to happen, prompting inevitable adjustments of the psychotropic medication. As changing antipsychotic dosage may have influenced TD severity, this could have biased the effect of the BTA in four patients.

Conclusion

In conclusion, BTA was well tolerated, whereas the results of its efficacy on OTD were inconclusive. However, given the severity of TD as a clinical problem and the scarcity of efficacious treatments available to date, the therapeutic potential of BTA should be further explored, adequately dosed in a double blind placebo-controlled study design.

Acknowledgments

This study was supported by the Stichting tot Steun VCVGZ, Arnhem, the Netherlands.

The BTA ampules were purchased from Ipsen, Porton, United Kingdom.

The results of this study were presented in part at the Schizophrenia Winter Workshop at Davos, February 2006.

We would like to thank Majid Aramideh, Huib Burger, Tonko Hoffman, Hans Oolders and Cokky van der Venne for their clinical and statistical support.

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