Management of patients with functional neurological symptoms: a single-centre randomised controlled trial

Pleizier, Marc; Haan, Rob J. de; Vermeulen, M.

doi:10.1136/jnnp-2015-312889

Cited by 6 publications

(7 citation statements)

References 18 publications

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“…The amount of patients included was the result screening of a large number of eligible patients (48 (20%) of 239 patients screened). This is in line with other studies of FNS,20 22 23 but questions the generalisability of the results to all jerky and tremulous FMD patients. However, of the 109 excluded patients the reason was clinically relevant as in almost half of them symptoms diminished severely or resolved, in about a quarter the symptoms were not amendable for injections, and of the remaining quarter there were other reasons including a non-functional disorder.…”

Section: Resultssupporting

confidence: 91%

“…Although we assumed the placebo effect to be larger than in a similar trial in writer’s cramp,13 we didn’t anticipate the placebo effect to be this large (57%) as most patients had long-lasting symptoms and have had several other treatments before. Other randomised treatment studies in FNS are scarce and concern physiotherapy,20 rehabilitation,21 disease education,22 23 psychotherapy24 and transcranial magnetic stimulation (TMS) 25. Most are not placebo-controlled and the majority reveals significant and clinically relevant improvement in a large proportion of patients (30%–70%).…”

Section: Resultsmentioning

confidence: 99%

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Botulinum neurotoxin treatment in jerky and tremulous functional movement disorders: a double-blind, randomised placebo-controlled trial with an open-label extension

Dreissen

Dijk

Gelauff

et al. 2019

J Neurol Neurosurg Psychiatry

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ObjectiveTo study the effect of botulinum neurotoxin (BoNT) treatment in jerky and tremulous functional movement disorders (FMD).MethodsPatients with invalidating, chronic (>1 year) symptoms were randomly assigned to two subsequent treatments with BoNT or placebo every 3 months with stratification according to symptom localisation. Improvement on the dichotomised Clinical Global Impression-Improvement scale (CGI-I) (improvement vs no change or worsening) at 4 months, assessed by investigators blinded to the allocated treatment was the primary outcome. Subsequently all patients were treated with BoNT in a ten month open-label phase.ResultsBetween January 2011 and February 2015 a total of 239 patients were screened for eligibility of whom 48 patients were included. No difference was found on the primary outcome (BoNT 16 of 25 (64.0%) vs Placebo 13 of 23 patients (56.5%); proportional difference 0.075 (95% CI −0.189 to 0.327; p=0.77). Secondary outcomes (symptom severity, disease burden, disability, quality of life and psychiatric symptoms) showed no between-group differences. The open-label phase showed improvement on the CGI-I in 19/43 (44.2%) of remaining patients, with a total of 35/43 (81.4%) improvement compared with baseline.ConclusionsIn this double-blind randomised controlled trial of BoNT for chronic jerky and tremulous FMD, we found no evidence of improved outcomes compared with placebo. Motor symptoms improved in a large proportion in both groups which was sustained in the open-label phase. This study underlines the substantial potential of chronic jerky and tremulous FMD patients to recover and may stimulate further exploration of placebo-therapies in these patients.Trial registration numberNTR2478

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Section: Resultssupporting

confidence: 91%

Section: Resultsmentioning

confidence: 99%

Botulinum neurotoxin treatment in jerky and tremulous functional movement disorders: a double-blind, randomised placebo-controlled trial with an open-label extension

Dreissen

Dijk

Gelauff

et al. 2019

J Neurol Neurosurg Psychiatry

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“…Since there were no differences between treatment arms with regard to participants' baseline characteristics at entry of the study, the use of psychotherapy and a wide range of primary and secondary outcomes at 12 months [3], we combined the two treatment arms for this analysis.…”

Section: Discussionmentioning

confidence: 99%

“…The participants of this study had been included between 2009 and 2013 in a single centre randomised controlled trial at the outpatient department of neurology of the Academic Medical Center (AMC), Amsterdam, the Netherlands [3]. The ethics committee of the AMC approved the study.…”

Section: Participants and Settingmentioning

confidence: 99%

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Favourable outcome without psychotherapy in patients with functional neurologic disorder

Vermeulen¹,

Haan

2020

Journal of Clinical Neuroscience

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Objective: To investigate whether patients with functional neurologic disorder (FND) may improve without psychotherapy as was suggested by a retrospective study. Methods: We prospectively studied patients with newly diagnosed FND. At baseline and at 12 months participants filled out a set of self-reported health questionnaires. During the one-year follow up we recorded the use of psychotherapy. Results: The study group consisted of 193 included participants. After 12 months 60 participants (60/193 = 31.1%) perceived a favourable outcome. Sixty participants (60/191 = 31.4%) were referred for psychotherapy. Multivariable logistic regression showed that participants with a high level of somatisation were less likely to have a favourable outcome (adjusted OR = 0.55; 95% CI: 0.29 to 1.04; p = 0.07). We could not demonstrate an independent significant impact of the use of psychotherapy on favourable outcome (adjusted OR = 0.65; 95% CI: 0.33 to 1.30; p = 0.22). Conclusion:Our study confirms the results of the retrospective study. The association between a high level of somatisation and a less favourable outcome suggests that neurologists should pay more attention to symptoms other than the neurological, but this does not necessarily mean referral for a psychological intervention.

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Psychosocial interventions for conversion and dissociative disorders in adults

Ganslev

Storebø

Callesen

et al. 2020

Cochrane Database of Systematic Reviews

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Management of patients with functional neurological symptoms: a single-centre randomised controlled trial

Abstract: NTR 2570.

Cited by 6 publications

References 18 publications

Botulinum neurotoxin treatment in jerky and tremulous functional movement disorders: a double-blind, randomised placebo-controlled trial with an open-label extension

Botulinum neurotoxin treatment in jerky and tremulous functional movement disorders: a double-blind, randomised placebo-controlled trial with an open-label extension

Favourable outcome without psychotherapy in patients with functional neurologic disorder

Psychosocial interventions for conversion and dissociative disorders in adults

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