A systematic review: efficacy of botulinum toxin in walking and quality of life in post-stroke lower limb spasticity

Anupam Datta Gupta, Wing Hong Chu, Stuart Howell, Subhojit Chakraborty, Simon Koblar, Renuka Visvanathan, Ian Cameron, David Wilson, Anupam Datta Gupta, Wing Hong Chu, Stuart Howell, Subhojit Chakraborty, Simon Koblar, Renuka Visvanathan, Ian Cameron, David Wilson

Abstract

Background: Improved walking is one of the highest priorities in people living with stroke. Post-stroke lower limb spasticity (PSLLS) impedes walking and quality of life (QOL). The understanding of the evidence of improved walking and QOL following botulinum toxin (BoNTA) injection is not clear. We performed a systematic review of the randomized control trials (RCT) to evaluate the effectiveness of BoNTA injection on walking and QOL in PSLLS.

Methods: We searched PubMed, Web of Science, Embase, CINAHL, ProQuest Thesis and Dissertation checks, Google Scholar, WHO International Clinical Trial Registry Platform, ClinicalTrials.gov , Cochrane, and ANZ and EU Clinical Trials Register for RCTs looking at improvement in walking and QOL following injection of BoNTA in PSLLS. The original search was carried out prior to 16 September 2015. We conducted an additional verifying search on CINHAL, EMBASE, and MEDLINE (via PubMed) from 16 September 2015 to 6 June 2017 using the same clauses as the previous search. Methodological quality of the individual studies was critically appraised using Joanna Briggs Institute's instrument. Only placebo-controlled RCTs looking at improvement in walking and QOL were included in the review.

Results: Of 2026 records, we found 107 full-text records. Amongst them, we found five RCTs qualifying our criteria. No new trials were found from the verifying search. Two independent reviewers assessed methodological validity prior to inclusion in the review using Joanna Briggs Institute's appraisal instrument. Two studies reported significant improvement in gait velocity (p = 0.020) and < 0.05, respectively. One study showed significant improvement in 2-min-walking distance (p < 0.05). QOL was recorded in one study without any significant improvement. Meta-analysis of reviewed studies could not be performed because of different methods of assessing walking ability, small sample size with large confidence interval and issues such as lack of power calculations in some studies. Findings from our systematic and detailed study identify the need for a well-designed RCT to adequately investigate the issues highlighted.

Conclusions: This review could not conclude there was sufficient evidence to support or refute improvement on walking or QOL following BoNTA injection. Reasons for this are discussed, and methods for future RCTs are developed.

Keywords: Botulinum toxin; Lower limb; Spasticity; Stroke.

Conflict of interest statement

Ethics approval and consent to participate

Not applicable.

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Not applicable.

Competing interests

The authors declare that they have no competing interests.

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Figures

Fig. 1
Fig. 1
PRISMA flow diagram

References

    1. Bonita R, Mendis S, Truelsen T, Bogousslavsky, Toole James, Yatsu Frank. The global stroke initiative. Lancet Neurol. 2004;3(7):391–393.
    1. Wissel J, Manack A, Brainin M. Toward an epidemiology of post stroke spasticity. Neurology. 2013;80(3):S13–S19. doi: 10.1212/WNL.0b013e3182762448.
    1. Zorowitz RD, Gillard PJ, Brainin M. Post stroke spasticity. Neurology. 2013;80(Suppl 2):S45–S52. doi: 10.1212/WNL.0b013e3182764c86.
    1. Stinear C. Prediction of recovery of motor function after stroke. Lancet Neurol. 2010;9(12):1228–1232. doi: 10.1016/S1474-4422(10)70247-7.
    1. Shaw L, Rodgers H. Botulinum toxin type A for upper limb spasticity after stroke. Expert Rev Neurother. 2009;9(12):1715–1725. doi: 10.1586/ern.09.121.
    1. Barnes MP. Management of spasticity. Age Ageing. 1998;27(2):239–245. doi: 10.1093/ageing/27.2.239.
    1. Intercollegiate Stroke Working Party . National clinical guideline for stroke. London: Royal College of Physicians; 2008.
    1. Elia AE, Filippini G, Calandrella D, Albanese MD. Botulinum neurotoxins for post stroke spasticity in adults: a systematic review. Mov Disord. 2009;24(6):801–812. doi: 10.1002/mds.22452.
    1. Rosales RL, Chua-Yap AS. Evidence-based systematic review on the efficacy and safety of botulinum toxin-A therapy in post-stroke spasticity. J Neural Trans. 2008;115:617–623. doi: 10.1007/s00702-007-0869-3.
    1. Lukban MB, Rosales RL. Effectiveness of botulinum toxin A for upper and lower limb spasticity in children with cerebral palsy: a summary of the evidence. J Neural Transm. 2009;116:319–331. doi: 10.1007/s00702-008-0175-8.
    1. Anderson P. FDA approves botox for lower limb spasticity. 2016. . Accessed 29 Nov 2017.
    1. Dashtipour K, Chen JJ, Walker HW, Lee MY. Systematic literature review of abobotulinum toxin a in clinical trials for lower limb spasticity. Medicine. 2016;95:1–13. doi: 10.1097/MD.0000000000002468.
    1. Portelli R, Lowe D, Irwin P, Pearson M, Rudd AG. Intercollegiate stroke working party. Institutionalization after stroke. Clin Rehabil. 2005;19(1):97–108. doi: 10.1191/0269215505cr822oa.
    1. Wade DT, Skilbeck CE, Wood VA, Langton Hewer R. Long-term survival after stroke. Age Ageing. 1984;13(2):76–82. doi: 10.1093/ageing/13.2.76.
    1. Newman AB, Simonsick EM, Naydeck BL, et al. Association of long-distance corridor walk performance with mortality, cardiovascular disease, mobility limitation, and disability. JAMA. 2006;295(17):2018–2016. doi: 10.1001/jama.295.17.2018.
    1. Bohannon RW, Andrews AW, Smith MB. Rehabilitation goals of patients with hemiplegia. Int J Rehabil Res. 1988;11(2):181–183. doi: 10.1097/00004356-198806000-00012.
    1. Esquenazi A. The human and economic burden of post stroke spasticity and muscle overactivity. J Clin Outcomes Management. 2011;18:607–614.
    1. Chu WH, Gupta AD. Effectiveness of botulinum toxin type A on gait and quality of life in adult post-stroke patients with lower limb spasticity: a systematic review protocol. JBI Database System Rev Implement Rep. 2016;14(6):23–29. doi: 10.11124/JBISRIR-2016-002472.
    1. Peters M, Godfrey CM, McInerney P, Soares C, Khalil H, Parker D. The Joanna Briggs Institute Reviewers' Manual 2015. Methodology for JBI Scoping Reviews. Adelaide: Joanna Briggs Institute; 2015. p. 9–10.
    1. Tao W, Yan D, Li JH, Shi ZH. Gait improvement by low-dose botulinum toxin A injection treatment of the lower limbs in subacute stroke patients. J Phys Ther Sci. 2015;27(3):759–762. doi: 10.1589/jpts.27.759.
    1. Johnson CA, Burridge JH, Strike PW, Wood DE, Swain ID. The effect of combined use of botulinum toxin type A and functional electric stimulation in the treatment of spastic drop foot after stroke: a preliminary investigation. Arch Phys Med Rehabil. 2004;85(6):902–909. doi: 10.1016/j.apmr.2003.08.081.
    1. Kaji R, Osako Y, Suyama K, Maeda T, Uechi Y, Iwasaki M. Botulinum toxin type A in PSLLS: a multicenter, double-blind, placebo-controlled trial. J Neurol. 2010;257(8):1330–1337. doi: 10.1007/s00415-010-5526-3.
    1. Pittock SJ, Moore AP, Hardiman O, Ehler E, Kovac M, Bojakowski J, Al Khawaja I, Brozman M, Kanovsky P, Skorometz A, Slawek J, Reichel G, Stenner A, Timerbaeva S, Stelmasiak Z, Zifko UA, Bhakta B, Coxon EA. Double-blind randomised placebo-controlled evaluation of three doses of botulinum toxin type A (Dysport) in the treatment of spastic equinovarus deformity after stroke. Cerebrovasc Dis. 2003;15(4):289–300. doi: 10.1159/000069495.
    1. Burbaud P, Wiart L, Dubos JL, Gaujard E, Debelleix X, Joseph PA, Mazaux JM, Bioulac B, Barat M, Lagueny A. A randomised, double blind, placebo controlled trial of botulinum toxin in the treatment of spastic foot in hemiparetic patients. J Neurol Neurosurg Psychiatry. 1996;61(3):265–269. doi: 10.1136/jnnp.61.3.265.
    1. Begley CG, Ellis LM. Drug development: raise standards for preclinical cancer research. Nature. 2012;483:531–533. doi: 10.1038/483531a.
    1. Kaku M, Simpson DM. Spotlight on outline toxin (BONT) is proven safe and effective in the treatment of focal post-stroke spasticity. Drug Des Devel Ther. 2016;10:1085–1099. doi: 10.2147/DDDT.S80804.
    1. World Health Organization. The International Classification of Functioning, Disability and Health-ICF. Geneva: WHO; 2001.
    1. Singer JC, Nishihara K, Mochizuki G. Does poststroke lower-limb spasticity influence the recovery of standing balance control? A 2-year multilevel growth model. Neurorhabil Neural Repair. 2016;30(7):626–634. doi: 10.1177/1545968315613862.
    1. Eng J, Tang PF. Gait training strategies to optimize walking ability in people with stroke: a synthesis of the evidence. Expert Rev Neurother. 2007;7(10):1417–1436. doi: 10.1586/14737175.7.10.1417.
    1. Foley N, Murie-Fernandez M, Speechley M, Salter K, Sequeira K, Teasell R. Does the treatment of spastic equinovarus deformity following stroke with botulinum toxin increase gait velocity? A systematic review and meta-analysis. Eur J Neurol. 2010;17(12):1419–1427. doi: 10.1111/j.1468-1331.2010.03084.x.
    1. Baker JA, Pereira G. The efficacy of botulinum toxin A for limb spasticity on improving activity restriction and quality of life: a systematic review and meta-analysis using the GRADE approach. Clin Rehabil. 2016;30(6):549–558. doi: 10.1177/0269215515593609.
    1. Wu T, Hua Li J, Song HX, Dong Y. Effectiveness of botulinum toxin for lower limbs spasticity and stroke: a systematic review and meta-analysis. Top Stroke Rehabil. 2016;23(3):217–223. doi: 10.1080/10749357.2016.1139294.
    1. Olver J, Esquenazi A, Fung VS, Singer BJ, Ward AB. Botox assessment intervention and after care for lower limb disorders of movement and muscle tone in adults: international consensus statement. Eur J Neurol. 2010;17(Suppl 2):57–73. doi: 10.1111/j.1468-1331.2010.03128.x.
    1. . Accessed 7 Dec 2017.

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