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

Abstract

Objectives:

A systematic review and meta analysis using the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) approach. The aim was to evaluate the efficacy of Botulinum Toxin type A for limb spasticity on improving activity restriction and quality of life outcomes.

Data sources:

Pubmed, Cinahl, Amed, Embase and Cochrane databases. English Language. Search to January 2015.

Review methods:

All randomized, placebo controlled trials on adults with active function or quality of life measures for the arm and leg relating to spasticity of any origin and treated with a single dose of Botulinum Toxin A. Evidence quality was assessed by GRADE.

Results:

Twenty-five studies were reviewed. Meta analysis was carried out on six upper limb and six lower limb studies. Evidence quality for the upper limb was low/very low. A significant result for Botulinum Toxin A was found at four to twelve weeks for the upper limb for active function (SMD 0.32 CI 0.01, 0.62, P=0.04) These effects were maintained for up to six months for Active Research Arm Test (ARAT) only (MD 1.87 CI 0.53, 3.21, P=0.006).

Evidence quality was very low for the lower limb. No significant effect was found. Meta analysis was not possible for quality of life measures.

Conclusion:

Botulinum Toxin A may improve active outcomes in the upper limb but further evidence is needed. No conclusion can be drawn about the effect on active outcomes for the lower limb or for quality of life measures in either limb.

Keywords

Botulinum toxin activity limitation quality of life systematic review

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References

GRADE working group. Grading quality of evidence and strength of recommendations. BMJ 2004; 328: 1490–1497.

Sheean

Lannin

Turner-Stokes

Rawicki

Snow

. Botulinum toxin assessment, intervention and after-care for upper limb hypertonicity in adults: international consensus statement. Eur J Neurol 2010; 17: 74–93.

Sheean

Botulinum treatment of spasticity: why is it so difficult to show a functional benefit?

Curr Opinion Neurol 2001; 14: 771–776.

Cardoso

Rodrigues

Lucena

. Botulinum toxin type A for the treatment of the upper limb spasticity after stroke- a meta analysis. Arq Neuropsiquiatr 2005; 63: 30–33.

Turner-Stokes

Fheodoroff

Jacinto

. Results from the Upper Limb International SpasticityStudy-II (ULIS-II): a large, international, prospective cohort study investigating practice and goal attainment following treatment with botulinum toxin A in real-life clinical management. BMJ Open 2013; 3: e002771.

Royal College of Physicians, British Society of Reha-bilitation Medicine, Chartered Society of Physiotherapy, Association of Chartered Physiotherapists Interested in Neurology. Spasticity in adults: management using botulinum toxin. National guidelines. London: RCP, 2009.

Baker

Pereira

. The efficacy of Botulinum toxin A for spasticity and pain: a systematic review and meta analysis using the Grades of Recommendation Assessment, Development and Evaluation approach. Clin Rehabil 2013; 27: 1084–1096.

Harbour

Miller

. A new system for grading recommendations in evidence based guidelines. BMJ 2001; 323: 334–336.

Guyatt

Oxman

Kunz

. GRADE guidelines:2. Framing the question and deciding on important outcomes. J Clin Epidemiol 2011; 64: 395–400.

10.

Guyatt

Oxman

Akl

. GRADE guidelines:1. Introduction-GRADE evidence profiles and summary of findings tables. J Clin Epidemiol 2011; 64: 383–394.

11.

Balshem

Helfand

Schunemann

. GRADE guidelines:3. Rating the quality of evidence. J Clin Epidemiol 2011; 64: 401–406.

12.

Guyatt

Oxman

Vist

. GRADE guidelines:4. Rating the quality of evidence-study limitations (risk of bias). J Clin Epidemiol 2011; 64: 407–415.

13.

Guyatt

Oxman

Montori

. GRADE guidelines: 5. Rating the quality of evidence- publication bias. J Clin Epidemiol 2011; 64: 1277–1282.

14.

Guyatt

Oxman

Kunz

. GRADE guidelines: 6. Rating the quality of evidence- imprecision. J Clin Epidemiol 2011; 64: 1283–1293.

15.

Guyatt

Oxman

Kunz

. GRADE guideline: 7. Rating the quality of evidence- inconsistency. J Clin Epidemiol 2011; 64: 1294–1302.

16.

Guyatt

Oxman

Kunz

. GRADE guidelines: 8. Rating the quality of evidence-indirectness. J Clin Epidemiol 2011; 64: 1303–1310.

17.

Guyatt

Oxman

Sultan

. GRADE guidelines: 9. Rating up the quality of evidence. J Clin Epidemiol 2011; 64: 1311–1316.

18.

GRADE working group. Available at; http://www.gradeworkinggroup.org/index.htm (accessed May 2012).

19.

Higgens

JPT

Green

(eds). Cochrane Handbook for systematic reviews of Interventions Version 5.1.0 (updated March 2011). The Cochrane Collaboration, 2011. Available at: www.cochrane-handbook.org.

20.

Cousins

Ward

Roffe

Rimington

. Does low dose botulinum toxin help the recovery of arm function when given early after stroke? A phase II randomised controlled pilot study to estimate effect size. Clin Rehabil 2010; 24: 501–513.

21.

Maanum

Jahnsen

Stanghelle

. Effects of botulinum toxin A in ambulant adults with spastic cerebral palsy: a randomised double blind placebo controlled trial. J Rehabil Med 2011; 43: 338–347.

22.

Wolf

Milton

Reiss

Easley

Shenvi

Clark

. Further assessment to determine the additive effect of Botulinum toxin type A on an upper extremity exercise program to enhance function among individuals with chronic stroke but extensor capability. Arch Phys Med Rehabil 2012; 93: 578–587.

23.

Ward

Wissel

Borg

. Functional Goal Achievement in post-stroke Spasticity patients: The BOTOX® Economic Spasticity Trial (BEST). J Rehabil Med 2014; 46: 504–513.

24.

Suputtitada

Suwanwela

. The lowest effective dose of Botulinum A Toxin in adult patients with upper limb spasticity. Disabil Rehabil 2005; 27: 176–184.

25.

Rodgers

Shaw

Price

. BoTULS trial: a randomised controlled trial to evaluate the clinical effect and cost effectiveness of treating upper limb spasticity due to stroke with botulinum toxin type A. Health Technol Assess 2010; 14: 1–141.

26.

McCrory

Turner-Stokes

Baguley

. Botulinum toxin A for treatment of upper limb spasticity following stroke: a multi centre randomised placebo controlled study of the effects on quality of life and other person-centred outcomes. J Rehabil Med 2009; 41: 536–544.

27.

Meythaler

Vogtle

Brunner

. A preliminary assessment of the benefits of the addition of botulinum toxin A to a conventional therapy program on the function of people with longstanding stroke. Arch Phys Med Rehabil 2009; 90: 1453–1461.

28.

Bakheit

AMO

Thilman

Ward

. A randomised, double-blind, placebo-controlled, dose-ranging study to compare the efficacy and safety of three doses of botulinum toxin Type A (Dysport) with placebo in upper limb spasticity after stroke. Stroke 2000; 31: 2402–2406.

29.

Bakheit

AMO

Pittock

Moore

. A randomized, double blind, placebo controlled study of the efficacy and safety of botulinum toxin type A in upper limb spasticity in patients with stroke. J Neurol 2001; 8: 559–565.

30.

Rosales

Kong

Goh

. Botulinum Toxin Injection for Hypertonicity of the upper extremity within 12 weeks after stroke: A randomised controlled trial. J Neurorehabil Neural Repair 2012; 26: 812–821.

31.

Smith

Ellis

White

. A double-blind, placebo-controlled study of botulinum toxin in upper limb spasticity after stroke or head injury. Clin Rehabil 2000; 14: 5–13.

32.

Bhakta

Cozens

Chamberlain

. Impact of botulinum toxin Type A on disability and carer burden due to arm spasticity after stroke: a randomised double blind placebo controlled trial. J Neurol Neurosurg Psychiatry 2000; 69: 217–221.

33.

Dunne

Gracies

J-M

Hayes

Zeman

Singer

. A prospective, multicenter, randomized, double-blind, placebo-controlled trial of onabotulinumtoxin A to treat plantarflexor/invertor overactivity after stroke Clin Rehabil 2012; 26: 787–797.

34.

Hyman

Barnes

Bhakta

. Botulinum toxin (Dysport) treatment of hip adductor spasticity in multiple sclerosis: a prospective, randomized, double blind, placebo controlled, dose ranging study. J Neurol Neurosurg Psychiatry 2000; 68: 707–712.

35.

Pittock

Moore

Hardiman

. A double blind randomized 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: 289–300.

36.

Jahangir

Tan

Norlinah

. Intramuscular injection of Botulinum Toxin for the treatment of wrist and finger spasticity after stroke. Med J Malaysia 2007; 62: 319–323.

37.

Kaji

Osako

Suyama

. Botulinum toxin type A in post stroke lower limb spasticity: a multicenter, double blind, placebo controlled trial. J Neurol 2010; 257: 1330–1337.

38.

Burbaud

Wiart

Dubos

. A randomised, double blind, placebo controlled trial of botulinum tocin in the treatment of spastic foot in hemiparetic patients. J Neurol Neurosurg Psychiatry 1996; 61: 265–269.

39.

Simpson

Gracies

Yablon

Barbano

Brashear

. Botulinum neurotoxin versus tizanidine in upper limb spasticity: a placebo controlled study. J Neurol Neurosurg Psychiatry 2009; 80: 380–385.

40.

Richardson

Sheean

Werring

. Evaluating the role of botulinum toxin in the management of focal hypertonia in adults. J Neurol Neurosurg Psychiatry 2000; 69: 499–506.

41.

Simpson

Alexander

O’Brien

. Botulinum toxin type A in the treatment of upper extremity spasticity: a randomised, double blind, placebo controlled trial. Neurology 1996; 46: 1306–1310.

42.

Marciniak

Harvey

Gagnon

. Does Boutlinum Toxin Type A decrease pain and lessen disability in hemiplegic survivors of stroke with shoulder pain and spasticity? Am J Phys Med Rehabil 2012; 91: 1007–1019.

43.

Hesse

Mach

Behrend

Werner

Melzer

. An early botulinum toxin A treatment in subacute stroke patients may prevent a disabling finger flexor stiffness six months later: a randomised controlled trial. Clin Rehabil 2011; 26: 239–245.

44.

Childers

Brashear

Jozefczyk

. Dose-dependent response to intramuscular botulinum toxin type A for upper limb spasticity in patients after stroke. Arch Phys Med Rehabil 2004; 85: 1063–1069.

45.

Cohen

. Statistical power analysis for the behavioural sciences (2^nd ed). New York: Academic Press, 1988.

46.

Edwards

. Physiotherapy management of established spasticity In: Sheean

(ed) Spasticity Rehabilitation. London: Churchill Communications Ltd, 1998.

47.

Carr

Shepherd

. Stroke Rehabilitation. London: Butterworth Heineman, 2003.

48.

Cohen

. Neuroscience for rehabilitation (2^nd ed) London: Lippincott Williams and Wilkins 1999.

49.

Slawek

Bogucki

Reclawowicz

. Botulinum Toxin type A for upper limb spasticity following stroke: an open label study with individualised, flexible injection regimes. Neurol Sci 2005; 26: 32–39.

50.

Cardoso

Pedreira

Prazeres

Ribeiro

Melo

. Does Botulinum Toxin improve the function of the patient with spasticity after stroke? Arq Neuropsiquiatr 2007; 65: 592–595.

51.

Sun

S-F

Hsu

C-W

Sun

H-P

Hwang

C-W

Yang

C-L

Wang

J-L

. Combined Botulinum Toxin Type A with modified constraint induced movement therapy for chronic stroke patients with upper extremity spastcity: a randomised controlled study Neurorehabil Neural Repair 2010; 24: 34–41.

52.

Bensmail

Robertson

Fermanian

Roby-Brami

. Botulinum Toxin to treat upper limb spasticity in hemiparetic patients: analysis of function and kinematics of reaching movements Neurorehabil Neural Repair 2010; 24: 273–281.

53.

Caty

G.D

Detrembleur

Bleyenheuft

Deltombe

Lejeune

. Effect of simultaneous Botulinum Toxin injections into several muscles on impairment, activity, participation and quality of life among stroke patients presenting with a stiff knee gait. Stroke 2008; 39: 2803–2808.

54.

Liberati

Altman

Tetzlaff

. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration. Ann Intern Med 2009; 151: W65–W94.

55.

Moore

. Botulinum toxin A (BoNT-A) for spasticity in adults. What is the evidence? Eur J Neurol 2002; 9: 42–47.

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