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Practice Parameter: Neuroprotective Strategies and Alternative Therapies for Parkinson’s Disease (An Evidence-Based Review)

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Title: Practice Parameter: Neuroprotective Strategies and Alternative Therapies for Parkinson’s Disease (An Evidence-Based Review)


1
Practice Parameter Neuroprotective Strategies
and Alternative Therapies for Parkinsons
Disease (An Evidence-Based Review)
  • American Academy of Neurology
  • Quality Standard Subcommittee
  • O. Suchowersky, MD G. Gronseth, MD J.
    Perlmutter, MD S. Reich, MD T. Zesiewicz, MD
    W.J. Weiner, MD

2
Presentation Objectives
  • To define key issues in the management of
    Parkinsons disease (PD) relating to
    neuroprotective strategies and alternative
    treatments
  • To make evidence-based recommendations

3
Overview
  • Background and epidemiology
  • Gaps in PD care
  • AAN guideline process
  • Neuroprotective strategies
  • Alternative treatments
  • Summary
  • Recommendations for future research

4
Background
  • PD a neurodegenerative disorder
  • Classic symptoms
  • Bradykinesia
  • Rigidity
  • Rest tremor
  • Strategies to delay onset or slow progression
    important considerations in overall treatment

5
Descriptive Epidemiology of Parkinson
Syndrome
  • Incidence 13/100,000
  • (Van Den Eeden et al. Am J Epidemiol
    20031015-22)
  • Prevalence
  • 300/100,000 (Strickland Bertoni, 2004)
  • Prevalence of PS/PD rising slowly with aging
    population

6
Gaps in PD Care
  • Widespread fear that levodopa is neurotoxic and
    speeds up disease symptoms
  • Neuroprotection Is there anything that will help
    slow the advancement of the disease?

7
Gaps in PD Care
  • Many patients and caregivers use alternative or
    complementary medications and vitamins
  • 63 of patients use nutritional supplements, but
    less than 50 report this to their physician
    (Rajendran et al., 2001)
  • Only 4 are aware of possible drug interactions
    (Carter et al., 2003)

8
Seeking Answers
  • How do we find the answers to the questions that
    arise in daily practice?
  • In order to keep up to date, need to read 29
    articles a day, 365 days a year (Didsbury, 2003)
  • Or find someone who has found and summarized the
    relevant data for you

9
American Academy of Neurology Guideline Process
  • Clinical Question
  • Evidence
  • Conclusions
  • Recommendations

10
Clinical Question
  • Question should address an area of quality
    concern, controversy, confusion, or variation in
    practice
  • Question must be answerable with sufficient
    scientific data
  • Potential to improve clinical care and patient
    outcomes

11
Literature Search/Review Rigorous,
Comprehensive, Transparent

12
AAN Classification for Evidence
  • All studies rated Class I, II, III, or IV
  • Therapeutic Studies
  • Randomization, control, blinding
  • Diagnostic Studies
  • Comparison to gold standard spectrum
  • Prognostic Studies

13
AAN Level of Recommendations
  • A Established as effective, ineffective, or
    harmful for the given condition in the specified
    population
  • B Probably effective, ineffective, or harmful
    for the given condition in the specified
    population
  • C Possibly effective, ineffective, or harmful
    for the given condition in the specified
    population
  • U Data is inadequate or conflicting given
    current knowledge, treatment is unproven

14
AAN Level of Recommendations
  • A Requires two consistent Class I studies
  • B Requires one Class I study or two consistent
    Class II studies
  • C Requires one Class II study or two consistent
    Class III studies
  • U Studies not meeting criteria for Class I
    through Class III

15
Clinical Questions
  1. Are there any therapies that can slow progression
    of PD?
  2. Are there any nonstandard, pharmacologic or
    nonpharmacologic therapies that have been shown
    to improve motor function in PD?

16
Methods
  • Literature Search
  • MEDLINE, EMBASE, CINHAL, and Cochrane Database of
    Systematic Reviews (1997-2002)
  • Only articles written in English included
  • Second MEDLINE search (1966 through Aug. 2004)
  • Followed by a secondary search extending to
    January 2005 using the bibliographies of
    retrieved articles

17
Methods
  • At least two authors reviewed each full article
  • Risk of bias determined using the classification
    of evidence for each study (Class IIV)
  • Strength of practice recommendations linked
    directly to level of evidence (Level AU)
  • Conflicts of interests disclosed

18
Literature Search/Review Neuroprotective
Strategies

Exclusion criteria -Articles dealing only with
symptomatic benefit -Articles with at least 6
months of follow up -Articles that were off
topic -Review articles
19
Literature Search/Review Alternative Therapies

Exclusion criteria -Studies including at least
10 subjects with treatment of at least 1 week
duration -Articles that were off topic -Review
articles
20
Neuroprotective Strategies
21
PD Neuroprotection
  • Challenge in defining and measuring
    neuroprotection
  • Potential clinical surrogate markers not
    validated
  • Neuroimaging weakened by confounding
  • Long-term follow-up required to test possible
    neuroprotective benefit

22
Clinical Question 1
  • Are there any therapies that can slow
    progression of PD?

23
PD Neuroprotection
  • Neuroprotective therapies considered
  • Vitamin E
  • Riluzole
  • Coenzyme Q10
  • Levodopa
  • Pramipexole
  • Ropinirole
  • Other

24
Neuroprotective Strategies
  • 11 articles met inclusion criteria for clinical
    question
  • 7 Class 1 studies
  • 1 Class II study
  • 3 Class IV studies

25
PD Neuroprotection Vitamin E
  • Two articles identified
  • Class IV study (Fahn, 1992)
  • Nonrandomized, unblinded study
  • No independent assessment
  • Suggested slower rate of progression in patients
    with early PD treated with vitamin E (3,200
    IU/day) combined with vitamin C (3,000 mg/day)

26
PD Neuroprotection Vitamin E
  • Class I trial DATATOP (PSG, 1993)
  • Randomized, double-blind, prospective
  • 800 patients randomized to a dose of 2,000 IU of
    vitamin E/day or placebo
  • Followed for 14 6 months
  • Primary endpoint onset of disability requiring
    use of levadopa
  • No difference between tocopherol and placebo
    groups in the average time to required levodopa
    (hazard ratio 0.91, 95 CI .74 to 1.12)

27
PD Neuroprotection Recommendation for Vitamin E
  • For patients with PD, treatment with 2,000 units
    of vitamin E should not be considered for
    neuroprotection (Level B)

28
PD Neuroprotection Levodopa
  • One Class I study (PSG, 2004)
  • Double-blinded, controlled trial
  • Randomized 361 patients with PD to placebo or
    levodopa (150mg/day, 300 mg/day, or 600 mg/day)
  • Primary outcome masked assessment of change in
    UPDRS from baseline after 40 weeks of treatment
    and 2-week washout
  • Patients randomized to all levodopa doses
    significantly better UPDRS scores than patients
    on placebo

29
PD Neuroprotection Levodopa
Parkinson Study Group 2004, NEJM.
30
PD Neuroprotection Recommendation for Levodopa
  • Levodopa may be considered for initial treatment
    of PD (Level B)
  • 9 months
  • Does not accelerate disease progression
  • Safe
  • No long term evidence to recommend levodopa for
    neuroprotection (Level U)

31
PD Neuroprotection Rasagiline
32
Recommendations for Neuroprotection
  • Insufficient evidence for neuroprotection (Level
    U)
  • Coenzyme Q10
  • Rasagile
  • Riluzole
  • Selegiline

33
Recommendations for Neuroprotection
  • Insufficient evidence for neuroprotection (Level
    U)
  • Amantadine
  • Ropinirole
  • Pramipexole
  • Thalamotomy

34
Alternative Therapies
35
Clinical Question 2
  • Are there any non-standard pharmacological or
    nonpharmacological therapies that have been shown
    to improve motor function in PD?

36
Alternative Therapies
  • Use of complementary medication and treatment
    common in patients with PD
  • 40 of patients in the United States and 54 of
    patients in the United Kingdom use herbs,
    vitamins, massage and acupuncture (Rajendran et
    al., 2001 Ferry et al., 2002)

37
Alternative Therapies
  • Foods
  • Mucuna pruriens (cowhage or velvet bean)
  • Vicia faba (broad or fava bean)
  • Vitamins
  • Vitamin C
  • Folic acid, pyridoxine
  • Vitamin E
  • Acupuncture

38
Alternative Therapies
  • Manual Therapy
  • Chiropractic manipulation
  • Osteopathic manipulation
  • Trager therapy
  • Exercise therapy
  • Speech therapy

39
Alternative Therapies
  • 22 articles met inclusion criteria for clinical
    question
  • 2 Class 1 studies
  • 15 Class II study
  • 2 Class III studies
  • 3 Class IV studies

40
Recommendations for Alternative Therapies in PD
  • Insufficient evidence (Level U)
  • M pruriens
  • Acupuncture
  • Biofeedback
  • Manual therapy
  • Alexander technique

41
Exercise Therapy in PD
  • Multidisciplinary rehabilitation
  • Music therapy
  • Treadmill training
  • Balance training
  • Cued exercise training

42
Exercise Therapy in PD
Author Cohort size Outcome Variables Treatment Duration
Wade et al 2003 144 PDQ-39, SC-36, peg test, walking multidisciplinary rehab vs. placebo 1 x per week x 6 weeks, FU 48 weeks
Marchese et al 2000 20 UPDRS cued vs. non-cued exercises 3 x per week x 6 weeks, FU 12 weeks
Miyai et al 2000 10 UPDRS, ambulation BWSTT vs. physiotherapy 3 x per week x 4 weeks, FU 8 weeks
43
Exercise Therapy in PD
Author Cohort size Outcome Variables Treatment Duration
Miyai et al 2002 24 UPDRS, ambulation BWSTT vs. physiotherapy 3 x per week x 4 weeks, FU 6 months
Hirsch et al 2003 18 balance, falls, strength Balance/resistance vs. balance 3 x per week x 10 weeks, FU 14 weeks
Pachetti et al 2000 32 UPDRS, PDQualif Music therapy vs. physical therapy 1 x per week x 3 months, FU 5 months
Comella et al 1994 18 UPDRS, depression General exercise vs. placebo 3 x per week x 1 month, FU 12 months
44
Recommendation for Exercise Therapy in PD
  • Exercise therapy may be considered to improve
    function (Level C)
  • Results in improvement in UPDRS
  • Decrease in falls

45
Exercise Therapy in PD
  • No specific exercise program shown to be superior
    to another
  • Benefit not sustained after exercise is
    discontinued

46
Speech Therapies in PD
  • For patients with PD complicated by dysarthria,
    speech therapy may be considered to improve
    speech volume (Level C)
  • 5 trials identified
  • No specific therapy shown to be superior to
    another

47
Summary
  • Levodopa does not appear to accelerate disease
    progression
  • No treatment has been shown to be neuroprotective
  • No evidence that vitamin or food additives can
    improve motor function in PD

48
Summary
  • Exercise may be helpful in improving motor
    function
  • Speech therapy may be helpful in improving speech
    volume
  • No manual therapy has been shown to be helpful in
    the treatment of motor symptoms

49
Recommendations for Future Research
  • Reliable and validated surrogated endpoints that
    mirror nigrostriatal dopaminergic neuron loss
  • Accurate early diagnosis and improved knowledge
    of disease progression

50
Recommendations for Future Research
  • Development of methods to identify presymptomatic
    patients for clinical trials
  • Innovative trials with long-term follow-up
  • Studies to demonstrate safety or effectiveness of
    neuroprotective therapies

51
Questions, Comments?
52
Thanks for your participation!
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