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Estrogen improves motor disability in parkinsonian postmenopausal women with motor fluctuations.

Abstract

OBJECTIVE

To test the efficacy, tolerance, and safety of low-dose oral estrogen in postmenopausal women with PD associated with motor fluctuations.

BACKGROUND

Motor fluctuations in PD may be predictable or unpredictable, and eventually affect most patients after long-term levodopa therapy. Although estrogen can modulate nigrostriatal dopamine levels, its effects on PD are unclear.

METHODS

Patients were randomized to receive conjugated estrogen (oral Premarin 0.625 mg daily; n = 20) or placebo (n = 20) in a double-blind, parallel-group, prospective study over 8 weeks. Existing antiparkinsonian drug regimes were kept unchanged. Changes in "on" and "off" periods using patient diaries, Unified Parkinson's Disease Rating Scale (UPDRS) score, timed tapping score, and Hamilton Depression Scale score were determined by one rater. Subgroup analyses were also performed on patients with only predictable motor fluctuations.

RESULTS

Both treatment groups were similar in age, duration of disease and menopause, antiparkinsonian medication, and compliance with test medication and diary assessments. "On" and "off" times, and motor score (UPDRS subscale III) improved with estrogen, using the Mann-Whitney U test (p < 0.05 after Bonferroni adjustment). Mean "on" time improved by 7% (9 hours/week of awake time) in estrogen-treated patients versus a deterioration of 0.5% (1.4 hours) in placebo-treated patients (95% confidence interval, [CI] of mean difference, 5.73 to 14.9). Mean "off" time improved by 4% (4.4 hours/week of awake time) in estrogen-treated patients versus no change in placebo-treated patients (95% CI, 1.54 to 7.16). Mean subscale III score improved by 3.5 points in estrogen-treated patients versus 0.4 in placebo-treated patients (95% CI, 1.02 to 5.18). No other significant changes were observed (p > 0.05). Subgroup analyses in patients with only predictable motor fluctuations showed similar results, except improvement in mean subscale III score was marginally not significant (p = 0.07; 95% CI, 1.06 to 6.24). Five patients on estrogen had facial flushing, three had lower abdominal discomfort, and two had mild withdrawal vaginal bleeding. The adverse events were mild and resolved without sequelae.

CONCLUSION

Low-dose estrogen is a safe and effective adjunct therapy to existing antiparkinsonian treatment in reducing motor disability in postmenopausal women with PD associated with motor fluctuations.

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  • Publisher Full Text
  • Authors

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    Source

    Neurology 54:12 2000 Jun 27 pg 2292-8

    MeSH

    Activities of Daily Living
    Aged
    Antiparkinson Agents
    Circadian Rhythm
    Double-Blind Method
    Dyskinesias
    Estrogens, Conjugated (USP)
    Female
    Humans
    Medical Records
    Middle Aged
    Movement Disorders
    Parkinson Disease
    Postmenopause
    Prospective Studies
    Treatment Outcome

    Pub Type(s)

    Clinical Trial
    Journal Article
    Randomized Controlled Trial

    Language

    eng

    PubMed ID

    10881255

    Citation

    TY - JOUR T1 - Estrogen improves motor disability in parkinsonian postmenopausal women with motor fluctuations. AU - Tsang,K L, AU - Ho,S L, AU - Lo,S K, PY - 2000/7/6/pubmed PY - 2000/8/6/medline PY - 2000/7/6/entrez SP - 2292 EP - 8 JF - Neurology JO - Neurology VL - 54 IS - 12 N2 - OBJECTIVE: To test the efficacy, tolerance, and safety of low-dose oral estrogen in postmenopausal women with PD associated with motor fluctuations. BACKGROUND: Motor fluctuations in PD may be predictable or unpredictable, and eventually affect most patients after long-term levodopa therapy. Although estrogen can modulate nigrostriatal dopamine levels, its effects on PD are unclear. METHODS: Patients were randomized to receive conjugated estrogen (oral Premarin 0.625 mg daily; n = 20) or placebo (n = 20) in a double-blind, parallel-group, prospective study over 8 weeks. Existing antiparkinsonian drug regimes were kept unchanged. Changes in "on" and "off" periods using patient diaries, Unified Parkinson's Disease Rating Scale (UPDRS) score, timed tapping score, and Hamilton Depression Scale score were determined by one rater. Subgroup analyses were also performed on patients with only predictable motor fluctuations. RESULTS: Both treatment groups were similar in age, duration of disease and menopause, antiparkinsonian medication, and compliance with test medication and diary assessments. "On" and "off" times, and motor score (UPDRS subscale III) improved with estrogen, using the Mann-Whitney U test (p < 0.05 after Bonferroni adjustment). Mean "on" time improved by 7% (9 hours/week of awake time) in estrogen-treated patients versus a deterioration of 0.5% (1.4 hours) in placebo-treated patients (95% confidence interval, [CI] of mean difference, 5.73 to 14.9). Mean "off" time improved by 4% (4.4 hours/week of awake time) in estrogen-treated patients versus no change in placebo-treated patients (95% CI, 1.54 to 7.16). Mean subscale III score improved by 3.5 points in estrogen-treated patients versus 0.4 in placebo-treated patients (95% CI, 1.02 to 5.18). No other significant changes were observed (p > 0.05). Subgroup analyses in patients with only predictable motor fluctuations showed similar results, except improvement in mean subscale III score was marginally not significant (p = 0.07; 95% CI, 1.06 to 6.24). Five patients on estrogen had facial flushing, three had lower abdominal discomfort, and two had mild withdrawal vaginal bleeding. The adverse events were mild and resolved without sequelae. CONCLUSION: Low-dose estrogen is a safe and effective adjunct therapy to existing antiparkinsonian treatment in reducing motor disability in postmenopausal women with PD associated with motor fluctuations. SN - 0028-3878 UR - https://www.unboundmedicine.com/medline/citation/10881255/full_citation L2 - http://www.neurology.org/cgi/pmidlookup?view=long&amp;pmid=10881255 ER -