Acupuncture as adjuvant therapy for sleep ...

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[26] Eng ML, Lyons KE, Greene MS, Pahwa R. Open-label trial regarding the use of acupuncture and yin tui na in Parkinson's disease outpatients: a pilot study ...
Accepted Manuscript Acupuncture as adjuvant therapy for sleep disorders in parkinson's disease Fábio Henrique de Amorim Aroxa, Ihana Thaís Guerra de Oliveira Gondim, MSc, Physiotherapist, Elba Lúcia Wanderley Santos, MSc, Doctor acupuncturist, Maria das Graças Wanderley de Sales Coriolano, PhD, Physiotherapist, Amdore Guescel C. Asano, MSc, Doctor Neurologist, Nadja Maria Jorge Asano PII:

S2005-2901(17)30001-8

DOI:

10.1016/j.jams.2016.12.007

Reference:

JAMS 327

To appear in:

Journal of Acupuncture and Meridian Studies

Received Date: 3 May 2016 Revised Date:

15 December 2016

Accepted Date: 20 December 2016

Please cite this article as: Aroxa FHdA, Gondim ITGdO, Santos ELW, Coriolano MdGWdS, Asano AGC, Asano NMJ, Acupuncture as adjuvant therapy for sleep disorders in parkinson's disease, Journal of Acupuncture and Meridian Studies (2017), doi: 10.1016/j.jams.2016.12.007. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

ACCEPTED MANUSCRIPT CATEGORIE: RESEARCH ARTICLE ACUPUNCTURE AS ADJUVANT THERAPY FOR SLEEP DISORDERS IN PARKINSON'S DISEASE Authors:

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Fábio Henrique de Amorim Aroxa – AROXA, FHA Academic of Medicine graduation of Federal University of Pernambuco – Recife, Pernambuco (PE), Brazil. E-mail: [email protected] Ihana Thaís Guerra de Oliveira Gondim – GONDIM, ITGO Physiotherapist, MSc, Pro-Parkinson Program of Clinical Hospital of Federal University of Pernambuco – Recife (PE), Brazil. E-mail: [email protected]

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Elba Lúcia Wanderley Santos – SANTOS, ELW Doctor acupuncturist, MSc, Clinical Hospital of Federal University Pernambuco– Recife (PE), Brazil. E-mail: [email protected]

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Maria das Graças Wanderley de Sales Coriolano – CORIOLANO, MGWS Physiotherapist, PhD, Pro-Parkinson Program of Clinical Hospital of Federal University of Pernambuco – Recife (PE), Brazil. E-mail: [email protected] Amdore Guescel C Asano – ASANO, AGC Doctor Neurologist, MSc, Pro-Parkinson Program of Clinical Hospital of Federal University of Pernambuco – Recife (PE), Brazil. E-mail: [email protected]

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*Nadja Maria Jorge Asano – ASANO, NMJ Doctor acupuncturist, PhD, Clinical Medicine Department of Federal University Pernambuco – Recife (PE), Brazil. E-mail: [email protected]

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*Correspondence to author: Silveira de Carvalho Street – 252 Tamarineira - Recife/PE Brazil. Postal Code: 52110-060, telephone: +55 81 21268555, Fax: +55 81 21268554, e-mail: [email protected] , [email protected]

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Conflict of interest declaration: There was no interest conflict. The study was developed on Clinical Medicine Department of Clinical Hospital in a partnership of the extension Program Pro-Parkinson of Clinical Hospital of Federal University of Pernambuco– Recife (PE), Brazil. The resources for development of present study have obtained from Edictal 2015 PIBEX-Grande Recife – PROEXC –Federal University of Pernambuco– Recife (PE), Brazil.

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ACCEPTED MANUSCRIPT Introduction Parkinson disease (PD) is a neurodegenerative disorder which has presented a high prevalence on elder population, affecting 1 of 1000 people older than 60 years. Although has been widely accepted the relationship of dopaminergic neurons death, its

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etiology continues unknown [1,2].

Sleep disturbs responses of a very often non-motor symptom on PD. It is represented of excessive daytime sleepiness and maintenance insomnia [3,4,5,6]. It

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happens in consequence of evolution of disease, but also occurs as a side effect of antiparkinsonian medicines [7,8].

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Acupuncture is a method of the traditional Chinese medicine which had been developed on the first century before the Christian age [9,10]. On PD, some researches suggests attractive results, like relief of a wide range of symptoms and promoting, surprisingly, the reduction of pharmacological therapy and its side effects [11,12].

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Following the same perspective, the acupuncture has shown an improvement of score on the Parkinson Disease Sleep Scale (PDSS) [13]. Probably, the result mentioned is reflection of neuromodulation on substances like γ-aminobutyric acid (GABA),

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melatonin and β-endorphins [14].

Considering all information exposed, the present study intends to evaluate the

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effects of acupuncture on sleep disturbs of patients who have assistance on the ProParkinson Program of Clinical Hospital at Federal University of Pernambuco in Brazil.

Methodology Ethics Statement Randomized clinical trial conducted according checklist CONSORT 2010. All patients signed an informed consent form, approved by the Ethic Committee of 1

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ACCEPTED MANUSCRIPT Research with Humans from the Center of Health Sciences of Federal University of Pernambuco (Protocol CAAE: 49662915.4.0000.5208). This trial was registered in clinical trials NCT: 02731677.

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Participants

Twenty-two PD patients diagnosed by neurologist entered the study. Patients were recruited for the study during their routine outpatient visit to the Neurology Clinic

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(Pro-Parkinson Program) of the Clinical Hospital of the Federal University of Pernambuco, Brazil. Only patients with idiopathic Parkinson’s disease according UK

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Parkinson’s Disease Society Brain Bank criteria [15], stage I-III, according Hoehn-Yahr scale (HY) [16], both gender with age between 35 and 80 years old, who have presented on Mini Examination of Mental State (MMSE) a minimum score of 18 for low schooling or 26 for high schooling [17], stable dose of antiparkinsonian medication for

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at least 2 months were included in the study. Patients who have another neurological comorbid or who have been submitted with physiotherapy were excluded. The patients were enumerated and allocated to experimental or control group according a simple

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raffle.

The Pro-Parkinson Program promotes multidisciplinary assistance for patients

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with PD. It also offers educative activities for patients and them caregivers. Today, the program receives an average of 250 patients, and it is composed of professors and students

from

graduation

and

post-graduations

of Medicine,

Physiotherapy,

Odontology, Psychology, Speech Therapy, Occupational Therapy and a team of support.

Clinical Assessment 2

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ACCEPTED MANUSCRIPT All patients were clinically evaluated prior to starting the study with the following instruments: MMSE, HY and PDSS and after 8 session, only PDSS was applied.

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Hoehn-Yahr scale (HY)

Developed from Hoehn and Yahr [16], is constituted, on original version, of five stages which evaluate the severity of PD analyzing global signals and symptoms that

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allows classifies the individuals according them incapability. Patients classified on stage I present unilateral symptoms (tremor, stiffness and bradykinesia) and can have an

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autonomy life. Stage II is marked of bilateral symptoms together at an abnormal speech, bent posture and the famous “en bloc gait”. The addition of postural instability is the characteristic of stage III, and until this stage, patients can have them autonomy preserved. Despite of it, stages IV and V is compatible of severe diseases, which

(stage V).

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patients are dependents of caregivers (stage IV), or are restrict of bed or a wheelchair

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Mini Mental State Examination (MMSE)

It is a very useful tool for screening of cognition disturbs, in consequence of it

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easy and fast application, demanding a range of 5 to 10 minutes. It is composed of 11 items which can attribute a total score of 30 points. The first half of test evaluates memory and executive function (attention and concentration), the second one evaluates another cortical function. The cut off is according patient schooling: Analphabets or low schoolings- 18 points; 8 or more years of schooling- 28 points [17].

Parkinson Disease Sleep Scale (PDSS) 3

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ACCEPTED MANUSCRIPT It is a visual analogic and self-apply scale constituted of 15 items which addresses the domains: overall quality of night’s sleep; sleep onset and maintenance insomnia; nocturnal restlessness; nocturnal psychosis; nocturia; nocturnal motor symptoms; sleep refreshment; daytime dozing. It is applicate during ON phase, which

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mean on action of antiparkinsonian medicines. The severity of symptoms is register by the patient, who marks using an X along a line of 10 cm. The line is subdivided on 10 parts graduated from 0 (intense symptom) to 10 (without symptom). The maximum

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score is 150 points, which suggests patient free of symptoms [18].

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Intervention

The experimental group was submitted to 8 sections (once a week) which had duration of 30 minutes. On another hand, the control group had no intervention. The intervention was executed using the acupuncture points LR3 (Taichong), SP6

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(Sanyinjiao), LI4 (Hegu), TE5 (Wai-Guan), HT7 (Shenmen), PC6 (Neiguan), LI11 (Quchi), GB20 (Fengchi). All those acupuncture points had been selected according data of previous studies [19,20,21,22,23,24,25,26,27].

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This study was a randomized controlled clinical trial, in which PD patients were divided into two groups. One group received acupuncture treatment with the current

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drug treatment unchanged (acupuncture and drug), and another group maintained the prescribed anti-Parkinsonian drugs (drug alone). The patients were treated on a stable dose of anti- Parkinsonian medication for at least 2 months and did not report adverse events before the study.

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ACCEPTED MANUSCRIPT Statistical analysis A statistical analysis was calculated by the software Biostat™ 5.3, using a p