Systematic Review for the Development of the Clinical Study with Economical Assessment Protocol on Facial palsy

Na-Gyeong Gong; Eunsung Seo; Ji-Hye Seon; Nam-Kwen Kim; Gong, Na-Gyeong; Seo, Eunsung; Seon, Ji-Hye; Kim, Nam-Kwen

doi:10.13048/jkm.17005

JKM > Volume 38(1); 2017 > Article

Gong, Seo, Seon, and Kim: Systematic Review for the Development of the Clinical Study with Economical Assessment Protocol on Facial palsy

Original Article

The Journal of Korean Medicine 2017; 38(1): 46-55.

Published online: March 31, 2017

DOI: https://doi.org/10.13048/jkm.17005

Systematic Review for the Development of the Clinical Study with Economical Assessment Protocol on Facial palsy

Na-Gyeong Gong¹, Eunsung Seo², Ji-Hye Seon³, Nam-Kwen Kim¹^{, 3}

¹School of Korean Medicine, Pusan National University

²Seoul National University

³Center for Comparative Effectiveness Research & Economic Evaluation in Korean Medicine

Correspondence to：김남권(Nam Kwen Kim) 부산대학교 한방 의료 비교효과 및 경제성평가 연구센터, Tel: +82-55-360-5947, E-mail: drkim@pusan.ac.kr

Received February 25, 2017 Revised March 22, 2017 Accepted March 22, 2017

Abstract

Objectives

The aim of this study is reviewing the literature to extract the key parameter, study design, perspective, cost-effectiveness index and find the calibration parameter for the clinical study with economical evaluation protocol on facial palsy.

Methods

Literature search is performed using PUBMED for literature published from January 2000 to December 2016. We included randomized controlled trials(RCTs) and modelling study with economic assessment in which human participated.

Results

As a result of literature search, the 198 articles were found. After reviewing the title, abstract and full text, the 5 articles were selected. Selected articles are classified into 4 RCT studies dealing with quality of life and 1 CEA(cost-effectiveness analysis) study.

Conclusions

We found reliable key parameters, calibration parameters and elements of economical assessment study, which might be necessary factors for developing research protocol of clinical trial with economic evaluation about facial palsy patients.

Keywords: Facial palsy, Bell's palsy, Systematic review, Economical evaluation, Randomized controlled trial, Quality of life

Fig. 1

Flow chart of the Selection Results

Table 1

List of Selected Studies.

Study type	Study ID	Year	Country	Authors	Title	Source
RCT	1	2005	America	Gary Borodic.	Botulinum Toxin for Aberrant Facial Nerve Regeneration: Double-Blind, Placebo-controlled Trial Using Subjective Endpoint	Plastic and Reconstructive Surgery. 116: 36–43
RCT	2	2007	United Kingdom	Frank M. Sullivan.	Early Treatment with Prednisolone or Acyclovir in Bell’s Palsy	The New England Journal of Medicine. 357: 1598–607
RCT	3	2013	China	Sha-bei Xu.	Effectiveness of strengthened stimulation during acupuncture for the treatment of Bell palsy: a randomized controlled trial	Canadian Medical Association Journal. 185(6): 473–79
RCT	4	2014	Czech Republic	Petr Konecny.	Central facial paresis and its impact on mimicry, psyche and quality of life in patients after stroke	Biomed Pap Med. 158(1): 133–137
Modeling	5	2009	United Kingdom	RA Hernandez.	Economic evaluation of early administration of prednisolone and/or aciclovir for the treatment of Bell’s palsy	Family Practice journal. 26(2): 137–144

Table 2

Summary of reviewed RCT studies.

First Author	Study Population				Experimental /Control	Primary endpoint	Secondary endpoint	Author’s conclusion	Confounding variables
First Author	Subject	Age(M±SD)	Disease severity (standard)	Recruitment	Experimental /Control	Primary endpoint	Secondary endpoint	Author’s conclusion	Confounding variables
Gary Borodic (2005)	patients with facial paresis (n=30)	22 years or older	NR	3 centers	botulinum toxin / placebo	Synkinesis Physicians’ Grading Scale, Exposure Grading Scale	QoL, social interactions, personal appearance, visual function, perception of severity, physicians grading scale	Botulinum toxin injections are efficacious for synkinetic movements after facial paralysis and there are wide variations in personal perception of the degree of impairment.	NR
Frank M. Sullivan (2007)	patients with Bell’s palsy (n=496) (recruited within 72 hours after onset of symptoms)	16 years or older (44.0±16.4)	1–6 (HBGS)	17 centers	prednisolone, acyclovir, both agents, placebo	recovery of facial function (HBGS)	QoL, appearance, pain, cost	Early treatment with prednisolone significantly improves complete recovery at 3 and 9 months but no evidence of acyclovir alone and combination	Sex, Age, Time between onset of symptoms and start of treatment
Sha-bei Xu (2013)	patients with Bell’s palsy (n=355)	18–65 yrs E:38.12±12.76 C:38.15±12.75	2–5 (HBGS)	11 centers	De qi group / needles without any manipulation	facial-nerve function(HBGS)	FDI, WHOQoL	Acupuncture with strong stimulation(de qi) had a greater therapeutic effect	Sex, Age, Education, Occupation, Affected side
Petr Konecny (2014)	patients after stroke with chronic facial paresis (n=99)	mean: 60.0yr	2–5 (HBGS)	1 center	orofacial regulation therapy / without mimicry therapy	HBGS	distances between mouth and earlobe, BDI-II, BI(QOL)	Orofacial rehabilitation therapy has a significant influence on mimicry, mental functions and overall quality of life	NR

HBGS: House-Brackmann Grading Scale, QoL: Quality of Life, BDI: Beck Depression Inventory, BI: Bartel Index, VP: vertical palpebral distance, MCRD: lid margin to corneal light reflex distance FDI: Facial Disability Index, WHOQoL: World Health Organization’s Quality of Life, E:: experimental group, C: control group, NR: Not reported

Table 3

Summary of Reviewed Economic Evaluation Study.

First Author (Year)	Study design	Model	Time horizon	Perspective	Cost			Method of data collection	Assessment of cost effectiveness
First Author (Year)	Study design	Model	Time horizon	Perspective	Unit costs	Category	Currency	Method of data collection	Assessment of cost effectiveness
RA Hernandez. (2009)	CEA	Decision analytic model	9 months	British National Health Service	BNF Curtis& Netten	treatment: doses and length of trial medication follow-up: number of contact, hospital based services	Pound	HUI III	Ratio of the cost of administration of Prednisolone and/or acyclovir to placebo for treatment of BP

CEA: cost effectiveness analysis, BNF: British National Formulary, HUI: Health Utilities Index, BP: Bell’s palsy

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