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

Article information

J Korean Med. 2017;38(1):46-55
Publication date (electronic) : 2017 March 31
doi : https://doi.org/10.13048/jkm.17005
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 2017 February 25; Revised 2017 March 22; Accepted 2017 March 22.

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

List of Selected Studies.

Summary of reviewed RCT studies.

Summary of Reviewed Economic Evaluation Study.

References

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12. Peitersen E. Bell’s palsy : the spontaneous course of 2,500 peripheral facial nerve palsies of different etiologies. Acta Otolaryngol 2002;Suppl 549. 122:4–30.
13. Kim JI, Seo JC, Lee SH, Choi DY, Kang SK, Koh HK. The clinical observation on Bell’s palsy according to facial nerve grading system. The Journal of Korea Acupuncture & Moxibustion Society 2002;19(5):112–123.
14. Gronseth GS, Paduga R. Evidence-based guideline update: steroids and antivirals for Bell palsy: report of the Guideline Development Subcommittee of the American Academy of Neurology. Neurology 2012;79(22):2209–13.
15. Yi YJ, Kim HJ, Ryu EK. Comparison of Efficacy between Acupuncture Treatment and Collaborative Treatment with Prednisolone on Acute Bell’s Palsy. Journal of Korean Medicine Rehabilitation 2013;23(3):125–132.
16. Chu MG, Jo HG, Choi JB, Kim SJ, Park KM, Cho GR, et al. ing Facial Acupuncture. Korean J Oriental Physiology & Pathology 2009;23(5):1188–1192.
17. Borodic G, Bartley M, Slattery W, Glasscock M, Johnson E, Malazio C, et al. Botulinum Toxin for Aberrant Facial Nerve Regeneration: Double-Blind, Placebo -controlled Trial Using Subjective Endpoint. Plastic and Reconstructive Surgery 2005;116:36–43.
18. Sullivan FM, Iain RCS, Donnan PT. Early Treatment with Prednisolone or Acyclovir in Bell’s Palsy. The New England Journal of Medicine 2007;357:1598–607.
19. Xu SB, Huang B, Zhang CY, Du P, Yuan Q, Bi GJ, Xie MJ, et al. Effectiveness of strengthened stimulation during acupuncture for the treatment of Bell palsy: a randomized controlled trial. Canadian Medical Association Journal 2013;185(6):473–79.
20. Konecny P, Elfmark M, Horak S, Pastucha D, Krobot A, Urbanek K, et al. Central facial paresis and its impact on mimicry, psyche and quality of life in patients after stroke. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub 2014;158(1):133–137.
21. Hernandez RA, Sullivan F, Donnan P, Swan I, Vale L. Economic evaluation of early administration of prednisolone and/or aciclovir for the treatment of Bell’s palsy. Family Practice journal 2009;26(2):137–144.

Article information Continued

Copyright © 2017 The Society of Korean Medicine all rights reserved

Fig. 1

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
Subject Age(M±SD) Disease severity (standard) Recruitment
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
Unit costs Category Currency
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