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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

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.

Fig. 1
Flow chart of the Selection Results
jkm-38-1-46f1.gif
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

참고문헌

1 De Seta D, Mancini P, Minni A, Prosperini L, De Seta E, Attanasio G, et al. Bell’s palsy: symptoms preceding and accompanying the facial paresis. Scientific World Journal. 2014; Article ID 801971.


2 holland NJ, Weiner GM. Recent developments in Bell’s palsy. The British Medical Journal. 2004; 329:553–7.
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3 Korean Statistical Information Service. [Internet]. Gangwon-do: National Health Insurance Service;c1963–2017. available at: URL:http://kosis.kr/statHtml/statHtml.do?orgId=350&tblId=DT_35001_A803&conn_path=I2Accessed October 28, 2015.


4 Korean Statistical Information Service. [Internet]. Gangwon-do: National Health Insurance Service;c1963–2017. available at: URL:http://kosis.kr/statHtml/statHtml.do?orgId=350&tblId=DT_35001_A81311&conn_path=I2Accessed October 28, 2015.


5 Hong CK, Byun JY, Yeo SG, Park MS, Cha CI. Usefulness of Botulinum Toxin Injection in Rehabilitation of Facial Paralysis: Improving Mouth Angle Asymmetry. Korean J Otorhinolaryngol -Head Neck Surg. 2007; 50:1087–91.


6 Lee WS, Kim J. Facial Nerve Paralysis and Surgical Management. J Korean Med Assoc. 2009; 52:8. 807–818.
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7 Hong KE. Prevalence and Treatment Pattern of Korean Patients with Facial Palsy. The Journal of Korean Acupuncture & Moxibustion Society. 2010; 27:3. 137–146.


8 Korean Medicine Clinical Practice Guideline. [Internet]. Dae-jeon: Korea Institute Of Oriental Medicine;c1994–2017. available at : URL:https://www.kiom.re.kr/brdartcl/boardarticleView.do?menu_nix=WUNNW2Aq&brd_id=BDIDX_o9YEVvNb40b134N1Rt17aqAccessed January 15, 2016.


9 Fu L, Bundy C, Sadiq SA. Psychological distress in people with disfigurement from facial palsy. Eye. 2011; 25:1322–6.
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10 Anderson G. Anxiety, optimism, and symptoms reporting following surgery for acoustic neuroma. J Psychosom Res. 1999; 46:3. 257–60.
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11 Van Swearingen JM, Cohn J, Turnbull J, Mirzai T, Johnson P. Psychological distress: linking impairment with disability in facial neuromotor disorders. Otolaryngol Head Neck Surg. 1998; 118:6. 790–6.
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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.
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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.
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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.
crossref

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.
crossref

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.
crossref

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.
crossref

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.
crossref

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