Effect of duloxetine premedication for postherpetic neuralgia within 72 h of herpes zoster reactivation [PROCESS]: a study protocol for a randomized controlled trial.
Duloxetine
Herpes zoster
Postherpetic neuralgia
Prevention
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
09 Dec 2020
09 Dec 2020
Historique:
received:
30
04
2020
accepted:
19
11
2020
entrez:
10
12
2020
pubmed:
11
12
2020
medline:
22
6
2021
Statut:
epublish
Résumé
Postherpetic neuralgia (PHN) is the most common complication attributed to herpes zoster, which involves the reactivation of residual varicella zoster virus. It has been reported previously that pre-emptive amitriptyline following acute herpes zoster has shown latent positive effects in the prevention of PHN. In this study, by interfering with the same targets, norepinephrine and serotonin, we aim to evaluate whether pre-emptive duloxetine may proactively prevent PHN development. This is a nationwide multicentric, randomized, open-label, blinded-endpoint study that will recruit 750 participants from 18 primary centres in China. Patients aged more than 50 years who are diagnosed with uncomplicated HZ, present with vesicles within 72 h of their emergence, and have an average pain score of at least 40/100 mm on a visual analogue scale (VAS, 0 mm = no pain, 100 mm = worst possible pain, at opposite ends of a 100-mm line) will be recruited for this study. Participants will be randomized into a duloxetine arm and a control arm. Participants allocated to the duloxetine arm will be given antivirals, analgesics and duloxetine, while those allocated to the control arm will receive antivirals and analgesics but no duloxetine. The primary outcome of this study is preventive efficacy against PHN, which will be evaluated based on a 100 mm VAS. Any pain scores other than 0 mm on the VAS 12 weeks after HZ onset will be defined as PHN. The secondary outcomes will consist of the average weekly VAS score, the average weekly consumption of each analgesic, weekly feature of the pain, patients' quality of life based on the 12-item Short-Form Health Survey, Patient Global Impression of Change Scale, sleep quality as evaluated by the Pittsburgh Sleep Quality Index and adverse events during the study period. This study will investigate a prophylactic approach for reducing the prevalence of postherpetic neuralgia with duloxetine and will add significant new knowledge on the preventive effects of duloxetine on PHN. Clinicaltrials.gov NCT04313335 . Registered on 18 March 2020.
Sections du résumé
BACKGROUND
BACKGROUND
Postherpetic neuralgia (PHN) is the most common complication attributed to herpes zoster, which involves the reactivation of residual varicella zoster virus. It has been reported previously that pre-emptive amitriptyline following acute herpes zoster has shown latent positive effects in the prevention of PHN. In this study, by interfering with the same targets, norepinephrine and serotonin, we aim to evaluate whether pre-emptive duloxetine may proactively prevent PHN development.
METHODS
METHODS
This is a nationwide multicentric, randomized, open-label, blinded-endpoint study that will recruit 750 participants from 18 primary centres in China. Patients aged more than 50 years who are diagnosed with uncomplicated HZ, present with vesicles within 72 h of their emergence, and have an average pain score of at least 40/100 mm on a visual analogue scale (VAS, 0 mm = no pain, 100 mm = worst possible pain, at opposite ends of a 100-mm line) will be recruited for this study. Participants will be randomized into a duloxetine arm and a control arm. Participants allocated to the duloxetine arm will be given antivirals, analgesics and duloxetine, while those allocated to the control arm will receive antivirals and analgesics but no duloxetine. The primary outcome of this study is preventive efficacy against PHN, which will be evaluated based on a 100 mm VAS. Any pain scores other than 0 mm on the VAS 12 weeks after HZ onset will be defined as PHN. The secondary outcomes will consist of the average weekly VAS score, the average weekly consumption of each analgesic, weekly feature of the pain, patients' quality of life based on the 12-item Short-Form Health Survey, Patient Global Impression of Change Scale, sleep quality as evaluated by the Pittsburgh Sleep Quality Index and adverse events during the study period.
DISCUSSION
CONCLUSIONS
This study will investigate a prophylactic approach for reducing the prevalence of postherpetic neuralgia with duloxetine and will add significant new knowledge on the preventive effects of duloxetine on PHN.
TRIAL REGISTRATION
BACKGROUND
Clinicaltrials.gov NCT04313335 . Registered on 18 March 2020.
Identifiants
pubmed: 33298154
doi: 10.1186/s13063-020-04919-6
pii: 10.1186/s13063-020-04919-6
pmc: PMC7724804
doi:
Substances chimiques
Duloxetine Hydrochloride
9044SC542W
Banques de données
ClinicalTrials.gov
['NCT04313335']
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1012Références
N Engl J Med. 2013 Jul 18;369(3):255-63
pubmed: 23863052
Med Care. 1996 Mar;34(3):220-33
pubmed: 8628042
Dermatol Ther. 2016 May;29(3):184-90
pubmed: 26799145
Ann Intern Med. 1996 Sep 1;125(5):376-83
pubmed: 8702088
J Pain Symptom Manage. 1997 Jun;13(6):327-31
pubmed: 9204652
Clin J Pain. 2000 Jun;16(2 Suppl):S90-100
pubmed: 10870747
J Infect. 2018 Aug;77(2):131-136
pubmed: 29742472
Neuropsychopharmacology. 2001 May;24(5):511-21
pubmed: 11282251
N Engl J Med. 1994 Mar 31;330(13):896-900
pubmed: 8114860
PLoS Med. 2013;10(4):e1001420
pubmed: 23585738
N Engl J Med. 2014 Oct 16;371(16):1526-33
pubmed: 25317872
PLoS One. 2019 Jun 5;14(6):e0217335
pubmed: 31166976
Arch Dermatol. 2011 Aug;147(8):901-7
pubmed: 21482862
Psychiatry Res. 1989 May;28(2):193-213
pubmed: 2748771
Neurotherapeutics. 2009 Oct;6(4):630-7
pubmed: 19789068
BMC Psychiatry. 2019 Jun 11;19(1):177
pubmed: 31185948
Mayo Clin Proc. 2019 Mar;94(3):484-489
pubmed: 30718068
Prog Neurobiol. 2002 Apr;66(6):355-474
pubmed: 12034378
Blood Press. 1992 Aug;1(2):113-9
pubmed: 1366259
MMWR Surveill Summ. 2016 Feb 05;65(1):1-36
pubmed: 26844596
Clinicoecon Outcomes Res. 2019 Sep 03;11:539-550
pubmed: 31564930
JAMA. 2011 Jan 12;305(2):160-6
pubmed: 21224457
Adv Rheumatol. 2020 Jul 8;60(1):35
pubmed: 32641165
Pain. 2016 Jan;157(1):30-54
pubmed: 26218719
Pain Ther. 2019 Dec;8(2):249-259
pubmed: 31218562
Pain Med. 2007 Sep;8(6):503-13
pubmed: 17716324
Cochrane Database Syst Rev. 2014 Feb 06;(2):CD006866
pubmed: 24500927
CMAJ. 2010 Nov 9;182(16):1731-6
pubmed: 20921251
Lancet Neurol. 2015 Feb;14(2):162-73
pubmed: 25575710
Expert Opin Pharmacother. 2017 Nov;18(16):1739-1750
pubmed: 29025327
Medicine (Baltimore). 2018 Nov;97(46):e13178
pubmed: 30431592
Hum Vaccin Immunother. 2018;14(11):2632-2635
pubmed: 30059639