Evidence map›Paper›PMID 33298154›Full record

ArticleTrials2020

Effect of duloxetine premedication for postherpetic neuralgia within 72 h of herpes zoster reactivation [PROCESS]: a study protocol for a randomized controlled trial.

Zheng Chen, Niti Shrestha, Chunmei Zhao, Bifa Fan, Fang Luo

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04313335 (Prophylactic Duloxetine Administration During Acute Herpes Zoster Prevents Postherpetic Neuralgia), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.3field-weighted citation impact, top 38% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04313335 nacompletednot on this mapstarted 2021, after this paper: background citation

Prophylactic Duloxetine Administration During Acute Herpes Zoster Prevents Postherpetic Neuralgia

TypeinterventionalSponsorBeijing Tiantan HospitalRan2021 to 2023Enrolled750ConditionsPostherpetic NeuralgiaArmsDuloxetine
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 5 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
  4. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 2 institutions in 1 country.

Zheng ChenDepartment of Pain Management, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
Niti ShresthaDepartment of Pain Management, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
Chunmei ZhaoDepartment of Pain Management, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
Bifa FanNational Pain Management and Research Center, China-Japan Friendship Hospital, Beijing, China. fbf1616@yeah.net.
Fang LuoDepartment of Pain Management, Beijing Tiantan Hospital, Capital Medical University, Beijing, China. 13611326978@163.com.
Beijing Tian Tan Hospital · CNChina-Japan Friendship Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPostherpetic 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.

methodsThis 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: 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 registrationClinicaltrials.gov NCT04313335 . Registered on 18 March 2020.

Indexed as

Herpes ZosterNeuralgia, PostherpeticChinaDuloxetine HydrochlorideHerpesvirus 3, HumanHumansPremedicationQuality of LifeRandomized Controlled Trials as TopicDuloxetine HydrochlorideDuloxetineHerpes zosterPostherpetic neuralgiaPrevention

Identifiers

PMID33298154
PMCPMC7724804
OpenAlexW3112232728

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.