Evidence map›Paper›PMID 31791370›Full record

ArticleTrials2019

Healthy lifestyle consultation based on traditional Chinese medicine versus routine patient education in the treatment of idiopathic sudden sensorineural hearing loss after failure of systemic therapy: study protocol for a clinical randomised trial.

Ying-Ping Fei, Yun Zheng, Dan Lai, Ping Zhong, Jing-Zhe Lu, Gang Li, Peng Liu

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.1field-weighted citation impact, top 44% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 3 citations in OpenAlex.

  1. Article
  2. 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

7 authors at 3 institutions in 1 country.

Ying-Ping FeiHearing Center/Hearing and Speech Science Laboratory, Department of Otolaryngology Head and Neck Surgery, West China Hospital of Sichuan University, Chengdu, People's Republic of China.ORCID http://orcid.org/0000-0002-8844-3708
Yun ZhengHearing Center/Hearing and Speech Science Laboratory, Department of Otolaryngology Head and Neck Surgery, West China Hospital of Sichuan University, Chengdu, People's Republic of China. 1141679315@qq.com.
Dan LaiDepartment of Otolaryngology Head and Neck Surgery, The Affiliated Hospital of Southwest Medical University, 25 Taiping street, Jiangyang District, Luzhou, Sichuan, 646000, People's Republic of China.
Ping ZhongHearing Center/Hearing and Speech Science Laboratory, Department of Otolaryngology Head and Neck Surgery, West China Hospital of Sichuan University, Chengdu, People's Republic of China.
Jing-Zhe LuHearing Center/Hearing and Speech Science Laboratory, Department of Otolaryngology Head and Neck Surgery, West China Hospital of Sichuan University, Chengdu, People's Republic of China.
Gang LiHearing Center/Hearing and Speech Science Laboratory, Department of Otolaryngology Head and Neck Surgery, West China Hospital of Sichuan University, Chengdu, People's Republic of China.
Peng LiuDepartment of Otolaryngology Head and Neck Surgery, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, No. 16 Yard, Airport Road, Guangzhou, 510405, People's Republic of China.
Sichuan University · CNFirst Affiliated Hospital of Guangzhou University of Chinese Medicine · CNSouthwest Medical University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIdiopathic sudden sensorineural hearing loss (ISSNHL) is a major cause of deafness. Despite the advances in systemic therapy, some cases of ISSNHL are untreated, because the exact ISSNHL aetiology is unclear. Traditional Chinese medicine (TCM) has been used to treat diseases for thousands of years and is popular and widely practiced in Asia. TCM includes guidance on a healthy lifestyle. In recent decades, the relationship between lifestyle and disease has been emphasised; an unhealthy lifestyle may lead to illnesses. Thus, this study aims to compare the efficacy of lifestyle modification based on TCM with the usual consultation of ISSNHL after failure of a 2-week systemic therapy to provide a scientific basis for clinical decisions.

methodsThis study is a clinical randomised trial that involves 56 patients diagnosed with ISSNHL but who have had incomplete recovery after initial management (at least 2 weeks of routine Western medical treatment). The study is performed in accordance with the sudden hearing loss clinical guideline of the American Academy of Otolaryngology-Head and Neck Surgery, published in 2012. Participants are randomly distributed into two groups: the healthy lifestyle modification group based on TCM and the control group (1:1 ratio). Patient follow-up lasts for 3 months. The primary outcome measure is the effective rate of hearing improvement, which is defined as the proportion of patients with at least 15 dB of improvement in the average thresholds of hearing loss frequency. The secondary outcome measures are improvements in word recognition score, Tinnitus Handicap Inventory and visual analogue scale for ear blockage and dizziness. Assessments are made at baseline and after lifestyle modification for 1 and 3 months. DISCUSSION: The efficacy of healthy lifestyle modification based on a TCM programme for patients with ISSNHL with incomplete recovery after failure of initial systemic therapy is determined in this trial. Positive results will provide clinical evidence on the effects of a TCM-based healthy lifestyle, which could be recommended as salvage therapy for patients with ISSNHL.

trial registrationChinese Clinical Trial Registry, ChiCTR-INR-17011459. Registered on 22 May 2017.

Indexed as

Healthy LifestyleMedicine, Chinese TraditionalPatient Education as TopicRandomized Controlled Trials as TopicReferral and ConsultationAdultHearing Loss, SensorineuralHumansMiddle AgedOutcome Assessment, Health CareYoung Adult

Identifiers

PMID31791370
PMCPMC6889698
OpenAlexW2990624606

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

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.