Evidence map›Paper›PMID 31996267›Full record

ArticleTrials2020

Efficacy and safety of Ojeok-san plus Saengmaek-san for gastroesophageal reflux-induced chronic cough: protocol for a pilot, randomized, double-blind, placebo-controlled trial.

Yeon Hee Bhang, Kwan-Il Kim, Jaehyo Kim, Junmo Ahn, Hwan-Su Jung, Changsop Yang, Seok-Jae Ko, Youngmin Bu, Jae-Woo Park, Kyoung Sun Park and 3 more

Abstract 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. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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

4 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  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

13 authors.

Yeon Hee BhangDivision of Allergy, Immune and Respiratory System, Department of Internal Medicine, College of Korean Medicine, Kyung Hee University, 26 Kyung Heedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea.
Kwan-Il KimDivision of Allergy, Immune and Respiratory System, Department of Internal Medicine, College of Korean Medicine, Kyung Hee University, 26 Kyung Heedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea.
Jaehyo KimDivision of Allergy, Immune and Respiratory System, Department of Internal Medicine, College of Korean Medicine, Kyung Hee University, 26 Kyung Heedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea.
Junmo AhnDepartment of Clinical Korean Medicine, Graduate School, Kyung Hee University, 26 Kyung Heedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea.
Hwan-Su JungCollege of Korean Medicine, Sang-Ji University, 83 sangjidae-gil, Wonju-si, Ganwondo, 26339, Republic of Korea.
Changsop YangClinical Medicine Division, Korea Institute of Oriental Medicine, Daejeon, 34054, Republic of Korea.
Seok-Jae KoCollege of Korean Medicine, Kyung Hee University, 26 Kyung Heedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea.
Youngmin BuCollege of Korean Medicine, Kyung Hee University, 26 Kyung Heedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea.
Jae-Woo ParkCollege of Korean Medicine, Kyung Hee University, 26 Kyung Heedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea.
Kyoung Sun ParkCollege of Korean Medicine, Kyung Hee University, 26 Kyung Heedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea.
Hee-Jae JungDivision of Allergy, Immune and Respiratory System, Department of Internal Medicine, College of Korean Medicine, Kyung Hee University, 26 Kyung Heedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea.
Jun-Hwan LeeClinical Medicine Division, Korea Institute of Oriental Medicine, Daejeon, 34054, Republic of Korea. omdjun@kiom.re.kr.
Beom-Joon LeeDivision of Allergy, Immune and Respiratory System, Department of Internal Medicine, College of Korean Medicine, Kyung Hee University, 26 Kyung Heedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea. franchisjun@naver.com.ORCID http://orcid.org/0000-0003-4205-1175

Funding

Korea Institute of Oriental Medicine K18121
6 · The paper itself

Abstract

backgroundGastroesophageal reflux disease (GERD) is a major cause of chronic cough. GERD-induced chronic cough is difficult to diagnose because some patients do not complain of any gastrointestinal (GI) reflux symptoms. Although chronic cough due to GERD is highly prevalent, no effective treatment is currently available, especially for GERD-related cough without GI symptoms. Because the herbal medicines Ojeok-san and Saengmaek-san can effectively treat GERD and cough, we aim to evaluate the efficacy and safety of a combination of these components for relieving chronic cough due to GERD. METHODS/

designThis is a study protocol of a randomized, double-blind, placebo-controlled, single-center pilot trial. After a 1-week run-in period, a total of 30 patients with GERD-induced chronic cough will be randomly allocated to an intervention group (n = 15) or a placebo group (n = 15). Participants will receive 5.76 g of Ojeok-san plus Saengmaek-san or a placebo three times per day for 6 weeks. The primary outcome measures, which are the frequency and severity of cough, will be recorded using a cough diary. The secondary outcome measures will include a cough visual analogue scale, the Leicester Cough Questionnaire (Korean version), the Gastrointestinal Symptom Rating Scale, the Hull Airway Reflux (hypersensitivity) Questionnaire, the Pattern Identification for Chronic Cough Questionnaire, the Pattern Identification for Gastroesophageal Reflux Disease, and safety testing. Adverse events will also be reported. DISCUSSION: This will be the first clinical trial to explore the use of herbal medicines for GERD-related chronic cough, including patients without GI reflux symptoms. This study will provide useful evidence regarding the efficacy and safety of Ojeok-san plus Saengmaek-san treatment. In addition, this trial will offer a scientific basis for the combination of herbal medicines. This study will also provide important data for conducting a larger-scale clinical trial on GERD-induced chronic cough.

trial registrationThis trial has been registered with Clinical Research Information Service (CRIS) of South Korea (http://cris.nih.go.kr; registration number KCT0003115). Registered August 28, 2018.

Indexed as

Chronic DiseaseCoughDouble-Blind MethodGastroesophageal RefluxHumansLiriope PlantPanaxPilot ProjectsPlant ExtractsPlant PreparationsRandomized Controlled Trials as TopicRepublic of KoreaSchisandraojeok-sanPlant ExtractsPlant PreparationsChronic coughGastroesophageal reflux disease (GERD)Herbal medicineOjeok-sanRandomized controlled trialSaengmaek-san

Identifiers

PMID31996267
PMCPMC6990619

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Registered trials

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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.