Evidence map›Paper›PMID 32539850›Full record

ArticleTrials2020

Efficacy, safety, and economic assessment of hominis placental pharmacopuncture for chronic temporomandibular disorder: a protocol for a multicentre randomised controlled trial.

Jongho Kim, Kyoung Sun Park, Yoon Jae Lee, Koh-Woon Kim, Jae-Heung Cho, In-Hyuk Ha

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
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 NCT04087005 (Efficacy and Safety of JHG002), which is not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
0.2field-weighted citation impact, top 47% 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.

NCT04087005 nacompletednot on this map

Efficacy and Safety of JHG002(Hominis Placenta, 紫河車) Therapy for Chronic Temporomandibular Joint Dysfunction: A Multicenter Randomized Controlled Trial)

TypeinterventionalSponsorJaseng Medical FoundationRan2019 to 2020Enrolled82ConditionsTemporomandibular DisorderArmshominis placental pharmacopuncture
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it, 6 citations in OpenAlex.

  1. Pooled it
  2. Article
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

6 authors at 3 institutions in 1 country.

Jongho KimJaseng Hospital of Korean Medicine, 536 Gangnam-daero, Gangnamgu, Seoul, Republic of Korea.
Kyoung Sun ParkJaseng Hospital of Korean Medicine, 536 Gangnam-daero, Gangnamgu, Seoul, Republic of Korea.
Yoon Jae LeeJaseng Spine and Joint Research Institute, Jaseng Medical Foundation, 3F JS Tower, 538 Gangnam-daero, Gangnam-gu, Seoul, Republic of Korea.
Koh-Woon KimKyung Hee University Hospital at Gangdong, 892 Dongnam-ro, Gangdong-gu, Seoul, Republic of Korea.
Jae-Heung ChoKyung Hee University Hospital at Gangdong, 892 Dongnam-ro, Gangdong-gu, Seoul, Republic of Korea.
In-Hyuk HaJaseng Spine and Joint Research Institute, Jaseng Medical Foundation, 3F JS Tower, 538 Gangnam-daero, Gangnam-gu, Seoul, Republic of Korea. hanihata@gmail.com.
Jaseng Medical Foundation · KRKyung Hee University Hospital at Gangdong · KRJaseng Hospital of Korean Medicine · KR

Funding

Korea Health Industry Development Institute HB16C0059
6 · The paper itself

Abstract

backgroundTemporomandibular disorder (TMD) is a condition encompassing clinical symptoms of the temporomandibular joint, masseter muscle, and surrounding structures. Hominis placental pharmacopuncture (HPP), consisting of human placental extract, has been reported as effective for treating chronic musculoskeletal disorders, but a lack of well-designed randomised controlled trial s (RCTs) mean there is insufficient evidence to prove the efficacy of HPP.

methodsThis study is a two-arm parallel, assessor-blinded, multi-centre, randomised controlled trial. We will enrol 82 chronic TMD patients from rwo Korean Medicine hospitals in Axis 1, Group I according to RDC/TMD diagnostic criteria, and randomly allocate 41 patients each to an HPP group and a physical therapy (PT) group. Treatment will be administered in 10 rounds, after which there will be four follow-up visits 6, 9, 13, and 25 weeks from baseline. The primary end point is 6 weeks after baseline, and the primary outcome is the difference in Visual Analogue Scale (VAS) score for temporomandibular pain between baseline and week 6. Secondary outcomes will be Numeric Rating Scale (NRS) scores for temporomandibular pain and discomfort, temporomandibular joint range of motion, the Korean version of Beck's Depression Index-II (K-BDI-II), Jaw Functional Limitation Scale (JFLS), Patient Global Impression of Change (PGIC) scores, and quality of life. Using data on adverse events and cost-effectiveness in the two groups, we will perform a safety assessment and a cost-effectiveness analysis (economic assessment). DISCUSSION: This study will assess the efficacy and safety of HPP for chronic TMD compared with PT. This RCT will provide evidence for the efficacy, safety, and economics of HPP.

trial registrationclinicaTrials.gov (NCT04087005) / Clinical Research Information Service (CRIS) (KCT0004437) / IRB (JASENG 2017-09-002-002, KHNMCOH 2019-08-002) / Ministry of Food and Drug Safety (No. 31886).

Indexed as

Acupuncture TherapyChronic DiseaseCost-Benefit AnalysisHumansMulticenter Studies as TopicPlacental ExtractsQuality of LifeRandomized Controlled Trials as TopicRepublic of KoreaTemporomandibular JointTemporomandibular Joint DisordersTime FactorsTreatment OutcomeVisual Analog ScalePlacental ExtractsHominis placental pharmacopuncturePharmacopunctureProtocolRandomised controlled trialTemporomandibular disorder

Identifiers

PMID32539850
PMCPMC7294621
OpenAlexW3035210109

What OpenQuestion holds

Textmetadata
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.