Evidence map›Paper›PMID 29982213›Full record

ArticleBMJ open2018

Sipjeondaebo-tang in patients with breast cancer with fatigue: a protocol for a pilot, randomised, double-blind, placebo-controlled, cross-over trial.

Chunhoo Cheon, Sohyeon Kang, Youme Ko, Mia Kim, Bo-Hyoung Jang, Yong-Cheol Shin, Seong-Gyu Ko

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02858856 (Sipjeondaebo-tang for Alleviating Fatigue Measured by Brief Fatigue Inventory and EORTC-QLQ-C30, BR23 Score Change Among Patients With Breast Carcinoma Receiving Chemotherapy), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
–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.

NCT02858856 naunknown statusnot on this map

Sipjeondaebo-tang for Alleviating Fatigue Measured by Brief Fatigue Inventory and EORTC-QLQ-C30, BR23 Score Change Among Patients With Breast Carcinoma Receiving Chemotherapy

TypeinterventionalSponsorKyunghee University Medical CenterRan2017 to 2018Enrolled48ConditionsBreast CarcinomaArmsSipjeondaebo-tang
3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

  1. Trial
  2. Article
  3. Review
  4. Recent Advances inMetabolites · 2022
    Review
  5. Effectiveness a herbal medicine (Integrative medicine research · 2021
    Article
  6. Article
  7. Article
  8. 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

7 authors.

Chunhoo CheonDepartment of Korean Preventive Medicine, Graduate School, Kyung Hee University, Seoul, Republic of Korea.
Sohyeon KangDepartment of Korean Preventive Medicine, Graduate School, Kyung Hee University, Seoul, Republic of Korea.
Youme KoDepartment of Korean Preventive Medicine, Graduate School, Kyung Hee University, Seoul, Republic of Korea.
Mia KimDepartment of Cardiovascular and Neurologic Disease (Stroke Center), College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea.
Bo-Hyoung JangDepartment of Korean Preventive Medicine, Graduate School, Kyung Hee University, Seoul, Republic of Korea.
Yong-Cheol ShinDepartment of Korean Preventive Medicine, Graduate School, Kyung Hee University, Seoul, Republic of Korea.
Seong-Gyu KoDepartment of Korean Preventive Medicine, Graduate School, Kyung Hee University, Seoul, Republic of Korea.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionCancer-related fatigue is a frequent symptom in patients with cancer and one of the most distressing symptoms in patients with breast cancer. Sipjeondaebo-tang (Juzen-taiho-to in Japanese or Shi-Quan-Da-Bu-Tang in Chinese) is a widely used herbal medicine for the treatment of fatigue in Korea, China and Japan. The purpose of the present study is to evaluate the feasibility of Sipjeondaebo-tang for cancer-related fatigue. METHODS AND ANALYSIS: The present study is a randomised, double-blind, placebo-controlled, cross-over study. Forty-eight patients with breast cancer who are indicated for doxorubicin and cyclophosphamide will be recruited. The participants will receive 3 g of Sipjeondaebo-tang or a placebo three times a day for 56 days. The primary outcome measurement is the change in the Brief Fatigue Inventory scores. The secondary outcome measurements include the changes in the Visual Analogue Scale (VAS) of fatigue, and quality of life measured by the European Organization for Research and Treatment of Cancer-QLQ-C30 and QLQ-BR23. VAS of fatigue will be measured on every visit, and other outcomes will be measured on visits 2, 4, 6 and 7. The total study period is 14 weeks. ETHICS AND DISSEMINATION: This study has been approved by the Institutional Review Board of the Catholic Kwandong University International St Mary's Hospital (reference IS16MNSI0011). The results of this study will be published in a peer-reviewed journal and presented at a scientific conference. TRIAL REGISTRATION NUMBER: NCT02858856; Pre-results.

Indexed as

Randomized Controlled Trials as TopicAdultAntineoplastic AgentsBreast NeoplasmsCross-Over StudiesDouble-Blind MethodDrugs, Chinese HerbalFatigueFemaleHerbal MedicineHumansMiddle AgedPhytotherapyPilot ProjectsPlant ExtractsQuality of LifeAntineoplastic AgentsDrugs, Chinese HerbaljuzentaihotoPlant Extractsbreast tumoursclinical trialscomplementary medicineherbal medicine

Identifiers

PMID29982213
PMCPMC6042596

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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.