Evidence map›Paper›PMID 33834863›Full record

ArticleIntegrative cancer therapies

Exploring the Safety, Effectiveness, and Cost-Effectiveness of a Chinese Patent Medicine (Fufang E'jiao Syrup) for Alleviating Cancer-Related Fatigue: A Protocol for a Randomized, Double-Blinded, Placebo-Controlled, Multicenter Trial.

Zhuo Song, Ling-Yun Sun, Shan-Shan Gu, Xiao-Shu Zhu, He-Zheng Lai, Fang Lu, Ning Cui, Qiong-Yang Li, Yu Wu, Yun Xu

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Integrative cancer therapies. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04147312 (The Study on the Clinical Value of Fufang E'Jiao Jiang Intervening Cancer-related Fatigue), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing 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.

NCT04147312 naunknown statusnot on this map

The Study on the Clinical Value of Fufang E'Jiao Jiang Intervening Cancer-related Fatigue (Deficiency of Qi and Blood)

TypeinterventionalSponsorXiyuan Hospital of China Academy of Chinese Medical SciencesRan2019 to 2021Enrolled600ConditionsCancer-related FatigueArmsFufang E'Jiao Jiang, placebo containing low-dose fufang E'Jiao Jiang
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Review
  3. Article
  4. [Zi HuangjingSichuan da xue xue bao. Yi xue ban = Journal of Sichuan University. Medical science edition · 2023
    Article
  5. 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

10 authors.

Zhuo SongXiyuan Hospital of Chinese Academy of Chinese Medical Sciences, Beijing, China.ORCID 0000-0002-7007-297X
Ling-Yun SunXiyuan Hospital of Chinese Academy of Chinese Medical Sciences, Beijing, China.ORCID 0000-0002-7191-6177
Shan-Shan GuXiyuan Hospital of Chinese Academy of Chinese Medical Sciences, Beijing, China.ORCID 0000-0002-1153-6658
Xiao-Shu ZhuWestern Sydney University, Penrith, NSW, Australia.ORCID 0000-0002-2909-5926
He-Zheng LaiWestern Sydney University, Penrith, NSW, Australia.
Fang LuInstitution of Clinical Pharmacology, Xiyuan Hospital of Chinese Academy of Chinese Medical Sciences, Beijing, China.
Ning CuiXiyuan Hospital of Chinese Academy of Chinese Medical Sciences, Beijing, China.
Qiong-Yang LiBeijing Hospital of Traditional Chinese Medicine affiliated with Capital Medical University, Beijing, China.
Yu WuXiyuan Hospital of Chinese Academy of Chinese Medical Sciences, Beijing, China.
Yun XuXiyuan Hospital of Chinese Academy of Chinese Medical Sciences, Beijing, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo provide higher level evidence on the benefits of a Chinese patent medicine (CPM) (Fufang E'jiao Syrup, FFEJS) for alleviating cancer-related fatigue (CRF), this article describes a protocol for a randomized controlled trial. METHODS/

designWe designed a double-blind, placebo-controlled stratified permuted block randomization clinical trial on CRF among 3 types of cancer in China. Participants will be equally allocated to FFEJS group or placebo group according to the randomization sequence and the hospitals they were enrolled at. Each patient will receive 20 ml of either the study formula FFEJS or a placebo formula, 3 times a day for 6 weeks. The follow-up period will be another 4 weeks for safety evaluation. The primary outcome is the difference in improvement of fatigue as measured with the Revised Piper Fatigue Scale-Chinese Version (RPFS-CV). Secondary outcomes include change in fatigue (measured by routine blood panel and hormones in peripheral blood) and QoL (measured by Edmonton symptom assessment scale and Functional Assessment of Cancer Therapy). Patient safety will be measured by liver, renal or cardiac damage, and the risk of FFEJS having a tumor promotion and progression effect will be monitored throughout this study. Cost-effectiveness will also be evaluated mainly by incremental cost per each quality-adjusted life year gained. DISCUSSION: This article describes the study design of a CPM for CRF in patients with advanced cancer through exploring the effectiveness, safety, and cost-effectiveness of FFEJS.

trial registrationClinicalTrials.gov, NCT04147312. Registered on 1 Sep 2019.

Indexed as

Drugs, Chinese HerbalNeoplasmsChinaCost-Benefit AnalysisDouble-Blind MethodFatigueHumansMulticenter Studies as TopicNonprescription DrugsQuality of LifeRandomized Controlled Trials as TopicTreatment OutcomeDrugs, Chinese HerbalNonprescription Drugscancer-related fatigueChinese patent medicineFufang E’jiao syrupmulticenterrandomized-controlled trialtraditional Chinese medicine

Identifiers

PMID33834863
PMCPMC8711704

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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.