Evidence map›Paper›PMID 28830541›Full record

Trial reportTrials2017

Cardioprotective effect of Platycodon grandiflorum in patients with early breast cancer receiving anthracycline-based chemotherapy: study protocol for a randomized controlled trial.

Wei Hao, Sheng Liu, Yuenong Qin, Chenping Sun, Liying Chen, Chunyu Wu, Yijia Bao

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
1.1field-weighted citation impact, top 20% 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

12 citing papers in PubMed, 1 synthesis or guideline pooled it, 17 citations in OpenAlex.

  1. Pooled it
  2. Integrative cancer therapies
    Trial
  3. Article
  4. Review
  5. Review
  6. Article
  7. Cardio-Oncology: Mechanisms, Drug Combinations, and Reverse Cardio-Oncology.International journal of molecular sciences · 2022
    Review
  8. Article
  9. The Pharmacological Effects and Health Benefits ofFoods (Basel, Switzerland) · 2020
    Review
  10. Review
  11. Review
  12. 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 1 institution in 1 country.

Wei HaoDepartment of Breast Surgery (Integrated Traditional and Western Medicine), Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine, 725 South Wanping Road, Xuhui District, Shanghai, 200032, China.
Sheng LiuDepartment of Breast Surgery (Integrated Traditional and Western Medicine), Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine, 725 South Wanping Road, Xuhui District, Shanghai, 200032, China. lshtcm@163.com.ORCID 0000-0002-0972-1512
Yuenong QinDepartment of Breast Surgery (Integrated Traditional and Western Medicine), Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine, 725 South Wanping Road, Xuhui District, Shanghai, 200032, China.
Chenping SunDepartment of Breast Surgery (Integrated Traditional and Western Medicine), Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine, 725 South Wanping Road, Xuhui District, Shanghai, 200032, China.
Liying ChenDepartment of Breast Surgery (Integrated Traditional and Western Medicine), Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine, 725 South Wanping Road, Xuhui District, Shanghai, 200032, China.
Chunyu WuDepartment of Breast Surgery (Integrated Traditional and Western Medicine), Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine, 725 South Wanping Road, Xuhui District, Shanghai, 200032, China.
Yijia BaoDepartment of Breast Surgery (Integrated Traditional and Western Medicine), Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine, 725 South Wanping Road, Xuhui District, Shanghai, 200032, China.
Shanghai University of Traditional Chinese Medicine · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAnthracyclines, alone or in combination with other drugs, are among the most effective chemotherapeutic agents to treat breast cancer both in the adjuvant and neoadjuvant setting. Unfortunately, anthracycline-associated dose-dependent cardiotoxicity is a limiting factor in clinical use. Extensive efforts have been devoted to identifying strategies to prevent anthracycline-induced cardiotoxicity. However, most cardioprotective agents have shown little effect in clinical trials. Herbal medicines are pure, natural substances that have been used for centuries in many countries, including China. This trial aims to evaluate the cardioprotective effects and safety of Platycodon grandiflorum granules compared to placebo granules in patients with early breast cancer receiving anthracycline-based chemotherapy. METHOD/

designThis study is a single-center, double-blinded, randomized, placebo-controlled, parallel-group trial. A total of 120 patients will be randomly allocated in a 1:1 ratio to receive either P. grandiflorum granules or placebo granules twice daily for 12 weeks. The primary outcome is heart failure (either clinical or subclinical). The secondary outcomes include all-cause mortality, cardiac death, electrocardiogram (ECG) findings, left ventricular diastolic function, longitudinal systolic strain and velocities measured by tissue Doppler imaging, cardiac biomarkers, such as troponin I (TnI), brain natriuretic peptide (BNP), and creatine kinase isoenzymes (CK-MB). Assessments will be performed at baseline (before randomization) and 3, 6, 9, 12, 16, and 20 weeks after randomization. DISCUSSION: This will be the first clinical trial to evaluate the cardioprotective effects and safety of P. grandiflorum in patients with early breast cancer receiving anthracycline-based chemotherapy. We are also performing this trial to assess the feasibility of a larger-scale clinical trial in the future. TRAIL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR-IPR-16009256 . Registered on 23 September 2016.

Indexed as

PlatycodonAdultAgedAnthracyclinesAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCardiotoxicityChinaClinical ProtocolsDouble-Blind MethodEchocardiography, DopplerElectrocardiographyFemaleHeart FailureHumansMiddle AgedAnthracyclinesPlant ExtractsProtective AgentsAnthracyclinesCardiotoxicityHerbal medicinePlatycodon grandiflorumProtocol

Identifiers

PMID28830541
PMCPMC5568055
OpenAlexW2748925112

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.