Evidence map›Paper›PMID 27769284›Full record

Trial reportTrials2016

The effect of berberine on insulin resistance in women with polycystic ovary syndrome: detailed statistical analysis plan (SAP) for a multicenter randomized controlled trial.

Ying Zhang, Jin Sun, Yun-Jiao Zhang, Qian-Yun Chai, Kang Zhang, Hong-Li Ma, Xiao-Ke Wu, Jian-Ping Liu

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01138930 (Effect of Berberine on Hormonal and Metabolic Features in Obese Women With PCOS), which is not on this map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
0.9field-weighted citation impact, top 23% 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.

NCT01138930 naunknown statusnot on this map

Effect of Berberine on Hormonal and Metabolic Features in Obese Women With PCOS

TypeinterventionalSponsorHeilongjiang University of Chinese MedicineRan2010 to 2013Enrolled120ConditionsPolycystic Ovary Syndrome, ObesityArmsBerberine, Placebo
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 9 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Review
  4. Article
  5. Article
  6. 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

8 authors at 2 institutions in 1 country.

Ying ZhangCenter for Evidence-based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, 100029, China.
Jin SunCenter for Evidence-based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, 100029, China.
Yun-Jiao ZhangCenter for Evidence-based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, 100029, China.
Qian-Yun ChaiCenter for Evidence-based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, 100029, China.
Kang ZhangCenter for Evidence-based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, 100029, China.
Hong-Li MaDepartment of Obstetrics and Gynecology, First Affiliated Hospital of Heilongjiang University of Chinese Medicine, Harbin, 150040, China.
Xiao-Ke WuDepartment of Obstetrics and Gynecology, First Affiliated Hospital of Heilongjiang University of Chinese Medicine, Harbin, 150040, China. xiaokewu2002@vip.sina.com.
Jian-Ping LiuCenter for Evidence-based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, 100029, China. Jianping_l@hotmail.com.
Beijing University of Chinese Medicine · CNFirst Affiliated Hospital of Heilongjiang University of Chinese Medicine · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAlthough Traditional Chinese Medicine (TCM) has been widely used in clinical settings, a major challenge that remains in TCM is to evaluate its efficacy scientifically. This randomized controlled trial aims to evaluate the efficacy and safety of berberine in the treatment of patients with polycystic ovary syndrome. In order to improve the transparency and research quality of this clinical trial, we prepared this statistical analysis plan (SAP).

methodsThe trial design, primary and secondary outcomes, and safety outcomes were declared to reduce selection biases in data analysis and result reporting. We specified detailed methods for data management and statistical analyses. Statistics in corresponding tables, listings, and graphs were outlined. DISCUSSION: The SAP provided more detailed information than trial protocol on data management and statistical analysis methods. Any post hoc analyses could be identified via referring to this SAP, and the possible selection bias and performance bias will be reduced in the trial.

trial registrationThis study is registered at ClinicalTrials.gov, NCT01138930 , registered on 7 June 2010.

Indexed as

Data Interpretation, StatisticalInsulin ResistanceAdolescentAdultBerberineClinical ProtocolsDrugs, Chinese HerbalFemaleHumansModels, StatisticalPolycystic Ovary SyndromeResearch DesignTime FactorsTreatment OutcomeYoung AdultBerberineDrugs, Chinese HerbalBerberinePolycystic ovary syndromeRandomized controlled trialStatistical analysis planTraditional Chinese medicine

Identifiers

PMID27769284
PMCPMC5073878
OpenAlexW2535444310

What OpenQuestion holds

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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.