Evidence map›Paper›PMID 26839010›Full record

Trial reportBMJ open2016

Efficacy and safety of the Chaihuguizhiganjiang-suanzaoren granule on primary insomnia: study protocol for a randomised controlled trial.

Qing-Quan Liu, Jie Zhang, Rong-Juan Guo, Ying-Zhen Xie, Qing-Nan Fu, Tian He, Xue-Qi Zhu, Jie Du, Jing Yang, Jia-Lin Wang and 4 more

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMJ open, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.3field-weighted citation impact, top 18% 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

4 citing papers in PubMed, 11 citations in OpenAlex.

  1. Article
  2. Sour Jujube (Foods (Basel, Switzerland) · 2024
    Review
  3. Article
  4. 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

14 authors at 3 institutions in 1 country.

Qing-Quan LiuBeijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, Beijing, China.
Jie ZhangBeijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, Beijing, China.
Rong-Juan GuoDongfang Hospital affiliated to Beijing University of Traditional Chinese Medicine, Beijing, China.
Ying-Zhen XieDongzhimen Hospital Affiliated to Beijing University of Traditional Chinese Medicine, Beijing, China.
Qing-Nan FuBeijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, Beijing, China.
Tian HeBeijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, Beijing, China.
Xue-Qi ZhuBeijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, Beijing, China.
Jie DuBeijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, Beijing, China.
Jing YangBeijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, Beijing, China.
Jia-Lin WangDongfang Hospital affiliated to Beijing University of Traditional Chinese Medicine, Beijing, China.
Min-Min WeiDongzhimen Hospital Affiliated to Beijing University of Traditional Chinese Medicine, Beijing, China.
Qian-Qian LiBeijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, Beijing, China.
Guang-Xia ShiBeijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, Beijing, China.
Cun-Zhi LiuBeijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, Beijing, China.
Beijing Hospital of Traditional Chinese Medicine · CNCapital Medical University · CNDongzhimen Hospital Affiliated to Beijing University of Chinese Medicine · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionInsomnia is a highly prevalent, often debilitating and economically burdensome sleep disorder with limited effective therapies. Few data are available to understand which of the therapeutic alternatives is the most effective for patients with insomnia, especially for Traditional Chinese Medicine (TCM). Chinese herbal medicine, as a typical TCM, is one of the most popular complementary and alternative therapies for insomnia. We aim to evaluate the efficacy and safety of the Chaihuguizhiganjiang-suanzaoren granule (CSG), a Chinese herbal medicine treatment, in patients with primary insomnia. METHODS AND ANALYSIS: This is a multicentre, placebo-controlled, double-blinded, randomised controlled clinical trial. A total of 258 participants are randomly allocated to two groups: the intervention group or the placebo group. The intervention group receives CSG and the placebo group receives a placebo granule. The patients receive either CSG or placebo two times daily for 8 weeks. The primary outcome is the Pittsburgh sleep quality index (PSQI). Secondary outcomes include the Insomnia Severity Index (ISI), Total Sleep Time (TST) and the Short-Form Health Survey (SF-36). The assessment is performed at baseline (before randomisation), 4, 8 and 12 weeks after randomisation. ETHICS AND DISSEMINATION: The protocol has been approved by the Research Ethical Committee of Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University (reference: 2014BL-003-01). The trial will be helpful in identifying the efficacy and safety of CSG in patients with primary insomnia. TRIAL REGISTRATION NUMBER: ISRCTN22001145; Pre-results.

Indexed as

Research DesignAdolescentAdultAgedDouble-Blind MethodDrugs, Chinese HerbalFemaleHumansMaleMedicine, Chinese TraditionalMiddle AgedSleep Initiation and Maintenance DisordersTreatment OutcomeYoung AdultDrugs, Chinese Herbalsaiko-keishi-tosuanzaorenORAL MEDICINE

Identifiers

PMID26839010
PMCPMC4746467
OpenAlexW2262744133

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.