Evidence map›Paper›PMID 29284520›Full record

ArticleTrials2017

Chinese herbal medicine TangBi Formula treatment of patients with type 2 diabetic distal symmetric polyneuropathy disease: study protocol for a randomized controlled trial.

De Jin, Wen-Jing Huang, Xiang Meng, Fan Yang, Yu-Jiao Zheng, Qi Bao, Mei-Zhen Zhang, Ya-Nan Yang, Qing Ni, Feng-Mei Lian and 1 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03010241 (A Randomized, Multi-center, Double-blind, Placebo-controlled Trial of Traditional Chinese Medicine in the Treatment of Diabetes Distal Symmetric Polyneuropathy), 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
0.8field-weighted citation impact, top 27% 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.

NCT03010241 early_phase1unknown statusnot on this map

A Randomized, Multi-center, Double-blind, Placebo-controlled Trial of Traditional Chinese Medicine in the Treatment of Diabetes Distal Symmetric Polyneuropathy

TypeinterventionalSponsorGuang'anmen Hospital of China Academy of Chinese Medical SciencesRan2017 to 2020Enrolled188ConditionsType 2 Diabetes MellitusArmsTangbi (prescription), Placebo
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 10 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Clinical Features and Rules of Chinese Herbal Medicine in Diabetic Peripheral Neuropathy Patients.Evidence-based complementary and alternative medicine : eCAM · 2020
    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

11 authors at 2 institutions in 1 country.

De JinGuang'anmen Hospital, China Academy of Traditional Chinese Medical Sciences, No. 5, Bei xian ge Xicheng District, Beijing, 100053, China.
Wen-Jing HuangGuang'anmen Hospital, China Academy of Traditional Chinese Medical Sciences, No. 5, Bei xian ge Xicheng District, Beijing, 100053, China.
Xiang MengBeijing University of Chinese Medicine, No. 11, Bei San Huan Dong Lu, Chaoyang District, Beijing, 100029, China.
Fan YangBeijing University of Chinese Medicine, No. 11, Bei San Huan Dong Lu, Chaoyang District, Beijing, 100029, China.
Yu-Jiao ZhengBeijing University of Chinese Medicine, No. 11, Bei San Huan Dong Lu, Chaoyang District, Beijing, 100029, China.
Qi BaoGuang'anmen Hospital, China Academy of Traditional Chinese Medical Sciences, No. 5, Bei xian ge Xicheng District, Beijing, 100053, China.
Mei-Zhen ZhangGuang'anmen Hospital, China Academy of Traditional Chinese Medical Sciences, No. 5, Bei xian ge Xicheng District, Beijing, 100053, China.
Ya-Nan YangBeijing University of Chinese Medicine, No. 11, Bei San Huan Dong Lu, Chaoyang District, Beijing, 100029, China.
Qing NiGuang'anmen Hospital, China Academy of Traditional Chinese Medical Sciences, No. 5, Bei xian ge Xicheng District, Beijing, 100053, China. niqing669@163.com.
Feng-Mei LianGuang'anmen Hospital, China Academy of Traditional Chinese Medical Sciences, No. 5, Bei xian ge Xicheng District, Beijing, 100053, China. 694397644@qq.com.
Xiao-Lin TongGuang'anmen Hospital, China Academy of Traditional Chinese Medical Sciences, No. 5, Bei xian ge Xicheng District, Beijing, 100053, China. tongxiaolin66@sina.com.
Guang’anmen Hospital · CNBeijing University of Chinese Medicine · CN

Funding

the Special Scientific Research Fund of Traditional Chinese Medicine Profession of China No.201507001-11
6 · The paper itself

Abstract

backgroundDiabetic distal symmetric polyneuropathy (DSPN) is one of the most common microvascular complications of diabetes mellitus, and it has become a major public health problem worldwide because of its high and increasing prevalence, morbidity, and disability rate. The current medications for DSPN are not entirely satisfactory. Preliminary studies indicated that the Chinese herbal TangBi Formula may alleviate signs and symptoms and improve the velocity of nerve conduction in patients with DSPN. This study was designed to determine if Chinese herbal medicine used in combination with conventional treatment is more effective than conventional treatment alone. METHODS/

designWe are conducting a multicenter, placebo-controlled, double-blind, randomized, controlled clinical trial as a means of assessing the therapeutic effects of traditional Chinese medicine (TCM) treatment. A total of 188 patients will be randomized in a 1:1 ratio to a treatment group (TangBi Formula plus mecobalamin) and a control group (placebo plus mecobalamin). The test period lasts 6 months, during which all of the patients will be given standard medical care as recommended by established guidelines. The primary outcome will be development of differences in changes in clinical symptoms and signs in patients and changes in Michigan Diabetic Neuropathy Score (MDNS) between the two groups before and after treatment. The secondary outcome will be changes in nerve conduction velocity and in single clinical signs and symptoms. Safety assessments and adverse events will also be evaluated. DISCUSSION: We postulate that patients with DSPN will benefit from therapy that includes TCM. If successful, this work will provide an evidence-based complementary therapeutic approach for treatment of DSPN.

trial registrationClinicalTrials.gov, NCT03010241 . Registered on 2 January 2017.

Indexed as

Medicine, Chinese TraditionalAdultAgedDiabetes Mellitus, Type 2Diabetic NeuropathiesDouble-Blind MethodDrugs, Chinese HerbalHumansMiddle AgedMulticenter Studies as TopicOutcome Assessment, Health CareRandomized Controlled Trials as TopicDrugs, Chinese HerbalClinical trialsDiabetic distal symmetric polyneuropathyTraditional Chinese medicineTreatment

Identifiers

PMID29284520
PMCPMC5747122
OpenAlexW2779081467

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

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.