Evidence map›Paper›PMID 38374490›Full record

Trial reportChinese journal of integrative medicine2024

Effect and Safety of Herbal Medicine Foot Baths in Patients with Diabetic Peripheral Neuropathy: A Multicenter Double-Blind Randomized Controlled Trial.

Hao-Yue Huang, Yu-Ping Lin, Hua Wei, Yu Fu, Yue-Hong Zhou, Zhao-Hui Fang, Xiao-Tang Qiu, Mei Wang, Qing-Bo Li, Shan-Shan Li and 30 more

Abstract readRandomized Controlled TrialMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Chinese journal of integrative medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

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

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

  1. Pooled it
  2. Review
  3. 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

40 authors.

Hao-Yue HuangDepartment of Endocrinology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.
Yu-Ping LinDepartment of Endocrinology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.
Hua WeiDepartment of Endocrinology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.
Yu FuDepartment of Endocrinology, The First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, 450000, China.
Yue-Hong ZhouDepartment of Endocrinology, Liuyang Hospital of Chinese Medicine, Changsha, 410000, China.
Zhao-Hui FangDepartment of Endocrinology, The First Affiliated Hospital of Anhui University of Chinese Medicine, Hefei, 230000, China.
Xiao-Tang QiuDepartment of Endocrinology, Hainan Provincial Hospital of Traditional Chinese Medicine, Haikou, 570100, China.
Mei WangDepartment of Endocrinology, The Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Shenyang, 110000, China.
Qing-Bo LiDepartment of Geriatric, Luoyang No.1 Hospital of Traditional Chinese Medicine, Luoyang, Henan Province, 471000, China.
Shan-Shan LiDepartment of Endocrinology, The Second Affiliated Hospital of Guizhou University of Traditional Chinese Medicine, Guiyang, 550000, China.
Shi-Dong WangDepartment of Endocrinology, Beijing University of Chinese Medicine Affiliated Dongzhimen Hospital, Beijing, 100000, China.
Fang DaiDepartment of Endocrinology, The First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine, Guiyang, 550000, China.
Zhen-Jie LiuDepartment of Endocrinology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.
Ling ZhaoDepartment of Endocrinology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.
Jian-Xuan WenDepartment of Endocrinology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.
Li-Yan WuDepartment of Endocrinology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.
Hui-Yan ZengDepartment of Endocrinology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.
Jin-Ming ZhangDepartment of Endocrinology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.
Qi-Yun LuDepartment of Endocrinology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.
Liu HeDepartment of Endocrinology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.
Wei SongDepartment of Endocrinology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.
Lu SunDepartment of Endocrinology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.
Lu-Lu LuoDepartment of Endocrinology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.
Jia-Li HeDepartment of Endocrinology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.
Wen-Wen XieDepartment of Endocrinology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.
Qing-Shun LiangDepartment of Endocrinology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.
Yuan HuangDepartment of Endocrinology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.
Sheng-Ling ZhuDepartment of Endocrinology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.
Jie-Er LongDepartment of Endocrinology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.
Zhi-Juan GaoDepartment of Endocrinology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.
Ze-Huai WenThe Second Clinical College of Guangzhou University of Chinese Medicine, Guangzhou, 510120, China.
Chun-Ji LiThe Second Clinical College of Guangzhou University of Chinese Medicine, Guangzhou, 510120, China.
Wen-Wei OuyangThe Second Clinical College of Guangzhou University of Chinese Medicine, Guangzhou, 510120, China.
Geng LiThe Second Clinical College of Guangzhou University of Chinese Medicine, Guangzhou, 510120, China.
Ming-Hui WuDepartment of Endocrinology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.
An-Xiang LiDepartment of Endocrinology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.
Jin-Zhu HuangThe Second Clinical College of Guangzhou University of Chinese Medicine, Guangzhou, 510120, China.
Sanjoy K PaulMelbourne EpiCentre, The University of Melbourne and Melbourne Health, Melbourne, 3013, Australia.
Xian-Yu TangDepartment of Endocrinology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China. 13922212818@139.com.
Guan-Jie FanDepartment of Endocrinology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China. 13925119990@139.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate the effect and safety of foot baths with Tangbi Waixi Decoction (TW) in treating patients with diabetic peripheral neuropathy (DPN).

methodsIt is a multicenter double-blinded randomized controlled trial. Participants with DPN were recruited between November 18, 2016 and May 30, 2018 from 8 hospitals in China. All patients received basic treatments for glycemic management. Patients received foot baths with TW herbal granules either 66.9 g (intervention group) or 6.69 g (control group) for 30 min once a day for 2 weeks and followed by a 2-week rest, as a therapeutic course. If the Toronto Clinical Scoring System total score (TCSS-TS) ⩾6 points, the patients received a total of 3 therapeutic courses (for 12 weeks) and were followed up for 12 weeks. The primary outcome was change in TCSS-TS score at 12 and 24 weeks. Secondary outcomes included changes in bilateral motor nerve conduction velocity (MNCV) and sensory nerve conduction velocity (SNCV) of the median and common peroneal nerve. Safety was also assessed.

resultsTotally 632 patients were enrolled, and 317 and 315 were randomized to the intervention and control groups, respectively. After the 12-week intervention, patients in both groups showed significant declines in TCSSTS scores, and significant increases in MNCV and SNCV of the median and common peroneal nerves compared with pre-treatment (P<0.05). The reduction of TCSS-TS score at 12 weeks and the increase of SNCV of median nerve at 24 weeks in the control group were greater than those in the intervention group (P<0.05). The number of adverse events did not differ significantly between groups (P>0.05), and no serious adverse event was related with treatment.

conclusionTreatment of TW foot baths was safe and significantly benefitted patients with DPN. A low dose of TW appeared to be more effective than a high dose. (Registry No. ChiCTR-IOR-16009331).

Indexed as

Diabetes MellitusDiabetic NeuropathiesPlants, MedicinalBathsDouble-Blind MethodHumansPlant ExtractsPlant ExtractsChinese medicinediabetic peripheral neuropathyherbal medicine foot bathsrandomized controlled trialTangbi Waixi Decoction

Identifiers

What Socratic holds

Textmetadata
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 Socratic graph.