Evidence map›Paper›PMID 35610013›Full record

Trial reportJournal of traditional Chinese medicine = Chung i tsa chih ying wen pan2022

Efficacy and safety of Mianyi granules (+mianyi+) for reversal of immune nonresponse following antiretroviral therapy of human immunodeficiency virus-1: a randomized, double-blind, multi-center, placebo-controlled trial.

Liu Ying, Zou Wen, Xian Qingfei, Deng Xin, Zhang Fuchun, Wang Li, L I Yonghong, Lun Wenhui, Wang Jian

Open access · greenAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
0.1field-weighted citation impact, top 54% 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

2 citing papers in PubMed, 1 synthesis or guideline pooled it, 2 citations in OpenAlex.

  1. Pooled it
  2. 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

9 authors at 2 institutions in 1 country.

Liu YingTraditional Chinese Medicine Center for Acquired Immune Deficiency Syndrome Prevention and Treatment, China Academy of Chinese Medical Sciences, Beijing 100700, China.
Zou WenTraditional Chinese Medicine Center for Acquired Immune Deficiency Syndrome Prevention and Treatment, China Academy of Chinese Medical Sciences, Beijing 100700, China.
Xian QingfeiTraditional Chinese Medicine Center for Acquired Immune Deficiency Syndrome Prevention and Treatment, China Academy of Chinese Medical Sciences, Beijing 100700, China.
Deng XinRuikang Hospital Affiliated to Guangxi University of Chinese Medicine, Nanning 530011, China.
Zhang FuchunInfectious Disease Department of Guangzhou Eighth People's Hospital, Guangzhou 510060, China.
Wang LiInternal Medicine Department of Traditional Chinese Medicine, Yunnan Provincial Academy of Traditional Chinese Medicine, Kunming 650031, China.
L I YonghongDepartment of Hepatology, Shenyang Sixth People's Hospital, Shenyang 110006, China.
Lun WenhuiDepartment of Dermatology, Beijing Ditan Hospital, Beijing 100015, China.
Wang JianTraditional Chinese Medicine Center for Acquired Immune Deficiency Syndrome Prevention and Treatment, China Academy of Chinese Medical Sciences, Beijing 100700, China.
Ruikang Affiliated Hospital of Guangxi Medical University · CNThe Sixth People's Hospital of Shenyang · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo investigate whether Mianyi granules (+mianyi+) are effective and safe in reversing immune nonresponse following antiretroviral therapy (ART) in individuals with human immunodeficiency virus (HIV) infection.

methodsRandomized, double-blind, multi-center, placebo-controlled trial (factorial design) of daily oral Mianyi granules versus placebo for 72 weeks. A total of 361 HIV-positive individuals receiving ART at five Class III Grade I hospitals in China between September 2013 and January 2016 completed the study. The primary endpoints were frequencies of CD3+, CD4+, CD8+, and CD45RA+ cells at seven timepoints over the 72 weeks. Secondary endpoints included viral loads, clinical symptoms, and quality of life at 72 weeks.

resultsA total of 400 participants were enrolled in the study and randomized, of whom 361 completed the study: 189 individuals (140 men and 49 women) in the Mianyi granule group and 172 individuals (135 men and 37 women) in the placebo group. In the intent-to-treat population, CD4+ T cell counts increased from (193 ± 71) cells/mm at baseline to (288 ± 131) cells/mm post-treatment in the Mianyi granule group and from (200 ± 75) cells/mm at baseline to (264 ± 124) cells/mm post-treatment in the placebo group. Patients treated with Mianyi granule had higher increases in CD4+ T cell counts than those treated with placebo ( = 0.045). Reversal of immune nonresponse was defined as a CD4+ T cell increase of more than 100 cells/mm3. After treatment for 72 weeks, Mianyi granule was effective in reversing immune nonresponse in a higher proportion of individuals (20.2%) compared with placebo (9.7%). CD45RA+ cell counts increased from (34 ± 32) cell/mm at baseline to (51 ± 61) cells/mm post-treatment in the Mianyi granule group and from (37 ± 33) cells/mm at baseline to (48 ± 37) cells/mm post-treatment in the placebo group. Mianyi granules were more effective than placebo in increasing CD45RA+ cell counts.

conclusionsIn ART-treated HIV-positive adults with immune nonresponse, treatment with Mianyi granules for 72 weeks was safe and significantly increased CD4+ and CD45RA+ cell counts, thereby promoting immune reconstitution.

Indexed as

HIV-1HIV InfectionsAdultCD4 Lymphocyte CountDouble-Blind MethodFemaleHumansMaleQuality of LifeViral Loadantiretroviral therapyHIV-1immunityMianyi granulessafetytreatment outcome

Identifiers

PMID35610013
PMCPMC9924765
OpenAlexW4282917516

What OpenQuestion holds

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Registered trials

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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.