Evidence map›Paper›PMID 25309637›Full record

ArticleThe EPMA journal2014

Safety and tolerability of DIM-based therapy designed as personalized approach to reverse prostatic intraepithelial neoplasia (PIN).

Mikhail Paltsev, Vsevolod Kiselev, Ekaterina Muyzhnek, Vadim Drukh, Igor Kuznetsov, Olga Pchelintseva

Open access · hybridAbstract read
In one paragraph

Article in The EPMA journal, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.7field-weighted citation impact, top 25% 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

1 citing paper in PubMed, 4 citations in OpenAlex.

  1. 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

6 authors at 2 institutions in 1 country.

Mikhail PaltsevNational Research Centre (NRC 'Kurchatov Institute'), 1, Akademika Kurchatova pl., Moscow 123182, Russia.
Vsevolod KiselevPeoples' Friendship University of Russia, Miklukho-Maklaya str. 6, 117198 Moscow, Russia.
Ekaterina MuyzhnekZAO 'MiraxBioPharma', 12 Kutuzovsky av., 121248 Moscow, Russia.
Vadim DrukhPeoples' Friendship University of Russia, Miklukho-Maklaya str. 6, 117198 Moscow, Russia.
Igor KuznetsovMoscow State Medical Stomatological University (MGMSU), Delegatskaya St. 2/1, 127473 Moscow, Russia.
Olga PchelintsevaPeoples' Friendship University of Russia, Miklukho-Maklaya str. 6, 117198 Moscow, Russia.
Peoples' Friendship University of Russia · RUKurchatov Institute · RU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIt has been shown previously that novel formulation of 3,3'-diindolylmethane (DIM) substance with high bioavailability (Infemin) inhibits tumor development due to the tumor growth rate reduction in the xenograft model of prostate cancer. Prostatic intraepithelial neoplasia (PIN) is considered to be promising as a personalized and preventive treatment strategy of prostate cancer (PC). We assessed the safety of Infemin in men with PIN and discussed the interim results. MATERIALS AND

methodsA total of 14 patients with PIN were enrolled. They were randomized to 900 mg DIM or placebo daily for 3 months. Safety was evaluated by adverse events (AEs), laboratory tests and physical examinations. RESULTS AND

conclusionThe trial revealed that Infemin treatment is associated with minimal toxicity and no serious adverse events when administered orally for 3 months. We noted three adverse events including nausea and diarrhea in two patients (14%). Combined 95% confidence interval (CI) was 1.8%-42.8%. Therapy was continued in all cases of adverse events. Good tolerability of DIM-based formulation allows us to recommend it for further clinical trials among men diagnosed with PIN for its efficacy and long-term safety parameters.

Indexed as

3,3′-DiindolylmethaneBioavailabilityInfeminMolecularly targeted treatmentPersonalized medicinePreclinical trialsProstate cancerProstatic intraepithelial neoplasiaSafetyTargeted preventionTolerability

Identifiers

PMID25309637
PMCPMC4193909
OpenAlexW2115941637

What OpenQuestion holds

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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.