Evidence map›Paper›PMID 37424700›Full record

ArticleInternational journal of women's health2023

The Effect and Safety Assessment of Metformin and DLBS3233 (A Bioactive Fraction of

Syarief Thaufik Hidayat, Inu Mulyantoro, Suhartono Damas, Raymond R Tjandrawinata

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in International journal of women's health, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT01999686. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.1field-weighted citation impact, top 21% 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.

NCT01999686 phase3completed

Polycystic Ovary Syndrome Treatment Using DLBS3233, Metformin, and Combination of Both, and Its Relation to Fertility

Ran2014Enrolled186Registered outcomes14Posted comparisons0ConditionsInsulin Resistance, Polycystic Ovary Syndrome (PCOS)ArmsDLBS3233, Metformin XR, Placebo DLBS3233, placebo metformin
Open the trial in the graph
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 4 citations in OpenAlex.

  1. Review
  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

4 authors at 1 institution in 1 country.

Syarief Thaufik HidayatObstetric Gynecology Department, Faculty of Medicine, Diponegoro University, Semarang, Indonesia.
Inu MulyantoroObstetric Gynecology Department, Faculty of Medicine, Diponegoro University, Semarang, Indonesia.
Suhartono DamasEnviromental Health Department, Diponegoro University, Semarang, Indonesia.
Raymond R TjandrawinataResearch and Business Development, Dexa Laboratories of Biomolecular Science Research, Tangerang, Indonesia.ORCID 0000-0003-0461-9874
Diponegoro University · ID

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Polycystic ovary syndrome (PCOS) can lead to compensatory hyperinsulinemia with consequent metabolic abnormalities in women. In this study, DLBS3233 and Metformin were used to be tested. DLBS3233 itself is the new insulin-sensitizing drug, a combination-bioactive-fraction derived from two Indonesian herbals, Methods: A randomized, double-blind, 3-arm, double-dummy, non-inferiority, and also a controlled clinical study was conducted at the Dr. Kariadi Hospital, Indonesia, between October 2014 and February 2019. The study involved 60 female subjects (with 20 female subjects in each group) that had polycystic ovary syndrome (PCOS).Treatment I consists of one placebo capsule twice per day and one 100 mg DLBS3233 capsule once per day. Treatment II consists of one placebo caplet once per day and one 750 mg Metformin XR caplet twice per day. Treatment III consists of one 750 mg Metformin XR caplet twice per day and one 100 mg DLBS3233 capsule once per day. Results: In treatment I, the homeostatic model assessment for insulin resistance (HOMA-IR) levels were 3.55, 3.59, and 3.80 at pretest, 3 months, and 6 months after intervention, respectively. In treatment II, the HOMA-IR level were 4.00, 2.21, and 4.40 at pretest, 3 months, and 6 months after intervention respectively. In treatment III, the HOMA-IR levels were 3.30, 2.86, and 3.12 at pretest, 3 months, and 6 months after intervention, respectively. There was no apparent difference existed in the fasting plasma glucose (FPG), high-density lipoprotein (HDL), triglycerides, ferriman-gallwey scores (FGS), and safety assessment on vital signs and laboratory examinations (liver function and renal function) in all groups. Conclusion: Either DLBS3233 alone or the DLBS3233/Metformin combination showed no significant efficacy and did not negatively affect cardiovascular function, liver and kidney function in PCOS subjects. ClinicalTrialsgov Identifier: NCT01999686 Date: 3rd of December, 2013.

Indexed as

DLBS3233homeostatic model assessment for insulin resistancemetabolic parametersmetforminpolycystic ovary syndrome

Identifiers

PMID37424700
PMCPMC10329438
OpenAlexW4383068918

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.