Evidence map›Paper›PMID 38904899›Full record

Trial reportAdvances in therapy2024

Clinical Evaluation of Effectiveness and Safety of Combined Use of Dietary Supplements Amberen

Vera A Kachko, Lee P Shulman, Irina V Kuznetsova, Yulia B Uspenskaya, Denis I Burchakov

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Advances in therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03897738 (Clinical Evaluation of Effectiveness and Safety of Combined Use of Dietary Supplements Amberen and Smart B in Women With Climacteric Syndrome in Perimenopause), which is not on this map. Cited by 3 papers.

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

NCT03897738 nacompletednot on this map

Clinical Evaluation of Effectiveness and Safety of Combined Use of Dietary Supplements Amberen and Smart B in Women With Climacteric Syndrome in Perimenopause

TypeinterventionalSponsorI.M. Sechenov First Moscow State Medical UniversityRan2019 to 2020Enrolled106ConditionsPerimenopause, Climacteric SyndromeArmsAmberen, Smart B, Placebo
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Review
  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

5 authors.

Vera A KachkoAlliance Pharma plc and Alliance Pharmaceuticals Ltd. Avonbridge House, Bath Road, Chippenham, Wiltshire, SN15 2BB, England. Vera.Kachko@allianceph.com.ORCID 0000-0002-0617-7312
Lee P ShulmanDepartment of Obstetrics and Gynecology, Feinberg School of Medicine, Northwestern University, 250 East Superior Street, Room 05-2174, Chicago, USA.ORCID 0000-0002-4781-0866
Irina V KuznetsovaVitbiomed Medical Center, 11 bld 2 Donskaya Street, Moscow, 119049, Russia.ORCID 0000-0001-5541-3767
Yulia B UspenskayaMedsanchast No 14 LLC, 3 bld. 2 Stolyarny Pereulok, Moscow, 123022, Russia.ORCID 0000-0002-5714-3462
Denis I BurchakovNOCHU DPO "Higher School of Medicine", 3A bld. 2 Malaya Semenovskaya Street, Moscow, 107023, Russia.ORCID 0000-0001-9081-9041

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPerimenopause is a time of transition in a woman's life that links her reproductive years to the cessation of ovulation, or menopause. For many women, this time is characterized by a variety of physiological and lifestyle changes, including increasing irregularity in menstrual bleeding, frequency and severity of vasomotor symptoms, etc. Therapies evaluated specifically for the perimenopausal women are very limited. This study aimed to evaluate the effectiveness and safety of Amberen

methodsWomen up to 50 years of age, in perimenopause, with vasomotor and psychosomatic symptoms of the climacteric syndrome were enrolled for the study. The trial was randomized, double-blinded, placebo-controlled, comparative, and prospective.

resultsA total of 106 participants were enrolled in the trial and, per protocol, 105 completed the trial. We observed statistically significant improvements in most of the Greene Climacteric Scale symptoms, State-Trait Anxiety Inventory (STAI), Hospital Anxiety and Depression Scale (HADS), and Well-being, Activity, and Mood (WAM) scores. The intervention was well tolerated with few adverse effects reported to be mild and transient.

conclusionThe use of this dietary supplement is safe and eliminates or improves vasomotor and psychosomatic symptoms of climacteric symptoms in perimenopausal women: it improves sleep and cognitive abilities, lowers depression and anxiety, improves mood and well-being, and positively affects quality of life. CLINICALTRIALS: GOV IDENTIFIER: NCT03897738.

Indexed as

Dietary SupplementsPerimenopauseAdultAnxietyDepressionDouble-Blind MethodFemaleHot FlashesHumansMiddle AgedProspective StudiesQuality of LifeSyndromeTreatment OutcomeVitamin B ComplexVitamin B ComplexClimacteric symptomsGreene Climacteric ScaleHADSPerimenopauseSTAISuccinate-based dietary supplementWAM

Identifiers

What OpenQuestion holds

Textmetadata
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.