Evidence map›Paper›PMID 18591315›Full record

Trial reportObstetrics and gynecology2008

Effects of L-isoleucine and L-valine on hot flushes and serum homocysteine: a randomized controlled trial.

Thomas Guttuso, Michael P McDermott, Haiyan Su, Karl Kieburtz

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Obstetrics and gynecology, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00081952 (Amino Acid Therapy for Hot Flashes/Postmenopausal Women), which is not on this map. Cited by 5 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 2 pooled it
0.6field-weighted citation impact, top 29% 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.

NCT00081952 phase1 / phase2completednot on this map

Amino Acid Therapy for Hot Flashes/Postmenopausal Women

TypeinterventionalSponsorNational Center for Complementary and Integrative Health (NCCIH)Ran2003 to 2007Enrolled15ConditionsHot FlashesArmsL-norleucine
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 2 syntheses or guidelines pooled it, 7 citations in OpenAlex.

  1. Variation in menopausal vasomotor symptoms outcomes in clinical trials: a systematic review.BJOG : an international journal of obstetrics and gynaecology · 2020
    Pooled it
  2. Pooled it
  3. Trial
  4. Review
  5. 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 2 institutions in 1 country.

Thomas GuttusoUniversity at Buffalo, The State University of New York, Buffalo, NY 14214, USA. tguttuso@buffalo.edu
Michael P McDermott
Haiyan Su
Karl Kieburtz
University of Rochester · USUniversity at Buffalo, State University of New York · US

Funding

YOHIMBINE CHALLENGE IN PARKINSONIAN PATIENTS WITH PANIC DISORDERM01RR000044 · NCRR · UNIVERSITY OF ROCHESTER · PI GUZICK, DAVID S · 1985 to 2006
$13.8M
Effects of Amino Acid Therapy on Hot Flashes in Postmenopausal WomenK23AT001709 · NCCIH · STATE UNIVERSITY OF NEW YORK AT BUFFALO · PI GUTTUSO, THOMAS J · 2003 to 2007
$666k
NCCIH NIH HHS 1 K23 AT 1709-01NCCIH NIH HHS K23 AT001709NCRR NIH HHS M01 RR000044NCRR NIH HHS M01 RR 00044
6 · The paper itself

Abstract

objectiveTo investigate whether L-isoleucine was effective in the treatment of hot flushes and whether L-isoleucine, L-valine, or the combination of both amino acids reduced fasting serum homocysteine.

methodsAfter a 1-week baseline period, 100 postmenopausal women experiencing at least five moderate-severe hot flushes per day were randomized with equal probability to one of four groups (phase 1/phase 2): placebo/L-valine, placebo/L-valine and L-isoleucine, L-isoleucine/L-valine, and L-isoleucine/L-valine and L-isoleucine. Phase 1 was 12 weeks long, and phase 2 was 10 weeks long. Patients took five capsules by mouth, twice a day throughout the study, with each capsule containing 500 mg of compound. Data were obtained from daily hot flush diaries, fasting blood work, and several questionnaires. The primary outcome variable was the percent change in hot flush composite score from baseline to week 12.

resultsIn phase 1 of the study, there were no significant differences between the L-isoleucine and placebo groups for any of the outcome measures. At week 12, there was a mean 13.9% decrease in hot flush composite score compared with baseline in the L-isoleucine group and a mean 25% decrease in the placebo group (P=.28). In phase 2 of the study, there was no significant change in fasting serum homocysteine levels associated with any of the amino acid therapies.

conclusionL-isoleucine therapy appears to be ineffective in the treatment of hot flushes in postmenopausal women. L-isoleucine and L-valine, either alone or in combination, appear to have no effect on fasting serum homocysteine levels. CLINCIAL

trial registrationClinicalTrials.gov, (www.clinicaltrials.gov), NCT00081952. LEVEL OF EVIDENCE: I.

Indexed as

Dietary SupplementsCalcium Channel BlockersDrug Therapy, CombinationFemaleHomocysteineHot FlashesHumansIsoleucineMiddle AgedPostmenopauseSeverity of Illness IndexValineCalcium Channel BlockersHomocysteineIsoleucineValine

Identifiers

PMID18591315
PMCPMC2742338
OpenAlexW2042387729

What OpenQuestion holds

Textmetadata
LicenceTDM
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.