Evidence map›Paper›PMID 28097013›Full record

ArticleBMC obesity2017

Randomised, double-blind, clinical investigation to compare orlistat 60 milligram and a customized polyglucosamine, two treatment methods for the management of overweight and obesity.

Manfred Stoll, Norman Bitterlich, Umberto Cornelli

Registry-linked trialOpen access · hybridAbstract read
In one paragraph

Article in BMC obesity, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02529631 (Randomized, Double-blind, Clinical Investigation to Compare Orlistat 60 mg and a Customized Polyglucosamine, Two Treatment Methods for the Management of Overweight and Obesity), which is not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
0.4field-weighted citation impact, top 37% 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.

NCT02529631 nacompletednot on this map

Randomized, Double-blind, Clinical Investigation to Compare Orlistat 60 mg and a Customized Polyglucosamine, Two Treatment Methods for the Management of Overweight and Obesity

TypeinterventionalSponsorCertmedica International GmbHRan2009 to 2013Enrolled64ConditionsOverweight, ObesityArmsorlistat 60 mg, polyglucosamine
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 6 citations in OpenAlex.

  1. Pooled it
  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

3 authors at 2 institutions in 2 countries.

Manfred StollDiabetological Center, Frankfurter Str. 50, D-63303 Dreieich, Germany.
Norman BitterlichMedizin and Service GmbH, Abt. Biostatistik, Boettcherstr. 10, D-09117 Chemnitz, Germany.
Umberto CornelliLoyola University School of Medicine, 2160 South First Avenue, Maywood, Illinois 60153 USA.
Biotest (Germany) · DELoyola University Chicago · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe efficacy of a non-prescription drug to support weight loss programs has yet to be compared. This clinical trial investigates the comparability of orlistat 60 milligram (mg) and polyglucosamine.

methodsSixty-four overweight or obese subjects were included in a two-center double-blind study. One center was in Germany [center 1] and the other was in Italy [center 2]. The subjects (26 in center 1 and 38 in center 2) were recommended to follow a calorie deficit of about 2000 kilojoules/day and to increase their physical activity to 3 metabolic equivalent hours (MET h)/day. In both centers, subjects were randomized to receive polyglucosamine (2 tablets x 2) or orlistat (1 capsule x 3) for a period of 12 weeks. Weight loss was considered as a main variable together with the reduction of 5 per cent (%) of body weight (5R). Body Mass Index (BMI) and waist circumference (WC) were taken as secondary variables.

resultsA significant difference in weight loss between the two groups was shown, 6.7 ± 3.14 kilogram (kg) in group polyglucosamine versus 4.8 ± 2.24 kg in group orlistat (t test

conclusionsEven though both groups were instructed to adopt a calorie restricted diet together with increased physical activity an additional weight loss in the polyglucosamine group of 1.6 kilogram (kg) compared to the orlistat group (6.2 ± 3.46 versus 4.6 ± 2.36 kg) in both centers was seen despite the higher consumption of carbohydrates in Italy (center 2). A typical Italian diet is usually high in carbohydrate content whereas Germans tend to consume meals with higher fat content. This leads to the assumption that polyglucosamine limits both fat and carbohydrate absorption which would explain the comparable effective weight reduction in the Italian participants.

trial registrationTrial registration at ClinicalTrials.gov NCT02529631, registered on Aug 19, 2015 retrospectively registered.

Indexed as

L 112ObesityOrlistatOverweightPolyglucosamineWeight lossWeight reduction

Identifiers

PMID28097013
PMCPMC5225614
OpenAlexW2576881729

What OpenQuestion holds

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LicenceCC BY
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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.