FODMAP-dieet stimulatie via een APP geeft betere resultaten dan de standaard medicijnen bij patienten met eerste diagnose van PDS

Zie ook dit artikel: https://kanker-actueel.nl/het-effect-van-voeding-en-supplementen-op-prikkelbare-darm-syndroom-pds-kan-verbeterd-worden-door-bepaalde-voeding-wel-en-niet-te-eten.html

7 juli 2022: Bron: Neurogastroenterology

Een gerandomiseerde Belgische studie (N = 457) laat zien dat patiënten met een eerste diagnose van het Prikkelbare Darm Syndroom (PDS) beter kunnen worden gestimuleerd via een daarvoor ontwikkelde APP het FODMAP-dieet te gaan volgen dan drie keer daags de standaard medicijnen met otilonium en bromide, ook wel spasmomen genoemd in te nemen.

Een groter percentage patiënten in de dieetgroep dan in de medische therapiegroep had een symptoomrespons (verbetering van ten minste 50 punten op de IBS-Symptom Severity Score) na 4 weken (62% vs 51%) en na 8 weken (71% vs. 61%). Daarbij in acht nemend dat de medicijnen gecontroleerd drie keer daags werden ingenomen en het volgen van het FODMAP-dieet alleen werd gestimuleerd via een daarvoor ontwikkelde APP. Hoewel de onderzoekers wel schrijven dat er ook via de APP een hoge therapie trouw was.

Belang van deze studie staat omschreven in het abstract van de studie:

Wat is er al bekend over dit onderwerp?

Het dieet met laag fermenteerbare oligosachariden, disachariden, monosachariden en polyolen (FODMAP) is effectief voor de behandeling van IBS, zoals aangetoond bij patiënten in de tertiaire zorg.
De complexiteit van het dieet sluit de toepassing ervan bij IBS-patiënten in de eerstelijnszorg uit.
In de eerstelijnszorg worden farmacologische middelen zoals spasmolytica het vaakst gebruikt als eerstelijnstherapie.

Wat zijn de nieuwe bevindingen?

In een gecontroleerde studie met 470 nieuw gediagnosticeerde IBS-patiënten in de eerstelijnszorg, was een zelfmanagement FODMAP-verlagende smartphone-applicatie superieur aan standaard medische therapie bij het verlichten van IBS-symptomen.
De superioriteit van de dieet-app was al aanwezig bij 4 weken en hield aan bij 8 en 16 weken.
De dieet-app had een hoge acceptatie- en therapietrouw.

Hoe kan dit in de nabije toekomst van invloed zijn op de klinische praktijk?

Bij IBS-patiënten in de eerste lijn is een zelfmanagement FODMAP-verlagende smartphone-applicatie de meest effectieve initiële therapeutische benadering.

Het volledige studierapport is gratis in te zien. Klik daarvoor op de titel van het abstract:

Neurogastroenterology

Original research

Diet or medication in primary care patients with IBS: the DOMINO study - a randomised trial supported by the Belgian Health Care Knowledge Centre (KCE Trials Programme) and the Rome Foundation Research Institute

Florencia Carbone1,2,
Karen Van den Houte2,
Linde Besard1,
Céline Tack1,
Joris Arts1,3,
Philip Caenepeel1,3,
Hubert Piessevaux4,
Alain Vandenberghe5,
Christophe Matthys6,
Jessica Biesiekierski2,7,
Luc Capiau8,
Steven Ceulemans8,
Olivier Gernay8,
Lydia Jones8,
Sophie Maes8,
Christian Peetermans8,
Willem Raat9,
Jeroen Stubbe8,
Rudy Van Boxstael8,
Olivia Vandeput8,
Sophie Van Steenbergen8,
Lukas Van Oudenhove2,
Tim Vanuytsel1,2,
Michael Jones10,
http://orcid.org/0000-0002-3206-6704Jan Tack1,2,11,12
DOMINO Study Collaborators

Correspondence to Dr Jan Tack, Gastroenterology and Hepatology, KU Leuven University Hospitals Leuven, Leuven 3000, Belgium; jan.tack@med.kuleuven.ac.be

Abstract

Background In Europe, IBS is commonly treated with musculotropic spasmolytics (eg, otilonium bromide, OB). In tertiary care, a low fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP) diet provides significant improvement. Yet, dietary treatment remains to be explored in primary care. We evaluated the effect of a smartphone FODMAP-lowering diet application versus OB on symptoms in primary care IBS.

Methods IBS patients, recruited by primary care physicians, were randomised to 8 weeks of OB (40 mg three times a day) or diet and followed for 24 weeks. We compared IBS Symptom Severity Score and the proportion of responders (improvement ≥50 points) in all patients and the subgroup fulfilling Rome IV criteria (Rome+). We also evaluated treatment efficacy, quality of life, anxiety, depression, somatic symptom severity (Patient Health Questionnaire (PHQ15, PHQ9)) and treatment adherence and analysed predictors of response.

Results 459 primary care IBS patients (41±15 years, 76% female, 70% Rome+) were randomised. The responder rate after 8 weeks was significantly higher with diet compared with OB (71% (155/218) vs 61% (133/217), p=0.03) and more pronounced in Rome+ (77% (118/153) vs 62% (98/158), p=0.004). Patients allocated to diet (199/212) were 94% adherent compared with 73% with OB (148/202) (p<0.001). The significantly higher response rate with diet was already observed after 4 weeks (62% (132/213) vs 51% (110/215), p=0.02) and a high symptom response persisted during follow-up. Predictors of response were female gender (OR=2.08, p=0.04) for diet and PHQ15 (OR=1.10, p=0.02) for OB.

Conclusion In primary care IBS patients, a FODMAP-lowering diet application was superior to a spasmolytic agent in improving IBS symptoms. A FODMAP-lowering diet should be considered the first-line treatment for IBS in primary care.

Trial registration number NCT04270487.

Data availability statement

Data are available on reasonable request.

http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

Significance of this study

What is already known on this subject?

The low fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP) diet is efficacious for the treatment of IBS, as shown in tertiary care patients.
The complexity of the diet precludes its application in primary care IBS patients.
In primary care, pharmacological agents such as spasmolytics are most frequently used as first-line therapy.

What are the new findings?

In a controlled trial enrolling 470 newly diagnosed primary care IBS patients, a self-management FODMAP-lowering smartphone application was superior to standard medical therapy in alleviating IBS symptoms.
The superiority of the diet app was already present at 4 weeks and persisted at 8 and 16 weeks.
The diet app had a high acceptability and adherence rate.

How might it impact on clinical practice in the foreseeable future?

In primary care IBS patients, a self-management FODMAP-lowering smartphone application is the most effective initial therapeutic approach.

In conclusion, in this large primary care IBS cohort, an 8-week usage of a diet application was superior to standard medical therapy. The dietary application was associated to long-lasting significantly higher responder rates and improvement of IBS-SSS. Higher efficacy of the app-guided diet compared with medication was also found in Rome+ patients. Thus, the use of a simple diet application should be considered a first-line approach to manage IBS in primary care.

Data availability statement

Data are available on reasonable request.

Ethics statements

Patient consent for publication

Ethics approval

This study involves human participants and was approved by the Ethical Committee Research UZ/KU Leuven (S59482). Participants gave informed consent to participate in the study before taking part.

Acknowledgments

This study was supported by the Belgian Health Care Knowledge Centre (KCE), in collaboration with Nelle Stocquart and Hilde Nevens and by the Rome Foundation Research Institute. LVO is a research professor funded by the KU Leuven Special Research Fund (Bijzonder Onderzoeksfonds, BOF). TV is supported by a senior clinical research fellowship of the Flanders Research Foundation (FWO Vlaanderen). This study was conducted in collaboration with CRI (Cera HealthCare, Zwijnaarde Belgium) for the collection of biological samples. The DOMINO application was developed by EverywhereIM (Amsterdam, The Netherlands). We thank and acknowledge the 105 Belgian primary care physicians for their good performance and commitment in this trial as well as the 472 participating patients. The list of recruited study investigators is attached in the addendum.

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Supplementary materials

Supplementary Data

This web only file has been produced by the BMJ Publishing Group from an electronic file supplied by the author(s) and has not been edited for content.

Data supplement 1
Supplementary Data

This web only file has been produced by the BMJ Publishing Group from an electronic file supplied by the author(s) and has not been edited for content.

Data supplement 1

Footnotes

FC and KVdH are joint first authors.
Collaborators DOMINO study collaborators: Alain Goorden; Alegonda Snijkers; An Leys; Annemiek Roelofs; Bart Schoolmeesters; Bart Vander Putten; Benjamin Van den Broek; Birgitta Baade-Joret; Céline Huberlant; Christian Peetermans; David Van Humbeek; Dirk Van den Brande; Dirk Wyseyr; Els Lemmens; Ethel Brits; Guido Simons; Hans Baetens; Hendrika Van Overmeire; Hilde Tack; Ilse Cupers; Ive Talboom; Jeroen Stubbe; Jonas Docx; Judith Deseins; Julie Biot; Julie Vancaillie; Kara Vandeloo; Karlijn Louwies; Karolien De Ceulaer; Karolien Lemmens; Katrien Scheers; Leen Verleure; Lies De Sutter; Lies Plancke; Liesbet Bruyninckx; Liesbeth Vanzeir; Lieve Vandersmisse; Linde Wyseur; Lode Vermeersch; Lodewijk Pas; Lore De Greef; Luc Capiau; Luc Van Braeckel; Lut De Groote; Lydia Jones; Maria Groot; Marianne Busschots; Marie-Hélène Landenne; Marieke Monstrey; Marie-Magdalena Haemels; Marleen Snellings; Maura Sisk; Nathalie Van de Vyver; Nikea Sannen; Olivia Vandeput; Olivier Gernay; Philippe Thoné; Phouthalack Narongsack; Pierre Vrins; Pieterjan Geusens; Rik Sauwens; Rudy Van Boxstael; Sigrid Musch; Sigrid Nous; Sofie Mazereel; Sophie Maes; Sophie Van Steenbergen; Stéphanie Biot; Steven Ceulemans; Stijn Geeraert; Tine Caeyers; Vincent Vanbelle; Willem Raat.
Contributors FC: trial design, study coordination, data collection, analysis, manuscript drafting and reviewing. KVdH: study coordination, data collection, analysis, manuscript drafting and reviewing. LB: data collection, study follow-up, manuscript review. CT: data analysis, manuscript review. JA, PC, HP, AV: trial organisation support, manuscript review. CM: trial design, trial organisation support, manuscript review. JB: trial design, manuscript review. LC, SM, CP, WR, JS, RVB, OV, SVS: data collection, manuscript review. LVO, TV: manuscript review. MJ: trial design, data analysis, manuscript review. JT: trial concept, design, organisation, data collection, analysis, manuscript drafting, manuscript review and guarantor of the overall content of the article.
Funding The DOMINO study was funded through the Belgian Health Care Knowledge Centre (KCE) Trials Program (study ID KCE16001), a national public funding program of non-commercial trials. KCE provided feedback on the design and conduct of the study but was not involved in the collection, management, analysis or interpretation of the data. KCE provided comments on the drafted clinical study report and the manuscript for publication, but no publication restrictions apply. The Rome Foundation Research Institute provided diagnostic and patient-reported outcome questionnaires.
Competing interests JT has given Scientific advice to Alfa Wassermann, Allergan, Christian Hansen, Danone, Grünenthal, Ironwood, Janssen, Kiowa Kirin, Menarini, Mylan, Neutec, Novartis, Noventure, Nutricia, Shionogi, Shire, Takeda, Theravance, Tramedico, Truvion, Tsumura, Zealand and Zeria Pharmaceuticals, has received research support from Shire, Sofar and Tsumura, and has served on the Speaker Bureau for Abbott, Allergan, AstraZeneca, Janssen, Kyowa Kirin, Menarini, Mylan, Novartis, Shire, Takeda, Truvion and Zeria. Funding was provided by a Methusalem grant from Leuven University to JT. HP has given scientific advice to Allergan, Danone, Menarini, Merck Serono, Shire and Zeria and has served on the speaker Bureau of Menarini, Merck Serono, Shire and Zeria. LVO has given scientific advice to Danone and received research support from Nestlé. TV has given scientific advice to VectivBio, Shire, Dr. Falk Pharma, Takeda and Baxter; has received research support from Danone, MyHealth and VectivBio; and has served on the Speaker Bureau for Abbott, Tramedico, Truvion, Will Pharma, My Health, Kyowa Kirin, Menarini, Biocodex, Remedus, Fresenius Kabi and Dr. Falk Pharma. CM has served on the Speaker Bureau for Coca-Cola and Zespri and received travel/conference grants from Danone, Nestlé Health Sciences, Fresenius Kabi. This study was supported by a research grant from the Belgian Health Care Knowledge Centre (KCE). Questionnaires in this trial were developed, translated and provided by the Rome Foundation Research Institute.
Patient and public involvement Patients and/or the public were involved in the design, conduct, reporting or dissemination plans of this research. Refer to the Methods section for further details.
Provenance and peer review Not commissioned; externally peer reviewed.
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