Primjena placeba u kliničkim ispitivanjima

postgraduate specialist thesis

• Author: Antonija Sudarević
• Mentor: Viktorija Erdeljić Turk (mentor)
• Committee member: Lidija Bach-Rojecky (predsjednik povjerenstva)
• Committee member: Viktorija Erdeljić Turk (član povjerenstva)
• Committee member: Srećko Marušić (član povjerenstva)
• Granter: University of Zagreb; Faculty of Pharmacy and Biochemistry; Zagreb
• Defense date and country: 2024-09-11, Croatia
• Scientific / art field, discipline and subdiscipline: BIOMEDICINE AND HEALTHCARE; Pharmacy; Pharmacy

Abstract

Cilj istraživanja
Ovaj narativni pregled istražuje varijabilnost i mehanizme placebo učinka u kliničkim
ispitivanjima, s naglaskom na bol, depresiju, epilepsiju, bolesti crijeva i onkološke
bolesti. Cilj je razumjeti kliničke odluke iz placebom kontroliranih ispitivanja te etičke
principe koji osiguravaju dobrobit pacijenata i integritet znanstvenog istraživanja.
Materijali i metode
Ovaj specijalistički rad predstavlja narativni pregled literature, obuhvaćajući znanstvene i
stručne publikacije, kao i materijale relevantnih stručnih institucija poput Europske
agencije za lijekove i Američke agencije za hranu i lijekove. Za pretraživanje literature
korištene su elektronske bibliografske baze podataka PubMed, MEDLINE, Google
Scholar i ScienceDirect. Sva relevantna literatura objavljena do 1. ožujka 2024. godine
detaljno je istražena sukladno definiranim ciljevima rada.
Rezultati
Placebo učinak u kliničkim ispitivanjima uključuje kompleksne neurobiološke i
psihološke mehanizme. Placebo analgezija pokazuje interakciju psihičkih čimbenika,
očekivanja bolesnika i fizioloških procesa. Pozitivan placebo odgovor u ispitivanjima
epilepsije otežava potvrdu učinkovitosti terapije, a uzroci su nejasni. U onkologiji,
etičnost placebo kontrola ovisi o stadiju raka i dostupnosti terapija. Terapijska područja
poput upalnih bolesti crijeva, sindroma iritabilnog crijeva, depresije i epilepsije suočavaju
se s izazovima kao što su subjektivnost simptoma, varijabilnost bolesti i etičke dileme,
naglašavajući potrebu za poboljšanim dizajnom ispitivanja.
Zaključak
Razumijevanje uloge placeba ključno je za valjanost rezultata i procjenu stvarnog učinka
terapija. Etički izazovi zahtijevaju ravnotežu između novih spoznaja i individualne skrbi.
Transparentan i etički vođen proces placebom kontroliranih ispitivanja osigurava
optimalnu skrb bolesnika, uz prilagodbu pristupa ovisno o bolesti. Sveobuhvatno
razumijevanje placebo učinaka unaprjeđuje kvalitetu ispitivanja i zdravstvenih
intervencija, poboljšavajući skrb za bolesnike.

Abstract (english)

Objectives
This narrative review explores the variability and mechanisms of the placebo effect in
clinical trials, with a focus on pain, depression, epilepsy, bowel disease and oncology.
The goal is to understand clinical decisions from placebo-controlled trials and ethical
principles that ensure the well-being of patients and the integrity of scientific research.
Materials and methods
This specialist paper presents a narrative literature review, including scientific and
professional publications, as well as materials from relevant professional institutions such
as the European Medicines Agency and the US Food and Drug Administration. The
electronic bibliographic databases PubMed, MEDLINE, Google Scholar and
ScienceDirect were used for the literature search. All relevant literature published until
March 1, 2024 was investigated in detail in accordance with the defined objectives of the
work.
Results
The placebo effect in clinical trials involves complex neurobiological and psychological
mechanisms. Placebo analgesia shows the interaction of psychological factors, patient
expectations and physiological processes. A positive placebo response in epilepsy trials
makes it difficult to confirm the effectiveness of therapy, and the causes are unclear. In
oncology, the ethics of placebo controls depends on the stage of the cancer and the
availability of therapies. Therapeutic areas such as inflammatory bowel disease, irritable
bowel syndrome, depression and epilepsy face challenges such as symptom subjectivity,
disease variability and ethical dilemmas, highlighting the need for improved trial design.
Conclusion
Understanding the role of placebo is essential for validating results and assessing the real
effect of therapies. Ethical challenges require a balance between new knowledge and
individual care. A transparent and ethically guided process of placebo-controlled trials
ensures optimal patient care, with adaptation of the approach depending on the disease. A
comprehensive understanding of placebo effects improves the quality of trials and
healthcare interventions, improving patient care.

• Keywords: placebo; bol; depresija; epilepsija; bolesti crijeva; onkološke bolesti; kontrolirana ispitivanja
• Keywords (english): placebo; pain; depression; epilepsy; bowel diseases; oncological diseases; controlled trials
• Language: croatian
• URN:NBN: urn:nbn:hr:163:864129
• Study programme: Title: Drug development - specialistic study - university study; Study programme type: university; Study level: postgraduate specialist; Academic / professional title: sveučilišni specijalist razvoja lijekova (sveučilišni specijalist razvoja lijekova)
• Type of resource: Text
• File origin: Born digital
• Access conditions: Open access
• Created on: 2024-12-03 13:37:29