Functional DyspepsiaNCT01456273
From the Biomedical to the Biopsychosocial Model, From Theory to Practice
A study testing Traditional Medical Consultation and Therapeutic Encounter in people with Functional Dyspepsia, run by Faculdade de Medicina do ABC at 1 site in Brazil.
Trial summary
This study aims to evaluate, in patients with functional dyspepsia, a model example of medical care based upon the biopsychosocial model (called: the therapeutic encounter) compared with standard medical care based upon the biomedical model (called: medical consultation). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Functional Dyspepsia
- What is being tested?
- Traditional Medical Consultation and Therapeutic Encounter
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2009to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of functional dyspepsia (according to the Rome II criteria)
- They must be literate so they can read and fill out the questionnaire and a diary of symptoms without the aid of others
Who cannot join
- Patients who for any reason: not accepting to participate in research, not having signed an informed consent or not answering the questionnaire, the collection period, for whatever reasons
- Abuse or dependence on alcohol, tobacco, medications or other drugs (licit or illicit)
- Diabetes (any type
- pregnancy or breastfeeding (in any stage of the study)
- organic diseases or severe metabolic or evolving (heart disease, severe hypertension, infectious diseases)
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Faculdade de Medicina do ABC
Santo André, São Paulo, 09060-870
Fernando S Guedes, Master, 5511-7760-4287, amarelodosol@yahoo.com.br
Wilson R Catapani, Doctor, 5511-4993-5416, w.gastro@terra.com.br
About this study
Official title: Evaluation of the Efficacy of the Integral Approach (Therapeutic Encounter) Versus the Conventional Medical Approach (Medical Consultation) in Patients With Functional Dyspepsia
This study aims to evaluate, in patients with functional dyspepsia, a model example of medical care based upon the biopsychosocial model (called: the therapeutic encounter) compared with standard medical care based upon the biomedical model (called: medical consultation).
Read the detailed description
INTRODUCTION Addressing the high costs involved in new medical technology (biotechnology) is a problem that has led individuals and public health services to feel increasingly powerless.
Many authors say that not even an efficient use of resources can ensure better care and health care, a true bottomless pit.
The problem is the conceptual and ideological bases of thinking and acting of the professionals involved. The first misunderstanding is the "narrow approach" and the second is the "process of medicalization."
The curative model and the restricted approach The curative model gets this name because it is not concerned with the causes of the disease process (prevention), only with the effects (the disease). As the effects can be mitigated or even extinct, it is only temporary, because sooner or later they will return with the same format or not, in the same individual or another. It is extremely costly for individuals and for society, because the solutions are palliative. The approach is limited and so are results too.
The process of medicalization Medicalization is the ultimate expression of the distortions of thinking and consequences of the model of health care regulations. It can be understood as the increasingly high dependence on individuals and society overestimating the role that biotechnology could play, and creating a dependency in which one believes that for any problem, regardless of its severity or causal links, there will be a life-saving treatment.
The wrong postures and maintenance of unhealthy habits The model of health care can lead to wrong postures. Many of today's health problems have a direct causal relationship with the passive attitude of individuals, who delegate (to health care and biotechnology) full responsibility for treating their ailments, are reluctant to bring about changes in habits and behaviors because the "curative medicine holds that the doctors can take a magic bullet and get our problems solved."
The strong interest in maintaining the healing model The curative model has a tendency to concentrate on the application of biotechnology to strengthen the multinational pharmaceutical industry and large firms in highly sophisticated biomedical equipment. This has generated a stunning increase of expenditure on health as well as strong interest in this market maintaining its hegemonic space through emphasis on "cure(medicalization of life", rather than the emphasis on prevention and changing habits.
Aim of the study This study will aim to test, in patients with functional dyspepsia, a model example of medical care based upon the biopsychosocial model (called: the therapeutic encounter) compared with standard medical care based upon the biomedical model (called: medical consultation).
What is the biopsychosocial model The biopsychosocial model does not focus exclusively on organic disease. It considers the thinking process of becoming ill with multiple causalities. It tries to understand the man, their psychological, biological, socio-cultural and spiritual interconnections. It argues that the way of being and becoming ill are constructions of the life history of each individual, where the psychological and physiological are inextricably linked. In this perspective, disease becomes an expression of internal conflicts, has a personal character and is linked to the person's relationship with his world (its environment).
This approach has important consequences in medical practice as the doctor's focus of attention shifts to the individual diseases.
The medical care based upon the biopsychosocial model conserves the characteristics of art of medicine. Art in the sense of craftsmanship (the "tailored") as opposed to biomedical technique that is (to systematize, generalize). In fact one must know deeply the technique to apply it with art.
The primary focus continues to be what the patient has in common with others, but in its quirks (it is the art of medicine). It is considered less important if a particular treatment will work, thinking of the majority of patients (the technique), but whether it will work for this particular patient, with his personal problems at the moment of his life in this environment, this location in this country and this region of the world.
Why test it in functional dyspepsia patients
Functional dyspepsia is part of a group of diseases called "Functional Disorders of the Gastrointestinal Tract" that goes beyond the biomedical model:
- They are defined as variable combinations of symptoms, not explained by structural or biochemical changes.
- The diagnostic criteria and parameters for better or worse are based on symptoms reported by patients, this causes some skepticism in the face of more traditional medical view. There are no objective criteria for assessing these disorders.
Why to use placebo
The use of placebo in this study is justified due to the facts:
- Symptoms of functional dyspepsia have a high rate of improvement with placebo. Comparative studies with some drugs show that the placebo effect is up to the order of 30 to 40%.
- can not rule out the placebo effect, if the magnitude of this drug therapies are not compared to placebo.
Justification of the study This study is justified for several reasons, but mainly by the limitations of the biomedical model.
- The changes in the epidemiological profile (which has been occurring in recent decades) are increasingly leaving very clear the role of psychological, socio-cultural and spiritual factors, as expressed by the personality and lifestyle.
- The same biomedicine with its progress and sophistication is showing its inability to provide satisfactory or conclusive answers to many problems, especially for the subjective components that come into greater or lesser degree in any disease.
Biomedicine is too limited in its explanatory power. Many medical professionals realize the psychological reactions of patients and their socioeconomic problems involved in the disease but do not see how to incorporate this information in formulating diagnosis and treatment decisions. The idea of ilness as a phenomenon more or less accidental, originating in the biochemical processes of the body is very restricted, and therefore produces restricted results too.
- Conditions
- Functional Dyspepsia
- Being tested
- Traditional Medical Consultation, Therapeutic Encounter
- Keywords
- biopsychosocial model, biomedical model, functional dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Medical ConsultationProcedure or surgery
Group A will be divided into 2 subgroups : A1- Traditional medical consultation + placebo, and A2- traditional medical consultation plus omeprazole
Therapeutic EncounterProcedure or surgery
Group B (who receive care "Therapeutic Encounter") will be divided in subgroup B1, which will receive the "Drug Therapy Classic" and 2 in group B who received placebo.
| Study group | Role | What they receive |
|---|---|---|
| A2- Medical consultation + placebo | Placebo comparator | Traditional medical interview + placebo Receives: Procedure: Traditional Medical Consultation |
| B1 - Therapeutic Encounter / Omeprazol | Active comparator | Not described Receives: Procedure: Therapeutic Encounter |
| B2 - Therapeutic Encounter / Placebo | Placebo comparator | Not described Receives: Procedure: Therapeutic Encounter |
| A1- Medical consultation + omeprazole | Active comparator | Traditional medical interview + omeprazole Receives: Procedure: Traditional Medical Consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score of dyspeptic symptoms questionnaire administered at the beginning and end of treatment.
Measured: between four to six months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2011 (estimated)
- Study startMar 2009
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional DyspepsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Faculdade de Medicina do ABC
- Sponsor type
- University, hospital or other
- Collaborators
- Feculdade de Medicina da Universidade de Sao Paulo - Brasil
- Responsible party
- Principal investigator, Fernando Soares Guedes, Faculdade de Medicina do ABC
- Investigators
- Fernando S Guedes, Master, Principal investigator, Faculdade de Medicina do ABC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01456273
- Sponsor's protocol ID
- Guedes, FG 01
- Status last verified
- Oct 2011
- First submitted
- 23 Aug 2011
- Last updated
- 20 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of the Integral Approach (Therapeutic Encounter) Versus the Conventional Medical Approach (Medical Consultation) in Patients With Functional Dyspepsia
- ClinicalTrials.gov ID
- NCT01456273
- Acronym / sponsor ID
- Guedes, FG 01
- Conditions
- Functional Dyspepsia
- Keywords
- biopsychosocial model, biomedical model, functional dyspepsia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Faculdade de Medicina do ABCUniversity, hospital or other
- Collaborators
- Feculdade de Medicina da Universidade de Sao Paulo - Brasil
- Study start
- Mar 2009
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 20 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate, in patients with functional dyspepsia, a model example of medical care based upon the biopsychosocial model (called: the therapeutic encounter) compared with standard medical care based upon the biomedical model (called: medical consultation).
Detailed description
INTRODUCTION Addressing the high costs involved in new medical technology (biotechnology) is a problem that has led individuals and public health services to feel increasingly powerless.
Many authors say that not even an efficient use of resources can ensure better care and health care, a true bottomless pit.
The problem is the conceptual and ideological bases of thinking and acting of the professionals involved. The first misunderstanding is the "narrow approach" and the second is the "process of medicalization."
The curative model and the restricted approach The curative model gets this name because it is not concerned with the causes of the disease process (prevention), only with the effects (the disease). As the effects can be mitigated or even extinct, it is only temporary, because sooner or later they will return with the same format or not, in the same individual or another. It is extremely costly for individuals and for society, because the solutions are palliative. The approach is limited and so are results too.
The process of medicalization Medicalization is the ultimate expression of the distortions of thinking and consequences of the model of health care regulations. It can be understood as the increasingly high dependence on individuals and society overestimating the role that biotechnology could play, and creating a dependency in which one believes that for any problem, regardless of its severity or causal links, there will be a life-saving treatment.
The wrong postures and maintenance of unhealthy habits The model of health care can lead to wrong postures. Many of today's health problems have a direct causal relationship with the passive attitude of individuals, who delegate (to health care and biotechnology) full responsibility for treating their ailments, are reluctant to bring about changes in habits and behaviors because the "curative medicine holds that the doctors can take a magic bullet and get our problems solved."
The strong interest in maintaining the healing model The curative model has a tendency to concentrate on the application of biotechnology to strengthen the multinational pharmaceutical industry and large firms in highly sophisticated biomedical equipment. This has generated a stunning increase of expenditure on health as well as strong interest in this market maintaining its hegemonic space through emphasis on "cure(medicalization of life", rather than the emphasis on prevention and changing habits.
Aim of the study This study will aim to test, in patients with functional dyspepsia, a model example of medical care based upon the biopsychosocial model (called: the therapeutic encounter) compared with standard medical care based upon the biomedical model (called: medical consultation).
What is the biopsychosocial model The biopsychosocial model does not focus exclusively on organic disease. It considers the thinking process of becoming ill with multiple causalities. It tries to understand the man, their psychological, biological, socio-cultural and spiritual interconnections. It argues that the way of being and becoming ill are constructions of the life history of each individual, where the psychological and physiological are inextricably linked. In this perspective, disease becomes an expression of internal conflicts, has a personal character and is linked to the person's relationship with his world (its environment).
This approach has important consequences in medical practice as the doctor's focus of attention shifts to the individual diseases.
The medical care based upon the biopsychosocial model conserves the characteristics of art of medicine. Art in the sense of craftsmanship (the "tailored") as opposed to biomedical technique that is (to systematize, generalize). In fact one must know deeply the technique to apply it with art.
The primary focus continues to be what the patient has in common with others, but in its quirks (it is the art of medicine). It is considered less important if a particular treatment will work, thinking of the majority of patients (the technique), but whether it will work for this particular patient, with his personal problems at the moment of his life in this environment, this location in this country and this region of the world.
Why test it in functional dyspepsia patients
Functional dyspepsia is part of a group of diseases called "Functional Disorders of the Gastrointestinal Tract" that goes beyond the biomedical model:
- They are defined as variable combinations of symptoms, not explained by structural or biochemical changes.
- The diagnostic criteria and parameters for better or worse are based on symptoms reported by patients, this causes some skepticism in the face of more traditional medical view. There are no objective criteria for assessing these disorders.
Why to use placebo
The use of placebo in this study is justified due to the facts:
- Symptoms of functional dyspepsia have a high rate of improvement with placebo. Comparative studies with some drugs show that the placebo effect is up to the order of 30 to 40%.
- can not rule out the placebo effect, if the magnitude of this drug therapies are not compared to placebo.
Justification of the study This study is justified for several reasons, but mainly by the limitations of the biomedical model.
- The changes in the epidemiological profile (which has been occurring in recent decades) are increasingly leaving very clear the role of psychological, socio-cultural and spiritual factors, as expressed by the personality and lifestyle.
- The same biomedicine with its progress and sophistication is showing its inability to provide satisfactory or conclusive answers to many problems, especially for the subjective components that come into greater or lesser degree in any disease.
Biomedicine is too limited in its explanatory power. Many medical professionals realize the psychological reactions of patients and their socioeconomic problems involved in the disease but do not see how to incorporate this information in formulating diagnosis and treatment decisions. The idea of ilness as a phenomenon more or less accidental, originating in the biochemical processes of the body is very restricted, and therefore produces restricted results too.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A2- Medical consultation + placebo | Placebo comparator | Procedure: Traditional Medical ConsultationTraditional medical interview + placebo |
| B1 - Therapeutic Encounter / Omeprazol | Active comparator | Procedure: Therapeutic Encounter |
| B2 - Therapeutic Encounter / Placebo | Placebo comparator | Procedure: Therapeutic Encounter |
| A1- Medical consultation + omeprazole | Active comparator | Procedure: Traditional Medical ConsultationTraditional medical interview + omeprazole |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of functional dyspepsia (according to the Rome II criteria)
- They must be literate so they can read and fill out the questionnaire and a diary of symptoms without the aid of others
Key exclusion criteria (5 listed)
- Patients who for any reason: not accepting to participate in research, not having signed an informed consent or not answering the questionnaire, the collection period, for whatever reasons
- Abuse or dependence on alcohol, tobacco, medications or other drugs (licit or illicit)
- Diabetes (any type
- pregnancy or breastfeeding (in any stage of the study)
- organic diseases or severe metabolic or evolving (heart disease, severe hypertension, infectious diseases)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional Medical ConsultationGroup A will be divided into 2 subgroups : A1- Traditional medical consultation + placebo, and A2- traditional medical consultation plus omeprazole | Procedure or surgery | A1- Medical consultation + omeprazole, A2- Medical consultation + placebo |
| Therapeutic EncounterGroup B (who receive care "Therapeutic Encounter") will be divided in subgroup B1, which will receive the "Drug Therapy Classic" and 2 in group B who received placebo. | Procedure or surgery | B1 - Therapeutic Encounter / Omeprazol, B2 - Therapeutic Encounter / Placebo |
Primary outcome
Score of dyspeptic symptoms questionnaire administered at the beginning and end of treatment.
Time frame: between four to six months of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2011.
Related trials for Functional Dyspepsia
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Probiotic and Ginger Supplement for Symptoms and Quality of Life in Functional Dyspepsia (SUBTILE)
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Enrolling by invitationObservational study
Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and Controls
Motility Disorder, Gastroparesis
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Efficacy of Clostridium Butyricum in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia
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RecruitingPhase 2
Exploring Novel Therapeutic Approaches for Disorders of Gut-Liver-Brain Interaction-H1/H2
Functional Gastrointestinal Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fernando S Guedes, Master principal investigator
Faculdade de Medicina do ABC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Medical Consultation and Therapeutic Encounter in people with Functional Dyspepsia, run by Faculdade de Medicina do ABC at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fernando S Guedes, Master (5511-7760-4287, amarelodosol@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score of dyspeptic symptoms questionnaire administered at the beginning and end of treatment. (time frame: between four to six months of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2011.