Patient Education and Duloxetine, Alone and in Combination, for Patients With Multisystem Functional Somatic Disorder
brief summary
The goal of this clinical trial is to test if patient education or duloxetine can be used to treat multisystem functional somatic disorder (FSD). The main questions it aims to answer are: * Does duloxetine work better than placebo in the treatment of FSD? * Does patient education work better than usual treatment for FSD? * Does the combination of patient education and duloxetine work better than using only one of these treatments? Participants are patients with FSD. They will receive one of six different treatment combinations: 1. Patient education alone (three individual consultations with a doctor and one group session) 2. Treatment as usual (receiving the diagnosis and a short presentation of what FSD is) 3. Duloxetine 4. Active placebo (a treatment that looks like duloxetine and has similar side effects, but no known effect on FSD) 5. Patient education and duloxetine 6. Patient education and active placebo Researchers will compare the groups receiving patient education with those receiving only treatment as usual to see if patient education is a better treatment than just receiving a diagnosis and short explanation. Furthermore, researchers will compare the groups receiving duloxetine to those receiving placebo to see if duloxetine works better than placebo. Finally, researchers will compare the groups receiving both patient education and duloxetine to those receiving only one of these treatments to see if the combination works better than the treatments given alone. The researchers will also collect samples of blood and stool in a biobank to be used in future research.
detailed description
Background Functional somatic disorders (FSD) are characterized by specific patterns of persistent physical symptoms with a complex etiology involving a multiform interplay between physiological, psychological, and socio-cultural factors. Patients with FSD are prevalent in all medical settings and receive diagnoses such as fibromyalgia, chronic fatigue syndrome, irritable bowel syndrome, and other functional somatic syndromes (FSS) depending on which medical specialty they consult. Multisystem FSD describes a severely affected subgroup of patients who suffer from symptoms from multiple organ systems. The diagnosis can be operationalized by the criteria for the unifying research diagnosis bodily distress syndrome (BDS).
Multisystem FSD affects 1.3-2.2% of the general population. The condition inflicts suffering and is associated with a substantial socioeconomic impact, involving costly diagnostic examinations and procedures, sick leaves, and long-term disability.
Evidence on treatment options for multisystem FSD is emerging but not yet sufficient. A number of clinical trials investigating non-pharmacological interventions are available and clinical guidelines in some FSS, e.g. fibromyalgia and chronic primary pain, highlight the importance of patient education (PE). PE may support the effect of other treatments by empowering and engaging patients in managing their condition. As a stand-alone treatment, the effect of PE has only sparsely been investigated, yet a PE program targeting multisystem FSD has been tested in an uncontrolled pilot study with promising results.
Pharmacotherapy in FSS includes centrally acting drugs, especially antidepressants. In multisystem FSD, evidence exists for treatment with low-dose tricyclic antidepressants (TCA). Unfortunately, TCAs given in higher, antidepressive doses significantly reduces tolerability and thereby treatment potential for comorbid depression or anxiety which are common in multisystem FSD. Duloxetine, a serotonin-norepinephrine reuptake inhibitor (SNRI), offers effect sizes similar to low-dose TCA in FSS with a more favorable adverse event profile. Evidence furthermore suggests an effect on cognitive functioning. In addition to reducing symptoms in multisystem FSD, duloxetine could improve cognitive functioning and, if relevant, treat comorbid anxiety and depression.
From a clinical perspective, a synergic effect between a PE program and pharmacological treatment could be hypothesized. On one hand, PE may improve the effect of pharmacological treatment by balancing treatment expectations and enhancing treatment adherence. Conversely, pharmacological treatment may indirectly enhance the effect of PE by improving cognitive functioning and thereby improving the patients' ability to receive and implement relevant educational elements.
official title
Efficacy of Patient Education and Duloxetine, Alone or in Combination, for Patients With Multisystem Functional Somatic Disorder