Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Change, From Baseline to Endpoint (12 Weeks) in the Composite Score of Abdominal Pain, Abdominal Bloating and Metheorism Each One Measured in a 0-10 Visual Analog Scale |
Visual analogue scales are frequently used to evaluate subjective symptoms; they range from 0 (no symptom at all) to 10 (worst possible intensity of the symptom) points. In the present case the three most frequent abdominal symptoms reported by patients with fibromyalgia have been selected to compose the primary outcome variable. Total symptoms range was 0 to 30 points. Change = (week 12 score - baseline score) |
baseline and twelve weeks after treatment |
|
| Secondary |
Change, From Baseline to Endpoint (12 Weeks) in the Total Score of the Fibromyalgia Impact Questionnaire Revised (FIQR) |
The FIQR is a self-reported, validated questionnaire that evaluates the severity of fibromyalgia symptomatology in a scale ranging from 0 to 100 points; the higher the score, the worse the severity of the disease. Change = (week 12 score - baseline score) |
baseline and twelve weeks after treatment |
|
| Secondary |
Change, From Baseline to Endpoint (12 Weeks) in the Total Score of the Insomnia Severity Inventory (ISI) |
The ISI is a self-reported, validated questionnaire that measures the severity of sleep disturbances in a scale ranging from 0 to 28 points: higher scores indicate more severe sleep disturbance |
baseline and twelve weeks after treatment |
|
| Secondary |
Change, From Baseline to Endpoint (12 Weeks) in the Total Score of the Patient Health Questionnaire (PHQ-9) |
PHQ-9 is a self-reported, validated questionnaire that measures the severity of depression in a scale ranging from 0 to 27 points; higher scores indicate more severe depression. Change = (week 12 score - baseline score) |
baseline and twelve weeks after treatment |
|
| Secondary |
Change, From Baseline to Endpoint (12 Weeks) in the Short-Form Health Survey SF-36 PCS |
The SF-36 is a self-reported, validated questionnaire evaluating the general health quality in a scale ranging from 0 to 100 points; it evaluates 8 heath domains that yield two summary measures: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Higher scores indicate better general health quality. Change = (week 12 score - baseline score). |
baseline and twelve weeks after treatment |
|
| Secondary |
Change, From Baseline to Endpoint (12 Weeks) in the Short-Form Health Survey SF-36 MCS |
The SF-36 is a self-reported, validated questionnaire evaluating the general health quality in a scale ranging from 0 to 100 points; it evaluates 8 heath domains that yield two summary measures: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Higher scores indicate better general health quality. Change = (week 12 score - baseline score). |
baseline and 12 weeks after treatment |
|
| Secondary |
Number of Patients Considered as Responders to Treatment |
Patients that showed at least a a 30% reduction in the score of the primary variable, i.e. the composite ccore of abdominal pain, abdominal bloating and metheorism each one measured in a 0-10 Visual Analog Scale, were considered as responders to treatment. |
Baseline and 12 weeks after treatment |
|
| Secondary |
Change From Week 12 to Week 16 (Follow-up Period) in the Composite Score of Abdominal Pain, Bloating and Metheorism Among Responders After Discontinuing the Study Treatment |
Visual analogue scales are frequently used to evaluate subjective symptoms; they range from 0 (no symptom at all) to 10 (worst possible intensity of the symptom) points. In the present case the three most frequent abdominal symptoms reported by patients with fibromyalgia have been selected to compose the primary outcome variable. Total symptoms range was 0 to 30 points. Change = (week 16 score - week 12 score) |
Week 12 to week 16 |
|
| Secondary |
Change From Week 12 to Week 20 (Follow-up Period) in the Composite Score of Abdominal Pain, Bloating and Metheorism Among Responders After Discontinuing the Study Treatment |
Visual analogue scales are frequently used to evaluate subjective symptoms; they range from 0 (no symptom at all) to 10 (worst possible intensity of the symptom) points. In the present case the three most frequent abdominal symptoms reported by patients with fibromyalgia have been selected to compose the primary outcome variable. Total symptoms range was 0 to 30 points. Change = (week 20 score - week 12 score) |
Week 12 to week 20 |
|
| Secondary |
Change From Week 12 to Week 24 (Follow-up Period) in the Composite Score of Abdominal Pain, Bloating and Metheorism Among Responders After Discontinuing the Study Treatment |
Visual analogue scales are frequently used to evaluate subjective symptoms; they range from 0 (no symptom at all) to 10 (worst possible intensity of the symptom) points. In the present case the three most frequent abdominal symptoms reported by patients with fibromyalgia have been selected to compose the primary outcome variable. Total symptoms range was 0 to 30 points. Change = (week 24 score - week 12 score) |
Week 12 to week 24 |
|
