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Background: Hepatitis C virus infection and interferon treatment have shown to be risk factors for depression, distressing, psychosocial burden and poor health-related quality of life.
Aim: To determine the effect of a Sylibin-vitamin E-phoshpolipids complex on work ability and whether health related factors (anxiety and depression) were associated with work ability in subjects with chronic hepatitis C treated with Peg-IFN-α and RBV.
Patients and Methods: In this prospective, randomized, placebo controlled, double blind clinical trial, 31 subjects (Group A) with chronic hepatitis, received Pegylated-Interferon-α2b (1.5 mg/kg per week) plus Ribavirin and placebo, while 31 subjects (Group B) received the same dosage of Pegylated-Interferon-α2b plus Ribavirin plus association of Silybin 94 mg + vitamin E 90 mg + phospholipids 194 mg in one pill for 12 months. All subjects underwent laboratory exams and questionnaires to evaluate depression (Beck Depression Inventory - BDI), anxiety (State-trait anxiety inventory - STAI) and work ability (Work ability Index - WAI).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Silybin - vitamin E - phospholipids complex | Active Comparator | Silybin 94 mg + vitamin E 90 mg + phospholipids 194 mg in one pill for 12 months. |
|
| placebo | Placebo Comparator | sugar pill |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Silybin 94 mg + vitamin E 90 mg + phospholipids 194 mg | Drug |
| ||
| sugar pill |
| Measure | Description | Time Frame |
|---|---|---|
| Work ability index | Administration of questionnaire(Work ability Index - WAI)The work ability index is a tool to record the work ability of employees. It aims at identifying, at an early stage, health risks of early retirement an counteracting them. The questionnaire is aimed at: 1) the estimated current and future work ability; 2) diagnosed illness and the number of absenteeism days in the previous year; 3) the estimated sickness-related deterioration in the work performance; 4) mental ability reserves. The WAI evaluates current work ability compared with lifetime and in relation to the demands of the job, number of current diseases diagnosed by a physician, estimated work impairment due to diseases. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| depression | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Catania, Cannizzaro Hospital | Catania | 95125 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27842532 | Derived | Malaguarnera G, Bertino G, Chisari G, Motta M, Vecchio M, Vacante M, Caraci F, Greco C, Drago F, Nunnari G, Malaguarnera M. Silybin supplementation during HCV therapy with pegylated interferon-alpha plus ribavirin reduces depression and anxiety and increases work ability. BMC Psychiatry. 2016 Nov 15;16(1):398. doi: 10.1186/s12888-016-1115-z. |
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| Drug |
|
| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000077385 | Silybin |
| D014810 | Vitamin E |
| D010743 | Phospholipids |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D012838 | Silymarin |
| D044947 | Flavonolignans |
| D005419 | Flavonoids |
| D002867 | Chromones |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D002241 | Carbohydrates |
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