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Objective:
To study the impact of metformin on the outcome of gouty arthritis in a cohort of Egyptian gouty patients, and to evaluate its effect on local joint inflammation, inflammatory cytokines (IL-1β and IL-6), and life quality.
Methods:
A prospective randomized, single-blinded parallel randomized control study included 100 patients with active inflammatory gouty arthritis were randomized to receive metformin (1000mg/day) or placebo in addition to the traditional lines of treatment of gout. The clinical and laboratory data of the patients will be analyze at baseline, then after 3, and 6 months, with the assessment of gout disease activity, in addition, serum IL-1β and IL-6, the number of attacks per year, treatment satisfaction, quality of life, and disability index were evaluated at the 6th month from starting metformin and placebo therapy.
Background: Metformin has anti-inflammatory properties, as it suppresses the inflammatory process by down-regulating the transcription factor, nuclear factor kappa B (NF-kB), through AMP-activated protein kinase (AMPK)-dependent and independent pathways.
Objective:
To study the impact of metformin on the outcome of gouty arthritis in a cohort of Egyptian gouty patients, and to evaluate its effect on local joint inflammation, inflammatory cytokines (IL-1β and IL-6), and life quality.
Methods:
A prospective randomized, single-blinded parallel randomized control study included 100 patients with active inflammatory gouty arthritis were randomized to receive metformin (1000mg/day) or placebo in addition to the traditional lines of treatment of gout. The clinical and laboratory data of the patients will be analyzed at baseline, then after 3, and 6 months, with the assessment of gout disease activity, in addition, serum IL-1β and IL-6, the number of attacks per year, treatment satisfaction, quality of life, and disability index were evaluated at the 6th month from starting metformin and placebo therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group 1: gouty patients on metformin. | Active Comparator | metformin users: include gouty patients, who will receive metformin tablets (1000 mg) once daily for about 3 months. |
|
| gouty patients on placebo. | Placebo Comparator | placebo users: include gouty patients, who were on placebo tablets once daily for about 3 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | gouty patients, will receive metformin tablets (1000 mg) once daily for about 3 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serological remission criteria | by measuring serum uric acid for patients of the present study, it must be less than 6 mg/dL. | at 3 months post intervention. |
| Articular remission criteria | by examining the number of swollen and tender joints score, they must be less than 2 tender and swollen joints.. | at 3 months post intervention. |
| Clinical remission criteria | by assessing the grade of joint pain, it must be reduced from the first visit(regarding Visual analogue scale | at 3 months post intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Gout Impact Scale (GIS) | by measuring GIS score, as higher scores in the GIS (range 0-100) imply a greater restriction of activity and a greater impact of gout and vice versa. | at 3 months post intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Health-related quality of life HRQOL | Health-related quality of life HRQOL was assessed using the SF-36 subscale of physical functioning (PF-10), as Lower PF-10 scores (range 0-100) imply more functional limitations, and vice versa. | at 3 months post intervention. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dalia Salah Saif | Menoufia Governorate | MD | 123455 | Egypt |
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| ID | Term |
|---|---|
| D015210 | Arthritis, Gouty |
| ID | Term |
|---|---|
| D006073 | Gout |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| Placebo | Drug | gouty patients, will receive placebo tablets once daily for about 3 months. |
|
| D000070657 |
| Crystal Arthropathies |
| D012216 | Rheumatic Diseases |
| D011686 | Purine-Pyrimidine Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |