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Duloxetine is FDA approved as pharmacological treatment for Fibromyalgia. The use of SSRIs has been endorsed by the 2013 Canadian guidelines. The data available for Escitalopram as a treatment modality for Fibromyalgia is limited, however small trials have demonstrated its efficacy. No head to head comparisons between escitalopram and duloxetine have been undertaken. We aim to conduct a single blind, randomized control trial to assess the comparative efficacy of duloxetine vs escitalopram in drug naive patients with newly diagnosed Fibromyalgia.
180 drug naive patients with newly diagnosed fibromyalga according to the modified ACR 2016 criteria shall be enrolled by consecutive sampling after taking written informed consent. Baseline severity of fibromyalgia shall be assessed via the Revised Fibromyalgia Impact Questionnaire (FIQ-R). They shall be randomized via cluster randomization into two groups. The first group shall receive Duloxetine 30mg, will be increased to 60mg after one week. The second group shall receive Escitalopram 10mg to be increased to 20mg after one week. Patients shall be followed at 0,2,4,8 and 12 weeks. At each visit, any subjective change in symptoms shall be noted and the FIQ-R shall be re administered. At the end of the trial, the overall change in the FIQ-R from baseline shall be assessed and the difference between both groups will be analyzed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Duloxetine Group | Active Comparator | Duloxetine 30mg once daily to be started for 1 week. Dose will then be titrated to 60mg once daily and the patients followed for a total of 12 weeks. |
|
| Escitalopram Group | Experimental | Escitalopram 10mg once daily to be started for 1 week. Dose will then be titrated to 20mg once daily and the patients followed for a total of 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Duloxetine | Drug | Duloxetine 30mg PO once daily for 1 week followed by an increase to 60mg PO once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in FIQ-R (Revised Fibromyalgia Impact Questionnaire) from baseline | Percentage decrease in FIQ-R from baseline | 4,8 and 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohammad A Arif, MRCP, FRCP | Shaheed Zulfiqar Ali Bhutto Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pakistan Institute of Medical Sciences | Islamabad | Islamabad | 44000 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19369473 | Result | Bennett RM, Bushmakin AG, Cappelleri JC, Zlateva G, Sadosky AB. Minimal clinically important difference in the fibromyalgia impact questionnaire. J Rheumatol. 2009 Jun;36(6):1304-11. doi: 10.3899/jrheum.081090. Epub 2009 Apr 15. | |
| 20828282 | Result | Wright CL, Mist SD, Ross RL, Jones KD. Duloxetine for the treatment of fibromyalgia. Expert Rev Clin Immunol. 2010 Sep;6(5):745-56. doi: 10.1586/eci.10.64. |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D000068736 | Duloxetine Hydrochloride |
| D000089983 | Escitalopram |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
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Randomized Control Trial
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Patients shall be provided medication with numeric labels
| Escitalopram | Drug | Escitalopram 10mg PO once daily for 1 week followed by an increase to 20mg PO once daily |
|
|
| 21772818 | Result | Smith HS, Bracken D, Smith JM. Pharmacotherapy for fibromyalgia. Front Pharmacol. 2011 Mar 31;2:17. doi: 10.3389/fphar.2011.00017. eCollection 2011. |
| D009422 |
| Nervous System Diseases |
| D006571 |
| Heterocyclic Compounds |
| D011437 | Propylamines |
| D000588 | Amines |
| D009570 | Nitriles |
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |