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IRCT20210306050589N1 IRCT 2021-04-28 Islamic Azad University The effect of metformin in fibromyalgia The analgesic effect of metformin in patients with fibromyalgia 2021-06-22 anticipated 30 Complete https://irct.ir/trial/54853 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method would be based on block randomization with the block size of 3. For each possible cases numbers are assigned as mentioned below: ABC(1), ACB(2), BAC(3), BCA(4), CAB(5), CBA(6) Then a number between 1-6 would be assigned for each block using random number table, so that the therapeutic group for each participant is determined, Blinding description: A person other than the main researcher of the project determines the intervention and control groups with the name of A, B and C, put the medications in appropriate boxes with the name of group and provide them to the main researcher as they are sealed. In fact, the main researcher who acs the role of clinical care giver, outcome assessor and data analyst as well, would be unaware of the patients assignment to either control or intervention group until the end of the project. And would only deal with the group names A, B and C and also would not know the patients' name during clinical care in order to prevent possible bias of the project. 3 Condition 1: Fibromyalgia. Condition 2: Idiopathic peripheral autonomic neuropathy. Intervention 1: Control group (group A): The control group would be on the treatment with the standard medication of fibromyalgia (based on the latest available guidelines) including either Norepinephrine Reuptake Inhibitors (amitriptyline ,duloxetine or milnacipran) or Membrane Stabilizing agents (pregabalin or gabapentin). The duration of treatment would be 3 month. (For most patients we would prescribe Amitriptyline (with the initial dose of 5-10 mg/d 3 hour before bedtime and gradually increasing the dose to 25-50 mg/d if needed and tolerated). If there is sever fatigue or depression in patients we would use either Duloxetine (with the initial dose of 20-30 mg/d in the morning and gradually increasing the dose to 60 mg/d) or Milnacipran (with initial dose of 12.5 mg/d in the morning and gradually increasing the dose to 50-100 mg twice daily if needed and tolerated) and occasionally if there is sever sleep disturbance we would use either Pregabalin (with initial dose of 25-50 mg/d at bedtime and gradually increasing the dose to 300-450 mg/d if needed and tolerated) or Gabapentin (with initial dose of 100 mg/d at bedtime and gradually increasing the dose to 1200-2400 mg/d in divided doses if needed and tolerated)) Predicted Pharmaceutical companies: Amitriptyline: Pars Darou, Duloxetine: Dr. Abidi , Pregabalin: Sobhan Darou, Gabapentin: Razak. Because Milnacipran is not made in Iranian companies, we use Duloxetine instead. Intervention 2: First ntervention group (group B): The first intervention group would be on the treatment with metformin alone. The duration of treatment would be 3 month. (Metformin would be prescribed with the initial dose of 500 mg/d, and would be increased gradually until it reaches 1500 mg/d (the effective dose) if tolerated.) Predicted Pharmaceutical companies: Metformin: Razak. Intervention 3: Second intervention group (group C): The second intervention group would be on the combination therapy with both medications, standard medication of fibromyalgia and metformin together, according to the order of these two groups. The duration of treatment would be 3 month. Predicted Pharmaceutical companies: Amitriptyline: Pars Darou, Duloxetine: Dr. Abidi , Pregabalin: Sobhan Darou, Gabapentin: Razak, Metformin: Razak. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no plan to publish it.
public Sara Hallaji
Unit 2, 1st floor, Shahid Yazdanfar St, Sohanak Ave, Artesh Blvd
Tehran Iran (Islamic Republic of) 1955816453 +98 21 2246 0179 sahano1997@gmail.com Islamic Azad University scientific Sara Hallaji
Unit 2, 1st floor, Shahid Yazdanfar St, Sohanak Ave, Artesh Blvd
Tehran Iran (Islamic Republic of) 1955816453 +98 21 2246 0179 sahano1997@gmail.com Islamic Azad University Iran (Islamic Republic of) Iran (Islamic Republic of) American College of Rheumatology criteria for Fibromyalgia diagnosis Not using any medication for fibromyalgia and metformin no limit no limit Both Comorbid disorders including history of cerebrovascular disease, rheumatoid arthritis, untreated endocrine abnormalities(except diabetes), autoimmune conditions, neuromuscular diseases, active malignancy, immuno-deficiency, advanced renal failure Taking medications associated with insulin resistance such as glucocorticoids, thiazide diuretics, atypical anti-psychotics,beta-blockers, niacin, statins and NSAID Drug or alcohol abuse Opium addiction or cigarette smoking Using any medication for fibromyalgia and metformin M79.7 G90.0 Fibromyalgia Idiopathic peripheral autonomic neuropathy Treatment - Drugs Treatment - Drugs Treatment - Drugs Control group (group A): The control group would be on the treatment with the standard medication of fibromyalgia (based on the latest available guidelines) including either Norepinephrine Reuptake Inhibitors (amitriptyline ,duloxetine or milnacipran) or Membrane Stabilizing agents (pregabalin or gabapentin). The duration of treatment would be 3 month. (For most patients we would prescribe Amitriptyline (with the initial dose of 5-10 mg/d 3 hour before bedtime and gradually increasing the dose to 25-50 mg/d if needed and tolerated). If there is sever fatigue or depression in patients we would use either Duloxetine (with the initial dose of 20-30 mg/d in the morning and gradually increasing the dose to 60 mg/d) or Milnacipran (with initial dose of 12.5 mg/d in the morning and gradually increasing the dose to 50-100 mg twice daily if needed and tolerated) and occasionally if there is sever sleep disturbance we would use either Pregabalin (with initial dose of 25-50 mg/d at bedtime and gradually increasing the dose to 300-450 mg/d if needed and tolerated) or Gabapentin (with initial dose of 100 mg/d at bedtime and gradually increasing the dose to 1200-2400 mg/d in divided doses if needed and tolerated)) Predicted Pharmaceutical companies: Amitriptyline: Pars Darou, Duloxetine: Dr. Abidi , Pregabalin: Sobhan Darou, Gabapentin: Razak. Because Milnacipran is not made in Iranian companies, we use Duloxetine instead. First ntervention group (group B): The first intervention group would be on the treatment with metformin alone. The duration of treatment would be 3 month. (Metformin would be prescribed with the initial dose of 500 mg/d, and would be increased gradually until it reaches 1500 mg/d (the effective dose) if tolerated.) Predicted Pharmaceutical companies: Metformin: Razak Second intervention group (group C): The second intervention group would be on the combination therapy with both medications, standard medication of fibromyalgia and metformin together, according to the order of these two groups. The duration of treatment would be 3 month. Predicted Pharmaceutical companies: Amitriptyline: Pars Darou, Duloxetine: Dr. Abidi , Pregabalin: Sobhan Darou, Gabapentin: Razak, Metformin: Razak. Pain severity. Timepoint: At the first visit and 3 month after the beginning of interventions. Method of measurement: Numeric Pain Rating Scale (NPRS). Fibromyalgia severity. Timepoint: At the first visit and 3 month after the beginning of interventions. Method of measurement: Revised Fibromyalgia Impact Questionnaire (FIQR). Tender points. Timepoint: At the first visit and 3 month after the beginning of interventions. Method of measurement: Counting. Neuropathy severity. Timepoint: At the first visit and 3 month after the beginning of interventions. Method of measurement: Toronto Clinical Neuropathy Scoring System (TCNS). Islamic Azad University Approved 2021-01-18 Ethics Committee of Tehran Islamic Azad University of Medical Science Islamic Azad University of Medical Sciences, Tehran Branch, Khaghani St, Shariati Ave Tehran Tehran Iran (Islamic Republic of)