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Table 1 Characteristics of the systematic reviews included

From: Comparing the efficacy and safety of duloxetine and amitriptyline in the treatment of fibromyalgia: overview of systematic reviews

Author, year Number of Studies DLX Number of Studies AMT Participants Included Objectives Criteria for Inclusion Criteria for Exclusion Scales
Thorpe et al., 2018 [18] 2 1 133 To assess the efficacy, safety and tolerability of combination of drugs with monotherapy or placebo, or both, in the treatment of FMS Double-blind RCT comparing combinations of two or more drugs with placebo or other comparatives, or both, in the treatment of FMS Single-blind studies, complementary studies to those already selected, non-randomized, studies with other therapies and with patients having diverse fibromyalgia diseases VAS, NPS, pain reduction of 30% or more and 50% or more, FIQ, NNTH
Sommer et al., 2017 [19] 10 14 6038 To assess the efficacy and safety of drugs and non-drug therapy in the treatment of FMS Randomized clinical trials with drugs used to treat FMS, in databases, non-published articles and specialists’ opinion Studies with downgraded quality evidence according to the application of the GRADE method used by the authors 50% pain reduction, NNTB, VAS, FIQ
Smith et al., 2011 [20] 9 24 1368 To compare the efficacy and harms of drugs used in the treatment of FMS Studies with patients with FMS, according to the ACR criteria of 1990 and 2010, involving the use of diverse drugs and direct and indirect comparisons, assessing efficacy and damages Studies with ineligible results, intervention, population, publication and study design 50% pain reduction, MFI, MAF, VAS, FIQ
Häuser et al., 2011 [5] 4 10 2023 To assess and compare the efficacy and acceptability of amitriptyline (AMT), duloxetine (DLX) and milnacipran (MLN) antidepressants in the treatment of FMS RCT comparing AMT, DLX or MLN with placebo, assessing at least one FMS key domain: pain, sleep, fatigue or health-related quality of life; treatment discontinuation rate RCTs with combination of drugs with any other treatment VAS, 30% pain reduction, NPS, NNTB, Cohen’s category, VAS, FIQ
Üçeyler et al., 2008 [22] 2 13 891 To review systematically the efficacy of antidepressants in the treatment of FMS FMS or CWP diagnosis based on recognized criteria, controlled study design with a control group who received placebo, usual treatment or any other well-defined treatment; treatment with antidepressants, and measurement of specific symptom results Studies with cyclobenzaprine, which combines characteristics of antidepressant with relaxant, and studies with
S-adenosylmethionine, because this substance is officially available in two countries only (UK and Italy) as food supplement
VAS, tender point count, VAS, BDI, HAM-D, FIQ
Roskell et al., 2011 [6] 2 5 538 To compare pain response to licensed drugs or drugs commonly used in fibromyalgia, also addressing treatment discontinuation due to adverse reactions Randomized Controlled Clinical Trials with at least 4-week duration with patients aged 18 years or over with clinical FMS diagnosis, using Duloxetine (60 mg / day), Fluoxetine (40 to 50 mg / day), Gabapentin (2400 mg / day), Milnacipran (100 or 200 mg / day), Placebo, Pramipexol (4.5 mg / day), Pregabalin (300 or 450 mg / day), TCA (amitriptyline 25 to 75 mg / day or cyclobenzaprine 1030 mg / day), Tramadol with paracetamol (200 to 300 mg / day) Treatment of no interest for meta-analysis, no major outcome reported, different treatment doses, study not properly controlled, duplicated or of short duration, poor quality testing and when the article was irretrievable FIQ, BDI
Häuser et al., 2009 [5] 3 7 927 To determine the efficacy of antidepressants in the treatment of FMS through meta-analysis and randomized controlled clinical trials Patients effectively diagnosed FMS, RCT with one control group receiving placebo and one group treated with antidepressants (TCA, SSRIs, SNRIs or MAOIs) Studies assessing cyclobenzaprine, S-adenosylmethionine, or antidepressant combinations. Studies where only categorial data were provided and studies with incomplete data VAS, FIQ, NRS, HRQOL scale
Perrot et al., 2008 [23] 2 4 910 To review evidences of use of antidepressants in painful rheumatological conditions Articles published between 1966 and 2007 in 5 European idioms, addressing the use of antidepressants in various rheumatological conditions, including FMS. The authors attributed a rating scale based on the Jadad method (0–5), including studies with scoring above 2 Articles that were scored below 2 in the Jadad scale VAS, FIQ, NRS
  1. aFMS Fibromyalgia, DLX Duloxetine, AMT Amitriptyline, RCT Randomized Clinical Trial, ACR American College of Rheumatology, CWP Chronic Widespread Pain, TCA Tricyclic Antidepressant, SSRIs Selective Serotonin Reuptake Inhibitor, SNRIs Serotonin and Noradrenaline Reuptake Inhibitor, MAOIs Monoamine Oxidase Inhibitors, VAS Visual Analog Scale, NPS Numeric Pain Scale, FIQ Fibromyalgia Impact Questionnaire, NNTB Number needed to treat for an additional benefit, NNTH Number needed to treat to prevent one additional harm, MAF Multidimensional Assessment of Fatigue, MFI Multidimensional Fatigue Inventory, BDI Beck Depression Inventory, HAM-D Hamilton Depression Scale, BDI Brief Pain Inventory, NRS Numeric Rating Scale, HRQL Health-related Quality of Life