<abstract xmlns="http://www.w3.org/1999/xhtml"><sec id="j_1905-7415.1005.506_s_001_w2aab3b7b2b1b6b1aab1c17b1Aa"><h3>Background</h3><p>Fibromyalgia syndrome (FMS) is a physical and mood disorder that affects quality of life (QoL). Mirtazapine, which improves monoaminergic neurotransmission, may benefit patients with FMS.</p></sec><sec id="j_1905-7415.1005.506_s_002_w2aab3b7b2b1b6b1aab1c17b2Aa"><h3>Objectives</h3><p>To compare the QoL between Thai patients with FMS and healthy Thais, and investigate the effects of mirtazapine in a pilot study.</p></sec><sec id="j_1905-7415.1005.506_s_003_w2aab3b7b2b1b6b1aab1c17b3Aa"><h3>Methods</h3><p>We compared the QoL between 76 Thai patients with FMS and 80 healthy Thai volunteers (HVs). A double-blind, randomized, placebo-controlled trial using 40 patients with FMS was conducted using a block design with parallel assignment. QoL data were obtained at week 0 (baseline), and repeatedly for 13 weeks after receiving placebo or mirtazapine 15 or 30 mg/day.</p></sec><sec id="j_1905-7415.1005.506_s_004_w2aab3b7b2b1b6b1aab1c17b4Aa"><h3>Results</h3><p>The mean baseline of SF-36 QoL was significantly lower in all domains in patients with FMS than in HVs (bodily pain 33 vs 87, general health 36 vs 84, mental health 63 vs 82, physical functioning 59 vs 96, role limitation because of emotional problems 41 vs 92, role limitation because of physical problems 30 vs 96, social functioning 53 vs 93, and vitality 48 vs 75 (scale 0-100, <italic>P</italic> &lt; 0.01 all domains). Mirtazapine (15 and 30 mg/day) significantly reduced pain scores and improved all domains except social functioning, while placebo produced no change from baseline. Eight patients withdrew because of adverse events including somnolence and weight gain; no benefit, or lack of compliance.</p></sec><sec id="j_1905-7415.1005.506_s_005_w2aab3b7b2b1b6b1aab1c17b5Aa"><h3>Conclusions</h3><p>The QoL of patients with FMS is lower than for healthy Thais. Mirtazapine is effective for reducing pain and improving QoL in patients with FMS.</p></sec><sec id="j_1905-7415.1005.506_s_006_w2aab3b7b2b1b6b1aab1c17b6Aa"><h3>Trail registration</h3><p>ClinicalTrials.gov; Identifier: NCT00919295.</p></sec><sec id="j_1905-7415.1005.506_s_007_w2aab3b7b2b1b6b1aab1c17b7Aa"><h3>Funding</h3><p>Office of the Higher Education Commission, Thailand.</p></sec></abstract>

BackgroundFibromyalgia syndrome (FMS) is a physical and mood disorder that affects quality of life (QoL). Mirtazapine, which improves monoaminergic neurotransmission, may benefit patients with FMS.ObjectivesTo compare the QoL between Thai patients with FMS and healthy Thais, and investigate the effects of mirtazapine in a pilot study.MethodsWe compared the QoL between 76 Thai patients with FMS and 80 healthy Thai volunteers (HVs). A double-blind, randomized, placebo-controlled trial using 40 patients with FMS was conducted using a block design with parallel assignment. QoL data were obtained at week 0 (baseline), and repeatedly for 13 weeks after receiving placebo or mirtazapine 15 or 30 mg/day.ResultsThe mean baseline of SF-36 QoL was significantly lower in all domains in patients with FMS than in HVs (bodily pain 33 vs 87, general health 36 vs 84, mental health 63 vs 82, physical functioning 59 vs 96, role limitation because of emotional problems 41 vs 92, role limitation because of physical problems 30 vs 96, social functioning 53 vs 93, and vitality 48 vs 75 (scale 0-100, P < 0.01 all domains). Mirtazapine (15 and 30 mg/day) significantly reduced pain scores and improved all domains except social functioning, while placebo produced no change from baseline. Eight patients withdrew because of adverse events including somnolence and weight gain; no benefit, or lack of compliance.ConclusionsThe QoL of patients with FMS is lower than for healthy Thais. Mirtazapine is effective for reducing pain and improving QoL in patients with FMS.Trail registrationClinicalTrials.gov; Identifier: NCT00919295.FundingOffice of the Higher Education Commission, Thailand.

Effects of mirtazapine on quality of life of Thai patients with fibromyalgia syndrome: a double-blind, randomized, placebo-controlled trial

Department of Clinical Pharmacy and Research

Asian Biomedicine

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License.

BackgroundFibromyalgia syndrome (FMS) is a physical and mood disorder that affects quality of life (QoL). Mirtazapine, which improves monoaminergic...

Effects of mirtazapine on quality of life of Thai patients with fibromyalgia syndrome: a double-blind, randomized, placebo-controlled trial

Article Category: Original article

Published Online: Mar 31, 2017

Page range: 435 - 445

DOI: https://doi.org/10.5372/1905-7415.1005.506

Keywords
Fibromyalgia, mirtazapine, noradrenergic and specific serotonergic antidepressant, pain, quality of life

© 2016 Saithip Suttiruksa, Suwimon Yeephu, Pradit Prateepavanich, Chuthamanee Suthisisang

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License.

Effects of mirtazapine on quality of life of Thai patients with fibromyalgia syndrome: a double-blind, randomized, placebo-controlled trial

Article Category: Original article

Published Online: Mar 31, 2017

Page range: 435 - 445

DOI: https://doi.org/10.5372/1905-7415.1005.506

KeywordsFibromyalgia, mirtazapine, noradrenergic and specific serotonergic antidepressant, pain, quality of life

© 2016 Saithip Suttiruksa, Suwimon Yeephu, Pradit Prateepavanich, Chuthamanee Suthisisang

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License.

Keywords
Fibromyalgia, mirtazapine, noradrenergic and specific serotonergic antidepressant, pain, quality of life