A Comparison of Reboxetine and Amitryptilline in the Treatment of Fibromyalgia Syndrome with Co-morbid Depressive Symptoms: An Open-label Preliminary Study

Amac: Fibromyalji (FM) yeni tedavi aray›fllar›n›n surdu¤u onemli bir halk sal›¤› sorunudur. Bu cal›flmada FM tedavi- sinde s›kl›kla kullan›lan trisiklik antidepresan amitriptilin ile henuz yeterince araflt›r›lmam›fl secici noradrenalin geri al›m inhibitoru reboksetinin etkilerinin karfl›laflt›r›lmas› amaclanm›flt›r. Ayr›ca noradrenalinin ar› duyumundaki mekanizmalarla iliflkisi bak›m›ndan, secici noradrenalin ge- ri al›m inhibitoru reboksetinin FM hastalar›nda etkinliini de deerlendirmek amaclanm›flt›r. Yontem: Depresif semptomlar› da olan 21 FM hastas› 25- 75mg/gun amitriptilin ya da 8 mg/gun reboksetine rando- mize edildi. Hastalar bafllang›c, 2,4 ve 8. haftalarda Fibrom- yalji Etki Anketi (FEA), Beck Anksiyete ve Depresyon Olcek- leri (BAI, BDI), Hamilton Anksiyete ve Depresyon Olcekleri (HAM-A, HAM-D) ile deerlendirildi. Ar› fliddeti Gorsel Analog Skala (GAS) ile deerlendirildi. Bulgular: Her iki ilac grubunda FEA ve GAS puanlar› ile sap- tanan FM belirtileri ve depresif belirtilerinde iyileflme ile iliflkili bulundu. General Lineer Model Tekrarl› Olcumler tes- ti, FEA ve GAS puanlar›nda gruplar aras› fark ya da zaman x grup etkileflimi olmaks›z›n anlaml› azalman›n bulunuduu- nu gosterdi. Her iki grupta da kayda deer ciddi yan etki gozlenmedi. Sonuc: Bu ac›k cal›flmada gerek amitriptilinin gerekse re- boksetinin FM hastalar›n›n ar› ve depresif semptomlar›n- daki iyileflme ile iliflkili olduu gosterilmifltir. Etkililik cal›fl- mas› nedensellii ve etkinlii gostermediinden kesin so- nuclar c›karsamak icin daha buyuk gruplarda plasebo kon- trollu, cift kor cal›flmalara ihtiyac vard›r. Araflt›rmam›z›n bul- gular› FM tedavisi icin yap›lacak cal›flmalara dair onemli ipuclar› sunmaktad›r. ABSTRACT:of reboxetine and amitryptilline in the treatment of fibromyalgia syndrome with co-morbid depressive symptoms: an open-label preliminary study Objective: Fibromyalgia (FM) is a chronic debilitating disorder that results in millions of dollars of heathcare costs and lost wages each year worldwide. It is a significant public health concern and new treatments are needed. In this study, we aimed to compare the effectiveness of a widely used tricyclic antidepressant for FM (amitryptylline) and one that has not yet been widely used (reboxetine) for FM in a within-subject pre-posttreatment design. Additionally, since noradrenaline (NA) is thought to play a relevant role in the antinociceptive mechanisms, we also aimed to examine the effectiveness of reboxetine as a selective NA reuptake inhibitor (NARI) in patients with fibromialgia. Methods: Twenty-one patients with fibromyalgia were randomized to receive amitiriptylline (25-75 mg/day) or reboxetine (8 mg/day). Patients were administered the Fibromyalgia Impact Questionnaire (FIQ), the Beck Depression and Anxiety Inventories (BDI, BAI), and the Hamilton Rating Scales for Depression and Anxiety (HAM- D, HAM-A) at the treatment weeks 2, 4, and 8. The intensity of the pain was recorded using a Visual Analog Scale (VAS). Results: We found both medications to be associated with improvement in pain (decreased VAS scores), FIQ scores, and depressive symptomotology. General linear model repeated measures analysis on the VAS and FIQ scores showed a significant decrease over time in both treatment groups without significant group difference or time x group interaction effect. There were no serious adverse events in both groups. Conclusions: This open trial demonstrated that either reboxetine or amitryptylline would be effective for the treatment of pain symptoms in patients with FM. Since open-label clinical effectiveness studies do not provide definitive conclusions about causality or efficacy, double blind, placebo-controlled studies in larger clinical groups are needed to reach a definitive conclusion. Our findings provide clinical researchers important information about the novel treatment options for FM.