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<strong>Fibromyalgia</strong> Medications: TrazodoneBy Dr Colin Dell.This month’s article picks up on some research that hasonly recently been published. It concerns a drug calledtrazodone. Also known as molipaxin, trazodone is marketedfor depression and anxiety in adults. Whilst trazodone isnot approved for the treatment <strong>of</strong> FM, a research group hasconducted two clinical studies, one with trazodone alone,and the follow on with the addition <strong>of</strong> pregabalin (Lyrica).The results <strong>of</strong> these two clinical trials with trazodone in FMhave recently been published (2010 and 2011). In the first study,the efficacy and <strong>to</strong>lerability <strong>of</strong> trazodone was examined in agroup <strong>of</strong> 66 FM patients over a 12 week period. Patients wh<strong>of</strong>ulfilled the American College <strong>of</strong> Rheuma<strong>to</strong>logy criteria for FMwere eligible for the clinical trial. Additional requirements foradmission <strong>to</strong> the study were a willingness <strong>to</strong> discontinue thecurrent drug treatment regime, and furthermore a referral froma general practitioner, rheuma<strong>to</strong>logist or pain managementconsultant. The demographics were 61 women and 5 men,in the age range <strong>of</strong> 22-70. After a washout period, trazodonewas started at 25 mg at bedtime and titrated upwards inthis flexible dosing study until either a benefit or side effectswere noted (maximum dose 300 mg per day). The primaryoutcome measure was the Pittsburgh Sleep Quality Index(PSQI). Secondary outcome measures were the <strong>Fibromyalgia</strong>Impact Questionnaire (FIQ), the Beck Depression Inven<strong>to</strong>ry(BDI), the Hospital Anxiety and Depression Scale (HADS), theBrief Pain Inven<strong>to</strong>ry (BPI), the Short Form health survey (SF-36) and the Patient Global Improvement scale (PGI).Results from this brief trial indicated that trazodone markedlyimproved sleep quality (PSQI) with additional positiveimpacts on a variety <strong>of</strong> sub dimensions <strong>of</strong> “sleep” (duration,efficiency). Significant improvements were also noted in thescores in the FIQ, HADS and BPI. However, a major causefor concern was noted in the incidence <strong>of</strong> tachycardia as aside effect (21.6% <strong>of</strong> patients) and the authors <strong>of</strong> the studymade a recommendation <strong>to</strong> moni<strong>to</strong>r this adverse eventin any further studies. During the clinical trial, 23 patientswithdrew. Treatment emergent adverse events accounted for12 <strong>of</strong> these withdrawals.In a follow on study conducted by the same research group,41 patients who completed the 12 week trazodone studyelected <strong>to</strong> continue treatment with trazodone plus a flexibledose <strong>of</strong> pregabalin (75-450 mg per day) for a further 12weeks. Assessment <strong>of</strong> the outcome <strong>of</strong> the clinical trial wasagain made using the PSQI, FIQ, BPI, BDI, HADS, SF-36 and PGI(abbreviations as above). The quality <strong>of</strong> sleep as assessedby the PSQI failed <strong>to</strong> improve further during the secondphase <strong>of</strong> the trial presumably because pregabalin is notcontributing further <strong>to</strong> the sleep component <strong>of</strong> the trazodoneeffect. Significant effects on the FIQ were <strong>see</strong>n in the secondphase <strong>of</strong> the trial, with particular positive outcomes in thedimensions <strong>of</strong> work, pain, fatigue, morning tiredness andstiffness. The authors elected <strong>to</strong> use a responder analysis forthe assessment <strong>of</strong> pain relief by the BPI, with 28% <strong>of</strong> patientsobserving a ≥30% reduction and 18% a ≥50% reduction in thissecond phase. It is most likely that the pregabalin is the keycontribu<strong>to</strong>r <strong>to</strong> this effect – whilst modest effects were <strong>see</strong>nin the first 12 weeks, only 13% <strong>of</strong> patients achieved a ≥30%reduction in pain, and none achieved ≥50%, as measured bythe BPI. Depression and anxiety scores, as measured by BDIand HADS, also decreased. Only 2 patients withdrew fromthe second phase <strong>of</strong> the trial, indicating that once stabilisedon a dose <strong>of</strong> trazodone the addition <strong>of</strong> pregabalin causedfew major problems. Treatment emergent side effectswere noted by 34 patients but they were typically mild andtransient, including dizziness, light-headedness, dry mouthand oedema.Whilst the positive results are very encouraging, the authorsacknowledge that the two phases <strong>of</strong> the trial lacked a control(placebo) group meaning that the improvements cannot beaccurately ratified. However, it is suggested that the resultsusing an old antidepressant in combination with a morerecent FM drug warrant further investigation in a largerpatient group.References:Morillas-Arques, P., Rodriguez-Lopez, C. M., Molina-Barea, R.,Rico-Villademoros, F. And Calandre, E. P. (2010). “Trazodone forthe treatment <strong>of</strong> fibromyalgia: an open-label 12-week study”,BMC Musculoskeletal Disorders, 11, 204. [PDF available freeonline at: http://www.biomedcentral.com/content/pdf/1471-2474-11-204.pdf]Calandre, E. P., Morillas-Arques, P., Molina-Barea, R., Rodriguez-Lopez, C. M. and Rico-Villademoros, F. (2011). “Trazodone pluspregabalin combination in the treatment <strong>of</strong> fibromyalgia: atwo-phase, 24-week open-label uncontrolled study”, BMCMusculoskeletal Disorders, 12, 95. [PDF available free onlineat: http://www.biomedcentral.com/content/pdf/1471-2474-12-95.pdf]Page sixteen - Living with <strong>Fibromyalgia</strong>: What Helps MeThe <strong>Fibromyalgia</strong> <strong>Magazine</strong>. Year 12 Issue 6. April 2012. www.ukfibromyalgia.com
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