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Transcript
Kliiniline küsimus nr 6 Kas ärevushäirega patsientidel kasutada farmakoloogilist ravi koos mittefarmakoloogilise raviga vs mittefarmakoloogiline ravi vs farmakoloogiline ravi? Kriitilised tulemusnäitajad: Sheffield: Short, self-complete questionnaires (such as the panic subscale of the agoraphobic mobility inventory for individuals with panic disorder) should be used to monitor outcomes wherever possible. CPA: A response to therapy is often defined as a percentage reduction in symptoms (usually 25% to 50%) on an appropriate scale. Although it might not be possible for all patients, remissioon should be the goal of therapy. Remission is often defined as loss of diagnostic status, a prespecified low score on an appropriate disorder-specific scale, and no functional impairment. The goals of therapy in PD are to decrease the frequency and severity of panic attacks and to reduce anticipatory anxiety, fear-driven avoidance, and impaired functioning related to anxiety. According to the suggested criteria, PD is in remission 3, with no when the patient is essentially free of panic attacks (PDSS individual itemscore > 1) and has no ormild agoraphobic avoidance, no 10), no or mild functional disability, and no or minimal anxiety (HARS depressive symptomatology. Nice: Non-remission, non-response, dropouts, Mean rating scale scores for anxiety, depression, worry, somatic symptoms, quality of life. WFSBP: clinically meaningful difference on a specific rating scale (e.g.2 points on the HAMA); response is usually defined as a 50% improvement on this scale Tõendus ravijuhendites: NICE juhend: One trial examined combining pharmacological and psychological interventions. Based on the evidence of one study (BOND2002B), there was no significant difference found between the combination of buspirone and non-directive therapy over the combination of active control and non-directive therapy in the reduction of clinician-rated anxiety scores. However, the results indicate that the combination of buspirone and non-directive therapy may lead to slightly lower clinician-rated anxiety scores. Similarly, there were no significant differences between the treatment approaches on self-rated anxiety scores. Wide confidence intervals, lack of statistical significance and the small sample size, prevent any clear conclusions being drawn. Spanish NHS: Systematic reviw examined the effectiveness of CBT combined with medication (benzodiazepines, azaspirones, anti-depressants) in comparison with the effectiveness of each one of these therapies separately. Those that directly compare combined therapy with pharmacological treatment show that combined treatment is better, which suggests that the use of a cycle of CBT should be considered for patients that have obtained partial response from medications after receiving pharmacotherapy alone. Also, with the exception of PD, adding drugs to CBT appears to not interfere negatively in the effects achieved over the long term with CBT alone. GAD: In one RCT, CBT was combined with the use of diazepam. The CBT consisted of 7 sessions over a period of nine weeks. The patients received interventions such as cognitive therapy and progressive muscle relaxation, and took work home, working on the technique of exposure to situations and thoughts that generate anxiety. The evaluation of the effectiveness, using the Hamilton scale, continued until six months after the treatment. The study concluded that there is an advantage, in terms of severity and overall change in symptoms, of the combined treatment over the use of diazepam alone, but not over the use of CBT alone. The CBT either alone or in combination with a drug or placebo, showed the lowest incidence of referrals to psychologists and/or psychiatrists at a six-month follow-up. PD: One tiral examined the effectiveness of CBT combined with medication (benzodiazepines, azaspirones, anti-depressants) as compared to the effectiveness of each one of these therapies used [Type text] separately show that the differences between these treatments are not very clear. Also, during followup, it was observed that combined therapy interfered with the maintenance of the benefits obtained long-term by BCT. Meta-analysis studied the effectiveness of combined treatment with CBT and SSRI or tricyclic anti-depressants, and concludes that it is slightly more effective than CBT alone for all of the categories of symptoms, except for quality of life. One RCT evaluated the effectiveness of the combination of anxiolytic medication and CBT as opposed to the use of medication alone. It was found that the combination with CBT, in comparison with the use of medication alone, generates an improvement in indicators such as sensitivity to anxiety, social avoidance, and incapacitation, after 3 months of treatment and at a 12-month follow-up. RCT on patients with PD, which combines the use of antidepressants and/or benzodiazepines with reduced CBT intervention. The study concluded that the combined intervention produced a sustained and gradually increasing improvement according to the measurement scales used, in comparison with the improvement obtained with pharmacological treatment alone. Another RCT compared combined treatments, treatments alone, and with placebo. They all showed better results than the placebo, but the CBT group obtained a more robust and consistent response. Ravijuhendid Kokkuvõte ravijuhendites leiduvast Kokku on hinnatud üheksat ravijuhendit. Kombinatsioonravi kohta sisaldus soovitusi viies ravijuhendis (BAP, CPA, Spanish NHS, AMA, NICE). BAP ei soovita kombinatsioonravi kasutamist GAD ega PD esmases ravis kuna puuduvad järjepidevad tulemused uuringutest. CPA-l ei ole soovitust kombinatsioonravi kasutamiseks GAD ravis kuna väga vähestes uuringutes on võrreldud kombinatsioonravi eeliseid monoteraapia ees. PD ravi korral kinnitavad mitmed uuringud ja meta-analüüsid, et kombinatsioonravi kasutamine on efektiivsem kui CBT või farmakoteraapia monoravi. Spanish NHS soovitab GAD ravis kasutada CBT ja diasepaami kombinatsioonravi ning PD korral CBT kombinatsioonis antidepressantidega. AMA-l ei ole soovitust kombinatsioonravi kasutamiseks PD korral kuna pole piisavalt kinnitus sellele, et kombinatsioonravi on teistest raviviisidest efektiivsem või et kombinatsioonravi peaks rutiinselt kasutama. AMA hinnangul peaks kombinatsioonravi kaaluma neil patsientidel, kellel monoteraapia ei ole efektiivseks osutunud. NICE soovituse kohaselt tuleb psühholoogiline ravi lisada neil patsientidel, kes on osaliselt GAD farmakoteraapiale vastanud. Süstemaatilised ülevaated Kokkuvõte süstemaatilistest ülevaadetest Viited Kokkuvõtte (abstract või kokkuvõtlikum info) Viide kirjandusallikale GAD Combination of drugs and psychological treatment: Routinely combining drug and psychological approaches is not recommended for initial treatment in the absence of consistent evidence for enhanced efficacy over each treatment given alone (A). Panic disorder Combination of drugs and psychological treatment: Routinely combining drug and psychological approaches is not recommended for initial treatment in the absence of consistent evidence for Evidence-based guidelines for the pharmacological treatment of anxiety disorders: recommendations from the British Association for Psychopharmacology [Type text] enhanced efficacy over each treatment given alone (D) (2005) GAD Combined Psychological and Pharmacologic Treatment There is strong evidence for the effectiveness of either CBT or pharmacotherapy alone for GAD. Unfortunately, few studies compare these approaches in the same trial, and even fewer evaluate combined treatment. PD Combined Psychological and Pharmacologic Treatment There is considerable controversy over whether it is helpful to routinely combine CBT with pharmacotherapy and well-designed studies with medications currently in wide use are limited. Several studies and metaanalyses have found that combination therapy was superior to CBT or pharmacotherapy alone during the acute treatment phase and while medication was continued. Combination treatment (CBT and medication) for GAD (B) The combined treatment of CBT and diazepam or CBT alone, versus the use of diazepam alone, due to its advantage in terms of gravity and overall change of symptoms is recommended, although patient preferences must be taken into account. (B) In combined treatment, such as CBT in healthcare centres, 7 sessions over 9 weeks are recommended, provided by professionals trained in cognitive therapy and progressive muscular relaxation. The patient should also do work at home. Combined treatment (CBT and medication) for PD (A) The combination of CBT (exposure and cognitive restructuring techniques) and anti-depressants (TADs and SSRIs) is recommended, depending on patient preferences. (A) Treatment with anti-depressants alone is not recommended as first-line treatment, when the appropriate resources to provide CBT are available. (B) In long-term treatments, if anti-depressant drugs are added to the CBT, they should be monitored to ensure that they do not interfere with the beneficial effects of the CBT alone. Clinical practice guidelines, management of Anxiety Disorders, Canadian psychiatric Association (2006) There is insufficient evidence to recommend any of these pharmacological (SSRI, SNRI, TCA, benzodiazepine (appropriate as monotherapy only in the absence of a co-occurring mood disorder)) or psychosocial interventions (cognitive-behavioral therapy) as superior to the others, or to routinely recommend a combination of treatments over monotherapy [II]. Although combination treatment does not appear to be significantly superior to standard monotherapy as initial treatment for most individuals with panic disorder, psychiatrists and patients may choose this option based on individual circumstances (e.g., patient preference) [II]. Combined treatment should be considered for patients who have failed to respond to standard monotherapies and may also be used under certain clinical circumstances (e.g., using pharmacotherapy for temporary control of severe symptoms that are impeding the patient’s ability to engage in psychosocial treatment) [II]. Adding psychosocial treatment to pharmacotherapy either from the start, or at some later point in treatment, may enhance long-term outcomes by reducing the likelihood of relapse when pharmacological treatment is stopped [II]. Combination: In general, pharmacotherapy alone is not recommended for children and adolescents. Its use should ideally be preceded and complemented by psychotherapy and/or behavioural therapy. Employ pharmacological management strategies if non-pharmacological interventions are not achieving therapeutic goals. PRACTICE GUIDELINE FOR THE Treatment of Patients With Panic Disorder (2009) Inadequate response If a person’s GAD has not responded to a full course of a high-intensity psychological intervention, offer a drug treatment -If a person’s GAD has not responded to drug treatment, offer either a high intensity psychological intervention or an alternatiive drug treatment. Generalised Anxiety Disorder in Adults. The NICE Guideline on Management in Primary, Secondary and Community Clinical Practice Guideline for Treatment of Patients with Anxiety Disorders In Primary Care (2008) Anxiety and Depression in Children and Youth – Diagnosis and Treatment (2010) [Type text] -If a person’s GAD has partially responded to drug treatment, consider offering a high-intensity psychological intervention in addition to drug treatment. Care (2011) Paanikahäire korral: 1. Kuidas toimib kombineeritud ravi (farmakoloogia+psühhoteraapia) juhtudel kui pt pole monoteraapial paranenud? Kampman et al. 2002 eesmärgiks oli hinnata, kas patsiendid, kes on määratletud, kui CBTravile mittevastajad, reageeriksid ravile CBT + paroksetiin / CBT + platseebo. Uuringu tulemusena leiti, et patsientidel, kes ei vastanud 15 CBT sessioonile, oli paroksetiini lisamine CBT-le efektiivsem kui CBT + platseebo. Pollack et al. 1994, Otto et al 1999, Heldt et al. 2003 on leidnud, et CBT lisamine farmakoloogilisele ravile võib olla efektiivne farmakoloogilisele monoravile mittevastanute seas. GAD korral ei ole uuringuid, mis kinnitaks kombinatsioonravi efektiivsust neil, kellel monoteraapia ei ole efekti andnud. 2. Kuidas toimib kombineerimine ravi alguses ja lõpus? Paanikahäirete ravi käsitlenud Cochrane ülevaate kohaselt on lühiaegne, akuutses faasis (2-4 kuud) teostatud kombineeritud ravi efektiivsem kui psühhoteraapia või antidepressantide monoteraapia. Samas pikaaegses ravis on kombineeritud ravi sama efektiivne kui psühhoteraapia monoteraapia ning efektiivsem kui antidepressantide monoteraapia. Mitte 2005 meta-analüüsi kohaselt võib bensodiasepiine või antidepressante kasutanud patsientidel ravi lõpetamise ajal CBT sessioonide kasutamine vähendada relapsi tõenäosust ravi lõpetamise ajal ja sellele järgnevatel kuudel. GAD kohta häid andmeid ei ole. Üldiselt on kombineeritud ravi kasutatud enamustes uuringutes ravi alguses lühiaegselt (7 CBT sessiooni 9 nädala jooksul, 6 CBT sessiooni 12 nädala jooksul, 8 CBT sessiooni 12 nädala jooksul).