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Clinical Rheumatology Jul 2022Treatment recommendations for fibromyalgia (FM) include a range of predominantly pharmacological treatment options designed to ensure the maintenance of symptoms and... (Meta-Analysis)
Meta-Analysis Review
Treatment recommendations for fibromyalgia (FM) include a range of predominantly pharmacological treatment options designed to ensure the maintenance of symptoms and improvement in the quality of life of these patients. Our aim is to identify and compare the efficacy of amitriptyline (AMT), duloxetine (DLX), and pregabalin (PGB) for reducing pain intensity by 30% (R30%) and 50% (R50%) in adult patients with fibromyalgia. The review was conducted in the Medline/PubMed, Cochrane Library, and Embase databases up to February 2022. This study included systematic reviews (SR) of randomized clinical trials (RCTs) targeting adult patients over 18 years of age diagnosed with fibromyalgia according to the criteria of scientific societies, which include the basic clinical diagnosis characterized by the presence of pressure sensitivity in at least 11 of the 18 tender points, in addition to the presence of widespread musculoskeletal pain for a period longer than 3 months and a general assessment of the patient's health status. Pregnant women and children or adolescents were excluded. The Rob 2.0 tool from the Cochrane Collaboration was used to assess the risk of bias in RCTs. The quality of evidence of the reviews included was assessed according to the Grading of Recommendations Assessment, Development and Evaluation-GRADE. A meta-analysis for the evidence network was performed using the Bayesian approach, which allows simultaneous comparison of all treatment options (medication and dose). The different treatments were ranked according to the response rate according to the surface under the curve (SUCRA), which was expressed as a percentage. The results were presented in tables and figures. The protocol with the detailed methods was registered in PROSPERO (CRD42021229264). Eight systematic reviews were identified, and, from these, 15 clinical trials comparing AMT (n = 273), DLX (n = 2595), and PGB (n = 3,506) against placebo were selected. For the outcome R30%, PGB 450 mg was superior to DLX 30 mg and PGB 150 mg, while DLX 20 mg and 30 mg were not superior to placebo. For the outcome R50%, AMT 25 mg was superior to all other alternatives evaluated. The calculation of the SUCRA indicated that PGB 450 mg was the best performance option for R30% and AMT 25 mg for R50%. PGB 150 mg was the drug with the worst performance in the two outcomes evaluated. The drugs evaluated showed benefits for pain reduction in patients with fibromyalgia. In the absence of direct comparison studies, indirect comparison meta-analyses are an important resource for assisting in clinical decision-making. Our data only provide an indicator of the effectiveness of the three drugs evaluated, but as with other health conditions, tolerability and safety are important for the decision-making process and clinical management. In this regard, we encourage caution in interpreting our data.
Topics: Adolescent; Adult; Child; Female; Humans; Amitriptyline; Duloxetine Hydrochloride; Fibromyalgia; Network Meta-Analysis; Pain; Pregabalin; Randomized Controlled Trials as Topic
PubMed: 35347488
DOI: 10.1007/s10067-022-06129-8 -
JAMA Network Open May 2022Amitriptyline is an established medication used off-label for the treatment of fibromyalgia, but pregabalin, duloxetine, and milnacipran are the only pharmacological... (Meta-Analysis)
Meta-Analysis
IMPORTANCE
Amitriptyline is an established medication used off-label for the treatment of fibromyalgia, but pregabalin, duloxetine, and milnacipran are the only pharmacological agents approved by the US Food and Drug Administration (FDA) to treat fibromyalgia.
OBJECTIVE
To investigate the comparative effectiveness and acceptability associated with pharmacological treatment options for fibromyalgia.
DATA SOURCES
Searches of PubMed/MEDLINE, Cochrane Library, Embase, and Clinicaltrials.gov were conducted on November 20, 2018, and updated on July 29, 2020.
STUDY SELECTION
Randomized clinical trials (RCTs) comparing amitriptyline or any FDA-approved doses of investigated drugs.
DATA EXTRACTION AND SYNTHESIS
This study follows the Preferred Reporting Items for Systematic Reviews and Meta-analyses reporting guideline. Four independent reviewers extracted data using a standardized data extraction sheet and assessed quality of RCTs. A random-effects bayesian network meta-analysis (NMA) was conducted. Data were analyzed from August 2020 to January 2021.
MAIN OUTCOMES AND MEASURES
Comparative effectiveness and acceptability (defined as discontinuation of treatment owing to adverse drug reactions) associated with amitriptyline (off-label), pregabalin, duloxetine, and milnacipran (on-label) in reducing fibromyalgia symptoms. The following doses were compared: 60-mg and 120-mg duloxetine; 150-mg, 300-mg, 450-mg, and 600-mg pregabalin; 100-mg and 200-mg milnacipran; and amitriptyline. Effect sizes are reported as standardized mean differences (SMDs) for continuous outcomes and odds ratios (ORs) for dichotomous outcomes with 95% credible intervals (95% CrIs). Findings were considered statistically significant when the 95% CrI did not include the null value (0 for SMD and 1 for OR). Relative treatment ranking using the surface under the cumulative ranking curve (SUCRA) was also evaluated.
RESULTS
A total of 36 studies (11 930 patients) were included. The mean (SD) age of patients was 48.4 (10.4) years, and 11 261 patients (94.4%) were women. Compared with placebo, amitriptyline was associated with reduced sleep disturbances (SMD, -0.97; 95% CrI, -1.10 to -0.83), fatigue (SMD, -0.64; 95% CrI, -0.75 to -0.53), and improved quality of life (SMD, -0.80; 95% CrI, -0.94 to -0.65). Duloxetine 120 mg was associated with the highest improvement in pain (SMD, -0.33; 95% CrI, -0.36 to -0.30) and depression (SMD, -0.25; 95% CrI, -0.32 to -0.17) vs placebo. All treatments were associated with inferior acceptability (higher dropout rate) than placebo, except amitriptyline (OR, 0.78; 95% CrI, 0.31 to 1.66). According to the SUCRA-based relative ranking of treatments, duloxetine 120 mg was associated with higher efficacy for treating pain and depression, while amitriptyline was associated with higher efficacy for improving sleep, fatigue, and overall quality of life.
CONCLUSIONS AND RELEVANCE
These findings suggest that clinicians should consider how treatments could be tailored to individual symptoms, weighing the benefits and acceptability, when prescribing medications to patients with fibromyalgia.
Topics: Amitriptyline; Duloxetine Hydrochloride; Fatigue; Female; Fibromyalgia; Humans; Male; Middle Aged; Milnacipran; Network Meta-Analysis; Pain; Pregabalin; United States; United States Food and Drug Administration
PubMed: 35587348
DOI: 10.1001/jamanetworkopen.2022.12939 -
FP Essentials Oct 2023Fibromyalgia is a chronic pain syndrome that is considered a pain processing disorder; its pathophysiology is not completely understood. The estimated prevalence in the...
Fibromyalgia is a chronic pain syndrome that is considered a pain processing disorder; its pathophysiology is not completely understood. The estimated prevalence in the general population varies from 0.5% to 12%, depending on the population studied and diagnostic criteria used. It is more common in females than males. There is no diagnostic laboratory test. The two currently used diagnostic methods are scoring criteria from the American College of Rheumatology (ACR) and the Analgesic, Anesthetic, and Addiction Clinical Trial Translations Innovations Opportunities and Networks (ACTTION)-American Pain Society (APS). These diagnostic criteria include chronic widespread pain of at least 3 months' duration plus poor sleep and/or fatigue and other somatic symptoms. Other pain syndromes also should be considered in the differential diagnosis. A multimodal, targeted symptom management approach that emphasizes self-management is recommended. Nonpharmacotherapies include patient education, exercise, and cognitive behavior therapy. Pharmacotherapy should be based on predominant symptoms. Amitriptyline and pregabalin are effective for management of pain, fatigue, and sleep issues. Milnacipran (Savella) is effective for pain and fatigue. Duloxetine is effective for management of pain and depression. There is no evidence of benefit of analgesics. Common comorbidities, such as regional pain conditions and mental disorders, should be addressed.
Topics: Male; Female; Humans; Fibromyalgia; Chronic Pain; Pregabalin; Duloxetine Hydrochloride; Milnacipran; Fatigue
PubMed: 37812528
DOI: No ID Found -
The American Journal of Psychiatry Mar 2023The authors sought to determine the shared and unique changes in brain resting-state functional connectivity (rsFC) between patients with major depressive disorder who... (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVE
The authors sought to determine the shared and unique changes in brain resting-state functional connectivity (rsFC) between patients with major depressive disorder who achieved remission with cognitive-behavioral therapy (CBT) or with antidepressant medication.
METHODS
The Predictors of Remission in Depression to Individual and Combined Treatments (PReDICT) trial randomized adults with treatment-naive major depressive disorder to 12 weeks of treatment with CBT (16 1-hour sessions) or medication (duloxetine 30-60 mg/day or escitalopram 10-20 mg/day). Resting-state functional MRI scans were performed at baseline and at week 12. The primary outcome was change in the whole-brain rsFC of four seeded brain networks among participants who achieved remission.
RESULTS
Of the 131 completers with usable MRI data (74 female; mean age, 39.8 years), remission was achieved by 19 of 40 CBT-treated and 45 of 91 medication-treated patients. Three patterns of connectivity changes were observed. First, those who remitted with either treatment shared a pattern of reduction in rsFC between the subcallosal cingulate cortex and the motor cortex. Second, reciprocal rsFC changes were observed across multiple networks, primarily increases in CBT remitters and decreases in medication remitters. And third, in CBT remitters only, rsFC increased within the executive control network and between the executive control network and parietal attention regions.
CONCLUSIONS
Remission from major depression via treatment with CBT or medication is associated with changes in rsFC that are mostly specific to the treatment modality, providing biological support for the clinical practice of switching between or combining these treatment approaches. Medication is associated with broadly inhibitory effects. In CBT remitters, the increase in rsFC strength between networks involved in cognitive control and attention provides biological support for the theorized mechanism of CBT. Reducing affective network connectivity with motor systems is a shared process important for remission with both CBT and medication.
Topics: Adult; Female; Humans; Antidepressive Agents; Brain; Depressive Disorder, Major; Duloxetine Hydrochloride; Escitalopram; Magnetic Resonance Imaging; Psychotherapy
PubMed: 36651624
DOI: 10.1176/appi.ajp.21070727 -
The American Journal of Medicine Apr 2021
Topics: Burning Mouth Syndrome; Duloxetine Hydrochloride; Female; Humans; Middle Aged; Serotonin and Noradrenaline Reuptake Inhibitors; Taste Perception
PubMed: 32997980
DOI: 10.1016/j.amjmed.2020.08.031 -
BMJ Supportive & Palliative Care Mar 2023Duloxetine has previously been reported to be promising in the setting of chemotherapy-induced peripheral neuropathy (CIPN). The aim of this study was to conduct a... (Meta-Analysis)
Meta-Analysis
INTRODUCTION
Duloxetine has previously been reported to be promising in the setting of chemotherapy-induced peripheral neuropathy (CIPN). The aim of this study was to conduct a comprehensive systematic review and meta-analysis, on the use of duloxetine in prevention and treatment of CIPN.
METHODS
PubMed, Embase and Cochrane CENTRAL were searched from database inception up until April 2022. Articles were included in this review if they reported on duloxetine use in the setting of CIPN, in a multiarm comparative human trial. A random effects DerSimonian-Laird model was used to calculate summary risk ratios (RR) and corresponding 95% CIs, comparing duloxetine to placebo. This review was registered on.
RESULTS
Seven randomised controlled trials that included 645 patients were identified. Five reported on duloxetine for treatment of CIPN, and two for prevention of CIPN. Two studies had some concern for bias. Duloxetine was statistically similar to placebo in its efficacy, both in the treatment (RR 0.92, 95% CI 0.84 to 1.01) and prevention (RR 1.02, 95% CI 0.87 to 1.19) of CIPN. Safety profile was similar, in the treatment (RR 1.31, 95% CI 0.90 to 1.89) and prevention (RR 1.52, 95% CI 0.98 to 2.38) setting.
CONCLUSION
There is currently limited evidence supporting duloxetine's use for CIPN. There is a need for more comprehensive and higher-quality trials assessing duloxetine in the setting of CIPN, before further clinical practice recommendations.
TRIAL REGISTRATION NUMBER
PROSPERO (CRD42022327487).
Topics: Humans; Duloxetine Hydrochloride; Peripheral Nervous System Diseases; Antineoplastic Agents; Randomized Controlled Trials as Topic
PubMed: 36194493
DOI: 10.1136/spcare-2022-003815 -
American Family Physician Mar 2024Diabetic peripheral neuropathy occurs in up to 50% of patients with diabetes mellitus and increases the risk of diabetic foot ulcers and infections. Consistent screening...
Diabetic peripheral neuropathy occurs in up to 50% of patients with diabetes mellitus and increases the risk of diabetic foot ulcers and infections. Consistent screening and clear communication are essential to decrease disparities in assessment of neuropathic symptoms and diagnosis. Physicians should address underlying risk factors such as poor glycemic control, vitamin B12 deficiency, elevated blood pressure, and obesity to reduce the likelihood of developing neuropathy. First-line drug therapy for painful diabetic peripheral neuropathy includes duloxetine, gabapentin, amitriptyline, and pregabalin; however, these medications do not restore sensation to affected extremities. Evidence for long-term benefit and safety of first-line treatment options is lacking. Second-line drug therapy includes nortriptyline, imipramine, venlafaxine, carbamazepine, oxcarbazepine, topical lidocaine, and topical capsaicin. Periodic, objective monitoring of medication response is critical because patients may not obtain desired pain reduction, adverse effects are common, and serious adverse effects can occur. Opioids should generally be avoided. Nondrug therapies with low- to moderate-quality evidence include exercise and neuromodulation with spinal cord stimulation or transcutaneous electrical nerve stimulation. Peripheral transcutaneous electrical nerve stimulation is well tolerated and inexpensive, but benefits are modest. Other treatments, such as acupuncture, alpha-lipoic acid, acetyl-L-carnitine, cannabidiol, and onabotulinumtoxinA need further study in patients with diabetic peripheral neuropathy.
Topics: Humans; Diabetic Neuropathies; Duloxetine Hydrochloride; Capsaicin; Gabapentin; Pregabalin; Pain; Diabetes Mellitus
PubMed: 38574212
DOI: No ID Found -
Journal of Psychiatric Research May 2020Duloxetine has been increasingly administered, but the associated cardiovascular adverse event risk is not clearly understood. Therefore, we identified the association... (Meta-Analysis)
Meta-Analysis Review
Duloxetine has been increasingly administered, but the associated cardiovascular adverse event risk is not clearly understood. Therefore, we identified the association between duloxetine and cardiovascular adverse events through an analysis of heart rate and blood pressure change. We searched PubMed, EMBASE, Cochrane Central Register of Controlled Trials, ClinicalTrials.gov, and psycINFO in June 2019. The title, abstract, and full text were checked in order to obtain articles. A meta-analysis was conducted with random effect model and quality of articles was evaluated using Cochrane Risk of Bias 2.0. The manuscript has been written according to the PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses) harm checklist. A total of 4009 studies were screened by the title and abstract. After reviewing 186 full texts, 17 studies were finally selected for the meta-analysis. Nine of the 17 studied duloxetine given for mood disorders and 8 for pain control. The duration of 14 studies was under 13 weeks. Cardiovascular adverse events (hypertension, myocardial infarction, transient ischemic attack, tachycardia atrial fibrillation, and cerebrovascular accident) were reported. The meta-analysis demonstrated that duloxetine increased heart rate by 2.22 beats/min (95% confidence intervals [CIs]: 1.53, 2.91) and diastolic blood pressure by 0.82 mmHg (95% CI: 0.17, 1.47). Our findings may be the signal for the safety of cardiovascular disease for short-term use of duloxetine. Well-designed pharmaco-epidemiological studies evaluating the causal relationship between long-term use of duloxetine and cardiovascular disease is still necessary.
Topics: Blood Pressure; Cardiovascular Diseases; Duloxetine Hydrochloride; Humans; Hypertension; Myocardial Infarction; Stroke
PubMed: 32135389
DOI: 10.1016/j.jpsychires.2020.02.022 -
Turk Psikiyatri Dergisi = Turkish... 2019Hyponatremia can be asymptomatic or have a wide range of clinical presentations such as headaches, muscle cramps, nausea, seizures, coma, cerebral edema and may even...
Hyponatremia can be asymptomatic or have a wide range of clinical presentations such as headaches, muscle cramps, nausea, seizures, coma, cerebral edema and may even result in death. Despite it has been suggested that duloxetine has a relatively less risk of hyponatraemia, the number of case reports are increasing. A 45- year old female patient with complaints of fear, anxiety, sleeplessness and headache was started on duloxetine (30 mg/day). In the first week of the treatment, she was admitted to the emergency service with dizziness, dry mouth, polyuria and polydipsia. She had to be transferred to the intensive care unit because of agitation, loss of consciousness and a generalized tonic-clonic seizure. Blood levels of Sodium (Na+), Potassium (K+) and Chlorine (Cl-) were, respectfully, 121 mmol/L, 2.7 mmol/L and 87 mmol/L. Brain imaging displayed cerebral edema. Electrolyte levels were regulated with saline infusions. Amitriptyline was initiated for the ongoing headache and anxiety. In outpatient visits, hyponatremia did not recur in the following 3 months. Low dose duloxetine was associated with severe hyponatremia signs and symptoms in an individual who was not previously considered as high risk for hyponatraemia. The patient's history did not reveal any complaints related to hyponatremia when she was treated with sertraline two years ago. Based on these, we discussed the risk factors for hyponatremia and risky antidepressant classes.
Topics: Antidepressive Agents; Anxiety Disorders; Diagnosis, Differential; Duloxetine Hydrochloride; Female; Humans; Hyponatremia; Middle Aged; Serotonin and Noradrenaline Reuptake Inhibitors
PubMed: 32594491
DOI: No ID Found -
Revista Espanola de Anestesiologia Y... Dec 2022Neuropathic pain is an important and disabling clinical problem, its management constitutes a challenge for healthcare professionals. Vortioxetine is a new... (Review)
Review
Neuropathic pain is an important and disabling clinical problem, its management constitutes a challenge for healthcare professionals. Vortioxetine is a new antidepressant drug with multimodal action, which gives it a unique profile. Tricyclic antidepressants, in particular amitriptyline, and serotonin and norepinephrine reuptake inhibitors venlafaxine and duloxetine are first-line drugs in the treatment of neuropathic pain. The interaction between the pain and depression binomial is very frequent, being the most frequent psychological complication in patients with chronic pain. This comprehensive and descriptive review summarizes the most relevant pharmacological data on vortioxetine, as well as the specific literature on vortioxetine in neuropathic pain and chronic pain.
Topics: Humans; Vortioxetine; Chronic Pain; Antidepressive Agents; Duloxetine Hydrochloride; Neuralgia
PubMed: 36241510
DOI: 10.1016/j.redare.2022.09.003