Treatment of Neuropathic Pain With Venlafaxine a Systematic Review
Introduction
Depression and chronic pain are disabling and often concomitant pathologies; both are currently ii of the principal public wellness problems (1, 2). Major depressive disorder (MDD) is the most prevalent psychiatric affliction and has been recognized as a critical target of intervention in the psychiatric field (3, 4). All the same, depression remains underdiagnosed and consequently, undertreated (4, 5). Furthermore, generalized anxiety disorder (GAD), obsessive-compulsive disorder (OCD), and postal service-traumatic stress disorder (PTSD) are common psychiatric comorbidities with MDD, normally lead to worse prognosis and compromise the remission of MDD symptoms (6).
GAD is one of the well-nigh prevalent psychiatric disorders, affecting half-dozen% of the population during their lifetime (7, 8). GAD is a chronic condition that severely affects the quality of life, due to its repercussion on working and social functioning (viii). Even though anxiety is a widespread symptom, the diagnosis of GAD requires a complex procedure of screening for a right diagnosis (9). Moreover, GAD is usually associated with other clinical conditions such as MDD or pain syndromes, affecting drastically prognosis, and treatment efficacy (10).
Chronic pain is a persistent pain condition with a dual dimension, based on the signaling machinery pathways: nociceptive and neuropathic pain (NP) (11). Specifically, NP has a strong emotional implication, and has been associated with worse quality of life, and clinically, it is related with affective disturbances such every bit depression, anhedonia, working retention dysfunction, sleep disturbances, anxiety, and impaired cognition (12–14). Moreover, chronic pain involves a stress component that might play a bidirectional predictive part. That is, chronic stressful events produce biochemical and pathophysiologic alterations that lead to stress-related mood disorders, that besides may increase the risk of chronic pain or exacerbate it (14, 15).
On the other hand, fibromyalgia syndrome (FMS) is a chronic widespread pain condition with high heterogeneity clinically and etiologically (16, 17). It is estimated that 4–6% of adults worldwide suffer from FMS, whose incidence is increased in women (18). The well-nigh debilitating symptom of FMS is generalized pain. Other symptoms such as fatigue, sleep disturbances, cognitive impairment, or headache are as well part of the cadre symptoms of FMS (19). Concomitantly, MDD symptoms also overlap with the FMS, as well as GAD that is significantly higher in patients with FMS (20, 21).
There is a possible connexion betwixt anxiety, depression, and stress urinary incontinence (SUI). Evidence suggests that both feet and depression are predictor of SUI onset (22). SUI is characterized by an unintentional urinary leakage due to coughing, exertion or sneezing, which increment the intra-abdominal and bladder pressure that overcome urethral resistance (23). Serotonin (5-HT) pathways are involved in this disorder. Thus, 5-HT induces the urethral sphincter closure past inhibition of the micturition reflex (22).
In this perspective, duloxetine is a potential handling for these dissimilar clinical atmospheric condition, but with shared pathophysiological pathways. Duloxetine is a serotonin-norepinephrine reuptake inhibitor (SNRIs) canonical as a first-line drug to treat MDD, GAD, diabetic peripheral neuropathy (DPN), FMS and SUI (24–28). As a SNRIs, duloxetine increases both levels of serotonin and norepinephrine which are directly correlated with adverse events, such equally tachycardia, hypertension, among others (29). Pharmacokinetic and pharmacodynamic data of duloxetine accept been reported for several studies, whose evidence suggests that duloxetine is generally well-tolerated (30–33). Thus, the main goal of this systematic review was to determine the efficacy, tolerability, and safety of duloxetine in the treatment of the clinical conditions for which it is canonical.
Methodology
Study Blueprint
A qualitative systematic review of literature was performed, post-obit the 2009 Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines, and the Joanna Briggs Establish (JBI) critical appraisal checklist for the dissimilar types of studies reviewed (34). This systematic review aimed to depict and synthetize the evidence and potential benefits of duloxetine.
Protocol Registration
The protocol was registered in the international database PROSPERO of the National Institute for Health and Enquiry (NIHR) with the code CRD42020153634.
Eligibility Criteria
To accomplish this comprehensive systematic review the following inclusion criteria were causeless: all studies written in English and focused on human adults (at least xviii years old) with MDD, GAD, NP, FMS, or SUI (clinical atmospheric condition for which duloxetine has approval), published until 01/09/2020. Those studies whose primary outcomes were efficacy, tolerability, and/or rubber of duloxetine were included. Studies focused on other psychiatric or neurological status such as Parkinson'due south illness, Alzheimer's disease, chronic non-neuropathic hurting, bipolar, schizoaffective, and schizophrenia disorders were excluded. Moreover, qualitative research reports were besides excluded, as well every bit reports whose analyses were based on pooled integrative data analysis of randomized command trials (RCTs). Eligible designs included RCTs, non-randomized experimental studies, case-command, and cohort studies, which outcomes were quantitatively measured past social, functional, cognitive, quality of life (QoL), or treatment emergent adverse events (TEAEs) instruments.
Data Sources and Search Strategy
Studies were selected from PubMed, Medline, Web of Scientific discipline, and PsycINFO electronic databases, introducing the search terms: "duloxetine" AND "major depressive disorder" OR "MDD"; "duloxetine" AND "generalized anxiety disorder" OR "GAD"; "duloxetine" AND "neuropathic pain"; "duloxetine" AND "fibromyalgia"; and "duloxetine" AND "stress urinary incontinence." Ii contained researchers (DRA and JMO) conducted the search strategy, applying the filters described in the inclusion criteria to refine the process and obtain concise results.
Report Selection
Authors independently screened the reports. Firstly, titles and abstracts were reviewed to evaluate their concordance with our requirements. Secondly, the total-text of the potential studies were screened and appreciated and those that met our inclusion criteria were selected. Finally, 85 studies were included in this systematic review. Discrepancies were resolved through discussion amid the authors until consensus was reached.
Information Extraction and Synthesis
To summarize the relevant information of the selected studies, the authors extracted and performed a Tabular array with the post-obit data: offset writer and year of publication, number of participants, gender, mean historic period (years), duloxetine dose per day (mg), duration of the treatment (weeks), diagnosis scales or other clinical measuring instruments, relevant statistical results, type of study, and the principal outcomes. The process of synthesis allowed a disquisitional appraisal of the studies and the event size calculation based on the statistical information reported by studies.
Results
Search Results
The first stage of the searching process comprised a search in the electronic databases using specific search terms, where 2,661 reports were identified. In the second stage, inclusion criteria were practical, duplicate reports were removed, and 727 records by title and abstruse were studied. Three hundred and forty-2 studies were analyzed in the third stage, and their full-text versions were carefully examined. In this stage, they were 85 eligible studies that met the inclusion criteria and the JBI recommendations (Supplementary Tables 1–4). Finally, in the 4th stage, studies on the different clinical conditions for which duloxetine treatment is approved −32 studies on major depressive disorder (MDD), 11 studies on GAD, nineteen studies on NP, 9 studies on fibromyalgia, and xiv studies on SUI were selected (Effigy ane).
Figure 1. PRISMA 2009 catamenia diagram of search process. MDD, major depressive disorder; GAD, generalized feet disorder; NP, neuropathic pain; SUI, stress urinary incontinence.
Study Characteristics
The eligible studies were examined and categorized by clinical status. 5 clinical conditions were considered for the treatment with duloxetine: MDD, GAD, NP, FMS, and SUI. Thus, eighty-5 studies were scrutinized and a total of 34,808 participants were enrolled (25,448 female person, ix,108 male; and 581 participants that in their report were not differentiated past gender), with an historic period range of xviii–97 years. The studies included 21,406 patients that were treated with duloxetine with a dose ranged from 20 to 120 mg and a treatment elapsing of 12 ± 14.39 weeks. The main reasons of dropout were adverse events (59.5%), lack of effectiveness (20.iii%), patient's decision (9.5%), loss of follow-upwards (5.4%), non-adherence to handling (two.7%), hospitalizations (1.iii%), and others (1.iii%). Within adverse events, the near mutual were nausea (xviii.xiii%), dry mouth (ix.69%), constipation (7.42%), and somnolence (five.94%) (Figure two). Cardiovascular disease was an exclusion benchmark of 7% of the studies, and cardiovascular adverse events (hypertension, tachycardia, myocardial ischemia, increased claret pressure, and arrythmia) were evaluated in 68.2% of the studies, where 49.four% reported statistical insignificance for these TEAEs (P <0.05), and 11.eight% showed a correlation betwixt elevated heart rate and duloxetine treatment. Regarding the type of studies, 58.7% of the studies are RCTs, 25.nine% are cohort studies, 11.8% are quasi-experimental studies (non-randomized) and 3.v% are instance-control studies.
Figure two. Adverse events of duloxetine-treated patients and placebo patients. Bar graph of the most common adverse furnishings vs. the number (Northward) of participants who developed them (Ntotal duloxetine-treated patients = 4,848 and Ntotal placebo patients = three,536). The table shows the corresponding percentage.
Major Depressive Disorder
MDD studies comprised 1,836 patients that were treated with 20–120 mg of duloxetine during eight ± 17.05 weeks. This condition was diagnosed based on the Diagnosis and Statistical Manual of Mental Disorders (DSM) from their third to fifth edition. Efficacy of duloxetine was measured in 78.1% of the studies using the Hamilton Depression Rating Scale (HAMD), the Geriatric Depression Scale (GDS), the Montgomery and Asberg Depression Rating Scale (MADRS) or the Brief Pain Inventory (BPI) when pain, and MDD were concomitant. Safety of treatment with duloxetine was assessed in 25% of the studies based on TEAEs, and tolerability was evaluated in 31.3% of studies (35–66). Twenty-six studies were able to demonstrate the superiority of duloxetine over placebo or other antidepressants such as sertraline, fluvoxamine, venlafaxine, paroxetine, escitalopram, fluoxetine, and bupropion. Five studies did non discover statistical significance (P ≥ 0.05) regarding the correlation betwixt duloxetine and the outcomes and 1 report did not obtain significant results when comparing duloxetine with sertraline. Safe and tolerability were evaluated past TEAEs and the most common adverse events (AEs) were nausea, somnolence, dry mouth, hyperhidrosis, constipation, and sedation; patient's dropout rate was ~10% (Effigy ii). This result was not meaning in nearly of studies, concluding that duloxetine was safety and well-tolerated (meet Table 1).
Table 1. Characteristics of the selected studies and included in the systematic review.
Generalized Feet Disorder
11 studies focused on GAD were included in this systematic review, which involved two,608 patients treated with 20–120 mg of duloxetine with an average elapsing of treatment of 10 ± 6.59 weeks. All studies used the DSM to achieve the diagnosis. Clinical evidence was based on the correlation betwixt the Hamilton Anxiety Rating Calibration (HAMA) and the outcomes. Therefore, all studies found statistical significance (P ≤ 0.05) when measured the efficacy (90.9% of the studies), safety and tolerability (both 27.3% of the studies) (67–77). TEAEs were measured and nausea, dry mouth, dizziness, and somnolence were reported as the most frequent AEs (Figure ii). One written report reported suicidal ideation, although no statistical significance was plant between duloxetine and placebo groups (69). Duloxetine was more effective, safe and tolerated than placebo or other antidepressants (escitalopram and venlafaxine) (Table ane).
Neuropathic Pain
The selected NP studies reported the use of duloxetine in the handling of peripheral neuropathy induced by chemotherapy, diabetic peripheral neuropathic hurting (DPNP), radiculopathy and neuropathic pain associated with multiple sclerosis (NP-MS) (Tabular array 1). NP condition was diagnosed using specific criteria of pain detection, being the BPI the well-nigh commonly applied musical instrument. TEAEs were the measure for prophylactic and tolerability. The dose of duloxetine applied was ranged from 20 to 120 mg during 12 ± 14.53 weeks. The core of the studies focused on 4,627 patients with NP, where the efficacy, prophylactic, and tolerability of duloxetine were compared with placebo, anticonvulsant treatments (pregabalin and gabapentin), other antidepressants (venlafaxine and amitriptyline), or even with dissimilar daily doses of duloxetine. Thus, 78.nine% of the studies reported efficacy outcomes, 47.4 and 21.1% of the studies described safety and tolerability of duloxetine, respectively (78–96). Iii studies did not show statistical significance regarding efficacy, safety, and tolerability of duloxetine against anticonvulsants (P ≥ 0.05). Nausea, somnolence, insomnia, constipation, and decreased appetite were the almost prevalent TEAEs (Effigy two). A minority of patients discontinued the treatment with duloxetine due to AEs (12.2%). Notwithstanding, 84.two% of the studies supported the prove of duloxetine as first-line treatment of NP conditions.
Fibromyalgia
Nine studies focusing on FMS were assessed and eligible. They involved a total of 1,918 patients. The average duration of treatment was 24 ± 13.78 weeks and the dose of duloxetine oscillated from 20 to 120 mg per day (Table 1). The BPI scale and Fibromyalgia Touch on Questionnaire (FIQ) were the instruments employed to analyse the outcomes. Near studies (77.8%) evaluated the efficacy of duloxetine, and 55.6% provided information of the treatment safety (97–104, 119). Statistically significant results were obtained in 7 studies, where duloxetine improved symptomatology, reducing the pain impact registered past BPI. In contrast, two studies reported no statistical differences relative to BPI alter boilerplate and cognitive comeback in fibromyalgia patients. The duloxetine treatment was related to ~17% of agin effects. Taking all these studies into account, duloxetine showed to be safe and effective in FMS handling.
Stress Urinary Incontinence
Fourteen studies that involved half-dozen,395 patients (99.5% female person and 0.v% male person) were assessed. Duloxetine doses were between xx and 120 mg per solar day. Treatment elapsing was 12 ± 6.72 weeks and the Incontinence Episode Frequency (IEF) and Incontinence Quality of Life (I-QoL) were the instruments to measure the outcomes. All studies evaluated efficacy of duloxetine; 71.four and 7.1% of the studies measured safety and tolerability, respectively (105–118). Treatment was discontinued in 22.ane% of patients regarding TEAEs, beingness the most common fatigue, nausea, constipation, and dry mouth (Figure ii). These AEs tend to improve and disappear with continuing duloxetine therapy. In conclusion, significant results were found in all studies, proving the efficacy, condom, and tolerability of duloxetine in the treatment of SUI.
Quality Assessment
A systematic review summarizes the evidence of the relevant literature, nevertheless, an unbiased search of studies without an explicit assess strategy could lead to a poor scientific report. The relevance and quality of the studies selected and included in this systematic review fulfilled the PRISMA recommendations (120), and JBI critical appraisal guidelines. The JBI is an evidence-based arrangement that develops strategies to conduct and perform a loftier quality systematic reviews (121). Thus, the quality decision of the studies included indicates that our inquiry minimizes the chance of selection bias. Furthermore, a proficient systematic review relies on the studies it contains. Therefore, the inclusion of RCTs and clinical trials reduce the probability of bias due to their strict methodology (122).
Discussion
In the last years, mutual pathophysiological mechanisms have been identified in depression, pain, and anxiety (11). Neuropathic pain, specifically DPNP, coexists with mental disorders, predominantly with low and feet (123). Highlighting the functional harm as a consequence of unremitting pain symptoms, neuropathy has been correlated with an increased gamble of depression (124). On the other hand, the widespread spontaneous pain is the virtually debilitating symptom of FMS, that might be a link to depression and anxiety disorders as comorbid conditions (125). Due to the similar pathophysiologic mechanisms and high occurrence of FMS and depression, these clinical conditions were considered under a common approach to affective disorders, GAD and PTSD (19). Urinary incontinence is too a severe trouble that affects 15–30% of adults over 60 years, and several studies have reported a link between urinary incontinence, anxiety and low in women (22, 126).
The core of the pathophysiology of these clinical conditions is more often than not due to the disruption of five-HT and norepinephrine (NE) pathways (xix, 22, 127). The monoaminergic hypothesis is based on a fractional or total deficit of 5-HT or NE in the key nervous system (CNS) (128, 129). Somatic symptoms such as muscle tension, neuropathic and musculoskeletal pain, fatigue, or dizziness are common in MDD and GAD among other psychiatric disorders as issue of aberrant 5-HT and NE neurotransmission (130). Regarding pain, antinociception and pronociceptive modulation occurs through 5-HT receptors, in both the central and peripheral nervous systems (131). Equally in pain, SUI involves the action of monoaminergic system. Evidence demonstrates that endogenous regulation of serotoninergic and noradrenergic machinery in the spinal cord works simultaneously to maintain the reflex of urinary continence (132).
Therefore, the pharmacological treatment of clinical weather condition with similar pathophysiology involves a global perception of coexisting disorders. In this sense, antidepressants such as duloxetine accept been considered effective in the treatment of MDD, GAD, NP, FMS, and SUI (133). Duloxetine is a serotonin-norepinephrine reuptake inhibitor, that is, a potent inhibitor of 5-HT transporter (SERT) and norepinephrine transporter (Net) (134). Due to this dual machinery, its profile seems to have a different response compared to selective five-HT reuptake inhibitors (SSRIs) (135). In vivo studies, duloxetine presented preferential inhibition of 5-HT reuptake and low affinity for hitamine-H1, alpha-i-norepinephrine, v-HT(1A, 1B, 1D), muscarinic acetylcholine, and opioid receptors (136). Clinically, duloxetine has been canonical for diverse clinical conditions, acquiring new show over the years, also being prescribed to treat other neuropathic pain conditions and chronic musculoskeletal pain (eighty, 137).
In this systematic review, we considered the efficacy, prophylactic, and tolerability of duloxetine in the handling of current canonical clinical atmospheric condition. Firstly, an individual search by clinical status was achieved based on specific inclusion criteria. This strategy allowed u.s. to observe consistent results and objectively evaluate the outcomes. Apropos efficacy, duloxetine demonstrated effectiveness in over 80% of cases. Still, some TEAEs are frequent, such as dry rima oris, somnolence, nausea, constipation or hyperhidrosis, tending to decrease in time and disappear with continuing duloxetine therapy. Cardiovascular adverse events, such as hypertension, increased heart charge per unit, myocardial ischemia, are also associated with duloxetine administration (29). Within these, simply the increase in middle rate was statistically significant, although not existence clinically relevant. In sum, duloxetine was considered in all assessed reports every bit a safe and well-tolerated treatment even in cardiovascular disease, as well as in elderly patients (29, 51, 82, 93). In this sense, our results prove that duloxetine is an option with a valid and consolidated therapeutic value. Secondly, we focused on the clinical conditions' comorbidity. The coexistence of depression, anxiety, and pain is a frequent country, too every bit, depression and SUI, and FMS and depression. Therefore, the treatment with duloxetine is largely used due to its dual mechanism that ameliorate the symptoms associated with the concomitant clinical conditions (e.k., MDD and NP). Moreover, we observed a strong link between MDD and hurting. This correlation suggests a bidirectional blueprint: MDD could be a predictor of chronic hurting which in turn might predict the persistence of MDD (138). Thirdly, although the dropout rate with duloxetine treatment reaches around twenty% in certain cases, similar rates were plant in placebo and other antidepressants or anticonvulsants treatments. Finally, some considerations should exist taken into account regarding to duloxetine prescription and titration. Alcohol, tobacco and java (caffeine) are the most widely consumed psychoactive substances worldwide (139, 140). Evidence suggests that plasmatic serum levels of duloxetine were decreased (about 15%) in smoking patients due to the induction of CYP1A2 (141). Hepatotoxicity was besides observed in patients whose alcohol consumption was significant (142). Lastly, caffeine is also metabolized past CYP1A2, like duloxetine, and this may increment duloxetine serum levels. Nonetheless, this interference needs more supporting evidence.
We performed this systematic review in order to include as much evidence as possible. In this process, nosotros analyzed a big number of studies to support our conclusions. Still, we plant some limitations. The inclusion criteria exclude reports in a linguistic communication other than English. Thus, significant studies may have been missed with this strategy. Our research protocol dismisses qualitative and pooled integrative data analysis of RCTs to avoid repeated analysis of RCTs information and qualitative findings duplication. Regarding the effect size of studies, some of them did not report sufficient statistical data to compute Hedges'southward thou (e.thou., standard deviation). All the same, we decided to include these 19 studies due to their relevance respect to the evaluated outcomes.
In conclusion, there is a substantial amount of evidence in support of efficacy, safety, and tolerability of duloxetine in the treatment of MDD, GAD, NP, FMS, and SUI. The dose range of threescore–120 mg daily demonstrated efficacy in most of the studies assessed. TEAEs were balmy to moderate, and AEs decreased or remitted with continuing duloxetine treatment. Treatment discontinuation due to both AEs and ineffectiveness of duloxetine yielded enough acceptable results to conclude that duloxetine is safe and well-tolerated. In improver, duloxetine is a monotherapy approach that might be useful to treat concomitant disorders with parallel pathophysiological pathways such as MDD and NP, which is an advantage for patients (avoiding polytherapy issues) and a successful price-effective culling.
Data Availability Argument
All datasets generated for this report are included in the commodity/Supplementary Cloth.
Author Contributions
Data analysis and the first draft of the manuscript was written by DR-A and TR-B. All authors contributed to the study design, acquired data to assay, and read and approved the concluding manuscript.
Funding
This work was financially backed by the Foundation for Science and Technology (FCT, Fundação para a Ciência e Tecnologia) within the framework of grant SFRH/BD/135623/2018 awarded to DR-A and another grant of Fundación Tatiana Pérez de Guzmanel Bueno provided to CS. Our research was further supported by the Carlos Three Wellness Institute (ISCIII, Instituto Carlos III) through grant P16/00405 and co-funding awarded by the Spanish Foundation of Rare Diseases (FEDER, Fundación Española de Enfermedades Raras) to JO.
Conflict of Involvement
JO declares paid positions, honoraria or being part of advisory boards by Angelini, AstraZeneca, Bristol-Myers, Casen Ricordati, Esteve, GSK, Janssen, Lilly, Lundbeck, Novartis, Otsuka, Pfizer and Sanofi, and grants from Ministry of Health Castilian National Institute of Heath Carlos Iii, National Substance Abuse Plan, and Galician Innovation Programs (Gain) in the final ten years.
The remaining authors declare that the enquiry was conducted in the absence of whatsoever commercial or financial relationships that could be construed as a potential conflict of interest.
Acknowledgments
The authors would similar to thank the Galicia Sur Health Inquiry Found (Instituto de Investigación Sanitaria Galicia Sur) and the University Infirmary Complex of Vigo (Complexo Hospitalario de Vigo) for their support. In addition, the authors are especially thankful for the aid provided by the Psychiatric Nursing and Psychiatry Services of the Álvaro Cunqueiro and Nicolás Peña hospitals.
Supplementary Textile
The Supplementary Material for this article can be found online at: https://www.frontiersin.org/articles/10.3389/fpsyt.2020.554899/full#supplementary-material
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