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Diabetes & Metabolism Journal Nov 2023Diabetic peripheral neuropathy (DPN) is one of the most prevalent chronic complications of diabetes. The lifetime prevalence of DPN is thought to be >50%, and 15%-25% of... (Review)
Review
Diabetic peripheral neuropathy (DPN) is one of the most prevalent chronic complications of diabetes. The lifetime prevalence of DPN is thought to be >50%, and 15%-25% of patients with diabetes experience neuropathic pain, referred to as "painful DPN." Appropriate treatment of painful DPN is important because this pain contributes to a poor quality of life by causing sleep disturbance, anxiety, and depression. The basic principle for the management of painful DPN is to control hyperglycemia and other modifiable risk factors, but these may be insufficient for preventing or improving DPN. Because there is no promising diseasemodifying medication for DPN, the pain itself needs to be managed when treating painful DPN. Drugs for neuropathic pain, such as gabapentinoids, serotonin-norepinephrine reuptake inhibitors, tricyclic antidepressants, alpha-lipoic acid, sodium channel blockers, and topical capsaicin, are used for the management of painful DPN. The U.S. Food and Drug Administration (FDA) has approved pregabalin, duloxetine, tapentadol, and the 8% capsaicin patch as drugs for the treatment of painful DPN. Recently, spinal cord stimulation using electrical stimulation is approved by the FDA for the treatment for painful DPN. This review describes the currently available pharmacological and nonpharmacological treatments for painful DPN.
Topics: United States; Humans; Diabetic Neuropathies; Capsaicin; Quality of Life; Duloxetine Hydrochloride; Neuralgia; Diabetes Mellitus
PubMed: 37670573
DOI: 10.4093/dmj.2023.0018 -
Frontiers in Bioscience (Landmark... Aug 2023This study was carried out to compare the levels of inflammatory markers in the complete blood count before and after they began receiving duloxetine in patients with...
BACKGROUND
This study was carried out to compare the levels of inflammatory markers in the complete blood count before and after they began receiving duloxetine in patients with fibromyalgia syndrome (FMS).
METHODS
The patient and control groups were composed of 40 patients diagnosed with FMS in accordance with the 2016 American College of Rheumatology (ACR) criteria and 40 healthy volunteers, respectively. The data collection tools comprised the sociodemographic information form, the fibromyalgia impact questionnaire (FIQ), and the sleep hygiene index (SHI), which were used to assess patients' sociodemographic characteristics, FMS disease activity, and sleep quality, respectively. The inflammatory markers of the patient group were assessed by complete blood count before and after the duloxetine treatment and compared with those of the control group.
RESULTS
The white blood cell (WBC), neutrophil, and lymphocyte counts were significantly higher in the patient group than in the control group ( < 0.001, = 0.036 and = 0.004, respectively). Moreover, platelet distribution width (PDW) was significantly lower, whereas mean platelet volume (MPV) was significantly higher in the patient group than in the control group ( < 0.001 for both cases). In addition to patients' platelet-to-lymphocyte ratio (PLR) values, C-reactive protein (CRP) levels, and white blood cell (WBC) counts decreasing but not significantly ( = 0.083, = 0.068, and = 0.065, respectively), their neutrophil-to-lymphocyte ratio (NLR), hemoglobin (Hgb), and hematocrit (Hct) values declined substantially after commencing duloxetine treatment ( = 0.001, = 0.008, and = 0.001, respectively).
CONCLUSIONS
The significant reduction in NLR, Hgb, and Hct levels following duloxetine treatment may indicate that these parameters can be utilized as biomarkers in determining the efficacy of treatment and in the follow-up of the treatment in FMS patients.
Topics: Humans; Duloxetine Hydrochloride; Fibromyalgia; Leukocytes; Blood Platelets; Neutrophils
PubMed: 37664936
DOI: 10.31083/j.fbl2808161 -
Biomedicine & Pharmacotherapy =... Oct 2023Osteoarthritis represents a leading cause of disability with limited treatment options. Furthermore, it is frequently accompanied by cardiovascular and cognitive...
The antidepressant drugs vortioxetine and duloxetine differentially and sex-dependently affect animal well-being, cognitive performance, cardiac redox status and histology in a model of osteoarthritis.
Osteoarthritis represents a leading cause of disability with limited treatment options. Furthermore, it is frequently accompanied by cardiovascular and cognitive disorders, which can be exacerbated by osteoarthritis or drugs used for its treatment. Here, we examined the behavioral and cardiac effects of the novel antidepressant vortioxetine in an osteoarthritis model, and compared them to duloxetine (an established osteoarthritis treatment). Osteoarthritis was induced in male and female rats with an intraarticular sodium-monoiodoacetate injection. Antidepressants were orally administered for 28 days following induction. During this period the acetone, burrowing and novel-object-recognition tests (NORT) were used to assess the effects of antidepressants on pain hypersensitivity (cold allodynia), animal well-being and cognitive performance, respectively. Following behavioral experiments, heart muscles were collected for assessment of redox status/histology. Antidepressant treatment dose-dependently reduced cold allodynia in rats with osteoarthritis. Duloxetine (but not vortioxetine) depressed burrowing behavior in osteoarthritic rats in a dose-related manner. Osteoarthritis induction reduced cognitive performance in NORT, which was dose-dependently alleviated by vortioxetine (duloxetine improved performance only in female rats). Furthermore, duloxetine (but not vortioxetine) increased oxidative stress parameters in the heart muscles of female (but not male) rats and induced histological changes in cardiomyocytes indicative of oxidative damage. Vortioxetine displayed comparable efficacy to duloxetine in reducing pain hypersensitivity. Furthermore, vortioxetine (unlike duloxetine) dose-dependently improved cognitive performance and had no adverse effect on burrowing behavior (animal surrogate of well-being) and cardiac redox status/histology. Our results indicate that vortioxetine could be a potential osteoarthritis treatment (with better characteristics compared to duloxetine).
Topics: Female; Animals; Rats; Duloxetine Hydrochloride; Vortioxetine; Hyperalgesia; Antidepressive Agents; Myocytes, Cardiac; Hypersensitivity; Osteoarthritis; Cognition
PubMed: 37657261
DOI: 10.1016/j.biopha.2023.115360 -
Medicine Aug 2023Duloxetine, a serotonin-norepinephrine dual reuptake inhibitor, may improve analgesia after total joint arthroplasty (TJA). However, there is still no consensus on its... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Duloxetine, a serotonin-norepinephrine dual reuptake inhibitor, may improve analgesia after total joint arthroplasty (TJA). However, there is still no consensus on its effectiveness and safety. We conducted the meta-analysis to investigate the analgesic effect and safety of duloxetine for the treatment of patients received total knee or hip arthroplasty.
METHODS
Pubmed, Cochrane Central Registry for Clinical Trials, Embase, OVID, Web of Science, and Google Scholar were searched using a predetermined search strategy from inception to September 21, 2022. Only randomized controlled trials of duloxetine in treatment of patients after total knee or hip arthroplasty were included. Data collection and extraction, quality assessment, and data analyses were performed according to the Cochrane standards.
RESULTS
A total of 8 randomized controlled trials with 739 patients were included in the literature review of postoperative pain and adverse effects. The result of meta-analysis showed statistically significant lower opioid requirement with duloxetine (P < .05) for the different postoperative period. Duloxetine group had significant reductions in visual analog score for the 24-hour (walking: WMD = -0.98; 95% confidence interval [CI] = -1.69 to -0.26, P = .007; resting: WMD = -1.06; 95%CI = -1.85 to -0.27, P = .008) and 1-week (walking: WMD = -0.96; 95%CI = -1.42 to -0.50, P < .001; resting: WMD = -0.69; 95%CI = -1.22 to -0.16, P = .01); knee injury and osteoarthritis outcome score over 3-month (WMD = 2.94; 95%CI = -0.30 to 6.18, P = .008) and complication (odds ratio = 4.74; 95%CI = 0.23 to 96.56, P = .01) postoperative period compared with the control group. However, no difference on numeric rating scale (P > .05) for the different postoperative period; visual analog score (P > .05) for the 6-week or 3-month and knee injury and osteoarthritis outcome score (P > .05) for the 6-week postoperative period. Furthermore, it did not increase the incidence of adverse effects (odds ratio = 0.87; 95%CI = 0.72 to 1.05, P = .15).
CONCLUSION
Duloxetine could decrease the opioids consumption and relieve early postoperative pain without increasing the risk of adverse medication effects in patients undergoing total knee or hip arthroplasty. Considering the ongoing opioid epidemic, duloxetine could act as a good supplement in multimodal pain management protocol for patients undergoing total joint arthroplasty.
Topics: Humans; Arthroplasty, Replacement, Hip; Duloxetine Hydrochloride; Arthroplasty, Replacement, Knee; Pain Management; Knee Joint; Drug-Related Side Effects and Adverse Reactions; Analgesics, Opioid; Randomized Controlled Trials as Topic
PubMed: 37653762
DOI: 10.1097/MD.0000000000034895 -
Medicine Aug 2023This study aimed to evaluate the effectiveness of combined pelvic floor muscle exercise (PFME) and duloxetine treatment in the recovery from postprostatectomy urinary...
This study aimed to evaluate the effectiveness of combined pelvic floor muscle exercise (PFME) and duloxetine treatment in the recovery from postprostatectomy urinary incontinence (PPUI). Participants were patients who underwent radical prostatectomy (RP) between 2018 and 2021 and who were able to attend follow-up appointments every 3 months for at least 12 months. Continence was defined as the use of ≤1 pad per day. PPUI was compared at each follow-up period by dividing the participants into the PFME group (PFME only after RP) and the PFME + DUL group (PFME and 30 mg duloxetine daily after RP). A total of 197 patients were included. No significant differences were observed in the baseline characteristics between the 2 groups. In the PFME group (n = 127), the PPUI was 77.17%, 27.56%, 17.32%, 12.60%, and 9.45% at 2 weeks, 3 months, 6 months, 9 months, and 12 months, respectively. In the PFME + DUL group (n = 70), the PPUI was 62.50%, 17.86%, 12.50%, 8.93%, and 5.36%, respectively, at the same follow-up period. At 2 weeks, the PFME + DUL group demonstrated a better incontinence rate than the PFME group (P = .019). However, no significant differences were found in the incontinence rates between the 2 groups at each follow-up period after 3 months. Compared to PFME monotherapy, the combination therapy of PFME and duloxetine has short-term effectiveness in improving PPUI, but it does not have a significant long-term impact. Therefore, for early recovery from PPUI, duloxetine should be administered for a short period during PFME.
Topics: Male; Humans; Duloxetine Hydrochloride; Pelvic Floor; Retrospective Studies; Treatment Outcome; Exercise Therapy; Urinary Incontinence; Prostatectomy
PubMed: 37565859
DOI: 10.1097/MD.0000000000034657 -
BMC Pulmonary Medicine Aug 2023Refractory cough, a chronic cough with an unclear diagnosis or poor treatment response. The symptoms are often stubborn and persistent, causing serious complications and... (Randomized Controlled Trial)
Randomized Controlled Trial
INTRODUCTION
Refractory cough, a chronic cough with an unclear diagnosis or poor treatment response. The symptoms are often stubborn and persistent, causing serious complications and lowering the patient's quality of life. Cough hypersensitivity syndrome (CHS) is proposed as a potential cause, and reducing sensory nerve hyperresponsiveness is suggested as an effective treatment. However, current drugs have low efficacy and benefit rates and numerous side effects. This trail proposes using duloxetine, a selective 5-HT and norepinephrine reuptake inhibitor, as a potential treatment for refractory cough, which has shown promise in treating pain and depression. Duloxetine may inhibit pain conduction and oxidative stress in peripheral nerves by inhibiting the activity of TRPV1 channels, which play an important role in the peripheral afferent pathway of refractory cough. Meanwhile, the antidepressant effects of duloxetine may also play a role in the treatment of refractory cough.
METHODS AND ANALYSIS
This is a single-center, prospective, randomized, double-blind, and controlled trial. A total of 98 individuals will be randomized in a 1:1 ratio to duloxetine group and placebo control group (starting with 20 mg QD, increasing 20 mg daily until 20 mg TID). After a screening period, the second stage runs from baseline to the 42nd (last) day of treatment, with follow-up visits on the 3rd, 7th, 14th, 21st, 28th, 35th, 42nd and 49th days. The main end-stage observation indicators include objective cough frequency, cough visual analog scale (VAS), cough symptom score, Leicester Cough Questionnaire (LCQ), and cough evaluation test (CET); the secondary end-stage observation indicators include capsaicin cough sensitivity, Patient Health Questionnaire-9 (PHQ-9), Major Depression Inventory (MDI), the Generalized Anxiety Disorder-7 scale (GAD-7), Life Events Scale (LES-32), induced sputum supernatant. The safety measures will be AEs/SAEs, vital signs, liver and kidney function, fecal occult blood test.
DISCUSSION
This study is the first randomized, double-blind, and controlled clinical trial investigating the use of duloxetine in the treatment of refractory coughs. The study aims to provide a high-quality basis for evaluating the efficacy and safety of duloxetine for this condition.
TRIAL REGISTRATION
Our study was registered in the Chinese Clinical Trials Register ( www.chictr.org.cn/ ) (ChiCTR2000037429) in 28/08/2020.
Topics: Humans; Duloxetine Hydrochloride; Cough; Tablets, Enteric-Coated; Quality of Life; Prospective Studies; Pain; Double-Blind Method; Treatment Outcome
PubMed: 37533019
DOI: 10.1186/s12890-023-02575-5 -
International Journal of Surgery... Nov 2023
Topics: Humans; Arthroplasty, Replacement, Knee; Duloxetine Hydrochloride; Osteoarthritis, Knee; Treatment Outcome
PubMed: 37463005
DOI: 10.1097/JS9.0000000000000618 -
Journal of Orthopaedic Surgery and... Jul 2023The optimal dose of duloxetine in the management of fibromyalgia remains still controversial. Therefore, a systematic review and meta-analysis to investigate efficacy... (Meta-Analysis)
Meta-Analysis
INTRODUCTION
The optimal dose of duloxetine in the management of fibromyalgia remains still controversial. Therefore, a systematic review and meta-analysis to investigate efficacy and safety of duloxetine was conducted. The outcomes of interests were to assess changes in Fibromyalgia Impact Questionnaire (FIQ), Brief Pain Inventory (BPI), and Clinical Global Impression (CGI). The rate of of adverse events and those leading to therapy discontinuation were also investigated.
MATERIAL AND METHODS
This study followed the 2020 PRISMA guidelines. The literature search started in December 2022 accessing PubMed, Google scholar, Embase, and Scopus databases. All the RCTs investigating the efficacy and safety of daily administration of duloxetine for fibromyalgia were accessed. Studies reporting quantitative data under the outcomes of interest, and including a minimum of 10 patients who completed a minimum of 4 weeks follow-up, were included. Studies on combined pharmacological and non-pharmacological managements for fibromyalgia were not considered.
RESULTS
Data from 3432 patients (11 RCTs) were included. The mean age of the patients was 46.4 ± 10.7 years old, and the mean BMI 25.3 ± 3.2 kg/m. 90% (3089 of 3432 patients) were women. The 60 mg/daily cohort reported the higher FIQ, followed by the 30, 30-60, 120 mg/daily, and placebo groups, while the 60-120 mg /daily group performed the worst results. Concerning the CGI severity scale, placebo resulted in the lowest improvement, and no differences were found in the other groups. Concerning the BPI interference and severity pain scores, the 30-60 mg/daily group reported the worst result, along with the placebo group. The rate of adverse events leading to study discontinuation were lower in the 60-120 group, followed by the 30-60 and 30 mag/daily groups. Duloxetine was superior in all the comparisons to placebo, irrespective of the doses, in all endpoints analysed.
CONCLUSIONS
Duloxetine could help in improving symptoms of fibromyalgia. The dose of duloxetine should be customised according to individual patients. Irrespective of the doses, duloxetine was more effective than placebo in the management of fibromyalgia. The dose of duloxetine must be customised according to individual patients. Level of evidence I Meta-analysis of double-blind RCTs.
Topics: Humans; Female; Adult; Middle Aged; Male; Duloxetine Hydrochloride; Fibromyalgia; Thiophenes; Treatment Outcome; Pain; Randomized Controlled Trials as Topic
PubMed: 37461044
DOI: 10.1186/s13018-023-03995-z -
Journal of Orthopaedic Surgery and... Jul 2023To evaluate the efficacy of duloxetine in the treatment of patients with axial symptoms after posterior cervical spine surgery.
PURPOSE
To evaluate the efficacy of duloxetine in the treatment of patients with axial symptoms after posterior cervical spine surgery.
METHODS
Patients with axial symptoms after posterior cervical spine surgery treated by duloxetine or non-drug therapy from 2018 to 2021 were reviewed. Duloxetine was administered gradually, with oral administration of 30 mg in the first week and oral administration of 60 mg from the second week. Visual analogue scale (VAS), 36-Item Short-Form Health Survey questionnaire (SF-36) and EuroQol-5 Dimensions (EQ-5D) questionnaire were used to evaluate the severity of AS at baseline and 1 week, 2 weeks, 1 month, 3 months and 6 months after medication. The occurrence of adverse reactions was recorded.
RESULTS
A total of 63 eligible patients who received duloxetine therapy (n = 35) or non-drug therapy (n = 28) were included. All patients were followed up for 6 months. Significant improvements were found in VAS score compared with baseline in both groups (1.87 ± 0.81 vs 6.61 ± 1.16, 3.18 ± 0.67 vs 6.31 ± 1.40; P < 0.05 for all). Meanwhile, the VAS score of the duloxetine group was significantly better than that of the non-drug therapy group at 1 week, 2 weeks, 1 month, 3 months and 6 months (P < 0.05). Besides, according to 36-Item Short-Form Health Survey questionnaire (SF-36), the PCS score and MCS score are significantly higher than before the treatment in duloxetine group (PCS 62.82 ± 6.04 vs 44.36 ± 7.25, MCS 65.50 ± 4.53 vs 55.55 ± 6.06; P < 0.05 for all). And when we compared variables between the two groups, the PCS score of the duloxetine group was significantly better than that of the non-drug therapy group (P < 0.05), but there was no significant difference in MCS score between the two groups (P > 0.05). What's more, EQ-5D score had significant improvements in the duloxetine group compared with the non-drug therapy group at 1 week, 2 weeks, 1 month, 3 months and 6 months (P < 0.05).
CONCLUSION
Oral duloxetine has a better short-term outcome than conventional non-drug therapy in patients with axial symptoms following posterior decompression surgery in the cervical spine.
Topics: Humans; Retrospective Studies; Duloxetine Hydrochloride; Treatment Outcome; Administration, Oral; Cervical Vertebrae
PubMed: 37438835
DOI: 10.1186/s13018-023-03970-8 -
International Journal of Pharmaceutics:... Dec 2023Duloxetine hydrochloride (DUL) is a BCS class-II antidepressant drug, acting via serotonin and norepinephrine reuptake inhibition. Despite high oral absorption, DUL...
Formulation, optimization, in-vivo biodistribution studies and histopathological safety assessment of duloxetine HCl-loaded ultra-elastic nanovesicles for antidepressant effect after intranasal and transdermal delivery.
Duloxetine hydrochloride (DUL) is a BCS class-II antidepressant drug, acting via serotonin and norepinephrine reuptake inhibition. Despite high oral absorption, DUL suffers limited bioavailability due to extensive gastric and first-pass metabolism. To improve DUL's bioavailability; DUL-loaded elastosomes were developed, via full factorial design, utilizing various span®60: cholesterol ratios, edge activator types and amounts. Entrapment efficiency (E.E.%), particle size (PS), zeta potential (ZP) and in-vitro released percentages after 0.5 h (Q) and 8 h (Q) were evaluated. Optimum elastosomes (DUL-E1) were assessed for morphology, deformability index, drug crystallinity and stability. DUL pharmacokinetics were evaluated in rats following intranasal and transdermal application of DUL-E1 elastosomal gel. DUL-E1 elastosomes [comprising span®60 and cholesterol (1:1) and brij S2 (edge activator; 5 mg)] were optimum with high E.E.% (81.5 ± 3.2%), small PS (432 ± 13.2 nm), ZP (-30.8 ± 3.3 mV), acceptable Q (15.6 ± 0.9%), and high Q (79.3 ± 3.8%). Intranasal and transdermal DUL-E1 elastosomes revealed significantly higher C (251 ± 18.6 and 248 ± 15.9 ng/mL) at T (2 and 4 h) and improved relative bioavailability (≈ 2.8 and 3.1 folds) respectively, in comparison to oral DUL aqueous solution. In-vivo histopathological studies were conducted to ensure the safety of DUL-E1. Elastosomes are promising novel nano-carriers, capable of enhancing the bioavailability of DUL via various routes of administration.
PubMed: 37434966
DOI: 10.1016/j.ijpx.2023.100194