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In a randomized trial involving patients with sciatica, the antiepileptic drug pregabalin, at a dose of up to 600 mg per day, was no more effective than placebo in reducing pain or disability over the course of 8 weeks and resulted in a higher incidence of adverse events. Sciatica is characterized by radiating posterior or posterolateral leg pain, which is sometimes accompanied by back pain, sensory loss, weakness, or reflex abnormalities. 1 – 3 Few clinical guidelines for the treatment of sciatica exist, and evidence regarding effective medical treatments is limited. 2 , 3 Treatment with pregabalin (Lyrica, Pfizer) has been shown to be effective in reducing some types of neuropathic pain, including postherpetic neuralgia and diabetic peripheral neuropathy, 4 , 5 as well as allodynia and hyperalgesia from several conditions, 6 – 8 and some guidelines recommend pregabalin for the treatment of pain with neuropathic features. 5 Pregabalin therefore represents a potential treatment for sciatica. Its . . .

The objective of this study was to demonstrate that sustained-release (SR) pregabalin is non-inferior to immediate-release (IR) pregabalin in attenuating diabetic peripheral neuropathic (DPN) pain along with patient satisfaction and compliance. This was an 8-week, randomized, active-controlled, open-label, phase 4 study. Eligible subjects who had been on IR pregabalin for 4 weeks were randomized to 1:1 ratio to either continue with twice-daily IR pregabalin (75 mg), or to switch to once-daily SR pregabalin (150 mg). Primary efficacy endpoint was the change in visual analogue scale (VAS) scores after 8 weeks of treatment compared to baseline in both SR and IR pregabalin groups. Among 130 randomized subjects, 125 patients were included in full analysis set. For the change in VAS pain score, the least squares (LS) mean were −17.95 (SR pregabalin) and −18.74 (IR pregabalin) and the LS mean difference between both groups was 0.79, with the upper limit of the 95 % confidence interval [−5.99, 7.58] below the pre-specified non-inferiority margin of 9.2 mm. This study demonstrates that the new once-daily SR pregabalin formulation is not different to the twice-daily IR pregabalin in alleviating DPN pain, indicating its potential as a promising treatment for DPN pain with a comparable safety profile. ClinicalTrials.gov, NCT05624853. •Efficacy, safety and patient satisfaction of sustained-release (SR) pregabalin.•SR pregabalin is non-inferior to immediate-release (IR) pregabalin in attenuating diabetic peripheral neuropathy pain.•Comparing efficacy and safety profiles between SR and IR pregabalin formulations.•Gastroretentive drug delivery system effect on diabetic peripheral neuropathy pain.

Purpose Even with antiemetic prophylaxis, patients undergoing cancer chemotherapy often still experience chemotherapy-induced nausea and vomiting (CINV). Neurokinin-1 (NK-1) receptor antagonists will prevent CINV effectively but are not affordable for patients of low socioeconomic status. Methods In this group sequential, response adaptive randomized double-blinded clinical trial, patients of low socioeconomic who cannot afford NK-1 receptor antagonists, planned for highly emetogenic chemotherapy (HEC) agents received olanzapine 5 mg plus pregabalin 75 mg or placebo orally for five days add-on to standard antiemetic therapy (injection ondansetron 8 mg + injection dexamethasone 12 mg on day one followed by oral dexamethasone 8 mg on days 2 to 4). The primary outcome was the difference in the proportion of patients with “overall no nausea” between groups. Following the interim analysis, the allocation ratio was modified, resulting in more patients being assigned to the well-performing arm. Results Initially, 30 patients were equally randomized into two groups. As the experimental group performed well in the interim analysis, the allocation ratio was changed to 2:1 for the subsequent period. Finally, the experimental group ( n  = 36) performed better in terms of “overall no nausea” than the control group( n  = 18) (41.6% vs. 5.5%, p  = 0.008). Sedation and dizziness were significantly greater in the experimental group compared to the standard-of-care group. Conclusion Olanzapine 5 mg plus pregabalin 75 mg add-on to a combination of dexamethasone and ondansetron will significantly prevent the incidence of CINV compared to a combination of dexamethasone and ondansetron alone. However, the combination is associated with sedation and dizziness as adverse events. Trial registration: Clinical trial registry-India (CTRI/2021/08/035451). Registration Date: 05/08/2021.

Background Obese patients undergoing laparoscopic sleeve gastrectomy (LSG) are particularly at risk of opioid-related side effects. To reduce patient exposure to opioids, multimodal analgesia, which involves the use of drugs of different classes, may be utilized. One of the drugs under consideration is pregabalin. Despite an opioid-sparing potential, few studies assess the role of pregabalin as an element of multimodal analgesia in LSG. Considering the limited number and inconsistent results of available studies, we decided to conduct a randomized, prospective study on the effect of preemptive pregabalin administration in obese patients on opioid consumption, pain scores, the incidence of opioid side effects, and hemodynamical stability. Methods The study is designed as a prospective randomized controlled trial with double-blinding. Randomization will be performed in a block with a parallel 1:1 allocation. The intervention will involve receiving a pregabalin 150 mg capsule 1–2 h before the surgery, whereas the control group will receive an identically looking placebo. The primary outcome measure will be total oxycodone consumption in the first 24 h following surgery. Secondary outcome measures will be pain severity assessed using the Numerical Rating Scale (NRS) 1, 6, 12, and 24 h after surgery, postoperative sedation on the Ramsay scale, PONV impact scale, the incidence of desaturation episodes < 94%, and episodes of blurred vision at 1, 6, 12, and 24 h after surgery, intraoperative hemodynamic parameters such as heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MBP), total fluid volume, and total ephedrine dose. Patient comfort will be additionally assessed using the QoR-40 questionnaire at discharge. Discussion The study will explore the efficacy and safety of preemptive pregabalin in a dose of 150 mg as a co-analgesic used in multimodal analgesia for LSG. As studies on opioid-sparing regimes concern the safety of obese patients, we aim to contribute objective data with a relatively large study sample size. The result of the present clinical trial may support the reassessment of recommendations to use pregabalin in the studied population. Trial registration ClinicalTrials.gov NCT05804591. Registered on 07.04.2023.

Developing effective therapies for cough in lung cancer is an unmet need Neuromodulators like pregabalin may act centrally as cough suppressants. Randomized double-blind placebo-controlled study in patients with locally advanced/metastatic lung cancer and at least 2 weeks of moderate or severe cough. Randomization was 1:1 to pregabalin 300 mg orally daily or matching placebo, both administered for 9 weeks. Primary endpoint was the change in cough severity as measured by the difference in VAS scores. Between Jul 2022 and Dec 2023, we enrolled 166 patients: 83 to each arm. Baseline cough severity was grade 2 in 128 (77.1%) and grade 3 in 38 (22.9%) patients; median cough duration was 12 weeks (IQR, 6-20). Systemic cancer-directed therapy was started in 78 (94.0%) and 72 (86.7%) patients in the pregabalin and placebo arms, respectively; P = 0.187. The mean (SD) VAS score (in mm) decreased from 71.58 (14.99) at baseline, to 45.54 (26.60) on day 7, and 22.27 (24.20) by week 9 in the pregabalin arm; and 71.75 (17.58), 46.35 (25.00), and 23.08 (22.42), respectively in the placebo arm; P = 0.877. Pregabalin does not significantly decrease cough in patients with lung cancer. Systemic cancer-directed therapy is the most effective antitussive. Name of the registry: Clinical Trials Registry India Registration number: CTRI/2020/11/029275 Website: www.ctri.nic.in.

Residual pain after total knee arthroplasty (TKA) often causes patient dissatisfaction. Patients with preoperative central sensitization (CS) are especially susceptible to chronic pain after TKA. Although duloxetine and pregabalin are known to relieve pain in CS patients, there is limited evidence on the precise effectiveness and safety of increasing the dosage or combining these medications. To address this gap, we designed a randomized, triple-blind clinical trial to assess the efficacy and safety of increasing the maximum dosage or combining these drugs for patients who do not respond to standard doses. Patients scheduled to undergo primary unilateral TKA will be screened for CS using the central sensitization inventory (CSI). CS patients will then be randomly assigned to Groups 1-5, while non-CS patients will be assigned to Group 6. All groups will receive multimodal analgesia. Groups 1 and 6 will receive a placebo. During the initial 6-week period, Groups 2 and 3 will take 60 mg/day of duloxetine, while Groups 4 and 5 will take 300 mg/day of pregabalin. Subsequently, non-responders will enter a 6-week period of high-dose/combination therapy. Group 2 will receive 120 mg/day of duloxetine, Group 3 and 4 will receive a combination of 60 mg/day of duloxetine and 300 mg/day of pregabalin, and Group 5 will receive 600 mg/day of pregabalin. The primary outcome will be to compare residual pain intensity at 6 months between the high-dose monotherapy groups (Groups 2, 5 pooled) and the combination therapy groups (Groups 3, 4 pooled), which will be measured using the brief pain inventory (BPI) 24-hour average pain change. Secondary outcomes will assess pain and functionality. This study aims to evaluate the efficacy and safety of increasing medication to the highest dose or combining two medications in patients with CS who have not responded well to standard doses of duloxetine or pregabalin after TKA. The goal is to provide clinicians with evidence-based recommendations for choosing an appropriate pain management strategy for these patients. Chinese Clinical Trial Registry, ChiCTR2400081990. Registered on 18 March 2024.

Fibromyalgia (FM) is a chronic musculoskeletal pain disorder that is seldom reported in China. Recent studies have focused on nondrug treatments, particularly physical therapy, as an alternative to treatments using medication. With the rise of smartphones and mobile communication, mobile health technology has become a significant area of study. This study aims to explore whether using remote network applications to supervise patient exercise, in combination with medication, can improve FM pain. It builds on previous research that focuses on drug treatments and offers insights into individualized exercise therapy for FM.  The study used a prospective, randomized controlled design with 80 participants, who were divided into 2 groups: supervised and unsupervised. Both groups received a drug regimen: oral pregabalin (75-150 mg twice daily) and duloxetine (30-60 mg once daily). The supervised group followed exercise routines with guidance from web-based rehabilitation therapist via a remote network application, while the unsupervised group exercised without supervision. The study was blinded to the participants. Primary outcomes were pain levels over the past 24 hours as measured by the Brief Pain Inventory (BPI). Secondary outcomes included pain relief, sleep improvement, quality of life, and adverse event occurrences. Observations were made at the start of treatment (T0), 1 month after treatment (T1), and 3 months after treatment (T3). We recruited 80 participants, evenly divided into 2 groups, from August 2022 to December 2023 at West China Hospital of Sichuan University. Comparisons of the 2 groups were performed using analysis of variance and Bonferroni post hoc analyses (SPSS version 25 for Windows, P<.05 considered as significant). Compared with T0, the Widespread Pain Index (WPI), symptom severity score (SSS), and BPI (pain on average, least pain in past 24 h, pain right now) scores of the 2 groups of patients with fibromyalgia at T1 were significantly lower. Compared with T0, the WPI, SSS, BPI (pain on average, worst pain in past 24 h, least pain in past 24 h, pain right now), and Fibromyalgia Impact Questionnaire scores of the 2 groups of patients at T3 were significantly lower. The WPI, SSS, BPI (pain on average, worst pain in past 24 h, pain right now), and Pittsburgh Sleep Quality Index scores of the 2 groups at T3 were significantly lower than at T1. However, the significance of some of the data did not exist after Bonferroni correction. The changes in scores from T0 to T1 (T1-T0), from T0 to T3 (T3-T0), and from T1 to T3 (T3-T1) in the supervised group were all less statistically significant compared to the unsupervised group. The study showed that exercise combined with drug therapy can significantly improve the prognosis of FM, including pain relief, better sleep, and better overall quality of life; long-term supervised exercise training is more effective in improving FM symptoms and is safer and more reliable than unsupervised exercise.

Bariatric surgery may affect the pharmacokinetics of medications by altering the gastrointestinal physiology. Pharmacokinetic changes of first-line neuropathic pain medications such as gabapentin and pregabalin following bariatric treatment have barely been investigated. In our prospective five-case study we included gabapentin- or pregabalin-treated patients undergoing bariatric surgery at hospitals in Central Norway. Concentrations of gabapentin and pregabalin were assessed using serial blood samples over a dose interval, preoperatively and one, six and twelve months postoperatively. The primary outcomes of the study included changes in area under the time-concentration curve (AUC) with secondary outcomes comprising full pharmacokinetic profiling. Formal statistical testing was not performed due to few cases. Three pregabalin-treated obese patients undergoing Roux-en-Y gastric bypass (RYGB) and two gabapentin-treated patients undergoing RYGB (n = 1) and sleeve gastrectomy (SG) (n = 1) were included. Largest changes for dose-adjusted AUC values after surgery were seen in pregabalin-treated patients at one and six months (average increases of 53% one month and 28% 6 months postoperatively). In the patients on gabapentin, mean AUC changes were less than 10% from baseline throughout the study period. The inter-individual variation was high. Postoperative pharmacokinetic changes for gabapentin were minimal, but for pregabalin we observed more pronounced changes, particularly in one patient. Due to few cases, the results should be interpreted with caution. Given the large inter-individual variation, therapeutic drug monitoring could be considered to capture pharmacokinetic changes and guide dose adjustments postoperatively.

Objective This clinical study evaluated an experimental pregabalin (PG) gel in reducing dental sensitivity (DS) and color change after dental bleaching. Materials and methods Seventy-five volunteers were selected and randomized into three groups: GPG (10% pregabalin gel), GKF (5% potassium nitrate and 2% sodium fluoride), and GP (placebo gel). Prior to the bleaching treatment, GPG and GKF received applications of the respective desensitizing gels for 10 min. The GP group received an application of placebo gel, similar to the other groups. The bleaching was performed with 35% hydrogen peroxide in 3 sessions, with a 7-day interval between sessions. Post-bleaching DS was assessed using the visual analog scale (VAS) over 21 days of follow-up. Color Assessment (ΔE00, ΔWID, and ΔEab) and luminosity (L) were measured at baseline (T0) and 7 days after the third session (T1). Friedman, Kruskal-Wallis, one-way ANOVA, and Tukey tests were used, with α = 5%. Results Intergroup analysis showed that on the 1st, 8th, and 15th days, DS was higher for GP ( p  < 0.006; p  = 0.004; p  < 0.001) and did not differ between GKF and GPG ( p  = 0.203; p  = 0.178; p  = 0.09). In the intragroup analysis, GP showed a significant increase in DS on the 15th day ( p  < 0.001). Conclusions The experimental 10% pregabalin gel reduced dental sensitivity and did not interfere with bleaching results. Clinical significance The topical application of 10% pregabalin gels and NKF was effective in reducing tooth sensitivity 24 hoursafter whitening with 35% hydrogen peroxide. Trial registration ClinicalTrials.gov trial registry with the identifier NCT06180707.

Introduction Preemptive multimodal analgesia (PMA) is commonly employed for pain control after total knee arthroplasty (TKA). However, the optimal timing for initiating PMA remains unclear. This study aimed to compare the efficacy of PMA administered at different time points before TKA. Materials and methods In this prospective, double-blind, placebo-controlled, randomized trial, 120 patients who underwent TKA were randomized into three groups. PMA (200 mg celecoxib and 150 mg pregabalin administered every 12 h) was initiated 48 h (group A), 24 h (group B), and 1 h (group C) before surgery. The primary outcome was the postoperative administration of morphine hydrochloride as a rescue analgesic. Secondary outcomes included time to first rescue analgesia, postoperative pain assessed using the visual analog scale (VAS), functional recovery assessed by knee motion range and ambulation distance, time until hospital discharge, and complication rates. Results Compared with group C, groups A and B exhibited significantly lower morphine consumption within 24 h after surgery, lower total morphine consumption, longer time to first rescue analgesia, and superior range of knee motion on the day of surgery. Groups A and B did not exhibit significant differences in these outcomes. The three groups did not differ significantly in postoperative VAS pain scores, ambulation distance, length of hospital stay, or complication rates. Conclusions In comparison with PMA starting at 1 h preoperatively, initiating PMA at 24 and 48 h preoperatively provided better postoperative pain relief. Considering the aim of minimizing the amount of ineffective medication received by patients, initiating PMA at 24 h preoperatively may be a more favorable option for patients undergoing TKA. However, the clinical significance of our results and the optimal starting time for PMA require further investigation.