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Nicolau syndrome caused by non-steroidal anti-inflammatory drugs: Systematic literature review.
Lardelli, PF, Jermini, LMM, Milani, GP, Peeters, GGAM, Ramelli, GP, Zgraggen, L, Terrani, I, Bianchetti, MG, Vanoni, F, Faré, PB, et al
International journal of clinical practice. 2020;(10):e13567
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Abstract
AIM: Intramuscular or, more rarely, local drug injection is occasionally followed by immediate local pain, livedoid skin lesions and, some days later, the development of ischemic lesions. This very uncommon but potentially severe reaction, termed Nicolau syndrome, is traditionally associated with bismuth and β-lactam antimicrobials. The aim of this report was to review the literature associating Nicolau syndrome with the administration of non-steroidal anti-inflammatory drugs. METHODS The National Library, Excerpta Medica, Web of Science and Cochrane library databases were used. RESULTS Sixty-two cases (40 females and 22 males aged from 13 to 81, median 57 years) of Nicolau syndrome were published after 1992. Fifty-three cases occurred after diclofenac. The remaining nine cases were associated with ketoprofen (N = 2), ketorolac (N = 2), phenylbutazone (N = 2), etofenamate (N = 1), ibuprofen (N = 1) and piroxicam (N = 1). CONCLUSION Although Nicolau syndrome is extremely uncommon, physicians must be aware of this complication after intramuscular administration of non-steroidal anti-inflammatory drugs and should avoid unnecessary injections.
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Electroporation technique for joint pain - Pilot feasibility study on TMD patients.
Tartaglia, GM, Gizdulich, A, Farronato, M, Gupta, RJ, Connelly, ST
Clinical and experimental dental research. 2020;(6):642-649
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OBJECTIVE(S): It is well appreciated that traditional analgesic delivery routes used to treat pain associated with temporomandibular disorder (TMD) often have harmful unintended side effects as a consequence of systemic distribution. Further, localized delivery of analgesic medication via intra-articular injections involves a different set of issues limiting their clinical viability. As an option, transdermal analgesic delivery provides for prolonged pain relief and flexibility in dose administration, while limiting systemic exposure and minimizing adverse events. Incorporation of a novel electroporation technique may further increase transdermal drug penetration into synovial tissue/fluid and enhance pain reduction. The present feasibility study compares the effectiveness of an electroporation-enhanced transdermal application of diclofenac sodium to a conventional intra-articular injection of triamcinolone acetonide suspension (corticosteroids) to treat patients with TMD associated pain. METHODS Pre- and post-treatment maximal incisal mouth opening (MIO), pain visual analog scale (VAS) and surface electromyography (EMG) of 22 patients treated with electroporation-enhanced diclofenac and 37 patients treated with corticosteroids injections were collected and analyzed. RESULTS In general, patients treated with electroporation exhibited better results in terms of pain improvement (corrected p-value = .01) compared to the standard treatment, but both methods were similarly effective for improvement of MIO (corrected p-value = .71) and improvement of all EMG indices (corrected p-values ≥ .05). CONCLUSION The enhancing effect of electroporation in transdermal delivery of diclofenac sodium was demonstrated by decreased pain, increase MIO and EMG improvement to normal values. Its analgesic and inflammatory results are comparable with standard treatment offered by corticosteroids.
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Efficacy and safety of combination of curcuminoid complex and diclofenac versus diclofenac in knee osteoarthritis: A randomized trial.
Shep, D, Khanwelkar, C, Gade, P, Karad, S
Medicine. 2020;(16):e19723
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BACKGROUND To compare the efficacy and safety of combination of curcuminoid complex and diclofenac vs diclofenac alone in the treatment of knee osteoarthritis (OA). METHODS In this randomized trial, 140 patients of knee OA received either curcuminoid complex 500 mg (BCM-95) with diclofenac 50 mg 2 times daily or diclofenac 50 mg alone 2 times daily for 28 days. Patients were assessed at baseline, day 14 and day 28. Primary efficacy measures were Knee injury and OA outcome score (KOOS) subscale at day 14 and day 28. Anti-ulcer effect and patient-physician's global assessment of therapy at day 28 were included as secondary endpoints. Safety after treatment was evaluated by recording adverse events and laboratory investigations. RESULTS Both treatment groups showed improvement in primary endpoints at each evaluation visit. Patients receiving curcuminoid complex plus diclofenac showed significantly superior improvement in KOOS subscales, viz. pain and quality of life at each study visit (P < .001) when compared to diclofenac. Less number of patients required rescue analgesics in curcuminoid complex plus diclofenac group (3%) compared to diclofenac group (17%). The number of patients who required histamine 2 (H2) blockers was significantly less in curcuminoid complex plus diclofenac group compared to diclofenac group (6% vs 28%, respectively; P < .001). Adverse effects were significantly less in curcuminoid complex plus diclofenac group (13% vs 38% in diclofenac group; P < .001). Patient's and physician's global assessment of therapy favored curcuminoid complex plus diclofenac than diclofenac. CONCLUSION Combination of curcuminoid complex and diclofenac showed a greater improvement in pain and functional capacity with better tolerability and could be a better alternative treatment option in symptomatic management of knee OA. TRIAL REGISTRATION ISRCTN, ISRCTN10074826.
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Amine functionalized egg albumin hydrogel with enhanced adsorption potential for diclofenac sodium in water.
Godiya, CB, Kumar, S, Xiao, Y
Journal of hazardous materials. 2020;:122417
Abstract
The removal of diclofenac sodium (DFS) from wastewater has attracted increasing attention because it is within the extensively prescribed nonsteroidal anti-inflammatory drugs and pose ecotoxicity. Therefore, fabrication of versatile adsorbents of low-cost, higher-effectiveness and excellent recyclability is significant for the treatment of DFS contaminated wastewater. This work reports a promising biobased egg albumin (ALB) hydrogel functionalized with a large density of adsorptive amine sites via polyethyleneimine (PEI). The composite ALB/PEI hydrogel demonstrated an excellent DFS removal capacity, i.e. 232.5 mg/g, in an optimum experimental condition (pH∼6; contact time∼180 min; adsorbent dosage∼0.5 g/L) which revealed to be considerably higher or competitive than many reported adsorbents. The adsorption isotherms better accorded with the Langmuir model and the kinetics with the pseudo second-order model, indicating the mono-layer chemisorption process. Besides, the regeneration steps up to four sequential adsorption/desorption cycles demonstrated an excellent reusability. The Fourier-transform infrared spectrometry (FTIR), and X-ray photoelectron spectroscopy (XPS) results implied that the adsorption process followed via the electrostatic interactions, hydrogen bonding, and π-π stacking between the functionality of hydrogel and aromatic rings of DFS. Considering the low-cost, and an excellent DFS removal capacity, the natural composite ALB/PEI hydrogel could be a promising adsorbent for the treatment of DFS contaminated wastewater.
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Effect of Combined Diclofenac and B Vitamins (Thiamine, Pyridoxine, and Cyanocobalamin) for Low Back Pain Management: Systematic Review and Meta-analysis.
Calderon-Ospina, CA, Nava-Mesa, MO, Arbeláez Ariza, CE
Pain medicine (Malden, Mass.). 2020;(4):766-781
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BACKGROUND Cumulative evidence suggests an analgesic effect of thiamine, pyridoxine, and cyanocobalamin (TPC) in monotherapy, and also when combined with nonsteroidal anti-inflammatory drugs (NSAIDs), particularly diclofenac, in a synergistic manner. The aim of this review was to determine the effects of diclofenac combined with TPC compared with diclofenac monotherapy for low back pain (LBP) management. METHODS We searched for randomized clinical trials on the MEDLINE, EMBASE, LILACS, and Cochrane databases of records of clinical trials, among other sources. We evaluated the risk of bias regarding randomization, allocation concealment, blinding, incomplete outcome data, selective reporting, and other biases. A random-effects meta-analysis to examine patients with acute LBP (N = 1,108 adults) was performed, along with a subsequent sensitivity analysis. RESULTS Five studies in patients with LBP were included in the qualitative synthesis. Four of these studies in acute LBP were included in the first meta-analysis. A sensitivity test based on risk of bias (three moderate- to high-quality studies) found that the combination therapy of diclofenac plus TPC was associated with a significant reduction in the duration of treatment (around 50%) compared with diclofenac monotherapy (odds ratio = 2.23, 95% confidence interval = 1.59 to 3.13, P < 0.00001). We found no differences in the safety profile and patient satisfaction. CONCLUSIONS This meta-analysis demonstrated that combination therapy of diclofenac with TPC might have an analgesic superiority compared with diclofenac monotherapy in acute LBP. However, there is not enough evidence to recommend this therapy in other types of pain due to the scarcity of high-quality studies.
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Formulation of Topical Dosage Forms Containing Synthetic and Natural Anti-Inflammatory Agents for the Treatment of Rheumatoid Arthritis.
Jurca, T, Józsa, L, Suciu, R, Pallag, A, Marian, E, Bácskay, I, Mureșan, M, Stan, RL, Cevei, M, Cioară, F, et al
Molecules (Basel, Switzerland). 2020;(1)
Abstract
Topical anti-inflammatory and analgesic effect for the treatment of rheumatoid arthritis is of major interest because of their fewer side effects compared to oral therapy. The purpose of this study was to prepare different types of topical formulations (ointments and gels) containing synthetic and natural anti-inflammatory agents with different excipients (e.g.,: surfactants, gel-forming) for the treatment of rheumatoid arthritis. The combination of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), diclofenac sodium, a topical analgesic agent methyl salicylate, and a lyophilized extract of Calendula officinalis with antioxidant effect were used in our formulations. The aim was to select the appropriate excipients and dosage form for the formulation in order to enhance the diffusion of active substances and to certify the antioxidant, analgesic, and anti-inflammatory effects of these formulations. To characterize the physicochemical properties of the formulations, rheological studies, and texture profile analysis were carried out. Membrane diffusion and permeability studies were performed with Franz-diffusion method. The therapeutic properties of the formulations have been proven by an antioxidant assay and a randomized prospective study that was carried out on 115 patients with rheumatoid arthritis. The results showed that the treatment with the gel containing diclofenac sodium, methyl salicylate, and lyophilized Calendula officinalis as active ingredients, 2-propenoic acid homopolymer (Synthalen K) as gel-forming excipient, distilled water, triethanolamine, and glycerol had a beneficial analgesic and local anti-inflammatory effect.
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Oral Diclofenac Potassium Versus Intravenous Acetaminophen in Acute, Isolated, Closed-Limb Trauma.
Momeni, M, Vahidi, E, Badrizadeh, M, Naderpour, Z, Saeedi, M
Advanced emergency nursing journal. 2019;(1):48-55
Abstract
Pain control is an important concern in limb trauma. The most ideal agent for this purpose varies among different hospitals. The objective of this study was to compare the analgesic effect of oral diclofenac potassium versus intravenous acetaminophen in patients with limb trauma. This was a double-blind randomized clinical trial conducted on 60 adult patients. Oral diclofenac potassium (50 mg) was given in Group D, and intravenous acetaminophen (1 g in 500 ml normal saline over 20 min) was administered in Group A. Patients' pain scores (visual analogue scale) were recorded and compared at baseline, 5, 15, 30, 60 min, and 4 hr after drug administration. The mean age was 42.62 ± 15.42 and 38.04 ± 17.48 years in Group A and Group D, respectively. No significant change was observed between the 2 groups (p = 0.11). In this study, both drugs could decrease the pain score effectively and safely in isolated limb trauma.
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Efficient Removal of Diclofenac from Aqueous Solution by Potassium Ferrate-Activated Porous Graphitic Biochar: Ambient Condition Influences and Adsorption Mechanism.
Thi Minh Tam, N, Liu, Y, Bashir, H, Yin, Z, He, Y, Zhou, X
International journal of environmental research and public health. 2019;(1)
Abstract
Porous graphitic biochar was synthesized by one-step treatment biomass using potassium ferrate (K2FeO4) as activator for both carbonization and graphitization processes. The modified biochar (Fe@BC) was applied for the removal of diclofenac sodium (DCF) in an aqueous solution. The as-prepared material possesses a well-developed micro/mesoporous and graphitic structure, which can strengthen its adsorption capacity towards DCF. The experimental results indicated that the maximum adsorption capacity (qmax) of Fe@BC for DCF obtained from Langmuir isotherm simulation was 123.45 mg·L-1 and it was a remarkable value of DCF adsorption in comparison with that of other biomass-based adsorbents previously reported. Thermodynamic quality and effect of ionic strength studies demonstrated that the adsorption was a endothermic process, and higher environmental temperatures may be more favorable for the uptake of DCF onto Fe@BC surface; however, the presence of NaCl in the solution slightly obstructed DCF adsorption. Adsorption capacity was found to be decreased with the increase of solution pH. Additionally, the possible mechanism of the DCF adsorption process on Fe@BC may involve chemical adsorption with the presence of H-bonding and π-π interaction. With high adsorption capacity and reusability, Fe@BC was found to be a promising absorbent for DCF removal from water as well as for water purification applications.
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Rectal Diclofenac administration for prevention of post-Endoscopic Retrograde Cholangio-Pancreatography (ERCP) acute pancreatitis. Randomized prospective study.
Geraci, G, Palumbo, VD, D'Orazio, B, Maffongelli, A, Fazzotta, S, Lo Monte, AI
La Clinica terapeutica. 2019;(5):e332-e336
Abstract
INTRODUCTION Post-Endoscopic Retrograde Cholangio-Pancreatography pancreatitis (PEP) is a relevant (1-4%) complication of biliopancreatic operative endoscopy. Rectal nonsteroidal anti-inflammatory drugs (specifically, 100 mg of diclofenac) have shown promising prophylactic activity in PEP. The aim of our prospective study is to report whether prophylactic oral versus rectal suppository versus intramuscular diclofenac versus placebo are able to reduce the incidence and the severity of ERCP-induced pancreatitis. MATERIALS AND METHODS In this randomized, double-blinded, prospective study, 100 patients (49 male, 51 female), similar with regard to indication for ERCP, were enrolled between January 2016 and November 2017 to undergo ERCP in the Section of General and Thoracic Surgery of University Hospital of Palermo. They were randomized into five groups, respectively 20 patients with placebo by mouth; 20 patients with 50 mg diclofenac sodium enteric-coated capsules by mouth; 20 with 100 mg rectal suppository diclofenac, 20 with 75 mg/3 ml intramuscular diclofenac sodium, 20 with 75 mg/3 ml intramuscular diclofenac sodium and 20 with 75 mg/3 ml intravenous diclofenac. All drugs were administered 30 to 90 minutes before ERCP. All clinical data were collected one day before and 2, 12 and 24 hour after ERCP. RESULT Data were prospectively collected and to demonstrate the preventive effect of rectal diclofenac on PEP, a two-by-two table and chi-square test with Yates correction were used: the incidence of PEP was significantly lower (p < 0.001) in the rectal diclofenac group respect to other groups and, in the same way, the incidence of post-ERCP pain was significantly lower in the rectal diclofenac group than in the other groups (p = 0.001) and patients discharge was consequently earlier (p < 0.01). CONCLUSION 100 mg dose rectal diclofenac administered 30-60 minutes before ERCP can effectively prevent PEP.
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A comparative evaluation of transdermal diclofenac patch with oral diclofenac sodium as an analgesic drug following periodontal flap surgery: A randomized controlled clinical study.
Diwan, V, Srinivasa, TS, Ramreddy, KY, Agrawal, V, Nagdeve, S, Parvez, H
Indian journal of dental research : official publication of Indian Society for Dental Research. 2019;(1):57-60
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BACKGROUND Pain is an inevitable outcome of any periodontal surgery. Controlling postoperative pain is of utmost importance so as to increase patient compliance. The present study aims to compare the degree of postoperative analgesia with the use of oral diclofenac sodium and transdermal diclofenac patch following periodontal flap surgery in patients with chronic periodontitis. MATERIALS AND METHODS A total of 20 patients requiring full mouth flap surgery were selected for this study. Flap surgery was performed quadrant-wise and transdermal diclofenac patch was applied on the right arm following surgery of one of the quadrants and 100 mg oral diclofenac sodium twice daily was prescribed following surgery of the subsequent quadrant. The postoperative pain was recorded on visual analog scale and pain intensity scale 24 h after the surgery. RESULTS Both the statistical and clinical observation showed that diclofenac sodium administered transdermally has equal efficacy as compared to drug administered orally. CONCLUSION The study concludes that the diclofenac administered transdermally has equal potency in relieving postoperative pain as compared to orally administered diclofenac sodium following modified flap surgery. Transdermal patch has an added advantage of better patient compliance as it does not cause gastric disturbance.