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Prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis with a combination of pharmacological agents based on rectal non-steroidal anti-inflammatory drugs: A systematic review and network meta-analysis.
Oh, HC, Kang, H, Park, TY, Choi, GJ, Lehman, GA
Journal of gastroenterology and hepatology. 2021;(6):1403-1413
Abstract
BACKGROUND AND AIMS Rectally administered non-steroidal anti-inflammatory drugs (NSAIDs) are effective but suboptimal in the prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis or PEP. New trials with the combination of rectal NSAIDs and other pharmacological agents have been conducted. This network meta-analysis (NMA) aimed to determine the relative efficacy of combination regimens and identify an optimal regimen for preventing PEP. METHODS We performed a systematic and comprehensive search to identify and analyze all the randomized controlled studies published until October 15, 2019, examining rectal NSAIDs and their combination with other pharmacological agents for the prevention of PEP. The primary outcome was the frequency of PEP. We conducted an NMA to combine the direct and indirect comparisons of rectal NSAIDs and their combination with other pharmacological agents. RESULTS The NMA included 24 studies evaluating 14 regimens in 11 321 patients. According to predictive interval plot and surface under the cumulative ranking curve values, indomethacin + lactated Ringer's solution, followed by diclofenac + nitrate and indomethacin + normal saline, is the most efficacious combination of pharmacological agents for the overall prevention of PEP. Rectal indomethacin alone is the most efficacious agent for prevention of moderate to severe PEP, and rectal diclofenac is the most useful agent for prevention of PEP among the high-risk group. CONCLUSIONS Rectal indomethacin with intravenous hydration and rectal diclofenac with sublingual nitrate are the most efficacious combination regimens for the overall prevention of PEP.
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Treatment responder analysis in actinic keratosis: can it lead the way to individualized choice of treatment?
Schmitz, L, Hansen, JB, Bastian, M, Larsson, T, Stockfleth, E
The Journal of dermatological treatment. 2021;(4):411-417
Abstract
BACKGROUND It is unclear if there are any distinct AK patient populations that might respond best to a given treatment. OBJECTIVE To identify if a distinct subgroup of patients with AK might respond better to treatment with ingenol mebutate (IngMeb) versus diclofenac sodium (DS). METHODS Complete clearance of AK and mean lesion reduction at end of first treatment course and week 17 were evaluated within subgroups. RESULTS 502 patients (255 IngMeb; 247 DS) were included in the analysis. At week 17, complete clearance was achieved by more patients treated with IngMeb versus DS within the majority of patient subgroups, including patients with <6 lesions and ≥6 lesions at baseline, aged ≥65 years, males, females, Fitzpatrick skin types II and III, and facial lesions. Mean lesion reduction at week 17 was greater with IngMeb than DS within the same subgroups, and in patients with scalp lesions. CONCLUSIONS This responder analysis did not identify any distinct population that responded more optimally than others with IngMeb or DS. More patients achieved complete clearance and higher lesion reduction of AK with IngMeb compared with DS in most subgroups.
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Intradermal sterile water injection versus diclofenac sodium in acute renal colic pain: A randomized controlled trial.
Moussa, M, Papatsoris, AG, Chakra, MA
The American journal of emergency medicine. 2021;:395-400
Abstract
OBJECTIVES We aimed to evaluate the efficacy of intracutaneous sterile water injection (ISWI) to relieve the pain of acute renal colic compared with diclofenac and placebo. METHODS The study included 150 patients presented to the Emergency Department with renal colic randomized into 3 groups: control group received intracutaneous injections of 0.5 cm3 isotonic saline in the flank, group A received intracutaneous injections of 0.5 cm3 ISWI in the flank, and group B received an intramuscular injection of 75 mg Diclofenac in the gluteal region. The severity of the pain was assessed by a visual analogue scale system at baseline and 30, 45 min, and 60 min after injections. Subjects with inadequate pain relief at 1 h received rescue analgesia. RESULTS The mean baseline pain score was 9.6 ± 0.61 in the ISWI group, 9.72 ± 0.64 in the diclofenac group and 9.26 ± 0.89 in the control group. The mean pain score at 30 min of the control group was reduced to 6.9 ± 1.56. This mean at 30 min after ISWI and diclofenac injections were reduced to 1.98 ± 1.41 and 1.88 ± 1.19 respectively. The mean of pain sore of the ISWI and diclofenac group at 45 and 60 min was constant. Rescue analgesics at 1 h were required by 47 patients receiving the saline injection and by 4 patients and by 7 patients receiving ISWI and diclofenac injection respectively. CONCLUSIONS ISWI and diclofenac were equally effective for the pain relief of acute renal colic.
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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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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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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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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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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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Comparison of EMLA and Diclofenac on Reduction of Pain and Phlebitis Caused by Peripheral IV Catheter: A Randomized-Controlled Trial Study.
Babaieasl, F, Yarandi, HN, Saeidzadeh, S, Kheradmand, M
Home healthcare now. 2019;(1):17-22
Abstract
Peripheral venous catheters (PVC) are often used to provide hydration, medications, and blood products when the length of therapy is expected to be less than 1 week. Pain and phlebitis are frequent complications of PVC. Diclofenac and EMLA have been used to minimize these adverse effects; however, conflicting results have been reported regarding which has better outcomes. This double-blind, randomized controlled trial was conducted to compare the efficacy of EMLA and Diclofenac (TDP) in attenuating PVC pain and phlebitis. The inpatient setting was chosen because of the higher frequency of PVC insertions, allowing for a sufficient sample size. One hundred fifty-four subjects were randomly assigned to three groups: EMLA patch (n = 61), a TDP patch (n = 50), or a patch with lubricant gel (n = 46) as a placebo. The pain was measured by Visual Analogue Scale (VAS). Phlebitis was examined based on Boxter criteria in intervals of 6, 12, 18, 24, and 48 hours after PVC insertion. The mean score of VAS was 41.86 ± 22.49 for the control, 39.40 ± 21.60 for TDP, and 38.77 ± 23.28 for the EMLA group, with no significant differences in pain severity between the three groups. The rate of phlebitis in the group with EMLA was significantly higher than the other two groups at 6, 12, and 18 hours (p = 0.02, p = 0.003 and p = 0.04, respectively). In all interval times, the rate of phlebitis in the TDP group was significantly lower than the other groups. Compared with men, women experienced higher rate of phlebitis and intensity of PVC pain. EMLA and TDP had similar analgesic effects, but phlebitis was less frequently observed with TDP, suggesting TDP as a potential medication for reducing pain and phlebitis before PVC insertion.