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1.
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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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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Abstract
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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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.
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Comparison of the Effects of Piroxicam and Diclofenac Sodium as Treatments for Primary Dysmenorrhea.
Camlibel, M, Erdur, B, Yilmaz, A, Ozen, M, Uyanik, A
Medical science monitor : international medical journal of experimental and clinical research. 2019;:157-164
Abstract
BACKGROUND NSAIDs are the most common agents used in dysmenorrhea treatment. They reduce menstrual pain by reducing uterine pressure and PGF2alpha levels in the menstrual fluid. The aim of this study was to compare the effects of piroxicam and diclofenac sodium as treatments for primary dysmenorrhea. MATERIAL AND METHODS The study was conducted using a randomized and double-blind method. Patients with Visual Analogue Scale (VAS) scores greater than 5 were accepted into the study. The patients who were suitable for inclusion were randomized into 2 groups and received either intramuscular piroxicam or diclofenac sodium. The patients' pain levels were measured at baseline and at 15, 30, 45, and 60 min. A VAS of 10 cm, a numeric scale, a verbal scale, and additional symptoms, as well as pain relapse after 24 hours and required analgesics, were recorded. RESULTS The study included 400 patients. Overall, 200 patients (50%) were in the proxicam group, and 200 patients were in the diclofenac sodium group. The average decrease on the VAS after piroxicam or diclofenac administration was measured as 7.9±1.8 cm and 7.9±1.7 cm (median ± standard deviation), respectively. The pain-reducing efficiency of all the treatments was compared using the Mann-Whitney U test (p=0.929). Rescue medication was needed for 25 patients in the proxicam group (p=0.014). Overall, 30 patients in the proxicam group and 41 patients in the proxicam group needed analgesics again in the 24-hour period after treatment (p=0.150). CONCLUSIONS At the end of our study, it was observed that there was no difference in the results of primary dysmenorrhea treatment with 20 mg piroxicam or 75 mg diclofenac sodium.
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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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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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Comparison Between Diclofenac and Ketorolac Ophthalmic Drops for Pain Management After Photorefractive Keratectomy: A Randomized Clinical Study.
Mohammadpour, M, Heidari, Z, Molani, R
Eye & contact lens. 2019;(2):137-140
Abstract
OBJECTIVES To assess and compare the efficacy of two nonsteroidal anti-inflammatory drugs (NSAIDs), namely diclofenac and ketorolac, for pain control after photorefractive keratectomy (PRK). METHODS In this double-masked clinical study, 60 patients treated bilaterally with PRK were randomly allocated into two groups. Postoperatively, one group of patients received diclofenac 0.1% drops and the other group was prescribed ketorolac 0.5% ophthalmic drops in both eyes every 6 hr on the first day and then, no NSAID was applied until the third day. No oral analgesic drug was used after surgery. Patients completed the Visual Analog Scale questionnaire to determine the degree of pain and ocular discomfort (tearing, foreign body sensation, blurred vision, and photophobia) on the first and the third day after surgery. RESULTS Pain relief was achieved with both medications after surgery, and there was no significant intergroup difference in the level of pain reduction at 24 and 72 hr postoperatively (P>0.05). The ketorolac group experienced less tearing and photophobia only at 24 hr postoperatively (P=0.01), and by 72 hr after surgery, the results were similar in two groups (P>0.05). There was no significant intergroup difference in terms of foreign body sensation or blurred vision on the first or third postoperative days (P>0.05). CONCLUSIONS Both diclofenac and ketorolac are effective in reducing pain and ocular discomfort after PRK, and ketorolac may have greater control on tearing and photophobia during the first 24 postoperative hours.
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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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Abstract
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.