-
1.
A Comparative Study to Evaluate Efficacy of Curcumin and Aloe Vera Gel along with Oral Physiotherapy in the Management of Oral Submucous Fibrosis: A Randomized Clinical Trial.
Nerkar Rajbhoj, A, Kulkarni, TM, Shete, A, Shete, M, Gore, R, Sapkal, R
Asian Pacific journal of cancer prevention : APJCP. 2021;(S1):107-112
Abstract
UNLABELLED Rationale (Hypothesis): The antioxidant,anti-inflammatory,immunomodulatory and anti-tumorigenic properties of natural plant's extracts like aloe Vera and curcumin may produce beneficial therapeutic effects on OSMF patients and may lead to their symptomatic relief. Also, increase in the tissue elasticity with the help of oral physiotherapy excercises , would help in reinforcing increment in mouth opening. AIM: The aim of the study is to compare the efficacy of Curcumin gel with Aloe Vera gel when both the gel are supplemented along with oral physiotherapy in the management of OSMF. MATERIALS AND METHODS A study of parallel group trial design, using simple randomization technique, was conducted on confirmed cases of OSMF. Patients were divided into two groups, one group(30 patients) was given curcumin gel(Curenext) and other group (30 patients) aloe Vera gel (Aloe Vera 100% relief) and each group was asked to do same oral physiotherapy excercises supplementally. Follow-up was done for 6 weeks and patients were assessed on the basis of improvement in mouth opening and burning sensation at 2, 4, and 6 weeks. RESULTS There was an improvement in both the parameters at subsequent visits, but the Aloe Vera gel showed better improvement than curcumin gel in burning sensation after 6 weeks of treatment which was highly statistically significant p < 0.01. CONCLUSION Curcumin gel and Aloe Vera gel are effective in improving OSMF symptoms, but aloe Vera gel is more efficacious in burning sensation improvement without any side effects. Hence, we can advocate these drugs as adjuvant treatment in addition to the recommended treatment.
-
2.
A triple-blind randomized clinical trial of different associations between dexamethasone and non-steroids anti-inflammatories for preemptive action in third molar extractions.
Momesso, GAC, Grossi-Oliveira, GA, Silva, WPP, Akira, R, Chiba, F, Polo, TOB, de Lima Neto, TJ, Rios, BR, Bassi, APF, Sumida, DH, et al
Scientific reports. 2021;(1):24445
Abstract
The aim of this study is to evaluate the preemptive analgesic effects of dexamethasone (DEX) alone or combined with non-steroidal anti-inflammatory drugs (NSAIDs) in third molar surgeries. The subjects were divided into five groups (n = 20 teeth/group); subjects received only 8 mg of dexamethasone 1 h before the surgical procedure (DEX group), or in combination with etodolac (DEX + ETO), ketorolac (DEX + KET), ibuprofen (DEX + IBU), loxoprofen (DEX + LOX). Paracetamol 750 mg was provided as the number of rescue analgesics (NRA). Salivary PGE2 expression was measured preoperatively and at 48 h. Edema and Maximum mouth opening (MMO) were measured postoperatively at 48 h and 7 days. A visual analog scale (VAS) was performed postoperatively at 6, 12, 24, 48, 72 h, and 7 days. Salivary expression of PGE2 showed a decrease only for the DEX group. Edema and MMO and NRA consumption showed no significant differences among the groups (P > 0.05). The VAS showed a significantly lower pain perception at 6 h after the surgery for the DEX + ETO and DEX + KET groups (P < 0.05). The combination of DEX and NSAIDS should be considered for preemptive acute postsurgical pain management in third molar surgery. In some drug associations such as dexamethasone 8 mg + NSAIDS (ETO and KET) in the pre-operative time, only a few rescue analgesics are necessary.
-
3.
Randomised trial of IV metoclopramide vs IV ketorolac in treatment of acute primary headaches.
Soltani, KM, Motamed, H, Eslami, K, Majdinasab, N, Kouti, L
The American journal of emergency medicine. 2021;:376-380
Abstract
INTRODUCTION Headache is one of the most common neurological conditions among emergency department visits (ED), although the best therapy has not been identified yet. Therefore, in the current study, we aimed to compare the pain-relieving effect of metoclopramide and ketorolac in acute primary headaches patients. METHODS This double-blind, randomised clinical trial was conducted at Golestan Hospital, Ahvaz, Iran. This research involved all adult patients with acute primary (migraine or tension-type) headaches presented to the ED. Pain intensity was assessed with 0 to 10 verbal Numeric Rating Scales (NRS). The subjects were randomised into 10 mg intravenous (IV) metoclopramide or 30 mg IV ketorolac groups. Pain score and drug adverse reactions were compared between the two groups at baseline, 15, 30, and 60 min after baseline. RESULTS 108 patients completed this trial and were equally divided into two groups (mean age of 34 ± 8.54 years; 57.4% female). Before treatment, the mean pain score was 6.9 and 6.8 in metoclopramide and ketorolac groups, respectively (p > 0.05). Metoclopramide failed to provide more improvement in pain score at 30 min (p = 0.55) and 60 min (p = 0.15) from baseline. There were no serious adverse events in this study. Only five patients required rescue medication which four of them were in ketorolac group. CONCLUSION We were unable to reject the null hypothesis that there would be no difference in pain outcomes between metoclopramide and ketorolac.
-
4.
Anti-Neuroinflammatory Properties of n-3 Fatty Acids and Nano- Curcumin on Migraine Patients from Cellular to Clinical Insight: A Randomized, Double-Blind and Placebo-Controlled Trial.
Honarvar, NM, Soveid, N, Abdolahi, M, Djalali, M, Hatami, M, Karzar, NH
Endocrine, metabolic & immune disorders drug targets. 2021;(2):365-373
Abstract
BACKGROUND AND OBJECTIVES Migraine is an exhausting neuro-inflammatory disorder recognized as recurrent headache attacks. Evidence has shown that Interleukin (IL)-1β plays a substantial role in the neuro-immunity pathogenicity of migraine. n-3 fatty acids and curcumin revealed neuromodulatory and anti-inflammatory effects through several pathways, of which the suppression of IL-1β gene expression is an important inflammatory pathway. The aim of this study was the investigation of synergistic relation of n -3 fatty acids and nano-curcumin on IL-1β gene expression and serum levels in migraine patients. METHODS This study was performed as a randomized, double-blind, placebo-controlled trial in a period of two months. A total of 80 episodic migraines were assigned into 4 groups of 1) n-3 fatty acids and curcumin combination; 2) n -3 fatty acids; 3) nano-curcumin; and 4) n-3 fatty acids and curcumin placebo. The gene expression and serum level of IL-1β were measured by real-time PCR and ELISA methods respectively, at the beginning and the end of the interventions. RESULTS Results showed the n-3 fatty acids and nano-curcumin combination significantly reduced the attack frequency in a synergistic status (P < 0.001). A significantly greater reduction in the serum level of IL-1β was observed in the combination group, and the differences in the other groups were not statistically significant. The IL-1β gene expression in the combination group showed a significant reduction for other treatment groups (P < 0.05), but these significant differences were absent after multiple testing Bonferroni corrections. CONCLUSION Present findings revealed that n -3 fatty acids and curcumin co-supplementation can be suggested as a promising new approach in migraine headache management, but further studies are needed to confirm these findings.
-
5.
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.
-
6.
Effect of low salicylate diet on clinical and inflammatory markers in patients with aspirin exacerbated respiratory disease - a randomized crossover trial.
Sowerby, LJ, Patel, KB, Schmerk, C, Rotenberg, BW, Rocha, T, Sommer, DD
Journal of otolaryngology - head & neck surgery = Le Journal d'oto-rhino-laryngologie et de chirurgie cervico-faciale. 2021;(1):27
Abstract
BACKGROUND Aspirin-exacerbated respiratory disease (AERD) is characterized by eosinophilic rhinosinusitis, nasal polyposis, and bronchial asthma, along with the onset of respiratory reactions after the ingestion of nonsteroidal anti-inflammatory drugs (NSAIDs) or acetylsalicylic acid (ASA). In addition to the therapeutic routines and surgical options available, a low dietary intake of food salicylate has been suggested as adjunctive therapy for this condition. This study aimed to assess the influence of a short-term low salicylate diet on inflammatory markers in patients with AERD and whether that would result in symptomatic improvement. METHODS Prospective study with randomization to either a high or low salicylate diet for 1 week, followed by cross-over to the other study arm. Participants were asked to record their dietary salicylate for each week of the study. Urinary creatinine, salicylate and leukotriene levels were measured at the time of recruitment, end of week one and end of week two and the SNOT-22 questionnaire was filled out at the same time points. RESULTS A total of seven participants completed the study. There was no statistical difference in the urinary salicylate and leukotriene levels between the two diets; nevertheless, participants on low salicylate diet reported improved SNOT-22 symptoms scores (p = 0.04), mainly in the rhinologic, ear/facial, and sleep dysfunction symptom domains. In addition, these last two domains outcomes were more significant than the minimal clinically important difference. CONCLUSIONS A short-term low salicylate diet may not result in biochemical outcomes changes but seems to provide significant symptomatic relief for patients with AERD. TRIAL REGISTRATION NCT01778465 ( www.clinicaltrials.gov ).
-
7.
Aggressive fluid hydration plus non-steroidal anti-inflammatory drugs versus non-steroidal anti-inflammatory drugs alone for post-endoscopic retrograde cholangiopancreatography pancreatitis (FLUYT): a multicentre, open-label, randomised, controlled trial.
Sperna Weiland, CJ, Smeets, XJNM, Kievit, W, Verdonk, RC, Poen, AC, Bhalla, A, Venneman, NG, Witteman, BJM, da Costa, DW, van Eijck, BC, et al
The lancet. Gastroenterology & hepatology. 2021;(5):350-358
Abstract
BACKGROUND Pancreatitis is the most common complication of endoscopic retrograde cholangiopancreatography (ERCP). Prophylactic rectal administration of non-steroidal anti-inflammatory drugs (NSAIDs) is considered as standard of care to reduce the risk of post-ERCP pancreatitis. It has been suggested that aggressive hydration might further reduce this risk. Guidelines already recommend aggressive hydration in patients who are unable to receive rectal NSAIDs, although it is laborious and time consuming. We aimed to evaluate the added value of aggressive hydration in patients receiving prophylactic rectal NSAIDs. METHODS FLUYT, a multicentre, open-label, randomised, controlled trial done across 22 Dutch hospitals, included patients aged between 18 and 85 years with moderate to high risk of post-ERCP pancreatitis. Patients were randomly assigned (1:1) by a web-based module with varying block sizes to a combination of aggressive hydration and rectal NSAIDs (100 mg diclofenac or indomethacin; aggressive hydration group) or rectal NSAIDs (100 mg diclofenac or indomethacin) alone (control group). Randomisation was stratified according to treatment centre. Aggressive hydration comprised 20 mL/kg intravenous Ringer's lactate solution within 60 min from the start of ERCP, followed by 3 mL/kg per h for 8 h. The control group received normal intravenous saline with a maximum of 1·5 mL/kg per h and 3 L per 24 h. The primary endpoint was post-ERCP pancreatitis and was analysed on a modified intention-to-treat basis (including all patients who underwent randomisation and an ERCP and for whom data regarding the primary outcome were available). The trial is registered with the ISRCTN registry, ISRCTN13659155. FINDINGS Between June 5, 2015, and June 6, 2019, 826 patients were randomly assigned, of whom 388 in the aggressive hydration group and 425 in the control group were included in the modified intention-to-treat analysis. Post-ERCP pancreatitis occurred in 30 (8%) patients in the aggressive hydration group and in 39 (9%) patients in the control group (relative risk 0·84, 95% CI 0·53-1·33, p=0·53). There were no differences in serious adverse events, including hydration-related complications (relative risk 0·99, 95% CI 0·59-1·64; p=1·00), ERCP-related complications (0·90, 0·62-1·31; p=0·62), intensive care unit admission (0·37, 0·07-1·80; p=0·22), and 30-day mortality (0·95, 0·50-1·83; p=1·00). INTERPRETATION Aggressive periprocedural hydration did not reduce the incidence of post-ERCP pancreatitis in patients with moderate to high risk of developing this complication who routinely received prophylactic rectal NSAIDs. Therefore, the burden of laborious and time-consuming aggressive periprocedural hydration to further reduce the risk of post-ERCP pancreatitis is not justified. FUNDING Netherlands Organisation for Health Research and Development and Radboud University Medical Center.
-
8.
Randomized, double-blind, placebo-controlled clinical trial studying the effects of Turmeric in combination with mefenamic acid in patients with primary dysmenorrhoea.
Hesami, S, Kavianpour, M, Rashidi Nooshabadi, M, Yousefi, M, Lalooha, F, Khadem Haghighian, H
Journal of gynecology obstetrics and human reproduction. 2021;(4):101840
Abstract
Primary dysmenorrhea (PDM) is one of the common complaints in women. This study aimed to assess the effects of turmeric and mefenamic acid and a combination compared with placebo on PDM. This clinical trial was conducted on dormitory students with PDM. Subjects completed the visual analog scale (VAS) before randomization. One hundred twenty-eight patients, randomly assigned to one of following groups: Turmeric group (n=32), mefenamic acid group (n=32), turmeric and mefenamic acid group (n=32), and placebo group (n=32). Turmeric and mefenamic acid were administrated in 500mg and 250mg, respectively. Pain severity was assessed in the baseline and the end line by VAS. Statistical analysis was performed using SPSS software. The combination of turmeric and mefenamic acid, dramatically, alleviated pain in comparison to other groups. Our results illustrated that combination of turmeric and mefenamic acid would be better in pain alleviation in PDM.
-
9.
Comparison of intradermal mesotherapy with systemic therapy in the treatment of low back pain: A prospective randomized study.
Akbas, I, Kocak, AO, Kocak, MB, Cakir, Z
The American journal of emergency medicine. 2020;(7):1431-1435
Abstract
INTRODUCTION Musculoskeletal pain such as low back pain (LBP) are routinely encountered in the ED and contribute to ED overcrowding. The aim of our study was to compare the efficiency of mesotherapy with systemic therapy in pain control in patients with lumbar disk herniation. METHODS We conducted this prospective parallel randomized controlled trial with the patients admitted to the emergency department with low back pain related to herniated lumbar disk. Mesotherapy was performed to one group, while intravenous dexketoprofen was administered to the control group. Changes in pain intensity at 15th minute, 30th minute, 60th minute and 24th hours after treatment using Visual Analogue Scale (VAS), need to use analgesic drug within 24 h after treatment, and adverse effect of the treatment methods were compared between groups. RESULTS The decreases in pain intensity were statistically significantly higher in mesotherapy group for all time intervals. The need to use analgesics was statistically significantly three fold higher in the systemic therapy group. There was no statistically significant difference in having any adverse effect between study groups during one-week follow-up period. CONCLUSIONS Changes in medical practices, from the systemic administration of NSAIDs to the minimally invasive techniques such as mesotherapy with potent efficacy and minimal side effects, may enhance the ability of EDs to meet the waiting time targets and improve patient's satisfaction.
-
10.
Topical Ketoprofen Versus Placebo in Children Presenting With Ankle Sprain to the Emergency Department: A Randomized Controlled Study.
Serinken, M, Eken, C, Tünay, K, Gölcük, Y
Pediatric emergency care. 2020;(8):e447-e450
Abstract
OBJECTIVE Despite the favorable data concerning topical agents use in outpatient clinics, they are not commonly in emergency departments (EDs). The present study aimed to compare the effect of 2.5% topical ketoprofen (gel form) to placebo in children presenting with ankle sprain to the ED. STUDY DESIGN Children between 7 and 18 years old presenting with ankle sprain composed the study population. Study patients were randomized into 2 study arms: 2.5% ketoprofen gel and placebo administered in a 5-cm area locally. Pain improvements at 15 and 30 minutes were measured by visual analog scale. RESULTS Median pain reductions at 15 minutes for ketoprofen and placebo groups were 27.5 (16-39) and 5 (4-10), respectively. Median changes in pain intensity at 30 minutes for ketoprofen and placebo gel groups were 48 (43-52) and 9 (6-16), respectively. When compared 2 arms for the pain improvement at 15 and 30 minutes, the differences between 2 study drugs were 20 (13-28) and 35 (29-41), respectively. There were 7 (12.7%) rescue drug needs in the placebo group and 1 (1.7%) in the ketoprofen group (difference, 10.9%; 95% confidence interval, -6% to 7%; P = 0.83). There were no adverse effects in either group. CONCLUSIONS Ketoprofen gel is superior to placebo in ceasing pain in children presenting with ankle sprain to the ED with a high safety profile.