Medication discrepancies identified by medication reconciliation among patients with acute coronary syndrome.

Medication errors such as medication discrepancies are known as one of the leading cause of death. Medication discrepancies mostly occur during admission and at time transfer of care and discharge. Medication reconciliation process has pivotal role to avert medication discrepancies and improve patient safety and quality. Patients with acute coronary syndrome (ACS) are prone to medication discrepancies due to acute manifestations, simultaneous use of different medicines and having different co-morbidities. This study aimed to determine medication discrepancies identified by medication reconciliation among patients with ACS. In an observational study, patients with ACS admitted to a specialized Hospital in Baneh County, Kurdistan province during September 2023 and January 2024 were included. Medication reconciliation process was done when the patient was admitted. The history of medicine use was collected through interviews with the patient, their caregivers, as well as observing the medicines that were accompany with the patients. Number and type of unintentional medication discrepancies and related factors were evaluated. A total of 280 ACS patients (mean age: 63.8 ± 14.2, male gender: 59.3%) were included in the study. About 68% had at least 2 underlying diseases. The mean daily medicines taken by the patients during admission were 8.5 ± 1.54. The number (percentage) of unintentional inconsistency was observed in 78 (27.3%), and omission (39.7%) and changes in dosage (20.5%) had the highest frequency of unintentional medication discrepancies, respectively. Cardiovascular agents such as anti-dyslipidemia and antiplatelet had the highest frequency of unintentional medication discrepancies. The number of underlying diseases and daily medications before hospitalization increase the odds of discrepancies by 2.15 and 1.49 times, respectively (p-value < 0.05). Medication discrepancies identified by medication reconciliation among patients is relatively common. Unintentional medication discrepancies that have the potential to harm the ACS patients should be given more attention, especially in patients with multiple comorbidities and polypharmacy.

Evaluation of the sedative effect of sublingual lorazepam versus placebo in patients underwent endoscopy: a double-blind, randomized controlled clinical trial.

Background: Digestive endoscopy (DE) is uncomfortable for most patients. Lorazepam is a potent benzodiazepine with anxiolytic and sedative effects. Objective: This study aims to determine the sedative effect of sublingual lorazepam versus placebo as a premedication in patients who underwent DE. Design: This is a mono-center, double-blind, and randomized controlled trial. Methods: A lorazepam sublingual tablet was made by researchers and physical tests were done on it, then the double-blind placebo-controlled trial was done to investigate the efficacy of 2 mg sublingually administered lorazepam as a premedication for endoscopy. Lorazepam or a placebo tablet was administered sublingually 30 min before the endoscopy. The patients, nurses, and physicians were blinded to the patient group. The depth of sedation was evaluated according to the American Society of Anesthesiology. Results: In all, 116 patients were randomly assigned to take either lorazepam (n = 58) or a placebo (n = 58). The results of physical properties tests were acceptable according to United States Pharmacopeia. There were no statistical differences between groups regarding age and gender. In the lorazepam group, 75.8% of patients showed mild sedation, and 24.2% of patients showed no sedation. All of the patients in the placebo had no sedation (p = 0.001). Time of procedure (p < 0.001), intraoperative O2 saturation (p < 0.001), intraoperative heart rate (p < 0.001), and intraoperative blood pressure (p < 0.001) were significantly lower in the lorazepam group. No significant or dangerous side effects were observed except a bit of giddiness and dizziness. Conclusion: The results of this study showed that prescription of sublingual lorazepam 25-30 min before endoscopy provided mild sedation. Registration: IRCT201611039014N130 (05/11/2016); https://en.irct.ir/trial/9568.

Role of vitamin C and rectal indomethacin in preventing and alleviating post-endoscopic retrograde cholangiopancreatography pancreatitis: a clinical study.

BACKGROUND/AIMS: This study aimed to determine whether vitamin C in addition to indomethacin decreases the occurrence and severity of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) occurrence and severity. METHODS: This randomized clinical trial included patients undergoing ERCP. The participants were administered either rectal indomethacin (100 mg) plus an injection of vitamin C (500 mg) or rectal indomethacin (100 mg) alone just before ERCP. The primary outcomes were PEP occurrence and severity. The secondary amylase and lipase levels were determined after 24 hours. RESULTS: A total of 344 patients completed the study. Based on intention-to-treat analysis, the PEP rates were 9.9% for indomethacin plus vitamin C plus indomethacin and 15.7% for indomethacin alone. Regarding the per-protocol analysis, the PEP rates were 9.7% and 15.7% in the combination and indomethacin arms, respectively. There was a remarkable difference between the two arms in PEP occurrence and severity on intention-to-treat and per-protocol analyses (p=0.034 and p=0.031, respectively). The post-ERCP lipase and amylase concentrations were lower in the combination arm than in the indomethacin alone arm (p=0.034 and p=0.029, respectively). CONCLUSION: Vitamin C injection in addition to rectal indomethacin reduced PEP occurrence and severity.

Assessing the Risk of Nephrotoxicity Associated with Aminoglycosides in Brucellosis Patients: A Cross-sectional Study.

OBJECTIVE: The purpose of this study was to investigate renal function in patients with brucellosis before and at the end of gentamicin therapy. To ensure the safety of therapeutic doses of gentamicin, renal functions in brucellosis patients were monitored regarding drug serum levels and check for early detection biomarkers of nephrotoxicity. METHODS: In this cross-sectional study, 41 patients (25 men and 16 women, aged over 15 years) were included, with confirmed acute brucellosis that referred to Brucellosis Research Center in Hamadan, west of Iran between March 2018 to February 2019. At baseline before treatment (first step) and 7 days after gentamicin administration (second step), serum uric acid, blood urea nitrogen (BUN), serum and urine creatinine, erythrocyte sedimentation rate (ESR), quantitative C-reactive protein (CRP) and urinary ß2-microglobulin (ß2M) were measured. Gentamycin serum level due to the highest risk of nephrotoxicity with this drug in aminoglycoside class was also checked by HPLC method. The data were analyzed using SPSS version 22. RESULTS: The mean urinary ß 2M level, serum and urinary creatinine, uric acid, BUN, and quantitative CRP levels in the first step and second step, there were no statistical differences between the two steps. There was a correlation between urinary creatinine and ESR. In addition, a positive correlation was found between urinary ß2M and serum gentamicin level. ESR levels have been significantly reduced in the patients after the treatment compared to before it. CONCLUSION: Our findings confirm that gentamicin is safe at the dose of 5 mg/kg/day for one week intravenously in brucellosis patients.

Analgesic effect of curcumin topical formulation in knee osteoarthritis patients: a clinical trial.

OBJECTIVES: The aim of this study was to recognize the efficacy and safety of curcumin ointment on patients with knee osteoarthritis (OA) compare to diclofenac as standard medication. METHODS: The topical effects of curcumin (10%) and diclofenac (1%) ointments were assessed through the visual analog scale (VAS) and Western Ontario and McMaster Universities Arthritis (WOMAC) index after three times a day administration for two weeks in 60 patients. RESULTS: Desirable effects compared to the pre-treatment period were observed after two weeks of continuous treatment. Based on our results, VAS and WOMAC index were altered after treatment significantly (p<0.0001). CONCLUSIONS: Two-week use of curcumin ointment could ameliorate the pain, stiffness and function disability in patients with OA.

A Comprehensive Review of the Role of Complementary and Dietary Medicines in Eradicating Helicobacter pylori.

Antibiotic-resistant Helicobacter pylori isolates have become a global concern. The standard triple or quadruple therapies have recently become the most effective protocol for eradicating H. pylori in the gastrointestinal tract. There is evidence regarding the impact of different complementary or dietary supplements on H. pylori eradication. This review article intended to search electronic bibliographic databases for any clinical studies that evaluated the use of any herbal or dietary supplements to eradicate H. pylori up to June 2021. A total of 20 human studies met our criteria and were reviewed. Although some herbal medicines have shown their efficacy and safety in eradicating H. pylori in different clinical trials, more randomized blind, placebo-controlled human trials with a large sample size must be performed to extend our knowledge.

Post marketing new adverse effects of oral therapies in multiple sclerosis: A systematic review.

BACKGROUND: There is a lack of safety information about the post-marketing adverse effects of several disease-modifying drugs (DMDs) used to control multiple sclerosis (MS). Investigating the post-marketing side effects is required to manifest the safety of the appropriate therapy. Therefore, the present systematic review aimed to identify disease-modifying drugs used to control multiple sclerosis attacks and progress. METHODS: The Web of Science, PubMed, and Scopus databases were searched for studies published until November 2020 based on the research strategy terms. Inclusion criteria involved all full texts exploring disease-modifying drugs used to control multiple sclerosis based on case reports and case series studies. The Joanna Briggs Institute (JBI) critical appraisal checklist was used to assess the quality of case report studies. RESULTS: In total, 25 articles that met the criteria for inclusion were retrieved in the present systematic review. The most side effects were observed with fingolimod and teriflunomide, respectively, while dimethyl fumarate had minor side effects. CONCLUSION: The oral therapies have some significant post-marketing adverse effects that have been diagnosed in numerous case reports. Some of them are serious and must be noticed by neurologists. Accordingly, in this review, we assessed the post-marketing adverse effects of oral therapies for multiple sclerosis.

Functionalized Nanostructured Bioactive Carriers: Nanoliposomes, Quantum Dots, Tocosome, and Theranostic Approach.

BACKGROUND: Lipid nanocarriers have great potential for the encapsulation and delivery of numerous bioactive compounds. They have demonstrated significant benefits over traditional disease management and conventional therapy. The benefits associated with the particular properties of lipid nanocarriers include site-specific drug deposition, improved pharmacokinetics and pharmacodynamics, enhanced internalization and intracellular transport, biodegradability, and decreased biodistribution. These properties result in the alleviation of the harmful consequences of conventional treatment protocols. MATERIALS & METHODS: The administration of various bioactive molecules has been extensively investigated using nanostructured lipid carriers. In this article, theranostic applications of novel formulations of lipid nanocarriers combined or complexed with quantum dots, certain polymers, such as chitosan, and metallic nanoparticles (particularly gold) are reviewed. These formulations have demonstrated better controlled release features, improved drug loading capability, as well as a lower burst release rate. As a recent innovation in drug delivery, tocosomes and their unique advantages are also explained in the final section of this review. RESULTS AND CONCLUSION: Theranostic medicine requires nanocarriers with improved target-specific accumulation and bio-distribution. To this end, lipid-based nanocarrier systems and tocosomes combined with unique properties of quantum dots, biocompatible polymers, and metallic nanoparticles seem to be ideal candidates to be considered for safe and efficient drug delivery.

Benefits and Risks of Melatonin in Hepatic and Pancreatic Disorders; A Review of Clinical Evidences.

Melatonin is the "clock factor" produced from the pineal gland dominating regular circadian rhythm in mammalians. It is an indoleamine with potent multifunctional pharmacological effects, both receptor dependent and non-receptor dependent effects, including antioxidant and anti-inflammatory activities. The aim of this review is to summarize clinical evidence related to melatonin's effectiveness in the treatment of liver and pancreas diseases. Databases including PubMed, Scopus, and Cochran Library were searched up to November 2020.Finally, this review has summarized up-to-date clinical evidence to investigate the efficacy and safety of melatonin for the management of liver and pancreas diseases. Melatonin has been demonstrated to have beneficial effects on the management of Non-alcoholic fatty liver disease (NAFLD), sleep disturbance of cirrhotic patients, prevention of drug/poison induced liver toxicity,and prevention of post endoscopic retrograde cholangiopancreatography pancreatitis (PEP);more data is needed to recommend melatonin administration in the treatment of mentioned disorders.

Antioxidative effects of silymarin on the reduction of liver complications of fingolimod in patients with relapsing-remitting multiple sclerosis: A clinical trial study.

Multiple sclerosis (MS) is a chronic disease that affects the central nervous system and is characterized by inflammation, demyelination, and degenerative changes. Relapsing-remitting MS (RRMS) is the most common form of MS. Fingolimod (FTY720) is a once-daily disease-modifying agent approved to treat RRMS, and it binds to sphingosine 1-phosphate receptors. Milk thistle (silybum marianum; SM) is an herb generally used to protect the liver with antioxidant and antifibrotic effects. The purpose of this study was to evaluate the effects of silymarin on reducing liver complications of FTY720 in patients with RRMS and decrease the oxidative stress that plays an important role in the pathogenesis of this disease. Forty-eight patients with RRMS were divided into two groups using random assignment: the placebo and drug-treated groups. Participants of intervention and control groups took FTY720 with silymarin and placebo without silymarin per day for six months. Findings showed a significant reduction in the level of ALT and AST, reduction of main pathogenic factors in MS containing malondialdehyde, and also a significant rise in total antioxidant capacity, and total thiol groups in the serum of patients treated with silymarin as compared with the placebo group. Our outcomes propose the practical effects of silymarin in multiple sclerosis and reduction of hepatic side effects of fingolimod.

Clinical and phytochemical studies of Plantago major in pressure ulcer treatment: A randomized controlled trial.

BACKGROUND: Plantago major L. is used by local people to improve various wounds and lesions such as pressure ulcer. In this study, the therapeutic effects of P. major topical formulation on the stage 1 pressure ulcer in patients have been investigated. MATERIALS AND METHODS: This randomized triple blind clinical trial study was performed on 130 patients. During the 14 days of study, each of the test and control groups was checked according to check list. Also the topical formulation was standardized by HPLC based on the amount of quercetin. RESULTS: The findings of this study indicated a significant difference in resolution of the damage between the test and control groups. Topical formulation was standardized by HPLC based on the quercetin (1.88 mg/100g) and no side effects associated with this topical formulation was found. CONCLUSION: The results confirmed the traditional use of P. major in resolution of the damage. CLINICAL TRIAL ID: (IRCT201609209014N117).

Pentoxifylline Attenuates Arsenic Trioxide-Induced Cardiac Oxidative Damage in Mice.

This study was undertaken to evaluate the therapeutic potential effect of pentoxifylline (PTX) against arsenic trioxide (ATO)-induced cardiac oxidative damage in mice. Thirty-six male albino mice were divided into six groups and treated intraperitoneally with normal saline (group 1), ATO (5 mg/kg; group 2), PTX (100 mg/kg; group 3), and different doses of PTX (25, 50, and 100 mg/kg; groups 4, 5, and 6, respectively) with ATO. After four weeks, the blood sample was collected for biochemical experiments. In addition, cardiac tissue was removed for assessment of oxidative stress markers and histopathological changes (such as hemorrhage, necrosis, infiltration of inflammatory cells, and myocardial degeneration). The findings showed that ATO caused a significant raise in serum biochemical markers such as lactate dehydrogenase (LDH), creatine phosphokinase (CPK) and troponin-I (cTnI), glucose, total cholesterol (TC), and triglyceride (TG) levels. In addition to histopathological changes in cardiac tissue, ATO led to the significant increase in cardiac lipid peroxidation (LPO) and nitric oxide (NO); remarkable decrease in the activity of cardiac antioxidant enzymes such as catalase (CAT), superoxide dismutase (SOD), and glutathione peroxidase (GPx); and the depletion of the total antioxidant capacity (TAC) and total thiol groups (TTGs). PTX was able to reduce the increased levels of serum cardiac markers (LDH, CPK, cTnI, TC, and TG), cardiac LPO, and improve antioxidant markers (TAC, TTGs, CAT, SOD, and GPx) alongside histopathologic changes. However, no significant changes were observed in elevated serum glucose and cardiac NO levels. In conclusion, the current study showed the potential therapeutic effect of PTX in the prevention of ATO-induced cardiotoxicity via reversing the oxidative stress.

Homocysteine-Lowering Interventions in Chronic Kidney Disease.

The incidence of cardiovascular events and mortality is higher in patients with chronic kidney disease (CKD) compared to the general population. Homocysteine (Hcy) appears to be an independent risk factor for cardiovascular diseases in general populations and patients with CKD. Further, hyperhomocysteinemia can cause endothelial damage and increase the activity and production of coagulation factors, and its prevalence among patients with end-stage renal disease is approximately 85%-100%. Most treatments, which lower Hcy levels and have been considered in previous studies, include folic acid, B vitamins, omega-3 fatty acids, and N-acetylcysteine. However, the effect of therapies that can decrease Hcy levels and thus cardiovascular events in these patients is still unclear. The results are conflicting and require further investigation. To guide treatment decisions and improve patient outcomes, multiple databases were searched, including Web of Science, PubMed, and Medline to summarize the available evidence (i.e., clinical trial and meta-analyses) on Hcy-lowering interventions and cardiovascular events.

Potential Benefits of Selenium Supplementation in Patients with Kidney Disease.

Trace element deficiency is common among patients with end-stage renal disease (ESRD); the reason is that since these patients undergo dialysis, they lose these elements more than healthy people, and also the use of trace elements is restricted due to loss of appetite. Selenium (Se) is a trace element that is essential for the oxidative stress defense system. Se deficiency leads to some complications similar to those often seen in ESRD patients, such as all-cause mortality due to cardiovascular diseases, bone loss, uric acid elevation, and anemia. This article aims to review the evidence on consequences of Se deficiency in ESRD patients, as well as effects of Se supplementation in hemodialysis patients. Multiple databases were searched to summarize the available evidence on selenium's role in kidney diseases. Since the complications of ESRD and those of Se deficiency are mostly similar, this triggers the idea that Se deficiency may be considered as a cause of these problems, but it needs to be more assessed that Se deficiency is a single factor or there are other factors participated in. Also the role of Se supplementation on resolving the mentioned complications, needs to be more studied through welldesigned clinical studies.

Therapeutic Potential of Dihydropyridine Calcium Channel Blockers on Oxidative Injury Caused by Organophosphates in Cortex and Cerebellum: An In Vivo Study.

This study was designed to investigate the effects of amlodipine (AM), a dihydropyridine calcium channel blocker, on the oxidative damage induced by diazinon (DZN) in the rat cortex and cerebellum. Forty-two rats were randomly divided into six groups. The rats were treated intraperitoneally with normal saline (group 1), AM (9 mg/kg; group 2), DZN (32 mg/kg; group 3) and different doses of AM (3, 6, and 9 mg/kg; groups 4, 5, and 6, respectively) with DZN. After 14 days, the cerebellum and cortex tissues were removed for biochemical and histological experiments. DZN significantly decreased acetylcholinesterase activity (AChE; 57%, p < 0.001 and 39.1%, p < 0.05), depleted total antioxidant capacity (TAC; 46.2%, p < 0.01 and 44.7%, p < 0.05), and increased lactate dehydrogenase activity (LDH; 96%, p < 0.001 and 202%, p < 0.001), nitric oxide (NO; 130%, p < 0.001 and 74.4%, p < 0.001), and lipid peroxidation levels (LPO; 35.6%, p < 0.001 and 128.7%, p < 0.001), in the cerebellum and cortex tissues, respectively. In addition, DZN induced structural alterations in the cerebellum and cortex. Following AM administration, a remarkable improvement was observed in LDH activity and some of the oxidative markers, such as NO and LPO; however, no significant changes were found in AChE activity when the DZN group was compared with the AM-treated groups. This study suggests that AM may prevent DZN-induced neurotoxicity via improvement of the oxidative/antioxidant balance in the cerebellum and cortex tissues.

Evaluation of drug interventions for the treatment of sleep disorders in children with autism spectrum disorders: a systematic review.

A structured review study of drug interventions on sleep disorders in patients with autism spectrum disorders (ASD) has not been published to date. This systematic review aimed to investigate drug interventions for the treatment of sleep disorders in children with ASD. The Web of Science, PubMed, and Scopus databases were searched until March 2019. Study quality was assessed using the Delphi checklist. Due to the heterogeneity of the findings, a meta-analysis was not possible. Drug interventions for the treatment of sleep disorders in patients with ASD included melatonin, atomoxetine, and risperidone. Atomoxetine had no effect on sleep disorders in patients with ASD. A total of 10 studies were reviewed. Melatonin appears to be useful for the treatment of sleep problems in patients with ASD, but further studies are needed to determine the effects of other drugs.

Comparison of Sertraline with Rifampin in the treatment of Cholestatic Pruritus: A Randomized Clinical Trial.

BACKGROUND: Pruritus is one of the most common and disabling symptoms of liver disease such as Primary Sclerosing Cholangitis and Primary Biliary Cholangitis. Cholestyramine, rifampin, opioid antagonists, antihistaminic agents and SSRIs are used for the management of pruritus. Due to rifampin drug interactions as well as its serious side effects such as hepatotoxicity, clinicians are endeavoruing to find a safer and a more effective substitution. OBJECTIVE: The purpose of this study was to compare the efficacy and safety of sertraline with rifampin in the management of cholestatic pruritus. METHODS: In a single-blinded randomized clinical trial a total of 36 patients of PSC and PBC were divided into two equal groups, one group received 100 mg/day sertraline and the other group received rifampin 300 mg/day for 4 weeks. Visual analog scale was used to record pruritus severity at baseline and 4 weeks after drug intervention, also, ALT, AST, ALP and total bilirubin of all patients were measured at three different time points. RESULTS: Over the follow-up period, pruritus had relieved in both groups, but there was no significant differences between sertraline and rifampin in pruritus management (pvalue=0.740), also there was no significant difference between the two intervention strategies (A versus B) in total bilirubin level (pvalue=0.106). Moreover, the ALT, AST and ALP levels were found to be significantly different between the two groups (Pvalue˂0.01). CONCLUSION: There is no difference between sertraline and rifampin in pruritus improvement, but sertraline has less adverse effects on hepatobiliary enzyme levels, so it seems to be safer than rifampin.

A Pilot Study to Evaluate the Effects of Oral N-Acetyl Cysteine on Inflammatory and Oxidative Stress Biomarkers in Rheumatoid Arthritis.

BACKGROUND: Rheumatoid Arthritis (RA) is a common inflammatory disease of the joints. Due to the importance of inflammation and oxidative stress in the pathogenesis of RA, drugs that have anti-oxidant and anti-inflammatory properties, such as N-acetyl Cysteine (NAC), can be used as adjunctive therapy in patients with RA. AIMS: The aim of this study was to evaluate the effects of oral NAC on inflammatory cytokines and oxidative stress in patients with RA. METHODS: Adjunct to standard treatment, the NAC group (23 patients) received 600 mg of NAC twice daily and the placebo group (19 patients) received identical placebo twice daily for 12 weeks. Serum levels of Total Oxidant Status (TOS), Total Antioxidant Capacity (TAC), nitric oxide (NO), Total Thiol Groups (TTG), Malondialdehyde (MDA), tumor necrosis factor-alpha (TNF-α), interleukin- 6 (IL-6), C-reactive Protein (CRP), and Erythrocyte Sedimentation Rate (ESR) were measured at baseline and at the end of the study. RESULTS: Results showed that in the NAC group, the serum levels of MDA, NO, IL-6, TNF-α, ESR and CRP were significantly lower than the baseline. Also, the serum level of TAC and TTG, as antioxidant parameters, increased significantly. However, only NO, MDA and TTG showed a significant difference in the NAC group as compared to the placebo group at the end of study. CONCLUSION: According to the results of this study, oral NAC can significantly reduce the several oxidative stress factors and inflammatory cytokines. These results need to be confirmed in larger studies while considering clinical outcomes of RA patients.

A comparative study on the effect of "black cohosh" and "evening primrose oil" on menopausal hot flashes.

INTRODUCTION: Hot flashes are considered to be a common experience for menopausal women and they can compromise the quality of life. The objective of this study is to assess the efficacy of Cimicifuga racemosa in comparison with evening primrose oil (EPO) in postmenopausal women with menopause-related symptoms. MATERIALS AND METHODS: This study was performed on 80 postmenopausal women with hot flashes. The participants were randomly divided into two groups by blocked randomization. The participants of one group received black cohosh and the other group received EPO for 8 weeks. The severity and number of hot flashes and quality of life were measured by four-point scale, and the Menopause-Specific Quality of Life (MENQOL) questionnaire at pre-intervention, 1st, 4th, and 8th weeks after treatment. Data were analyzed in SPSS Version 16 using independent t-test, Chi-square, and Fisher's exact test. RESULTS: Average severity of hot flashes in both groups and number of hot flashes in black cohosh group in 8th week were significantly lower than 1st week (P < 0.001), but number of hot flashes in primrose oil group in 8th week showed no significant differences (P = 0.32). The number of hot flashes and quality of life score in black cohosh arm compared to EPO showed a significant decrease in the 8th week (P < 0.05). All MENQOL scores were significantly improved in two groups (P < 0.05), but the percentage of improvement in black cohosh arm was significantly superior to EPO group. CONCLUSION: Both herbs were effective in reduction of severity of hot flashes and improvement of the quality of life, but it seems that black cohosh is more effective than primrose oil because it was able to reduce the number of hot flashes too.

Evaluating the Effect of Oral N-acetylcysteine as an Adjuvant Treatment on Clinical Outcomes of Patients with Rheumatoid Arthritis: A Randomized, Double Blind Clinical Trial.

OBJECTIVE: Oxidative stress and Overproduction of pro-inflammatory cytokines are contributed in Rheumatoid Arthritis (RA) pathogenesis. N-acetylcysteine (NAC) is an antioxidant and antiinflammatory agent which demonstrated analgesic effects in some studies. This study is designed to assess the effects of oral NAC as an adjuvant therapy on the clinical outcomes of patients with active RA. METHODS: In this randomized clinical trial, 51 RA patients with active RA were studied in 2 groups: NAC group (27 patients) received standard treatment of RA and 600 mg NAC twice a day for 12 weeks, and placebo group (24 patients) received the standard treatment of RA and placebo. Disease activity score (DAS28) was used to assess the activity of RA, Visual Analog Scale (VAS) for the severity of pain, Health Assessment Questionnaire (HAQ) for the patients' physical performance, and Global Health (GH) parameter for the patients' assessment of their disease activity. The number of tender and swollen joints and Erythrocyte Sedimentation Rate (ESR) were also determined for each patient. Data were analyzed using SPSS version 16.0 (Chicago, IL, USA). RESULTS: After 12 weeks of intervention, there were no significant differences between two groups in DAS28 score and ESR (P values were 0.4 and 0.6, respectively). However, GH, VAS, and HAQ scores were improved significantly in the NAC group compared to the placebo group. CONCLUSION: Our findings indicate that oral administration of NAC may be associated with improving health status in RA patients and considered as an adjuvant therapy in these patients. Further studies with larger sample size, longer study duration and higher doses of NAC are needed to confirm the effects of oral NAC in RA patients.