Publications by authors named "Pooneh Salari"

32 Publications

Publication Trend in Islamic Medical Ethics in Iran and the World: Designing a Road.

J Relig Health 2021 Apr 5;60(2):941-960. Epub 2021 Jan 5.

Medical Ethics and History of Medicine Research Center, Tehran University of Medical Sciences, 23# 16 Azar Ave, Keshavarz Blvd, 1417633114, Tehran, Iran.

This study aimed at determining the publication trend in Islamic medical ethics; finally, a road map was designed. All published English and Persian papers in Islamic medical ethics were searched until June 2017. Finally, 971 English papers and 204 Persian papers were analyzed. Our results show that publication in Islamic medical ethics started in 1973. The beginning of life was considered the most favorable subject followed by public health and biotechnology by both Iranian and non-Iranian scholars. Taken together, the publication trend in Islamic medical ethics has experienced ups and downs and is not as satisfactory as it should be.
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http://dx.doi.org/10.1007/s10943-020-01154-wDOI Listing
April 2021

Priority setting for research in the field of medical ethics in the Islamic Republic of Iran: a Delphi study.

East Mediterr Health J 2020 May 21;26(5):531-538. Epub 2020 May 21.

Medical Ethics and History of Medicine Research Center.

Background: Priority-setting is one way to develop research in a particular field.

Aims: We aimed to identify and prioritize the most important medical ethics issues for research in the Islamic Republic of Iran.

Methods: A 3-round Delphi survey was conducted using a questionnaire covering 77 medical ethics topics in 10 categories and subcategories (extracted from literature review); this was emailed to 40 experts in medical ethics. The participants rated categories and subcategories for importance on a 5-point Likert scale and ranked the topics based on their research priorities. The highest Likert score showed the most important issue and the lowest priority score indicated the first priority.

Results: After consensus, the panel identified 6 categories as the highest priority and most important areas: professionalism [priority score = 2.66, standard deviation (SD) 2.63, importance score = 4.45, SD 0.72], education (priority score=3.12, SD 1.89, importance score = 4.25, SD 0.84), end of life (priority score = 3.79, SD 1.91, importance score = 4.47, SD 0.66), beginning of life (priority = 4.62, SD 1.68, importance score= 4.26, SD 0.61), public health (priority score = 5.20, SD 2.39, importance score = 4.29, SD 0.75), and ethics in research (priority score = 5.33, SD 1.97, importance score = 4.34, SD 0.64).

Conclusion: The rankings for priority and importance was not the same. Our results highlight a lack of applicable knowledge in the areas of professionalism and end of life. This study could be used as a foundation for developing further investigations by ensuring the most appropriate use of limited resources.
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http://dx.doi.org/10.26719/emhj.19.085DOI Listing
May 2020

COVID-19 and off label use of drugs: an ethical viewpoint.

Daru 2020 Dec 8;28(2):789-793. Epub 2020 May 8.

Medical Ethics and History of Medicine Research Center, Tehran University of Medical Sciences, 23# 16 Azar Ave, Keshavarz Blvd, Tehran, Iran.

Background: The COVID-19 outbreak is rapidly spread over the world and kills infected patients. There is no proven medication for its treatment, so, all of the medications used for treatment are considered to be off-label. Off-label uses are not under regulation in the outbreak because there is no specific regulation for this condition.

Objectives: In this short communication we aim at describing two ways of off-label use as clinical practice or investigational use. Further, we will describe the third way of off-label use, we named it pseudo-research and then we will state the most possible ethical challenges of off-label use for better perceptions and responsibility.

Results: The WHO considers off-label uses as country-specific. All international regulatory bodies consider off-label prescription as the physician's responsibility and legal by necessitating some requirements. There is no international guideline for regulating investigational off-label uses as clinical practice.

Conclusion: There are different types of approaches, none of them is comprehensive and conclusive. Furthermore, respecting the four ethical principles necessitates codification and strict regulation of off-label uses either as clinical practice or investigational. Besides, compilation of a special guideline based on ethical principles especially non-maleficence and autonomy for investigational off-label uses in disasters is highly recommended.
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http://dx.doi.org/10.1007/s40199-020-00351-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7207985PMC
December 2020

Challenges of Confidentiality in Clinical Settings: Compilation of an Ethical Guideline.

Iran J Public Health 2018 Jun;47(6):875-883

Medical Ethics and History of Medicine Research Center, Tehran University of Medical Sciences, Tehran, Iran.

Background: Respecting patients confidentiality and privacy are considered as the patients' rights. Confidentiality is the key virtue for trust building in physician-patient relationship. While law considers confidentiality as absolute except for legal situations, despite efforts to maintaining confidentiality, sometimes breaching confidentiality is unavoidable but not necessarily unethical. There is no Iranian unified ethical guideline to define clear approaches to patient confidentiality in clinical setting. To keep all medical data confidential it is necessary to identify the scope of the problem. In this study, we aimed at identifying the scope of the problem.

Methods: This study was conducted in three phases including literature review, qualitative study (semi-structured interview) and focus group discussion. The literature review provided a framework for the second phase.

Results: The content analysis of the interviews presented 3 main themes indicating problems in maintaining confidentiality in clinical setting including management issues, organizational ethics and physician-patient relationship.

Conclusion: Based on the results a draft guideline in confidentiality in clinical setting was prepared and finalized in focus groups discussions.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6077627PMC
June 2018

Assessment of Pharmacists Experiences and Attitudes Toward Professionalism and its Challenges in Pharmacy Practice.

Iran J Pharm Res 2018 ;17(Suppl):168-177

Medical Ethics and History of Medicine Research Center, Tehran University of Medical Sciences.

Nowadays pharmacists should be involved in patients care and providing pharmaceutical care more than before, but still there is a gap between standard of care and pharmacy practice in pharmacies. In this study we aimed at evaluating the pharmacists experiences and attitudes about ethical professional practice in pharmacies. The study was conducted in the Tehran University of Medical Sciences, Tehran, Iran. This study performed as a mixed method study including 12 semi-structured interviews and two focus group discussions (FGDs). All interviews and FGDs were recorded verbatim. The study evaluates the pharmacy practice based on the Code of Ethics for National Pharmaceutical System requirements. Our study presents the pharmacists ethical challenges in 14 areas of practice such as lack of proper pharmacists-patients and inter and intra-professional relationship; poor management of medication error; lack of pharmacists awareness about their responsibilities, professional rules and regulations; non-OTC drug dispensing without prescription; no collaboration with custodian organizations; dissatisfaction from profession; financial problems; mismanagement in confronting with ads and offers of pharmaceutical companies, and conflict of interest; and uneven drug distribution during shortage. For providing standard pharmaceutical care modification of infra structures, educational system and regulations in pharmaceutical system is highly recommended.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5958337PMC
January 2018

Pharmacokinetic Behavior of Phenytoin in Head Trauma and Cerebrovascular Accident Patients in an Iranian Population.

J Res Pharm Pract 2017 Oct-Dec;6(4):217-222

Department of Clinical Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.

Objective: Acute brain injury is one of the leading causes of morbidity and mortality worldwide. Phenytoin has been commonly used as an anticonvulsant agent for the treatment or prophylaxis of seizures following acute brain injury. After a severe head injury, several pharmacokinetic changes occur. The aim of this study is the comparative evaluation of phenytoin serum concentration in patients with traumatic and nontraumatic brain injury (TBI).

Methods: This prospective observational study was performed on twenty adult brain injury patients who were admitted to an Intensive Care Unit and required phenytoin for the treatment or prophylaxis of postinjury seizures. For all the patients, phenytoin serum concentration was determined in three scheduled time points. Phenytoin serum concentration and pharmacokinetic parameters were compared between patients with TBI and cerebrovascular accident (CVA).

Findings: The Vand Kwere significantly higher in head trauma (HT) patients than the CVA group. The phenytoin concentration (C) and the C/dose ratio were significantly higher in the CVA group patients during the first sampling ( < 0.05). The Acute Physiology and Chronic Health Evaluation П (APACHE П) score was significantly lower than the baseline at the end of the study in each group of patients ( < 0.05). In addition, no significant correlation was observed between V, K, C, C/dose ratio, and APACHE II scores at the time of sampling.

Conclusion: Due to significant differences in phenytoin plasma concentration and pharmacokinetic parameters between HT and CVA patients, close attention must be paid to the pharmacokinetic behavior of phenytoin in the efforts to improve the patient's outcome after a severe HT.
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http://dx.doi.org/10.4103/jrpp.JRPP_17_58DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5787907PMC
February 2018

To Tell, or Not to Tell; Confidentiality in an Iranian HIV Positive Patient: A Viewpoint.

J Family Reprod Health 2017 Mar;11(1):50-55

Medical Ethics and History of Medicine Research Center, Tehran University of Medical Sciences, Tehran, Iran.

Confidentiality is a basic concept in medical ethics and protecting confidentiality is considered as physicians' duty. In some occasions, this protection is in conflict with the right of the patient's sexual partner, who should be informed about the possibility of being infected. The sexual partner being pregnant, the situation is going to be more complicated. In this paper, we present a case discussion with special ethical, legal, social, cultural, and religious aspects. According to this informing sexual partner with the patient's assent, opt-out Human immunodeficiency virus (HIV) screening in pregnant women and enhancing psychosocial and family support are highly recommended. Strategic changes in health system policies and regulations seem to be necessary as well.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5664990PMC
March 2017

Hospital/clinical ethics committees' notion: an overview.

J Med Ethics Hist Med 2016 18;9:17. Epub 2016 Dec 18.

Associate Professor, School of Nursing, University of British Columbia, Vancouver, Canada.

Hospital ethics committees (HECs) help clinicians deal with the ethical challenges which have been raised during clinical practice. A comprehensive literature review was conducted to provide a historical background of the development of HECs internationally and describe their functions and practical challenges of their day to day work. This is the first part of a comprehensive literature review conducted between February 2014 and August 2016 by searching through scientific databases. The keyword ethics committee, combined with hospital, clinic, and institution, was used without a time limitation. All original and discussion articles, as well as other scientific documents were included. Of all the articles and theses found using these keywords, only 56 were consistent with the objectives of the study. Based on the review goals, the findings were divided into three main categories; the inception of HECs in the world, the function of HECs, and the challenges of HECs. According to the results, the Americas Region and European Region countries have been the most prominent considering the establishment of HECs. However, the majority of the Eastern Mediterranean Region and South-East Asia Region countries are only beginning to establish these committees in their hospitals. The results highlight the status and functions of HECs in different countries and may be used as a guide by health policymakers and managers who are at the inception of establishing these committees in their hospitals.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5432947PMC
December 2016

Coronary Artery Calcium Score and Bone Metabolism: A Pilot Study in Postmenopausal Women.

J Bone Metab 2017 Feb 28;24(1):15-21. Epub 2017 Feb 28.

Department of Epidemiology, Center for Academic and Health Policy, and Knowledge Utilization Research Center, Tehran University of Medical Sciences, Tehran, Iran.

Background: Since 1991 many studies evaluated the link between cardiovascular diseases and osteoporosis, two age-related conditions, but the main common pathologic pathway has not been determined yet. The histological similarity between arterial calcified plaque and bone matrix and involvement of similar cells and mediators provide a special field of research. Therefore in the present study, we aimed to evaluate the relationship between coronary artery calcium score (CACS) as a surrogate marker of atherosclerosis and bone mediators and parameters in postmenopausal women.

Methods: Eleven postmenopausal women who had CACS higher than 80 were enrolled into the study and underwent bone densitometry. In addition, their serum and urine samples were taken for measuring osteoprotegerin, osteocalcin, and β cross laps. Patients' 10-year probability of fracture was calculated by the World Health Organization fracture-risk assessment tool (FRAX).

Results: The regression analysis of our results showed the association between CACS and OC (std β=0.66, 95% confidence interval [CI] 5.47-72.27, =0.027), femoral bone density (std β=-0.6, 95% CI -6864.34-14.27, =0.05) and T-score (std β=-0.6, 95% CI -773.08-1.28, =0.05) which remained significant after adjustment for age, weight, years since menopause and body mass index. No association was found between CACS and osteoprotegerin, spinal bone density and FRAX score.

Conclusions: In conclusion, this pilot study with small sample size showed the potential association between CACS and osteocalcin, femoral bone density and T-score. However, the relationship between CACS and osteoprotegerin, receptor activator of nuclear factor-kappa B ligand, FRAX score and other bone parameters remain to be clarified in larger sample size studies.
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http://dx.doi.org/10.11005/jbm.2017.24.1.15DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5357608PMC
February 2017

Ethical Issues Surrounding Personalized Medicine: A Literature Review.

Acta Med Iran 2017 Mar;55(3):209-217

Endocrinology and Metabolism Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical.

More than a decade ago, personalized medicine was presented in modern medicine. Personalized medicine means that the right drug should be prescribed for the right patient based on genetic data. No doubt is developing medical sciences, and its shift into personalized medicine complicates ethical challenges more than before. In this review, we categorized all probable ethical considerations of personalized medicine in research and development and service provision. Based on our review, extensive changes in healthcare system including ethical changes are needed to overcome the ethical obstacles including knowledge gap and informed consent, privacy and confidentiality and availability of healthcare services. Furthermore social benefit versus science development and individual benefit should be balanced. Therefore guidelines and regulations should be compiled to represent the ethical framework; also ethical decision making should be day-to-day and individualized.
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March 2017

New horizons in treatment of osteoporosis.

Daru 2017 Feb 7;25(1). Epub 2017 Feb 7.

Endocrinology and Metabolism Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Fifth floor, Dr.Shariati Hospital, North Kargar Ave, Tehran, 14114, Iran.

Background: Prevalence of osteoporosis is increasing both in developed and developing countries. Due to rapid growth in the burden and cost of osteoporosis, worldwide, it seems reasonable to focus on the reduction of fractures as the main goal of treatment. Although, efficient pharmacological agents are available for the treatment of osteoporosis, there still remains a need to more specific drugs with less adverse effects.

Main Body: This review article provides a brief update on the pathogenesis, presenting current pharmacological products approved by the US Food and Drug Administration (FDA) or Europe, and also newer therapeutic agents to treat osteoporosis according to the clinical trial data available at PubMed, UpToDate, International Osteoporosis Foundation (IOF), and clinical practice guidelines. As well, the effect of combination therapy and recommendations for future research will be further discussed.

Short Conclusion: The use of current antiresorptive and anabolic agents alone or in combinations for the treatment of osteoporosis entails several limitations. Mainly, their efficacy on non-vertebral fracture reduction is lower than that observed on vertebral fracture. In addition, they have potential adverse events on long time usage. Development of newer agents such as cathepsin k inhibitor and strontium ranelate not only have increased the available options for treating osteoporosis, but also have opened doors of opportunity to improvements in the effective treatment. However, the high cost of new agents have restricted their usage in selective patients who are at high risk of fracture or whom failed response to first line treatment options. Thus, personalized medicine should be considered for future evaluation of genetic risk score and also for environmental exposure assessment. In addition to permanent attention to early diagnosis of osteoporosis and understanding of the pathophysiology of osteoporosis for novel approach in drug discovery, there seems a need to more well-designed clinical trials with larger sample sizes and longer duration on current as well as on newer agents. Also, continuous research on plant-derived components as the source of discovering new agents, and conducting more clinical trials with combination of two or more synthetic drugs, plants, or drug-plant for the treatment of osteoporosis are recommended. Summary of treatment modalities for osteoporosis.
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http://dx.doi.org/10.1186/s40199-017-0167-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5297185PMC
February 2017

Ethics in Pharmacy Curriculum for Undergraduate Pharmacy Students: A Needs Assessment Study.

Arch Iran Med 2017 Jan;20(1):38-42

Department of Toxicology and Pharmacology, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran, Toxicology and Diseases Group, Pharmaceutical Sciences Research Center, Tehran University of Medical Sciences, Tehran, Iran.

Introduction: Recent advances in pharmacy practice have created serious ethical challenges for the pharmacists. Pursuing a new philosophy of practice is required to overcome these challenges and optimize the standard of care. In this regard, the current ethics guideline in the Pharmacy curriculum used in Tehran University of Medical Sciences, does not provide a fully comprehensive understanding of the issue. Therefore, the aim of the present study was to revise the current curriculum based on a needs assessment study.

Methods: In this study, a two-part questionnaire was presented to pharmacists to obtain their views on the importance of topics in their daily routine practice. Part one of the questionnaire consisted of demographic data and part two of 23 topics in pharmacy ethics.

Results: Out of a total of 200 questionnaires, 158 questionnaires were returned. We reached consensus on 24 topics, of which 8 topics gained a score of higher than 4 (the highest score was considered to be 5) and the rest obtained a score of 3 and higher. The highest score pertained to the pharmacists' relationship with patients, awareness of the rules and regulations, and medication error.

Conclusion: Based on the results, a revised curriculum was designed for ethics in pharmacy. It seems that the designed curriculum is context-based and will develop appropriate educational material regarding pharmacists' requirements in daily practice. Consideration of interactive methods for teaching the curriculum is highly recommended.
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http://dx.doi.org/0172001/AIM.009DOI Listing
January 2017

The influence of pregnancy and lactation on maternal bone health: a systematic review.

J Family Reprod Health 2014 Dec;8(4):135-48

Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran ; Pharmaceutical Sciences Research Center, Tehran University of Medical Sciences, Tehran, Iran ; Endocrinology & Metabolism Research Center, Tehran University of Medical Sciences, Tehran, Iran.

Osteoporosis is considered as an important public health problem especially in postmenopausal women. There are some hypotheses support the contributory effect of pregnancy and lactation on osteoporosis later in life. High calcium demand during pregnancy and lactation and low estrogenic state support those hypotheses. Numerous studies have investigated on the issue but there is no consensus about the contributory effect of pregnancy and lactation on osteoporosis. To explore the current state of fact, in the present study, all bibliographic databases were searched and all relevant studies on the topic of osteoporosis, lactation, and pregnancy were reviewed. The review shows that despite of controversial results, pregnancy may have protective effect on bone especially if followed by lactation.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4266784PMC
December 2014

Effect of folic acid on bone metabolism: a randomized double blind clinical trial in postmenopausal osteoporotic women.

Daru 2014 Sep 16;22:62. Epub 2014 Sep 16.

Background: In spite of several studies, the impact of homocysteine level and folic acid supplementation on bone metabolism is yet to be recognized. In this registered clinical trial (IRCT2014042217385N1), we aimed to find out the power of 6-month folic acid supplementation on homocysteine level and bone metabolism.

Methods: Forty postmenopausal osteoporotic women (50 to 87 years) were enrolled in the study. All participants were randomized to receive folic acid 1 mg (n = 17) or placebo (n = 14). At baseline, 3 months, and finally 6 months post intervention, the level of homocysteine, vitamin B12, and bone biomarkers were measured.

Results: Both groups were similar at baseline. The homocysteine decreased in both groups but statistically non-significant (P > 0.05). The changes of the serum level of vitamin B12, osteocalcin, and β cross laps were significant between groups after 6 months (P ≤ 0.05).

Conclusion: The trend of changes of bone biomarkers after 6 months folic acid supplementation shows that homocysteine concentration and/or folic acid supplementation have impact on the rate of bone metabolism. However, further investigations by larger sample size and differentiating age and gender are still needed to clarify the exact role of folate, homocysteine and vitamin B12.
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http://dx.doi.org/10.1186/s40199-014-0062-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4172791PMC
September 2014

Evaluation of the effect of pentoxifylline on erythropoietin-resistant anemia in hemodialysis patients.

Saudi J Kidney Dis Transpl 2014 Jan;25(1):73-8

Nephrology Ward, Department of Internal Medicine, Imam-Reza Hospital, Mashhad University of Medical Sciences, Mashhad, Iran.

Use of recombinant human erythropoietin (rh-Epo) improves hemoglobin (Hgb) in 90-95% of the cases of anemia of chronic kidney disease (CKD). However, it is known that pro-inflammatory cytokines such as interferon-gamma (IFN-γ), tumor necrosis factor-alfa (TNF-α) and interleukin-1 (IL-1) suppress erythropoiesis, resulting in inadequate response to rh-Epo. Pentoxifylline has been shown to have modulatory effects on the immune system. This prospective study to evaluate the effect of pentoxyphylline on erythropoeisis was performed on 15 (eight males, seven females) clinically stable patients who had been on hemodialysis for at least six months with anemia (Hgb of <10.7 g/dL) unresponsive to rh-Epo despite high doses. They were treated with 400 mg pentoxifylline tablets once daily for 12 weeks. Hgb increased after one and two months of drug administration, but significant changes were observed in eight (53%) patients after three months (P <0.05). Our study illustrates a probable new use for an old medicine. Three months treatment with pentoxifylline was seen to increase Hgb significantly in rh-Epo-resistant patients. More prospective studies with a larger sample size are needed to determine the inhibitory role of cytokines on hematopoiesis and exploring new drugs or new drug indications to overcome anemia in advanced renal failure.
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http://dx.doi.org/10.4103/1319-2442.124492DOI Listing
January 2014

Code of ethics for the national pharmaceutical system: Codifying and compilation.

J Res Med Sci 2013 May;18(5):442-8

Medical Ethics and History of Medicine Research Center, Tehran University of Medical Sciences, Tehran, Iran.

Pharmacists as one of health-care providers face ethical issues in terms of pharmaceutical care, relationship with patients and cooperation with the health-care team. Other than pharmacy, there are pharmaceutical companies in various fields of manufacturing, importing or distributing that have their own ethical issues. Therefore, pharmacy practice is vulnerable to ethical challenges and needs special code of conducts. On feeling the need, based on a shared project between experts of the ethics from relevant research centers, all the needs were fully recognized and then specified code of conduct for each was written. The code of conduct was subject to comments of all experts involved in the pharmaceutical sector and thus criticized in several meetings. The prepared code of conduct is comprised of professional code of ethics for pharmacists, ethics guideline for pharmaceutical manufacturers, ethics guideline for pharmaceutical importers, ethics guideline for pharmaceutical distributors, and ethics guideline for policy makers. The document was compiled based on the principles of bioethics and professionalism. The compiling the code of ethics for the national pharmaceutical system is the first step in implementing ethics in pharmacy practice and further attempts into teaching the professionalism and the ethical code as the necessary and complementary effort are highly recommended.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3810583PMC
May 2013

A meta-analysis of the role of statins on renal outcomes in patients with chronic kidney disease. Is the duration of therapy important?

Int J Cardiol 2013 Oct 28;168(6):5437-47. Epub 2013 Aug 28.

Biomedical Department of Internal Medicine and Medical Specialties, University of Palermo, Italy.

Introduction: The efficacy of statin treatment in chronic kidney disease (CKD) patients remains controversial. Therefore, we performed a meta-analysis to investigate whether statins modulate renal function in patients with CKD.

Methods: Data from Scopus, PubMed, Web of Science, and the Cochrane Central Register of randomized controlled trials for years 1966-December 2012 were searched for appropriate studies.

Results: Twenty trials with 6452 CKD subjects randomized to receive either statin or placebo were included. Statin therapy significantly influenced high sensitivity C-reactive protein levels in patients on or off dialysis [-0.28 mg/dl, 95%CI: -0.93 to -0.37; p<0.05 and -0.46 mg/dl, 95%CI: -0.87 to -0.05; p=0.03], respectively], urinary protein (-0.77 g/24 h, 95%CI: -1.24 to -0.29, p<0.02; this effect persisted for treatment ≤12 months), and serum creatinine but only for long-term therapy (3 years) (-0.65 mg/dl, 95%CI: -1.00 to -0.30; p=0.0003). The summary for standardized effect size of mean differences of glomerular filtration rate was 0.29 ml/min/1.73 m(2) (95%CI: 0.01 to 0.58; p=0.04), and depended on treatment duration - a significant increase was observed for between 1 and 3 years of statin therapy (0.50 ml/min/1.73 m(2), 95%CI: 0.40 to 0.60; p<0.0001), with no significant increase for both ≤1 and >3 years of the therapy.

Conclusion: Statins might exert significant renoprotective effects in CKD patients; however, benefit may depend on the duration of treatment. This is an issue that warrants more definitive investigation. More studies are necessary in dialysis patients to credibly evaluate the renal effects of statin therapy.
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http://dx.doi.org/10.1016/j.ijcard.2013.08.060DOI Listing
October 2013

Brief report: The Third Annual Medical Ethics Congress in Iran.

J Med Ethics Hist Med 2013 2;6. Epub 2013 May 2.

Assistant Professor, Medical Ethics and History of Medicine Research Center, Tehran University of Medical Sciences, Tehran, Iran;

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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3740194PMC
August 2013

Statins decrease all-cause mortality only in CKD patients not requiring dialysis therapy--a meta-analysis of 11 randomized controlled trials involving 21,295 participants.

Pharmacol Res 2013 Jun 28;72:35-44. Epub 2013 Mar 28.

Department of Internal Medicine and Cardiological Rehabilitation, Medical University of Lodz, Poland.

The available studies have reported the benefits of statins on all-cause and cardiovascular mortality in chronic kidney disease (CKD) patients. However studies in end-stage renal disease patients on dialysis yielded conflicting results. Therefore, we performed a meta-analysis and provide the most reliable trial data to date on the impact of statin therapy on cardiovascular events and death from all causes in CKD patients. Data from PubMed, Web of Science, Cochrane Library, and Scopus for the years 1966 to October 2012 were searched. The final meta-analysis included 11 randomized controlled trials involving 21,295 participants with CKD. Among them 6857 were on dialysis. The use of statins in subjects with non-dialysis-dependent CKD resulted in a marked reduction in death from all causes (relative risk [RR]: 0.66; 95% confidence interval [CI]: 0.55-0.79; p<0.0001), cardiac causes (RR: 0.69; 95%CI: 0.55-0.68; p=0.0012), cardiovascular events (RR: 0.55; 95%CI: 0.4-0.75; p=0.0001) and stroke (RR: 0.66; 95%CI: 0.5-0.88; p=0.0022). The use of statins in dialysis-dependent CKD patients resulted in a non-significant effect on death from all causes (RR: 0.99; 95%CI: 0.88-1.11; p=0.85) and stroke (RR: 1.31; 95%CI: 0.9-1.89; p>0.05), but had the effect of reducing death from cardiac causes (RR: 0.79; 95%CI: 0.64-0.98; p<0.05) and cardiovascular events (RR: 0.81; 95%CI: 0.7-0.94; p<0.05). In conclusion, the use of statins should be indicated in cardiovascular disease prevention especially in patients with non-dialysis-dependent CKD. According to the very limited data the obtained results suggest caution in expecting a reduction in cardiovascular events in patients on dialysis.
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http://dx.doi.org/10.1016/j.phrs.2013.03.007DOI Listing
June 2013

Key ethical issues in pediatric research: islamic perspective, Iranian experience.

Iran J Pediatr 2012 Dec;22(4):435-44

Medical Ethics and History of Medicine Research Center, Tehran University of Medical Sciences, Tehran, Iran ; Faculty of Medicine, Kerman University of Medical Sciences, Kerman, Iran.

Objective: The importance of pediatric research especially in the ethically proven trials resulted in considerable legislative attempts in association with compiling ethical guidelines. Because of children's vulnerability conducting pediatric research raises different ethical issues; the two most important of which are informed consent and risk-benefit assessment. Differences in religious and socio-cultural context limit implication of ethical standards.

Methods: At the aim of finding a solution we critically reviewed guidelines, and literatures as well as Islamic points in addition to comparing different viewpoints in application of ethical standards in pediatric research.

Findings: The literature review showed that pediatric research guidelines and authors' viewpoints have the same basic ethical core, but there are some variations; depend on cultural, religious, and social differences. Furthermore, these standards have some limitations in defining informed consent according to child's age and capacity upon application.

Conclusion: In this regard Islamic approach and definition about growth development and puberty sheds light and clarifies a clearer and more rational address to the issue.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3533141PMC
December 2012

Effects of statins on lipid profile in chronic kidney disease patients: a meta-analysis of randomized controlled trials.

Curr Med Res Opin 2013 May 11;29(5):435-51. Epub 2013 Mar 11.

BioMedical Department of Internal Medicine and Medical Specialties, University of Palermo, Italy.

Objective: The available data on statin effects in chronic kidney disease (CKD) patients are still conflicting. We investigated the impact of short- and long-term statin therapy on lipid profiles in CKD patients requiring or not requiring dialysis.

Research Design And Methods: Data from Scopus, PubMed, Web of Science, and the Cochrane Library from 1966 to May 2012 were searched for studies that investigated this effect. We included all randomized controlled clinical trials that investigated the impact of statin therapy on lipids and lipoproteins.

Results: The final analysis included 16 trials with 3594 subjects. In CKD patients, statin therapy significantly reduced total cholesterol (TC), triglycerides (TG) and low-density lipoprotein cholesterol (LDL-C) (p < 0.003 for all comparisons), and the effect insignificantly intensified with duration of statin therapy (56.3 vs 66.8, 22.5 vs 24.1, and 53 vs 56.1 mg/dl, respectively). Comparing statin therapy for ≤ 3 and >3 months in CKD patients on dialysis, the magnitude of TC and LDL-C decreased (26.3 vs 25.9, and 42.2 vs 29.8 mg/dl, respectively, p > 0.05 for both), while TG increased modestly (4.5 vs 13.4 mg/dl). Short-term statin therapy increased high density lipoprotein cholesterol by a mean 0.7 mg/dl (p = 0.04), and long-term therapy was associated with a mean reduction of 2.4 mg/dL.

Conclusions: Statin therapy significantly modifies the lipid profile in CKD patients not on dialysis therapy (with the trend to be more effective with longer therapy), and have less beneficial effect in patients on dialysis with the trend to be less effective with longer duration of therapy.
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http://dx.doi.org/10.1185/03007995.2013.779237DOI Listing
May 2013

Current opinion on treatment of inflammatory bowel disease in pregnant women.

Arch Med Sci 2012 Dec 19;8(6):983-6. Epub 2012 Dec 19.

Medical Ethics and History of Medicine Research Center, Tehran University of Medical Sciences, Tehran, Iran.

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http://dx.doi.org/10.5114/aoms.2012.32403DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3542487PMC
December 2012

Long term bisphosphonate use in osteoporotic patients; a step forward, two steps back.

J Pharm Pharm Sci 2012 ;15(2):305-17

Medical Ethics and History of Medicine Research Center, Tehran University of Medical Sciences, Tehran, Iran.

Purpose: Bisphosphonates are the main class of drugs widely used in prevention and treatment of osteoporosis. Along with the beneficial effects, recent studies point to the harms of long-term treatment with bisphosphonates.

Methods: The most relevant articles reporting serious adverse effects of bisphosphonates were selected and reviewed with the aim of assessing the risk-benefit of bisphosphonates. We searched PubMed, Web of Science, and Scopus using keywords bisphosphonates, risk of fracture, atrial fibrillation, osteonecrosis jaw, esophageal cancer, and adverse effects with no time limitation. We limited our s research to English articles.

Results: Our review shows that bisphosphonates reduce vertebral fractures in short term use while in long-term can cause osteonecrosis jaw, esophageal cancer, atrial fibrillation, and increase the risk of atypical fractures and probably adynamic bone disease. There is no consensus on the time limitation of bisphosphonate usage or its long term adverse effects. Thus, more studies on long-term side effects of bisphosphonates are highly recommended. In addition, new approaches for prevention and treatment of osteoporosis seem necessary.

Conclusion: Prescribers should act cautionary and consider full assessment of risk-benefit and the duration of treatment.
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http://dx.doi.org/10.18433/j3rk5jDOI Listing
September 2012

The efficacy and tolerability of exenatide in comparison to placebo; a systematic review and meta-analysis of randomized clinical trials.

J Pharm Pharm Sci 2012 ;15(1):1-30

Department of Pharmacoeconomics and Pharmaceutical Administration, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.

Recent investigations in finding new drugs in the treatment of diabetes have led to the discovery of several pathological pathways involved in diabetes. Exenatide a drug with incretin mimetic activity was studied in several in vivo and in vitro as well as human studies. It has shown promising results in controlling metabolic indices in type-2 diabetes and was approved by FDA but still there is an active safety alert on it. In this study we aimed to meta-analyze all placebo-controlled clinical trials on the efficacy or tolerability of exenatide in type 2 diabetes. The literature search provided 1016 articles while only 14 articles were eligible to be included in the meta-analysis with a total of 2583 patients enrolled in the study. According to the wide variation in design of various studies, the study duration of 16 weeks and less or more and dose (5 μg bid versus 10 μg bid) were considered and analyzed. The results of this meta-analysis show that exenatide decreases fasting plasma glucose and HbA1C significantly regardless of dose and study duration. The effect of exenatide on weight reduction was more prominent at the dose of 10 μg bid regardless of the study duration, however at the dose of 5 μg bid, significant results were observed after drug administration for more than 16 weeks. Exenatide usage decreased serum triglycerides indifferent to dose and study duration while its effect on cholesterol was not prominent. Along with these impacts, exenatide changed LDL and HDL cholesterol at the lower dose. The hemodynamic effect of exenatide was observed as significant decrements in systolic and diastolic blood pressure at the higher dose. The risk of nausea, vomiting and hypoglycemia was significant and indifferent to dose while headache and nasopharyngaitis were seen more at lower dose. It is concluded that exenatide can be considered as a good hypoglycemic agent in type-2 diabetic patients with benefits on lipid profile and blood pressure with partially questionable tolerability.
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http://dx.doi.org/10.18433/j3g883DOI Listing
June 2012

A meta-analysis and systematic review on the effect of probiotics in acute diarrhea.

Inflamm Allergy Drug Targets 2012 Feb;11(1):3-14

Medical Ethics and History of Medicine Research Center, Tehran University of Medical Sciences, Tehran, Iran.

Objectives: Diarrhea the second leading cause of death in childhood is caused by a variety of organisms. Rehydration reduces the risk of death but it is not effective in shortening duration of disease. Recently, probiotics have been recommended for prevention or treatment of gastrointestinal disorders including diarrhea. Considering existing documents from different aspects, it seems that results are somehow controversial or non-conclusive. Thus, we aimed to meta-analyze clinical trials to show actual benefit of probiotics in treatment of diarrhea.

Methodology: The literature search provided 1228 articles while only 19 articles focusing on the analyses performed on children were eligible to be included in the meta-analysis with a total of 3867 patients enrolled in the study. Studies in adults' diarrhea, HIV patients, diarrhea induced by Clostridium difficile, radiation and chemotherapy were also systematically reviewed.

Results: The meta-analysis showed that probiotics decrease the duration of diarrhea and fever significantly in children while their effects on the duration of hospitalization, vomiting and number of stools per day were not significant. The results of systematic review on adults' diarrhea, amoebiasis, clostridium difficile-associated diarrhea, diarrhea in HIV positive patients, radiation-induced diarrhea, and chemotherapy-induced diarrhea did not support efficacy of probiotics in acute diarrhea.

Conclusion: Probiotics may reduce duration of diarrhea and fever in children but their exact efficacy in treatment of diarrhea is not obvious yet.
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http://dx.doi.org/10.2174/187152812798889394DOI Listing
February 2012

Phosphodiesterase inhibitors in inflammatory bowel disease.

Expert Opin Investig Drugs 2012 Mar 6;21(3):261-4. Epub 2012 Feb 6.

Inflammatory bowel disease (IBD) is fundamentally a relapsing and remitting disease appearing in forms of ulcerative colitis (UC) or Crohn's disease (CD) with a non-well-known etiology. With the hope to prevent adverse drug events and to increase the efficacy of therapies for IBD, in the recent years, other than new monoclonal antibodies such as infliximab, the novel phosphodiesterase inhibitors (PDEIs) have been introduced. Among PDE4Is, rolipram, OPC-6535, mesopram, roflumilast and tetomilast have shown beneficial effects in experimental colitis. Unfortunately until now, human studies have not been successful in showing significant superiority of PDE4Is in the treatment of IBD. Parallel with discovery of PDE4Is and their anti-inflammatory properties, inhibiting other PDE isoenzymes in immune and proinflammatory cells is on the way. PDE7Is have shown synergistic effect with PDE4Is and they may act similar to PDE3Is in experimental settings. Sildenafil as the PDE5I has shown good effects in experimental colitis by balancing oxidant-antioxidant status. Although the present data about PDE superfamily and their specific roles in gastrointestinal tract is limited but inhibitors of PDE4, PDE5 and PDE7 seem good candidates as the next generation of effective drugs. The synergistic anti-inflammatory effect of PDE4Is and PDE7Is is also important.
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http://dx.doi.org/10.1517/13543784.2012.658915DOI Listing
March 2012

Behind the pathogenesis of osteoporosis and cardiovascular diseases.

Arch Med Sci 2011 Aug 2;7(4):568-9. Epub 2011 Sep 2.

Medical Ethics and History of Medicine Research Center, Tehran University of Medical Sciences, Tehran, Iran.

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http://dx.doi.org/10.5114/aoms.2011.24121DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3258779PMC
August 2011

Systematic review of modulators of benzodiazepine receptors in irritable bowel syndrome: is there hope?

World J Gastroenterol 2011 Oct;17(38):4251-7

Several drugs are used in the treatment of irritable bowel syndrome (IBS) but all have side effects and variable efficacy. Considering the role of the gut-brain axis, immune, neural, and endocrine pathways in the pathogenesis of IBS and possible beneficial effects of benzodiazepines (BZD) in this axis, the present systematic review focuses on the efficacy of BZD receptor modulators in human IBS. For the years 1966 to February 2011, all literature was searched for any articles on the use of BZD receptor modulators and IBS. After thorough evaluation and omission of duplicate data, 10 out of 69 articles were included. BZD receptor modulators can be helpful, especially in the diarrhea-dominant form of IBS, by affecting the inflammatory, neural, and psychologic pathways, however, controversies still exist. Recently, a new BZD receptor modulator, dextofisopam was synthesized and studied in human subjects, but the studies are limited to phase IIb clinical trials. None of the existing trials considered the neuroimmunomodulatory effect of BZDs in IBS, but bearing in mind the concentration-dependent effect of BZDs on cytokines and cell proliferation, future studies using pharmacodynamic and pharmacokinetic approaches are highly recommended.
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http://dx.doi.org/10.3748/wjg.v17.i38.4251DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3214699PMC
October 2011

Assessment of professionalism in Iranian pharmacists.

J Med Ethics Hist Med 2011 26;4. Epub 2011 Jun 26.

Assistant Professor, Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran;

In the recent years, the role of a pharmacist has been significantly changed. Traditionally, in the late 20(th) century, a pharmacist's role was considered as merely dispensing medication to patients. This view however, has been significantly altered, and, today, a pharmacist is supposed to provide patients with information regarding the medication they are to take, as well as on different aspects of their disease. Therefore, one can suggest that some other factors have recently come into play in the daily tasks of a pharmacist such as accountability and authority. The current cross-sectional survey is conducted on a cohort of community pharmacists attending a continuing education program. A questionnaire comprised of 26 Likert-type scale questions was designed to assess pharmacists' attitude towards professionalism and its subscales which are defined later in detail. A total number of 1000 pharmacists were surveyed and 560 of them filled and returned the questionnaires. On a scale from 1-5 on which 1 was corresponded with strongly agree and 5 with strongly disagree, the total score of pharmacists professionalism was 92.9 ± 10.4 out of 130. As regards the subscales, in the subscale of accountability 46.8% of participants, in the subscale of altruism 90.1% of participants, in the theme of duty 85.7% of participants, and in the subscale of working relationship with physicians 84% of pharmacist achieved more than two third of the total score. Only in term of conflict of interest 67.9% of participants scored less than two third (17-25) of the total score. Women obtained significantly higher scores in altruism (P<0.05). Furthermore, there was a correlation between age and the score of accountability and working relationship with physicians; and, the same was observed in regards with work experience with the score of working relationship with physicians. The employment position affected neither our participants' response to the whole questionnaire nor any of subscales. Although the total score for professionalism was not dramatically decreased, the significantly low results are alarming and they should be considered more seriously. In order to enhance the level of pharmacists' professionalism, especially in some special aspects, it seems necessary to conduct similar surveys on pharmacy students and registered pharmacists with a more comprehensive questionnaire. Overall, it can be concluded that designing a proper teaching course in professionalism for pharmacy students is of paramount importance if we are to promote professionalism in future pharmacists.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3713883PMC
August 2013

Controversial effects of non-steroidal anti-inflammatory drugs on bone: a review.

Inflamm Allergy Drug Targets 2009 Jul;8(3):169-75

Medical Ethics and History of Medicine Research Center, Tehran University of Medical Sciences, Tehran, Iran.

Bone turnover is much important in normal homeostasis of body skeleton. Medications, nutritional status, and systemic illnesses may affect bone metabolism by altering biochemical mediators. Prostaglandins, especially of E and F series are much important in bone physiology by affecting osteoclastic activity and osteoblastic differentiation. In bone fracture, production of prostaglandins affects fracture healing. There is the possibility that non-steroidal anti-inflammatory drugs (NSAIDs) affect bone health by inhibiting cyclooxygenase (COX) enzymes which reduce synthesis of prostaglandins. The aim of this paper is to review the effects of NSAIDs on bone by evaluating both animal and human studies. Using key words such as bone, bone marker, bone mineral density, NSAIDs, COX inhibitor, bone metabolism and search engines like Web of sciences, Scopus, Pubmed, and Google scholar, all relevant studies were collected. Although NSAIDs showed anti-resorptive properties in animal studies and some few human studies, to date no conclusive result has been observed in bone formation. Some limited studies reported higher bone mineral density in daily users of NSAIDs.
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http://dx.doi.org/10.2174/187152809788681065DOI Listing
July 2009