Ethical considerations and concerns in the implementation of AI in pharmacy practice: a cross-sectional study.

BACKGROUND: Integrating artificial intelligence (AI) into healthcare has raised significant ethical concerns. In pharmacy practice, AI offers promising advances but also poses ethical challenges. METHODS: A cross-sectional study was conducted in countries from the Middle East and North Africa (MENA) region on 501 pharmacy professionals. A 12-item online questionnaire assessed ethical concerns related to the adoption of AI in pharmacy practice. Demographic factors associated with ethical concerns were analyzed via SPSS v.27 software using appropriate statistical tests. RESULTS: Participants expressed concerns about patient data privacy (58.9%), cybersecurity threats (58.9%), potential job displacement (62.9%), and lack of legal regulation (67.0%). Tech-savviness and basic AI understanding were correlated with higher concern scores (p < 0.001). Ethical implications include the need for informed consent, beneficence, justice, and transparency in the use of AI. CONCLUSION: The findings emphasize the importance of ethical guidelines, education, and patient autonomy in adopting AI. Collaboration, data privacy, and equitable access are crucial to the responsible use of AI in pharmacy practice.

Perspectives of Pharmacy Students on Ethical Issues Related to Artificial Intelligence: A Comprehensive Survey Study.

Background: The integration of artificial intelligence (AI) into pharmacy education and practice holds the potential to advance learning experiences and prepare future pharmacists for evolving healthcare practice. However, it also raises ethical considerations that need to be addressed carefully. This study aimed to explore pharmacy students' attitudes regarding AI integration into pharmacy education and practice. Methods: A cross-sectional design was employed, utilizing a validated online questionnaire administered to 702 pharmacy students from diverse demographic backgrounds. The questionnaire gathered data on participants' attitudes and concerns regarding AI integration, as well as demographic information and factors influencing their attitudes. Results: Most participants were female students (72.8%), from public universities (55.6%) and not working (64.2%). Participants expressed a generally negative attitude toward AI integration, citing concerns and barriers such as patient data privacy (62.0%), susceptibility to hacking (56.2%), potential job displacement (69.3%), cost limitations (66.8%), access (69.1%) and the absence of regulations (48.1% agree), training (70.4%), physicians' reluctance (65.1%) and patient apprehension (70.8%). Factors including country of residence, academic year, cumulative GPA, work status, technology literacy, and AI understanding significantly influenced participants' attitudes (p < 0.05). Conclusion: The study highlights the need for comprehensive AI education in pharmacy curricula including related ethical concerns. Addressing students' concerns is crucial to ensuring ethical, equitable, and beneficial AI integration in pharmacy education and practice.

Sildenafil prevents chronic psychosocial stress-induced working memory impairment: Role of brain-derived neurotrophic factor.

Background: Psychosocial stress, a common feature in modern societies, impairs cognitive functions. It is suggested that stress hormones and elevated excitatory amino acids during stress are responsible for stress-induced cognitive deficits. Reduced brain-derived neurotrophic factor (BDNF) levels, increased oxidative stress, and alteration of synaptic plasticity biomarkers are also possible contributors to the negative impact of stress on learning and memory. Sildenafil citrate is a selective phosphodiesterase type 5 (PDE5) inhibitor and the first oral therapy for the treatment of erectile dysfunction. It has been shown that sildenafil improves learning and memory and possesses antioxidant properties. We hypothesized that administering sildenafil to stressed rats prevents the cognitive deficit induced by chronic psychosocial stress. Methods: Psychosocial stress was generated using the intruder model. Sildenafil 3 mg/kg/day was administered intraperitoneally to animals. Behavioral studies were conducted to test spatial learning and memory using the radial arm water maze. Then, the hippocampal BDNF level and several antioxidant markers were assessed. Results: This study revealed that chronic psychosocial stress impaired short-term but not long-term memory. The administration of sildenafil prevented this short-term memory impairment. Chronic psychosocial stress markedly reduced the level of hippocampal BDNF (P˂0.05), and this reduction in BDNF was normalized by sildenafil treatment. In addition, neither chronic psychosocial stress nor sildenafil significantly altered the activity of measured oxidative parameters (P > 0.05). Conclusion: Chronic psychosocial stress induces short-term memory impairment. The administration of sildenafil citrate prevented this impairment, possibly by normalizing the level of BDNF.

Navigating parental attitudes on childhood vaccination in Jordan: a cross-sectional study.

This study investigated parental attitudes toward childhood vaccination in Jordan, focusing on acceptance, concerns, and perceptions. A cross-sectional survey conducted from January to February 2024 included 939 parents. Findings indicated that 85.4% (n = 802) of respondents received the COVID-19 vaccine, while only 25% (n = 229) vaccinated their children. Concerns regarding vaccine safety and efficacy were prevalent, with 63.9% (n = 600) expressing worries about side effects and 46.9% (n = 440) trusting immunization programs. Post-pandemic, 34% (n = 319) reported a more negative attitude. Logistic regression showed parents not vaccinating their children against COVID-19 were significantly less likely to exhibit positive attitudes toward childhood vaccination (OR = 0.412, p < 0.001). Older participants were more inclined toward negativity post-pandemic (OR = 1.031, p = 0.007). In conclusion, parental attitudes shifted post-COVID-19, reflecting hesitancy and decreased trust. Addressing concerns and restoring confidence are crucial, especially for children's health. Education through healthcare providers and dispelling social media misinformation are essential. Implementing strategies to enhance post-pandemic vaccine acceptance is imperative for preventing outbreaks of vaccine-preventable diseases.

Vitamin B12 Protects Against Genotoxicity Induced by Cisplatin.

BACKGROUND: Cisplatin is an effective synthetic chemotherapeutic drug used for cancer treatment. Vitamin B12 has been shown to possess anti-genotoxic activity. This study aimed to investigate the effect of vitamin B12 on chromosomal damage induced by cisplatin. METHODS: The level of sister chromatid exchanges (SCEs) and chromosomal aberrations (CAs) were measured in cultured human blood lymphocytes treated with cisplatin and/or vitamin B12. RESULTS: The results showed a significantly elevated frequency of CAs and SCEs of cisplatin-treated cultures compared to the control (P < 0.05). The CAs and SCEs induced by cisplatin were significantly lowered by pretreatment of cell cultures with vitamin B12. In addition, cisplatin caused a slight reduction in the mitotic index (MI), while vitamin B12 did not modulate the effect of cisplatin on MI. CONCLUSION: Vitamin B12 can protect human lymphocytes against genotoxicity associated with cisplatin.

Long-term effects of neonatal pain and sucrose treatment.

Purpose: In neonatal intensive care units, applying sucrose solution for analgesia is now a routine treatment for mild procedural pain. Studies of animal and human infants provide clear evidence of benefits in the short term, but few studies have investigated the long term benefits. Thus, we determined whether sucrose could ameliorate painful stimulation during infancy in Sprague-Dawley rats and also explored the long-term effects of repeated sucrose administration during infancy. Female and male rats were included to investigate sex-related differences. Methods: Rat pups were stimulated either with painful or tactile stimuli for the first 14 days of their lives. Pups were pretreated either with sucrose or not treated before stimulation. Behavioral tests were conducted during adolescence and adulthood. Hotplate, rotarod, open field, elevated plus maze, and radial arm water maze tests were employed to assess the behavioral consequences of early life manipulations and treatments. Results: Painful stimulation during infancy increased the sensitivity to pain later in life, and sucrose did not remedy this effect. Motility, coordination, anxiety, and cognition tests in adulthood obtained mixed results. Pain during infancy appeared to increase anxiety during adulthood. Learning and memory in adulthood were affected by pain during infancy, and sucrose had a negative effect even in the absence of pain. No sex-related differences were observed in any of the behavioral tests by employing this model of neonatal pain. Conclusion: Painful stimulation during infancy resulted in deficiencies in some behavioral tests later in life. Sucrose pretreatment did not mitigate these shortcomings and it actually resulted in negative outcomes.

Pandemic H1N1 influenza virus triggers a strong T helper cell response in human nasopharynx-associated lymphoid tissues.

The pH1N1 belongs to influenza A family that is sometimes transmitted to humans via contact with pigs. Human tonsillar immune cells are widely used as in vitro models to study responses to influenza viruses. In the current study, human memory (M) and naïve (N) T cells responses in mononuclear cells of tonsil (TMCs) and peripheral blood (PBMCs) were stimulated by pH1N1/sH1N1, and then stained for estimation of T cells proliferation index. Individuals with an anti-pH1N1 hemagglutination (HA) inhibition (HAI) titer of forty or greater exhibited stronger HA-specific M-CD4+ T cells responses to pH1N1 in TMCs/PBMCs than those with an HAI titer of less than forty (P < 0.01). In addition, a positive correlation was observed between proliferation indices of M-CD4+ T cells induced by exposure to sH1N1/pH1N1 (p < 0.01). Moreover, a strong correlation (p < 0.001) was detected between subjects' age and their HA-specific M-CD4+ T cells induced by pH1N1 exposure, indicating that this response was age-dependent. Finally, stimulation of TMCs with pH1N1-HA resulted in a significant M-CD8+ T cells response (p < 0.05). In conclusion, pH1N1 HA elicits a strong M-CD4+ T cells response in TMCs. Additionally, this response correlates with the response to sH1N1 suggesting cross-reactivity in T cells epitopes directed against HAs of both viral strains.

Effect of vitamin E on doxorubicin and paclitaxel-induced memory impairments in male rats.

PURPOSE: In addition to peripheral neuronal dysfunction, conventional chemotherapy can be associated with other neurological treatment-limiting adverse effects, including cognitive dysfunction, memory impairment, and anxiety, which are referred to as "chemobrain". This study aimed to investigate the effects of doxorubicin (DOX) and paclitaxel (PAC) on learning and memory in rats using radial arm water maze (RAWM) and investigated a potential beneficial effect of vitamin E (Vit. E). METHODS: Adult male rats were injected with four doses of 2 mg/kg/week DOX, or 2 mg/kg PAC every other day intraperitoneally. Vit. E was co-administered with these drugs in other groups to study its antioxidative effects. Using the RAWM, each rat was assessed for learning and memory performance through two sets of six trials separated by a 5-min rest period evaluating both short- and long-term effects on memory. RESULTS: There was no deficit in learning or long-term memory in both drug groups compared to control. However, rats in both drug groups made significantly more errors in all short-term memory trials. This effect was mitigated when Vit. E was co-administered with either drug. Moreover, PAC (but not DOX) induced hippocampal lipid peroxidation by increasing the levels of standard biomarker thiobarbituric acid reactive substances (TBARS). Interestingly, Vit. E prevented PAC-induced hippocampal oxidative stress. Furthermore, both DOX and PAC were correlated with reduction in Brain-Derived Neurotrophic Factor (BDNF) expression levels in the hippocampus, which was overcome by the co-administration of Vit. E. CONCLUSION: There is a potential role of Vit. E in alleviating short-term memory impairment in rats exposed to chemotherapy, possibly by reducing hippocampal oxidative stress and neurodegeneration.

The Impact of COVID-19 Confinement on Reading Behavior.

Background: The COVID-19 pandemic was detrimental to lifestyle and behavior. In this investigation, changes in reading habits during the pandemic were examined. Methods: The study is cross-sectional and survey-based. 1844 individuals completed an online survey about sociodemographic and reading habits during COVID-19. Multinomial logistic regression was used to examine the relationship between the study variables. Results: Most of the participants were active readers (71.5%-83.2%). Fewer (13.8-18.0%) reported a decrease in reading, while about half reported a no change, and 1/3rd reported an increase. Changes in reading habits were related to age, education, job type, and income. Conclusion: About half of the participants during the pandemic reported a change in reading habits. Interventions to further enhance reading among people during the pandemic might help ameliorate the negative impacts of the pandemic.

Attitude towards donation of the excised foreskin after circumcision surgery for research: A study from Madinah, Saudi Arabia.

Studies have shown the possibility of using the part of the foreskin removed after circumcision in the field of scientific and therapeutic research. Donations of tissues and organs are always associated with ethical challenges posed by bioethicists and societies to ensure the appropriate use of these tissues/organs. The purpose of this study was to understand the attitudes and awareness of parents/guardians regarding donation of excised foreskin to research and medical use. The study was based on a questionnaire and included 133 parents/guardians who visited Uhud Children's Hospital in Madinah, Saudi Arabia for newborn male circumcision. The results showed a high willingness (61.7%) to donate the extracted foreskin to research. The willingness to donate the extracted foreskin to research associated with undergraduate degree (P = 0.018), male sex (P = 0.011), high income (P = 0.029), and participation in previous research studies (P = 0.002). About 41.8% were convinced that written informed consent should be obtained before circumcision surgery, 38.1% (n = 51) were convinced that written informed consent should be taken after surgery, while the remaining 19.4% reported that the timing of written informed consent is unimportant. Finally, fear of excision of excess tissue (74.5%), lack of confidence in the research (68.6%), and potential for commercial use (64.7%) were the main barriers to unwillingness to donate the excised foreskin for research. In conclusion, a reasonable portion of Saudis agreed to donate their foreskin for research purposes. There is an urgent need to enhance awareness and attitudes towards tissue donation for research and therapeutic use.

Coriandrum sativum and Aloysia triphylla can Protect the Development of Cancer: an in Vivo Study Using Mouse Painting Assay.

AIM: The aim of this study is to examine the protective properties of Coriandrum sativum and Aloysia triphylla against the development of skin cancer. METHOD: The skin cancer balb/c mouse model was utilized in the study. Plant extracts were administered to animals using oral gavage. In addition, skin cancer was induced using 7,12-dimethylbenz(a) anthracene (DMBA). RESULTS: The study found that A. triphylla extract reduced both tumor incidence (P<0.01) and papilloma frequency (P<0.001) and delayed the onset of tumor development (P<0.001). The A. triphylla extract did not affect tumor size in animals. C. sativum leaf extract reduced the number of tumors per animal, the incidence of tumors, and the frequency of papilloma (P<0.05). In addition, it delayed (P<0.01) the onset of tumors. Treatment of animals with C. sativum seed extract reduced the frequency of papilloma (P<0.05) and delayed the onset of tumors (P<0.05). However, the examined plant extracts did not impact the size of tumors induced by DMBA (P>0.05). CONCLUSION: The findings of this study revealed that C. sativum and A. triphylla could protect against cancer development as indicated using the animal model of skin painting assay.

Investigation of the association of the RAN (rs14035) and XPO5 (rs11077) polymorphisms with venous thromboembolism.

INTRODUCTION: Venous thromboembolism (VTE) is the third most common hemostatic disease worldwide. Studies have reported a role for microRNA (miRNA) in the homeostasis and development of VTE. The ras-related nuclear protein (RAN) and exportin 5 (XPO5) genes are involved in miRNA biogenesis, as both regulate the transport of pre-miRNA from the nucleus to the cytoplasm. Therefore, the aim of the current study is to examine the association between RAN (rs14035) and XPO5 (rs11077) single nucleotide polymorphisms (SNPs) and VTE. METHODS: The study sample consisted of 300 subjects (150 patients and 150 age and sex matched controls). The polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP) and tetra-primer amplification refractory mutation system (T-ARMS) techniques were used to genotype rs14035 and rs11077, respectively. RESULTS: The results showed that there was a significant association between the XPO5 rs11077 and the risk of VTE (P < 0.05). Subjects with AC (OR: 2.08, CI:1.26-3.44) and CC (OR: 1.77, CI: 0.88-3.55) genotypes were at increased risk of the developing VTE. Regarding RAN gene, no association was found between rs14035 and VTE (P > 0.05). In addition, no associations were found between XPO5 rs11077 and RAN rs14035 genotypes with blood cell parameters (P > 0.05). As for the demographic characteristics, the results indicated a strong association between family history and body mass index (BMI) with the risk of VTE (P < 0.01). CONCLUSION: The XPO5 rs11077, BMI and family history might contribute to the development of VTE in Jordan.

The impact of COVID-19 pandemic on tobacco use: A population-based study.

BACKGROUND: Various aspects of lifestyle seem to change during confinement, particularly during the COVID-19 pandemic. The current study examines confinement's effects on tobacco smoking habits (SH). METHODS: A survey was distributed among adults living in Jordan (age >18 years) of both genders during April-May of 2020, of which 1925 responded to the survey. RESULTS: The prevalence of smoking was 33.3%, 46.1%, and 21.1% for cigarettes (Cg), waterpipe (Wp), and E-cigarettes (ECg), respectively. Among the smokers, 38.5-45.8% reported a "no-change," while 32.1-41.7% reported a "decrease" in SH during confinement. On the other hand, 18.0-22.1% reported an "increase" in the SH. However, concerning the factors that might affect SH, the results showed that age, gender, income, and job sector contribute to the observed changes. CONCLUSIONS: Changes in the SH during COVID-19 have been reported in about 50% of participants who smoke tobacco, with a more reported decrease than increase in use. Studies and interventions are needed to confirm further and understand the current results and discourage smoking during the COVID-19 pandemic.

Health-Related Quality of Life for Jordanian-Recovered Individuals During Post-COVID-19 Era: A Cross-Sectional Study.

Aim: This study aims to determine health-related quality of life (HRQoL) that includes the physical and mental health of recovered patients of COVID-19 and examines the significant impact of variables such as period of infection, sample demographics characteristics, hospitalization past, and chronic disease past and the other variables on HRQoL of COVID-19-recovered patients. Methods: An exploratory, community-based, cross-sectional research layout was adopted, using an electronic self-reporting survey disseminated online to recovered COVID-19 patients in Jordan. Targeted COVID-19 patients were individuals who were 18 years old or above. They had a documented background of COVID-19 illness, as stated in the following inclusion requirements: Those who had not been formally proven to have been afflicted by COVID-19 were excluded. Results: The mean of the physical well-being of study participants during COVID-19 was M=68.00 (SD=6.95), representing medium physical well-being status. The mean of psychological well-being of study participants during COVID-19 was M=60.20 (SD=8.85), representing medium physical health. Multiple regression showed that female recovered patients who are not working, with a low level of income, married women, and who getting COVID-19 more than once are having lower health-related quality of life compared to other recovered patients. Conclusion: The HRQoL of COVID-19 patients was significantly impacted, independent of the period since hospitalization or rehabilitation. Policymakers and health workers should research strong ways to enhance the HRQoL of COVID-19 patients as soon as possible. Elderly patients and those who have been infected more than one time and being hospitalized have a greater probability of decreased HRQoL after infection.

Public Perception Toward COVID-19 Disease Nature, Susceptibility to Complication, and Relationship to Influenza: A Cross-Sectional Study from Yemen.

Background: Following the coronavirus disease (COVID-19) declaration as a pandemic, Yemen has started applying preventive measures to prevent its spread. This study aims to identify the perception regarding the nature of the COVID-19 disease, susceptibility to severe forms of the disease, and its relationship to seasonal influenza among the population of Yemen. Methods: This was a cross-sectional study of the public in Yemen. The relationship between participants' sociodemographic factors and their responses was assessed by the chi-square test. Results: A total of 748 participants agreed to participate in the study. Regarding the nature of the diseases, nearly half of the participants (48.8%, n=352) believed that COVID-19 is a naturally occurring human virus that is a serious and fatal disease (61.2%, n=448). The majority (74.9%; n=518) did not agree that bacteria cause COVID-19. More than half of the participants (57.5%, n=423) believed this disease is transmitted to humans through a host animal. Regarding the vulnerable groups to develop severe COVID-19 infection, most of the participants pointed out that the elderly (94.3%, n=705), people with chronic diseases (89.9%, n=669), and pregnant women (53%, n=365) were more susceptible to severe diseases. Regarding symptoms, the majority (61.9%, n=458) of the participants agreed that the symptoms of COVID-19 are similar to those of seasonal influenza. Additionally, the majority (81.9%, n=579) agreed that some individuals develop more severe symptoms than seasonal influenza, particularly those with chronic illness. Gender, age, and education were found to be associated with participants' perceptions regarding the nature of the virus and susceptibility to severe disease. Conclusion: Participants demonstrate a good understanding of the nature and susceptibility to complications associated with COVID-19 disease and its relationship to influenza. However, the respondents with a lower level of education might require additional educational campaigns to improve their awareness of the disease.

Understanding Mental Health Status of Syrian Refugee and Jordanian Women: Novel Insights from a Comparative Study.

(1) Background: War and displacement are well-known predictors of negative mental health outcomes among affected populations. This is especially relevant for refugees of war, particularly women, who often repress their mental health needs due to family responsibilities, social stigma, and/or cultural pressures. In this study, we compared the mental health status of urban Syrian refugee women (n = 139) with local Jordanian women (n = 160). (2) Methods: Psychometrically validated Afghan Symptom Checklist (ASC), Perceived Stress Scale (PSS), and Self-Report Questionnaire (SRQ) examined psychological distress, perceived stress, and mental health, respectively. (3) Results: According to independent t-tests, Syrian refugee women scored higher than Jordanian women on the ASC [mean score (SD): 60.79 (16.67) vs. 53.71 (17.80), p < 0.001], PSS [mean score (SD): 31.59 (8.45) vs. 26.94 (7.37), p < 0.001], and SRQ [mean score (SD): 11.82 (4.30) vs. 10.21 (4.72), p = 0.002]. Interestingly, both Syrian refugee and Jordanian women scored higher than the clinical cutoff in the SRQ. Regression analyses indicated that more educated women were less likely to score high on the SRQ (ß = -0.143, p = 0.019), particularly in the anxiety and somatic symptoms subscale (ß = -0.133, p = 0.021), and were less likely to exhibit symptoms of ruminative sadness (ß = -0.138, p = 0.027). Employed women were more likely to exhibit high coping ability than unemployed women (ß = 0.144, p = 0.012). (4) Conclusions: Syrian refugee women scored higher than Jordanian women in all used mental health scales. Access to mental health services and enhancing educational opportunities would help mitigate perceived stress and may enhance stress-coping abilities.

Breast Cancer Beliefs and Screening Practices among Syrian Refugee Women and Jordanian Women.

Despite significant declines in breast cancer (BC) incidence in the West, this disease is widespread in Jordan, where cancer detection occurs at much advanced stages. This is particularly concerning for Syrian refugee women resettled in Jordan, who are less likely to undergo cancer preventative procedures because of poor health literacy and lack of health services access. The present work assesses and compares breast cancer awareness and breast cancer screening behaviors among Syrian refugee women and Jordanian women residing close to the Syrian-Jordanian border city of Ar-Ramtha. A cross-sectional survey was conducted using a validated Arabic version of the Breast Cancer Screening Beliefs Questionnaire (BCSBQ). A total of 138 Syrian refugee women and 160 Jordanian women participated in the study. Results indicate that 93.6% of Syrian refugee women and Jordanian women ≥ 40 years of age reported never having undergone a mammogram. Syrian refugee women and Jordanian women reported low attitudes toward general health checkup (mean score for Syrian refugees 45.6 vs. 42.04 among Jordan women; p = 0.150). Barriers for BC screening were higher among Syrian refugees (mean score = 56.43) than Jordanian women (mean score = 61.99, p = 0.006). Women with higher education were more likely to report fewer barriers to screening (p = 0.027). The study documents a significant lack of BC screening awareness among Syrian refugee women and Jordanian women, indicating that future work is needed to alter current attitudes towards mammograms and early detection measures especially for Syrian refugee women and Jordanian women residing in rural areas of Jordan.

Sleep quality and sleep patterns among recovered individuals during post-COVID-19 among Jordanian: A cross-sectional national study.

This study aims to investigate sleep patterns and quality in patients who had SARS-CoV-2 (COVID-19) infection and to determine the sleep quality and pattern among patients. A cross-sectional design was used to assess sleeping patterns during the post-COVID-19 era for recovered individuals from April 1st, 2022, to June 1st, 2022. The participants had to meet the following requirements: both genders, ages 18 to 70, and previously infected with COVID-19. The prevalence of low sleep quality among the recovered individuals during post-COVID-19 era was 834 (40.6%), and the prevalence of disturbance in sleep quality was 1308 (63.6%). Lower economic status and younger ages in twenties and thirties experienced more disturbances in sleep patterns than other older ages. Many predictors were determined the quality of sleep. These predictors were age (B = .105, P = .00), income (B = .05, P = .035) and educational level (B = .20, P = .006). To sum up, our study found that the prevalence of low sleep quality among the recovered individuals during post-COVID-19 era was moderate, and the prevalence of disturbance in sleep quality was high. The predictors of quality of sleep were age, income, and educational level. Practitioners should be trained to evaluate and manage sleep disturbances, as this comprehensive approach has the potential to reduce mental distress and prevent the consequences of sleep disturbances.

Review of Clinical Equipoise: Examples from Oncology Trials.

BACKGROUND: The current standards that govern clinical research have been shaped over the years through many historical, social, and political events. The third principle of the Belmont Report, Justice, guides the scientific community toward the equal distribution of benefits and risks in research involving human subjects. Clinical equipoise is the status of genuine uncertainty by the investigator about the superiority of one treatment arm over the other. The term clinical equipoise was proposed to provide an ethical ground to conduct randomized controlled clinical trials. OBJECTIVE: The objective of this review is to provide the reader with an overview of the emergence of the term equipoise and its utilization in randomized controlled trials. METHODS: In the current review article, the major oncology clinical trials and relevant patents were reviewed for the application/utilization of clinical equipoise. RESULTS: The concept of clinical equipoise has been challenged, and different alternatives were proposed. Yet, these alternatives received numerous critiques and failed to fully replace equipoise. In addition, several patents related to anticancer agents tested in the described studies were examined. No specific reference was made as part of the patent to the status of clinical equipoise. Alternatively, a description of the study arms was provided. CONCLUSION: There is a need for revisiting the concept of equipoise and its suggested alternatives for its ethical essence while addressing related challenges.

Genotoxicity of nedaplatin in cultured lymphocytes: modulation by vitamin E.

Nedaplatin is a chemotherapeutic agent used widely in cancer therapy. Nedaplatin has been shown to cause DNA damage to cells via the induction of oxidative stress. Vitamin E (Vit E) has an anti-mutagenic activity that can protect cells from DNA damaging agents. The objective of this study is to examine the genotoxic and cytotoxic effects of nedaplatin in human cultured lymphocytes. In addition, modulation of such effects by Vit E was also examined. The frequencies of sister chromatid exchange (SCE) and chromosomal aberrations (CAs) were used as an indicator for genotoxicity. The mitotic and proliferative indices were used to examine the cytotoxic effects of nedaplatin. The results showed that nedaplatin significantly elevated SCE and CA frequencies in human lymphocytes (p Ë‚ 0.01). The increases in the frequencies of SCE and CA caused by nedaplatin were lowered by pretreatment treatment with Vit E (p < 0.05). Nedaplatin significantly lowered mitotic index but Vit E pretreatment did not modulate this effect. These results suggest that Vit E has the potential to ameliorate the genotoxicity of nedaplatin in cultured lymphocytes.