Search results for: immunosuppressant medications

Authors: Jun Won Kim

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Objective: Theta-phase gamma-amplitude coupling (TGC) was used as a novel evidence-based tool to reflect the dysfunctional cortico-thalamic interaction in patients with schizophrenia. However, to our best knowledge, no studies have reported the diagnostic utility of the TGC in the resting-state electroencephalographic (EEG) of neuroleptic-naive patients with schizophrenia compared to healthy controls. Thus, the purpose of this EEG study was to understand the underlying mechanisms in patients with schizophrenia by comparing the TGC at rest between two groups and to evaluate the diagnostic utility of TGC. Method: The subjects included 90 patients with schizophrenia and 90 healthy controls. All patients were diagnosed with schizophrenia according to the criteria of Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) by two independent psychiatrists using semi-structured clinical interviews. Because patients were either drug-naïve (first episode) or had not been taking psychoactive drugs for one month before the study, we could exclude the influence of medications. Five frequency bands were defined for spectral analyses: delta (1–4 Hz), theta (4–8 Hz), slow alpha (8–10 Hz), fast alpha (10–13.5 Hz), beta (13.5–30 Hz), and gamma (30-80 Hz). The spectral power of the EEG data was calculated with fast Fourier Transformation using the 'spectrogram.m' function of the signal processing toolbox in Matlab. An analysis of covariance (ANCOVA) was performed to compare the TGC results between the groups, which were adjusted using a Bonferroni correction (P < 0.05/19 = 0.0026). Receiver operator characteristic (ROC) analysis was conducted to examine the discriminating ability of the TGC data for schizophrenia diagnosis. Results: The patients with schizophrenia showed a significant increase in the resting-state TGC at all electrodes. The delta, theta, slow alpha, fast alpha, and beta powers showed low accuracies of 62.2%, 58.4%, 56.9%, 60.9%, and 59.0%, respectively, in discriminating the patients with schizophrenia from the healthy controls. The ROC analysis performed on the TGC data generated the most accurate result among the EEG measures, displaying an overall classification accuracy of 92.5%. Conclusion: As TGC includes phase, which contains information about neuronal interactions from the EEG recording, TGC is expected to be useful for understanding the mechanisms the dysfunctional cortico-thalamic interaction in patients with schizophrenia. The resting-state TGC value was increased in the patients with schizophrenia compared to that in the healthy controls and had a higher discriminating ability than the other parameters. These findings may be related to the compensatory hyper-arousal patterns of the dysfunctional default-mode network (DMN) in schizophrenia. Further research exploring the association between TGC and medical or psychiatric conditions that may confound EEG signals will help clarify the potential utility of TGC.

Keywords: quantitative electroencephalography (QEEG), theta-phase gamma-amplitude coupling (TGC), schizophrenia, diagnostic utility

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Authors: Esra Yuce, Isil D. S. Yamaner, Murude Yazan

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Aims and objective: Antiresorptive agents including bisphosphonates and denosumab as strong suppressors of osteoclasts are the most commonly used antiresorptive medications for the treatment of osteoporosis which counteract the negative quantitative alteration of trabecular and cortical bone by inhibition of bone turnover. Oral bisphosphonate therapy for the treatment of osteopenia, osteoporosis or Paget's disease is associated with the low-grade risk of osteonecrosis of the jaw, while higher-grade risk is associated with receiving intravenous bisphosphonates therapy in the treatment of multiple myeloma and bone metastases. On the other hand, there has been a remarkable increase in incidences of antiresorptive related osteonecrosis of the jaw (ARONJ) in oral bisphosphonate users. This clinical presentation will evaluate the healing outcomes via piezoelectric bone surgery under the irrigation of PVP-I solution irrigation in patients received bisphosphonate therapy. Material-Method: The study involved 8 female and 5 male patients that have been treated for ARONJ. Among 13 necrotic sites, 9 were in the mandible and 4 were in the maxilla. All of these 13 patients treated with surgical debridement via piezoelectric bone surgery under irrigation by solution with 3% PVP-I concentration in combination with long-term antibiotic therapy and 5 also underwent removal of mobile segments of bony sequestrum. All removable prosthesis in 8 patients were relined with soft liners during the healing periods in order to eliminate chronic minor traumas. Results: All patients were on oral bisphosphonate therapy for at least 2 years and 5 of which had received intravenous bisphosphonates up to 1 year before therapy with oral bisphosphonates was started. According to the AAOMS staging system, four cases were stage II, eight cases were stage I, and one case was stage III. The majority of lesions were identified at sites of dental prostheses (38%) and dental extractions (62%). All patients diagnosed with ARONJ stage I had used unadjusted removable prostheses. No recurrence of the symptoms was observed during the present follow-up (9–37 months). Conclusion: Despite their confirmed effectiveness, the prevention and treatment of osteonecrosis of the jaw secondary to oral bisphosphonate therapy remain major medical challenges. Treatment with piezoelectric bone surgery with irrigation of povidone-iodine solution was effective for management of bisphosphonate-related osteonecrosis of the jaw. Taking precautions for patients treated with oral bisphosphonates, especially also denture users, may allow for a reduction in the rate of developing osteonecrosis of the maxillofacial region.

Keywords: antiresorptive drug related osteonecrosis, bisphosphonate therapy, piezoelectric bone surgery, povidone iodine

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Authors: Roya Yumul, Ofelia Loani Elvir-Lazo, Sevan Komshian, Ruby Wang, Jun Tang

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BACKGROUND: An objective means for monitoring the anti-nociceptive effects of perioperative medications has long been desired as a way to provide anesthesiologists information regarding a patient’s level of antinociception and preclude any untoward autonomic responses and reflexive muscular movements from painful stimuli intraoperatively. To this end, electroencephalogram (EEG) based tools including BIS and qCON were designed to provide information about the depth of sedation while qNOX was produced to inform on the degree of antinociception. The goal of this study was to compare the reliability of qCON/qNOX to BIS as specific indicators of response to nociceptive stimulation. METHODS: Sixty-two patients undergoing general anesthesia with LMA were included in this study. Institutional Review Board (IRB) approval was obtained, and informed consent was acquired prior to patient enrollment. Inclusion criteria included American Society of Anesthesiologists (ASA) class I-III, 18 to 80 years of age, and either gender. Exclusion criteria included the inability to consent. Withdrawal criteria included conversion to the endotracheal tube and EEG malfunction. BIS and qCON/qNOX electrodes were simultaneously placed on all patients prior to induction of anesthesia and were monitored throughout the case, along with other perioperative data, including patient response to noxious stimuli. All intraoperative decisions were made by the primary anesthesiologist without influence from qCON/qNOX. Student’s t-distribution, prediction probability (PK), and ANOVA were used to statistically compare the relative ability to detect nociceptive stimuli for each index. Twenty patients were included for the preliminary analysis. RESULTS: A comparison of overall intraoperative BIS, qCON and qNOX indices demonstrated no significant difference between the three measures (N=62, p> 0.05). Meanwhile, index values for qNOX (62±18) were significantly higher than those for BIS (46±14) and qCON (54±19) immediately preceding patient responses to nociceptive stimulation in a preliminary analysis (N=20, * p= 0.0408). Notably, certain hemodynamic measurements demonstrated a significant increase in response to painful stimuli (MAP increased from 74 ±13 mm Hg at baseline to 84 ± 18 mm Hg during noxious stimuli [p= 0.032] and HR from 76 ± 12 BPM at baseline to 80 ± 13 BPM during noxious stimuli [p=0.078] respectively). CONCLUSION: In this observational study, BIS and qCON/qNOX provided comparable information on patients’ level of sedation throughout the course of an anesthetic. Meanwhile, increases in qNOX values demonstrated a superior correlation to an imminent response to stimulation relative to all other indices

Keywords: antinociception, BIS, general anesthesia, LMA, qCON/qNOX

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Authors: Yael Wolff Sagy, Yiska Loewenberg Weisband, Vered Kaufman Shriqui, Michal Krieger, Arie Ben Yehuda, Ronit Calderon Margalit

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Background: Obesity is both a risk factor and common comorbidity of diabetes. Obesity impedes the achievement of glycemic control, and enhances damage caused by hyperglycemia to blood vessels; thus it increases diabetes-related complications. This study assessed the prevalence of obesity and morbid obesity among Israeli adults with diabetes, and estimated disparities associated with sex and socioeconomic position (SEP). Methods: A cross-sectional study was conducted in the setting of the Israeli National Program for Quality Indicators in Community Healthcare. Data on all the Israeli population is retrieved from electronic medical records of the four health maintenance organizations (HMOs). The study population included all Israeli patients with diabetes aged 20-64 with documented body mass index (BMI) in 2016 (N=180,451). Diabetes was defined as the existence of one or more of the following criteria: (a) Plasma glucose level >200 mg% in at least two tests conducted at least one month apart in the previous year; (b) HbA1c>6.5% at least once in the previous year (c) at least three prescriptions of diabetes medications were dispensed during the previous year. Two measures were included: the prevalence of obesity (defined as last BMI≥ 30 kg/m2 and <35 kg/m2) and the prevalence of morbid obesity (defined as last BMI≥ 35 kg/m2) in individuals aged 20-64 with diabetes. The cut-off value for morbid obesity was set in accordance with the eligibility criteria for bariatric surgery in diabetics. Data were collected by the HMOs and aggregated by age, sex and SEP. SEP was based on statistical areas ranking by the Israeli Central Bureau of Statistics and divided into 4 categories, ranking from 1 (lowest) to 4 (highest). Results: BMI documentation among adults with diabetes was 84.9% in 2016. The prevalence of obesity in the study population was 30.5%. Although the overall rate was similar in both sexes (30.8% in females, 30.3% in males), SEP disparities were stronger in females (32.7% in SEP level 1 vs. 27.7% in SEP level 4; 18.1% relative difference) compared to males (30.6% in SEP level 1 vs. 29.3% in SEP level 4; 4.4% relative difference). The overall prevalence of morbid obesity in this population was 20.8% in 2016. The rate among females was almost double compared to the rate in males (28.1% and 14.6%, respectively). In both sexes, the prevalence of morbid obesity was strongly associated with lower SEP. However, in females, disparities between SEP levels were much stronger (34.3% in SEP level 1 vs. 18.7% in SEP level 4; 83.4% relative difference) compared to SEP-disparities in males (15.7% in SEP level 1 vs. 12.3% in SEP level 4; 27.6% relative difference). Conclusions: The overall prevalence of BMI≥ 30 kg/m2 among adults with diabetes in Israel exceeds 50%; and the prevalence of morbid obesity suggests that 20% meet the BMI-criteria for bariatric surgery. Prevalence rates show major SEP- and sex-disparities; especially strong SEP disparities in morbid obesity among females. These findings highlight the need for greater consideration of different population groups when implementing interventions.

Keywords: diabetes, health disparities, health policy, obesity, socio-economic position

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Authors: Anne Giles

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Humans naturally wish they could forget traumatic experiences. To help prevent future harm, however, the human brain has evolved to retain data about experiences of threat, alarm, or violation. When given compassionate support and assistance with thinking helpfully and realistically about traumatic events, most people can adjust to experiencing hardships, albeit with residual sad, unfortunate memories. Persistent, recurrent, intrusive memories, difficulty sleeping, emotion dysregulation, and avoidance of reminders, however, may be symptoms of Post-traumatic Stress Disorder (PTSD). Brain scans show that PTSD affects brain functioning. We currently have no physical means of restoring the system of brain structures and functions involved with PTSD. Medications may ease some symptoms but not others. However, forms of "talk therapy" with cognitive components have been found by researchers to reduce, even resolve, a broad spectrum of trauma symptoms. Many cultures have taboos against talking about hardships. Individuals may present themselves to mental health care professionals with severe, disabling trauma symptoms but, because of cultural norms, be unable to speak about them. In China, for example, relationship expectations may include the belief, "Bad things happening in the family should stay in the family (jiāchǒu bùkě wàiyán 家丑不可外扬)." The concept of "family (jiā 家)" may include partnerships, close and extended families, communities, companies, and the nation itself. In contrast to many trauma therapies, Cognitive Processing Therapy (CPT) for Post-traumatic Stress Disorder asks its participants to focus not on "what" happened but on "why" they think the trauma(s) occurred. The question "why" activates and exercises cognitive functioning. Brain scans of individuals with PTSD reveal executive functioning portions of the brain inadequately active, with emotion centers overly active. CPT conceptualizes PTSD as a network of cognitive distortions that keep an individual "stuck" in this under-functioning and over-functioning dynamic. Through asking participants forms of the question "why," plus offering a protocol for examining answers and relinquishing unhelpful beliefs, CPT assists individuals in consciously reactivating the cognitive, executive functions of their brains, thus restoring normal functioning and reducing distressing trauma symptoms. The culturally sensitive components of CPT that allow people to "talk about it without talking about it" may offer the possibility for worldwide relief from symptoms of trauma.

Keywords: cognitive processing therapy (CPT), cultural norms, post-traumatic stress disorder (PTSD), trauma recovery

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Authors: Mohammed Khalil Ur Rahman, Mohammed Alsharon, Arshad Muktar, Zahid Shaik

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Any ailment can go into terminal stages, cancer being one such disease which is many times detected in latent stages. Cancer is often characterized by constitutional symptoms which are agonizing in nature which disturbs patients and their family as well. In order to relieve such intolerable symptoms treatment modality employed is known to be ‘Palliative Care’. The goal of palliative care is to enhance patient’s quality of life by relieving or rather reducing the distressing symptoms of patients such as pain, nausea/ vomiting, anorexia/loss of appetite, excessive salivation, mouth ulcers, weight loss, constipation, oral thrush, emaciation etc. which are due to the effect of disease or due to the undergoing treatment such as chemotherapy, radiation etc. Ayurveda and Unani as well as other traditional medicines is getting more and more international attention in recent years and Ayurveda and Unani holistic perspective of the disease, it seems that there are many herbs and herbomineral preparation which can be employed in the treatment of malignancy and also in palliative care. Though many of them have yet to be scientifically proved as anti-cancerous but there is definitely a positive lead that some of these medications relieve the agonising symptoms thereby making life of the patient easy. Health is viewed in Islam in a holistic way. One of the names of the Quran is al-shifa' meaning ‘that which heals’ or ‘the restorer of health’ to refer to spiritual, intellectual, psychological, and physical health. The general aim of medical science, according to Islam, is to secure and adopt suitable measures which, with Allah’s permission, help to preserve or restore the health of the human body. Islam motivates the Physician to view the patient as one organism. The patient has physical, social, psychological, and spiritual dimensions that must be considered in synthesis with an integrated, holistic approach. Aims & Objectives: - To suggest herbs which are mentioned in Ayurveda Unani with potential palliative activity in case of Cancer patients. - Most of tibb nabawi [Prophetic Medicine] is preventive medicine and must have been divinely inspired. - Spiritual Aspects of Healing: Prayer, dua, recitation of the Quran - Remembrance of Allah play a central role.Materials & Method: Literary review of the herbs supported with experiential evidence will be discussed. Discussion: On the basis of collected data subject will be discussed in length. Conclusion: Will be presented in paper.

Keywords: palliative care, holistic, Ayurvedic and Unani traditional system of medicine, Quran, hadith

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Authors: Ming-Dong Wang, Abigail F. Ruby, Michelle E. Ross

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Methylphenidate is a first-line treatment drug for attention deficit hyperactivity disorder (ADHD), a common mental health disorder in children and adolescents. Over the last several decades, the rate of children and adolescents using ADHD medication has been increasing in many countries. A recent study found that the prevalence of ADHD medication use among children aged 3-18 years increased in 13 different world regions between 2001 and 2015, where the absolute increase ranged from 0.02 to 0.26% per year. The goal of this study was to examine the use of methylphenidate in Canadian children and its associated adverse reactions. Methylphenidate use information among young Canadians aged 0-14 years was extracted from IQVIA data on prescriptions dispensed by pharmacies between April 2014 and June 2020. The adverse reaction information associated with methylphenidate use was extracted from the Canada Vigilance database for the same time period. Methylphenidate use trends were analyzed based on sex, age group (0-4 years, 5-9 years, and 10-14 years), and geographical location (province). The common classes of adverse reactions associated with methylphenidate use were sorted, and the relative risks associated with methylphenidate use as compared with two second-line amphetamine medications for ADHD were estimated. This study revealed that among Canadians aged 0-14 years, every 100 people used about 25 prescriptions (or 23,000 mg) of methylphenidate per year during the study period, and the use increased with time. Boys used almost three times more methylphenidate than girls. The amount of drug used was inversely associated with age: Canadians aged 10-14 years used nearly three times as many drugs compared to those aged 5-9 years. Seasonal methylphenidate use patterns were apparent among young Canadians, but the seasonal trends differed among the three age groups. Methylphenidate use varied from region to region, and the highest methylphenidate use was observed in Quebec, where the use of methylphenidate was at least double that of any other province. During the study period, Health Canada received 304 adverse reaction reports associated with the use of methylphenidate for Canadians aged 0-14 years. The number of adverse reaction reports received for boys was 3.5 times higher than that for girls. The three most common adverse reaction classes were psychiatric disorders, nervous system disorders and injury, poisoning procedural complications. The number one commonly reported adverse reaction for boys was aggression (11.2%), while for girls, it was a tremor (9.6%). The safety profile in terms of adverse reaction classes associated with methylphenidate use was similar to that of the selected control products. Methylphenidate is a commonly used pharmaceutical product in young Canadians, particularly in the province of Quebec. Boys used approximately three times more of this product as compared to girls. Future investigation is needed to determine what factors are associated with the observed geographic variations in Canada.

Keywords: adverse reaction risk, methylphenidate, prescription trend, use variation

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Authors: Edison Ramos, John Peter V. Dacanay, Milwida Josefa Villanueva

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Soil-Transmitted Helminth (STH) infections caused by helminths are the most prevalent neglected tropical diseases (NTDs). They are commonly found in warm, humid regions and developing countries, particularly in rural areas with poor hygiene. Occasionally, human hosts exposed to pig manure may harbor Ascaris suum parasites without experiencing any symptoms. To address the significant issue of helminth infections, an effective anthelmintic is necessary. However, the effectiveness of various medications as anthelmintics can be reduced due to mutations. In recent years, there has been a growing interest in using plants as a source of medicine due to their natural origin, accessibility, affordability, and potential lack of complications. Herbal medicine has been advocated as an alternative treatment for helminth infections, especially in underdeveloped countries, considering the numerous adverse effects and drug resistance associated with commercially available anthelmintics. Medicinal plants are considered suitable replacements for current anthelmintics due to their historical usage in treating helminth infections. The objective of this research was to investigate the effects of aqueous extraction of pomegranate peel (Punica granatum L.) as an anthelmintic on female Ascaris suum in vitro. The in vitro assay involved observing the motility of Ascaris suum in different concentrations (25%, 50%, 75%, and 100%) of pomegranate peel aqueous extraction, along with mebendazole as a positive control. The results indicated that as the concentration of the extract increased, the time required to paralyze the worms decreased. At 25% concentration, the average time for paralysis was 362.0 minutes, which decreased to 181.0 minutes at 50% concentration, 122.7 minutes at 75% concentration, and 90.0 minutes at 100% concentration. The time of death for the worms was directly proportional to the concentration of the pomegranate peel extract. Death was observed at an average time of 240.7 minutes at 75% concentration and 147.7 minutes at 100% concentration. The findings suggest that as the concentration of pomegranate peel extract increases, the time required for paralysis and death of Ascaris suum decreases. This indicates a concentration-dependent relationship, where higher concentrations of the extract exhibit greater effectiveness in inducing paralysis and causing the death of the worms. These results emphasize the potential anthelmintic properties of pomegranate peel extract and its ability to effectively combat Ascaris suum infestations. There was no significant difference in the anthelmintic effectiveness between the pomegranate peel extract and Mebendazole. These findings highlight the potential of pomegranate peel extract as an alternative anthelmintic treatment for Ascaris suum infections. The researchers recommend determining the optimal dose and administration route to maximize the effectiveness of pomegranate peel as an anthelmintic therapeutic against Ascaris suum.

Keywords: pomegranate peel, aqueous extract, anthelmintic, in vitro

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Authors: Faris Alkhalil, Rana Bitar, Amer Azaz, Hisham Natour, Noora Almeraikhi, Mohamad Miqdady

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Background: Children with liver transplantation are achieving very good survival and so there is now a need to concentrate on achieving good health in these patients and preventing disease. Immunosuppressive medications have side effects that need to be monitored and if possible avoided. Glucocorticoids and calcineurin inhibitors are detrimental to bone and mineral homeostasis in addition steroids can also affect linear growth. Steroid sparing regimes in renal transplant children has shown to improve children’s height. Aim: We aim to review the growth and bone health of children post liver transplant by measuring bone mineral density (BMD) using dual energy X-ray absorptiometry (DEXA) scan and assessing if there is a clear link between poor growth and impaired bone health and use of long term steroids. Subjects and Methods: This is a single centre retrospective Cohort study, we reviewed the medical notes of children (0-16 years) who underwent a liver transplantation between November 2000 to November 2016 and currently being followed at our centre. Results: 39 patients were identified (25 males and 14 females), the median transplant age was 2 years (range 9 months - 16 years), and the median follow up was 6 years. Four patients received a combined transplant, 2 kidney and liver transplant and 2 received a liver and small bowel transplant. The indications for transplant included, Biliary Atresia (31%), Acute Liver failure (18%), Progressive Familial Intrahepatic Cholestasis (15%), transplantable metabolic disease (10%), TPN related liver disease (8%), Primary Hyperoxaluria (5%), Hepatocellular carcinoma (3%) and other causes (10%). 36 patients (95%) were on a calcineurin inhibitor (34 patients were on Tacrolimus and 2 on Cyclosporin). The other three patients were on Sirolimus. Low dose long-term steroids was used in 21% of the patients. A considerable proportion of the patients had poor growth. 15% were below the 3rd centile for weight for age and 21% were below the 3rd centile for height for age. Most of our patients with poor growth were not on long term steroids. 49% of patients had a DEXA scan post transplantation. 21% of these children had low bone mineral density, one patient had met osteoporosis criteria with a vertebral fracture. Most of our patients with impaired bone health were not on long term steroids. 20% of the patients who did not undergo a DEXA scan developed long bone fractures and 50% of them were on long term steroid use which may suggest impaired bone health in these patients. Summary and Conclusion: The incidence of impaired bone health, although studied in limited number of patients; was high. Early recognition and treatment should be instituted to avoid fractures and improve bone health. Many of the patients were below the 3rd centile for weight and height however there was no clear relationship between steroid use and impaired bone health, reduced weight and reduced linear height.

Keywords: bone, growth, pediatric, liver, transplantation

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Authors: Muhammad Qamar Masood, Syed Abbas Raza, Umar Yousaf Raja, Imran Hassan, Bilal Afzal, Muhammad Aleem Zahir, Atika Shaheer

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Background: Cardiovascular disease (CVD) is a major burden among people with type 2 diabetes (T2D) with 1 in 3 reported to have CVD. Therefore, understanding real-world clinical characteristics and prescribing patterns could help in better care. Objective: The CONVERGE (Cardiovascular Outcomes and Value in the Real world with GLP-1RAs) study characterized demographics and medication usage patterns in T2D intensified (add-on to metformin) overall population. The data were further divided into subgroups {dipeptidyl peptidase-4 inhibitors (DPP-4is), sulfonylureas (SUs), insulins, glucagon-like peptide-1 receptor agonists (GLP-1 RAs) and sodium-glucose cotransporter-2 inhibitors (SGLT-2is)}, according to the latest prescribed antidiabetic agent (ADA) in India/Pakistan/Thailand. Here, we report findings from Pakistan. Methods: A multi-center retrospective study utilized data from medical records between 13-Sep-2008 (post-market approval of GLP-1RAs) and 31-Dec-2017 in adults (≥18-year-old). The data for this study were collected from 05 centers / institutes located in major cities of Pakistan, including Karachi, Lahore, Islamabad, and Multan. These centers included National Hospital, Aga Khan University Hospital, Diabetes Endocrine Clinic Lahore, Shifa International Hospital, Mukhtar A Sheikh Hospital Multan. Data were collected at start of medical record and at 6 or 12-months prior to baseline based on variable type; analyzed descriptively. Results: Overall, 1,010 patients were eligible. At baseline, overall mean age (SD) was 51.6 (11.3) years, T2D duration was 2.4 (2.6) years, HbA1c was 8.3% (1.9) and 35% received ≥1CVD medications in the past 1-year (before baseline). Most frequently prescribed ADAs post-metformin were DPP-4is and SUs (~63%). Only 6.5% received GLP-1RAs and SGLT-2is were not available in Pakistan during the study period. Overall, it took a mean of 4.4 years and 5 years to initiate GLP-1RAs and SGLT-2is, respectively. In comparison to other subgroups, more patients from GLP-1RAs received ≥3 types of ADA (58%), ≥1 CVD medication (64%) and had higher body mass index (37kg/m2). Conclusions: Utilization of GLP-1RAs and SGLT-2is was low, took longer time to initiate and not before trying multiple ADAs. This may be due to lack of evidence for CV benefits for these agents during the study period. The planned phase 2 of the CONVERGE study can provide more insights into utilization and barriers to prescribe GLP-1RAs and SGLT-2is post 2018 in Pakistan.

Keywords: type 2 diabetes, GLP-1RA, treatment intensification, cardiovascular disease

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Authors: Rebecca Pryce, Nijole Bernaitis, Andrew K. Davey, Shailendra Anoopkumar-Dukie

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Background: Warfarin is an oral anticoagulant widely used in the prevention of strokes in patients with atrial fibrillation (AF) and in the treatment and prevention of deep vein thrombosis (DVT). Regular monitoring of Internationalised Normalised Ratio (INR) is required to ensure therapeutic benefit with time in therapeutic range (TTR) used to measure warfarin control. A number of factors influence TTR including diet, concurrent illness, and drug interactions. Extensive literature exists regarding the effect of conventional medicines on warfarin control, but documented interactions relating to complementary medicines are limited. It has been postulated that fish oil and krill oil supplementation may affect warfarin due to their association with bleeding events. However, to date little is known as to whether fish and krill oil significantly alter the incidence of bleeding with warfarin or impact on warfarin control. Aim:To assess the influence of fish oil and krill oil supplementation on warfarin control in AF and DVT patients by determining the influence of these supplements on TTR and bleeding events. Methods:A retrospective cohort analysis was conducted utilising patient information from a large private pathology practice in Queensland. AF and DVT patients receiving warfarin management by the pathology practice were identified and their TTR calculated using the Rosendaal method. Concurrent medications were analysed and patients taking no other interacting medicines were identified and divided according to users of fish oil and krill oil supplements and those taking no supplements. Study variables included TTR and the incidence of bleeding with exclusion criteria being less than 30 days of treatment with warfarin. Subject characteristics were reported as the mean and standard deviation for continuous data and number and percentages for nominal or categorical data. Data was analysed using GraphPad InStat Version 3 with a p value of <0.05 considered to be statistically significant. Results:Of the 2081 patients assessed for inclusion into this study, a total of 573 warfarin users met the inclusion criteria. Of these, 416 (72.6%) patients were AF patients and 157 (27.4%) DVT patients and overall there were 316 (55.1%) male and 257 (44.9%) female patients. 145 patients were included in the fish oil/krill oil group (supplement) and 428 were included in the control group. The mean TTR of supplement users was 86.9% and for the control group 84.7% with no significant difference between these groups. Control patients experienced 1.6 times the number of minor bleeds per person compared to supplement patients and 1.2 times the number of major bleeds per person. However, this was not statistically significant nor was the comparison between thrombotic events. Conclusion: No significant difference was found between supplement and control patients in terms of mean TTR, the number of bleeds and thrombotic events. Fish oil and krill oil supplements when used concurrently with warfarin do not significantly affect warfarin control as measured by TTR and bleeding incidence.

Keywords: atrial fibrillation, deep vein thormbosis, fish oil, krill oil, warfarin

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Authors: Olufunke Olufunmilayo Ilemobayo, Barakat. O Abdulazeez

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Profit making among poultry egg farmers has been a challenge to efficient distribution of scarce farm resources over the years, due majorly to low capital base, inefficient management, technical inefficiency, economic inefficiency, thus poultry egg production has moved into an underperformed situation, characterised by low profit margin. Though previous studies focus mainly on broiler production and efficiency of its production, however, paucity of information exist in the areas of profit efficiency in the study area. Hence, determinants of profit efficiency among poultry egg farmers in Ondo State, Nigeria were investigated. A purposive sampling technique was used to obtain primary data from poultry egg farmers in Owo and Akure local government area of Ondo State, through a well-structured questionnaire. socio-economic characteristics such as age, gender, educational level, marital status, household size, access to credit, extension contact, other variables were input and output data like flock size, cost of feeder and drinker, cost of feed, cost of labour, cost of drugs and medications, cost of energy, price of crate of table egg, price of spent layers were variables used in the study. Data were analysed using descriptive statistics, budgeting analysis, and stochastic profit function/inefficiency model. Result of the descriptive statistics shows that 52 per cent of the poultry farmers were between 31-40 years, 62 per cent were male, 90 per cent had tertiary education, 66 per cent were primarily poultry farmers, 78 per cent were original poultry farm owners and 55 per cent had more than 5 years’ work experience. Descriptive statistics on cost and returns indicated that 64 per cent of the return were from sales of egg, while the remaining 36 per cent was from sales of spent layers. The cost of feeding take the highest proportion of 69 per cent of cost of production and cost of medication the lowest (7 per cent). A positive gross margin of N5, 518,869.76, net farm income of ₦ 5, 500.446.82 and net return on investment of 0.28 indicated poultry egg production is profitable. Equipment’s cost (22.757), feeding cost (18.3437), labour cost (136.698), flock size (16.209), drug and medication cost (4.509) were factors that affecting profit efficiency, while education (-2.3143), household size (-18.4291), access to credit (-16.027), and experience (-7.277) were determinant of profit efficiency. Education, household size, access to credit and experience in poultry production were the main determinants of profit efficiency of poultry egg production in Ondo State. Other factors that affect profit efficiency were cost of feeding, cost of labour, flock size, cost of drug and medication, they positively and significantly influenced profit efficiency in Ondo State, Nigeria.

Keywords: cost and returns, economic inefficiency, profit margin, technical inefficiency

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Authors: Ana Julia Acevedo Urquiaga, Jose A. Acevedo Suarez, Ana Julia Urquiaga Rodriguez, Neyfe Sablon Cossio

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Despite the progress made in logistics and supply chains fields, it is unavoidable the development of business models that use efficiently information to facilitate the integrated logistics flows management between partners. Collaborative management is an important tool for materializing the cooperation between companies, as a way to achieve the supply chain efficiency and effectiveness. The first face of this research was a comprehensive analysis of the collaborative planning on the Cuban companies. It is evident that they have difficulties in supply chains planning where production, supplies and replenishment planning are independent tasks, as well as logistics and distribution operations. Large inventories generate serious financial and organizational problems for entities, demanding increasing levels of working capital that cannot be financed. Problems were found in the efficient application of Information and Communication Technology on business management. The general objective of this work is to develop a methodology that allows the deployment of a planning and control system in a coordinated way on the medicine’s logistics system in Cuba. To achieve these objectives, several mechanisms of supply chain coordination, mathematical programming models, and other management techniques were analyzed to meet the requirements of collaborative logistics management in Cuba. One of the findings is the practical and theoretical inadequacies of the studied models to solve the current situation of the Cuban logistics systems management. To contribute to the tactical-operative management of logistics, the Collaborative Logistics Flow Management Model (CLFMM) is proposed as a tool for the balance of cycles, capacities, and inventories, always to meet the final customers’ demands in correspondence with the service level expected by these. The CLFMM has as center the supply chain planning and control system as a unique information system, which acts on the processes network. The development of the model is based on the empirical methods of analysis-synthesis and the study cases. Other finding is the demonstration of the use of a single information system to support the supply chain logistics management, allows determining the deadlines and quantities required in each process. This ensures that medications are always available to patients and there are no faults that put the population's health at risk. The simulation of planning and control with the CLFMM in medicines such as dipyrone and chlordiazepoxide, during 5 months of 2017, permitted to take measures to adjust the logistic flow, eliminate delayed processes and avoid shortages of the medicines studied. As a result, the logistics cycle efficiency can be increased to 91%, the inventory rotation would increase, and this results in a release of financial resources.

Keywords: collaborative management, medicine logistic system, supply chain planning, tactical-operative planning

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Authors: Neha Farid

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Due to the abuse of antimicrobial medications in animal feed, the occurrence of multi-drug resistant (MDR) pathogens in foods is currently a growing public health concern on a global scale. MDR infections have the potential to penetrate the food chain by posing a serious risk to both consumers and animals. Food pathogens are those biological agents that have the tendency to cause pathogenicity in the host body upon ingestion. The major reservoirs of foodborne pathogens include food-producing fauna like cows, pigs, goats, sheep, deer, etc. The intestines of these animals are highly condensed with several different types of food pathogens. Bacterial food pathogens are the main cause of foodborne disease in humans; almost 66% of the reported cases of food illness in a year are caused by the infestation of bacterial food pathogens. When ingested, these pathogens reproduce and survive or form different kinds of toxins inside host cells causing severe infections. The genus Listeria consists of gram-positive, rod-shaped, non-spore-forming bacteria. The disease caused by Listeria monocytogenes is listeriosis or gastroenteritis, which induces fever, vomiting, and severe diarrhea in the affected body. Campylobacter jejuni is a gram-negative, curved-rod-shaped bacteria causing foodborne illness. The major source of Campylobacter jejuni is livestock and poultry; particularly, chicken is highly colonized with Campylobacter jejuni. Serious public health concerns include the widespread growth of bacteria that are resistant to antibiotics and the slowing in the discovery of new classes of medicines. The objective of this study is to provide some potential antibacterial activities with certain broad-range antibiotics and our desired bacteriocins, i.e., Enterococcus faecium from specific strains preventing microbial contamination pathways in order to safeguard the food by lowering food deterioration, contamination, and foodborne illnesses. The food pathogens were isolated from various sources of dairy products and meat samples. The isolates were tested for the presence of Listeria and Campylobacter by gram staining and biochemical testing. They were further sub-cultured on selective media enriched with the growth supplements for Listeria and Campylobacter. All six strains of Listeria and Campylobacter were tested against ten antibiotics. Campylobacter strains showed resistance against all the antibiotics, whereas Listeria was found to be resistant only against Nalidixic Acid and Erythromycin. Further, the strains were tested against the two bacteriocins isolated from Enterococcus faecium. It was found that bacteriocins showed better antimicrobial activity against food pathogens. They can be used as a potential antimicrobial for food preservation. Thus, the study concluded that natural antimicrobials could be used as alternatives to synthetic antimicrobials to overcome the problem of food spoilage and severe food diseases.

Keywords: food pathogens, listeria, campylobacter, antibiotics, bacteriocins

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Authors: Abdulaziz Alakeel, Roaa Alamri, Abdulrahman Alomair, Mohammed Fouda

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Introduction: Ibrutinib is a selective, potent, and irreversible small-molecule inhibitor of Bruton's tyrosine kinase (BTK). It forms a covalent bond with a cysteine residue (CYS-481) at the active site of Btk, leading to inhibition of Btk enzymatic activity. The drug is indicated to treat certain type of cancers such as mantle cell lymphoma (MCL), chronic lymphocytic leukaemia and Waldenström's macroglobulinaemia (WM). Cardiac failure is a condition referred to inability of heart muscle to pump adequate blood to human body organs. There are multiple types of cardiac failure including left and right-sided heart failure, systolic and diastolic heart failures. The aim of this review is to evaluate the risk of cardiac failure associated with the use of ibrutinib and to suggest regulatory recommendations if required. Methodology: Signal Detection team at the National Pharmacovigilance Center (NPC) of Saudi Food and Drug Authority (SFDA) performed a comprehensive signal review using its national database as well as the World Health Organization (WHO) database (VigiBase), to retrieve related information for assessing the causality between cardiac failure and ibrutinib. We used the WHO- Uppsala Monitoring Centre (UMC) criteria as standard for assessing the causality of the reported cases. Results: Case Review: The number of resulted cases for the combined drug/adverse drug reaction are 212 global ICSRs as of July 2020. The reviewers have selected and assessed the causality for the well-documented ICSRs with completeness scores of 0.9 and above (35 ICSRs); the value 1.0 presents the highest score for best-written ICSRs. Among the reviewed cases, more than half of them provides supportive association (four probable and 15 possible cases). Data Mining: The disproportionality of the observed and the expected reporting rate for drug/adverse drug reaction pair is estimated using information component (IC), a tool developed by WHO-UMC to measure the reporting ratio. Positive IC reflects higher statistical association while negative values indicates less statistical association, considering the null value equal to zero. The results of (IC=1.5) revealed a positive statistical association for the drug/ADR combination, which means “Ibrutinib” with “Cardiac Failure” have been observed more than expected when compared to other medications available in WHO database. Conclusion: Health regulators and health care professionals must be aware for the potential risk of cardiac failure associated with ibrutinib and the monitoring of any signs or symptoms in treated patients is essential. The weighted cumulative evidences identified from causality assessment of the reported cases and data mining are sufficient to support a causal association between ibrutinib and cardiac failure.

Keywords: cardiac failure, drug safety, ibrutinib, pharmacovigilance, signal detection

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Authors: Amar Ghelani

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People with auditory verbal hallucinations (AVH) who seek support from mental health services commonly report feeling unheard and invalidated in their interactions with social workers and psychiatric professionals. Current mental health training and clinical approaches have proven to be inadequate in addressing the complex nature of voice hearing. Childhood trauma is a key factor in the development of AVH and can render people more vulnerable to hearing both supportive and/or disturbing voices. Lived experiences of racism, poverty, and immigration are also associated with development of what is broadly classified as psychosis. Despite evidence affirming the influence of environmental factors on voice hearing, the Western biomedical system typically conceptualizes this experience as a symptom of genetically-based mental illnesses which requires diagnosis and treatment. Overemphasis on psychiatric medications, referrals, and directive approaches to people’s problems has shifted clinical interventions away from assessing and addressing problems directly related to AVH. The Maastricht approach offers voice hearers and mental health workers an alternative and respectful starting point for understanding and coping with voices. The approach was developed by voice hearers in partnership with mental health professionals and entails an innovative method to assess and create meaning from voice hearing and related life stressors. The objectives of the approach are to help people who hear voices: (1) understand the problems and/or people the voices may represent in their history, and (2) cope with distress and find solutions to related problems. The Maastricht approach has also been found to help voice hearers integrate emotional conflicts, reduce avoidance or fear associated with AVH, improve therapeutic relationships, and increase a sense of control over internal experiences. The proposed oral presentation will be guided by a recovery-oriented theoretical framework which suggests healing from psychological wounds occurs through social connections and community support systems. The presentation will start with a brainstorming exercise to identify participants pre-existing knowledge of the subject matter. This will lead into a literature review on the relations between trauma, intersectionality, and AVH. An overview of the Maastricht approach and review of research related to its therapeutic risks and benefits will follow. Participants will learn trauma-informed coping skills and questions which can help voice hearers make meaning from their experiences. The presentation will conclude with a review of resources and learning opportunities where participants can expand their knowledge of the Hearing Voices Movement and Maastricht approach.

Keywords: Maastricht interview, recovery, therapeutic assessment, voice hearing

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Authors: Geum Yeon Sim, Jasal Patel, Anand Kumthekar, Stanley Wainapel

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A 65-year-old right-hand dominant African-American man, formerly employed as a security guard, was referred to Rehabilitation Medicine with bilateral hand stiffness and weakness. His past medical history was only significant for myelofibrosis, diagnosed 4 years earlier, for which he was receiving scheduled blood transfusions. Approximately 2 years ago, he began to notice stiffness and swelling in his non-dominant hand that progressed to pain and decreased strength, limiting his hand function. Similar but milder symptoms developed in his right hand several months later. There was no history of prior injury or exposure to cold. Physical examination showed enlargement of metacarpophalangeal (MCP) and proximal interphalangeal (PIP) joints with finger flexion contractures, Swan-neck and Boutonniere deformities, and associated joint tenderness. Changes were more prominent in the left hand. X-rays showed mild osteoarthritis of several bilateral PIP joints. Anti-nuclear antibodies, rheumatoid factor, and cyclic citrullinated peptide antibodies were negative. MRI of the hand showed no erosions or synovitis. A rheumatology consultation was obtained, and the cause of his symptoms was attributed to myelofibrosis-related arthropathy with secondary osteoarthritis. The patient was tried on diclofenac cream and received a few courses of Occupational Therapy with limited functional improvement. Primary myelofibrosis (PMF) is a rare myeloproliferative neoplasm characterized by clonal proliferation of myeloid cells with variable morphologic maturity and hematopoietic efficiency. Rheumatic manifestations of malignancies include direct invasion, paraneoplastic presentations, secondary gout, or hypertrophic osteoarthropathy. PMF causes gradual bone marrow fibrosis with extramedullary metaplastic hematopoiesis in the liver, spleen, or lymph nodes. Musculoskeletal symptoms are not common and are not well described in the literature. The first reported case of myelofibrosis related arthritis was seronegative arthritis due to synovial invasion of myeloproliferative elements. Myelofibrosis has been associated with autoimmune diseases such as systemic lupus erythematosus, progressive systemic sclerosis, and rheumatoid arthritis. Gout has been reported in patients with myelofibrosis, and the underlying mechanism is thought to be related to the high turnover of nucleic acids that is greatly augmented in this disease. X-ray findings in these patients usually include erosive arthritis with synovitis. Treatment of underlying PMF is the treatment of choice, along with anti-inflammatory medications. Physicians should be cognizant of recognizing this rare entity in patients with PMF while maintaining clinical suspicion for more common causes of joint deformities, such as rheumatic diseases.

Keywords: myelofibrosis, arthritis, arthralgia, malignancy

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Authors: Nisa Mohan

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Clinical coding is a feasible method for estimating the national prevalence of adverse drug event (ADE) admissions. However, under-coding of ADE admissions is a limitation of this method. Whilst the under-coding will impact the accurate estimation of the actual burden of ADEs, the feasibility of the coded data in estimating the adverse drug event admissions goes much further compared to the other methods. Therefore, it is necessary to know the reasons for the under-coding in order to improve the clinical coding of ADE admissions. The ability to identify the reasons for the under-coding of ADE admissions rests on understanding the decision-making process of coding ADE admissions. Hence, the current study aimed to explore the decision-making process of clinical coders when coding cases of ADE admissions. Clinical coders from different levels of coding job such as trainee, intermediate and advanced level coders were purposefully selected for the interviews. Thirteen clinical coders were recruited from two Auckland region District Health Board hospitals for the interview study. Semi-structured, one-on-one, face-to-face interviews using open-ended questions were conducted with the selected clinical coders. Interviews were about 20 to 30 minutes long and were audio-recorded with the approval of the participants. The interview data were analysed using a general inductive approach. The interviews with the clinical coders revealed that the coders have targets to meet, and they sometimes hesitate to adhere to the coding standards. Coders deviate from the standard coding processes to make a decision. Coders avoid contacting the doctors for clarifying small doubts such as ADEs and the name of the medications because of the delay in getting a reply from the doctors. They prefer to do some research themselves or take help from their seniors and colleagues for making a decision because they can avoid a long wait to get a reply from the doctors. Coders think of ADE as a small thing. Lack of time for searching for information to confirm an ADE admission, inadequate communication with clinicians, along with coders’ belief that an ADE is a small thing may contribute to the under-coding of the ADE admissions. These findings suggest that further work is needed on interventions to improve the clinical coding of ADE admissions. Providing education to coders about the importance of ADEs, educating clinicians about the importance of clear and confirmed medical records entries, availing pharmacists’ services to improve the detection and clear documentation of ADE admissions, and including a mandatory field in the discharge summary about external causes of diseases may be useful for improving the clinical coding of ADE admissions. The findings of the research will help the policymakers to make informed decisions about the improvements. This study urges the coding policymakers, auditors, and trainers to engage with the unconscious cognitive biases and short-cuts of the clinical coders. This country-specific research conducted in New Zealand may also benefit other countries by providing insight into the clinical coding of ADE admissions and will offer guidance about where to focus changes and improvement initiatives.

Keywords: adverse drug events, clinical coders, decision making, hospital admissions

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Authors: Ivana Knezevic, Kenneth D. Candido, N. Nick Knezevic

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Background: While pain intensity scales remain generally accepted assessment tool, and the numeric pain rating score is highly subjective, we nevertheless rely on them to make a judgment about treatment effects. Misinterpretation of pain can lead practitioners to underestimate or overestimate the patient’s medical condition. The purpose of this study was to analyze how the numeric rating pain scores given by patients with low back pain correlate with their functional activity levels. Methods: We included 100 consecutive patients with radicular low back pain (LBP) after the Institutional Review Board (IRB) approval. Pain scores, numeric rating scale (NRS) responses at rest and in the movement,Oswestry Disability Index (ODI) questionnaire answers were collected 10 times through 12 months. The ODI questionnaire is targeting a patient’s activities and physical limitations as well as a patient’s ability to manage stationary everyday duties. Statistical analysis was performed by using SPSS Software version 20. Results: The average duration of LBP was 14±22 months at the beginning of the study. All patients included in the study were between 24 and 78 years old (average 48.85±14); 56% women and 44% men. Differences between ODI and pain scores in the range from -10% to +10% were considered “normal”. Discrepancies in pain scores were graded as mild between -30% and -11% or +11% and +30%; moderate between -50% and -31% and +31% and +50% and severe if differences were more than -50% or +50%. Our data showed that pain scores at rest correlate well with ODI in 65% of patients. In 30% of patients mild discrepancies were present (negative in 21% and positive in 9%), 4% of patients had moderate and 1% severe discrepancies. “Negative discrepancy” means that patients graded their pain scores much higher than their functional ability, and most likely exaggerated their pain. “Positive discrepancy” means that patients graded their pain scores much lower than their functional ability, and most likely underrated their pain. Comparisons between ODI and pain scores during movement showed normal correlation in only 39% of patients. Mild discrepancies were present in 42% (negative in 39% and positive in 3%); moderate in 14% (all negative), and severe in 5% (all negative) of patients. A 58% unknowingly exaggerated their pain during movement. Inconsistencies were equal in male and female patients (p=0.606 and p=0.928).Our results showed that there was a negative correlation between patients’ satisfaction and the degree of reporting pain inconsistency. Furthermore, patients talking opioids showed more discrepancies in reporting pain intensity scores than did patients taking non-opioid analgesics or not taking medications for LBP (p=0.038). There was a highly statistically significant correlation between morphine equivalents doses and the level of discrepancy (p<0.0001). Conclusion: We have put emphasis on the patient education in pain evaluation as a vital step in accurate pain level reporting. We have showed a direct correlation with patients’ satisfaction. Furthermore, we must identify other parameters in defining our patients’ chronic pain conditions, such as functionality scales, quality of life questionnaires, etc., and should move away from an overly simplistic subjective rating scale.

Keywords: pain score, functionality scales, low back pain, lumbar

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Authors: Jaspinder Kaur, Jatinder Pal Singh

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Introduction- Delusional parasitosis is a rare psychotic illness characterized by a fixed belief of manifesting a parasite in a body when in reality, it was not. Also known as Ekbom syndrome or delusional infestations, or acarophobia. Although the patient has no primary skin pathology, but all skin findings were secondary to skin manipulation by the patient itself, which is why up to 90% of patients first seek consultation from a dermatologist. Most commonly, it was seen in older people with female to male ratio is 2:1. For treatment, the patient first need to be investigated to rule all other possible causes, as Delusional parasitosis can be caused by Vitamin B12 deficiency, pellagra, hepatic and renal disease, diabetes mellitus, multiple sclerosis, and leprosy. When all possible causes ruled out, psychiatric referral to be done. Rule out other psychiatric comorbidities, and treatment should be done accordingly. Patient with delusional parasitosis responds well to second generation antipsychotics and need to continuous medication over years, and relapse is likely if treatment is stopped. Case Presentation- A 79-year-old female, belonging to lower socio-economic status, presented with complaints of itching sensation with erythematous patches over the scalp and multiple scratch excoriations lesion over the scalp, face and neck from the past 7-8 months. She had a feeling of small insect crawling under her skin and scalp area. To reduce the itching and kill the insect, she would scratch and squeeze her skin repeatedly. When the family tried to give her explanation that there was no insect in her body, she would not get convinced, rather got angry and abuse family members for not believing her. Gradually, her sleep would remain disturbed, she would be seen awake at night, seen to be scratching her skin, pull her scalp hair, even squeeze out her healed lesions. She collected her skin debris, scalp hairs and look out for insect. Because of her continuous illness, the patient started to remain sad and had crying spells. Her appetite decreased. She became socially isolated and stopped doing her activities of daily living. Family member’s first consulted dermatologist, investigated thoroughly with routine investigations, autoimmune and malignancy workup. As all investigations were normal, following which patient was referred for psychiatric evaluation. The patient was started on Tablet Olanzapine 2.5 mg, gradually increased to 7.5 mg. Over 1 month, there was reduction in itching, skin pricking. Lesions were gradually healed, and the patient continued to take other dermatological medications and ointment and was in regular follow up with psychiatric liaison from past 2 months with 70-80 % improvement in her symptoms. Conclusion- Delusional parasitosis is a psychiatric disorder of insidious onset, seen commonly in middle and old age people. Both psychiatric and dermatology consultation liaison will help the patient for an early diagnosis and adequate treatment. If a primary psychiatric diagnosis, the patient respond well to second generation antipsychotics but always require a further evaluation and treatment management if it is secondary to some physical or other psychiatric comorbidity.

Keywords: delusional parasitosis, delusional infestations, rare, primary psychiatric diagnosis, antipsychotic agents

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Authors: Benedict Ofori, Kwabena Sarpong, Stephen Antwi

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Background: Medicinal plants are utilized all around the world and are becoming increasingly important economically. The WHO notes that ‘inappropriate use of traditional medicines or practices can have negative or dangerous effects and that future research is needed to ascertain the efficacy and safety of such practices and medicinal plants used by traditional medicine systems. The poor around the world have limited access to palliative care or pain relief. Pharmacologists have been focused on developing safe and effective anti-inflammatory drugs. Most of the issues related to their use have been linked to the fact that numerous traditional and herbal treatments are classified in different nations as meals or dietary supplements. As a result, there is no need for evidence of the quality, efficacy, or safety of these herbal formulations before they are marketed. The fact that access to drugs meant for pain relief is limited in low-income countries means advanced studies should be done on home drugs meant for inflammation to close the gap. Methods: The ethanolic extracts of the plant were screened for the presence of 10 phytochemicals. The Pierce BCA Protein Assay Kit was used for the determination of the protein concentration of the egg white. The rats were randomly selected and put in 6 groups. The egg white was sub-plantar injected into the right-hand paws of the rats to induce inflammation. The animals were treated with the three plant extracts obtained from the root bark, stem, and leaves of the plant. The control groups were treated with normal saline, while the standard groups were treated with standard drugs indomethacin and celecoxib. Plethysmometer was used to measure the change in paw volume of the animals over the course of the experiment. Results: The results of the phytochemical screening revealed the presence of reducing sugars and saponins. Alkaloids were present in only R.L.S (1:1:1), and phytosterols were found in R.L(1:1) and R.L.S (1:1:1). The estimated protein concentration was found to be 103.75 mg/ml. The control group had an observable increase in paw volume, which indicated that inflammation was induced during the 5 hours. The increase in paw volume for the control group peaked at the 1st hour and decreased gradually throughout the experiment, with minimal changes in the paw volumes. The 2nd and 3rd groups were treated with 20 mg/kg of indomethacin and celecoxib. The anti-inflammatory activities of indomethacin and celecoxib were calculated to be 21.4% and 4.28%, respectively. The remaining 3 groups were treated with 2 dose levels of 200mg/kg plant extracts. R.L.S, R.L, and S.R.L had anti-inflammatory activities of 22.3%, 8.2%, and 12.07%, respectively. Conclusions: Egg albumin-induced paw model in rats can be used to evaluate the anti-inflammatory activity of herbs that might have potential anti-inflammatory activity. Herbal medications have potential anti-inflammatory activities and can be used to manage various inflammatory conditions if their efficacy and side effects are well studied. The three extracts all possessed anti-inflammatory activity, with R.L.S having the highest anti-inflammatory activity.

Keywords: inflammation, capparis erythrocarpos, anti-inflammatory activity, herbal medicine, paw volume, egg albumin

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Authors: Ofelia Loani Elvir Lazo, Roya Yumul, Sevan Komshian, Ruby Wang, Jun Tang

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Background: Monitoring the anti-nociceptive drug effect is useful because a sudden and strong nociceptive stimulus may result in untoward autonomic responses and muscular reflex movements. Monitoring the anti-nociceptive effects of perioperative medications has long been desiredas a way to provide anesthesiologists information regarding a patient’s level of antinociception and preclude any untoward autonomic responses and reflexive muscular movements from painful stimuli intraoperatively.To this end, electroencephalogram (EEG) based tools includingBIS and qCON were designed to provide information about the depth of sedation whileqNOXwas produced to informon the degree of antinociception.The goal of this study was to compare the reliability of qCON/qNOX to BIS asspecific indicators of response to nociceptive stimulation. Methods: Sixty-two patients undergoing general anesthesia with LMA were included in this study. Institutional Review Board(IRB) approval was obtained, and informed consent was acquired prior to patient enrollment. Inclusion criteria included American Society of Anesthesiologists (ASA) class I-III, 18 to 80 years of age, and either gender. Exclusion criteria included the inability to consent. Withdrawal criteria included conversion to endotracheal tube and EEG malfunction. BIS and qCON/qNOX electrodes were simultaneously placed o62n all patientsprior to induction of anesthesia and were monitored throughout the case, along with other perioperative data, including patient response to noxious stimuli. All intraoperative decisions were made by the primary anesthesiologist without influence from qCON/qNOX. Student’s t-distribution, prediction probability (PK), and ANOVA were used to statistically compare the relative ability to detect nociceptive stimuli for each index. Twenty patients were included for the preliminary analysis. Results: A comparison of overall intraoperative BIS, qCON and qNOX indices demonstrated no significant difference between the three measures (N=62, p> 0.05). Meanwhile, index values for qNOX (62±18) were significantly higher than those for BIS (46±14) and qCON (54±19) immediately preceding patient responses to nociceptive stimulation in a preliminary analysis (N=20, * p= 0.0408). Notably, certain hemodynamic measurements demonstrated a significant increase in response to painful stimuli (MAP increased from74±13 mm Hg at baseline to 84± 18 mm Hg during noxious stimuli [p= 0.032] and HR from 76±12 BPM at baseline to 80±13BPM during noxious stimuli[p=0.078] respectively). Conclusion: In this observational study, BIS and qCON/qNOX provided comparable information on patients’ level of sedation throughout the course of an anesthetic. Meanwhile, increases in qNOX values demonstrated a superior correlation to an imminent response to stimulation relative to all other indices.

Keywords: antinociception, bispectral index (BIS), general anesthesia, laryngeal mask airway, qCON/qNOX

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Authors: Shashikant Iyengar, Jasmeet Kaur, Anup Singh, Arun Kumar, Ira Sahay

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Insulin resistance (IR) is a condition that occurs when cells in the body become less responsive to insulin, leading to higher levels of both insulin and glucose in the blood. This condition is linked to metabolic syndromes, including diabetes. It is crucial to address IR promptly after diagnosis to prevent long-term complications associated with high insulin and high blood glucose. This four-month case study highlights the importance of treating the underlying condition to manage diabetes effectively. Insulin is essential for regulating blood sugar levels by facilitating the uptake of glucose into cells for energy or storage. In IR individuals, cells are less efficient at taking up glucose from the blood resulting in elevated blood glucose levels. As a result of IR, beta cells produce more insulin to make up for the body's inability to use insulin effectively. This leads to high insulin levels, a condition known as hyperinsulinemia, which further impairs glucose metabolism and can contribute to various chronic diseases. In addition to regulating blood glucose, insulin has anti-catabolic effects, preventing the breakdown of molecules in the body, such as inhibiting glycogen breakdown in the liver, inhibiting gluconeogenesis, and inhibiting lipolysis. If a person is insulin-sensitive or metabolically healthy, an optimal level of insulin prevents fat cells from releasing fat and promotes the storage of glucose and fat in the body. Thus optimal insulin levels are crucial for maintaining energy balance and plays a key role in metabolic processes. During the four-month study, researchers looked at the impact of a low-carb dietary (LCD) intervention on two male individuals (A & B) who had Type-2 diabetes. Althoughvneither of these individuals were obese, they were both slightly overweight and had abdominal fat deposits. Before the trial began, important markers such as fasting blood glucose (FBG), triglycerides (TG), high-density lipoprotein (HDL) cholesterol, and Hba1c were measured. These markers are essential in defining metabolic health, their individual values and variability are integral in deciphering metabolic health. The ratio of TG to HDL is used as a surrogate marker for IR. This ratio has a high correlation with the prevalence of metabolic syndrome and with IR itself. It is a convenient measure because it can be calculated from a standard lipid profile and does not require more complex tests. In this four-month trial, an improvement in insulin sensitivity was observed through the ratio of TG/HDL, which, in turn, improves fasting blood glucose levels and HbA1c. For subject A, HbA1c dropped from 13 to 6.28, and for subject B, it dropped from 9.4 to 5.7. During the trial, neither of the subjects were taking any diabetic medications. The significant improvements in their health markers, such as better glucose control, along with an increase in energy levels, demonstrate that incorporating LCD interventions can effectively manage diabetes.

Keywords: metabolic disorder, insulin resistance, type-2 diabetes, low-carb nutrition

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Authors: Robert E. Kenney, Richard B. Aguilar, Efrain Antunez, Gregory Schor-Haskin, Rafael Rey, Catie Falcon, Luis Arce

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This study sought to explore the effect of Sarapin injections on chronic knee pain (CKP). Many adults suffer from CKP which is most often attributed to osteoarthritis. Current treatment regimens for CKP involve the use NSAIDS medications, injections with steroids/analgesic, platelet rich plasma injections, or orthopedic surgical interventions. Sarapin is a commercially available homeopathic aqueous extract from the pitcher plant. Studies on the use of Sarapin as a treatment for cervical, thoracic, and lumbosacral facet joint nerve blocks have been performed with mixed results. There is little available evidence on the use of Sarapin in CKP. This study examines the effect of a series of 3 weekly injections of aqueous Sarapin in 95 elderly patients with CKP in a primary care setting. Cano Health, a primary care group, identified 95 successive patients with CKP from its multimodal physiotherapy program for chronic pain. Patients underwent evaluation by a clinician, underwent diagnostic Xrays of the knees, and the treatment plan with three weekly Sarapin injections was discussed. A pain and functional limitation survey (a modified Lower Extremity Functional Scale (mLEFS)) was administered prior to initiating treatment (Entry Survey (ES)). Each patient received an intraarticular injection of 2 cc of aqueous Sarapin with 1cc 1% lidocaine during weeks 1, 2 and 3. The mLEFS was administered again at week 4, one week after the third Sarapin injection (Exit Survey (ExS)). Demographics: Mean Age 62 +/- 9.8; 73% female; 89% Hispanic/Latino; mean time between ES and ExS was 27.5 +/-8.2 days. Survey: The mLEFS was based on a published Lower Extremity Functional Scale and each patient rated their pain or functional limitation from 0 (no difficulty) to 5 (severe difficulty) for 10 questions. Answers were summed and compared. Maximum score for severe difficulty would be 50 points. Results: Mean pain/functional scores: ES was 30.3 +/-12.1 and ExS was 19.5 +/- 12.5. This represents a relative improvement of 35.7% (P<0.00001). A total of 81% (77/95) of the patients showed improvement in symptoms at week four as assessed by the mLEFS. There were 11 patients who reported an increase in their survey scores while 7 patients reported no change. When evaluating the cohort that reported improvement, the ES was 30.9 +/-11.4 and ExS was 16.3 +/-9.8 yielding a 47.2% relative improvement (P<0.00001). Injections were well tolerated, and no adverse events were reported. Conclusions: In this cohort of 95 elderly patients with CKP, treatment with 3 weekly injections of Sarapin significantly improved pain and function as assessed by a mLEFS survey. The majority (81%) of patients responded positively to therapy, 12% had worsening symptoms and 7% reported no change. The use of intraarticular injections of Sarapin for CKP was shown to be an effective modality of treatment. Sarapin’s low cost, tolerability, and ease of use make it an attractive alternative to NSAIDS, steroids, PRP or surgical intervention for this common debilitating condition.

Keywords: Sarapin, intraarticular, chronic knee pain, osteoarthritis

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Authors: J. Yan, B. Pieper, B. Bucsky, B. Nasseri, S. Klotz, H. H. Sievers, S. Mohamed

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Cryoablation is evermore applied for interventional treatment of paroxysmal (PAAF) or persistent atrial fibrillation (PEAF). In the cardiac surgery, this procedure is often combined with coronary arterial bypass graft (CABG) and valve operations. Three different methods are feasible in this sense in respect to practicing extents and mechanisms such as lone left atrial cryoablation, Cox-Maze IV and III in our heart center. 415 patients (68 ± 0.8ys, male 68.2%) with predisposed atrial fibrillation who initially required either coronary or valve operations were enrolled and divided into 3 matched groups according to deployed procedures: CryoLA-group (cryoablation of lone left atrium, n=94); Cox-Maze-IV-group (n=93) and Cox-Maze-III-group (n=8). All patients additionally received closure of the left atrial appendage (LAA) and regularly underwent three-year ambulant follow-up assessments (3, 6, 9, 12, 18, 24, 30 and 36 months). Burdens of atrial fibrillation were assessed directly by means of cardiac monitor (Reveal XT, Medtronic) or of 3-day Holter electrocardiogram. Herewith, attacks frequencies of AF and their circadian patterns were systemically analyzed. Furthermore, anticoagulants and regular rate-/rhythm-controlling medications were evaluated and listed in terms of anti-rate and anti-rhythm regimens. Concerning PAAF treatment, Cox Maze IV procedure provided therapeutically acceptable effect as lone left atrium (LA) cryoablation did (5.25 ± 5.25% vs. 10.39 ± 9.96% AF-burden, p > 0.05). Interestingly, Cox Maze III method presented a better short-term effect in the PEAF therapy in comparison to lone cryoablation of LA and Cox Maze IV (0.25 ± 0.23% vs. 15.31 ± 5.99% and 9.10 ± 3.73% AF-burden within the first year, p < 0.05). But this therapeutic advantage went lost during ongoing follow-ups (26.65 ± 24.50% vs. 8.33 ± 8.06% and 15.73 ± 5.88% in 3rd follow-up year). In this way, lone LA-cryoablation established its antiarrhythmic efficacy and 69.5% patients were released from the Vit-K-antagonists, while Cox Maze IV liberated 67.2% patients from continuous anticoagulant medication. The AF-recurrences mostly performed such attacks property as less than 60min duration for all 3 procedures (p > 0.05). In the sense of the circadian distribution of the recurrence attacks, weighted by ongoing follow-ups, lone LA cryoablation achieved and stabilized the antiarrhythmic effects over time, which was especially observed in the treatment of PEAF, while Cox Maze IV and III had their antiarrhythmic effects weakened progressively. This phenomenon was likewise evaluable in the therapy of circadian rhythm of reverting AF-attacks. Furthermore, the strategy of rate control was much more often applied to support and maintain therapeutic successes obtained than the one of rhythm control. Derived from experiences in our heart center, lone LA cryoablation presented equivalent effects in the treatment of AF in comparison to Cox Maze IV and III procedures. These therapeutic successes were especially investigable in the patients suffering from persistent AF (PEAF). Additional supportive strategies such as rate control regime should be initialized and implemented to improve the therapeutic effects of the cryoablations according to appropriate criteria.

Keywords: AF-burden, atrial fibrillation, cardiac monitor, COX MAZE, cryoablation, Holter, LAA

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Authors: Trina Isabel D. Santiago, Juan Raphael M. Perez, Maria Angelica O. Soriano, Teresita B. Suing, Jumee F. Tayaban

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To achieve universal healthcare for everyone, the World Health Organization has emphasized the importance of National Medicines Policies for increased accessibility and utilization of high-quality and affordable medications. In the Philippines, significant challenges have been identified surrounding the sustainability of essential medicines, resulting in limited access such as high cost and dominance and market dominance and monopoly of multinational companies (MNCs) in the Philippine pharmaceutical industry. These identified challenges have been addressed by several initiatives, such as the Philippine National Drug Policy and Generics Act of 1988 (Republic Act 6675), to attempt to reduce drug prices. Despite these efforts, the concerns with drug accessibility and affordability continue to persist; hence, Republic Act 9502 was enacted. This paper attempts to review RA 9502 in the pursuit of making medicines more affordable for Filipinos, analyze and critique the problems and challenges associated with the law, and provide recommendations to address identified problems and challenges. A literature search and review, as well as an analysis of the law, has been done to evaluate the policy. RA 9502 recognizes the importance of market competition in drug price reduction and quality medicine accessibility. Contentious issues prior to enactment of the law include 1) parallel importation, pointing out that the drug price will depend on the global market price, 2) contrasting approaches in the drafting of the law as the House version focused on medicine price control while the Senate version prioritized market competition, and 3) MNCs opposing the amendments with concerns on discrimination, constitutional violations, and noncompliance with international treaty obligations. There are also criticisms and challenges with the implementation of the law in terms of content or modeling, interpretation and implementation, and other external factors or hindrances. The law has been criticized for its narrow scope as it only covers specific essential medicines with no cooperation with the national health insurance program. Moreover, the law has sections taking advantage of the TRIPS flexibilities, which disallow smaller countries to reap the benefits of flexibilities. The sanctions and penalties have an insignificant role in implementation as they only ask for a small portion of the income of MNCs. Proposed recommendations for policy improvement include aligning existing legislation through strengthened price regulation and expanded law coverage, strengthening penalties to promote law adherence, and promoting research and development to encourage and support local initiatives. Through these comprehensive recommendations, the issues surrounding the policy can be addressed, and the goal of enhancing the affordability and accessibility of medicines in the country can be achieved.

Keywords: drug accessibility, drug affordability, price regulation, Republic Act 9502

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Authors: Zahra Mohajer, Afsaneh Soltani

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Doping is a major issue in competitive sports and is favored by vast groups of athletes. The feeling of being higher-ranking than others and gaining fame has caused many athletes to misuse drugs. The definition of doping is to use prohibited substances and/or methods that help physical or mental performances or both. Doping counts as the illegal use of chemical substances or drugs, excessive amounts of physiological substances to increase the performance at or out of competition or even the use of inappropriate medications to treat an injury to gain the ability to participate in a competition. The International Olympic Committee (IOC) and World Anti-Doping Agency (WADA) have forbidden these substances to ensure fair and equal competition and also the health of the competitors. As of 2004 WADA has published an international list of illegal substances used for doping, which is updated annually. In the process of the Genome Project scientists have gained the ability to treat numerous diseases by gene therapy, which may result in bodily performance increase and therefore a potential opportunity to misuse by some athletes. Gene doping is defined as the non-therapeutic direct and indirect genetic modifications using genetic materials that can improve the performances in sports events. Biosynthetic drugs are a form of indirect genetic engineering. The method can be performed in three ways such as injecting the DNA directly into the muscle, inserting the genetically engineered cells, or transferring the DNA using a virus as a vector. Erythropoietin is a hormone majorly released by the kidney and in small amounts by the liver. Its function is to stimulate the erythropoiesis and therefore the more production of red blood cells (RBC) which causes an increase in Hemoglobin (Hb). During this process, the oxygen delivery to muscles will increase, which will improve athletic performance and postpone exhaustion. There are ways to increase the oxygen transferred to muscles such as blood transfusion, stimulating the production of red blood cells by using Erythropoietin (EPO), and also using allosteric effectors of Hemoglobin. EPO can either be injected as a protein or can be inserted into the cells as the gene which encodes EPO. Adeno-associated viruses have been employed to deliver the EPO gene to the cells. Employing the genes that naturally exist in the human body such as the EPO gene can reduce the risk of detecting gene doping. The first research about blood doping was conducted in 1947. The study has shown that an increase in hematocrit (HCT) up to 55% following homologous transfusion makes it more unchallenging for the body to perform the exercise at the altitude. Thereafter athletes’ attraction to blood infusion escalated. Also, a study has demonstrated that by reinfusing their own blood 4 weeks after being drawn, three men have shown a rise in Hb level which improved the oxygen uptake, and a delay in exhaustion. The list of performance-enhancing drugs is published by WADA annually and includes the following drugs: anabolic agents, hormones, Beta-2 agonists, Beta-blockers, Diuretics, Stimulants, narcotics, cannabinoids, and corticosteroids.

Keywords: doping, PEDs, sports, WADA

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Authors: Karolina Wieczorek, Sophie Wiliams

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Introduction: Patient data is often collected in Electronic Health Record Systems (EHR) for purposes such as providing care as well as reporting data. This information can be re-used to validate data models in clinical trials or in epidemiological studies. Manual validation of automated tools is vital to pick up errors in processing and to provide confidence in the output. Mentioning a disease in a discharge letter does not necessarily mean that a patient suffers from this disease. Many of them discuss a diagnostic process, different tests, or discuss whether a patient has a certain disease. The COVID-19 dataset in this study used natural language processing (NLP), an automated algorithm which extracts information related to COVID-19 symptoms, complications, and medications prescribed within the hospital. Free-text patient clinical patient notes are rich sources of information which contain patient data not captured in a structured form, hence the use of named entity recognition (NER) to capture additional information. Methods: Patient data (discharge summary letters) were exported and screened by an algorithm to pick up relevant terms related to COVID-19. Manual validation of automated tools is vital to pick up errors in processing and to provide confidence in the output. A list of 124 Systematized Nomenclature of Medicine (SNOMED) Clinical Terms has been provided in Excel with corresponding IDs. Two independent medical student researchers were provided with a dictionary of SNOMED list of terms to refer to when screening the notes. They worked on two separate datasets called "A” and "B”, respectively. Notes were screened to check if the correct term had been picked-up by the algorithm to ensure that negated terms were not picked up. Results: Its implementation in the hospital began on March 31, 2020, and the first EHR-derived extract was generated for use in an audit study on June 04, 2020. The dataset has contributed to large, priority clinical trials (including International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC) by bulk upload to REDcap research databases) and local research and audit studies. Successful sharing of EHR-extracted datasets requires communicating the provenance and quality, including completeness and accuracy of this data. The results of the validation of the algorithm were the following: precision (0.907), recall (0.416), and F-score test (0.570). Percentage enhancement with NLP extracted terms compared to regular data extraction alone was low (0.3%) for relatively well-documented data such as previous medical history but higher (16.6%, 29.53%, 30.3%, 45.1%) for complications, presenting illness, chronic procedures, acute procedures respectively. Conclusions: This automated NLP algorithm is shown to be useful in facilitating patient data analysis and has the potential to be used in more large-scale clinical trials to assess potential study exclusion criteria for participants in the development of vaccines.

Keywords: automated, algorithm, NLP, COVID-19

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Authors: Makda Aamir, Sood Aayushi, Syed Omar, Nihan Khuld, Iskander Peter, Ijaz Naeem, Sharma Nishant

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Introduction:Glycogen Storage Disease Type-1 (GSD-1) is a rare phenomenon primarily affecting the liver and kidney. Excessive accumulation of glycogen and fat in liver, kidney, and intestinal mucosa is noted in patients with deficiency of Glucose-6-phosphatase deficiency. Patients with GSD-1 have a wide spectrum of symptoms, including hepatomegaly, hypoglycemia, lactic acidemia, hyperlipidemia, hyperuricemia, and growth retardation. Age of onset, rate of disease progression and its severity is variable in this disease.Case:An 18-year-old male with GSD-1a, Von Gierke’s disease, hyperuricemia, and hypertension presented to the hospital with nausea and vomiting. The patient followed an hourly cornstarch regimen during the day and overnight through infusion via a PEG tube. The complaints started at work, where he was unable to tolerate oral cornstarch. He washemodynamically stable on arrival. ABG showed pH 7.372, PaCO2 30.3, and PaO2 92.2. WBC 16.80, K+ 5.8, HCO3 13, BUN 28, Cr 2.2, Glucose 60, AST 115, ALT 128, Cholesterol 352, Triglycerides >1000, Uric Acid 10.6, Lactic Acid 11.8 which trended down to 8.0. CT abdomen showed hepatomegaly and fatty infiltration with the PEG tube in place.He was admitted to the ICU and started on D5NS for hypoglycemia and lactic acidosis. Per request by the patient’s pediatrician, he was transitioned to IV D10/0.45NS at 110mL/Hr to maintain blood glucose above 75 mg/L. Frequent accuchecks were done till he could tolerate his dietary regimen with cornstarch. Lactic acid downtrend to 2.9, and accuchecks ranged between 100-110. Cr improved to 1.3, and his home medications (Allopurinol and Lisinopril) were resumed. He was discharged in stable condition with plans for further genetic therapy work up.Discussion:Mainstay therapy for Von Gierke’s Disease is the prevention of metabolic derangements for which dietary and lifestyle changes are recommended. A low fructose and sucrose diet is recommended by limiting the intake of galactose and lactose to one serving per day. Hypoglycemia treatment in such patients is two-fold, utilizing both quick and stable release sources. Cornstarch has been one such therapy since the 1980s; its slow digestion provides a steady release of glucose over a longer period of time as compared with other sources of carbohydrates. Dosing guidelines vary from age to age and person to person, but it is highly recommended to check BG levels frequently to maintain a BG > 70 mg/dL. Associated high levels of triglycerides and cholesterol can be treated with statins, fibrates, etc. Conclusion:The management of hypoglycemia in GSD 1 disease presents various obstacles which could prove to be fatal. Due to the deficiency of G6P, treatment with a specialized hypoglycemic regimen is warranted. A D10 ½ NS infusion can be used to maintain blood sugar levels as well as correct metabolic or lactate imbalances. Infusion should be gradually weaned off after the patient can tolerate oral feeds as this can help prevent the risk of hypoglycemia and other derangements. Further research is needed in regards to these patients for more sustainable regimens.

Keywords: von gierke, glycogen storage disease, hypoglycemia, genetic disease

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Authors: Kamal Tolani, Sandeep Kumar, Rohit Luthra, Ankit Dadhania, Krishnaprasad K., Ram Gupta, Deepa Joshi

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Background: Post-operative analgesia remains a clinical challenge, with central and peripheral sensitization playing a pivotal role in treatment-related complications and impaired quality of life. Centrally acting opioids offer poor risk benefit profile with increased intensity of gastrointestinal or central side effects and slow onset of clinical analgesia. The objective of this study was to assess the clinical feasibility of induction and maintenance therapy with Tapentadol Nasal Spray (NS) in moderate to severe acute post-operative pain. Methods: Phase III, randomized, active-controlled, non-inferiority clinical trial involving 294 cases who had undergone surgical procedures under general anesthesia or regional anesthesia. Post-surgery patients were randomized to receive either Tapentadol NS 45 mg or Tramadol 100mg IV as a bolus and subsequent 50 mg or 100 mg dose over 2-3 minutes. The frequency of administration of NS was at every 4-6 hours. At the end of 24 hrs, patients in the tramadol group who had a pain intensity score of ≥4 were switched to oral tramadol immediate release 100mg capsule until the pain intensity score reduced to <4. All patients who had achieved pain intensity ≤ 4 were shifted to a lower dose of either Tapentadol NS 22.5 mg or oral Tramadol immediate release 50mg capsule. The statistical analysis plan was envisaged as a non-inferiority trial involving comparison with Tramadol for Pain intensity difference at 60 minutes (PID60min), Sum of Pain intensity difference at 60 minutes (SPID60min), and Physician Global Assessment at 24 hrs (PGA24 hrs). Results: The per-protocol analyses involved 255 hospitalized cases undergoing surgical procedures. The median age of patients was 38.0 years. For the primary efficacy variables, Tapentadol NS was non-inferior to Inj/Oral Tramadol in relief of moderate to severe post-operative pain. On the basis of SPID60min, no clinically significant difference was observed between Tapentadol NS and Tramadol IV (1.73±2.24 vs. 1.64± 1.92, -0.09 [95% CI, -0.43, 0.60]). In the co-primary endpoint PGA24hrs, Tapentadol NS was non–inferior to Tramadol IV (2.12 ± 0.707 vs. 2.02 ±0.704, - 0.11[95% CI, -0.07, 0.28). However, on further assessment at 48hr, 72 hrs, and 120hrs, clinically superior pain relief was observed with the Tapentadol NS formulation that was statistically significant (p <0.05) at each of the time intervals. Secondary efficacy measures, including the onset of clinical analgesia and TOTPAR, showed non-inferiority to Tramadol. The safety profile and need for rescue medication were also similar in both the groups during the treatment period. The most common concomitant medications were anti-bacterial (98.3%). Conclusion: Tapentadol NS is a clinically feasible option for improved compliance as induction and maintenance therapy while offering a sustained and persistent patient response that is clinically meaningful in post-surgical settings.

Keywords: tapentadol nasal spray, acute pain, tramadol, post-operative pain

Procedia PDF Downloads 213