Open Access Original Research Article

Questionable International Pediatric Studies in the United States and Russia Triggered by Regulatory Authorities

Klaus Rose, Jane M. Grant-Kels

Asian Journal of Research in Medical and Pharmaceutical Sciences, Page 1-10
DOI: 10.9734/AJRIMPS/2018/40776

Background: The concept of children as "therapeutic orphans" claims that children were/are denied the use of many modern drugs. Both the United States (US) and the European Union (EU) enacted laws based on this concept. Their regulatory authorities promote industry-sponsored pediatric studies. These studies recruit worldwide. We challenge their medical rationale.

Methods: We analyzed exemplarily international industry-sponsored pediatric studies in cancer and rheumatology listed in www.clinicaltrials.gov with at least one center in the US and Russia, respectively, for their medical value.

Findings: Most studies were/are pharmacokinetic (PK) and efficacy studies in young patients with limited or no medical value. Adolescents are physiologically (vis-à-vis drug metabolism) comparable to adults; for children only PK- and dose finding studies are necessary. Only newborns'/babies' organs are physiologically so different that separate proof of efficacy is needed for drugs with a therapeutic potential in this population. The identified studies were/are justified formally, regulatorily, but are medically unnecessary and therefore unethical. Parts of pediatric academia are misled by industry funds channeled by regulatory decisions into medically questionable studies. There are resulting substantial conflicts of interest; a blind spot in today's societal perception of drug development prevents us from recognizing them.

Interpretation: Pediatric studies triggered by regulatory demands constitute a worldwide systematic abuse of young patients. They are medically redundant at best, deter patients with lethal diseases participating in these studies from getting access to known effective innovative therapy, and have the potential to jeopardize public trust in science, research and authorities. Institutional Review Boards (IRBs)/ ethics committees (ECs) should become alerted. IRBs/ECs worldwide should suspend questionable pediatric studies and reject newly submitted ones. US and EU pediatric laws need revision.

 

Open Access Original Research Article

Hepatic, Renal, and Anti-oxidant Function Markers Can Improve in Dose-dependent Administration of Fresh Coconut Oil

E. M. Aisuodionoe, O. M. Odigie, A. O. Naiho, M. O. Oyovwi, J. C. Igweh

Asian Journal of Research in Medical and Pharmaceutical Sciences, Page 1-12
DOI: 10.9734/AJRIMPS/2018/40811

Overtime, Oxidative stress has been implicated in the progression of diabetes mellitus (DM) and its related disorders. To this point, several studies posit that antioxidant constituents of virgin coconut oil among others might have a helpful effect in ameliorating diseases. In this study, the effect of per oral administration of fresh coconut oil (FCO) on the liver, kidney, and anti-oxidant biomarkers was investigated in alloxan-induced diabetic Sprague Dawley rats. Ninety-eight (98) albino rats (100 - I50 g) were randomly divided into two (2) units of forty-nine (49) rats each; with each unit subdivided into seven (7) groups of seven (7) animals each. At induction of diabetes mellitus (DM) in subgroups 2, 3, 4, 5, 6, 7 of unit 1 and B, C, D, E, F and G of Unit 2, rats in the 1 and A subgroups were left untouched to serve as a control. Whereas unit 1 (treated for 2 weeks), subgroups 2-7 respectively received nothing (after DM confirmation), nothing (after DM confirmation), 7.5 mg/kg of FCO, 10 mg/kg of FCO, 7.5 mg/kg of FCO plus Vitamin E, 10 mg/kg of FCO plus Vitamin E, and only Vitamin E; Unit 2 animals (treated for 4 weeks) were given untreated (after confirming diabetes), 7.5 mg/kg of FCO, 10 mg/kg of FCO, 7.5 mg/kg of FCO + Vitamin E, 10 mg/kg of FCO and Vitamin E, and Vitamin E respectively for B-G subgroups. Following administration of test substance, serum samples were then collected from animals for biochemical analysis of liver, renal, and antioxidant marker enzymes. One way analysis of variance (ANOVA) proved that liver enzymes were significantly (p < .05) reduced, while antioxidant enzymes (SOD and CAT) were significantly increased (p < .05). However, electrolyte levels, as well as renal markers (urea and creatinine), were insignificant. Also, compared to controls, changes recorded after four weeks followed the same pattern, showing that dietary factor (Vitamin E) modulates the effect of FCO. From this result, it is implied that FCO significantly improved metabolic parameters especially with the significant reduction in oxidative stress in Type 1 diabetes mellitus.

 

Open Access Original Research Article

Evaluation of Insulin, Malondialdehyde and Blood Pressure in Male Obese Individuals in Nnewi and Subsequent Effect of Green Tea Supplementation

Meludu Samuel Chukwuemeka, Onuora Ifeoma Joy, Dioka Chudi Emmanuel, Obi-Ezeani Chikaodili Nwando, Usman Saheed Opeyemi

Asian Journal of Research in Medical and Pharmaceutical Sciences, Page 1-7
DOI: 10.9734/AJRIMPS/2018/41153

Background: Obesity is a major public health issue worldwide, contributing to increased cardiovascular diseases, diabetes, insulin resistance and oxidative stress. This is due to sedentary lifestyles; poor dieting and low consumption of antioxidant supplement (example green tea). The objective of this study was to evaluate the level of fasting blood sugar, insulin, insulin resistance blood pressure and MDA in obese subjects and subsequent effect of green tea at 6weeks and 12weeks supplementation.

Methods: This was a cross sectional and interventional study. In the cross sectional study, 88 obese subjects (46 class I and 42 class II obese) and 50 normal weight subjects (control) were recruited. In the interventional study, 20 male obese subjects were randomly selected and were given 200ml of commercially prepared green tea. Fasting blood samples were collected before the intervention (baseline), at 6weeks and 12weeks of intervention and were later analyzed by standard method Enzyme Linked immunoassay and colorimeteric method. It was analysed statistically using SPSS version 23.0.

Results: There were significant increases in the mean levels of HOMA-IR, systolic and diastolic blood pressures, fasting plasma glucose and insulin in obese subjects (class II and class I obese) when compared with control group (P<0.05), likewise in Class II obese when compared with Class I obese (P<0.05) while in the case of MDA, there was a significant increase only in Class II obese subjects when compared with the normal weight subjects (P<0.05). Green tea supplementation significantly reduced the mean level of MDA, fasting plasma glucose, weight, HOMA-IR and blood pressure at 12weeks of intervention while only Insulin and waist circumference were significantly reduced at 6weeks and 12weeks of intervention.

Conclusion: In conclusion, obesity is the major cause of diabetes, high blood pressure and insulin resistance. Green tea could be beneficial to diabetic patients and obese hypertensives. Green tea compounds- phytochemicals could be beneficial as one of the components of their diet.

 

Open Access Original Research Article

Infrared Spectroscopy and Microorganisms Associated with African Nutmeg (Monodora myristica) Seeds Sold in a Municipal Market in Imo State, Nigeria

Eberechukwu M. Maduike, Nkiruka C. Anuna

Asian Journal of Research in Medical and Pharmaceutical Sciences, Page 1-7
DOI: 10.9734/AJRIMPS/2018/40661

This work evaluated the infra-red (IR) spectra of the oil extract from African nutmeg (Monodora myristica) seeds, popularly called ‘ehuru’ in the eastern part of Nigeria – among the Igbos. The microbial analysis of the dried ‘ehuru’ seeds was also carried out in order to ascertain the prevailing bacteria and fungi on the outer coat of this invaluable seed as sold in the market. Monodora myristica oil extract was obtained through soxhlet extractor using ethanol of Analar grade. About 15 g of the extract (oil) was obtained after assessing 400 g of the ground dried seeds of the sample. Infra-red analysis of the oil extract was evaluated. The IR spectra of the extract indicated that the sample contained the following functional groups: phosphate esters, ketones, amides, amines, amino acids, ammonium salts, alkenes, phenols, alkanes, ether, lactams and carboxyl groups. There is no doubt that the presence of these chemical functional groups in Monodora myristica seed conferred to its antimicrobial quality, therapeutic potentials, and its use as food additive (spice). Common microorganisms associated with the dried ‘ehuru’ seeds were bacteria - Streptococcus sp. and Staphylococcus sp.; fungus - mucor sp. The presence of these microorganisms on the seed might have been introduced as a result of exposure to unhygienic conditions by local handlers and frequent touching by buyers.

 

Open Access Original Research Article

Assessment Role of Dehydroepiandrosterone (DHEA) and Melatonin or Their Mixture on Physiological and Biochemical Parameters in Alzheimer's Rats Induced by Aluminium Chloride

Mona, I. M. Shahin

Asian Journal of Research in Medical and Pharmaceutical Sciences, Page 1-12
DOI: 10.9734/AJRIMPS/2018/40465

Alzheimer’s disease is progressing neuronal degeneration disease leads to impairment of memory and cognitive ability. It is the most common cause of dementia and its increases with age. the present study was to investigate whether the Dehydroepiandrosterone (DHEA) and Melatonin or their mixture could potentially prevent aluminium-induced neurotoxicity in the cerebral cortex, hippocampus and cerebellum of the rat brain. The results showed that malondialdehyde (MDA) and total nitric oxide (TNO) showed significant (P< 0.001) increase in the mean values of Al intoxicated rats. However, the cortex and hippocampus SOD, CAT activities and GSH contents were significantly decreased in rats intoxicated with AlCl3.Additionally, choline acetyl transferase ( ChAT ) was a significant increase. The administration of Dehydroepiandrosterone (DHEA) and Melatonin corrected all these alterations and the maximum ameliorating effects were exhibited in the rats treated with the mixture of Dehydroepiandrosterone (DHEA) and Melatonin.