Investigating the informed consent process, therapeutic misconception and motivations of Egyptian research participants: a qualitative pilot study.

Few studies have explored the informed consent process among research participants in developing countries. This study aimed to evaluate the informed consent process, therapeutic misconception and motivation for participation among Egyptians participating in clinical trials. In a cross-sectional qualitative pilot study 103 participants in 10 clinical trials responded to a questionnaire. Over 90% agreed they had time to ask questions and received adequate information about the risks prior to consenting. All participants thought the research and the drug would improve their condition; only 46.1% were aware of receiving a non-approved experimental drug and 21.3% of being randomized. Reasons for participation included: better treatment (100%), to benefit society & advance science (85.4%), to receive free drugs (42.6%) and medical care (43.6%), to get hospitalized (15.8%) and to receive money or gifts (4.9%). Investigators need to emphasize the distinction between research and clinical care to address the high rate of therapeutic misconception.

Regional versus IV analgesics in labor.

AIM: The aim of this study was to compare combined spinal epidural (CSE), epidural (E) and IV pethidine analgesia and their effects on the mother, fetus, newborn and the labor course. METHODS: This is a prospective parallel single blind study, where 60 women in active labor were recruited and were allocated to five subgroups to receive analgesia by different routes. The mother and the fetus were assessed. The results were recorded and compared using Visual Analogue Scale (VAS) and modified Bromage scale for motor block, in addition to other clinical findings. RESULT: The duration of first stage of labor was significantly longer in the E group, compared with the CSE and IV pethidine groups. When the pain control achieved by CSE bupivacaine and lidocaine was compared with the corresponding epidural, it was found that the first technique achieved better pain control. Women who received pethidine had higher incidence of nausea and vomiting compared to those received CSE or E analgesia. There was no significant difference between the five groups with respect to other side effects. CONCLUSION: Regional analgesia especially CSE using bupivacaine or lidocaine is a safe effective method for analgesia in labor with relative better efficacy of bupivacaine.

Knowledge, attitude and practice of community pharmacists towards nutrition counseling.

Background The World Health Organization considers health promotion a top health service priority. Nutrition, weight management and physical activity are necessary health promotion strategies to improve overall quality of life and decrease the personal and societal consequences or poor health. Community pharmacists are in the best position to implement health promotion strategies due to their excellent accessibility and the lack of a requirement to make an appointment to interact with them. Enabling people to change their lifestyle and control their health through nutrition education and counseling is a great opportunity for community pharmacists to promote health. Nutrition counseling as a part of clinical nutrition therapy aims to provide dietary advice and to assist the selection of appropriate over-the-counter supplements. Objective To investigate the community pharmacist role in nutrition counseling and identify the barriers and strategies to improve nutrition counseling in Egypt. Setting Community pharmacies in Egypt. Methods A descriptive, cross-sectional study was conducted with a knowledge, attitude, and practice survey. A specially developed and validated questionnaire was used to collect data via face-to-face structured interviews. Primary outcomes Pharmacists' knowledge about, attitudes towards and practice of nutrition counseling. Results A total of 368 community pharmacists participated in this study, with a response rate of 73.6%. A total of 255 (69.3%) of the participants considered medical nutrition therapy a part of a pharmacist's duties. Only 146 (39.7%) of the participants believed that dietary supplements positively impact public health. According to 321 (87.2%) of the participants, the lack of pharmacists' expertise in nutrition counseling was the main barrier to nutrition counseling. Conclusions The majority of the participating community pharmacists had positive attitudes towards their role in nutritional assessment and medical nutrition therapy. There is a need to improve the nutritional knowledge of community pharmacists in Egypt. The current practice of community pharmacists in nutrition counseling is limited to adults. Obesity, diabetes and hypertension were the main medical conditions of the patients who received nutrition counseling from the community pharmacists. Inadequate knowledge in nutrition and the unavailability of educational materials were the main barriers to nutrition counseling.

Evaluation of crude and purified Toxocara canis antigens in serodiagnosis of human toxocariasis.

Three serological tests: Immunodiffusion (ID), Counterimmunoelectrophoresis (CIEP) and Enzyme-linked immunosorbent assay (ELISA) were used to study the role of crude adult worm antigen (CAWA) of Toxocara canis and each of its purified fractions in the serodiagnosis of human toxocariasis. Sensitivities of the three tests were lower in the ocular than in the visceral group, using different antigens. Purified fraction 1 showed more sensitive and specific reactions in the three tests, compared to CAWA or purified fraction 2 (P-F2) antigen. The other purified fractions (P-F3, P-F4 and P-F5) gave no positive reactions in any of the three tests. Using P-F1 antigen, ELISA was the most sensitive technique for diagnosis of both visceral and ocular toxocariasis followed by CIEP and then ID and the difference was statistically significant. However, CIEP was the most specific test followed by ELISA and lastly ID test. The ELISA test using Excretory-Secretory (E-S) larval antigen of Toxocara canis was less sensitive than the ELISA test using P-F1, although it was 100% specific. Thus, ELISA test using P-F1 is the test of choice for diagnosis of human toxocariasis, but when the specificity of a reaction is in doubt, CIEP test using the same antigen can be of value.

Factors affecting warfarin dose requirements and quality of anticoagulation in adult Egyptian patients: role of gene polymorphism.

BACKGROUND: Warfarin is the mainstay of anticoagulation therapy worldwide. CYP2C9 and VKORC1 are two major genetic factors associated with inter-individual and inter-ethnic variability in the warfarin dose. AIM: This study aims to assess the impact of VKORC1-1639G>A polymorphism and the most common CYP2C9 variant alleles (*2 and *3) on warfarin response in Egyptian patients. METHODS: Genetic analysis of VKORC1-1639G>A and CYP2C9*2, CYP2C9*3 was performed using real-time PCR system. Patients maintained on a constant dose targeting an international normalized ratio range of 2-3.5 for at least three consecutive times were considered as good candidates. A stepwise linear regression analysis was used to determine the independent effects of genetic and non-genetic factors on daily warfarin dose requirements. RESULTS: Patients carrying VKORC1 and CYP2C9 variant genotypes needed a 44.8 % lower mean daily warfarin dose as compared to wild types. Patients with G allele for VKORC1-1639G>A had a significantly higher number of thromboembolic complications per month during therapy. On the first 30 days of therapy, presence of a variant allele either in VKORC1 or in CYP2C9 was associated with increased time required to achieve stable dosing. Multiple regression analysis showed that, VKORC1-1639G>A, age, CYP2C9*3, and smoking status explained 43.4 % of the overall variability in the warfarin dose. CONCLUSION: VKORC1-1639G>A and CYP2C9 polymorphisms contribute to the difference in warfarin dose requirements and quality of anticoagulation amongst Egyptian patients. Study results support using personalized warfarin treatment in Egyptian patients.

Vitamin D levels in Egyptian HCV patients (genotype 4) treated with pegylated interferon.

BACKGROUND/AIM: Vitamin D has been shown to play an important immunomodulatory role. Deficiency of vitamin D has been recently associated to the lack of response to interferon therapy in Hepatitis C virus genotype 1 infected patients. This study aims to evaluate serum level of vitamin D and verify whether circulating vitamin D has any independent role in predicting the rates of HCV virologic response after the administration of pegylated interferon to Egyptian patients infected with genotype 4 HCV. METHODS: Fifty patients infected with HCV genotype 4 and not co-infected with neither Hepatitis B virus nor Human Immunodeffiency Virus were recruited for the study. They were treated with ribavirin-pegylated interferon alpha 2a. Viral titer was determined at baseline, at 12 weeks and at end of treatment (48 weeks). Vitamin D levels and a biochemical profile were obtained for the patients at baseline and at end of treatment. Vitamin D control group consisting of 20 healthy patients of similar age and weight to the study group were recruited to obtain vitamin D levels. RESULTS: Vitamin D levels in HCV infected patients were significantly lower than in healthy subjects. Responders to ribavirin plus pegylated interferon alpha 2a therapy had significantly higher vitamin D levels than non-responders. CONCLUSION: Vitamin D deficiency predicts an unfavorable response to interferon-based treatment of HCV.

Investigating the informed consent process, therapeutic misconception and motivations of Egyptian research participants:a qualitative pilot study

لا يوجد إلا القليل من الدراسات التي استكشفت عملية الموافقة المسبقة لدى المشاركين في البحوث في البلدان النامية. وقد هدفت هذه الدراسة إلى تقييم عملية الموافقة المسبقة والمفهوم العلاجي الخاطئ والدافع للمشاركة لدى المصرين المشاركين في تجارب سريرية. ففي دراسة تجريبية كيفية مستعرضة قام 103 مشاركين في 10 تجارب سريرية بالإجابة عى استبيان. فأقر أكثر من 90 % منهم بأنه كان لديهم وقت لطرح الأسئلة وبأنهم تلقوا معلومات كافية عن المخاطر قبل الموافقة. واعتقد جميع المشاركين أن البحث والدواء من شأنه أن يحسن حالتهم، وكان 46.1 % منهم فقط عى علم بأنهم يتلقون دواء تجريبياً غر معتمد، و 21.3 % عى علم بأن اختيارهم تم بصورة عشوائية. وكان من أسباب المشاركة: الحصول عى معالجة أفضل 100%، وإفادة المجتمع والتقدم في العلوم 85.4 %، والحصول عى أدوية مجانية 42.6 % ورعاية طبية مجانية 43.6 %، والحصول عى قبول في المستشفى 15.8 %، وتلقي المال أو الهدايا 4.9 %. يجب عى القائمن بالاستقصاء أن يؤكدوا عى التمييز بن الأبحاث والرعاية السريرية لمواجهة ارتفاع معدل المفهوم العلاجي الخاطئ.

Few studies have explored the informed consent process among research participants in developing countries. This study aimed to evaluate the informed consent process, therapeutic misconception and motivation for participation among Egyptians participating in clinical trials. In a cross-sectional qualitative pilot study 103 participants in 10 clinical trials responded to a questionnaire. Over 90% agreed they had time to ask questions and received adequate information about the risks prior to consenting. All participants thought the research and the drug would improve theircondition; only 46.1% were aware of receiving a non-approved experimental drug and 21.3% of being randomized.Reasons for participation included: better treatment (100%), to benefit society & advance science (85.4%), to receive free drugs (42.6%) and medical care (43.6%), to get hospitalized (15.8%) and to receive money or gifts (4.9%). Investigators needto emphasize the distinction between research and clinical care to address the high rate of therapeutic misconception

Les études ayant examiné le processus du consentement éclairé chez les participants à des études de recherche dans les pays en développement sont peu nombreuses. La présente étude visait à évaluer le processus de consentement éclairé, les idées fausses en matière de traitement et les motivations des Égyptiens pour participer à des essais cliniques. Dans une étude pilote qualitative et transversale, 103 participants dans 10 essais cliniques ont répondu à un questionnaire. Plus de 90 % ont convenu qu’ils avaient eu le temps de poser des questions et qu’ils avaient reçu des informations adéquates sur les risques avant d’accorder leur consentement. Tous les participants pensaient que la recherche et le médicament pourraient améliorer leur état ; seuls 46,1 % savaient qu’ils recevaientun médicament à l’essai n’ayant pas été autorisé et 21,3 % qu’ils étaient randomisés. Parmi les raisons pourparticiper, on peut citer : un meilleur traitement (100 %), qui sera utile pour la société et pour les progrès de lascience (85,4 %), des médicaments gratuits (42,6 %) et des soins médicaux gratuits (43,6 %), une hospitalisation(15,8 %) et des compensations financières ou matérielles (4,9 %). Les chercheurs doivent insister sur la différenceentre recherche et soins cliniques pour s’attaquer au fort pourcentage d’idées fausses en termes de traitement.

Transdermal patch incorporating salbutamol sulphate: In vitro and clinical characterization.

Eudragit patches containing salbutamol sulphate were prepared and evaluated as a rate-controlling membrane for transdermal use. The effect of different Eudragit polymers and various plasticizers on the permeability and mechanical properties of the prepared patches were studied. Drug patches of Eudragit polymers were prepared by a casting method employing methanol as a solvent and dibutylphthalate, polyethylene glycol 400, Propylene glycol, and triacetin as plasticizers. These patches were evaluated for weight and thickness uniformity, swelling index, tensile strength, percentage of elongation, and moisture absorption capacity. In vitro release characteristics of these patches were studied and analyzed. The patches were found to have a uniform thickness. Patches prepared using Eudragit RS 100 (T(8)) as well as RS100 + L100 in a ratio of 3:1 (T(15)) plasticized with triacetin were found to have a tensile strength lower than that of other patches. Permeability characteristics of selected patches were studied. Patch formulations T(8) and T(15) containing 10% oleic acid and 5% dimethyl formamide as penetration enhancers, respectively, displayed the highest permeability to salbutamol sulphate. These two formulations were selected for further clinical investigation and although both resulted in improvement in respiratory function tests, only the first formulation resulted in significant improvement.

Comparison between the effect of two different widths of circular lamellar keratectomy on refraction and corneal curvature in rabbits' eyes.

Twenty rabbits' eyes were subjected to circular lamellar keratectomy. Two trephines were used to mark rings at a depth of 0.3 mm, and the lamellar cornea in between was removed. A 1-mm-wide ring was removed from the right eyes, and a 0.5-mm-wide ring from the left ones. We found that removing a 1-mm ring more effectively corrected hypermetropia (3.09 +/- 1.72 diopters) than removing a 0.5-mm ring (1.81 +/- 0.95 D).

Effect of immunomodulation on the course of experimental toxocariasis in mice.

Immunosuppressed groups treated with cortisone showed fulmination of Toxocara canis infection in terms of significant increase in brain parasitism, total larval count and significant decrease in the percentage reduction of the total count. Suppression of the host inflammatory responses was detected in the liver, lungs, brain and muscles. Accelerated transit of larvae through the liver was observed when cortisone was given before infection. Whether BCG was given before or after infection, it showed no significant changes regarding all criteria compared to the control group. Induction of diabetes, whether before or after infection, led to persistence of larvae in the liver, insignificant increase in brain and total larval parasitism and insignificant decrease in the percentage reduction of the total count.

Histopathological evidences for the antifibrogenic effect of colchicine in schistosomiasis mansoni in mice.

Colchicine treated mice showed significant decrease in prevalence of fibrocellular and fibrocellular and fibrous granulomas in liver specimens compared to corresponding control groups. Percentage of spindle cell component and red fibrillar (RF) material showed significant reduction compared to control groups. These evidences of the antifibrogenic effect of colchicine were more prominent when treatment was given early after infection. Combined therapy with colchicine and praziquantel gave the same results. Mice treated with praziquantel alone showed no significant change compared to control groups. Colchicine showed also an immunomodulant effect evidenced by a significant decrease in the intensity of small and medium-sized to large cell components compared to control groups.

Effect of immunomodulation on experimental hymenolepiasis nana in mice.

Oral infection of cortisone treated and diabetes induced groups of mice (immunosuppressed) with H. nana eggs, whether before or after infection, showed persistent hyperinfection of the gut with H. nana worms and cysticercoids, dissemination of cysticercoids to the liver and marked degenerative changes in the intestinal mucosa and liver. BCG treated groups (immunostimulated) whether before or after infection, showed no significant changes compared to the control group. Subcutaneous infection of mice resulted in severe localized cellular reaction around and infiltrating the injected H. nana eggs in BCG treated and control groups. BCG did not inhibit larval development, as cysticercoids were found in the injected sites. In cortisone treated and diabetic groups, mild cellular reaction was observed.

A survey for enteroparasites in Menoufia governorate, Egypt with special reference to Strongyloides stercoralis.

The prevalence of Strongyloides stercoralis and other enteroparasites was studied in Menoufia Governorate. 565 stool & 500 serum samples were examined by direct smear, zinc sulphate, stool culture & IFAT using ultrasonicated non digested non fixed filariform larva as antigen. IFAT proved superior than the direct methods since it detected 11.1% of cases while the latter detected only up to 3.4%. The prevalence of enteroparasites was found to be 62.3%. E. histolytica and A. lumbricoides showed the highest incidence while Taenia showed the lowest incidence.

Parasitic infections associated with malignancy and leprosy.

Results of parasitic infections, as revealed by urine and stool examination was significant (P less than 0.05) in 43.3% of patients suffering from different malignant diseases and non significant (P greater than 0.05) in 29.3% of leprosy patients compared to 22% in control subjects. The most prevalent parasites were E. histolytica and G. lamblia. Cryptosporidium occysts were not detected. By stool examination and culture, S. stercoralis larvae were detected only in the malignancy group. The most common parasites occurring concomitantly were A. duodenale and S. stercoralis. By the IFAT, strongyloidiasis gave significantly higher positive results in the malignancy group than in the leprosy and control groups. IFAT for toxocariasis, showed highly significant positivity in the leprosy group and significantly positivity in the malignancy group. For toxoplasmosis, it showed highly significant positive results in both leprosy and malignancy groups. Eosinophilia was significantly more prominent among malignancy patients and insignificant among those with leprosy. Parasitic infection detected by urine and stool examination among patients with eosinophilia was found in 76% of the malignancy patients and in 66.7% of the leprosy patients.

Serum levels of tumour necrosis factor- alpha in schistosomiasis mansoni and their analogous changes in collagen diseases and schistosomal arthropathy.

Serum levels of TNF-alpha was quantitatively estimated by the use of solid enzyme amplified sensitivity immunoassay (EASIA) in different stages of schistosomiasis mansoni, rheumatoid arthritis (RA), systemic lupus erythematosus (SLE) and schistosomal arthropathy. Statistically, significant higher levels were detected in the different groups compared to the normal control group. The level was found highest in hepatosplenic schistosomiasis with ascites (group 1c). The difference was significantly higher compared to cases of early S. mansoni infection (group Ia) and insignificant compared to hepatosplenic schistosomiasis without ascites (group 1b). No significant difference was detected comparing groups 1a and 1b, or groups 2a (RA) and 2b (SLE). Cases of schistosomal arthropathy (group 3) showed significantly higher level compared to groups 1a and 1b, although the level in group 1c was still significantly higher compared to group 3, the level was also significantly higher in group 3 compared to cases of RA but not to cases of SLE.