Documentation of ethical conduct of human subject research published in Saudi medical journals

We evaluated the documentation of ethical conduct [obtaining institutional review board approval and consent and following ethical guidelines] of human subject research studies published in Saudi Arabian medical journals between 1979 and 2007. Studies were classified as retrospective, prospective noninterventional, interventional or survey/interview. Of 1838 studies published in 286 journal issues of 11 Saudi Arabian medical journals, only 0.9% documented the ethical guidelines followed, with a significantly higher rate for studies published after year 2000 [1.7%]. Of 821 studies requiring institutional review board approval, 8.6% documented obtaining the approval and informed consent, with a significantly higher rate for interventional studies [19.4%], post-year 2000 studies [19.7%] and studies performed outside Saudi Arabia [15.9%]. The low documentation rate suggests editor's lack of rigor and/or investigators' ignorance of guidelines. The higher documentation rate after year 2000 suggests an ongoing improvement

Impact of diet habits on clinical and biological characteristics of type 2 diabetics originating from south and costal regions

Type 2 diabetes is a very frequent pathology in our country. The objective of this study was to compare two diabetic populations recruited in the Monastir [M] and Sfax [S] areas. The aim of our study was to evaluate the effect of the diet on the evolution of the disease. The duration of diabetes was longer in the sample from Sfax and their levels for glycated haemoglobin and triglycerides were higher: 8.51 +/- 2.8 vs 10.2 +/- 3.6% [p=0.035] and 1.7 +/- 1.1 vs 2.6 +/- 1.3 mmol/l [p=0.006] respectively for group M and S. Total cholesterol, LDL-cholesterol and Apo AI levels were significantly higher in the M. group. Total homocysteine plasmatic levels were also significantly higher in the Monastir sample compared to the one from Sfax: respectively 23.3 +/- 15.4 vs 14.8 +/- 5.92 micro mol/l [p=0.002]. The protein food intake was positively correlated to the plasmatic homocysteine level only in the M. group [r= 0.439, p<0.001]. Olive oil consumption proved to be beneficial with a lowering of both systolic and diastolic blood pressure in the 2 groups [Monastir: r= -0.113, p<0.05 and Sfax: r= -0.403, p<0.001]. An appropriate and early management following the [Mediterranean diet] is called for in type 2 diabetes

Factor VII polymorphisms associated with plasma factor VII coagulant activity levels in healthy Tunisians

Factor VII gene polymorphisms may contribute to elevations in factor VII coagulant [FVIIc] levels that have been associated with cardiovascular risk. We therefore studied the association of two polymorphisms--R353Q polymorphism at codon 353 involving the catalytic region and the 10 base pair [bp] insertion polymorphism involving the promoter region--with FVllc levels in 176 healthy Tunisians. The variant Q allele had a frequency of 0.213 [SD 0.021] whereas the frequency of the 10 bp insert allele was 0.250 [SD 0.023]. Subjects with R/R genotype had significantly higher FVllc levels than Q353 heterozygote and homozygote subjects [96.36 versus 59.52]. FVIIc levels with the 10 bp insertion polymorphism were not significantly different. The Q353 allele of the factor VII gene polymorphism is associated with decreased factor VII and could be protective against cardiovascular disease

Elevated serum creatinine level in thyroid cancer patients undergoing withdrawal of throxine therapy for radioiodine scan/treatment

Chronic hypothyroidism is known to cause a significant reversible decrease in glomerular filtration rate [GFR], However, the effect on GFR of acute hypothyroidism, routinely induced in thyroid cancer patients in preparation for radioiodine scan/treatment, is not known. We studied the prevalence of abnormal serum creatinine level and the degree of its increase in hypothyroid patients with thyroid cancer four weeks after the withdrawal of thyroxine therapy. Creatinine level was measured in 116 patients on 191 hypothyroid episodes and in 56/116 and 18/116 patients while euthyroid or mildly hyperthyroid respectively. Abnormal creatinine level was significantly more prevalent in the hypothyroid state [34.5% vs 4% in the euthyroid or mildly hyperthyroid states] and significantly more common in males [50% vs 29% in females], in patients 150 mU/L [55% vs 30% with TSH 150 mU/L, 29.8 vs 41.4 years; in females, 28.3 vs 42.5 years] and there was a significant negative association between the presence of abnormal creatinine levels and different age groups. Compared to levels obtained in the euthyroid or mild hyperthyroid states, creatinine levels increased in the hypothyroid state on average 32% [23micro M/L, P=0.0001] with 24% of patients having >/= 50% increase. Elevated serum creatinine levels are rather common in thyroid cancer patienis undergoing temporary withdrawal of thyroxine treatment and more so in males, younger patients or in association with higher TSH levels. Since the clearance of iodine is linearly related to GFR, our study suggests that in the setting of hypothyroidism, the bioavailability of a given dose of radioiodine may have significant individual variation

Influence of age and sex in modulating TSH level in primary hypothyroidism

Previous studies addressing the interaction of age and sex with the function of the hypothalamic-pituitary-thyrotrophs axis yielded conflicting results, due in part to inability to control for the effect of variable free thyroid hormone levels. We studied the effect of age and sex on TSH levels in patients with severe primary hypothyroidism who have essentially undetectable plasma thyroid hormone levels. The TSH levels were measured in 116 thyroid cancer patients four weeks after the withdrawal of thyroxine therapy in preparation for radioiodine scan/treatment. All patients had a TSH >/= 30 mU/L [normal = 0.2-5] and a free T[4] <6 pmol/L [normal = 10-25]. Thirty males and 86 females with a mean age [ +/- SD] of 40 +/- 16 [range 6-89 years] were studied on up to four hypothyroid episodes, with a total of 191 episodes. The TSH level during the first hypothyroid episode correlated significantly with the TSH level during subsequent episodes [first episode versus second episode, r = 0.7, P - 0.0001; first versus third episode, r = 0.6, P - 0.03]. There was a significant negative correlation between age and TSH level [r = -0.24, P - 0.0009] that persisted when only the first hypothyroid episode was considered [r = -0.23, P = 0.01], or when only males [r = -0.32, P = 0.02] or only females [r = -0.23, P = 0.005] were considered. Means of TSH levels in males and females were not significantly different [130 versus 114 mU/L, respectively; P = 0.28]. We conclude that age but not sex may modulate the sensitivity/responsiveness of the hypothalamic-pituitary thyrotroph axis to primary hypothyroidism