The Characteristics of Clinical Studies Submitted to the Saudi Food and Drug Authority from 2009 until 2020.

BACKGROUND: Clinical trials are crucial in contemporary evidence-based medicine for discovering new treatments for diseases. Their registration in a registry increases the transparency in the dissemination of knowledge about clinical research. It is essential to understand the activity of clinical trials in a country, thus identifying research gaps. OBJECTIVE: This study, therefore, aims to describe the clinical trial activity since the inception of clinical trials' administration and national clinical trials' registry within the Kingdom of Saudi Arabia (KSA). METHOD: A descriptive study was conducted by reviewing all clinical studies that have been registered during 2009 and June 2020. The inclusion criterion was all phases of the clinical trials registered in the national registry during that period. Data analysis was done using descriptive statistics. RESULTS: Since 2009, 352 studies have been registered. However, a total of 333 studies with complete data was included in the analysis. A total of 80 sponsors funded the clinical studies in the KSA. The majority of the clinical studies are funded by multinational pharmaceutical companies. Oncology (13.81%) and diabetes (11.71%) were the most common therapeutic areas and constituted the largest proportion of the overall studies. 44% were phase 4 and 40% were phase 3 studies. CONCLUSION: With a population approaching 34 million, the number of clinical trials in the KSA is not sufficient. Since the inception of the clinical trial's administration and SCTR, the emphasis has been on phase 3 and phase 4 clinical studies. The most studied therapeutic areas were oncology and diabetes. Many clinical studies in the KSA were sponsored by multinational pharmaceutical companies.

The Utilization of Complementary and Alternative Medicine among Saudi Older Adults: A Population-Based Study.

BACKGROUND: Complementary and alternative medicine (CAM) is an integral part of patients' therapeutic experience worldwide. Among Saudi older adults, less is known about CAM utilization. OBJECTIVES: To determine the prevalence, patterns, and factors associated with CAM utilization among SOA. METHODS: In the Saudi National Survey for Elderly Health (SNSEH), subjects were asked about CAM use during the last twelve months before the interview. CAM use was defined as any use of herbal products, acupuncture, bloodletting, cauterization, medical massage, bones manual manipulation, honey, or religious rituals. Demographic characteristics included gender, age, marital status, region, educational level, and residence area. In addition, multiple comorbidities were included as possible factors that may be associated with CAM use. Multivariable logistic regression was used to explore factors associated with CAM utilization. All statistical analyses were done using STATA v.14. RESULTS: Out of 2946 respondents, 50.4% were males, the mean age was 70.3 ± 8.3 years, and 70% were illiterate. CAM use was prevalent (62.5%). The most common CAM types were herbal products (25.4%), acupuncture (21.2%), bloodletting (12%), honey (9.5%), cauterization (7.4%), medical massage and bones manual manipulation (4%), and traditional bone setting (2.1%). In the multivariable regression, age, gender, and marital status did not have an impact on the odds of using CAM. Subjects from rural areas were 2.92 times more likely to use CAM compared with subjects in urban areas (OR = 2.92; 95%CI: 2.28-3.75). Subjects with metabolic disorders (OR = 0.50; 95% CI: 0.42-0.60) or kidney disease were less likely to use CAM (OR = 0.30; 95%CI: 0.14-0.64). About pain, CAM is used more in neck pain (OR = 1.69; 95%CI: 1.30-2.21) and also used in back pain (OR = 1.22; 95%CI: 1.03-1.46). CONCLUSIONS: CAM use was very prevalent among SOA. Clinicians and pharmacists must ask about CAM use among older adults as many of CAM may interact with patients medications.

The association of vitamin D deficiency and glucose control among diabetic patients.

OBJECTIVE: To evaluate the association between the level of vitamin D and glycemic control among patients with diabetes. RESEARCH DESIGN AND METHOD: We analyzed data collected from NHANES 2003-2006. We included only non-pregnant adult diabetic persons 18 years or older. Participants who had vitamin D level less than 20 ng/ml were considered as having vitamin D deficiency. Participants were considered to have a glucose control if the HbA1c level was less than 7% [53 mmol/L]. We used student's t test to compare the difference in HbA1c means between people with Diabetes with and without a vitamin D deficiency. We used a multivariate logistic regression model to predict the relationship between glucose control and vitamin D deficiency. We used race/ethnicity, BMI, age, gender, type of diabetic medication used, having health insurance or not, and comorbid conditions (hypertension, anemia, cholesterol, liver disease, and kidney disease) as control variables. RESULTS: The study population included a total of 929 non-institutionalized, non-pregnant, diabetic adult persons. About 57% of patients with diabetes had a vitamin D deficiency. Blacks (non-Hispanic patients) with diabetes had the highest rate of vitamin D deficiency (79%). The unadjusted means of HbA1c were significantly different between diabetic patients with no vitamin D deficiency and those with a vitamin D deficiency (7.06% [54 mmol/L], 7.56 % [59 mmol/L], respectively, P < 0.0001). Multivariate adjustment showed a small but not significant, increase in odds (11%) of having uncontrolled diabetes in patients with a vitamin D deficiency after adjustment for other factors. CONCLUSION: Vitamin D deficiency is very common in patients with diabetes. We found no significant association between vitamin D level and glycemic control in patients with diabetes after adjustment for control variables.