BACKGROUND/AIMS: Nonsteroidal anti-inflammatory drugs relieve osteoarthritis (OA) symptoms but cause adverse effects. D-002, a mixture of beeswax alcohols, is effective against experimental OA. A pilot study found that D-002 (50 mg/day) for 8 weeks improves OA symptoms. The aim of this study was to investigate the effects of D-002 (50 to 100 mg/day) administered for 6 weeks on OA symptoms. METHODS: Patients with OA symptoms were double-blindly randomized to D-002 (50 mg) or placebo for 6 weeks. Symptoms were assessed by the Western Ontario and McMaster Individual Osteoarthritis Index (WOMAC) and the visual analog scale (VAS) scores. Patients without symptom improvement at week 3 were titrated to two daily tablets. The primary outcome was the total WOMAC score. WOMAC pain, joint stiffness and physical function scores, VAS score, and use of rescue medications were secondary outcomes. RESULTS: All randomized patients (n = 60) completed the study, and 23 experienced dose titration (two in the D-002 and 21 in the placebo groups). At study completion, D-002 reduced total WOMAC (65.4%), pain (54.9%), joint stiffness (76.8%), and physical function (66.9%) WOMAC scores, and the VAS score (46.8%) versus placebo. These reductions were significant beginning in the second week, and became enhanced during the trial. The use of rescue medication by the D-002 (6/30) group was lower than that in the placebo (17/30) group. The treatment was well tolerated. Seven patients (two in the D-002 and five in the placebo group) reported adverse events. CONCLUSIONS: These results indicate that D-002 (50 to 100 mg/day) for 6 weeks ameliorated arthritic symptoms and was well tolerated.
Administration, Oral ; Adult ; Aged ; Aged, 80 and over ; Anti-Infective Agents/administration & dosage/adverse effects/*therapeutic use ; Cuba ; Double-Blind Method ; Drug Administration Schedule ; Fatty Alcohols/administration & dosage/adverse effects/*therapeutic use ; Female ; Humans ; Male ; Middle Aged ; Osteoarthritis/diagnosis/*drug therapy/physiopathology ; Pain Measurement ; Questionnaires ; Tablets ; Time Factors ; Treatment Outcome ; Young Adult

PURPOSE: This study aimed to determine the frequency of abnormalities in the newborn oral cavity and to evaluate the association with prenatal and perinatal factors. METHODS: This cross-sectional study evaluated 2,216 newborns. Oral findings were assessed in the first 24 hours of life using visual examination. Sex, weight, length, gestational age, and medical disorders at birth were recorded. Maternal demographic and medical information was also obtained. RESULTS: The most common oral findings were Bohn’s nodules, Epstein’s pearls, and dental lamina cysts. Other intraoral findings included odontogenic cysts, ankyloglossia, and natal teeth, among others. In logistic regression analyses, folic acid consumption during pregnancy was significantly associated with Bohn’s nodules (odds ratio [OR], 1.79; 95% confidence interval [CI], 1.23–2.55; P=0.002), Epstein’s pearls (OR, 1.63; 95% CI, 1.14–2.33; P=0.007), and dental lamina cysts (OR, 1.45; 95% CI, 1.02–2.05; P=0.038). Moreover, preterm births were negatively associated with prevalence of Bohn’s nodules (OR, 0.63; 95% CI, 0.50–0.80; P≤0.0001). Comparison between newborns with and without oral inclusion cysts showed that maternal folic acid and iron intake were significantly different (P < 0.05). CONCLUSION: Maternal folic acid and iron intake were associated with the prevalence of oral inclusion cysts.
Cross-Sectional Studies ; Folic Acid ; Gestational Age ; Humans ; Infant ; Infant, Newborn* ; Iron ; Logistic Models ; Mouth ; Mouth Abnormalities ; Natal Teeth ; Odontogenic Cysts ; Parturition ; Pregnancy ; Premature Birth ; Prevalence