Flavocoxid is as effective as naproxen for managing the signs and symptoms of osteoarthritis of the knee in humans: a short-term randomized,double-blind pilot study

Flavocoxid (Limbrel), a proprietary mixture of flavonoid molecules (baicalin and catechin), was tested against a traditional nonsteroidal anti-inflammatory drug, naproxen, for the management of the signs and symptoms of moderate osteoarthritis (OA) in humans. Discomfort and global disease activity were used as the primary end points, and safety assessments were also taken for both treatments as a secondary endpoint. In this double-blind study, 103 subjects were randomly assigned to receive either flavocoxid [500 mg twice daily (BID)] or naproxen (500 mg BID) in a 1-month onset of action trial. Outcome measures included the short Western Ontario and McMaster University Osteoarthritis Index, subject Visual Analogue Scale for discomfort and global response, and investigator Visual Analogue Scale for global response and fecal occult blood. Both flavocoxid and naproxen showed significant reduction in the signs and symptoms of knee OA (P ≤ .001). There were no statistically detectable differences between the flavocoxid and naproxen groups with respect to any of the outcome variables. Similarly, there were no statistically detectable differences between the groups with respect to any adverse event, although there was a trend toward a higher incidence of edema and nonspecific musculoskeletal discomfort in the naproxen group. In this short-term pilot study, flavocoxid was as effective as naproxen in controlling the signs and symptoms of OA of the knee and would present a safe and effective option for those individuals on traditional nonsteroidal anti-inflammatory drugs or cyclooxygenase-2 inhibitors. A low incidence of adverse events was reported for both groups.     

Impact de l’estimation de la population affiliée à l’assurance-maladie sur le calcul de la prévalence pharmacologique du diabète à l’échelle régionale et territoriale

BackgroundData derived from Health Insurance databases are very useful for health observation. These data are however still underused, particularly for small local areas. This may be partly explained by the lack of reliable data on the number of insured people. Recent simplification of the Répertoire national interrégimes de l’assurance-maladie (RNIAM) indicator (French register of health insurance) gives the opportunity to improve the usefulness of these databases. This indicator specifies the beneficiaries’ status towards the General Health Insurance Fund. This study aimed to select the population of beneficiaries, which could be most adequately used to calculate health indicators based on these data.MethodsData were collected from the outpatient database of the Southeastern France General Health Fund. We compared beneficiaries’ characteristics according to the RNIAM indicator, calculated the annual unadjusted and age-adjusted regional and local prevalence of diabetes mellitus in two different populations: the whole initial beneficiaries database, and the population of “effective” beneficiaries (persons whose reimbursements were effectively managed by the General Health Insurance).ResultsThe initial database included 4,817,871 beneficiaries. Almost 80% were in the “effective” population, 14% had left the General Health Insurance, or Southeastern France, and 4% were doubles. The annual unadjusted prevalence of diabetes mellitus was 3.31% in the initial database, and more than 20% higher when calculated among “effective” beneficiaries. Impact on aged-adjusted prevalence was less important (+9% at regional level), but the increase varied from 6 to 42% for the small local areas. Impact was much higher on age and gender specific rates.ConclusionWhen Health Insurance databases are used to calculate health indicators at various geographical levels, only “effective” beneficiaries should be selected. The methodology for determining health indicators might be improved by updating databases (e.g. the date of the RNIAM indicator last update should be added).