Multicriteria decision analysis enabled participants to evaluate the OTC analgesics against a range of favourable and unfavourable effects in a group setting that enabled all issues to be openly aired and debated. The model was easily communicated and understood by the peer reviewers, so the model should be comprehensible to physicians, pharmacists and other health professionals.
The formulations of OTC ibuprofen differ in their disintegration and dissolution properties, pharmacokinetic profiles and apparent gastrointestinal tolerability. Spontaneously reported abdominal symptoms were five times lower with the liquid gelatine capsule as compared with ibuprofen acid despite a 30% increase in C .
Objective: To evaluate the efficacy of a multi-vitamin/mineral preparation (MMP) in achieving erythrocyte folate levels (Fol-E) considered preventive of neural tube defects (NTDs).
Methods:In this single-center, double-blind, randomized, placebo (PBO)-controlled trial, healthy women of childbearing potential (WCBP) took either an oral MMP containing 400 µg folic acid and 451 µg L-5-methyltetrahydrofolate (MTHF) or PBO once daily for 16 weeks. Primary endpoints were achievement of Fol-E ≥ 906 nmol/L at Week 4 and maintenance of this level once achieved. Secondary efficacy variables were plasma concentrations of folate, homocysteine, and vitamins B2, B6, and B12 at Week 4, 8, 12, and 16.
Results:Of the 40 women enrolled, 20 were randomized to each study arm. All but one PBO-subject completed the study as planned. Baseline characteristics in both groups were comparable with mean Fol-E around 500 nmol/L. In contrast to only one PBO-subject, all MMP subjects achieved and maintained the target Fol-E (MMP: 100% vs PBO: 5%, p<0.001), 14 (70%) MMP subjects already by Week 4 (means ± SD: 976 ± 186 vs 629 ± 215 nmol/L, p<0.001). In plasma, the only change under PBO was a 10% decrease of vitamin B12 whereas under MMP folate and vitamin B6 significantly increased and homocysteine significantly decreased. There was no serious and only one severe adverse event (AE); most common AEs were gastrointestinal with greater incidence in the MMP group (30% versus 5%).
Conclusion:Supplementation with folic acid and MTHF at equimolar amounts was efficacious in replenishing Fol-E of WCBP within 4 weeks to levels considered protective of NTDs.
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