Focus on Alternative and Complementary Therapies
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Focus Alternat Complement Ther©2005 Pharmaceutical Press
Focus Altern Complement Ther 2003; 8: 522
The public assumes that over-the-counter health products (OTCs) are safe and effective when used as directed. Few valid studies exist that report on the adverse effects of OTCs. We sought to determine the safety of OTCs when healthy individuals use them as directed.
Fifty-one female and 17 male healthy volunteers (mean age 27 years, SD 4.4) participated in a randomised, placebo-controlled blinded trial of a single dose of an OTC, immediate-release niacin 500 mg (n = 33), or a single dose of placebo (n = 35) on an empty stomach. The outcomes measured were self-reported incidence of flushing and other adverse effects.
Thirty-three volunteers on niacin (100%) and one volunteer on placebo (3%) flushed (relative risk 35, 95% CI 6.8–194.7). Mean time to flushing on niacin was 18.2 min (95% CI 12.7–23.6); mean duration of flushing was 75.4 min (95% CI 62.5–88.2). Other adverse effects occurred commonly in the niacin group: uncomfortable localised flushing (48% vs. 0%, P < 0.0001), chills (51.5% vs. 0%, P < 0.0001), generalised pruritus (39% vs. 0%, P = 0.0001), gastrointestinal upset (30% vs. 3%, P = 0.005), and cutaneous tingling (21% vs. 0%, P = 0.004). Six participants did not tolerate the adverse effects of niacin and three required medical attention.
This study (1) demonstrates the need for randomised trials to inform policy and patient choice about the safety of OTCs, (2) underscores the adverse public health impact of OTCs and (3) likely underestimates the adverse impact of adverse effects of OTCs in patients with comorbidities.
