Clinical Studies

In an open trial of steroid-dependent asthma patients using 14 mg/kg/day TAO (maximum dose, 1 g) and methylprednisolone, 62 of 74 patients had improvement in clinical symptoms and/or a reduction in corticosteroid dosage (70). Several case series found similar effects (74,75). A subsequent study reduced the starting TAO dose to 250 mg once or twice daily with a rapid methylprednisolone taper to alternate-day dosing for > 4 to 8 days, and found that steroid-related and GI side effects could be reduced (76).

In one large prospective, double-blind, randomized, placebo-controlled trial of TAO, 75 steroid-dependent asthma patients were randomized to TAO, 250 mg daily, or placebo, with attempted tapering of methylprednisolone as tolerated (77). The study was hampered by a high patient dropout rate (TAO group: seven patients at one year, 20 patients at two years; placebo group: 11 patients at one year, 30 patients at two years.) Those TAO patients continuing on the study did tolerate lower steroid doses at one year (p < 0.03), but they did not have a significant reduction in the number of hospitalizations and emergency department visits, and had more cases of bone loss (p < 0.01) and higher cholesterol levels (p < 0.05) than did placebo subjects. The study concluded that TAO offered no advantage for asthma outcome, and was associated with greater steroid-related side effects. In a Cochrane review of aggregate data from three randomized trials in which 112 patients were recruited, data from 90 patients were analyzed (78). Addition of TAO was not associated with benefits in lung function.

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