TABLE 5.
Summary of clinical studies using TTO
| Study population | Study type | Treatment groups (no. of evaluable patients) | Administration of treatment | Outcomes | Adverse events | Reference |
|---|---|---|---|---|---|---|
| 124 patients with mild to moderate acne | RCTa, investigator blindedb | 5% TTO gel (58), 5% benzoyl peroxide (61) | 3 mo | Both significantly reduced inflamed lesions (P < 0.001) but BP better than TTO (P < 0.05); BP better at reducing oiliness (P < 0.02); less scaling (P < 0.02), pruritis (P < 0.05), dryness (P < 0.001) with TTO; treatments equivalent for noninflamed lesions, erythema | 27 (44%) in TTO group, 50 (79%) in BP group (e.g., dryness, stinging, burning, redness); significantly fewer events in TTO group (P < 0.001) | 14 |
| 18 patients with recurrent herpes labialis (cold sores) | RCT, investigator blindedb | 6% TTO gel (9), placebo gel (9) | 5 times daily | Median time to reepithelization of 9 days for TTO vs 12.5 days for placebo (not significant) | 1 in TTO group (event not stated) | 30 |
| 126 patients with mild to moderate dandruff | RCT, investigator blindedb | 5% TTO shampoo (63), placebo shampoo (62) | Daily for 4 wk | Whole scalp lesion score significantly improved in TTO group (41.2%) compared to placebo group (11.2%) (P < 0.001) | 3 (5%) in TTO group, 8 (13%) in placebo group (e.g., mild burning, stinging, itching) | 130 |
| 30 hospital inpatients colonized or infected with MRSA | Randomized, controlled pilot study | 4% TTO nasal ointment + 5% TTO body wash (15), 2% mupirocin nasal ointment + Triclosan body wash (15) | Frequency not stated, minimum of 3 days | For TTO, 33% cleared, 20% chronic, 47% incomplete; for routine treatment, 3% cleared, 53% chronic, 33% incomplete (no significant differences) | With TTO nasal ointment (no. not stated), mild swelling of nasal mucosa to acute burning | 28 |
| 236 hospital patients colonized with MRSA | RCT | 10% TTO cream + 5% TTO body wash (110), 2% mupirocin nasal ointment + 4% Triclosan body wash + 1% silver sulfadiazine cream (114) | Once daily for 5 days | For TTO, 41% cleared; for routine treatment, 49%cleared; treatment regimens did not differ significantly (P = 0.0286); mupirocin significantly better than TTO at clearing nasal carriage (P = 0.0001) | None | 56 |
| 117 patients with culture-positive onychomycosis | RCT, double blind | 100% TTO (64), 1% clotrimazole (53) | Twice daily for 6 mo | Full or partial resolution for 60% of TTO and 61% of clotrimazole patients after 6 months of therapy (not significant; P > 0.05) | 5 (7.8%) in TTO group, 3 (5.7%) in clotrimazole group (erythema, irritation, edema) | 26 |
| 60 outpatients with a clinical diagnosis of onychomycosis | RCT, double blind | 2% butenafine hydrochloride with 5% TTO cream (40), 5% TTO cream (20) | 3 times daily for 8 wk | Cure in 80% of butenafine/TTO group and 0% of TTO group (P < 0.0001) | 4 (10%) in butenafine/TTO group (mild inflammation) | 143 |
| 13 patients with AIDS and fluconazole-refractory oral candidiasis | Case series | Melaleuca oral solution (15 ml) (12) | 4 times daily for 2-4 wk | Clinical response rate of 67% after 4 weeks (cure in 2 patients, improvement in 6 patients, no response in 4 patients, 1 deterioration) | None | 92 |
| 27 patients with AIDS and fluconazole-refractory oral candidiasis | Open-label trial | Melaleuca oral solution (15 ml) (12), alcohol-free melaleuca oral solution (5 ml)c (13) | 4 times daily for 2-4 wk | Mycological and clinical response in 58% (alcohol-based solution) and 54% (alcohol-free solution) of patients after 4 wk | 8 (66.7%) in alcohol-based solution group, 2 (15.4%) in alcohol-free solution group (mild to moderate burning) | 149 |
| 121 patients with clinically diagnosed tinea pedis | RCT, double blind | 10% TTO in sorbolene (37), 1% tolnaftate (33), placebo (sorbolene) (34) | Twice daily for 4 wk | Mycological cure and clinical improvement in 46% (tolnaftate), 22% (TTO), and 9% (placebo) of patients; tolnaftate significantly better than placebo (P = 0.003) but not TTO (P = 0.59); TTO not different from placebo (P = 0.3) | None | 145 |
| 137 patients with culture-positive tinea pedis | RCT, double blind | 25% TTO (36), 50% TTO (38), placebo (46) | Twice daily for 4 wk | Effective cure in 48% (25% TTO), 50% (50% TTO), and 13% (placebo) of patients; TTO significantly better than placebo (P < 0.0005) | 1 (2.8%) in 25% TTO group, 3 (7.9%) in 50% TTO group (moderate to severe dermatitis) | 131 |
a
RCT, randomized controlled trial.
b
The distinctive odor of TTO was stated as preventing patient blinding.
c
The alcohol-free solution was more concentrated, and thus a smaller volume was used.