Assessment of Different Cetirizine Dosing Strategies on Seasonal Allergic Rhinitis Symptoms: Findings of Two Randomized Trials.

BACKGROUND: Cetirizine has been shown to be effective for relief of seasonal allergic rhinitis (SAR) symptoms. Allergic rhinitis symptoms have been reported to have circadian variations, with symptoms tending to be most bothersome overnight and in the morning. OBJECTIVE: To evaluate the effects of different cetirizine dosing schedules in comparison to twice daily (BID) chlorpheniramine and placebo on SAR symptoms at 12 and 24 hours postdose. METHODS: Study 1 subjects received cetirizine 10-mg once daily in the morning (QAM), cetirizine 10-mg once daily at bedtime (QHS), cetirizine 5-mg twice daily, or placebo. Study 2 subjects received cetirizine 5-mg QAM, cetirizine 10-mg QHS, chlorpheniramine 8-mg BID, or placebo. The primary end point was total symptom severity complex (TSSC); TSSC was the sum of symptom severity ratings averaged over the 2-week study period. Post hoc analyses of reflective symptom severity assessed in the morning (TSSCAM) and in the evening (TSSCPM) were conducted to evaluate cetirizine's effects at 12 and 24 hours postdose. RESULTS: In study 1, subject- and investigator-assessed TSSC was significantly lower in all cetirizine groups versus placebo (P ≤ .003). In study 2, subject-assessed TSSC was significantly lower in all cetirizine groups versus placebo (P ≤ .04) and was numerically lower for investigator-assessed TSSC. Post hoc analyses demonstrated that cetirizine significantly improved TSSCAM at 12 and 24 hours postdose versus placebo in both studies regardless of dosing schedule. TSSCPM significantly improved at 12 and 24 hours postdose in all study 1 cetirizine groups versus placebo. In study 2, versus placebo, TSSCPM significantly improved at 12 hours postdose in cetirizine 5-mg QAM group and numerically improved at 24 hours postdose in cetirizine 10-mg QHS group. CONCLUSION: Regardless of dosing regimen, cetirizine demonstrates effective 24-hour relief of SAR symptoms, particularly on TSSCAM, which assesses overnight and early morning symptom control.

SPF 100+ sunscreen is more protective against sunburn than SPF 50+ in actual use: Results of a randomized, double-blind, split-face, natural sunlight exposure clinical trial.

BACKGROUND: The value of additional photoprotection provided by use of high-sun protection factor (SPF) sunscreens is controversial, and limited clinical evidence exists. OBJECTIVE: To compare the sunburn protection provided by SPF 100+ and SPF 50+ sunscreen in conditions of actual use. METHODS: A total of 199 healthy men and women (≥18 years) participated in a natural sunlight, single-exposure, split-face, randomized, double-blind study in Vail, Colorado. Each participant wore both sunscreens simultaneously during activities, with no use restrictions other than designation of the treatment area. Erythema was clinically assessed on the day following exposure. Comparative efficacy was evaluated through bilateral comparison of sunburn between treatment areas and erythema score, as evaluated separately for each treatment area. RESULTS: Following an average 6.1 ± 1.3 hours of sun exposure, investigator-blinded evaluation identified 55.3% of the participants (110 of 199) as more sunburned on the SPF 50+ protected side and 5% (10 of 199) on the SPF 100+ protected side. After exposure, 40.7% of the participants (81 of 199) exhibited increased erythema scores (by ≥1) on the SPF 50+ protected side as compared with 13.6% (27 of 199) on the SPF 100+ protected side. LIMITATIONS: Single-day exposure may not extrapolate to benefits of longer-term protection. CONCLUSION: SPF 100+ sunscreen was significantly more effective in protecting against sunburn than SPF 50+ sunscreen in actual use conditions.

Randomized, placebo-controlled study of cetirizine and loratadine in children with seasonal allergic rhinitis.

BACKGROUND: Pharmacologic treatment is a mainstay of allergy therapy and many caregivers use over-the-counter antihistamines for the treatment of seasonal allergic rhinitis (SAR) symptoms in children. OBJECTIVE: To assess the efficacy and safety of cetirizine 10 mg syrup versus loratadine 10 mg syrup versus placebo syrup in a randomized double-blind study of children, ages 6-11 years, with SAR. METHODS: This randomized, double-blind, parallel-group, placebo-controlled study was conducted at 71 U.S. centers during the spring tree and grass pollen season. After a 1-week placebo run-in period, qualified subjects were randomized to once-daily cetirizine 10 mg (n = 231), loratadine 10 mg (n = 221), and placebo (n = 231) for 2 weeks. The primary efficacy end point was change from baseline in the subject's mean reflective total symptom severity complex (TSSC) score over 14 days. RESULTS: Children treated with cetirizine experienced significantly greater TSSC score reductions versus children treated with placebo over 14 days (least square mean change, -2.1 versus -1.6; p = 0.006). The differences in TSSC score improvement over 14 days between the cetirizine versus loratadine groups (-2.1 versus -1.8; p = 0.124) and between the loratadine versus placebo groups (-1.8 versus -1.6; p = 0.230) were not statistically significant. Predominant adverse events in the cetirizine, loratadine, and placebo groups were headache (3.5, 3.6, and 3.1%, respectively) and pharyngitis (3.5, 2.7, and 3.5%, respectively). Somnolence was reported in three subjects (1.3%) treated with cetirizine and in none of the other subjects. CONCLUSION: Cetirizine 10 mg was statistically significantly more efficacious than placebo in the treatment of SAR symptoms in children ages 6-11 years. Symptom improvement was not significantly different between the loratadine 10 mg and placebo groups.

Gingival health benefits of essential oil, 0.075% cetylpyridinium chloride and control mouthrinses: A 4-week randomized clinical study.

PURPOSE: This randomized, single center, examiner-blind, controlled, parallel-group, 4-week clinical study compared the antiplaque/anti-gingivitis efficacy of an essential oil (EO) containing mouthrinse versus a 0.075% cetylpyridinium chloride (CPC) containing mouthrinse. A 5% hydroalcohol solution was included as a control group. METHODS: 165 systemically healthy volunteers (18-72 years of age), with mild to moderate plaque-related gingivitis were enrolled in this clinical trial; 162 subjects completed the study. At baseline and 4-week visits, subjects received an oral examination, gingivitis (MGI), gingival bleeding (BI) and plaque (PI) assessments. Following randomization, subjects began rinsing with 20 mL of the assigned mouthrinse for 30 seconds, in conjunction with their usual oral hygiene, twice daily for the duration of the study. RESULTS: All rinses were well tolerated by the subjects. EO was statistically significantly superior to CPC with a reduction in mean MGI of 5.9%, and in mean PI of 6.4%. Statistically significant reductions in gingivitis, bleeding and plaque were observed for both EO and CPC when compared to the negative control; mean MGI and mean PI were reduced by 13.0% and 18.9% for EO and by 7.6% and 13.3% for CPC. EO also statistically significantly reduced the proportion of gingival bleeding sites compared to CPC by 7.6% (P = 0.012) and compared to control by 10.6% (P < 0.001). For the post hoc sitewise analyses, at 4 weeks, the mean percentage of healthy sites for EO, CPC and Control were 7.4%, 1.1% and 0.8%, respectively and the mean percentage of virtually plaque free sites for EO, CPC and control were 5.4%, 3.8% and 0.4% respectively. The mean percentages of more inflamed gingival sites for EO, CPC and control were 20.4%, 26.2% and 45.7%, respectively. The mean percentage of tooth surfaces with heavier accumulations of plaque (PI scores ≥ 3) was 50.9% for EO, 56.1% for CPC and 81.1% for control. Reduction of gingival inflammation and dental plaque was statistically significantly superior for EO compared to both 0.075% CPC and negative control. Both marketed antimicrobial mouthrinses showed a beneficial result in gingival health and in reducing plaque accumulation as early as 4 weeks.

Effect of cetirizine on symptom severity and quality of life in perennial allergic rhinitis.

The effect of cetirizine on quality of life (QOL) in subjects with perennial allergic rhinitis (PAR) has been previously evaluated using generic instruments. While generic QOL tools are used across various conditions, disease-specific instruments evaluate the impact of treatment on areas that are affected by that particular condition. This study evaluated the effect of cetirizine on symptom severity and health-related QOL, using a disease-specific instrument, in adults with PAR. This randomized, double-blind, placebo-controlled study was conducted at 15 U.S. centers outside the pollen allergy season. After a 1-week placebo run-in period, qualified subjects aged 18-65 years with PAR were randomized to once-daily cetirizine 10 mg (n = 158) or placebo (n = 163) for 4 weeks. Change from baseline in total symptom severity complex (TSSC) and overall Rhinitis Quality of Life Questionnaire (RQLQ) scores were primary efficacy end points. Cetirizine produced significantly greater improvements in mean TSSC for each treatment week (p < 0.05) and for the entire 4-week treatment period (p = 0.005) compared with placebo. After 4 weeks, cetirizine-treated subjects reported significantly greater overall improvement in RQLQ scores compared with placebo-treated subjects (p = 0.004). After 1 week, cetirizine produced significant improvements in the nasal symptoms, practical problems, and activities RQLQ domain scores compared with placebo (p < 0.05). After 4 weeks, cetirizine-treated subjects reported significant reductions in these RQLQ domain scores and in emotion domain scores compared with placebo-treated subjects (p < 0.05). Cetirizine 10 mg daily produced significant improvements in symptom severity and allergic rhinitis-related QOL compared with placebo in adults with PAR.

Comparative antiplaque and antigingivitis efficacy of a multipurpose essential oil-containing mouthrinse and a cetylpyridinium chloride-containing mouthrinse: A 6-month randomized clinical trial.

OBJECTIVE: This 6-month, examiner-blind, single-center, randomized, parallel group clinical trial compared the antiplaque and antigingivitis effects of an essential oil-containing mouthrinse with zinc chloride and sodium fluoride (EO) to a 0.05% cetylpyridinium chloride-containing mouthrinse (CPC) also with fluoride. METHOD AND MATERIALS: Four hundred and eight gingivitis subjects were monitored for the primary outcomes of modified Gingival Index (MGI) and Plaque Index (PI) at baseline and 3 and 6 months. Subjects were randomly assigned to 6-month twice a day unsupervised use of EO, CPC, or negative control rinse in conjunction with normal brushing and flossing. RESULTS: EO was always better than CPC at 3 and 6 months considering all parameters. All benefits allowed by EO increased from 3 to 6 months. CPC was better than the negative control at 3 and 6 months with respect to whole mouth plaque, and the proportion of more severe sites (baseline scores ≥ 3) in PI and MGI. At 6 months, CPC did not differ from negative control in relation to whole mouth MGI reduction, proximal MGI reduction, and percentages of sites improved over baseline in PI and MGI. CONCLUSION: This new EO mouthrinse provided superior clinical benefits to CPC and demonstrated increasing plaque and gingivitis reductions over 6 months. Our findings support the regular long-term use of the EO mouthrinse and selection over a 0.05% CPC rinse for better efficacy.

Superiority of an essential oil mouthrinse when compared with a 0.05% cetylpyridinium chloride containing mouthrinse: a six-month study.

OBJECTIVE: To evaluate the antiplaque/antigingivitis effectiveness of an essential oils containing mouthrinse as compared to a 0.05% cetylpyridinium chloride mouthrinse. METHOD: Generally healthy subjects with mild to moderate levels of plaque and gingivitis participated in a 6-month, examiner-blind, single centre, randomised, parallel-group controlled clinical trial. They were randomised into three mouthrinse groups--control (C), 0.05% cetylpyridinium chloride (CPC), or a fixed combination of essential oils (EO). Subjects received a dental prophylaxis at baseline and rinsed twice daily in addition to their usual oral hygiene for six months. Plaque Index and Modified Gingival Index were determined at 3 and 6 months. RESULTS: At 6 months, the EO group exhibited statistically significantly lower mean scores for MGI and PI than CPC (32.4% and 56.2% reductions, respectively). Compared to control, EO provided statistically significantly lower mean MGI and PI scores (36.3% and 69.7 %, respectively). The CPC group showed statistically significantly lower mean MGI and PI scores than the C group (5.8% and 30.7%, respectively). CONCLUSION: This study demonstrated the superiority of an EO rinse compared to a 0.05% CPC rinse in reducing plaque and gingivitis and confirmed that the daily use of an EO containing mouthrinse can provide a clinically significant benefit in reducing plaque and gingivitis.

Comparative antiplaque and antigingivitis efficacy of three antiseptic mouthrinses: a two week randomized clinical trial.

The objective of this randomized, examiner blind, parallel group, controlled clinical trial was to compare the antiplaque and antigingivitis efficacy of an essential oil-containing mouthrinse (EO) to two mouthrinses containing 0.05% Cetylpyridinium Chloride (CPC), one with alcohol and one alcohol-free, using a two-week experimental gingivitis validated-model with a 5% hydroalcohol rinse serving as the negative control. One hundred and fifty-nine subjects, 56 males and 103 females; ranging in age from 18 to 58 years in good general health were assigned to one of the four treatment groups: EO (n = 40), 0.05% CPC with alcohol (CPCa, n = 39), 0.05% CPC alcohol-free (CPCna, n = 40), and 5% hydroalcohol negative control (n = 40). The Mean Turesky Modification of the Quigley-Hein Plaque Index (PI) and the Mean Modified Gingival Index (MGI) were the primary efficacy endpoints and were evaluated at baseline and at two weeks. Following baseline examinations, subjects received a complete dental prophylaxis and began supervised rinsing with their assigned mouthrinse twice daily for two weeks, as their sole oral hygiene measure; 151 subjects completed the trial. Two weeks after baseline the EO adjusted mean PI and MGI scores were significantly lower than those of both CPC rinses and negative control (p < 0.001). In conclusion, the EO mouthrinse demonstrated significantly greater antiplaque and antigingivitis efficacy than both CPC-containing mouthrinses and the negative control.

Comparative antiplaque and antigingivitis efficacy of three antiseptic mouthrinses: a two week randomized clinical trial

The objective of this randomized, examiner blind, parallel group, controlled clinical trial was to compare the antiplaque and antigingivitis efficacy of an essential oil-containing mouthrinse (EO) to two mouthrinses containing 0.05 percent Cetylpyridinium Chloride (CPC), one with alcohol and one alcohol-free, using a two-week experimental gingivitis validated-model with a 5 percent hydroalcohol rinse serving as the negative control. One hundred and fifty-nine subjects, 56 males and 103 females; ranging in age from 18 to 58 years in good general health were assigned to one of the four treatment groups: EO (n = 40), 0.05 percent CPC with alcohol (CPCa, n = 39), 0.05 percent CPC alcohol-free (CPCna, n = 40), and 5 percent hydroalcohol negative control (n = 40). The Mean Turesky Modification of the Quigley-Hein Plaque Index (PI) and the Mean Modified Gingival Index (MGI) were the primary efficacy endpoints and were evaluated at baseline and at two weeks. Following baseline examinations, subjects received a complete dental prophylaxis and began supervised rinsing with their assigned mouthrinse twice daily for two weeks, as their sole oral hygiene measure; 151 subjects completed the trial. Two weeks after baseline the EO adjusted mean PI and MGI scores were significantly lower than those of both CPC rinses and negative control (p < 0.001). In conclusion, the EO mouthrinse demonstrated significantly greater antiplaque and antigingivitis efficacy than both CPC-containing mouthrinses and the negative control.

Efficacy of diphenhydramine vs desloratadine and placebo in patients with moderate-to-severe seasonal allergic rhinitis.

BACKGROUND: Previous studies have shown that diphenhydramine and desloratadine effectively relieve symptoms of seasonal allergic rhinitis (SAR). OBJECTIVE: To compare the relative efficacy of 50 mg of diphenhydramine hydrochloride, 5 mg of desloratadine, and placebo in relieving symptoms in patients with moderate-to-severe SAR. METHODS: In this 1-week, multicenter, parallel-group, randomized, double-blind, double-dummy, placebo-controlled study, 610 patients with moderate-to-severe SAR received 50 mg of diphenhydramine hydrochloride 3 times daily, 5 mg of desloratadine once daily, or placebo. Daily 24-hour reflective total nasal symptom scores (TNSSs) (primary end point), total symptom scores, and individual symptom scores were evaluated. A global evaluation of response to treatment was conducted at 2 posttreatment visits. RESULTS: The mean reduction from baseline in 24-hour reflective TNSSs relative to the placebo response was 77.6% for the diphenhydramine group (P < .001) and 21.0% for the desloratadine group (P = .12). A TNSS between-treatment difference of -1.81 (46.7%; P < .001) was observed when comparing diphenhydramine with desloratadine. A similar between-treatment difference was observed for the 24-hour reflective total symptom score comparing diphenhydramine to desloratadine (-3.35; 45.5%; P < .001). Diphenhydramine provided clinically and statistically significant reductions vs placebo and desloratadine in all individual symptoms, including nasal congestion. Desloratadine had a tendency toward improvement compared with placebo for most individual symptom scores. However, a statistically significant result was reached only for sneezing (-0.27; 33.9%; P = .04). CONCLUSIONS: Diphenhydramine, 50 mg, given for 1 week provided statistically significant and clinically superior improvements in symptoms compared with 5 mg of desloratadine in patients with moderate-to-severe SAR. Somnolence occurred more frequently with diphenhydramine (22.1%) compared with desloratadine (4.5%) and placebo (3.4%).

Remineralization potential of an anticaries/antigingivitis mouthrinse.

PURPOSE: To assess the ability of a new formulation (Listerine with 0.022% NaF) to remineralize initially decalcified bovine enamel compared to a positive control, clinically established 0.022% NaF rinse. METHODS: A cyclic demineralization/remineralization in vitro model was utilized and the level of remineralization was monitored by examining the Knoop microhardness over 6 and 18 D/T/R cycles RESULTS: (1) both the test formulation and positive control rinses were statistically significantly effective in remineralizing artificial lesions in vitro; and (2) the test formulation performed "at least as good as" the positive control. These results support the concept that the remineralization potential of the fluoride rinse is not adversely affected by the addition of essential oils.

Effect of fluoride/essential oils-containing mouthrinse on the microhardness of demineralized bovine enamel.

PURPOSE: To assess the ability of a fluoride mouthrinse containing a fixed combination of essential oils (thymol, menthol, eucalyptol, and methyl salicylate) to inhibit demineralization as compared with that of a clinically established NaF rinse. METHODS: Inhibition in sound bovine enamel to demineralization was assessed utilizing a cyclic T/R/D (treatment/remineralization/demineralization) in vitro model where Knoop microhardness was monitored over 6, 12, and 18 T/R/D cycles. RESULTS: Both fluoride-containing mouthrinses resulted in statistically significant increase in microhardness when compared to the non-fluoride control mouthrinse, possibly demonstrating and validating the in vitro model's ability to parallel the clinically established benefit of a 0.022% NaF rinse to inhibit demineralization. In addition, the test formulation was shown to be "at least as good as" the NaF positive control in increasing enamel microhardness following each of the 6, 12, and 18 T/R/D cycles.