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Secondary endpoints encompassed detailed TSS analysis, Urticaria Composite Score (UCS), Dermatology Life Quality Index (DLQI), Visual Analog Scale (VAS), and Global Clinical Impression (GCI). Items Bilastine 20 mg Levocetirizine 5 mg Difference, LS means (95% CI) P-value Primary endpoint, n 122 120 TSS (reflective) Day 28 1.53 ± 1.91 1.37 ± 1.88 Change from baseline –2.54 ± 2.59 –3.06 ± 2.47 0.17 (–0.19, 0.54) 0.356* Secondary endpoint, n 139 140 TSS domain Itching intensity, daytime, LS mean (95% CI) –0.81 (–0.89, –0.73) –0.88 (–0.96, –0.79) 0.07 (–0.05, 0.18) 0.2525 Itching intensity, nighttime, LS mean (95% CI) –1.0 (–1.08, –0.92) –1.07 (–1.15, –0.99) 0.07 (–0.05, 0.18) 0.2393 Wheals number, daytime, LS mean (95% CI) –0.67 (–0.76, –0.58) –0.75 (–0.84, –0.66) 0.08 (–0.05, 0.21) 0.2033 Wheals number, nighttime, LS mean (95% CI) –0.83 (–0.92, –0.74) –0.87 (–0.96, –0.79) 0.05 (–0.08, 0.17) 0.4773 Maximum size of wheals, daytime, LS mean (95% CI) –0.84 (–0.94, –0.74) –0.88 (–0.98, –0.78) 0.04 (–0.11, 0.18) 0.6239 Maximum size of wheals, nighttime, LS mean (95% CI) –1.03 (–1.14, –0.92) –1.02 (–1.13, –0.91) –0.01 (–0.16, 0.14) 0.9039 UCS (reflective) Day 28 0.98 ± 1.22 0.87 ± 1.19 Change from baseline –1.62 ± 1.63 –2.05 ± 1.59 0.171 Participant-assessed TSS (instantaneous) Day 28 1.34 ± 1.87 1.06 ± 1.77 Change from baseline –2.13 ± 2.94 –2.04 ± 2.68 0.829 Investigator-assessed TSS (instantaneous) Day 28 1.35 ± 1.83 1.30 ± 2.09 Change from baseline –2.12 ± 2.76 –2.29 ± 2.93 0.861 Participant-assessed UCS (instantaneous) Day 28 0.9 ± 1.2 0.6 ± 1.1 Change from baseline –1.3 ± 1.9 –1.4 ± 1.7 0.127 Investigator-assessed USC (instantaneous) Day 28 0.9 ± 1.2 0.8 ± 1.2 Change from baseline –1.3 ± 1.8 –1.5 ± 1.8 0.522 Investigator’s GCI, n (%) Marked improvement 71 (51.1) 71 (50.7) 0.420 Moderate marked improvement 41 (29.5) 48 (34.3) 0.964 Minimal slight improvement 20 (14.4) 13 (9.3) 0.805 No change or worse 1 4 Not evaluated 6 4 QoL Day 28 4.1 ± 4.6 3.7 ± 4.3 Change from baseline –6.1 ± 5.1 –7.2 ± 5.8 0.209 Sleep quality impacted by chronic idiopathic urticarial, n (%) 0.707 Not at all 80 (57.6) 89 (63.6) Somewhat 43 (30.9) 37 (26.4) Moderately 7 (5.0) 8 (5.7) A lot 2 (1.4) 1 (0.7) Very much 1 (0.7) 0 *Non-inferiority test. Least square; QoL: Quality of life; SD: [3] Although superiority wasn’t established, possibly due to primary endpoint selection and insufficient power for superiority analysis, bilastine stands as a strong first-line treatment candidate for Chinese patients with chronic idiopathic urticaria, despite potential regional variations in rescue medication use.

Androgenetic alopecia (AGA) is the most common cause of hair loss in both genders with a higher psychological impact on females. Currently, topical minoxidil is the only FDA-approved treatment for female AGA and it needs life-long application and causes side effects. Cetirizine is an antihistamine that may be effective in hair loss treatment. This study aimed to compare the efficacy and safety of topical cetirizine with minoxidil (group 1) versus topical minoxidil with placebo (group 2) in female patients with AGA. This was a double-blind, randomized, controlled, parallel study conducted at Dermatology Clinic, Cairo University Teaching Hospital (Kasr- Al- Ainy), Egypt. Sixty-six patients with female AGA, aged 20–50 years, Sinclair (II–IV), were randomly assigned to one of the 2 groups for 24 weeks. The trichoscopic parameters, patients’ self-assessment, side effects and global photographic assessment were evaluated. There was a statistically significant change from baseline in frontal and vertex terminal and vellus hair density ( P  < 0.0005) with a significant increase in vertex hair shaft thickness and average number of hairs per follicular unit in group 1 ( P  < 0.05). Patients reported significantly better scores in patient self-assessment in group 1 ( P  < 0.05). Side effects were not significantly different between groups ( P  > 0.05). Topical cetirizine increases hair shaft thickness and results in a higher clinical improvement from patients’ perspective with a good safety profile (NCT04481412, study start date: July 2020).

Background: Ocrelizumab is an effective medication for multiple sclerosis. However, infusion-related reactions (IRRs) are a concern for patients and may lead to discontinuation of ocrelizumab. To minimize IRRs, pre-medications are administered. However, from our experience, these medications, especially diphenhydramine, can cause marked drowsiness. The primary objective of this study was to evaluate whether cetirizine is non-inferior to diphenhydramine in limiting the proportion and severity of reactions from ocrelizumab infusions. Methods: Twenty participants were serially randomized in a 1:1 ratio to receive 10 mg of cetirizine or 25 mg of diphenhydramine orally prior to their first three ocrelizumab infusions. Results: The rate of IRRs in this study was similar across both treatment groups with no increase in the risk of severity, and no grade 3 IRRs. Further, patients receiving cetirizine experienced a reduction in fatigue. While there was not a significant difference in global satisfaction, this score increased over time in the cetirizine arm while it remained unchanged in the diphenhydramine arm. Conclusions: Overall, our results suggest that cetirizine does not increase the risk of infusion-related reactions compared to diphenhydramine.

Globally, the prevalence of diabetes mellitus is rising. One of the main causes of end-stage renal disease (ESRD) and a risk factor for higher morbidity and death in diabetic patients is diabetic nephropathy (DN), sometimes referred to as diabetic kidney disease (DKD). DN, a microvascular consequence of diabetes, affects 20–40 % of diabetics globally. The study's objective was to assess if levocetirizine may have albuminuria lowering effect and anti-inflammatory effect in patients treated with angiotensin receptor blockers (ARBs) and sodium-glucose cotransporter 2 (SGLT2) inhibitors therapy by reducing albuminuria and improving DKD indicators. A controlled, parallel, trial was carried out on sixty DKD patients. Sixty patients were divided into two groups at random. Group 1 (control group) received an empagliflozin 10 mg once day in addition to 80 mg valsartan. Group 2 (levocetirizine group) received the same medications as the control group plus a 5 mg of levocetirizine once daily in the evening, titrated dose based on each patient's creatinine clearance (CrCl) for three months. Serum creatinine, serum urea, serum cystatin-C, HbA₁c, tumor necrosis factor alpha (TNF-α), estimated glomerular filtration rate (eGFR), and urinary albumin to creatinine ratio (UACR) were measured at baseline and compared to these data three months after drug administration. Levocetirizine decreased significantly UACR at the end of the three-months (p = 0.037) compared to the control group. There was no variation in eGFR between the two groups, eGFR was significantly lower than baseline (p < 0.001) in both groups. Comparing the levocetirizine group to the control group, there is a substantial drop in TNF-α (p = 0.004), cystatin-C (p = 0.034), and HbA₁c (p = 0.007). Levocetirizine reduces albuminuria, inflammatory, and renal indicators, which makes it a potentially has albuminuria lowering effect and anti-inflammatory drug which decreases disease progression. NCT05638880 •Diabetic kidney disease is one of the complications of diabetes and may lead to renal failure and renal transplantation.•How levocetirizine, an antihistaminic drug affects diabetic kidney disease progression.•Levocetirizine can be used as adjuvant therapy with antidiabetic drugs in patients who developed microalbuminuria.

We conducted randomized clinical trials to examine the impact of direct-to-consumer advertisements on the efficacy of a branded drug. We compared the objectively measured, physiological effect of Claritin (Merck & Co.), a leading antihistamine medication, across subjects randomized to watch a movie spliced with advertisements for Claritin or advertisements for Zyrtec (McNeil), a competitor antihistamine. Among subjects who test negative for common allergies, exposure to Claritin advertisements rather than Zyrtec advertisements increases the efficacy of Claritin. We conclude that branded drugs can interact with exposure to television advertisements.

We assessed the long-term effects of pulsed high-intensity laser therapy (HILT) in post-burn pruritus treatment. A total of 49 adult burn patients with mean age of 31.53 ± 10.14 years participated, with 24 patients randomly assigned to the active laser group (ALG) and 25 in the placebo laser group (PLG). The ALG received HILT three times per week for 6 weeks, while the PLG received placebo HILT. Both groups received 10-mg cetirizine tablets twice daily and 10 mg at bedtime. All patients were advised to massage their burn scars with coconut oil for 5 min four times daily. The outcomes measured were the itch severity scale (ISS), impairment of pruritus-related quality of life (QoL), pain level by the visual analog scale (VAS), hand grip strength by handheld dynamometer, and daily cetirizine intake. Repeated-measures ANOVA was used to compare the baseline and post-treatment measurements and after 12 weeks of follow-up. Statistical significance was set at P  < 0.05. ISS decreased significantly in the ALG after 6 weeks of treatment and after 12 weeks of follow-up compared with the PLG. The QoL results showed a significant improvement in the ALG compared with the PLG, which continued after 12 weeks. VAS results significantly decrease, hand grip strength significantly improved, and cetirizine intake significantly decreased post-treatment in the ALG relative to the PLG. HILT combined with cetirizine seems more effective in patients with post-burn pruritus than a placebo laser procedure with cetirizine.

Objective and design This double-blind cross-over study compared the potential of bilastine, cetirizine, and fexofenadine to relieve the symptoms of allergic rhinitis. Subjects and methods Seventy-five allergic volunteers were challenged with grass pollen in the Vienna Challenge Chamber (VCC) on two consecutive days of allergen provocation; 6 h on day 1 and 4 h day 2. Bilastine 20 mg, cetirizine 10 mg, fexofenadine 120 mg, or placebo were taken orally 2 h after the start of provocation on day 1 only. Total nasal symptom scores, the global symptom scores, nasal secretions, and eye symptoms were assessed on both day 1 and day 2. Results and conclusions Bilastine had a rapid onset of action, within 1 h, and a long duration of action, greater than 26 h. Cetirizine was similar. Fexofenadine was similar on day 1 but less effective on day 2, indicating a shorter duration of action. Bilastine, like cetirizine and fexofenadine, was safe and well tolerated in this study.

Background: Persistent allergic rhinitis (PER) has a moderate impact on the sense of smell, but no controlled study has reported the effect of antihistamines on the loss of smell in patients with PER. Methods: Patients with PER and subjective loss of the sense of smell (n = 27) were included in this pilot randomised, double-blind, placebo-controlled study. Nasal symptoms, nasal endoscopy, skin prick test, acoustic rhinometry, peak nasal inspiratory flow, nasal nitric oxide (nNO), and olfactometry (Barcelona Smell Test-24; BAST-24) were performed and evaluated in all PER patients at baseline and after 7 and 30 days of treatment with levocetirizine 5 mg or placebo. Results: The study population was randomized into two homogeneous groups: levocetirizine (n = 14) and placebo groups (n = 13). The evolution of symptoms reflected the therapeutic effect of levocetirizine treatment on rhinorrhea, nasal itching, eye itching, sneezing, and the total symptoms score after 7 and 30 days. Significant improvement in loss of smell by a visual analog scale (VAS) was observed after 7 days of levocetirizine treatment (7.2 ± 4.3; p < 0.05) compared to placebo (–9.4 ± 6.2). Improvement in smell identification by BAST-24 was strongly correlated (r = 0.72; p < 0.05) with smell improvement by VAS after 30 days. After 7 days of treatment with levocetirizine, the nNO values decreased (–494 ± 188) compared to placebo (155 ± 284 ppb; p < 0.05). Conclusions: The CIRANO study suggests that levocetirizine is effective on PER symptoms, including a transient improvement in loss of smell, and that this improvement concurs more with reduction of nasal inflammation than of nasal patency.

Abstract Azelastine nasal spray and oral cetirizine are selective histamine H1-receptor antagonists that are approved in the United States for the treatment of seasonal allergic rhinitis (SAR). The objective of the present study was to compare the efficacy and tolerability of azelastine nasal spray administered at the recommended dosage of 2 sprays per nostril twice daily with those of cetirizine in the treatment of moderate to severe SAR. This multicenter, randomized, double-blind, parallel-group, 2-week comparative study was conducted during the 2004 fall allergy season in patients with moderate to severe SAR. After a 1-week placebo lead-in period, patients were randomized to receive azelastine nasal spray 2 sprays per nostril twice daily plus placebo tablets or cetirizine 10-mg tablets once daily plus a placebo saline nasal spray for the 2-week double-blind treatment period. The primary efficacy variables were (1) change from baseline to day 14 in the 12-hour reflective total nasal symptom score (TNSS), which combines scores for rhinorrhea, sneezing, itchy nose, and nasal congestion, and (2) onset of action, based on the instantaneous TNSS over 4 hours after the first dose of study drug. During the double-blind treatment period, patients recorded their symptom scores on diary cards twice daily (morning and evening). Patients aged ≥18 years also completed the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) at baseline and on day 14. Three hundred seven patients were randomized to treatment, and 299 completed 2 weeks of study treatment. The age of the population ranged from 12 to 74 years (mean, 35 years), 62.9% were female, and 69.6% were white. Over 2 weeks of treatment, both groups had significant improvements in the TNSS compared with baseline (P < 0.001). The overall change in TNSS was significantly greater with azelastine nasal spray compared with cetirizine (29.3% vs 23.0% improvement, respectively; P = 0.015). In terms of onset of action, azelastine nasal spray significantly improved the instantaneous TNSS compared with cetirizine at 60 and 240 minutes after the initial dose (both, P = 0.040). Scores on each domain of the RQLQ were significantly improved in both groups compared with baseline (P < 0.001); the overall RQLQ score was significantly improved with azelastine nasal spray compared with cetirizine (P = 0.049). Both treatments were well tolerated. In this 2-week study in patients with moderate to severe SAR, azelastine nasal spray was well tolerated and produced significantly greater improvements in TNSS and total RQLQ score compared with cetirizine.

Abstract Objectives: To compare the efficacy and tolerability of butterbur (Petasites hybridus) with cetirizine in patients with seasonal allergic rhinitis (hay fever). Design: Randomised, double blind, parallel group comparison. Setting: Four outpatient general medicine and allergy clinics in Switzerland and Germany. Participants: 131 patients were screened for seasonal allergic rhinitis and 125 patients were randomised (butterbur 61; cetirizine 64). Interventions: Butterbur (carbon dioxide extract tablets, ZE 339) one tablet, four times daily, or cetirizine, one tablet in the evening, both given for two consecutive weeks. Main outcome measures: Scores on SF-36 questionnaire and clinical global impression scale. Results: Improvement in SF-36 score was similar in the two treatment groups for all items tested hierarchically. Butterbur and cetirizine were also similarly effective with regard to global improvement scores on the clinical global impression scale (median score 3 in both groups). Both treatments were well tolerated. In the cetirizine group, two thirds (8/12) of reported adverse events were associated with sedative effects (drowsiness and fatigue) despite the drug being considered a non-sedating antihistamine. Conclusions: The effects of butterbur are similar to those of cetirizine in patients with seasonal allergic rhinitis when evaluated blindly by patients and doctors. Butterbur should be considered for treating seasonal allergic rhinitis when the sedative effects of antihistamines need to be avoided. What is already known on this topic Seasonal allergic rhinitis (hay fever) is common in countries with temperate climates. Most patients have their symptoms treated for short periods, particularly during peaks in atmospheric pollen count What this study adds After two weeks, the effects of butterbur and cetirizine were comparable in patients with hay fever Butterbur produced fewer sedating effects than cetirizine Butterbur should be considered when the sedating effects of antihistamines must be avoided