Ginger extract versus Loratadine in the treatment of allergic rhinitis: a randomized controlled trial.

BACKGROUND: Allergic rhinitis (AR) is a non-infectious immune disease and incidents of the disease has continuously increased in Thailand. Ginger, a Thai herb, is used in food and Thai traditional medicine. This study was designed to assess efficacy and safety of ginger extract in comparison with loratadine for AR treatment. METHODS: AR patients were treated with ginger extract 500 mg (n = 40) against those treated with loratadine 10 mg (n = 40) in a randomized, double-blind, controlled trial for 3 and 6 weeks. The efficacy was evaluated from clinical examinations i.e. total nasal symptom scores (TNSS), cross-sectional area of the nasal cavity with acoustic rhinometry (ARM) and rhinoconjunctivitis quality of life questionnaire (RQLQ). The safety of treatment was measured by blood pressure, blood analysis and history-taking for side effects. RESULTS: The results showed both ginger extract and loratadine treated groups significantly decreased TNSS scores but there was no significant difference between the two groups. In acoustic rhinometry measurement, the ginger treated group significantly gradually increased the estimated volume of the nasal cavity and decreased distances from the nostril, but the loratadine treated group did not cause a change. Both groups gave significantly improvement in every aspect of the RQLQ at third weeks. The treatment with ginger extract was as safe as loratadine as shown by renal and liver function results obtained from blood analysis. Both treatments had no effect on blood pressure of the patients. CONCLUSIONS: The ginger extract is as good as loratadine in improving nasal symptoms and quality of life in AR patients. However, ginger extract caused less side effects especially, drowsiness, fatigue, dizziness and constipation. Therefore, the ginger extract could be used as alternative treatment for patients with AR. TRIAL REGISTRATION: Registered with ClinicalTrials.gov (Registration number: NCT02576808) on 15 October 2015.

Efficacy of Desloratadine and Levocetirizine in Patients with Cedar Pollen-Induced Allergic Rhinitis: A Randomized, Double-Blind Study.

BACKGROUND: No comparative study of antihistamines that differ in structural system has been conducted in allergic rhinitis. OBJECTIVE: This was a randomized, double-blind, crossover comparative study to verify the efficacy of antihistamines that differ in structural system. METHODS: A total of 50 patients with moderate or more severe Japanese cedar pollen-induced allergic rhinitis were randomized to receive either placebo, desloratadine 5 mg (a tricyclic), or levocetirizine 5 mg (a piperazine). One dose of the study drug was orally administered at 9 pm on the day before a pollen exposure test, which was performed for 3 h (9 a.m. to 12 p.m.) to assess symptoms in an environmental challenge chamber (ECC). Nasal and ocular symptoms were compared at an airborne pollen level of 8,000 grains/m3. The primary endpoint was mean total nasal symptom score (TNSS) from 120 to 180 min in the ECC. Subjects with a difference of ≥1 in TNSS between 2 drugs were extracted to the relevant drug-responsive group. RESULTS: The difference in TNSS from placebo was -2.42 (p < 0.0001) with levocetirizine and -1.66 (p < 0.01) with desloratadine, showing that both drugs were significantly more effective than placebo in controlling symptoms, but with no statistically significant difference between the 2 drugs. There were 12 subjects in the desloratadine-responsive group and 24 subjects in the levocetirizine-responsive group, with no contributor to response was detected. CONCLUSION: Levocetirizine tended to control nasal symptoms more effectively than desloratadine. However, the response to each antihistamine varied among individuals and the predictors to the response are unknown. CLINICAL TRIAL REGISTRATION NUMBER: UMIN ID: UMIN000029653.

Effects of a Novel Barley-Based Formulation on Allergic Rhinitis: A Randomized Controlled Trial.

OBJECTIVE: Current treatment options for Allergic Rhinitis (AR) may have their own limitations and side effects. This study aimed to investigate the effects of Ma-al-Shaeer (MS), a novel natural formulation based on Hordeum vulgare, in the treatment of AR compared with Fexofenadine (FX). METHODS: A total of 77 patients with AR were divided into two groups: MS group (n=38) and FX group (n=39). The first group received 15 g of dried MS powder, and the second group received 60 mg of FX twice daily for 14 days. At baseline (week zero) and after the 14-day treatment period (week two), both groups were evaluated for sneezing, rhinorrhea, nasal congestion, nasal itching, post nasal drip, eye, throat, or ear symptoms, headache, cough, mental function, quality of life scores, blood eosinophil count and total IgE levels. Rhinitis control assessment tests were conducted at week zero and again at one week after cessation of treatment (week three) in both groups. RESULTS: All symptoms of AR except cough were significantly reduced in both groups; for nasal congestion, post nasal drip, and headache, the MS treatment was found to be superior. Rhinitis control was significantly increased after treatment in both groups (p value < 0.001). Both drugs significantly reduced total IgE levels. There was no significant change in eosinophil count in either group. CONCLUSION: MS formulation based on H. vulgare may be an effective treatment for AR. Further studies are needed to confirm the effect of MS as an alternative treatment in AR.

A preliminary study on topical cetirizine in the therapeutic management of androgenetic alopecia.

BACKGROUND: Androgenetic alopecia (AGA) is a common form of scalp hair loss that affects up to 50% of males between 18 and 40 years old. Several molecules are commonly used for the treatment of AGA, acting on different steps of its pathogenesis (Minoxidil, Finasteride, Serenoa repens) and show some side effects. In literature, on the basis of hypertrichosis observed in patients treated with analogues of prostaglandin PGF2a, it was supposed that prostaglandins would have an important role in the hair growth: PGE and PGF2a play a positive role, while PGD2 a negative one. OBJECTIVE: We carried out a pilot study to evaluate the efficacy of topical cetirizine versus placebo in patients with AGA. PATIENTS AND METHODS: A sample of 85 patients was recruited, of which 67 were used to assess the effectiveness of the treatment with topical cetirizine, while 18 were control patients. RESULTS: We found that the main effect of cetirizine was an increase in total hair density, terminal hair density and diameter variation from T0 to T1, while the vellus hair density shows an evident decrease. The use of a molecule as cetirizine, with no notable side effects, makes possible a good compliance by patients. CONCLUSION: Our results have shown that topical cetirizine 1% is responsible for a significant improvement of the initial framework of AGA.

Effectiveness of Autologous Whole-Blood Injections in Patients with Refractory Chronic Spontaneous Urticaria.

BACKGROUND: Nonsedating antihistamines are the treatment of choice for chronic spontaneous urticaria (CSU), while omalizumab and immunosuppressants have also been approved as an add-on treatment. Autologous whole-blood injection (AWBI) has been used in previous studies with ambiguous results. The aim of our study was to evaluate changes in the Urticaria Activity Score (UAS7), Dermatology Life Quality Index (DLQI), and Chronic Urticaria Quality of Life (CU-Q2oL) score, and also the association of serologic markers with disease severity measures after AWBI. METHODS: In this observational study, AWBIs were performed (8 courses on a weekly basis) in adults with refractory CSU, who refused an add-on treatment with either omalizumab or immunosuppressants. UAS7, DLQI, and CU-Q2oL questionnaires and serum concentrations of total IgE, C-reactive protein (CRP), and D-dimer were evaluated before and after the intervention. RESULTS: Nineteen patients (12 females; mean age 54 ± 20.8 years) completed the protocol. Following AWBI, significant improvements in the UAS7 (34.26 ± 8.04 vs. 12.52 ± 10.83, p < 0.001), DLQI (11.63 ± 5.51 vs. 3.47 ± 2.85, p < 0.001), and CU-Q2oL score (32.97 ± 18.71 vs. 10.94 ± 7.71, p < 0.001) were recorded. A negative correlation between the baseline D-dimer levels and UAS7 and DLQI variations (p = 0.002 and p = 0.001, respectively) was noted. D-dimer levels ≥292 ng/mL have been associated with poor responsiveness (sensitivity 75%; specificity 83.3%). No correlation with either total immunoglobulin E or CRP levels was observed. CONCLUSION: AWBI appears to be a safe, alternative, add-on therapeutic option in refractory CSU, particularly in patients with low plasma levels of D-dimer.

Treatment of solar urticaria using antihistamine and leukotriene receptor antagonist combinations tailored to disease severity.

BACKGROUND: Solar urticarial (SU) is characterized by erythema, whealing, and/or pruritus occurring minutes after sun exposure. Treatment is difficult and often unsatisfactory. OBJECTIVES: To determine the action spectra and minimal urticaria dose (MUD) and to tailor a treatment regimen graded according to disease severity in a series of patients with SU. PATIENTS AND METHODS: Eleven patients (seven females, four males, age range: 5-60 years) with a clinical history suggestive of SU, verified by photo-provocation tests to ultraviolet A (UVA), visible light, and/or UVB, were treated with various combinations of antihistamines and leukotriene receptor antagonist. RESULTS: All patients were sensitive to visible light (median MUD 50 J/cm(2)). Three patients were sensitive to UVA (median MUD 3.75 J/cm(2)), and one patient was sensitive to UVB (MUD of 0.03 J/cm(2)). Two patients experienced a spontaneous remission without treatment. One patient declined treatment. The remaining eight patients were managed by a combination of antihistamines (desloratidine, fexofenadine, cetirizine HCl) and a leukotriene receptor antagonist (montelukast). Seven of the 8 patients experienced a sustained remission of symptoms and signs following treatment. CONCLUSIONS: Photoprovocation for SU with determination of action spectra and MUD enables specifically tailored treatment regimens consisting of combinations of antihistamines and leukotriene receptor antagonist.

Temperature thresholds in assessment of the clinical course of acquired cold contact urticaria: a prospective observational one-year study.

Cold contact urticaria is the second most common subtype of physical urticaria. Cold stimulation standardized tests are mandatory to confirm the diagnosis. The aim of this study is to define the utility of determining thresholds (critical time and temperature) in assessment of the clinical course of typical acquired cold contact urticaria. Nineteen adult patients (10 women and 9 men; mean age 45 years) were included in the study and the diagnosis was confirmed with the ice-cube test and TempTest 3.0. Patients were treated continuously for 1 year with 20 mg/day rupatadine (anti-H1). Thresholds measurements were made before and after treatment. Improvements in temperature and critical time thresholds were found in the study sample, demonstrating the efficacy of continuous treatment with rupatadine. In most cases association with a clinical improvement was found. We propose an algorithm for the management of acquired cold contact urticaria based on these results.

Comparison of clinical effectiveness of acupuncture and a Western drug on allergic rhinitis: study protocol for a randomized controlled trial.

OBJECTIVE: To compare the efficacy of an acupuncture regimen for persistent allergic rhinitis (PER), aimed at improving a patient's mind or Shen in Traditional Chinese Medicine, to that of a second-generation Hi-receptor antagonist, cetirizine hydrochloride. METHODS: This multicenter, randomized, controlled clinical trial on PER will be conducted at three institutions in China. The total study period will be 9 weeks. After a 1-week preparatory screening period, 240 eligible participants with PER will be randomized to receive acupuncture or pharmacotherapy (1:1) for 4 weeks with a 4-week follow-up. The primary outcome will be changes in 7-day average total nasal symptom score. Secondary outcome measures include rhinoconjunctivitis quality of life questionnaire score and total non-nasal symptom score. RESULTS: The presence and seriousness of psychological and emotional impairments should be considered in therapeutic programs for allergic rhinitis. No clinical trial for treating allergic rhinitis via acupuncture regulation of psychological and emotional activities has been reported. CONCLUSION: The findings of the trial will allow us to determine the effects of the mind (Shen)-regulation treatment approach. We will also be able to confirm if the effects of acupuncture are equivalent to those of the conventional drug cetirizine hydrochloride.

Vernal keratoconjunctivitis: a severe allergic eye disease with remodeling changes.

Vernal keratoconjunctivitis (VKC) is an unusually severe sight-threatening allergic eye disease, occurring mainly in children. Conventional therapy for allergic conjunctivitis is generally not adequate for VKC. Pediatricians and allergists are often not familiar with the severe clinical symptoms and signs of VKC. As untreated VKC can lead to permanent visual loss, pediatric allergists should be aware of the management and therapeutic options for this disease to allow patients to enter clinical remission with the least side effects and sequelae. Children with VKC present with severe ocular symptoms, that is, severe eye itching and irritation, constant tearing, red eye, eye discharge, and photophobia. On examination, giant papillae are frequently observed on the upper tarsal conjunctiva (cobblestoning appearance), with some developing gelatinous infiltrations around the limbus surrounding the cornea (Horner-Trantas dot). Conjunctival injections are mostly severe with thick mucus ropy discharge. Eosinophils are the predominant cells found in the tears and eye discharge. Common therapies include topical antihistamines and dual-acting agents, such as lodoxamide and olopatadine. These are infrequently sufficient and topical corticosteroids are often required for the treatment of flare ups. Ocular surface remodeling leads to severe suffering and complications, such as corneal ulcers/scars. Other complications include side effects from chronic topical steroids use, such as increased intraocular pressure, glaucoma, cataract and infections. Alternative therapies for VKC include immunomodulators, such as cyclosporine A and tacrolimus. Surgery is reserved for those with complications and should be handled by ophthalmologists with special expertise. Newer research on the pathogenesis of VKC is reviewed in this article. Vernal keratoconjunctivitis is a very important allergic eye disease in children. Complications and remodeling changes are unique and can lead to blindness. Understanding of pathogenesis of VKC may lead to better therapy for these unfortunate patients.

Tap water nasal irrigation in adults with seasonal allergic rhinitis: a randomized double-blind study.

Saline nasal irrigation is effective in the treatment of seasonal allergic rhinitis, and sodium chloride itself has no antiallergic effects. The mechanism of saline nasal irrigation depends mainly on washing away allergens and inflammatory mediators induced by allergic reactions. Tap water has the same washing effects as saline. In this study, it was investigated if tap water nasal irrigation was effective in the treatment of seasonal allergic rhinitis. Sixty-four patients diagnosed with seasonal allergic rhinitis were enrolled. Patients were randomized to tap water nasal irrigation group and non-tap water nasal irrigation group for treatment. Patients of both groups were treated with desloratadine. Treatment outcomes were measured using allergic rhinitis Quality of Life (QoL) survey was completed at baseline and after 3 weeks of therapy. There were statistically significant differences in QoL scores between tap water nasal irrigation group and non-tap water nasal irrigation group. The tap water nasal irrigation group had better QoL scores than the non-tap water nasal irrigation group. Tap water nasal irrigation can be a valuable adjuvant therapy for patients with seasonal allergic rhinitis.

Protective efficacy of sunglasses on the conjunctival symptoms of seasonal rhinitis.

BACKGROUND: Although allergen avoidance can lead to significant improvements in symptoms of allergic rhinitis, there are very few studies in this area. Sunglasses could be effective for protection of eyes from pollen as a cheap, comfortable, and simple avoidance option for allergens. The aim of this study is to determine if wearing sunglasses can decrease ocular symptoms. METHODS: Ocular symptomatic patients (39 total) who had a confirmed history of seasonal rhinitis by skin prick tests and negative skin prick tests for perennial allergens were included in the study. The duration of the study was 4 weeks with 3 required visits. At the onset of the 1-week run-in period, patients were randomized and divided into 2 groups. Group I (n = 18) received topical aqueous nasal budesonide regularly and loratadine once daily as a rescue medication. Group II (n = 21) wore sunglasses during daytime as an addition to this medication. Subjective data included a daily diary recording nasal and ocular symptom scores and antihistamine need during the study period. RESULTS: Sunglasses significantly reduced ocular symptoms (p = 0.002) and use of antihistamines (p = 0.009). CONCLUSION: Sunglasses are an inexpensive and simple treatment for patients with allergic conjunctivitis.

A four arm, double blind, randomized and placebo controlled study of pregabalin in the management of post-burn pruritus.

Post-burn itch is a distressing symptom in burns rehabilitation and its treatment often proves frustrating for the patient and the multidisciplinary burns team. Traditionally, the mainstay of antipruritic therapy for decades has been antihistamines and massage with emollients. With a better understanding of the neurophysiology of itch emerged a new dimension in the treatment of post-burn pruritus. Gabapentin, a centrally modulating anti-epileptic agent and α2δ ligand, proved in clinical trials to be immensely better in the treatment of post-burn pruritus. Pregabalin is a newer structural analog of gabapentin. It has a much better anxiolytic effect and pharmacokinetic profile as compared to gabapentin. The current study was initiated to specifically study the role of pregabalin in relieving post-burn itch as this has never been investigated before. This double blind, randomized and placebo controlled study had four arms and was carried out on 80 adult patients (20 each). The four arms were: pregabalin, cetirizine with pheniramine maleate, combination of pregabalin, cetirizine and pheniramine maleate, and placebo (vit. B comp.). Massage with coconut oil was integral to all groups. Drug dosage was determined by initial VAS (visual analog scale) scores. All groups matched in demographic data and initial VAS scores. VAS scores were evaluated over next 28 days (days 3, 7, 14, 21 and 28). In patients with mild itch (VAS scores 2-5) or moderate itch (VAS scores 6-8) near complete remission of itch was seen in combination group and pregabalin group where the response was comparable and close to 95%. This was significantly better response than antihistaminic combination or massage alone. However, massage alone was sufficient in decreasing mean scores in mild itch, in a large percentage of patients. Amongst the patients with severe itch (VAS scores 9-10), 3/6 and 6/7 patients dropped out of trial in the antihistaminic and placebo groups, respectively. Combination therapy and pregabalin alone had exactly similar decrease in itch scores by day 28 (78.9%). This far exceeded the response in the antihistaminic and placebo groups (23.9% and 9.2% respectively). We conclude that moderate to severe pruritus (VAS 6-10) should be treated with a systemic, centrally acting agent like pregabalin or gabapentin to eliminate itch or bring it down to tolerable limits. Patients with mild itch having VAS scores between 4 and 5 may be better served with addition of pregabalin even if massage and antihistaminics can control post-burn itch to a reasonable extent because of quicker, predictable and complete response, along with anxiolysis.

[Allergies in summer]. / Allergia monilla, kesä kaikilla.

Summertime allergic symptoms include sneezing, running and stuffy nose, burning and itching eyes and wheal formation on the skin. In Finland the problems in allergic people during the spring and summer are mainly associated with the pollen of birch, alder, hazel, grasses and mugwort. The efficacy of drugs used for the treatment of seasonal allergic rhinitis varies. Treatment is usually initiated with a non-sedating antihistamine, and nasally sprayable corticosteroids can be used if the symptoms are more severe.

Efficacy of Tripterygium hypoglaucum Hutch in adults with chronic urticaria.

OBJECTIVES: The study objectives were to evaluate the efficacy and safety of Tripterygium hypoglaucum Hutch (THH) in adult with severe chronic urticaria (CU) by performing a randomized, double-blind, placebo-controlled clinical trial. METHODS: Seventy-eight (78) adult patients with severe CU, 21-58 years of age, responding poorly to antihistamines alone, were randomly divided into two groups: the therapeutic group with THH 3 tablets 3 times daily (n = 40) and the control group with placebo 3 tablets 3 times daily (n = 38). Meanwhile, all patients jointly received cetirizine hydrochloride (HCl) 10 mg once daily throughout the study period. The efficacy of THH was assessed by the scoring system of 4-point scale and the subject's global assessment of relief. RESULTS: Sixty-nine (69) of 78 patients (37 in the therapeutic group, 32 in the control group) completed the study. By the end of the fourth week, there was a 67% improvement of total effective rate (TER) with THH compared with a 28% improvement with placebo by per-protocol analysis (χ(2) = 10.68, p = 0.0011), while by intention-to-treat analysis, 63% and 24% improvements of TER were respectively observed in the therapeutic group and the control group (χ(2) = 11.36, p = 0.001). THH with cetirizine showed statistical superiority to placebo with cetirizine during each study week for changes in total severity scores (p ≤ 0.001). In weekly analyses, THH was also statistically superior to placebo in reducing the mean pruritus scores during each study week (p ≤ 0.005). CONCLUSIONS: This study shows that the therapeutic effect of THH with cetirizine is predominant over that of cetirizine alone in adult CU. THH with cetirizine may play an important role in the therapy of CU and be a useful treatment for CU.

Olopatadine hydrochloride inhibits capsaicin-induced flare response in humans.

Capsaicin, a vanilloid, has the potential for releasing substance P (SP) from sensory nerves. Topical application of capsaicin induces a flare response in the skin. However, it has not been clarified whether the release of SP is involved in the process of flare response or not. A potent antihistamine drug, olopatadine hydrochloride, is known to have inhibitory action against the release of SP. We examined the effects of olopatadine (at a dose of 5 mg) on skin reaction induced by topical application of capsaicin in 10 healthy subjects. The scores of capsaicin-induced flare responses after olopatadine administration were significantly lower at 30 min than at baseline. Our findings suggest that olopatadine hydrochloride could inhibit capsaicin-induced flare responses.

Pre-seasonal treatment with topical olopatadine suppresses the clinical symptoms of seasonal allergic conjunctivitis.

PURPOSE: To evaluate the effectiveness of pre-seasonal treatment with topical olopatadine on the reduction of clinical symptoms of seasonal allergic conjunctivitis (SAC). DESIGN: Prospective interventional case series. METHODS: Eleven patients with SAC received topical olopatadine in one eye at least two weeks before the onset of allergy symptoms, and the other eye served as the control. After the onset of allergic conjunctivitis, both eyes were treated with topical olopatadine. Visual analogue scale (VAS), which evaluated the subjective symptoms of ocular allergy, and the tear levels of histamine and substance P were measured up to six weeks. RESULTS: At the onset of allergy symptoms, the VAS score in the pretreatment eyes was statistically significantly lower than that in the control eyes. The VAS score in the control eyes decreased with time but did not decrease to the level seen in the pretreatment eyes until four weeks later. The tear level of substance P at the onset of allergy symptoms was significantly suppressed in the pretreatment eyes, while the level of histamine was not suppressed. Alteration of the VAS scores in the pretreatment eyes significantly correlated with the level of substance P, but not of histamine. CONCLUSIONS: To suppress clinical symptoms in patients with SAC, pre-seasonal treatment with topical olopatadine is effective. The effectiveness of treatment correlates with the tear level of substance P.

Improving SAR symptoms with levocetirizine: evaluating active and placebo effects in pollen challenge vs. natural exposure studies.

OBJECTIVE: Despite a plethora of published data on levocetirizine, no meta-analyses exist on the effect of study design, and covariates like age, gender, and baseline symptom severity on treatment response. The objective of this study was the efficacy of levocetirizine 5 mg tablets and matching placebo at reducing allergy symptoms in adult subjects with seasonal allergic rhinitis under various pollen exposure study conditions and by age, gender and baseline symptom severity. METHODS: This was a meta-analysis of original reports from randomized, double-blind, placebo-controlled studies. Clinical studies without detailed reports, open-label, non-randomized and non-controlled studies, or paediatric studies, were excluded. Study subjects were divided into an environmental exposure (EE) group or a natural exposure (NE) group. RESULTS: Data from 3640 subjects were analysed (n = 2174 for levocetirizine, n = 1466 for placebo). The overall results confirmed the efficacy of levocetirizine 5 mg, with an approximately 40% symptom score improvement from baseline, in both the EE and NE groups. While levocetirizine showed no gender- or age-related differences in efficacy, female subjects responded better to placebo in the EE, but not in the NE group; younger subjects (<30 years of age) responded less favourably to placebo compared with older subjects (≥ 50 years of age). Levocetirizine was consistently superior to placebo regardless of baseline symptom score levels. The highest significance levels between the active and placebo groups were observed in subjects sensitized to animal dander and grass. CONCLUSIONS: Differences between an oral antihistamine and placebo in clinical studies of allergic rhinitis might be due to a different response to placebo rather than to the active drug. Levocetirizine seems to have consistent efficacy regardless of age, gender, and baseline scores.