Assessment Of Itch Research Articles

Questionnaires to Assess Chronic Itch: A Consensus Paper of the Special Interest Group of the International Forum on the Study of Itch

Chronic itch affects millions of patients worldwide and has a significant impact on quality of life. The assessment of itch and its associated effects is a significant component of clinical practice in itch management. Despite itch being a common complaint, there are few studies describing the use of structured questionnaires for evaluation and measurement of itch and its sensory and affective dimensions. The International Society of the Study of Itch (IFSI) has recently provided invaluable data on the use of visual analogue scales as an assessment tool for itch. However, it is clear that additional tools are needed to better assess the different dimensions of chronic itch and better tailor management. With this goal in mind, a Special Interest Group was initiated by members of IFSI to determine which of the various psychometric properties of itch questionnaires offer the greatest utility in the evaluation of chronic itch. This first consensus paper addresses what domains and structure of itch questionnaires need to be implemented to better assess chronic itch and guide therapy.

Itch Assessment Scale for the Pediatric Burn Survivor

The objective of the study is to evaluate the validity and reliability of the Itch Man Scale developed in 2000 by Blakeney and Marvin in assessing the intensity of itch in the pediatric burn patient. Forty-five patients (31 males and 14 females; average age 9.9 ± 5.0 years; and % TBSA burned 41 ± 25%) with an established itch complaint were studied. They were asked to describe the severity of their itch by two independent raters to determine test-retest reliability. Individuals aged 6 years or older were assessed using parental informants. Concurrent validity was determined by comparing three scales to quantify the level of itch: the Itch Man Scale (a 5-point Likert scale), the 5-D Itch Scale (adapted from a scale for peripheral neuropathy), and the Visual Analog Scale for itch. Itch Man Scale ratings collected from independent raters showed a strong correlation (r = .912, P < .0001). The Itch Man Scale also correlated significantly with the Visual Analog Scale, the gold standard for measurement of pruritus (r = .798, P < .0001). The total summated score of the Duration, Degree, Direction, and Disability domains from the 5-D Itch Scale had a significant correlation with the Itch Man Scale (r = .614, P < .0001). The Degree domain is the only individual component with a significant correlation (r = .757, P < .0001). The Itch Man Scale is a reliable and valid tool to assess itching in pediatric burn patients and to quantify postburn pruritus.

THE INFLUENCE OF TOPICAL GLUCOCORTICOSTEROIDS ONCYTOKINE GENE EXPRESSION IN THE SKIN AND PERIPHERALBLOOD OF ATOPIC DERMATITIS PATIENTS

Background. To investigate the influence of mometasone furoate 0,1% cream on cytokine gene expression in the skin and peripheral blood of atopic dermatitis (AD) patients comparing with control. Material and methods. 40 AD patients were included in the study and divided into 2 groups. group 1 patients were given continuous course of mometasone furoate 0,1% cream treatment for 14 days. group 2 patients were given indifferent emollient elobase cream for 14 days. Clinical efficacy of the treatment was assessed on the following features: SCORAD index, Investigators global Assessment (IgA) score and subjective assessment of itch and dryness of the skin according to skin area to be studied. Skin samples and peripheral blood of atopic dermatitis were used as material for immunological study. Interleukin (IL)1B, IL2, IL2r, IL4, IL5, IL6, IL7, IL8, IL10, IL 12A, IL12B, IL15 (total), IL15 , IL17A, IL18, IL23, IL28, IL29, Interferon (IFN)-ƒ, Tumor necrosis factor (TNF), Transforming growth factor beta 1 (TGFB1), forkhead box P3 (FOXP3) gene expression were defined in the skin and peripheral blood of AD patients by realtime reverse transcription polymerase chain reaction (RT-pCR). Results. positive clinical effect was found with all AD patients on the mometasone furoate 0,1% cream therapy background for 14 days and also dryness, rushes and skin itch decreased. Stаtistical significant decrease of proinflammatory cytokines IL2, IL2r, IL5, IL8, IL12В, IL23, IFN-ƒ gene expression was marked. They are the markers of chronic inflammation and Th1 immune response. Studying peripheral blood after mometasone furoate 0,1% cream treatment increase of TGFB1, FOXP3 gene expression level was found. no significant changes of cytokine gene expression in AD patients, who got elobase cream were found. Conclusion. Antiinflammatory activity of mometasone furoate 0,1% cream was shown by its influence on proinflammatory cytokines IL2, IL2r, IL5, IL8, IL12В, IL23, IFN-ƒ gene expression in the skin and mechanisms of immune response in moderate and severe AD patients.

Overview of efficacy and safety of tacrolimus ointment in patients with atopic dermatitis in Asia and other areas

To assess the efficacy and safety of tacrolimus ointment in a large population of patients with atopic dermatitis (AD) by pooling data from individual Asian studies, and to compare the results of this study with those in the United States, Europe, and Japan. We analyzed the pooled data from individual studies conducted in the eight Asian areas. The efficacy assessments included success rate based on Physician's Global Evaluation of Clinical Response, Eczema Area Severity Index (EASI), Percent Body Surface Area (%BSA) affected, Patient's Assessment of Itch (Itch), Dermatology Life Quality Index (DLQI) and children's DLQI (CDLQI). The results that were published in the United States, Europe, and Japan were cited. A total of 860 patients were included in this study. The success rates were more than 80% in both adult and pediatric patients. Similar success rates were shown in the United States, European, and Japanese studies. There were no differences in the improvements in %BSA affected, EASI, and Itch between this study and the United States study. In both Asia and the United States, tacrolimus therapy improved total quality of life and all subscales in DLQI and CDLQI. Skin burning and pruritus were common adverse events among the Asian, United States and European studies. Tacrolimus ointment is an effective and well-tolerated treatment option in patients with AD in Asia. In this study, the efficacy and safety of tacrolimus are similar to those in the United States, European, and Japan studies.

A randomized, double-blind, placebo-controlled study to evaluate the efficacy in AD of liquid soap containing 12% ammonium lactate + 20% urea

Atopic dermatitis (AD) is a common chronic skin disease, which mainly affects children. Xerosis is one of the most troublesome signs of the disease. The aim of this study was to evaluate the efficacy of liquid soap containing 12% ammonium lactate + 20% urea in patients with AD. In a randomized, double-blind study, 36 patients (both male and female patients; age range 3-40 years) with mild to moderate AD were enrolled. Patients were divided randomly into two groups, in a ratio of 2:1 (active:placebo). The prescribed soap was used on a daily basis during a shower for 3 weeks. All patients continued all other systemic or topical medication but avoided any other soap or emollients. After 3 weeks of treatment, efficacy was assessed both by clinician and patient. There were significant improvements in scaling (P < 0.0001), skin dryness (P < 0.0001) and redness (P = 0.03) as rated by the investigator, and subjective patient assessment of itch also improved (P < 0.001) in the study group compared with the control group. The liquid soap was found to be effective in patients with AD, as use of this soap in patients with stable mild to moderate AD improved the parameters studied.

The Effectiveness of Combined Chinese Herbal Medicine and Acupuncture in the Treatment of Atopic Dermatitis

Patients with atopic dermatitis increasingly use complementary medicine. The objective of this study was to assess the effectiveness of the combination of Chinese herbal medicine and acupuncture for the treatment of atopic dermatitis. Twenty (20) patients between the ages of 13 and 48 who had mild-to-severe atopic dermatitis were given a combined treatment of acupuncture and Chinese herbal medicine and were followed prospectively. The patients received acupuncture treatment twice a week and the Chinese herbal formula 3 times daily for a total of 12 weeks. Assessments were performed before treatment, and at weeks 3, 6, 9, and 12 of treatment. The primary outcomes were defined as the changes in the Eczema Area and Severity Index (EASI), Dermatology Life Quality Index (DLQI), and patient assessment of itch measured on a visual analogue scale (VAS). After 12 weeks of treatment, an improvement in EASI was noted in 100% of patients, when compared with the baseline. The mean EASI fell from 4.99 to 1.81; the median percentage of decrease was 63.5%. Moreover, 78.8% of patients experienced a reduction in DLQI and VAS, as compared with the baseline. The mean DLQI decreased from 12.5 to 7.6 at the end of treatment, with 39.1% improvement. Mean VAS decreased from 6.8 to 3.7, with 44.7% improvement. No adverse effects were observed. The results of this study suggest that the combination of acupuncture and Chinese herbal medicine have a beneficial effect on patients with atopic dermatitis and may offer better results than Chinese herbal medicine alone.

Effects of nonpathogenic gram-negative bacteriumVitreoscilla filiformislysate on atopic dermatitis: a prospective, randomized, double-blind, placebo-controlled clinical study

Atopic dermatitis (AD) is associated with elevated IgE levels and Th2 responses. The oral administration of nonpathogenic bacteria such as probiotics may improve the course of atopic diseases. It is believed that nonpathogenic bacteria prevent the development of allergic diseases by modulating intestinal immune responses. However, the effects of oral probiotics on AD could not be reproduced in all studies and the direct immunomodulation of the skin-associated immune response by nonpathogenic bacteria has not yet been investigated. We performed a prospective, double-blind, placebo-controlled clinical study with a cream containing a 5% lysate of the nonpathogenic bacteria Vitreoscilla filiformis. Seventy-five volunteers with AD (6-70 years of age) were randomized to receive either V. filiformis cream 5% or vehicle cream daily for 30 days. Efficacy was evaluated by the SCORe of Atopic Dermatitis (SCORAD), transepidermal water loss (TEWL), assessment of microflora, and the patient's assessment of itch and loss of sleep. Compared with placebo, V. filiformis lysate significantly decreased SCORAD levels (P=0.0044) and pruritus (P=0.0171). Active cream significantly decreased loss of sleep from day 0 to day 29 (P=0.0074). Qualitative and quantitative assessment of cutaneous microbial colonization revealed that V. filiformis lysate reduced Staphylococcus aureus colonization of the skin. The skin barrier as determined by TEWL also improved significantly with the cream alone. V. filiformis lysate significantly improved AD. This may be in part due to reduction of S. aureus, but seems to relate in most parts to a direct immunomodulatory effect on skin-associated immune responses.

Efficacy and safety of methylprednisolone aceponate ointment 0.1% compared to tacrolimus 0.03% in children and adolescents with an acute flare of severe atopic dermatitis

Topical glucocorticosteroids are the gold standard in treatment of atopic dermatitis (AD). Recently, topical calcineurin inhibitors have been developed for treatment of this condition. This study compared efficacy and safety of 0.1% methylprednisolone aceponate (MPA) ointment with 0.03% tacrolimus ointment for 3 weeks, in children and adolescents with severe to very severe flare of AD. The primary end point was treatment success, defined as a score of 'clear' or 'almost clear' in the static Investigator's Global Assessment (IGA) score. Secondary end points were the percentage change in the Eczema Area and Severity Index (EASI) and patients' assessment of itch and sleep, Children's Dermatology Life Quality Index, patient's assessment of global response, affected Body Surface Area and medication costs. 265 patients were randomized to either MPA (n = 129) or tacrolimus (n = 136) treatment, 257 patients completed the study. Methylprednisolone aceponate 0.1% ointment once daily provided rapid and relevant clinical benefit. Tacrolimus 0.03% ointment twice daily was equally effective with regard to success rate. Methylprednisolone aceponate was superior to tacrolimus for EASI, itch and sleep. Both treatments were well tolerated. Drug-related adverse events were only observed in the tacrolimus group. Medication costs were significantly lower for MPA. While both treatment groups showed similar efficacy results regarding treatment success (IGA), significant advantages were observed for EASI, itch and sleep with MPA 0.1%. These advantages and the significantly lower treatment costs highlight the benefits of MPA treatment, underlining its first-line role in treatment of children and adolescents with severe AD.

Tacrolimus ointment is more effective than pimecrolimus cream in adult patients with moderate to very severe atopic dermatitis

Objective: To compare the efficacy and safety of tacrolimus ointment 0.1% and pimecrolimus cream 1% in adult patients with moderate to very severe atopic dermatitis (AD). Methods: A total of 281 patients (141 treated with tacrolimus and 140 treated with pimecrolimus) were randomized to a multicenter, investigator‐blinded, 6‐week study. Results: Tacrolimus‐treated patients had significantly greater improvements in the Eczema Area Severity Index score compared with pimecrolimus‐treated patients (mean percent reduction from baseline to study end: 57% vs 39%, respectively; p = 0.0002). Treatment success was also significantly greater among the tacrolimus‐treated patients compared with pimecrolimus‐treated patients (40% vs 22% at study end; p = 0.001), as was the improvement in percentage of total body surface area affected (a reduction of 49% vs 34% at study end; p = 0.01). Both treatment groups had similar improvements in patient assessment of itch. There were no significant differences in the incidences of adverse events, including application‐site burning and application‐site pruritus, the two most commonly reported adverse events. Significantly more pimecrolimus‐treated patients than tacrolimus‐treated patients withdrew from the study due to lack of efficacy (10 vs 1, p = 0.005). Conclusion: Tacrolimus ointment is more effective than pimecrolimus cream in adults with moderate to very severe AD. Both agents have a similar safety profile.

Tacrolimus Ointment 0.03% Is Safe and Effective for the Treatment of Mild to Moderate Atopic Dermatitis in Pediatric Patients: Results From a Randomized, Double-Blind, Vehicle-Controlled Study

This study was designed to compare the safety and efficacy of tacrolimus ointment 0.03% with vehicle ointment for the treatment of mild to moderate atopic dermatitis (AD) in pediatric patients. A total of 317 patients (2-15 years of age) with mild to moderate AD were randomized to receive tacrolimus ointment or vehicle ointment twice daily in a 6-week, multicenter, double-blind study. Efficacy evaluations, including the Investigators' Global Atopic Dermatitis Assessment, eczema area and severity index, percentage of total body surface area affected, and patient assessment of itch occurred at baseline, day 4, and weeks 2, 4, and 6. Cutaneous adverse events were recorded to evaluate safety. At the end of study, 50.6% (80 of 158) of the patients were treated successfully with tacrolimus ointment based on Investigators' Global Atopic Dermatitis Assessment scores, a significant improvement compared with patients treated with vehicle ointment (25.8% [41 of 159]). The percent improvement from baseline in eczema area and severity index scores was also significantly greater in tacrolimus-treated patients (54.8%) compared with vehicle-treated patients (20.8%). There was also a significant improvement in the percentage of total body surface area affected of tacrolimus-treated patients (50.5% reduction from baseline) compared with vehicle-treated patients (16.4%). Patient itch scores were significantly lower in tacrolimus-treated patients (2.1) versus vehicle-treated patients (3.7). Overall, the incidence of cutaneous adverse events reported was similar for both treatment groups. There was no significant difference in the incidence of burning or stinging between treatment groups. Significantly fewer tacrolimus-treated patients prematurely discontinued from the study because of a cutaneous adverse event in the treatment area or experienced increased itching and erythema at the application site. Monotherapy with tacrolimus ointment 0.03% is a safe and effective treatment alternative for pediatric patients with mild to moderate AD.

Tacrolimus ointment 0.03 is safe and effective for the treatment of mild to moderate atopic dermatitis in pediatric and adult patients1,2

A total of 599 patients at least 2 years of age were enrolled in two identically designed 6-week, double-blind, randomized, vehicle-controlled studies. Patients or caregivers applied either tacrolimus ointment 0.03 or vehicle twice daily for up to six weeks. Evaluations for safety and efficacy were at Baseline, Day 4, Weeks 2, 4 and 6/End of Study. Efficacy evaluations included the Investigator’s Global Atopic Dermatitis Assessment (IGADA), the Eczema Area and Severity Index (EASI), Assessment of Itch and Total Percent Body Surface Area (BSA) affected. Safety was assessed by incidence of cutaneous adverse events reported by patient/caregiver or observed by physician. Patient demographics and baseline characteristics were similar in the two treatment groups. Of the patients who received tacrolimus, 50.0 achieved treatment success, compared to 28.3 of patients who received vehicle (p0.0001). The median percent change in EASI score at End of Study for tacrolimus patients was −64.3 compared to −33.3 in vehicle patients (p0.0001). The median percent change in Assessment of Itch at End of Study for tacrolimus patients was −71.3 compared to − 31.0 in vehicle patients (p0.0001). The median percent change in Total BSA Affected at End of Study for tacrolimus patients was −63.6 compared to −25.0 in vehicle patients (p0.0001). The most common cutaneous adverse events included skin burning/stinging, increased itching, and skin erythema. Incidence rates of skin burning/stinging were similar in both treatment groups, 28.1 in tacrolimus patients compared to 25.7 in vehicle patients (p0.51). However, increased itching was reported significantly more often in vehicle patients, 29.4 of tacrolimus patients compared to 38.9 in vehicle patients (p0.01). Skin erythema was also reported significantly more often in vehicle patients, 13.2 in tacrolimus patients compared to 25.0 in vehicle patients (p0.002). Warts, molluscum, and herpes zoster were not reported in either treatment group. Herpes simplex was reported in 0.7 of tacrolimus-treated patients and in 0.3 of the vehicle-treated patients. Eczema herpeticum was reported in none of the tacrolimus-treated patients and in 0.3 of the vehicle-treated patients. Conclusion: Tacrolimus ointment 0.03 is safe and effective in the treatment of mild to moderate atopic dermatitis in pediatric and adult patients.

Perceptual Matching for Assessment of Itch; Reliability and Responsiveness Analyzed by a Rank-Invariant Statistical Method

The aim of this study was to evaluate the reliability and responsiveness of a new device-perceptual matching by Matcher (Cefar Medical AB, Lund, Sweden)-in the assessment of the progress of experimentally induced itch as well as determine the reliability of the method in patients with skin disease and itch. The perceptual matching unit electrically stimulates the skin of the fingers in the left hand. When the amplitude of the sensation corresponded to that of the experienced itch, the subject was instructed to halt the stimulation and a value was automatically saved in the electronic device. A total of 36 healthy subjects and nine patients participated in the study. The healthy subjects were asked to rate the level of itch every 30 s during the first 5 min and thereafter every minute. The reliability was determined in a test-retest procedure of the time points 5, 10, and 15 min after induction of itching. To test the stability of the method, the first sensation of pain in healthy subjects without itch was determined every 10th minute during 60 min. In patients, the test-retest procedure was repeated within 5 min. Perceptual matching was found to be a reliable method of itch assessment, with no evidence for random individual disagreement between the assessments. The augmented rank order coefficient ra was excellent: 1.00 at 5 min; 0.99 at 10 min; and 1.00 at 15 min. There was a clear indication of responsiveness for detecting changes in itch over time, p<or=0.05. The perceptual matcher device can detect immediate changes in perceived itch and is also sensitive to gradual decreases after the induction of itch. The first sensation of pain in healthy subjects without itch was unaffected when assessed every 10th minute during 60 min. In patients, no evidence for random disagreement or systematic disagreement by group between repeated assessments was detected. The augmented rank order coefficient was high (0.98). In conclusion, Matcher measures itch intensity via perceptual matching with a high reliability and excellent responsiveness. The method is stable and can be recommended as an assessment tool for itch intensity both in experimental conditions as well as in patients with skin disease and itch.

Measurement of itch.

Measurement in its broadest sense can be defined as the assignment of numerals to objects or events according to rules. The rules settle the scale level, which in turn determines the mathematical and statistical operations permissible when handling the data. Itch is a subjective symptom that can be assessed only by the subject himself. No animal models are established for the investigation of itch. In contrast to pain research, a field with many similarities, rather few scientific attempts have been made to develop and evaluate methods for the quantitative analysis of itch. However, several investigators have recently addressed the challenge of itch measurement in both experimental and clinical situations. This is important, as valid quantitative techniques for the assessment of itch are of considerable value for studying the mechanisms of pruritus, and for the evaluation of antipruritic therapies.

The measurement of itch with sensitive limb movement meters.

A sensitive electromagnetic movement detector has been developed to estimate itch by measuring scratch during sleep. The cumulative time of nocturnal limb movements of patients with itchy and non-itchy liver diseases was estimated. Non-itchy patients moved their arms for 24 +/- 9.3 min/8 h (mean +/- s.d.) and their legs for 16 +/- 7.0 min/8 h. The limb movements were not related to left or right handedness or the sex or age of the patient. Itchy patients had increased nocturnal limb movements; however, the increase in arm movement (up to five times control level) was much greater than the increase in leg movement (up to twice control level). The marked increase in arm movements in itchy patients supports the view that this movement is largely due to scratching. The reproducibility of the estimates of arm movements was reasonable (within-person coefficient of variation 22%). In three studies, treatment resulted in a reduction of arm movements to normal levels. The measurement of cumulative nocturnal arm movement by these sensitive meters appears to be a valid estimate of scratch and superior to a subjective assessment of itch. The devices may also be applied to other studies, such as the effects of hypnotic drugs on sleep movement and the measurement of vibration.