Urticaria is a common condition with a physiopathology that is both complicated and poorly understood. The cutaneous mast cell is the primary effector cell. Histamine and other mediators may be released, leading to the growth and formation of wheals. This process can be triggered by various stimuli such as medications, chemicals, autoantibodies, complement factors, and proteases, which can cause degranulation.1

Acute urticaria is a common condition, affecting approximately 15% to 20% of the general population. It is typically self-limiting, with over 90% of cases resolving completely within three weeks. Spontaneous urticaria is traditionally categorized into acute when it lasts less than six weeks and chronic when it persists beyond six weeks. Viral infections of the upper respiratory tract are responsible for about 40% of acute urticaria cases, with drugs and food being other common causes.2,3 Chronic urticaria (CU) affects 0.5 to 3 percent of the general population, rarely affects children, and typically lasts for months or years.4 Although some factors (such as drugs, infections, emotional stress, and food) can serve as eliciting stimuli, there is no clear cause for chronic urticaria. There is proof that certain patients' CU is brought on by autoantibodies to FcRI or IgE itself.2 The disease significantly affects the patient’s quality of life, as intense itching and skin lesions disrupt sleep, work, and leisure activities.7 Impaired quality of life (QOL) has been linked to poor treatment adherence.3The impact that CU has on the well- being and quality of life of patients is a crucial aspect of management.

The aim is to evaluate the quality of life using a range of questionnaires that are easy for patients to complete.

In India, chronic urticaria is a common condition that significantly affects both the physical and emotional well-being of patients. The questionnaires used in previous research did not address all aspects of physical and mental health. Therefore, this study aims to comprehensively assess these dimensions by utilizing the DLQI and CU-Q2oL questionnaires together in a single study of CU patients. Furthermore, due to the lack of similar research in this field, this study was undertaken to fill that gap.

This cross-sectional study was conducted among all patients of chronic urticaria coming in the OPD in Department of Dermatology, Venereology and Leprosy, Rohilkhand Medical College, Bareilly, Uttar Pradesh. Duration of study was one year from August 2023-July 2024. This study was conducted after taking approval from Institutional Ethics Committee and obtaining informed written consent from the study participants.

Inclusion Criteria:

• Patients willing to give written consent.
• Patients of both genders aged over 18 years.
• Patients with Chronic Urticaria defined as urticarial eruption of more than 6 weeks duration characterized by hives or wheals.
• Free from any other chronic illness, systemic disease and patients with normal psyche.

Exclusion Criteria:

• Patients diagnosed with acute urticaria, contact urticaria, urticarial vasculitis, angioedema with no urticaria.

Sample Size:

Formula for sample size calculation in cross-sectional studies is as following: Here, as in majorityof studies P values are considered significant below 0.05 hence 1.96 is used in formula. P = Expected proportion in population based on previous studies or pilot studies. D or L = Absolute error or precision, it is decided by researcher.

According to Godse KV, more than75% of patients had a DLQI score of 10 or lower.4

p          =          75%

q          =          100-p

L          =          Absolute error (5%)

N          =          Sample size 4pq / L2

            =          (4 x 75 x 25) / 25

            =          300

Study Tool: A questionnaire based on DLQI (Dermatology life quality index), CU- Q2oL (Chronic Urticaria Quality of Life Questionnaire). Both of the following questionnaires are provided below:

Dermatology Life Quality Index (DLQI) Questionnaire: This questionnaire intended for adults (both male and female) diagnosed with urticaria. It applies to individuals aged 16 years and older who experience wheals at least three days per week for six or more consecutive weeks.5

The DLQI is determined by adding up the scores from each question, with a range from 0 to 30. Higher scores indicate a greater impairment in quality of life. Alternatively, the DLQI can be represented as a percentage of the maximum score of 30.5

Meaning of DLQI scores:

0-1= no effect at all on patient's life.

2- 5= small effect on patient's life

6-10= moderate effect on patient's life

11-20= very large effect on patient's life

21-30= extremely large effect on patient's life

The data were collected and fulfilled according to a prepared preform.

When data were ready, they were collected in one book then entered on SPSS (version 23.0) software and were analyzed by using t-test, and chi – square tests (fisher exact test or likehood ratio when chi square test was not applicable).

CU-Q2oL (Chronic Urticaria Quality of Life Questionnaire)

The CU-Q2oL is simple to administer and yields results that are well accepted by responding patients. On average, it requires 5 minutes to complete and can be filled out without assistance. The questionnaire is also easily evaluated using software that provides a score for the six extracted dimensions and highlights critical items (items where patients reported the highest scores).6

Statistical Analysis: The data were coded and entered; it’s clearing and compiling was done in Statistical Package for Social Sciences (SPSS) version 23.0 for Statistical analysis. The Data were analysed by applying frequency, percentage, mean, standard deviation. Appropriate statistical tests were applied based on distribution and type of data. A p value of <0.05 was considered statistically significant.

In our study, out of 300 patients, 35.3% of patients were male while 64.7% were female and 60.7% were from rural areas and 39.3% were from urban areas.

Maximum of 53.0% of patients were in the 21-40 years age group followed by 41-60 years in 29.0%, 14.7% in the 18-20 years of age group, and 3.3 % in 61-80 years of age group. The mean age of patients in our study was 35.6 ±13.6 years.71.0% of patients were married and 29.0% were unmarried.

Out of 300 cases, 22.7% of cases were 10^th Pass, 46.0% of cases were 12^th Pass, 25.3% of cases were Graduate, and 6.0 % of cases were Post Graduate.

Maximum of 28.7% of patients' duration of illness was up to 6 months, 16.0% of patients' duration of illness was 6 months to 1 year, 7.0% of patients' duration of illness was 1 year -2 years, 16.3% of patients' duration of illness was 2-4 years, and 4 years in 3.0 % of patients' duration of illness was >4 years. Our study's mean duration of illness of patients was 0.9 ±0.85 years.

Out of 300 cases, 10.0 % of them were students, 12.0% of them were Farmers, 20.0% of patients were housewives, 24.0% of cases were in services and 21.3% of cases were doing business and 12.7% of them were retired persons. 11.7% of cases had a family history of illness.

Table 1: Dermatology Quality Life Index (DLQI) Scores

Moderate effects of illness were seen in 60.7% of cases, very large effects were seen in 30.7% of cases, and extremely large effects were seen in 8.7% of cases according to the Dermatology Quality Life Index (DLQI).  Over all 80.0% of cases possessed a high frequency of poor life in our study. 72.3% of them had sore and painful stinging on their skin, 82.7% of them were embarrassed or self-conscious because of their skin, 39.7% of them had skin influenced the clothes they wear, 31.3% of their skin condition made it difficult for them to do any sport, 68.0% of them had skin condition that prevented them from working or studying and 44.0% of cases had sexual difficulties due to their skin condition. According to the DLQI Score, overall 75.0% to 80.0% of cases had prevalence of poor life in our study.

Table 2: Chronic Urticaria Quality of Life Questionnaire

In above mentioned table F denotes frequency and % denotes percentage. In our study out of 300 cases, in the past 14 days, 71.3% of cases were troubled by itching, 62.7% by wheels, and 30.0% by eye swelling and lips swelling. 51.4% of cases indicated that they were limited by their hives (urticaria) in the following areas of daily life; 51.3% in their work, 30.0% in physical activities, 83.0% in sleep, 51.3% in free time, 62.7% in social relationship, and 30.0% in eating. 88.0% of cases had issues falling asleep, 72.3% of cases woke up at night, 72.0% of cases were tired during the day because did not sleep well, 85.3% of cases had difficulty in concentrating, 86.3% of cases felt nervous, 86.7% of cases felt miserable, 61.3% of cases had to limit their food choices, 61.3% of cases were bothered by the symptoms of hive (urticaria) that appeared on their body, 82.7% of cases were embarrassed to go to public places, 48.7% of cases had problem in using cosmetics, 40% of cases had to limit their clothing choices, sports activities were limited because of hives in 31.3% of cases, 38.7% of cases suffered side effects from the medications they took for hives (urticaria).

Table 3: Comparison of Mean Dermatology Quality Life Index (DLQI) Score in Different Age Groups.

#P>0.05(statistically not significant)

The mean DLQI score in the Age group of 18-20 years of patients was 21.9 ± 4.8, mean DLQI score in the Age group of 21-40 years of patients was 21.9 ± 5.5, mean DLQI score in the Age group of 41-60 years of patients was 21.6 ± 5.0 and the mean DLQI score in the Age group of 61-80 years of patients was 21.0 ± 5.5, The mean DLQI score in the all of 300 patients was 21.8 ± 5.3. There was no significant difference in the mean DLQI score in different age groups of Patients (P=0.917).

Mean DLQI score in the male patients was 20.9 ± 5.5, and in the female patients was 22.3 ± 5.1. The mean DLQI score in female patients was higher as compared to male patients and there was a significant difference in the mean DLQI score in different gender of Patients (P=0.023).

The mean DLQI score in the married patients was 21.8 ± 5.2, and in the unmarried patients was 21.7 ± 5.4. There was no significant difference in the mean DLQI score in different married and unmarried patients (P=0.912).

The mean DLQI score in the students was 21.9 ± 5.2, in the farmers was 22.3 ± 5.1, and in the housewives was 21.0 ± 5.6. In the service class, it was 22.2 ± 5.2; in the business class, it was 21.2 ± 5.3; and in the retired class, it was 22.6 ± 5.1. There was no significant difference in the mean DLQI score in different professions in patients (P=0.217).

The mean DLQI score for patients with family history of illness was 22.0 ± 5.1 and for patients no family history was 20.3 ± 6.0.

Table 4: Mean Dermatology Quality Life Index (DLQI) Score

In the above-mentioned table F denotes frequency and % denotes percentage. Out of 300 cases, 9.3% were a little embarrassed or self-conscious because of their skin, 61.3 % had a lot of embarrassment and 21.3% were very much embarrassed or self-conscious because of their skin. Overall, 82.7 % of cases in our study were embarrassed or self-conscious because of their skin and 68.0 % of cases in our study had skin condition that prevented them from working or studying.

Table 5: DLQI

In the above-mentioned table F denotes frequency and % denotes percentage. Out of 300 cases, (regarding the past 14 days) 88.0% of cases had issues falling asleep, 72.3% of cases woke up at night, 72.0% of cases were tired during the day because they did not sleep well, 85.3% of cases had difficulty in concentrating, 86.3% of cases felt nervous, 86.7% of cases felt miserable.

The mean age of 35.6 ± 13.6 years among study participants underscores the need to further explore the relationship between age and quality of life indicators, such as DLQI scores, in chronic urticaria patients.

Finlay and Khan (1994)5 had established DLQI as a reliable and valid tool in dermatology. Their findings suggested that younger individuals, particularly those in their late teens to early twenties, often report higher DLQI scores, reflecting the significant impact of skin conditions on this demographic. This observation aligns with our results, where participants around 21.8 years old demonstrated diverse scores that highlight their unique experiences with dermatological challenges.

The mean DLQI score in males, while significant, was overshadowed by the higher mean observed in females. This result is consistent with the conclusions drawn from the research conducted by Sachdeva et al., (2011)7, which reported higher DLQI scores in females across various skin disorders, suggesting that gender-related factors, such as differing societal expectations and psychosocial stressors, may influence these scores. The findings of our study, with a female-to-male ratio of approximately 1.78:1 among chronic urticaria patients, are consistent with the study by Sachdeva et al., (2011)7, which reported a similar female preponderance with a ratio of 1.47:1, further supporting the observation that CU is more prevalent in females than in males.

The DLQI index serves as a valuable tool in assessing the detrimental effects of CU on patient’s QoL, corroborated by multiple studies. Our findings contribute to the growing body of evidence that emphasizes the need for effective management strategies to alleviate this condition's burden and improve patient outcomes.

A significant portion of patients reported experiencing discomfort and painful stinging on their skin, with 72.3% acknowledging this issue. Additionally, 82.7% expressed feelings of embarrassment or self-consciousness due to their skin condition. The impact of their skin impeded day-to-day operations, as evidenced by 17.7% stating it hindered their shopping experiences. Furthermore, 39.7% noted that their skin influenced their clothing choices. Social and leisure activities were affected for 74.0% of individuals, while 31.3% indicated that their skin issues posed challenges in participating in sports. Occupational and educational pursuits were impeded for 68.0% of patients, and 52.0% reported that their skin problems strained relationships with partners or relatives. The condition also contributed to sexual difficulties for 44.0% of patients, while 31.3% found that the treatment for their skin issues was a considerable concern.

In the past 14 days, 71.3% of cases were troubled by itching, 62.7% by wheals, and 30.0% by eye swelling and lips swelling, 51.3% of cases faced difficulties in their work, 62.7% in social relationship, 30.0% in eating, 30.0% in doing physical activities and 83.0% had trouble sleeping.

Restrictions in clothing choices were experienced by 40% of individuals, while 31.3% reported limitations in sports activities due to hives. Lastly, 38.7% suffered from side effects associated with medications prescribed for urticaria.

Wheals were documented at 62.7%, confirming how often this symptom occurs in chronic urticaria, as supported by the research of Zuberbier et al., (2018)8, who highlighted the prevalence of hives in their extensive review.

Furthermore, the significant prevalence of eye and lip swelling raises concerns over the possible influence on patients’ self-esteem and social interactions. This aligns with the comprehensive analysis conducted by Sachdeva et al.,(2011)7, which illustrated how facial involvement in urticaria can exacerbate emotional distress and reduce the over-all QoL.

The effects of chronic urticaria on eating habits further highlights the extensive nature of its effects. This aligns with findings from a study by Młynek et al., (2009)9, which suggested that dietary restrictions due to urticaria can result in nutritional deficiencies and related health concerns. A factor analysis of the German CU-Q(2)oL revealed six key scales: functionality, sleep, mental state, eating/swelling, itching/embarrassment, and boundaries on appearance. The median CU-Q (2) oL scores for these scales were 29 for functioning, 44 for sleep, 50 for itching/embarrassment, 50 for mental status, 31 for swelling/eating, and 31 for limits on appearance. Disease severity was a significant predictor for all scales, while age affected eating/edema, itching/embarrassment, sleep, and functioning. Sex was associated with itching/embarrassment and limits on appearance.

The Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) and the Dermatology Life Quality Index (DLQI) have been instrumental in shedding light on the psychosocial challenges faced by individuals with chronic urticaria. Our findings show that a remarkable 82.7% of patients reported feelings of embarrassment, which were closely tied to social interactions. This emotional burden was exacerbated by anxiety and distress, confirming the findings of Khan et al., (2013)10, who noted a strong link between visible skin conditions and social anxiety. The DLQI subscale related to sleep difficulties revealed a notably high score, highlighting the profound chronic urticaria's effects on both sleep quality and overall well-being. This is consistent with the work of Abdel-Meguidet al., (2024)11, who established a connection between chronic urticaria and sleep disturbances. The mean DLQI score of 24.8 ± 4.37 reflects a severe impact on quality of life.

Our study also highlighted a notably high prevalence of nervousness (86.3%) and misery (86.7%) among chronic urticaria patients, which further intensify the psychological burden. These emotions, coupled with feelings of shame due to their lesions, echo the concerns raised by Dias et al., (2016)12 regarding the emotional challenges faced by individuals with chronic skin diseases. Moreover, chronic urticaria’s impact on daily activities and its interference with work or study reveal a complex deterioration in quality of life (QoL). While 75% of patients did not engage in sports, only 16% attributed this to chronic urticaria. Among the 28 patients who participated in sports, 42.8% reported that urticaria interfered to some degree with their sporting activity and QoL. Of the 13 patients who avoided sports due to their condition, 69% said it had a significant or very significant impact. Similarly, 31.3% of our study participants indicated that their skin issues hindered their participation in sports.

In a study by Gonçaloet al., (2021)13, absenteeism (work time missed) averaged 6%, while presenteeism (reduced productivity at work) was reported at 25%, and general impairment at work was 27% among chronic urticaria patients. In contrast, our study found that 68% of cases experienced work impairment, with most patients belonging to the service sector.

The statistical findings from the DLQI and CU-Q2oL indices emphasize the significant psychosocial impact of chronic urticaria on patients’ lives. The correlations with existing research not only validate these results but also highlight the pressing need for comprehensive management strategies that address both the physical and psychological characteristics of chronic urticaria. Such an integrated approach could alleviate the burdens patients face, improving their overall quality of life.

Comparative analyses across studies are vital to deepen our understanding of the full scope of chronic urticaria’s impact. While the DLQI focuses more on physical symptoms and limitations, the CU-Q2oL offers a deeper insight into emotional suffering and its consequences forsocial interactions and personal identity. This distinction is important when tailoring treatment plans to address the dual physical and emotional burdens of the condition.

Lakshminath and Sukumar D. (2016)14 offered valuable contributions to the existing body of knowledge on Chronic urticaria's effects on life quality. Their research reinforced the significance of using tools like the DLQI and CU-Q2oL questionnaires to assess quality of life in patients with chronic urticaria, underscoring the need to prioritize quality of life in managing the condition and calling for further research into more effective treatment strategies.

The combined use of The Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) and the Dermatology Life Quality Index (DLQI) in chronic urticaria research provides valuable insights into the multifaceted impact of the condition on patients’ lives. The DLQI offers a broad overview of the dermatological effects on quality of life, while the CU-Q2oL provides a more detailed understanding of the unique emotional and social challenges associated with chronic urticaria. By acknowledging and correlating findings from these tools with previous studies, researchers and clinicians can deepen their comprehension of the illness. This approach highlights the need for a comprehensive assessment that addresses both the physical and psychological dimensions of chronic urticaria, highlighting the importance of integrating these insights into effective management and treatment strategies.

Chronic urticaria is a common disease and constitutes a major health problem in our dermatology department in terms of diagnosis, investigations and pharmacologic treatment. In this study, majority of our patients were females and constitute (64.7%) of the cases, the average patient age was 35.6 years and the common age group was 21- 40 year. In this study of 300 cases, (20.0%) among of the patients were housewives, (71%) were married and (60%) the level of education was low. Stress has been reported as an important aggravating factor (80%) and drugs like aspirin, paracetamol and ibuprofen (20%) have also been implicated. Symptoms and feelings are the most affected part assessed in our patients followed by work and school and no statistically significant correlation was found between QOL scores and disease duration, associated angioedema, and disease severity.

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