Assessment of quality of life in patients with post kalaazar dermal leishmaniasis

Leishmaniasis is a vector-borne disease caused by protozoa that belongs to the genus Leishmania. This is one of the most neglected diseases. Its global prevalence is 12 million with 350 million people at risk [1, 2]. The clinical manifestations of leishmaniasis range from benign cutaneous leishmaniasis (CL) to visceral leishmaniasis [3, 4]. Visceral leishmaniasis (VL)/ Kala-azar is one of the World’s most neglected and poverty-related diseases, affecting the poorest people in developing countries associated with malnutrition, weakness of the immune system, displacement, poor housing, illiteracy, gender discrimination and lack of resources [5].

More than 90% of global VL occurs in India, Sudan, Bangladesh, Nepal, Ethiopia and Brazil. In India Visceral leishmaniasis is endemic in North-eastern states like Bihar, Jharkhand, West Bengal, Assam and Uttar Pradesh; sporadic cases are also reported from other states. Post kala-azar dermal leishmaniasis (PKDL) is a dermatological complication occurring among the treated visceral leishmaniasis (VL) patients and also among those without a history of VL. The disease is characterized by hypo-pigmented macule, papule and nodule or a combination of these lesions. In India, PKDL usually occurs at an interval of 2-3 years in 5- 10% of cases after successful treatment of VL [6]. Prevalence of confirmed PKDL cases in Bihar, India is found to be 4.4/10,000 and 7.8/10,000 including probable cases [7].

PKDL is non-fatal and it does not interfere with routine activities of affected individuals, but social stigma associated with the disease makes the life difficult. Patient with visible rashes may suffer from physical discomfort, embarrassment, social isolation and may go into hiding. Thereby, day to day relationship with friends and close relatives may be hampered, which can lead to emotional distress. For girls at the marriageable age cosmetic disfigurement or eroded beauty may decrease the likelihood of getting married [8]. Social stigma is thought to be more when the lesions are present in the uncovered portion of the body [9]. A healthy skin is not only required for mental and physical well being, but simultaneous enhancement of sexual attractiveness and self confidence of an individual. The Chronic dermatological disorder may profoundly affect the physical, emotional and social well being of an individual. Patients with cutaneous leishmaniasis are reported to have a negative impact on quality of life (QOL) and subjected to anxiety, depression due to psychological impairment.

Treatments of dermatological disorders are mainly directed towards the sign and symptoms. Beside these traditional measures of treatment outcome, the assessment of QOL can advance the knowledge to understand the real needs of patients with regard to their disease. It also progresses our knowledge concerning psychological problem attached to the skin disorder which in turn, will be helpful for considering an appropriate therapeutic decision for them. Despite the high endemicity of PKDL in Indian subcontinent, the impact of PKDL on QOL has not been studied previously. Therefore, we aimed to estimate the effect of PKDL on quality of life in Indian PKDL patients by using Dermatology life quality index (DLQI), Short form 36 questionnaire (SF36) and also tried to evaluate the socio-demographic and characteristics of lesions associated with the impairment of QOL.

In total, 92 patients with PKDL and 96 healthy participants were recruited in the study. The study group consisted of 50 (56.5%) males and 42 (45.6%) females, aged 16-60 years (mean 27.4) while, comparison group (healthy participants) consisted of 53 (55.2%) male and 43 (44.79%) female, aged 18-67 years (mean 29.5).

The mean (± SD) DLQI score was 11.41 ± 4.89 for PKDL cases, indicating a very large impact on quality of life. The highest impact was found for the symptoms and feelings domains; the lowest impact was observed for the personal relationship domain of the DLQI. The mean DLQI scores of different domains are presented in (Table 1).

Figure 1 demonstrates the impact of PKDL on quality of life in patients. The maximum number of patients, (54.34%) experienced very large effect and 4.34% of patients had extremely large effect on QOL. The mean scores of DLQI in male and female were 11.28 (± 4.71) and 11.57 (± 5.91) respectively, however, this difference was not statistically significant (p = 0.77). The mean scores of the DLQI varies significantly in different age groups (p = 0.03). The highest impairment of QOL was found among the patient below 20 years of age. We did not find any significant association in QOL with respect to the marital status (p = 0.50) and type of lesions (p = 0.07) (Table 2). Patients with nodular lesions had lower QOL when compared to macular or papular lesions. Patients who had lesions for longer duration and present in both exposed and unexposed parts had reported higher DLQI. However, statistically no significant difference was observed with respect to duration (p = 0.15) and location (p = 0.91) of lesions. The significant effect in QOL was found in the severity of PKDL (p = 0.001) and treatment status (p = 0.04) (Table 2). Patients with mild lesions had better QOL than moderate and severe lesions. Patients before initiation of treatment had a higher effect on QOL when compared to patients receiving treatment.

There is statistically no significant relationship found between total DLQI scores and age.

(r = 0.003, p = 0.974) as well as duration of disease (r = 0.166, p = 0.115) (Table 3). Linear regression model of factors affecting the quality of life showed that severity was the only significant predictor of impaired quality of life (p < 0.001) and R² = 0.14 indicates that severity accounts for 14% of variation in the overall scores of DLQI (Table 4).

The mean individual scores of SF36 for the study and comparison group are shown in (Table 5). Apart from body pain, the study group had lower scores than the comparison group. The PKDL cases showed significant difference in various aspects of QOL such as mental health (MH), social functioning (SF), bodily pain (BP) and general health (GH) as compared to control group. There was no significant difference (P > 0.05) between two groups with respect to the physical functioning (PF), role physical (RP), role emotional (RE) and vitality (VT).

There are studies on QOL for other skin diseases, however to the best of our knowledge there was no study on QOL in patients with PKDL. A study in cutaneous leishmaniasis (CL) revealed a negative impact of the disease on QOL and concluded that CL has a moderate to large negative effect on the QOL [13]. Another study by Yanik et al. reported that CL not only impairs the QOL but also the psychological functioning in the form of depression and anxiety in contrast to control group [14]. Study on QOL in patients with PKDL may be helpful in identifying those cases whose QOL is highly affected. To provide a more comprehensive assessment of the burden associated with PKDL, dermatology specific (DLQI) and general health specific (SF36) questionnaires were used together in the present study.

We evaluated a high impact of PKDL on patients QOL. The average DLQI scores 11.41, indicating a very large impairment of QOL. The highest score (2.18) was obtained in symptoms and feelings domain which represents how itching or painful were the lesions, embarrassment owned by the patients due to PKDL lesions. This finding was concordant with the result published in other skin related disorder such as psoriasis [15], contact dermatitis [16], primary cutaneous amyloidosis [17]. Treatment also showed equally comparable DLQI score (2.06). The recommended treatment options are miltefosine at 2.5 mg/kg for 12 weeks and amphotericin B in the dose of 1 mg/kg in 5% dextrose IV, alternate days for 20 injections in 3 to 4 courses at 15 days interval. These treatments are lengthy and also associated with numerous side effects. The possible explanation for such high DLQI score may be the longer hospitalization and prolonged treatment. The lowest score was found for the personal relationship domain of DLQI, which was in congruence to the findings of a study conducted on cutaneous lesihmaniasis in Brazil [13].

In our study, the mean DLQI scores of PKDL patients were 11.41, showing better result when compared to the other chronic skin disorders such as burns (17.7) [18], psoriasis (12.8) [19] and epidermolysis bullosa (12.1) [20] but worse than cutaneous leishmaniasis (5.87) [21], acne vulgaris (8.18) [22], alopecia (8.3) [23] and primary cutaneous amyloidosis (9.05) [17]. Around half of the patients (54.34%) in our study reported to have very large effect on QOL, whereas in cutaneous leishmaniasis only 15% patients experienced the same [21].

DLQI score revealed that quality of life (QOL) of PKDL patients did not vary significantly with respect to gender, marital status and type of skin lesions, except for nodular lesions which had poor QOL. The possible explanation may be the fact that nodular lesions generally appears on the exposed part of the body; more markedly on face, which lead to clinical and social discomfort. Nodular lesions contained a large amount of leishmania parasites, which may possibly play a significant role in transmission of the disease and thus have public health importance.

We did not find any significant difference for gender, similar observation was reported by Behrooze et al. in Iranian cutaneous leishmaniasis patients [21]. However, it is a common perception that females are more likely to have lower QOL than males as they are more concerned about their beauty and social relationship. The mean score of DLQI for age found under this study revealed that late adolescents had a higher degree of impairment of QOL than the adult. As the late adolescents are more conscious about their self esteem and self appearance, skin lesions may put an effect on their mental health and social obligations. Patients with no formal education were found to have lower quality of life. This may be explained as patients without formal education might be less aware of PKDL and/or pay less attention to the skin lesions at the initial stage, which appears as a small macule and later on gradually convert to more severe form thereby, leading to poor QOL. Patients with severe PKDL and persistence of lesions for several years were reported to have lower quality of life. Lesions of PKDL initially appear as hypopigmented macules but progressively converted to papules, nodules or mixture of these. Moreover, with increasing duration plaques and ulceration may develop. This ultimately affects their aesthetic appearance, physical and mental well-being. Therefore, patient’s education and awareness could be a key strategy to prevent severity of lesions and treatment delay.

For the first time, we report the impact of PKDL on QOL measured by SF-36, using comparison groups. The PKDL cases showed significant difference in various aspects of QOL viz. mental health (MH), social functioning (SF), bodily pain (BP) and general health (GH) as compared to control group. This finding is similar to a study conducted by Sheng et al. on Primary Cutaneous Amyloidosis [17]. PKDL patients also achieved lower scores as compared to control for role emotional, mental health and social functioning domain of SF36 test. This probably indicated that the psychological and social factors interfere with the QOL of PKDL patients. How these psychosocial parameters impair the QOL is needed to be explored in greater detail.

The present study has shown that the quality of life is highly impaired in patients with PKDL especially symptoms, feelings and treatment domain. Hence, a dermatologist should consider the psychological aspects of the disease in conjugation with therapeutic intervention to formulate an effective patient care management plan for PKDL. Issue related to QOL for PKDL patients need further research using clinical and epidemiological reviews to better understand the natural history, pathogenesis and long term impact of persisting manifestation following nodular/maculopapular/papulonodular lesions for PKDL. This has important implications for developing intervention programs in the country with high risk of PKDL increase. Studies with larger number of patients are recommended to evaluate the effects of location, number, size and duration of PKDL lesions, as well as the effects of treatment and residual scars on the QOL of patients. The possibility of using the DLQI as an outcome measure in future clinical studies on PKDL should also need to be kept in mind.