Psoriasis Clinical Trial
Official title:
Efficacy of Low Dose Naltrexone in Psoriasis; Clinical Trial in a Tertiary Care Hospital of Karachi.
Objective of the study is to determine the efficacy of low dose naltrexone in the patients of psoriasis, which is a chronic relapsing and remitting disease. A non-randomized clinical trial was carried out in the Department of dermatology in Jinnah Postgraduate Medical Center, Karachi. All patients with mild, moderate and severe psoriasis with age above 13 years without any co-morbid, were prescribed tablet Naltrexone 6 mg daily after assessing PASI, BSA and DLQI scores before starting treatment. Patients were called monthly for follow up to monitor lipid profiles and liver function tests. After 3 months of treatment, PASI, BSA and DLQI scores were assessed again. The results were significant when analysed with paired t test in SPSS 23.
Psoriasis is a chronic T-cell mediated disorder. The activated T cell secretes cytokines that
result in keratinocytes hyper-proliferation and abnormal differentiation. These cytokines
result in chemo-taxis of neutrophils and lymphocytes in skin. It is a multi-factorial
disease. Individual has genetic susceptibility for psoriasis, but environmental factors
trigger the disease like infections, drugs, cold, trauma and stress. It is a multi-system
disease but mainly affects skin, nails and joints. It impacts adversely on patients' quality
of life, causes embarrassment, limitation in clothing choice, psychological distress which
further aggravates the disease. It impacts economically due to off days from work as well. In
its most common form, it presents as salmon pink plaques, covering with thick silver scales,
mostly on scalp, trunk, buttocks and external surfaces of limbs.
In the management of psoriasis, there are multiple treatment options which includes topical,
systemic and photo-therapy. But all have their side effects and contraindication. Low dose
naltrexone(LDN) is an attractive emergent therapy with analgesic, anti-pruritic and
anti-inflammatory properties for various dermatological disorders including psoriasis. In
this study, the effectiveness of low dose naltrexone in cases of psoriasis was assessed.
The study was conducted in the department of dermatology in Jinnah Postgraduate Medical
Centre, Karachi, after receiving approval letter from the institutional ethical and research
committee of the hospital.Forty two patients were selected of either gender with age ranging
from 13-60 years, after excluding hypertension, cardiovascular disorders, pregnancy and
lactation. The procedure has been explained to each patient & written consent has been taken.
Before prescribing LDN treatment, Psoriasis area and severity index(PASI), Body surface
area(BSA) and Dermatology life quality index(DLQI) has been calculated. Each case has
prescribed tablet naltrexone 6mg daily after checking all baselines investigations of
complete blood picture , renal and liver function profiles. The cases were asked to follow up
monthly to observe patient compliance, response of medicine and its side effects. After 3
months of treatment, PASI, BSA and DLQI have been calculated to assess the effectiveness of
treatment.
PASI score is used to measure the severity and extent of disease, in terms of intensities of
erythema, induration and scaling of lesion and the area of body involved with disease.
Body surface area (BSA) is calculated through 'rule of nine' which is a convenient and rapid
method of estimating the extent of body surface area affected with disease. If BSA is <3%,
3-10%, or >10%, it is categorized as mild, moderate and severe disease, respectively.
The dermatology life quality index is a simple questionnaire, that consists of 10 questions
to assess the impact of disease and its treatment on daily activities and the impact on the
social behavior of the patients. DLQI scores has been interpreted in terms of effect of
disease on patients' life as follows:
- 0-1 = No effect
- 2-5 = Small effect
- 6-10 = Moderate effect
- 11-20 = Very large effect
- 21-30 = Extremely large effect After 3 months, all three scores were assessed again to
observe the effectiveness of treatment. The evaluation was done by SPSS version 23. The
side effects were assessed regarding nausea, headache, decreased appetite, dizziness,
palpitation, liver enzymes level, renal and complete blood profiles.
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