Laboratory investigations:-
  1. Investigations before starting treatment (baseline investigations): Serum TNF-α, differential complete blood picture (CBC), renal function testing, hepatitis C serology, and liver function testing.
  2. Investigations after three months of treatment: Serum TNF-α.
  3. Repeated liver function tests and CBC : for patients of methotrexate treatment group during treatment (at 2nd, 4th, 8th, and 12th weeks).
TNF-α measurement: Enzyme-linked immunosorbent assay (ELISA) investigated serum TNF-α according to the instructions of the manufacturer with the commercial package of Sinogen Clon Biotech co., ltd. (TNF-α) ELISA package.
Evaluation of the patients after three months of treatment:Patients were evaluated according to the clinical response into; Complete (total lesions and pruritus disappearance), partial (over 50 percent lesion clearance and no or moderate residual pruritus), and no response (less than 50 percent lesion clearance and/or significant residual pruritus).10
Statistical analysis: The researcher processed, coded, and evaluated the data with version 21 of the SPSS. Descriptive statistics: Means were calculated, standard deviation, inter-quartile range (IQR), and percentages. The chi-square test was utilized to compare frequency distribution variations between different groups. The independent t-testing analysis was performed to compare the means by which data for the continuous variables were usually distributed, while the median data variations that do not meet normal distribution were tested by the Mann Whitney U test. P-value < 0.05 was considered significant.