Introduction Uremic pruritus (UP) is a common and distressing symptom in end stage renal disease (ESRD) patients. Many approaches have been tested to improve UP without a clear success. We aimed to assess the effect of sertraline on UP in hemodialysis (HD) patients. Methods This research is a double-blinded, placebo-controlled, multicentric randomized clinical trial which included sixty patients maintained on regular HD. Patients were allocated to receive sertraline 50 mg twice daily or placebo for 8 weeks. The Visual analogue scale (VAS) and the 5-D itch scale were used to assess pruritus before and after the course of treatment. Results At study end in sertraline group, there was a significant decrease from baseline findings in the VAS score (p < 0.001), and the 5-D itch scale (p < 0.001). On the other hand, in placebo group the VAS score showed a slight non-significant decrease (p = 0.469), and the 5-D scale (p = 0.584) increased from baseline measurements. The percentage of patients with severe and very severe pruritus decreased significantly in the sertraline group in both scores [(VAS score: p = 0.004), (5-D itch score: p = 0.002)] with no significant change in the placebo group [(VAS score: p = 0.739), (5-D itch scale: p = 0.763)]. There was a significant positive relation between the VAS and 5-D itch scores and serum urea with p value of 0.002 and 0.001 respectively, and serum ferritin with p value of < 0.001 with both. Conclusions Patients treated with sertraline had a significant improvement in pruritus as compared with those who received placebo suggesting a potential role for sertraline to treat uremic pruritus in HD patients. Larger randomized clinical trials are needed to confirm these findings. Trial registration ClinicalTrials.gov NCT05341843. First registration date: 22/04/2022.

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