Effects of Pomegranate Peel Extract and Vitamin E on Quality of Life in Hemodialysis Patients: A Randomized Placebo-Controlled Clinical Trial

Abstract

Background and aims: Quality of life (QOL) is poor in hemodialysis (HD) patients. High oxidative stress and inflammatory conditions disturb their normal physiological, emotional, and physical functions. This study aimed to assess the effects of pomegranate peel extract (PPE) alone and in combination with vitamin E (Vit E) as anti-oxidant and anti-inflammatory substances on QOL of HD patients using Short-form 36 (SF-36) QOL questionnaire. Methods: This study was a double-blinded, placebo-controlled randomized clinical trial on HD patients. A total of 100 HD patients were randomly divided into 4 equal groups as follows: Pom+Vit E group, which received 2 PPE tablets + 1 Vit E soft gel daily, Pom group, which received 2 PPE tablets+1 Vit E placebo soft gel daily, Vit E group, which received 1 Vit E soft gel+2 PPE placebo tablets daily, and Placebo group, which received 2 PPE placebo tablets + 1 Vit E placebo soft gel daily. The intervention duration was 8 weeks. The stratified block randomization method based on sex, age, HD duration, and employment status was used for randomization. Results: The mean age of participants ranged between 51 and 57 years with an HD duration of 9-11.2 months. Bodily pain score and general health score significantly increased in the Pom group and Pom+ Vit E group. The emotional role functioning score of the Pom+Vit E group was significantly higher than that of the placebo group (P<0.05). Conclusion: The consumption of PPE and Vit E had beneficial effects on mental components but not the physical components of QOL. Moreover, combination therapy was more effective than single therapy.

Keywords

• hemodialysis
• pomegranate
• vitamin e
• quality of life
• clinical trial