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

Tina Jafari,Mohsen Saeedi,Leila Mahmoodnia

doi:10.34172/ijer.2020.23

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.

Highlights

Hemodialysis (HD) improves the survival of patients with end-stage renal failure
This study aimed to assess the effects of pomegranate peel extract (PPE) alone or in combination with vitamin E (Vit E) on quality of life (QOL) of HD patients
Materials and Methods Patient Selection This study was a double-blinded, placebo-controlled randomized clinical trial which assessed the effects of PPE and Vit E on the health status of HD patients referred to HD centers in Chaharmahal-va-Bakhtiari province, Iran

Summary

Introduction

Hemodialysis (HD) improves the survival of patients with end-stage renal failure. Many of these patients, who were previously threatened with death, experience a relatively normal life with HD procedure later and are more or less able to perform their personal tasks. Healthrelated outcomes can still be poor in HD patients Their morbidity and mortality rate are higher compared to the general population.[1] Studies have shown that the quality of life (QOL) is poor in HD patient population.[1,2] In addition to the chronic nature of underlying kidney disorder which influences physical, emotional, and social abilities of HD patients, higher incidence of cardiovascular events affects their general health status.[2] It has been reported that HD patients are in high levels of oxidative stress and chronic inflammatory status.[3] Clinical trials have shown that the consumption of anti-inflammatory agents or antioxidants in patients with chronic disorders ameliorates the inflammation and improves the health status and QOL of these patients.[4,5]. 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 Shortform 36 (SF-36) QOL questionnaire.

Objectives

Methods

Results

Conclusion