scholarly journals The efficacy and safety of silymarin in the treatment of chemotherapy-induced peripheral neuropathy, a randomized double-blinded clinical trial

Author(s):  
Ramin Shekarriz ◽  
Hojjat Ghorbani ◽  
Mahmoud Mousazadeh ◽  
Khatereh Vahedi ◽  
Ebrahim Salehifar

Aim: The aim of this study was to evaluate the efficacy and side effects of silymarin in the treatment of CIPN. Methods: Patients who referred to outpatient oncology department of a referral educational hospital affiliated to Mazandaran University of Medical Sciences and experienced CIPN were randomized to receive silymarin or placebo. Intervention group received 140 mg of the Silymarin twice daily accompanied and 300 mg/day Gabapentin, whereas control group received 300 mg/day of Gabapentin and placebo twice daily for 3 months. The grade of neuropathy was determined according to the CTCAE criterion. The improvement of neuropathy was defined as the reduction of at least one neuropathic score. The visual analogue scale (VAS) was used to assess the severity of patients’ pain and the EORTC-QLQ-C30 criterion was used to assess the quality of life. Patients were evaluated initially and at the follow up visit 3 months after the enrollment. Results: A total of 80 patients were enrolled in the study. There was no significant difference between the groups in terms of severity of neuropathy at baseline. At the end of the study, the number of people with improved neuropathy in the silymarin group was 82.8% patients, which was significantly higher than 48.4% observed in the patients received placebo (P= 0.005). The silymarin-treated group showed a significant reduction in pain compared with those receiving placebo. Despite the improvement in quality of life in the intervention group compared to the comparison group, this difference was not statistically significant. Gastrointestinal symptoms were the only reported side effects with a similar incidence in two groups. Conclusion: The present data demonstrate the potential clinical use of silymarin as an adjuvant therapy to reduce CIPN symptoms.

Author(s):  
Ali Abbasi ◽  
Hossein Ebrahimi ◽  
Hossein Bagheri ◽  
Mohammad Hasan Basirinezhad ◽  
Seyedmohammad Mirhosseini ◽  
...  

AbstractBackgroundOne of the factors associated with readmission is inappropriate sexual activity after myocardial infarction (MI). This study aimed to assess the effect of peer education on the sexual quality of life (SQOL) in patients with MI.MethodsIn this randomized controlled clinical trial, 70 patients with MI meeting the inclusion criteria were assigned to experimental or control groups using block randomization. Peer education for the intervention group was provided on the third day after MI. Education sessions lasted from 90 to 120 minutes. Data were collected using demographic, sexual quality of life-female (SQOL-F), and sexual quality of life-male (SQOL-M) questionnaires during the fourth week after MI.ResultsThere was no significant difference between the two groups before the intervention in terms of demographic and SQOL. The mean of SQOL in the peer education group was significantly higher than the control group at the 4-week follow-up.ConclusionsAccording to the results, using peer education is recommended for the sexual health care professionals.


2020 ◽  
Vol 9 (2) ◽  
Author(s):  
Maryam Abiz ◽  
Hasan Robabi ◽  
Alireza Salar ◽  
Farshid Saeedinezhad

Background: Tuberculosis (TB) affects various aspects of quality of life (QoL), and self-care is the most important form of primary care and one of the main factors involved in the process of treating chronic diseases and improving the patients’ QoL. Objectives: This study aimed to investigate the effect of self-care education on the QoL of TB patients. Methods: In this quasi-experimental study, 110 TB patients referred to the TB coordinating Center in Zahedan, Southeastern Iran, in 2018, are studied. Participants were selected using convenience sampling and were randomly assigned to the intervention (n = 55) and control (n = 55) groups. Data were collected using the tuberculosis quality of life-version 2 (TBQol-v2). For the intervention group, first, patients and their caregivers were divided into groups compromising of 4 to 6 members, and then three sessions of self-care education, including lectures and questions and answers meetings, each lasted for 30 minutes (in total 90 minutes) were provided to each group. Data were analyzed in SPSS version 21 using descriptive statistical tests, independent t-test, paired t-test, and chi-squared test. Results: Mean of the total QoL score of the two groups before the intervention was 67.56 ± 5.99 and 67.09 ± 5.03, respectively, indicating no significant difference (P = 0.65). But after providing the intervention, the mean score of patients QoL in the intervention group (74.84 ± 4.90) was significantly higher than the control group (67.98 ± 0.68) (P = 0.001). Conclusions: Since self-care education can effectively enhance the QoL of TB patients, it is recommended to provide such educations for both treatment and follow-up of these patients along with directly observed treatment, short-course (DOTS).


2022 ◽  
Vol 22 (1) ◽  
Author(s):  
Zahra Akbari Namvar ◽  
Reza Mahdavi ◽  
Masood Shirmohammadi ◽  
Zeinab Nikniaz

Abstract Background In this trial, we investigated the effect of a group-based education program on gastrointestinal (GI) symptoms and quality of life (QOL) in patients with celiac disease (CD). Method In the present study, 130 patients with CD who were on a GFD for at least 3 months, randomly assigned to receive group-based education (n = 66) or routine education in the celiac clinic (n = 64) for 3 months. We assessed gastrointestinal symptoms and quality of life using the gastrointestinal symptom rating scale (GSRS) questionnaire and SF-36 questionnaire at baseline and 3 months after interventions. Results The mean age of the participants was 37.57 ± 9.59 years. There were no significant differences between the two groups regarding the baseline values. Results showed that the mean score of total GSRS score in the intervention group was significantly lower compared with the control group 3 months post-intervention (p = 0.04). Also, there was a significant difference in the mean score of SF-36 between the two groups 3 months post-intervention (p = 0.02). Conclusion Results showed that group-based education was an effective intervention in patients with celiac disease to improve gastrointestinal symptoms and quality of life. Trial registration IRCT code: IRCT20080904001197N21; registration date: 5/23/2019.


Author(s):  
Jamileh Malekuti ◽  
Mojgan Mirghafourvand ◽  
Khadijeh Samadi ◽  
Fatemeh Abbasalizadeh ◽  
Laleh Khodaei

Abstract Introduction Due to the effects of hemorrhoids on physical and mental health, this study aimed to compare the effect of Myrtus communis herbal and anti-hemorrhoid ointments on symptoms of hemorrhoid and quality of life (primary outcomes) and satisfaction of the treatment and side effects (secondary outcomes). Methods This triple-blind randomized controlled trial was performed on women with grade I and II hemorrhoid referring to health centers in Tehran, Iran, in 2017. Individuals were randomly assigned to two groups of 67 people through block randomization method. The intervention group received the Myrtus communis herbal ointment and the control group received anti-hemorrhoid ointment twice a day, every 12 ± 2 h, an applicator of the drug through the rectum for 4 weeks. The Colorectal Evaluation of a Clinical Therapeutics Scale (CORECTS) was used to assess the severity of symptoms of hemorrhoid. To assess the quality of life, the World Health Organization Quality of Life questionnaire (WHOQOL-BREF) was used to measure the general quality of life of participants. This questionnaire was completed once before the start of the study, then on the fourth and the eighth week after the start of the intervention. Repeated measure ANOVA, Chi-square, Mann–Whitney U and independent t-test were used for data analysis. Results The severity of all symptoms of hemorrhoid decreased in both two group and there was no statistically significant difference between the two groups (p>0.05). However, the mean of anal itching at 4 and 8 weeks after the intervention was significantly lower in the Myrtus communis ointment group (p<0.05). There was no significant difference between groups in terms of quality of life at 4 and 8 weeks after the intervention (p>0.05). There was a significant difference between the two groups in terms of satisfaction with the drug (p=0.019) and the participants in the Myrtus communis ointment group were more satisfied with their drug use. Conclusions Myrtus communis herbal ointment was able to reduce the symptoms of hemorrhoid in the affected women. Therefore, it is likely that the use of this drug will promote the health of mothers with hemorrhoid.


2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 9617-9617
Author(s):  
B. Oh ◽  
P. Butow ◽  
B. Mullan ◽  
S. Clarke ◽  
P. Beale ◽  
...  

9617 Background: The quality of life (QOL) of cancer patients is often diminished due to the side effects of treatment and symptoms of the disease itself. This study examines the impact of Medical Qigong (MQ), including gentle exercise and relaxation through meditation and breathing exercise based on the Chinese Medicine theory of energy channels, on quality of life (QOL), fatigue, side effects, mood status and inflammation. Methods: One hundred sixty two patients diagnosed with a range of cancers recruited from three university teaching hospitals were randomly assigned to two groups: a control group (n=83) that received usual health care and an intervention group (n=79) who participated in a MQ program for 10 weeks in addition to receiving usual health care at the hospital. Quality of life and symptoms were measured by the FACT-G, cancer related fatigue by FACT-F and mood status by POMS. The inflammatory marker serum C-reactive protein (CRP) was also monitored serially. Results: Regression analysis indicated that the MQ intervention group significantly improved on measures of overall QOL (t144= -5.761, p<0.001), fatigue (t153= -5.621, p<0.001), mood disturbance (t122=2.346, p=0.021) and inflammation (CRP) (t99=2.042, p<0.044) compared to the usual care control group after controlling for baseline variables. Analysis of the FACT-G subscales revealed that the MQ intervention group also significantly improved in satisfaction with sex life (t92=-3.783, p<0.001) and reduced side effects of nausea (t152=-2.071, p=0.040) and sleep disturbance (t150=-2.603, p=0.010) compared to the usual care control group. Pain was improved in both intervention and control groups. Conclusions: This study suggests that MQ with usual health care can improve overall QOL, fatigue, positive mood status and reduce the side effects of nausea, sleep disturbance and inflammation of cancer patients. This study supports the use of MQ as an intervention for cancer care. No significant financial relationships to disclose.


2021 ◽  
Vol 27 (1) ◽  
pp. 34-43
Author(s):  
Oleksandr Y. Glavatskyi ◽  
Oksana V. Zemskova ◽  
Hennadii V. Khmelnytskyi ◽  
Konstantin A. Kardash ◽  
Iryna M. Shuba ◽  
...  

Objective: to study the effect of antiangiogenic therapy on the quality of life and the level of headache in patients with recurrent glioblastoma who underwent radiosurgical treatment. Materials and methods. A prospective randomized single-center study carried out at the Romodanov Neurosurgery Institute of National Academy of Medical Sciences of Ukraine in 2019-2020 involving 45 patients with GB with clinical and radiological signs of disease progression and local tumor recurrence. In this regard, patients underwent radiosurgical treatment. In the main group (BEV+) 21 patients after stereotactic radiosurgery (SRS) underwent antiangiogenic therapy with Bevacizumab (BEV). In the control group (BEV–), 24 patients did not receive antiangiogenic therapy after SRS. SRS with the use of a linear accelerator «Trilogy» (6 MeV) using intensity-modulated radiotherapy (IMRT). BEV was administered intravenously, once every 3 weeks at a dose of 10 mg / kg body weight. Antiangiogenic therapy was performed under the condition of preserved liver and kidney function, values of full blood count and blood biochemistry within normal range. Global health status and headache levels were calculated according to EORTC QLQ-C30 v. 3.0 and QLQ-BN20 before and six weeks after radiosurgery in the main and control groups. Results. There was no a statistically significant difference between the studied groups of patients’ in quality of life (p = 0.707372) and in headache level (p = 0.846660) before the SRS. Six weeks after SRS, patients in the main group had a statistically significantly higher quality of life (p = 0.000015) and a lower level of headache than patients in the control group (p = 0.000035). During the observation period in patients of both groups there were no adverse events of III-IV degree of toxicity, in particular specific complications of antiangiogenic therapy (hypertension, bleeding, thromboembolism, leukopenia, proteinuria, gastrointestinal disorders, etc.). Conclusions. Antiangiogenic therapy statistically significantly improves the quality of life and reduces the level of headache in patients who underwent radiosurgical treatment for glioblastoma recurrence.


2021 ◽  

To explore the effect of care transitions intervention (CTI) on the sense of benefit-finding of caregivers for patients with acute cerebral infarction (ACI). Ninety caregivers for patients with ACI were divided into two groups according to the random number table method (n = 45 in each group). The control group was given regular health guidance, and the intervention group was given care transitions intervention on the basis of the guidance used in the control group. The changes in the sense of benefit-finding and quality of life between the two groups were compared before and after the intervention. There was no statistically significant difference in caregivers between the two groups in gender, age, educational level, occupational status, gender and age of the patients, activities of daily living (ADL) scores before discharge, and the relationships between the caregiver and the patient. Before CTI, there was no statistically significant difference in the caregivers’ sense of benefit-finding (including sense of benefit, family relationship, personal growth, social relationship and healthy behavior) and quality of life (including benefit-finding of care, stress of care, choice of care, support to care and money issue) between the two groups. While after CTI, the scores of each dimension of the caregivers’ sense of benefit-finding and quality of life in the intervention group were significantly higher than those in the control group (p < 0.05). The CTI can help improve the sense of benefit-finding and quality of life of caregivers for patients with ACI.


Author(s):  
Azadeh Fallah ◽  
Kiana Parnian ◽  
Hamid Abdolazimi ◽  
Sajjad Tezerji ◽  
Zohreh Mazloom

Background: In cancer patients, weight loss due to malnutrition has a significant impact on the patients’ treatment and quality of life. This study aimed to determine the appropriate therapeutic strategy to control the side effects of chemotherapy in patients with breast cancer to improve their health, quality of life, and nutritional status. Methods: In our prospective study, we examined gastric cancer patients who were Seventy patients undergoing chemotherapy were included and randomly divided into intervention (n=35) and control groups (n=35). The intervention group received an individualized diet according to their nutritional needs for eight weeks, and the control group received dietary advice on the side effects of chemotherapy. Malnutrition, nutritional barriers, and patients’ quality of life were evaluated by PG-SGA, nutritional barriers, and QLQ-C30 questionnaires. Serum proteins were also assessed at the beginning and the end of the study. Results: The patients’ mean age was 50.91±1.72 years in the intervention group and 51±1.35 in the control group. According to the PG-SGA questionnaire classification, 68.5% of patients had malnutrition at baseline. In the intervention group, the mean score of PG-SGA decreased, which indicated an improvement in patients’ nutritional status. Increased scores in the functional section of QLQC30 and a decrease in the symptom section of this questionnaire indicated the improved quality of life in patients undergoing treatment at the end of the intervention. Albumin (P<0.001) and hemoglobin (P<0.001) levels increased in the intervention group, while there were no significant changes in these variables of the control group. Serum levels of ferritin did not show significant changes in either the intervention or the control group. Conclusion: Identifying nutritional barriers in breast cancer patients and individual diet therapy based on these barriers and nutritional needs reduces nutritional barriers. Consequently, malnutrition would decline, and the quality of life may enhance in these patients.


Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Renata de Barros e Silva ◽  
Denise Hachul ◽  
PEDRO GABRIEL M DE BARROS E SILVA ◽  
Mauricio I Scanavacca

Introduction: Vasovagal syncope presents a benign prognosis in terms of survival but is associated with significant impairment on quality of life (QoL). Poor emotional status contributes to the recurrence of events. Hypothesis: Among patients with recurrent vasovagal syncope, weekly sessions of psychotherapy may improve QoL and reduce the number of events during one year of follow-up. Methods: A randomized controlled trial was conducted including 10 patients with recurrent vasovagal syncope and positive tilt test. Cardiac disease and ongoing psychotherapeutic interventions were the main exclusion criteria. After randomization, half of the eligible patients underwent weekly sessions of psychotherapy during 12 months, while the control group was followed according to the standard of care, without psychotherapy. QoL by SF-36 and recurrence of syncope and pre-syncope were compared between the 2 groups and also in each group pre and post randomization. Results: All patients had a positive tilt test (80% with mixed vasovagal response), 70% were female and the mean age was 47.4 ± 11.1 years. The average rate of events before inclusion was 4.1 (± 3.4) syncopes/year and 1.26 (± 0.5) episodes of presyncope/week. The groups were well balanced at baseline and all patients completed the planned follow-up of one year. In the assessment of QoL by SF-36, comparing before and one year after randomization, there was no statistically significant difference in the control group (49.9 ± 9.8 vs 46.9 ± 3.4, P = 0.20) but there was a significant improvement in the intervention group (44.9 ± 11.9 vs 68.8 ± 7.8, P < 0.01). Comparing both groups at 12 months, patients that underwent sessions of psychotherapy had better QoL (68.8 ± 7.8 vs 46.9 ± 3.4, P < 0.01). Regarding the recurrence of syncope events, there was no significant change in the control group; however, in the intervention group there was a significant reduction in the rate of presyncope episodes per month (5.6 ± 2.1 vs 1.7 ± 0.9; P = 0.02) and also a significant reduction in the rate of syncope per year (4.6 ± 3.3 vs 1.0 ± 0.7; P = 0.04). Conclusions: In a randomized clinical trial, patients with recurrent vasovagal syncope undergoing regular psychotherapeutic intervention had less recurrence of events and improved quality of life in one year.


2012 ◽  
Vol 40 (04) ◽  
pp. 685-693 ◽  
Author(s):  
Peng-Fei Shen ◽  
Li Kong ◽  
Li-Wei Ni ◽  
Hai-Long Guo ◽  
Sha Yang ◽  
...  

Stroke is one of the most common causes of death and few pharmacological therapies show benefits in ischemic stroke. In this study, 290 patients aged 40–75 years old with first onset of acute ischemic stroke (more than 24 hours but within 14 days) were treated with standard treatments, and then were randomly allocated into an intervention group (treated with resuscitating acupuncture) and a control group (treated using sham-acupoints). Primary outcome measures included Barthel Index (BI), relapse and death up to six months. For the 290 patients in both groups, one case in the intervention group died, and two cases in the control group died from the disease (p = 0.558). Six patients of the 144 cases in the intervention group had relapse, whereas 34 of 143 patients had relapse in the control group (p < 0.001). The mean values for BI at six months were 70.25 ± 20.37 and 57.43 ± 19.61 for the two groups, respectively (p < 0.01). Acupuncture resulted in a significant difference between the two groups for the National Institute of Health Stroke Scale (NIHSS), not at two weeks (7.03 ± 3.201 vs. 8.13 ± 3.634; p = 0.067), but at four weeks (4.15 ± 2.032 vs. 6.35 ± 3.131, p < 0.01). The Chinese Stroke Scale (CSS) at four weeks showed more improvement in the intervention group than that in the control group (9.40 ± 4.51 vs. 13.09 ± 5.80, p < 0.001). Stroke Specific Quality of Life Scale (SS-QOL) at six months was higher in the intervention group (166.63 ± 45.70) than the control group (143.60 ± 50.24; p < 0.01). The results of this clinical trial showed a clinically relevant decrease of relapse in patients treated with resuscitating acupuncture intervention by the end of six months, compared with needling at the sham-acupoints. The resuscitating acupuncture intervention could also improve self-care ability and quality of life, evaluated with BI, NIHSS, CSS, Oxford Handicap Scale (OHS), and SS-QOL.


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