scholarly journals Comparison of the efficacy and tolerability of an oral dosage form made from Fumaria vaillantii versus cetirizinein management of chronic urticaria: A single-blind, randomized, clinical trial

2018 ◽  
Vol 5 (6) ◽  
Author(s):  
Fatemeh Eghbalian ◽  
Nafiseh Esmaili ◽  
Mehrdad Karimi ◽  
Fahimeh Mohajerani ◽  
Roja Rahimi ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Adverse Events ◽  
Chronic Urticaria ◽  
Fumaric Acid ◽  
Oral Dosage ◽  
Inflammatory Factor ◽  
Life Questionnaire ◽  
Significant Difference

BACKGROUND: Chronic urticaria (CU) is one of the common allergic diseases whose conventional treatments have failed to desirably manage it. Fumariavaillantii is used in Persian medicine to treat CU. The anti-inflammatory and anti-histaminic effects of chemical components of Fumaria such as fumaric acid and caffeic acid were confirmed. Dimethyl fumarate reduces the pro- inflammatory contribution and monomethyl fumarate can increase IL-4, an antiinflammatory interleukin, or can decrease IFN- , an inflammatory factor. The current study assesses the efficacy and tolerability of Fumaria vaillantii versus cetirizine in the management of CU. METHODS: The formulation and standardization of Fumaria syrup were done in Tehran University of Medical Sciences. Patients were randomized to twice- daily treatment with Fumaria syrup or cetirizine syrup (n=39 in each group) for four weeks. The efficacy assessment included Urticaria Activity Score (UAS) and Chronic Urticaria Quality of Life Questionnaire (CUQ2oL) and the safety evaluations included Common Terminology Criteria for Adverse Events Questionnaire. RESULTS: The fumaric acid content in 5 ml of Fumaria syrup was calculated to be 0.12 mg. The results of clinical trial showed that UAS was significantly higher in the Fumaria group than in the cetirizine group, after the first week of follow-up (p<0.001), but no significant difference was demonstrated between the two groups on week 4 (p=0.57). One month after the research was finished, the UAS score of the cetirizine group was significantly higher than that of the Fumaria group (p<0.001). After finishing the interventions, difference of CU-Q2oL was not significant between the two groups; however, the QOL score was significantly lower in the Fumaria group (p<0.001) at 8th week. About adverse events, the incidence of somnolence in the Fumaria group was significantly lower than in the cetirizine group (p<0.001). CONCLUSIONS: Fumaria vaillantii demonstrated its effects on CU later than cetirizine, but led to more permanent effects, better quality of life, and lower incidence of adverse events as compared to cetirizine. More clinical trials with higher populations are needed to achieve more conclusive results.

scholarly journals The Effect of Lactobacillus acidophilus YT1 (MENOLACTO) on Improving Menopausal Symptoms: A Randomized, Double-Blinded, Placebo-Controlled Clinical Trial

2020 ◽  
Vol 9 (7) ◽  
pp. 2173
Author(s):  
Eun Yeong Lim ◽  
So-Young Lee ◽  
Hee Soon Shin ◽  
Jaekwang Lee ◽  
Young-Do Nam ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Lactobacillus Acidophilus ◽  
Menopausal Symptoms ◽  
Controlled Clinical Trial ◽  
Life Questionnaire ◽  
Sexual Symptoms ◽  
Significant Difference ◽  
Double Blinded

This study evaluated the efficacy of Lactobacillus acidophilus YT1 (MENOLACTO) for alleviating menopausal symptoms. This study was a multi-center, randomized, double-blinded, placebo-controlled clinical trial involving female subjects (ages: 40–60 years) with menopausal symptoms and a Kupperman index (KMI) score ≥ 20. Subjects were administered 1 × 108 CFU/day MENOLACTO or placebo, with the primary endpoint being total KMI score, and the effect of secondary endpoints on alleviating menopausal symptoms according to individual categories of the modified KMI, as well as a quality of life questionnaire (MENQOL questionnaire). After 12 weeks, total KMI scores decreased significantly, demonstrating improved menopausal symptoms relative to placebo along with improved modified KMI scores. Additionally, quality of life, according to the MENQOL questionnaire, significantly improved in all four symptoms—physical, psychosocial, vasomotor, and sexual symptoms. Moreover, we observed no significant difference between the two groups or significant changes in blood follicle-stimulating hormone and estradiol levels or endometrial thickness. These results demonstrated that MENOLACTO alleviated menopausal symptoms without notable side effects and improved quality of life, suggesting its efficacy as an alternative supplement to alleviate menopausal symptoms in women ineligible for hormonal therapy.

Minimal important difference of the Chronic Urticaria Quality of Life Questionnaire (CU‐Q2oL)

Allergy ◽  
2019 ◽  
Vol 74 (12) ◽  
pp. 2542-2544 ◽  
Author(s):  
Ilaria Baiardini ◽  
Salvatore Fasola ◽  
Marcus Maurer ◽  
Karsten Weller ◽  
Giorgio Walter Canonica ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Chronic Urticaria ◽  
Minimal Important Difference ◽  
Life Questionnaire ◽  
Quality Of Life Questionnaire

Effectiveness analysis of the new method of antireflux surgery in patients with hiatal hernia

2020 ◽  
Vol 26 (4) ◽  
pp. 50-55
Author(s):  
A.R. Stasyshyn ◽  
◽  
A.A. Hurayevskyy ◽  
Yu.Y. Holyk ◽  
◽  
...  
Keyword(s):  
Quality Of Life ◽  
Los Angeles ◽  
Hiatal Hernia ◽  
Antireflux Surgery ◽  
New Method ◽  
Life Questionnaire ◽  
Post Surgery ◽  
Group I ◽  
Significant Difference

Aim. To analyze the effectiveness of a new method of antireflux surgery in patients with hiatal hernia. Materials and Methods. The results of treatment of 157 patients with hiatal hernia from 2016 to 2020 are analyzed. The patients were divided into 3 groups: group I, N=59, underwent laparoscopic antireflux operation modified by the authors (Patent of Ukraine № 59772); group II (N=77), underwent laparoscopic Nissen fundoplication; and group III (N=21) - laparoscopic Toupet fundoplication. Results and Discussion. At 36 months post-surgery follow-up, there was a statistically significant difference in favor of group I on the average scores of the visual analog scale for reflux symptoms, dysphagia and extraesophageal symptoms; the average quality of life questionnaire scores; the average DeMeester index; distribution of the patients by satisfaction; distribution of the patients by degree of reflux esophagitis according to the Los Angeles classification; and distribution by gas-bloat syndrome. Conclusions. Clinical application of the developed new method of laparoscopic surgery for hiatal hernia reduces the number of relapses and complications after surgery, and improves the quality of life of patients. Key words: hiatal hernia, antireflux surgery, new methods of treatment

scholarly journals Improving Rehabilitation for Patients with Intermittent Claudication: A Randomized Controlled Trial with a Mixed-Methods Evaluation (The CIPIC Rehab Study)

2021 ◽  
Author(s):  
Maj Siercke ◽  
Sanne Pagh Moller ◽  
Lau Caspar Thygesen ◽  
Henrik Sillesen ◽  
Dorthe Overgaard
Keyword(s):  
Quality Of Life ◽  
Physical Activity ◽  
Clinical Trial ◽  
Mixed Methods ◽  
Usual Care ◽  
Randomized Clinical Trial ◽  
Intermittent Claudication ◽  
Walking Distance ◽  
Significant Difference

Aim: This study aimed to explore how qualitative data about rehabilitation for patients with intermittent claudication do provide an enhanced understanding of the quantitative experimental results. Background: The study was a randomized clinical trial comparing a rehabilitation intervention with usual care. A statistically significant difference between rehabilitation and usual care was found in walking distance, physical activity, quality of life and diet. The findings from the quantitative and qualitative analyses were analysed separately on their own tradition. In this study, mixed methods address whether the qualitative results could help explain the quantitative results and bring forward additional information. Design: Complex mixed-method intervention design with a convergent questionnaire variant. Methods: From April 2017- May 2019, patients diagnosed with intermittent claudication were included in a randomized clinical trial (N=118). In addition, qualitative interview informants from the intervention group were sampled from the quantitative study population for a survey (N=43) and focus group interviews (N=10). Interviews were conducted from April 2018-August 2019. Results: Integrated analyses identified how improvement in walking distance, physical activity, diet and quality of life was affected by team spirit, pedometer, education and fun exercise in a local setting. Quantitative and qualitative findings primarily confirmed and expanded each other; however, two discordant results were also evident. Conclusion: Our study adds empirical evidence regarding how a mixed-methods study can be used to obtain a more nuanced understanding of complex healthcare problems. The study provides new knowledge concerning how to set up a rehabilitation programme for patients with intermittent claudication.

Impact of protracted venous infusion fluorouracil with or without interferon alfa-2b on tumor response, survival, and quality of life in advanced colorectal cancer.

1995 ◽  
Vol 13 (9) ◽  
pp. 2317-2323 ◽  
Author(s):  
M Hill ◽  
A Norman ◽  
D Cunningham ◽  
M Findlay ◽  
M Watson ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Colorectal Cancer ◽  
Advanced Colorectal Cancer ◽  
Symptomatic Improvement ◽  
Interferon Alfa ◽  
Life Questionnaire ◽  
European Organization ◽  
Significant Difference ◽  
Venous Infusion

PURPOSE The aim of this study was to investigate the effects of adding interferon alfa-2b (IFN) to protracted venous infusion fluorouracil (PVI 5-FU) from the start of treatment in patients with advanced colorectal cancer. PATIENTS AND METHODS Patients who attended our unit with histologically confirmed advanced colorectal cancer were randomized to receive either PVI 5-FU 300 mg/m2/d via Hickman line, and IFN 5 MU subcutaneously three times weekly, or PVI 5-FU alone. Treatment was given for a maximum of two 10-week blocks, with a 2-week gap for reassessment of all parameters. Quality of life (QL) was measured by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) pretreatment and every 6 weeks thereafter. RESULTS A total of 160 patients were randomized, with 155 eligible for assessment. Radiologic response was observed in 43 patients (28%): 17 of 77 (22%) in the 5-FU-plus-IFN arm (all partial responses [PRs]) and 26 of 78 (33%) in the 5-FU-alone group (complete responses [CRs] and 22 PRs) (difference not significant). Symptomatic improvement occurred in the majority of patients, and equally in both arms: 61% to 80% depending on the symptom. There was no significant difference between the two groups in failure-free survival (median, 161 v 193 days) or overall survival (median, 328 v 357 days). However, patients who received IFN did experience significantly more toxicity in the form of leukopenia (P = .001), neutropenia (P = .04), mucositis (P = .008), and alopecia (P = .0002). There were no toxic deaths and few notable differences in QL between the two arms. CONCLUSION This study confirms that PVI 5-FU is effective in treating the symptoms associated with metastatic colorectal carcinoma, with only mild to moderate toxicity and maintenance of QL. IFN 5 MU three times weekly does not enhance these palliative benefits.

Prolonged clinical remission and low disease activity statuses are associated with better quality of life in systemic lupus erythematosus

Lupus ◽  
2019 ◽  
Vol 28 (10) ◽  
pp. 1189-1196 ◽  
Author(s):  
N Poomsalood ◽  
P Narongroeknawin ◽  
S Chaiamnuay ◽  
P Asavatanabodee ◽  
R Pakchotanon
Keyword(s):  
Quality Of Life ◽  
Systemic Lupus Erythematosus ◽  
Disease Activity ◽  
Lupus Erythematosus ◽  
Clinical Remission ◽  
Life Questionnaire ◽  
Systemic Lupus ◽  
Low Disease Activity ◽  
Significant Difference

Objective The objective of this study was to determine the association between disease activity status and health-related quality of life (HRQoL) in systemic lupus erythematosus (SLE) patients. Methods SLE patients in an out-patient clinic during the previous 12 months were included in the study. The Systemic Lupus Erythematosus-specific Quality-of-Life questionnaire (SLEQoL) was administered at the last visit. Disease activity status was determined retrospectively during the previous year. The categories of disease activity status were defined as: clinical remission (CR): clinical quiescent disease according to Systemic Lupus Erythematosus Disease Activity Index 2000, prednisolone ≤ 5 mg/day; low disease activity (LDA): SLEDAI-2K (without serological domain) ≤ 2, prednisolone ≤ 7.5 mg/day; and non-optimally controlled status: for those who were not in CR/LDA. Immunosuppressive drugs (maintenance dose) and antimalarials were allowed. Prolonged CR or LDA was defined as those with sustained CR or LDA for at least one year. The association between disease activity status and HRQoL was assessed by using regression analysis adjusting for other covariates. Results Of 237 SLE patients, 100 patients (42.2%) achieved prolonged CR, 46 patients (19.4%) achieved prolonged LDA and 91 patients (38.4%) were not in CR/LDA. Non-CR/LDA patients had significantly higher total SLEQoL score and in all domains compared to CR/LDA patients. No significant difference in SLEQoL domain scores was found between CR and LDA groups. Multivariable analysis revealed that non-CR/LDA was positively associated with SLEQoL score compared with CR/LDA (β 20.02, 95% confidence interval (CI) 6.81–33.23, p < 0.003). Moreover, non-CR/LDA was at a higher risk of impaired QoL (SLEQoL score > 80) compared with CR (hazard ratio 3.8; 95% CI 1.82–7.95; p < 0.001). However, there was no significant difference between CR and LDA in terms of SLEQoL score or impaired QoL. Other factors associated with higher SLEQoL score were damage index (β 9.51, 95% CI 3.52–15.49, p = 0.002) and anemia (β 24.99, 95% CI 5.71–44.27, p = 0.01). Conclusion Prolonged CR and LDA are associated with better HRQoL in SLE patients and have a comparable effect. Prolonged CR or optional LDA may be used as the treatment goal of a treat to target approach in SLE.

scholarly journals Hyeonggaeyeongyo-Tang for Treatment of Allergic and Nonallergic Rhinitis: A Prospective, Nonrandomized, Pre-Post Study

2016 ◽  
Vol 2016 ◽  
pp. 1-7 ◽  
Author(s):  
Min-Hee Kim ◽  
Jaewoong Son ◽  
Hae Jeong Nam ◽  
Seong-Gyu Ko ◽  
Inhwa Choi
Keyword(s):  
Quality Of Life ◽  
Allergic Rhinitis ◽  
Life Questionnaire ◽  
Nonallergic Rhinitis ◽  
Prick Test ◽  
Chronic Rhinitis ◽  
Nasal Symptoms ◽  
Significant Difference

Hyeonggaeyeongyo-tang (HYT) is an ancient formula of oriental medicine traditionally used to treat rhinitis; however, clinical evidence has not yet been established. The aim of this study was to investigate the short-term and long-term efficacy and safety of HYT for chronic rhinitis. Adult subjects with chronic rhinitis symptoms were recruited. The subjects received HYT for 4 weeks and had follow-up period of 8 weeks. Any medicines used to treat nasal symptoms were not permitted during the study. The skin prick test was performed to distinguish the subjects with allergic rhinitis from those with nonallergic rhinitis. After treatment, the total nasal symptoms score and the Rhinoconjunctivitis Quality of Life Questionnaire score significantly improved in the whole subject group, in the allergic rhinitis group, and in the nonallergic rhinitis group, with no adverse events. This improvement lasted during a follow-up period of 8 weeks. Total IgE and eosinophil levels showed no significant difference after treatment in the allergic rhinitis group. HYT improved nasal symptoms and quality of life in patients with allergic rhinitis and nonallergic rhinitis. This is the first clinical study to evaluate the use of HYT to treat patients with rhinitis. This trial has been registered with the ClinicalTrials.gov IdentifierNCT02477293.

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