Preventive Efficacy and Safety of Yiqi-Wenjing-Fang Granules on Oxaliplatin-Induced Peripheral Neuropathy: A Protocol for a Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial

Background. Oxaliplatin-induced peripheral neuropathy (OIPN) is one of the most common side effects of oxaliplatin, which can cause reduction and cessation of oxaliplatin-based chemotherapy and significantly affect patients’ quality of life. However, no drug has got recognition to prevent or treat OIPN. Yiqi-Wenjing-Fang (YWF) is a joint name of Chinese medicine prescriptions with similar effects of tonifying qi and warming meridians, represented by Huangqi Guizhi Wuwu decoction (HGWD) and Danggui Sini decoction (DSD), both from “Treatise on Cold Pathogenic and Miscellaneous Diseases.” YWF granules, including HGWD granules and DSD granules, have been, respectively, demonstrated to be effective in preventing OIPN in previous small-sample observations. The purpose of this study is to enlarge the sample size for further evaluation of the preventive efficacy and safety of YWF granules on OIPN. Methods and Analysis. This study is a randomized, double-blind, placebo-controlled, and multicenter clinical trial. 360 postoperative patients with stage IIa-IIIc colorectal cancer will be randomly assigned into placebo-control group, intervention group I, and intervention group II, taking the mimetic granules of YWF as placebo, HGWD granules and DSD granules, respectively. All subjects will receive oxaliplatin-based chemotherapy regimen at the same time. EORTC QLQ-CIPN20 will be used to assess the degree of OIPN as the primary outcome measure. The grades of OIPN, quality of life, chemotherapeutic efficacy, and the number of completed chemotherapy cycles are selected as the secondary outcome measures. Discussion. Based on the condition of no recognized effective drugs in preventing OIPN, evidence-based medical study will be conducted for seeking a breakthrough in the field of Chinese herb medicine. This protocol could provide reliable and systemic research basis about the efficacy of YWF granules and the differentiation of two classical prescriptions of YWF on preventing OIPN objectively. Trial Registration. This study was registered at ClinicalTrials.gov on 26 December 2020 (ID: https://clinicaltrials.gov/ct2/show/NCT04690283).

Download Full-text

Efficacy and safety of levocetirizine on symptoms and health-related quality of life of children with perennial allergic rhinitis: a double-blind, placebo-controlled randomized clinical trial

Annals of Allergy Asthma & Immunology ◽

10.1016/s1081-1206(10)61208-2 ◽

2005 ◽

Vol 95 (2) ◽

pp. 175-180 ◽

Cited By ~ 41

Author(s):

Paul C. Potter

Keyword(s):

Quality Of Life ◽

Clinical Trial ◽

Efficacy And Safety ◽

Health Related Quality ◽

Perennial Allergic Rhinitis ◽

Double Blind ◽

Double Blind Placebo ◽

Related Quality ◽

Health Related

Download Full-text

Effects of Helichrysum Psudoplicatum supplementation on pruritus intensity, fatigue, quality of life and anorexia in hemodialysis patients: a randomized, double-blind placebo-controlled trial

Hormone Molecular Biology and Clinical Investigation ◽

10.1515/hmbci-2021-0015 ◽

2021 ◽

Vol 0 (0) ◽

Author(s):

Maryam Mohajeranirad ◽

Naser Saeidi ◽

Mohammad Kamali Nejad ◽

Amir Almasi-Hashiani ◽

Mehdi Salehi ◽

...

Keyword(s):

Quality Of Life ◽

Rating Scale ◽

Controlled Trial ◽

Intervention Group ◽

Controlled Clinical Trial ◽

Dialysis Patients ◽

Time Duration ◽

Double Blind ◽

Double Blind Placebo

Abstract Objectives Anorexia, fatigue and pruritus are common complications of hemodialysis (HD) patients. Today, the use of medicinal plants is more than synthetic drugs due to their safety. Therefore, we designed a randomized controlled clinical trial to evaluate the effects of Helichrysum psudoplicatum (H. psudoplicatum) supplementation on biochemical parameters, pruritus intensity, fatigue, quality of life and anorexia in HD patients. Methods This randomized, double-blind, placebo-controlled trial was performed on 50 subjects with, aged 55–65 years old. HD patients were randomly divided into two groups. Intervention group received 250 mg/day of H. psudoplicatum supplement capsule for 6 weeks (n=25), and the placebo group was given placebo capsule for the same time duration and dosage (n=25). The serum concentrations of urea, creatinine, albumin and hemoglobin were measured enzymatically methods. Anorexia, pruritus intensity, quality of life the dialysis patients with pruritus and fatigue score was measured using a Simplified Nutritional Appetite Questionnaire (SNAQ), Numerical rating scale (NRS), Fatigue severity scale (FSS) and ItchyQoL questionnaire, respectively. Shapiro–Wilk and independent-samples t-test or Mann–Whitney test were used for the analysis of the data. Results The results showed that the H. psudoplicatum supplementation significantly improved the pruritus intensity, quality of life the dialysis patients with pruritus and fatigue in HD patients, for 6 weeks (p<0.001). However, it did not significantly effect on the anorexia, albumin, hemoglobin, urea, creatinine, arm circumference, and body mass index (p>0.05). Conclusions According to the results of this study, H. psudoplicatum supplementation can be effective as an adjunct therapy to improve pruritus intensity, quality of life, fatigue and relative improvement of anorexia in HD patients.

Download Full-text

Changes in dermatology quality of life, sleep, and symptoms during the 24-week open-label period of XTEND-CIU: A phase IV, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of omalizumab through 48 weeks

Journal of the American Academy of Dermatology ◽

10.1016/j.jaad.2017.04.268 ◽

2017 ◽

Vol 76 (6) ◽

pp. AB65

Keyword(s):

Quality Of Life ◽

Controlled Study ◽

Efficacy And Safety ◽

Open Label ◽

Double Blind ◽

Double Blind Placebo ◽

Phase Iv

Download Full-text

An Extract ofGlycyrrhiza glabra(GutGard) Alleviates Symptoms of Functional Dyspepsia: A Randomized, Double-Blind, Placebo-Controlled Study

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2012/216970 ◽

2012 ◽

Vol 2012 ◽

pp. 1-9 ◽

Cited By ~ 30

Author(s):

Kadur Ramamurthy Raveendra ◽

Jayachandra ◽

Venkatappa Srinivasa ◽

Kadur Raveendra Sushma ◽

Joseph Joshua Allan ◽

...

Keyword(s):

Quality Of Life ◽

Functional Dyspepsia ◽

Global Assessment ◽

Short Form ◽

Secondary Outcome ◽

Controlled Study ◽

Secondary Outcome Measure ◽

Double Blind ◽

Double Blind Placebo

A randomized, double-blind, placebo-controlled study was conducted to evaluate the efficacy of GutGard, an extract ofGlycyrrhiza glabra, in patients with functional dyspepsia. The primary outcome variables of the study were the change in the severity symptoms and the global assessment of efficacy. The quality of life was evaluated as a secondary outcome measure. The patients received either placebo or GutGard (75 mg twice daily) for 30 days. Efficacy was evaluated in terms of change in the severity of symptoms (as measured by 7-point Likert scale), the global assessment of efficacy, and the assessment of quality of life using the short-form Nepean Dyspepsia Index. In comparison with placebo, GutGard showed a significant decrease (P≤.05) in total symptom scores on day 15 and day 30, respectively. Similarly, GutGard showed marked improvement in the global assessment of efficacy in comparison to the placebo. The GutGard group also showed a significant decrease (P≤.05) in the Nepean dyspepsia index on day 15 and 30, respectively, when compared to placebo. GutGard was generally found to be safe and well-tolerated by all patients. GutGard has shown significant efficacy in the management of functional dyspepsia.

Download Full-text

Clinical Efficacy and Safety of Low-Level Laser Therapy in Patients with Perennial Allergic Rhinitis: A Randomized, Double-Blind, Placebo-Controlled Trial

Journal of Clinical Medicine ◽

10.3390/jcm10040772 ◽

2021 ◽

Vol 10 (4) ◽

pp. 772

Author(s):

Hahn Jin Jung ◽

Young-Jun Chung ◽

Young-Seok Choi ◽

Phil Sang Chung ◽

Ji-Hun Mo

Keyword(s):

Quality Of Life ◽

Allergic Rhinitis ◽

Controlled Trial ◽

Low Level Laser Therapy ◽

Efficacy And Safety ◽

Double Blind ◽

Sham Treatment ◽

Double Blind Placebo ◽

Level Laser

Allergic rhinitis (AR) is a common disease that interferes with the daily activities and reduces the quality of life. Conventional treatments often do not provide complete resolution of the symptoms, and many new treatment modalities have been tried. This study aimed to evaluate the efficacy and safety of low-level laser therapy (LLLT) for AR in a randomized, double-blind, placebo-controlled trial. Patients diagnosed with AR were randomly allocated to receive LLLT or sham treatment. The primary outcome was a change in the reflective total nasal symptom score (TNSS). The secondary outcome was quality of life scores assessed using the Rhinoconjunctivitis Quality of Life Questionnaire. Incidences of adverse events were also recorded. Among 67 randomized subjects, 41 subjects (22 in LLLT group and 19 in sham treatment group) were included for efficacy analysis. The LLLT group showed a significantly improved TNSS score compared to the sham treatment group for decreasing AR symptom severity (p = 0.011) and improving quality of life regarding nasal symptoms (p = 0.036) at the end of treatment. Throughout the treatment period, no severe adverse events occurred. This clinical trial showed that LLLT is an effective and safe option for the management of AR regarding symptom relief and quality of life improvement.

Download Full-text

A Study Protocol for a Randomized, Double-Blind, Placebo-Controlled Clinical Study on the Effect of Qishen Yiqi Dripping Pills on Exercise Endurance and Quality of Life in Patients with Coronary Heart Disease after Percutaneous Coronary Intervention

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2021/7439852 ◽

2021 ◽

Vol 2021 ◽

pp. 1-9

Author(s):

Linghua Yu ◽

Xiaoyan Lu ◽

Xianlun Li ◽

Hong Jiang ◽

Ruihua Sun ◽

...

Keyword(s):

Quality Of Life ◽

Coronary Heart Disease ◽

Coronary Intervention ◽

Efficacy And Safety ◽

Efficacy Evaluation ◽

Double Blind ◽

Double Blind Placebo ◽

Percutaneous Coronary ◽

Exercise Endurance

Background. Percutaneous coronary intervention (PCI) is widely used in China, but it does not fundamentally improve exercise endurance or reduce mortality associated with cardiovascular disease. Standardized cardiac rehabilitation (CR) can reduce the mortality associated with coronary heart disease and reduce the need for repeated PCI procedures. Currently, research on CR after PCI is mainly based on traditional exercise prescription, while research on TCM is limited. Often, the combination of traditional Chinese medicine (TCM) and exercise rehabilitation is adopted, from which it is difficult to determine the unique advantages of TCM. Qishen Yiqi dripping pills (QSYQ) can improve myocardial energy metabolism and alleviate myocardial reperfusion injury after PCI. This paper describes the protocol for the clinical assessment of QSYQ on CR. Methods. A randomized, double-blind, placebo-controlled trial will be used to evaluate the efficacy and safety of QSYQ on improving exercise endurance and quality of life. We plan to recruit 66 patients with stable angina pectoris with Qi deficiency and blood stasis syndrome differentiation after PCI from the China-Japan Friendship Hospital. On the basis of conventional drug treatment, QSYQ or placebo will be used for 12 weeks. PeakVO2 will be the main efficacy evaluation index, while Seattle scale and quality of life scale will be the secondary efficacy evaluation indexes. Discussion. CR therapy with integrated traditional Chinese and Western medicine has been developed as a treatment modality in China and has been included in the expert consensus of TCM diagnosis and treatment. A rigorous trial design will ensure objective and scientific evaluation of the efficacy and safety of QSYQ in improving exercise endurance and quality of life in patients with PCI. Trial Registration. This trial is registered with Clinical trial registration in China: ChiCTR2000040838 (registration date: December 11, 2020).

Download Full-text

Effects of Meditation on Pain and Quality of Life in Multiple Sclerosis and Peripheral Neuropathy

International Journal of MS Care ◽

10.7224/1537-2073-13.4.163 ◽

2011 ◽

Vol 13 (4) ◽

pp. 163-168 ◽

Cited By ~ 33

Author(s):

Jinny Tavee ◽

Mary Rensel ◽

Sarah M. Planchon ◽

Robert S. Butler ◽

Lael Stone

Keyword(s):

Quality Of Life ◽

Multiple Sclerosis ◽

Peripheral Neuropathy ◽

Short Form ◽

Bodily Pain ◽

Intervention Group ◽

Secondary Outcome ◽

Sf 36 ◽

Before And After

The objective of this study was to determine whether meditation affects pain and quality of life in people with multiple sclerosis (MS) and peripheral neuropathy (PN). A total of 22 patients (10 with MS, 12 with PN) participated in a weekly meditation class over a 2-month period. A total of 18 controls (7 with MS, 11 with PN) received standard care. Primary outcome assessments were based on the 36-item Short Form Health Status Survey (SF-36) and a visual analogue scale (VAS) for pain at baseline and at 2 months. Secondary outcome measures included the Neuropathy Impairment Score (NIS) for PN patients and the Patient-Determined Disease Steps (PDDS) questionnaire and 5-item Modified Fatigue Impact Scale (MFIS-5) for MS patients. After 2 months, study participants who practiced meditation reported an improvement in pain on the VAS (P = .035 combined group), summed physical health scores on the SF-36 (P = .011 MS, P = .014 PN), summed mental health scores (P = .02 combined group), vitality (P = .005 combined group), and physical role (P = .003 combined group). A significant improvement was also observed for bodily pain (P = .031) in MS patients. In contrast, no significant differences before and after the intervention were observed for controls. Regarding the secondary measure of fatigue, improved scores for the cognitive and psychosocial components of the MFIS were noted in MS patients in the intervention group (P = .037, P = .032). No statistically significant changes were observed in the NIS for PN patients or in PDDS scores for MS patients. Meditation may be helpful in reducing pain and improving quality of life in patients with MS and PN. The lack of changes seen in mobility (MS) and sensorimotor deficits (PN) suggests that meditation may not affect the overall clinical course.

Download Full-text