scholarly journals The Effects of Propolis Extract Administration on HIV Patients Receiving ARV

2021 ◽  
Vol 13 (1) ◽  
pp. 75-83
Author(s):  
Erwin Astha Triyono ◽  
Sarah Firdausa ◽  
Heru Prasetyo ◽  
Joni Susanto ◽  
James Hutagalung ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Placebo Group ◽  
Clinical Symptoms ◽  
Cd4 Count ◽  
Controlled Clinical Trial ◽  
Human Immune System ◽  
Hiv Patients ◽  
Double Blind ◽  
Significant Difference

BACKGROUND: Human immunodeficiency virus (HIV) is an infectious disease that targets the human immune system by attacking cluster of differentiation (CD)4 cells. The use of propolis in HIV patients is expected to be safe and beneficial in terms of increasing endurance and immunity by its role in increasing CD4 level. This study aimed to analyze the influence of propolis supplementation in increasing the CD4 level in anti-retroviral (ARV)-treated HIV patients.METHODS: Double-blind randomized controlled clinical trial was conducted in 50 HIV patients who took regular ARV therapy. The subjects were divided into two groups, one group was treated with ARV and propolis, while another one was given ARV and placebo. The CD4 cell count was measured during pre-treatment, in the 3rd month, in the 6th month after treatment. The level of hemoglobin, leukocyte, and platelets were also measured. The SF-12 questionnaire was used to evaluate quality of life of the subject.RESULTS: Out of 50 subjects, 43 subjects completed the study, which were 19 subjects from the propolis group and 24 subjects from the placebo group. After 3-month of treatment, there was a statistically significant difference in the incrwase of CD 44 level in propolis group, while the increment was not significant in the placebo group. After 6-month treatment, the increase of CD4 level was occurred in both groups, propolis and placebo, however the increment was not statistically significant. The levels of hemoglobin, leukocyte, and platelets were not altered by the treatment and remained normal throughout the study. The quality of life was improved during the study; however, it was also not statistically significant. Mild adverse events occurred in 3 subjects which were relieved after the treatment stopped.CONCLUSION: Based on the result of this study, the administration of propolis on HIV patients receiving ARV bring significant difference in the increase of CD4 in propolis group from baseline to 3 month after the treatment. While in placebo group, this increment was not significant. At the end of study, CD4 count continued to rise up, however the increase was not statistically significant. There are no hemoglobin, leukocyte, platelets, and quality of life abnormalities. Therefore, it is necesary to do further research with a spesific CD4 count. However, it may be beneficial in relieving the clinical symptoms and quality of life of patient living with HIV.KEYWORDS: CD4, ARV, HIV, propolis

scholarly journals Ingestion of a THC-Rich Cannabis Oil in People with Fibromyalgia: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Pain Medicine ◽  
2020 ◽  
Vol 21 (10) ◽  
pp. 2212-2218
Author(s):  
Carolina Chaves ◽  
Paulo Cesar T Bittencourt ◽  
Andreia Pelegrini
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Placebo Group ◽  
Low Cost ◽  
Fibromyalgia Impact Questionnaire ◽  
Health Condition ◽  
Depression Score ◽  
Controlled Clinical Trial ◽  
Double Blind

Abstract Objective To determine the benefit of a tetrahydrocannabinol (THC)-rich cannabis oil on symptoms and quality of life of fibromyalgia patients. Methods A double-blind, randomized, placebo-controlled clinical trial was conducted for eight weeks to determine the benefit of a THC-rich cannabis oil (24.44 mg/mL of THC and 0.51 mg/mL of cannabidiol [CBD]) on symptoms and quality of life of 17 women with fibromyalgia, residents of a neighborhood with a low socioeconomic profile and a high incidence of violence in the city of Florianopolis, Brazil. The initial dose was one drop (∼1.22 mg of THC and 0.02 mg of CBD) a day with subsequent increases according to symptoms. The Fibromyalgia Impact Questionnaire (FIQ) was applied at pre- and postintervention moments and in five visits over eight weeks. Results There were no significant differences on baseline FIQ score between groups. However, after the intervention, the cannabis group presented a significant decrease in FIQ score in comparison with the placebo group (P = 0.005) and in comparison with cannabis group baseline score. (P < 0.001). Analyzing isolated items on the FIQ, the cannabis group presented significant improvement on the “feel good,” “pain,” “do work,” and “fatigue” scores. The placebo group presented significant improvement on the “depression” score after intervention. There were no intolerable adverse effects. Conclusions Phytocannabinoids can be a low-cost and well-tolerated therapy to reduce symptoms and increase the quality of life of patients with fibromyalgia. Future studies are still needed to assess long-term benefits, and studies with different varieties of cannabinoids associated with a washout period must be done to enhance our knowledge of cannabis action in this health condition.

scholarly journals Randomised, Double-Blind, Placebo-Controlled Study of Iguratimod in the Treatment of Active Spondyloarthritis

2021 ◽  
Vol 8 ◽  
Author(s):  
Yan Li ◽  
Kunpeng Li ◽  
Zheng Zhao ◽  
Yanyan Wang ◽  
Jingyu Jin ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Placebo Group ◽  
Physical Function ◽  
Combined Treatment ◽  
Final Analysis ◽  
Spinal Mobility ◽  
Controlled Study ◽  
Double Blind ◽  
Significant Difference

Background and Purpose: The effect of Iguratimod in the treatment of rheumatoid arthritis was confirmed in past studies. In terms of the mechanism of the effect and clinical application experience, Iguratimod has a potential value in the treatment of spondyloarthritis (SpA). This study evaluated the efficacy and safety of Iguratimod on active SpA.Methods: Subjects with active SpA were enrolled and randomly divided into two groups at a ratio of 1:2 (placebo vs. Iguratimod). On the basis of non-steroidal anti-inflammatory drugs, combined treatment with Iguratimod or placebo, followed by follow-up every 4 weeks for 24 weeks. The primary efficacy endpoint was to evaluate the alleviation rate of ASAS20; the important improvement of ASDAS and the efficacy of spinal mobility, physical function and quality of life at the 24th week.Results: A total of 48 cases in the Iguratimod group and 25 cases in the placebo group were included in the final analysis. On the 24th week, the percentage of responders to ASAS20 (80 vs. 44%) and ASAS40 (56 vs. 20%) treated with Iguratimod were significantly higher than that in the placebo group (P < 0.05). Twelve cases had gastrointestinal discomfort, of which eight were in the Iguratimod group (16.7%, one case withdrew from the study due to diarrhoea) and four were in the placebo group (16.0%). No significant difference was found between the two groups (P < 0.05). Three cases of elevated transaminase were observed in the Iguratimod group and none in the placebo group, with no significant difference (P < 0.05).Conclusion: Iguratimod could significantly reduce the symptoms and signs of patients with active SpA. It could improve the physical function and quality of life of these patients and the overall safety and tolerance are good.

scholarly journals Lovastatin as an Adjuvant to Lithium for Treating Manic Phase of Bipolar Disorder: A 4-Week, Randomized, Double-Blind, Placebo-Controlled Clinical Trial

2014 ◽  
Vol 2014 ◽  
pp. 1-6 ◽  
Author(s):  
Ahmad Ghanizadeh ◽  
Motahhar OmraniSigaroodi ◽  
Ali Javadpour ◽  
Mohammad Hossein Dabbaghmanesh ◽  
Sara Shafiee
Keyword(s):  
Clinical Trial ◽  
Bipolar Disorder ◽  
Placebo Group ◽  
Adverse Effects ◽  
Rating Scale ◽  
Clinical Symptoms ◽  
Controlled Clinical Trial ◽  
Young Mania ◽  
Double Blind ◽  
Significant Difference

Objectives. Many patients with bipolar disorder suffer from metabolic disorder. Lovastatin is effective for treating major depression. This double-blind randomized placebo controlled clinical trial investigates whether lovastatin is a useful adjuvant to lithium for treating mania.Methods. Fifty-four patients with bipolar disorder-manic phase were randomly allocated into lovastatin or placebo group. The clinical symptoms were assessed at baseline, week 2, and week 4 using Young Mania Rating Scale. Adverse effects were checked.Results. Forty-six out of 54 patients completed this trial. The mania score in the lovastatin group decreased from 40.6 (11.1) at baseline to 12.9 (8.7) and 4.1 (5.4) at weeks 2 and 4, respectively. The score in the placebo group decreased from 41.0 (11.2) at baseline to 12.8 (8.07) and 5.8 (4.6) at weeks 2 and 4, respectively. However, there was no significant difference between groups at week 2 and week 4. The adverse effects rates were comparable between the two groups. No serious adverse effect was found. Tremor and nausea were the most common adverse effects.Conclusions. Lovastatin neither exacerbated nor decreased the symptoms of mania in patients with bipolar disorder. Current results support that the combination of lovastatin with lithium is tolerated well in bipolar disorder. The trial was registered with the Iranian Clinical Trials Registry (IRCT201302203930N18).

A randomized trial of the effect of peer education on the sexual quality of life in patients with myocardial infarction

2020 ◽  
Vol 17 (3) ◽  
Author(s):  
Ali Abbasi ◽  
Hossein Ebrahimi ◽  
Hossein Bagheri ◽  
Mohammad Hasan Basirinezhad ◽  
Seyedmohammad Mirhosseini ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Myocardial Infarction ◽  
Health Care Professionals ◽  
Peer Education ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Sexual Quality Of Life ◽  
Significant Difference

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.

scholarly journals A randomised controlled clinical trial comparing the effectiveness of bandaging compared to the JuxtaCures™ device in the management of people with venous ulceration: Feasibility study

2021 ◽  
pp. 026835552098822
Author(s):  
Philip Stather ◽  
Carroll Petty ◽  
Helen Langthorne ◽  
Emma Rayner ◽  
Jufen Zhang ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Feasibility Study ◽  
Multicentre Trial ◽  
Compression Therapy ◽  
Controlled Clinical Trial ◽  
Venous Ulceration ◽  
Significant Difference ◽  
Potential Benefits ◽  
Randomised Controlled

Introduction The mainstay of treatment for venous ulceration remains compression therapy. Velcro Wrap devices are being increasingly used in these patients despite limited evidence. This feasibility study aimed to compare standard bandaging to the JuxtaCures™ Velcro wrap device. Methods A single centre, unblinded RCT compared participants with venous ulceration randomised to either the JuxtaCures™ device or short stretch bandaging. Participants were followed up for 26 weeks. Results 160 participants were screened with 40 randomised. 3 participants in bandaging and 1 in JuxtaCures™ didn’t complete the study. 60% in JuxtaCures™ healed v 55% in bandaging despite larger ulcers in the JuxtaCures™ arm (9.33 cm2 v 6.97 cm2). There was no significant difference in time to healing (12.17 v 13.64 weeks). JuxtaCures™ showed improved ulcer reduction for those that didn’t heal (14.91–5.00 cm2 v 14.20–8.62 cm2; P = 0.06). JuxtaCures™ had more consistent sub-bandage pressure dropping from 39–36 mmHg versus 41–25 mmHg in bandaging between application and removal (P < 0.001). Quality of life (EQ5D) was improved in JuxtaCures at 3 months (mean difference 0.14, p = 0.04), but not at 1 and 6 months, or in disease specific quality of life. Cost was lower in JuxtaCures™ £842.47 v £1064.68. Duration of appointment was significantly shorter in JuxtaCures™ (41 minutes v 53 minutes; P = 0.003). Conclusion This study has shown the feasibility and necessity of running a multicentre trial to evaluate the use of Velcro wrap devices for venous ulceration. It highlights the potential benefits of more consistent pressure, increased self-care, and potential with regards to ulcer healing, cost, nursing resource and quality of life.

scholarly journals Impact of Melatonin and Branched-Chain Amino Acids Cosupplementation on Quality of Life, Fatigue, and Nutritional Status in Cachectic Heart Failure Patients: A Randomized Controlled Trial

2019 ◽  
pp. 155982761987404 ◽  
Author(s):  
Hamed Jafari-Vayghan ◽  
Jalal Moludi ◽  
Sevda Saleh-Ghadimi ◽  
Elgar Enamzadeh ◽  
Mir Hossein Seyed-Mohammadzad ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Heart Failure ◽  
Amino Acids ◽  
Placebo Group ◽  
Nutritional Status ◽  
Branched Chain Amino Acids ◽  
Significant Difference ◽  
Branched Chain ◽  
The Impact

Background: Cardiac cachexia (CC) adversely affects the lifestyle of heart failure (HF) patients. The current study examined the impact of melatonin cosupplementation and branched-chain amino acids (BCAAs) on quality of life (QoL), fatigue, and nutritional status in cachectic HF patients. Methods: In this trial, 84 CC patients were randomized to melatonin, BCAAs, or coadministration (both) as intervention groups and a control group over 8 weeks. At baseline and postintervention, QoL, fatigue, and nutritional status were assessed. Results: After intervention, improvement in the overall and physical dimensions of QoL and appetite score were found to be statistically significant in the BCAAs (P < .001) and the melatonin+BCAAs (P < .001) groups compared with the placebo group. The emotional dimension score was significantly lower in the BCAAs group compared with the placebo group (P = .001). There was a statistically significant improvement in fatigue severity in all 3 intervention groups compared with the placebo group. The nutrition risk index (NRI) score increased significantly only in the melatonin group (P = .015), and there was no significant difference between the other groups (P = .804). Conclusions: Cosupplementation with BCAAs and melatonin improved QoL, fatigue status, and appetite in cachectic HF patients but did not affect NRI.

Daflon 500 mg: Symptoms and Edema

Angiology ◽  
2005 ◽  
Vol 56 (6_suppl) ◽  
pp. S25-S32 ◽  
Author(s):  
Albert-Adrien Ramelet
Keyword(s):  
Quality Of Life ◽  
Controlled Study ◽  
Venous Disease ◽  
Double Blind Study ◽  
Life Questionnaire ◽  
Double Blind ◽  
Randomized Controlled ◽  
Randomized Controlled Studies ◽  
Significant Difference

Patients suffering from any class of the Clinical, Etiological, Anatomical, Pathophysiological (CEAP) classification of chronic venous disease (CVD) may be symptomatic (C0s-C6s). Leg heaviness, discomfort, itching, cramps, pain, paresthesia, and edema (C3) are the most frequent manifestations of CVD and a major reason for medical consultation. Daflon 500 mg (micronized purified flavonoid fraction [MPFF]) is an effective treatment for symptoms and edema in CVD as demonstrated in several randomized controlled studies. A 2-month, double-blind study in 40 patients established the superiority of Daflon 500 mg over placebo with regard to symptoms and objective signs. This was confirmed in another double-blind, placebo-controlled trial (2 months’ treatment, 160 patients), and in the Reflux assEssment and quaLity of lIfe improvEment with micronized Flavonoids (RELIEF) study. The latter included 5,052 patients in 23 countries, using a visual analog scale for evaluating pain, leg heaviness, cramps, and a sensation of swelling. All symptoms showed significant and progressive improvement. The quality-of-life results (scores on the ChronIc Venous Insufficiency quality of life Questionnaire [CIVIQ]) paralleled those of symptoms. The decrease in the ankle and calf circumferences was significantly greater (p<0.001) in the group of patients treated with Daflon 500 mg in two studies, and correlated well with the improvement in the sensation of swelling (p<0.001). This was confirmed with more sophisticated measurement techniques as in the RELIEF study or in a trial assessing edema with an optoelectronic volumeter in 20 patients. A further double-blind, randomized, controlled study established a statistically significant difference in favor of Daflon 500 mg in comparison with diosmin, both on symptoms and edema. The therapeutic efficacy of Daflon 500 mg on CVD symptoms and edema has been demonstrated in double-blind, randomized, controlled studies. Further studies using a new approach may define the most precise and validated methodology for application in future research in phlebology.

scholarly journals Validation Study of Kim's Sham Needle by Measuring Facial Temperature: An N-of-1 Randomized Double-Blind Placebo-Controlled Clinical Trial

2012 ◽  
Vol 2012 ◽  
pp. 1-7 ◽  
Author(s):  
Sanghun Lee ◽  
Nara Lim ◽  
Sun Mi Choi ◽  
Sungchul Kim
Keyword(s):  
Thermal Imaging ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Infrared Thermal Imaging ◽  
Double Blind Placebo ◽  
Control Intervention ◽  
Significant Difference ◽  
Double Blinded ◽  
Stimulation Of

Introduction. In 2008, Kim's sham needle was developed to improve the quality of double-blinded studies. The aim of this study is to validate Kim's sham needle by measuring facial temperature.Methods. We designed “N-of-1” trials involving 7 smokers. One session was composed of 2 stimulations separated by a 2 h washout period. Six sessions were applied daily for all subjects. Infrared thermal imaging was used to examine the effects of acupuncture (HT8, KI2) on facial temperature following smoking-induced decrease.Results. All subjects demonstrated decreased temperatures after sham needle treatment, but 5 of the 7 subjects showed increased temperatures after real needle treatment. 6 of the 7 subjects showed a significant difference(P<0.05)between treatments with real and sham needles. Thus, the physiological stimulation of Kim's sham needle is different from that of a real needle, suggesting that Kim's sham needle is a potential inactive control intervention.

The effect of reflexology on quality of life in Iranian patients with breast cancer.

2016 ◽  
Vol 34 (26_suppl) ◽  
pp. 90-90
Author(s):  
Shadan Pedramrazi
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Placebo Group ◽  
Test Group ◽  
Control Group ◽  
Relaxation Techniques ◽  
Control Groups ◽  
Significant Difference ◽  
And Control

90 Background: Breast cancer is one the most prevalent cancers among Iranian women. One of the complementary therapies is reflexology. The extant paper has been provided with the objective of determining the effect of reflexology on quality of life of patients with breast cancer undergoing chemotherapy in the breast disease center. Methods: This study is a randomized clinical trial which has been applied to 60 patients suffering from breast cancer under chemotherapy in breast diseases center, in 2012. The patients were selected randomly in three test, control and placebo groups. In test group, reflexology was implemented for 3 weeks and each session lasted half an hour. In placebo group, only relaxation techniques were implemented for 3 weeks, each session lasted 20-30 minutes. Control group received the routine therapies of breast cancer center. Results: Data were collected by standard questionnaires of EORTIC QLQ-C30.V.3 and EORTIC QLQ-BR23.V.3. The questionnaires were filled before intervention and two weeks after applying study. There was no significant difference in demographic characteristics or quality of life score of three groups, before intervention. Total score of quality of life was higher in interventional group compared to placebo group before and two weeks after intervention (p < 0.001) Results also indicated a significant difference in total score of quality of life between three test, placebo, and control groups after intervention (p < 0.001). A considerable improvement was noticed in the different aspects of quality of life in the test group compared to two other placebo and control groups. Conclusions: Reduction of pain, anxiety, nausea, and other symptoms related to cancer in patients suffering from cancer are assumed as the important cases of nursing cares focus, and precise nursing may diminish these symptoms considerably. Using reflexology in patients suffering from breast cancer may improve the quality of life as an effective method, and can be recommended for use in patients with breast cancer if it is supervised by health system personnel.

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