scholarly journals Effects of Cinnamon on Anthropometry Status and Headache Disability of Migraine Patients: A Randomized Double-blind Placebo-controlled Trial

2020 ◽  
Author(s):  
Azadeh Zareie ◽  
Mohammad Bagherniya ◽  
Manoj Sharma ◽  
Fariborz Khorvash ◽  
Akbar Hasanzadeh ◽  
...  
Keyword(s):  
Placebo Group ◽  
Corn Starch ◽  
Controlled Trial ◽  
Intervention Group ◽  
Primary Headache ◽  
Control Group ◽  
Double Blind ◽  
Beneficial Effects ◽  
The Difference ◽  
Headache Disability

Abstract Background: Migraine is a common type of primary headache that is highly disabling and is possibly associated with obesity. Increasing body mass index (BMI) seems to be a risk factor for migraine attacks. Cinnamon has anti-inflammatory, neuroprotective, and anti-obesity effects. Thus, this study aimed to assess the effects of cinnamon on anthropometry status and headache disability of migraine patients.Methods: Fifty patients with migraine were randomized to receive either cinnamon powder, three capsules/day each containing 600 mg of cinnamon or three placebo capsules/day each containing 100 mg of corn starch (control group) for two months. Height, body weight (BW), waist circumference (WC), and hip circumference (HC) were measured at baseline and the end of the study. Furthermore, Minimal or Infrequent Disability (MIDAS) and Headache Daily Result (HDR) Questionnaire were recorded. Results: After follow-up, BW and BMI did not change in the intervention group, however, both of them significantly increased in the placebo group. The differences between the two groups were statistically significant (p=0.001). WC significantly decreased in the cinnamon group and remarkably increased in the control group; the difference between groups was significant (p<0.001). Furthermore, HC and WHR significantly decreased in the intervention group than the placebo group (p=0.001). HDR and the total score of disability in migraine patients were significantly decreased in the intervention versus the control group (p<0.001). Conclusion: Cinnamon seems to have beneficial effects on BW, BMI, WC, and HC and it reduces the headache disability of migraine patients. More randomized controlled trials should be undertaken to confirm these effects.

The Effect of Nanocurcumin in Improvement of Knee Osteoarthritis: A Randomized Clinical Trial

2020 ◽  
Vol 16 (2) ◽  
pp. 158-164
Author(s):  
Kamila Hashemzadeh ◽  
Najmeh Davoudian ◽  
Mahmoud R. Jaafari ◽  
Zahra Mirfeizi
Keyword(s):  
Placebo Group ◽  
Knee Osteoarthritis ◽  
Controlled Trial ◽  
Intervention Group ◽  
Final Analysis ◽  
Control Group ◽  
P Value ◽  
Antiinflammatory Drugs ◽  
Double Blind ◽  
Womac Questionnaire

Objective: Osteoarthritis is a degenerative disease of the joints. Non-steroidal antiinflammatory drugs (NSAIDs) are being used for the treatment of osteoarthritis. However, their use is limited due to complications, such as gastrointestinal bleeding. Therefore, it is necessary to find alternative treatments for osteoarthritis. Recently, nanomicelle curcumin has been developed to increase the oral bioavailability of curcumin. The aim of this study was to evaluate the effect of nano curcumin on the alleviation of the symptoms of knee osteoarthritis patients. Methods: In this randomized, double-blind controlled trial, the intervention group was administered 40 mg of nanocurcumin capsule every 12 hours over a period of six weeks, and the control group received the placebo (similar components of nanomicelle curcumin capsules yet without curcumin). In the final analysis, 36 patients in the nanocurcumin group and 35 patients in the placebo group were enrolled. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) was filled for patients in their first visit and at the end of six weeks. Differences were statistically significant at P-value < 0.05. Results: There were no significant differences between the two groups regarding gender, age, Kellgren score, and the duration of the disease before the intervention. A significant decrease was observed in the overall score, along with the scores of pain, stiffness and physical activity subscales of the WOMAC questionnaire in patients of the nano curcumin group compared with the placebo group. Conclusion: Nanocurcumin significantly improves the symptoms of osteoarthritis patients.

scholarly journals Azithromycin and hydroxychloroquine in hospitalised patients with confirmed COVID-19–a randomised double-blinded placebo-controlled trial

2021 ◽  
pp. 2100752
Author(s):  
Pradeesh Sivapalan ◽  
Charlotte Suppli Ulrik ◽  
Therese Sophie Lapperre ◽  
Rasmus Dahlin Bojesen ◽  
Josefin Eklöf ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Double Blind ◽  
Safety Outcome ◽  
Hospitalised Patients ◽  
Double Blinded ◽  
Combined Intervention

BackgroundCombining the antibiotic azithromycin and hydroxychloroquine induces airway immunomodulatory effects, with the latter also having in vitro antiviral properties. This may improve outcomes in patients hospitalised for COVID-19.MethodsPlacebo-controlled double-blind randomised multicentre trial. Patients ≥18 years, admitted to hospital for≤48 h (not intensive care) with a positive SARS-CoV-2 RT-PCR test, were recruited. The intervention was 500 mg daily azithromycin for 3 days followed by 250 mg daily azithromycin for 12 days combined with 200 mg twice daily hydroxychloroquine for all 15 days. The control group received placebo/placebo. The primary outcome was days alive and discharged from hospital within 14 days (DAOH14).ResultsAfter randomisation of 117 patients, at the first planned interim analysis, the data and safety monitoring board recommended stopping enrolment due to futility, based on pre-specified criteria. Consequently, the trial was terminated on February 1, 2021. A total of 61 patients received the combined intervention and 56 patients received placebo. In the intervention group, patients had a median of 9.0 DAOH14 (IQR, 3–11) versus. 9.0 DAOH14 (IQR, 7–10) in the placebo group (p=0.90). The primary safety outcome, death from all causes on day 30, occurred for 1 patient in the intervention group versus. 2 patients receiving placebo (p=0.52), and readmittance or death within 30 days occurred for 9 patients in the intervention group versus. 6 patients receiving placebo (p=0.57).ConclusionsThe combination of azithromycin and hydroxychloroquine did not improve survival or length of hospitalisation in patients with COVID-19.

scholarly journals Effectiveness of hamstring stretching using a pressure biofeedback unit for 4 weeks: A randomized controlled trial

2020 ◽  
Vol 40 (02) ◽  
pp. 99-107
Author(s):  
Jin-Oh Ahn ◽  
Jong-Hyuck Weon ◽  
Eun-Kyung Koh ◽  
Do-Young Jung
Keyword(s):  
Controlled Trial ◽  
Intervention Group ◽  
Knee Extension ◽  
Control Group ◽  
Post Intervention ◽  
Lower Back ◽  
Hamstring Muscles ◽  
Before And After ◽  
The Difference ◽  
Pressure Biofeedback

Background: Stretching and length test of hamstring muscles have been performed commonly to manage lower back pain (LBP) in sports rehabilitation. Previous literatures addressed that stretching techniques and length test of hamstring muscles should be performed with the pelvic maintained in an anterior tilt position. However, there is no study to determine the effectiveness of pressure biofeedback unit (PBU) to maintain in anterior pelvic tilting (APT) on length test and stretching of hamstring muscles. Objective: To determine the effectiveness of hamstring muscles stretching using a PBU. Methods: Forty participants with shortness of hamstrings randomized into two groups. Participants performed the active knee extension (AKE) stretching without (control group) or with PBU (intervention group) for four weeks. AKE tests without and with PBU were administered three times before and after hamstrings stretching by each group. Results: The AKE test without PBU showed a significant main effect of time ([Formula: see text]) but not of group ([Formula: see text]) on the AKE angle. The AKE test with PBU showed a significant increase in the AKE angle in the post-intervention compared to the pre-intervention assessments in both groups ([Formula: see text]). The difference of AKE angle between the pre- and post-intervention results was significantly greater in the intervention group than in the control group ([Formula: see text]). Conclusion: We recommend the use of a PBU to maintain the pelvic anterior tilting position when performing the AKE test or AKE stretching.

scholarly journals Effect of Oral Ingestion of Low-Molecular Collagen Peptides Derived from Skate (Raja Kenojei) Skin on Body Fat in Overweight Adults: A Randomized, Double-Blind, Placebo-Controlled Trial

Marine Drugs ◽  
2019 ◽  
Vol 17 (3) ◽  
pp. 157 ◽  
Author(s):  
Young Tak ◽  
Yun Kim ◽  
Jeong Lee ◽  
Yu-Hyun Yi ◽  
Young Cho ◽  
...  
Keyword(s):  
Body Fat ◽  
Animal Studies ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Double Blind ◽  
Collagen Peptides ◽  
Collagen Peptide ◽  
Skin Collagen ◽  
Overweight Adults

Recent animal studies found the potential of a collagen peptide derived from skate skin to have anti-obesity effects through the suppression of fat accumulation and regulation of lipid metabolism. However, no studies have yet been performed in humans. Here, this very first human randomized, placebo-controlled, and double-blinded study was designed to investigate the efficacy and tolerability of skate skin collagen peptides (SCP) for the reduction of body fat in overweight adults. Ninety healthy volunteers (17 men) aged 41.2 ± 10.4 years with a mean body mass index of 25.6 ± 1.9 kg/m2 were assigned to the intervention group (IG), which received 2000 mg of SCP per day or to the control group (CG) given the placebo for 12 weeks and 81 (90%) participants completed the study. Changes in body fat were evaluated using dual energy X-ray absorptiometry as a primary efficacy endpoint. After 12 weeks of the trial, the percentage of body fat and body fat mass (kg) in IG were found to be significantly better than those of subjects in CG (−1.2% vs. 2.7%, p = 0.024 and −1.2 kg vs. 0.3 kg, p = 0.025). Application of SCP was well tolerated and no notable adverse effect was reported from both groups. These results suggest the beneficial potential of SCP in the reduction of body fat in overweight adults.

Tranexamic Acid Effectiveness on the Amount of Bleeding during Surgery and Surgeon’s Satisfaction in Intertrochanteric Fracture Fixation: A Randomized Clinical Trial

2020 ◽  
Author(s):  
Morteza Saeb ◽  
Ali Mousapour ◽  
Alireza Shafiee ◽  
Seyyed Saeed Khabiri ◽  
Roya Safari-Faramani ◽  
...  
Keyword(s):  
Placebo Group ◽  
Blood Loss ◽  
Tranexamic Acid ◽  
Intertrochanteric Fracture ◽  
Intervention Group ◽  
Postoperative Blood Loss ◽  
Control Group ◽  
The Mean ◽  
The Difference ◽  
Fracture Surgery

Background: The purpose of this study was to evaluate the effect of intravenous tranexamic acid (TXA) on the blood loss volume during surgery and surgeon's satisfaction in intertrochanteric fracture surgery. Methods: A total of 62 patients with intertrochanteric fracture were involved in the study and accidentally categorized into two groups. In the control or first group, patients were medicated with placebo (age: 69.2 ± 6.1 years old) and in the second group or intervention, they received 1 g injection of TXA (age: 69.7 ± 6.4 years old). Intraoperative bleeding was measured by the amount of blood in the suction bottle and amount of gauze utilized and postoperative blood loss was measured by the amount of blood in the drain 48 hours after surgery. Also, hemoglobin (Hb) levels were compared before and after surgery. In the end, the surgeon’s satisfaction was measured by Likert scale. Results: The difference in the amount of intra-operative bleeding was significant between the groups (P < 0.050). The mean number of utilized gauze in the intervention group was meaningfully less than the placebo group (P < 0.050). The mean Hb in the control group was considerably inferior to the intervention group (P < 0.050). The respect of patients in need of transfusion in the placebo group was outstandingly superior to the intervention group (P < 0.005). Surgeon satisfaction in the intervention group was considerably greater than the control group (P < 0.050). Conclusion: The use of intravenous TXA during intertrochanteric fracture surgery can reduce hemorrhage during surgery, reduce the need for blood products, and finally improve the surgeon’s satisfaction.

scholarly journals Efficacy and Safety of Yokukansan in Treatment-Resistant Schizophrenia: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial

2015 ◽  
Vol 2015 ◽  
pp. 1-11 ◽  
Author(s):  
Tsuyoshi Miyaoka ◽  
Motohide Furuya ◽  
Jun Horiguchi ◽  
Rei Wake ◽  
Sadayuki Hashioka ◽  
...  
Keyword(s):  
Placebo Group ◽  
Controlled Trial ◽  
Controlled Study ◽  
Efficacy And Safety ◽  
Treatment Resistant ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Intention To Treat ◽  
The Difference ◽  
The Individual

Objectives. We aimed at evaluating both the efficacy and safety of TJ-54 (Yokukansan) in patients with treatment-resistant schizophrenia. This randomized, multicenter, double-blind, placebo-controlled study was conducted.Methods. One hundred and twenty antipsychotic-treated inpatients were included. Patients were randomized to adjuvant treatment with TJ-54 or placebo. During a 4-week follow-up, psychopathology was assessed using the Positive and Negative Syndrome Scale (PANSS).Results. TJ-54 showed a tendency of being superior to placebo in reduction total, positive, and general PANSS scores in treatment-resistant schizophrenia, but the difference was not statistically significant in both per-protocol set (PPS) and intention-to-treat (ITT). However, in PPS analysis, compared to the placebo group, the TJ-54 group showed statistically significant improvements in the individual PANSS subscale scores for lack of spontaneity and flow of conversation (TJ-54:−0.23±0.08; placebo:−0.03±0.08,P<0.018), tension (TJ-54:−0.42±0.09; placebo:−0.18±0.09,P<0.045), and poor impulse control (TJ-54:−0.39±0.10; placebo:−0.07±0.10,P<0.037).Conclusions. The results of the present study indicate that TJ-54 showed a tendency of being superior to placebo in reduction PANSS scores in treatment-resistant schizophrenia, but the difference was not statistically significant. However, compared to the placebo group, TJ-54 group showed statistically significant improvements in the individual PANSS subscale scores.

Effects of the Preoperative Administration of Dexketoprofen Trometamol on Pain and Swelling After Implant Surgery: A Randomized, Double-Blind Controlled Trial

2018 ◽  
Vol 44 (2) ◽  
pp. 122-129
Author(s):  
Arturo Sánchez-Pérez ◽  
Jesús Muñoz-Peñalver ◽  
María José Moya-Villaescusa ◽  
Carmen Sánchez-Matás
Keyword(s):  
Placebo Group ◽  
Postoperative Pain ◽  
Controlled Trial ◽  
Test Group ◽  
Control Group ◽  
Double Blind ◽  
Implant Surgery ◽  
Lower Pain ◽  
Dexketoprofen Trometamol ◽  
Group A

The fear of postoperative pain is often mentioned by patients as one of the factors that is most frequently associated with dental implants. To reduce this factor, a single oral dose of 25 mg dexketoprofen trometamol (DKT) or placebo was administered 15 minutes before implant surgery. One hundred patients who required single-implant treatments were randomly assigned to 1 of 2 blinded groups. The patients in the test group were given 25 mg DKT (DKT group), and those in the control group were given 500 mg vitamin C as a placebo (PLACEBO group). A subjective visual analogue scale of 100 mm in length was used to evaluate pain. Inflammation and complications were assessed using a 5-point Likert scale. An analysis of variance, t-tests, and a Mann-Whitney U test were performed. Among the 100 patients, 83 completed the study (there were 8 dropouts in the PLACEBO group and 9 in the DKT group). The patients who received DKT reported a lower pain intensity during the immediate postoperative period. The inflammatory response was weaker in the DKT group than the control group at 48 hours, but bleeding was greater. There were no other complications in either of the groups. In conclusion, the preemptive use of 25 mg soluble DKT administered orally 15 minutes before implant surgery can reduce the severity of immediate postoperative pain.

scholarly journals Consumption of melatonin supplement improves cardiovascular disease risk factors and anthropometric indices in type 2 diabetes mellitus patients: A double-blind, randomized, placebo-controlled trial

2020 ◽  
Author(s):  
Hadi Bazyar ◽  
Ahmad Zare Javid ◽  
Hossein Bavi Behbahani ◽  
Fardin Moradi ◽  
Bahman Moradi Poode ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Disease Risk ◽  
Controlled Trial ◽  
Cardiovascular Disease Risk ◽  
Intervention Group ◽  
Control Group ◽  
Post Intervention ◽  
Anthropometric Indices ◽  
Double Blind ◽  
Conicity Index

Abstract Background: Diabetes mellitus is a common chronic disease. Dyslipidemia and hypertension are two complications that may develop in diabetic patients if hyperglycemia, insulin resistance, and weight gain are not controlled. This study investigated the effects of melatonin supplementation on some cardiovascular disease risk factors and anthropometric indices in patients with type 2 diabetes mellitus (T2DM).Materials and Methods: In this double-blind, randomized, placebo-controlled trial, 50 T2DM patients were randomly allocated to intervention and control groups which received two tablets of either melatonin or placebo (250 mg) once a day for eight weeks. Mean arterial pressure (MAP), pulse pressure (PP), the atherogenic index of plasma (AIP), weight, body mass index (BMI), waist and hip circumference (WC, HC), body shape index (ABSI), abdominal volume index (AVI), body adiposity index (BAI), lipid accumulation product (LAP), conicity index, and waist-to-height ratio (WHR) were evaluated in all the patients pre- and post-intervention.Results: Melatonin supplementation for eight weeks significantly decreased the mean levels of MAP, PP, weight, BMI, WC, HC, BAI, AVI, conicity index, and WHR post-intervention (p<0.05). Also, the median changes of MAP, PP, weight, BMI, WC, HC BAI, AVI, and conicity index were significantly lower in the intervention group compared with the control group (p<0.05). A significant increase (p<0.001) was observed in the mean levels of ABSI in the intervention group. The median changes of ABSI were significantly greater in the intervention group compared with the control group (p<0.001).Conclusions: Consumption of melatonin supplement may be effective in controlling arterial pressure and anthropometric indices (as predictors of obesity) in T2DM patients.Trial registration: This trial was registered in the Iranian Registry of Clinical Trials website at 2019/5/17. (IRCT20190303042905N1).

scholarly journals The Effect of Vitamin B6 on Reducing the Number and the Size of Breast Cysts and the Amount of Recurrence after Aspiration in Women

2019 ◽  
pp. 1-7
Author(s):  
Setareh Soltany ◽  
Hamid Reza Hemmati ◽  
Jafar Alavy Toussy ◽  
Parisa Alavi Toosi
Keyword(s):  
Vitamin B6 ◽  
Intervention Group ◽  
Control Group ◽  
Control Groups ◽  
Double Blind ◽  
Breast Cyst ◽  
The Difference ◽  
Palpable Breast ◽  
Breast Lumps ◽  
And Control

Introduction: Palpable breast lumps are one of the most prevalent breast problems in women who visit a doctor. Most of these lumps are benign, and many of these benign lumps, have cystic nature. One of the suggested treatments for breast cyst is vitamin B6 intake. So, this study aimed to determine the effect of vitamin B6 on reducing the number and the size of breast cysts and reducing the amount of recurrence after aspiration. Materials and Methods: This study is a double-blind randomized clinical trial. Patients simply divided into two groups randomly, intervention group (receiving 150 mg vitamin B6 twice a day for two months) and control group (placebo). After data collection, the database produced, and information came in by SPSS-22 software. Descriptive results extracted in the form of tables and graphs. In all cases was used α=0.05. Results: At the end of the study, 65 patients (34 people in the intervention group, and 31 people in the control group) studied. At the end of the survey in the non-palpable cysts, was observed a significant decrease in the number and the size of breast cysts in each group receiving vitamin B6 or placebo. Still, the difference was not significant in comparing the two groups. 19 patients (2.29%) had palpable cysts that aspiration performed in all cases. After the study period, no recurrence of cysts observed in any of the intervention and control groups. Conclusion: The study showed that vitamin B6 had no effect on reducing the size and the number of non-palpable breast cysts and prevent recurrence of palpable cysts after aspiration.

scholarly journals Impact of Epley manoeuvre on self-perceived disability: A randomised controlled trial in primary care

2020 ◽  
Author(s):  
Ricard Carrillo Muñoz ◽  
Jose Luis Ballve Moreno ◽  
Ivan Villar Balboa ◽  
Yolanda Rando Matos ◽  
Oriol Cunillera Puertolas ◽  
...  
Keyword(s):  
Primary Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Perceived Disability ◽  
Randomised Controlled ◽  
The Impact

Abstract Background: Posterior canal benign paroxysmal positional vertigo (pc-BPPV) causes physical, functional, and emotional impairment. The treatment of choice is the Epley manoeuvre (EM). The purpose of the study was to compare the impact of the EM and a sham manoeuvre in primary care on self-perceived disability.Method: Randomised, double-blind, sham-controlled clinical trial conducted in primary care with a follow-up of 1 year. Patients aged ≥18 years old diagnosed with pc-BPPV according to the Dix-Hallpike test (DHT) were randomised to an intervention (EM) group or a control (sham manoeuvre) group. The main study covariables were age, sex, history of depression and anxiety, presence of nystagmus in the DHT, patient-perceived disability assessed with the Dizziness Handicap Inventory-screening version (DHI-S). Data were analyzed using bivariate and multivariate mixed Tobit analyses. Results: Overall, 134 patients were studied: 66 in the intervention group and 68 in the control group. Median age was 52 years (interquartile range [IQR], 38.25–68.00 years) and 76.12% of the patients were women. The DHT triggered nystagmus in 40.30% of patients. The median total DHI-S score for the overall sample at baseline was 16 (IQR, 8.00–22.00); 16 [IQR, 10.5–24.0] vs 10 [6.0–14.0] for women vs men (P<0.001) and 16 [IQR, 10.0-24.0] vs 12 [IQR, 8.0–18.0] for patients without nystagmus vs those with nystagmus (P=0.033).Patients treated with the EM experienced a mean reduction of 2.03 points in DHI-S score over the follow-up period compared with patients in the sham group. Conclusion: Pc-BPPV affects the quality of life of primary care patients. A single EM can improve self-perceptions of disability by around 2 points on the DHI-S scale, Trial registration: ClinicalTrials.gov Identifier: NCT01969513. Retrospectively registered. First Posted: October 25, 2013. https://clinicaltrials.gov/ct2/show/NCT01969513

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