scholarly journals Comparative Study on the Effect of Matricaria chamomile and Achillea millefolium Capsules on Primary Dysmenorrhea Intensity of Dormitory Students of Kurdistan University of Medical Sciences, 2018

2019 ◽  
pp. 1-7
Author(s):  
Shiva Radfar ◽  
Roonak Shahoie ◽  
Bijan Noori ◽  
Fereshteh Jalilian ◽  
Leila Hashemi Nasab
Keyword(s):  
Controlled Trial ◽  
Pain Severity ◽  
Achillea Millefolium ◽  
Data Collection Tool ◽  
Medical Sciences ◽  
Menstrual Pain ◽  
Double Blind ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Average Pain

Background: Menstrual pain is the most common pain and one of the main causes of referral to a doctor among young women. The aim of this study was to compare the effectiveness of Achillea millefolium (Yarrow) and Matricaria chamomile plants to treat menstrual pain. Methods: This double-blind randomized controlled trial study was performed on 50 female students of Kurdistan Medical Sciences residing in dormitory in 2018. Individuals were randomly divided into two groups of chmomile and yarrow using sealed envelopes. Twenty for people received 250 mg chamomile capsules every 8 hours and 26 people received 150 mg hydroalcoholic capsules of yarrow every 8 hours during the first three days of menstruation in two menstrual cycles. The data collection tool was a questionnaire and the severity of pain was assessed using visual analogue scale for the pain (VAS). Results: There was no significant difference between the two groups in terms of pain severity and duration of pain before taking the drug (p > 0.05). The average pain severity in the first menstrual cycle in the two groups decreased significantly (p< 0.05), which was more noticeable in the yarrow group. However, the average pain severity in the yarrow capsule group was lower than that of the chamomile capsule group, but this difference was not statistically significant (p > 0.05). Conclusion: Both capsules of yarrow and chamomile reduce the severity of pain, but the yarrow capsule, with its long-lasting sedative effect, proved more helpful to reduce the severity of menstrual pain and could be effective in solving one of the issues among women.

scholarly journals Randomized controlled trial of erdosteine for acute cough in children with colds

2011 ◽  
Vol 51 (2) ◽  
pp. 111
Author(s):  
Yenny Yenny ◽  
Roni Naning ◽  
Amalia Setyati
Keyword(s):  
Randomized Controlled Trial ◽  
Clinical Improvement ◽  
Common Cold ◽  
Controlled Trial ◽  
Research Subjects ◽  
Acute Cough ◽  
Chi Square ◽  
Double Blind ◽  
Randomized Controlled ◽  
Significant Difference

Background T h e prevalence of the common cold in children is high, v.ith 30% of cases exhibiting an acute cough, the most common complaint by parents. Erdosteine, a recently developed cough medicine, is available for children. Erdosteine has been reported to increase mucodliary clearance, act as an antioxidant and prevent bacterial adhesion.Objective To assess the clinical improvement in acute cough in children \\lith a common cold taking erdosteine vs. a placebo.Methods We conducted a double􀀾blind, randomized, controlled trial at the Public Health Center of Gedongtengen, Yogyakarta with 140 children selected by a consecutive sampling method. Research subjects were randomized by computer program into two treatment groups, those receiving erdosteine therapy and those receiving a placebo. Both groups were monitored for 6 days. A scoring system was used to assess the improvement of acute cough symptoms and analyzed by Chi-square test.Results No significant differences in basic characteristics, cough severity, or environment were found among the 140 children with common cold in the two groups. After 6 days of treatment, no significant difference in clinical improvement of acute cough was found between the erdosteine (65 subjects improved out of 70) and placebo groups (62/70),92.5% and 88.6%, respectively (P=0.382).Conclusion Erdosteine was not more effective than the placebo for treatment of acute cough in children with common cold.

Efficacy of a step-down regimen of oral prednisolone in axial spondyloarthritis: result of a double-blind randomized controlled trial (COBRA-AS Study)

Rheumatology ◽  
2020 ◽  
Author(s):  
Debashish Mishra ◽  
Varun Dhir ◽  
G S R S N K Naidu ◽  
Aastha Khullar ◽  
Vishal Kumar ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Oral Prednisolone ◽  
Functional Improvement ◽  
Inadequate Response ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Step Down

Abstract Objectives To evaluate the efficacy and safety of a step-down regimen of oral prednisolone over 24 weeks in patients of axial SpA (axSpA). Methods This proof-of-concept double-blind randomized controlled trial enrolled patients with active axSpA (BASDAI ≥4) having predominantly axial disease (≤1 active joint currently) and inadequate response to NSAIDs. They were randomized to receive either oral prednisolone (n = 32) or placebo (n = 33) at a dose of 60, 40, 30, 20, 15 and 10 mg daily for 1 week each, following which they received 5 mg prednisolone (or placebo) daily for 18 weeks. The primary endpoint was a 50% improvement in the BASDAI (BASDAI50) at week 24. Analysis was intention to treat. Results A BASDAI50 was achieved by 12 of 32 patients (37.5%) in the prednisolone arm and 3 of 33 patients (9.1%) in the placebo arm at 24 weeks [difference 28.4% (95% CI 7.9, 46.7)]. However, there was no difference in achieving a 20 or 40% improvement in the Assessment of SpondyloArthritis international Society response between the groups. Although there was a significant intergroup difference in adjusted ΔBASDAI and ΔAnkylosing Spondylitis Disease Activity Score with CRP at 24 weeks, there was no difference at 12 weeks. There was also no significant difference in ΔBASFI, ΔBAS-G or ΔBASMI at 12 or 24 weeks. No serious adverse events were noted. There was significant weight gain in the first 12 weeks in the prednisolone group vs placebo [0.9 (s.d. 0.4) kg], but not at 24 weeks. Conclusions In this small study, oral prednisolone was efficacious in axSpA in achieving the primary outcome, but many crucial secondary outcomes such as functional improvement were not met. Its impact on bone loss was not studied. Trial registration: CTRI/2018/01/011342.

Peritonitis in Continuous Ambulatory Peritoneal Dialysis (CAPD) Patients: A Randomized Clinical Trial of Cotrimoxazole Prophylaxis

1988 ◽  
Vol 8 (2) ◽  
pp. 125-128 ◽  
Author(s):  
D. N. Churchill ◽  
D. W. Taylor ◽  
S. I. Vas ◽  
J. Singer ◽  
M. L. Beecroft ◽  
...  
Keyword(s):  
Peritoneal Dialysis ◽  
Continuous Ambulatory Peritoneal Dialysis ◽  
Statistical Power ◽  
Controlled Trial ◽  
Double Blind ◽  
Randomized Controlled ◽  
Type 1 Error ◽  
Significant Difference ◽  
Monthly Changes

A double-blind randomized controlled trial compared the effectiveness of prophylactic oral trimethoprim/sulfamethoxazole (cotrimoxazole) to a placebo in preventing peritonitis in continuous ambulatory peritoneal dialysis (CAPD) patients. A daily trimethoprim/sulfamethoxazole dose of 160/800 mg gives a steady state dialysate concentration of 1.07/4.35 mg/L in the final dwell of each dosing interval. Identification of a 40% reduction in peritonitis probability with 80% statistical power and a type 1 error probability of 0.05 required 52 subjects per group. With stratification by previous peritonitis, 56 were allocated to cotrimoxazole and 49 to placebo. For cotrimoxazole there were five deaths and seven catheter losses. For placebo there were three deaths and nine catheter losses. There were 20 withdrawals from cotrimoxazole and 9 from the placebo group. With respect to time to peritonitis, there was no statistically significant difference between cotrimoxazole and placebo groups (p = 0.19). At 6 months, 64.1% of cotrimoxazole and 62.5% of placebo were peritonitis free; at 12 months 41.9% of cotrimoxazole and 35% of placebo were peritonitis free. There was no effect (p > 0.05) of age, sex, catheter care technique, spike or luer, or dialysate additives. Previous peritonitis increased the risk of peritonitis by 2.06 (95% CI, 3.61–1.18) while frequent (six weekly) extension tubing changes increased the risk of by 1.79, (95% CI, 3.04–1.02) when compared to six monthly changes. Cotrimoxazole appears ineffective in prevention of CAPD peritonitis.

scholarly journals Effects of Bupropion on Cognitive Function in Schizophrenia: A Double Blind Randomized Controlled Trial

2016 ◽  
Vol 9 (5) ◽  
pp. 67
Author(s):  
Mansoureh Mirzadeh ◽  
Najmeh Shahini ◽  
Masoud Kashani Lotf Abadi ◽  
Maryam Tavakoli ◽  
Arash Javanbakht ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cognitive Function ◽  
Rating Scale ◽  
Controlled Trial ◽  
Control Group ◽  
P Value ◽  
Double Blind ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Schizophrenic Patients

<p>Smoking habits are common in schizophrenic patients. Nicotine can suppress negative symptoms and cognitive impairments. The aim of this study was to determine the efficacy of bupropion on cognitive function in schizophrenic patients.<strong> </strong>This study is a double blind randomized controlled trial in a large referral psychiatric university hospital in Iran. Ninety smoker schizophrenic patients were randomly allocated (based on DSM -IV TR criteria) in two groups (46 patients for case group and 44 patients in control group). They get risperidone up to 6 mg/d and bupropion up to 400 mg/d .clinical assessment (Positive and Negative Syndrome Scale (PANSS), Brief psychiatric rating scale (BPRS) were taken in beginning of study, 14<sup>th</sup> and 28<sup>th</sup> days of study. Cognitive assessment (Stroop, Digit Span, and Wechsler, Wisconsin) were taken in begging of study, the days 2<sup>nd</sup>, 7<sup>th</sup>, 14<sup>th</sup>, 28<sup>th</sup>. All data were analyzed by SPSS Ver. 17 with analytic and descriptive tests. Mean age of patients was 37.66±1.01. Mean duration of disorder was 11.63±.98 years. The scores were significantly lower at the day 28<sup>th</sup> compared to the beginning of the study in both groups in Wechsler, Stroop color word , Stroop word , Stroop color , BPRS, PANSS p value ≤0.05 .The difference between the two treatments was not significant as indicated by the effect of group, the between-subjects factor<strong> </strong><strong>p </strong>value ≥0.05. In this study, the side effects were examined and there was no significant difference between the two groups p value ≥0.05.<strong> </strong>Augmentation of bupropion to routine treatment improves cognitive symptoms of schizophrenia in abstinence of tobacco.</p>

A prospective double-blind randomized controlled trial of the effect of topical bupivacaine on post-operative pain in bilateral nasal surgery with bilateral nasal packs inserted

2005 ◽  
Vol 119 (4) ◽  
pp. 284-288 ◽  
Author(s):  
Malcolm A Buchanan ◽  
Graham R Dunn ◽  
Gillian M MacDougall
Keyword(s):  
Randomized Controlled Trial ◽  
Local Anaesthetic ◽  
Controlled Trial ◽  
Nasal Surgery ◽  
Double Blind ◽  
Control Power ◽  
Randomized Controlled ◽  
Post Operative Pain ◽  
Number Of Patients ◽  
Significant Difference

To ascertain whether local anaesthetic use is of clinical benefit in nasal surgery, a prospective double-blind randomized controlled trial of topical bupivacaine on post-operative pain in patients packed after bilateral nasal surgery was carried out. Each patient received a bupivacaine-soaked and a saline-soaked Merocel pack, thereby acting as their own control. Power analysis ascertained the number of patients required to enter the trial to detect a statistically significant difference in pain. Fifty-seven patients completed the trial. Visual analogue scales determined the level of post-operative pain at different time points in each nostril. Less pain was demonstrated in nostrils containing bupivacaine-soaked packs compared with saline-soaked packs at two hours (p < 0.0001), four hours (p = 0.0183) and six hours (p = 0.0476) post-operatively. Although not statistically significant, less pain was noted on pack removal on the local anaesthetic sides. These results provide clinical-based evidence for the use of bupivacaine as a local anaesthetic in reducing pain following nasal surgery with packing.

scholarly journals Acupuncture to Treat Primary Dysmenorrhea in Women: A Randomized Controlled Trial

2011 ◽  
Vol 2011 ◽  
pp. 1-11 ◽  
Author(s):  
Caroline A. Smith ◽  
Caroline A. Crowther ◽  
Oswald Petrucco ◽  
Justin Beilby ◽  
Hannah Dent
Keyword(s):  
Randomized Controlled Trial ◽  
Treatment Effect ◽  
Controlled Trial ◽  
Acupuncture Group ◽  
Control Group ◽  
Primary Dysmenorrhea ◽  
Menstrual Pain ◽  
Randomized Controlled ◽  
Significant Difference

We examined the effectiveness of acupuncture to reduce the severity and intensity of primary dysmenorrhea. A randomized controlled trial compared acupuncture with control acupuncture using a placebo needle. Eligible women were aged 14–25 years with a diagnosis of primary dysmenorrhea. Women received nine sessions of the study treatment over 3 months. The primary outcomes were menstrual pain intensity and duration, overall improvement in dysmenorrhea symptoms and reduced need for additional analgesia, measured at 3, 6 and 12 months from trial entry. A total of 92 women were randomly assigned to the intervention (acupuncture and control ). At 3 months although pain outcomes were lower for women in the acupuncture group compared with the control group, there was no significant difference between groups. Women receiving acupuncture reported a small reduction in mood changes compared with the control group, relative risk (RR) 0.72, 95% confidence interval (CI) 0.53–1.00, . Follow-up at 6 months found a significant reduction in the duration of menstrual pain in the acupuncture group compared with the control group, mean difference –9.6, 95% CI –18.9 to –0.3, , and the need for additional analgesia was significantly lower in the acupuncture group compared with the control group, RR 0.69, 95% CI 0.49–0.96, , but the follow-up at 12 months found lack of treatment effect. To conclude, although acupuncture improved menstrual mood symptoms in women with primary dysmenorrhea during the treatment phase, the trend in the improvement of symptoms during the active phase of treatment, and at 6 and 12 months was non-significant, indicating that a small treatment effect from acupuncture on dysmenorrhea may exist. In the study, acupuncture was acceptable and safe, but further appropriately powered trials are needed before recommendations for clinical practice can be made.

scholarly journals Effects of thiamine on vasopressor requirements in patients with septic shock: a prospective randomized controlled trial

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Suttasinee Petsakul ◽  
Sunthiti Morakul ◽  
Viratch Tangsujaritvijit ◽  
Parinya Kunawut ◽  
Pongsasit Singhatas ◽  
...  
Keyword(s):  
Septic Shock ◽  
Sample Size ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Tertiary Hospital ◽  
Double Blind ◽  
Randomized Controlled ◽  
Prospective Randomized Controlled Trial ◽  
Significant Difference ◽  
Dependency Index

Abstract Background Thiamine, an essential vitamin for aerobic metabolism and glutathione cycling, may decrease the effects of critical illnesses. The objective of this study was to determine whether intravenous thiamine administration can reduce vasopressor requirements in patients with septic shock. Methods This study was a prospective randomized double-blind placebo-controlled trial. We included adult patients with septic shock who required a vasopressor within 1–24 h after admission between March 2018 and January 2019 at a tertiary hospital in Thailand. Patients were divided into two groups: those who received 200 mg thiamine or those receiving a placebo every 12 h for 7 days or until hospital discharge. The primary outcome was the number of vasopressor-free days over 7 days. The pre-defined sample size was 31 patients per group, and the study was terminated early due to difficult recruitment. Results Sixty-two patients were screened and 50 patients were finally enrolled in the study, 25 in each group. There was no difference in the primary outcome of vasopressor-free days within the 7-day period between the thiamine and placebo groups (mean: 4.9 days (1.9) vs. 4.0 days (2.7), p = 0.197, mean difference − 0.9, 95% CI (− 2.9 to 0.5)). However, the reductions in lactate (p = 0.024) and in the vasopressor dependency index (p = 0.02) at 24 h were greater among subjects who received thiamine repletion vs. the placebo. No statistically significant difference was observed in SOFA scores within 7 days, vasopressor dependency index within 4 days and 7 days, or 28-day mortality. Conclusions Thiamine was not associated to a significant reduction in vasopressor-free days over 7-days in comparison to placebo in patients with septic shock. Administration of thiamine could be associated with a reduction in vasopressor dependency index and lactate level within 24 h. The study is limited by early stopping and low sample size. Trial registration TCTR, TCTR20180310001. Registered 8 March 2018, http://www.clinicaltrials.in.th/index.php?tp=regtrials&menu=trialsearch&smenu=fulltext&task=search&task2=view1&id=3330.

Early analgesic effects of intravenous parecoxib and rectal diclofenac following laparoscopic sterilization: A double-blind, double-dummy randomized controlled trial

2018 ◽  
Vol 4 (1) ◽  
pp. 49
Author(s):  
Alexander Ng, MD, FRCA ◽  
Ajay Swami, FFARCSI ◽  
Graham Smith, MD, FRCA ◽  
Joe Emembolu, FRCOG
Keyword(s):  
Randomized Controlled Trial ◽  
Pain Intensity ◽  
Controlled Trial ◽  
Double Blind ◽  
Rescue Analgesia ◽  
Analgesic Effects ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Laparoscopic Sterilization ◽  
Rescue Antiemetic

The aim of this double-blind double-dummy randomized controlled trial was to investigate if there was any difference in analgesia between the maximum recommended doses of rectal diclofenac and iv parecoxib after laparoscopic sterilization. The authors studied 55 ASA I-II patients undergoing gynecological laparoscopy; each patient received either preoperative rectal diclofenac 100 mg and 2 mL of normal saline at induction of anesthesia, or preoperative placebo suppository and 2 mL of parecoxib 40 mg at induction. Pain intensity, sedation, and nausea were measured using a 100-mm visual analogue scale on awakening and at 1, 2, and 3 hour postoperatively. Median (interquartile range) pain intensity at rest on awakening and at 1, 2, and 3 hour postoperatively were 15 (0-40), 37 (10-56), 16 (6-29), and 13 (2-32) mm, respectively, in the parecoxib group, and 3 (0-34), 22 (5-45), 24 (6-37), and 10 (4-21) mm, respectively, in the diclofenac group. There was no significant difference in these scores. Furthermore, there was no significant difference between the two groups in sedation, nausea, rescue analgesia, or rescue antiemetic consumption. Preoperative rectal diclofenac 100 mg and parecoxib 40 mg iv at induction of anesthesia were found to have equianalgesic effects after laparoscopic sterilization. Both drugs appear to be useful after short anaesthetics.

Flexible Dosed Duloxetine in the Treatment of Fibromyalgia: A Randomized, Double-blind, Placebo-controlled Trial

2010 ◽  
Vol 37 (12) ◽  
pp. 2578-2586 ◽  
Author(s):  
LESLEY M. ARNOLD ◽  
DANIEL CLAUW ◽  
FUJUN WANG ◽  
JONNA AHL ◽  
PAULA J. GAYNOR ◽  
...  
Keyword(s):  
Short Form ◽  
Controlled Trial ◽  
Brief Pain Inventory ◽  
Pain Severity ◽  
Clinical Trial Registry ◽  
Double Blind ◽  
Global Improvement ◽  
Sf 36 ◽  
Average Pain ◽  
Sleep Difficulties

Objective.To investigate the efficacy of flexible dose duloxetine 60–120 mg/day on changes in fibromyalgia (FM) symptoms assessed by the Patient Global Impression of Improvement (PGI-I) scale.Methods.Outpatients ≥ 18 years of age who met American College of Rheumatology criteria for FM, and had ≥ 4 score on the Brief Pain Inventory (BPI) average pain item, were randomized to duloxetine (n = 263) or placebo (n = 267) for 24 week double-blind treatment (primary endpoint at Week 12). Key secondary measures included BPI average pain severity, patient-rated scales assessing mood, anxiety, pain, sleep, and stiffness, Clinical Global Impression of Severity (CGI-S), Multidimensional Fatigue Inventory, Cognitive and Physical Functioning Questionnaire, Beck Depression Inventory (BDI), Beck Anxiety Inventory, and Medical Outcome Study Short-Form Health Survey (SF-36).Results.At Week 12, duloxetine-treated patients reported significantly greater global improvement with mean PGI-I scores of 2.8 compared to 3.4 in the placebo group (p < 0.001). Significantly more duloxetine- versus placebo-treated patients (57% vs 32%; p < 0.001) reported feeling “much” or “very much better” (PGI-I score ≤ 2). There was significantly greater improvement with duloxetine versus placebo treatment in BPI average pain severity, mood (including BDI total), anxiety (patient-rated only), stiffness, CGI-S, fatigue, all SF-36 domains (except role-physical and physical component summary), and being less bothered by pain or sleep difficulties. Treatment-emergent adverse events occurring significantly more frequently with duloxetine included: nausea, headache, constipation, dry mouth, dizziness, diarrhea, and hyperhidrosis.Conclusion.Treatment with duloxetine 60, 90, and 120 mg/day was associated with feeling much better, pain reduction, being less bothered by sleep difficulties, and improvement in mood, stiffness, fatigue and functioning. (Clinical trial registryNCT00673452).

scholarly journals Levothyroxine versus Levothyroxine with Iodine in Reduction of Thyroid Nodule Volume: A Double-Blind Randomized Controlled Trial

2019 ◽  
Vol 34 (1) ◽  
pp. 14-19
Author(s):  
Donnie Jan D. Segocio ◽  
Joseph E. Cachuela
Keyword(s):  
Randomized Controlled Trial ◽  
Placebo Group ◽  
Thyroid Nodule ◽  
Controlled Trial ◽  
Therapeutic Use ◽  
Volume Reduction ◽  
Double Blind ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Nodule Volume

Objective: To compare levothyroxine alone and in combination with iodine on thyroid nodule volume reduction. Methods:           Design:           Double-Blind Randomized Controlled Trial           Setting:           Tertiary Government Hospital           Participants: Nineteen (19) euthyroid patients age 19­-54 with at least 1 cytologically benign thyroid nodule were randomized to receive either levothyroxine + iodine or levothyroxine + placebo, taken once a day for 6 months with ultrasound and thyroid stimulating hormone monitoring on the 3rd and 6th month of intervention. Results: Main outcome measures included thyroid nodule volume reduction after six months of intervention. The mean change in volume from baseline to six months of levothyroxine + iodine group showed no statistically significant difference in nodule volume across time between  levothyroxine + placebo group, -0.010 ± 1.250 (CI -0.521 - 0.501) versus 0.507 ± 1.128 (CI 0.025 - 0.990), p=.158.  There were also new nodules (4 nodules) in the placebo group and none in the iodine group. No major adverse events were noted during the study. Conclusion: The two groups did not significantly differ in terms of nodule volume reduction. Keywords: thyroid nodule, prevention and control; drug therapy; iodine compounds, therapeutic use; levothyroxine, therapeutic use

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