Double-blind Randomized Trial Research Articles

Double blind, randomised trial to compare efficacy of escitalopram versus citalopram for interferon induced depression in hepatitis C patients

ObjectivesThe objective of the study was to compare the two antidepressant drugs citalopram and escitalopram on the basis of efficacy in depressed patients of Hepatitis C patients receiving interferons. MethodsIn this double blind randomized trial, the hepatitis C patients visited National institute of liver and Gastro intestinal diseases (NILGID), Dow University Hospital, were screened for depression before starting treatment with interferons. The Institutional review board approval was obtained and its letter reference no.is: IRB-682/DUHS/Approval/2016/169. Patients with previous history of depression were excluded from the study. The patients who started with Interferon therapy were assessed for depression on baseline and then on each visit. Those who developed depression were randomly assigned to receive either citalopram or escitalopram. Treatment groups were assessed with depression scale each time they visit the clinic. Two antidepressants were compared for their efficacy at an interval of 4 weeks, 8weeks and then 12 weeks. ResultsIn the current study 80 patients were randomized to receive either citalopram or escitalopram. The study outcome was better in patients treated with escitalopram. The mean change in depression score from baseline to the end of the study was greater in escitalopram group i.e. 10.41 as compared to citalopram group i.e. 14.17. The difference in depression score was also calculated as 4.28 and.3.76 (p < 0.001) for both the drugs at week 8 and week 12 respectively, which was statistically significant. Difference in depression score were also calculated for gender 0.576 (p = 0.497) and age 0.950 (p = 0.265), which were found to be non-significant, statistically. ConclusionThe results demonstrated superiority of escitalopram over citalopram, the drug is twice as potent as the racemic mixture. Additionally the drug is well tolerated and exhibited better effects. Escitalopram proved to be a safer alternative to citalopram.

Intralymphatic immunotherapy improves grass pollen allergic rhinoconjunctivitis: A 3-year randomized placebo-controlled trial

Allergic rhinoconjunctivitis is a global health problem. Different allergen immunotherapy regimes are marketed but have low adherence because they are expensive, complex, and time-consuming. New allergen immunotherapy forms are needed. In a 3-year follow-up double-blind randomized placebo-controlled trial, we aimed to investigate the effect of intralymphatic allergen immunotherapy (ILIT). Patients with grass pollen rhinoconjunctivitis were treated with 3 ILIT injections and an ILIT booster 1 year later, 3 ILIT injections and a placebo booster, or 3 placebo injections and a placebo booster. Primary outcome was improvement in a combined symptom and medication score (cSMS). Anovel evaluation tool with a linear regression model of cSMS and grass pollen counts was developed. Secondary outcomes were changes in grass specific immunoglobulins and skin and nasal provocation tests to grass pollen. A total of 36 patients were included. Log10-transformed cSMS was reduced by 0.30 (95% CI, 0.11-0.49; P= .002), equaling 48.5% (95% CI, 24.5%-62%), in the entire 3-year follow-up period, significant only in the first follow-up season but not in the second and third seasons. The regression model showed a 37% (P< .001) reduction in cSMS. The booster injection 1 year later had no additional effect. Secondary, repeated measures of IgE and IgG4 to grass showed significant between-group difference and within-group change in the ILIT groups. No change in provocation test results was found. ILIT gives a substantial reduction in grass pollen allergy symptoms and use of rescue medication, significant in the first season after treatment. Abooster injection had no additional effect.

The efficacy of vitamin D combined with clomiphene citrate in ovulation induction in overweight women with polycystic ovary syndrome: a double blind, randomized clinical trial.

The aim of this study was to assess the effect of vitamin D supplementation on ovulation rate in overweight subfertile women with PCOS undergoing ovulation induction. This was a single center, parallel-groups, double-blind, and placebo-controlled randomized trial involving 186 eligible women undergoing induction of ovulation with clomiphene citrate (Clomid®, Aventis) 50 mg tablet twice daily starting from the third day of menstrual cycle and for 5 days combined with either oral Vitamin D (ossofortin®, EVA PHARMA) 10,000 IU twice weekly and calcium (calciprex®, Marcyrl Pharmaceutical Industries) 1250 mg twice daily or to receive a placebo with calcium for three successive induction cycles. The vitamin D or placebo supplementation started 1 month before induction cycles (total four cycles). Cycles were monitored with ultrasound follicle tracking and mid-luteal serum progesterone measurement. The primary outcome was the ovulation rate after three induction cycles. The study was performed during the period between January 2018 and September 2018, Eighty six (92.5%) women in the treatment group and 73 (78.5%) in the control group had successful ovulation (p = 0.007). The absolute and relative risk reduction was 14% and 65% respectively. Biochemical and clinical pregnancy occurred in 61.3 and 50.5% in the treatment group, and in 49.5 and 39.8% in the control group (p = 0.105 and 0.141 respectively). In subfertile women with PCOS undergoing induction of ovulation, vitamin D supplementation significantly improved the ovulation rate; however, there was no effect on clinical or biochemical pregnancy.

Comparison between two mixtures of lidocaine and bupivacaine for infraclavicular block: a double blind randomized trial

Background: We compare the two mixtures in terms of efficiency, analgesia, and side effects.Methods: 30 patients scheduled for upper limb surgery were randomized in 2 groups. the group A received a mixture of 50% lidocaine 2% and 50% of bupivacaine 0.5% the group B received a mixture of 75% lidocaine 1% and 25% of bupivacaine 0.5%. Volumes, block onset times, blocks duration times, analgesia, and toxicity were compared.Results: The volumes were equals in both groups. Sensory block onset was 5.43 min in the group A versus 6.73 min in the group B, motor block onset was 11.93 for the group A versus 13.46 min for the group B. Sensory block duration was 5.48 hours in the group A versus 4.05 hours for the group B (p=0.037), motor block duration was 7.75 hours for group A versus 5.50 hours for group B (p=0.014). Analgesia levels are equals between the two groups, there was no side effects listed.Conclusions: The use of low concentrated lidocaine and bupivacaine mixture induces an adequate anaesthesia and decreases the duration of motor block with a reduced level of pain and an equal level of analgesia.

Perianal block with ropivacaine as a supplement to anaesthesia in proctological surgery: double-blind randomized placebo-controlled trial (PERCEPT).

The benefit of a perianal block as an adjunct to general or regional anaesthesia is debated. This RCT aimed to compare pain at 24 h and up to 14 days after proctological surgery in patients with and without a perianal block. Between January 2018 and April 2019, patients were allocated to receive a perianal block with ropivacaine or placebo as an adjunct to anaesthesia. Patients, surgeons and assessors were blinded. The primary outcome was pain measured on a numerical rating scale (NRS) after 24 h. Secondary outcomes were need for rescue analgesia, and pain after 1, 2, 3, 6 and 12 h. The mean, rest and maximum NRS scores were measured for 14 days. A total of 138 patients were included, of whom 46 and 44 received general anaesthesia with or without ropivacaine respectively, and 23 and 25 received spinal anaesthesia with or without ropivacaine respectively (P = 0·858). The mean NRS score differed significantly at 24 h (mean(s.d.) 1·1(0·1) versus 2·3(0·2); P < 0·001), but not at 1 h (1·4(0·2) versus 2·2(0·3); P = 0·051). The NRS score was lower with use of ropivacaine at 2 h (1·0(0·2) versus 1·6(0·2); P = 0·045), 3 h (0·9(0·2) versus 1·5(0·2); P = 0·022), 6 h (1·1(0·2) versus 1·8(0·2); P = 0·042) and 12 h (1·2(0·2) versus 1·8(0·2); P = 0·034). The use of oral morphine equivalents was 10·2(1·4) and 16·6(2·5) mg with and without ropivacaine respectively (P = 0·028). The mean and maximum NRS scores within 14 days were lower when ropivacaine was used (95 per cent c.i. for difference 0·14 to 0·49 (P = 0·002) and 0·39 to 0·63 (P < 0·001) respectively). There was no injection-associated morbidity. Perianal block as an adjunct to general or regional anaesthesia should be recommended for proctological surgery. It yields a reduction in pain, a reduced need for opioids, and a faster recovery with minimal risk of adverse events. Registration number: NCT03405922 ( http://www.clinicaltrials.gov).

Sonidegib and vismodegib in the treatment of patients with locally advanced basal cell carcinoma: a joint expert opinion.

Sonidegib and vismodegib are hedgehog pathway inhibitors (HhIs) approved for the treatment of advanced basal cell carcinoma (BCC). Until recently, vismodegib was the only targeted treatment available for patients with locally advanced BCC (laBCC) in cases where surgery and radiotherapy are inappropriate. Sonidegib has recently been approved and now presents an alternative treatment option. The clinical differences between the two HhIs in patients with laBCC are unclear, as no head-to-head randomized controlled trials are or will be initiated. Moreover, there were important differences in the designs of their pivotal studies, BOLT (sonidegib) and ERIVANCE (vismodegib), and these differences complicate evidence-based analysis of their relative efficacy and safety profiles. In this paper, a group of clinical experts in the management of laBCC summarizes the clinical and pharmacological profiles of sonidegib and vismodegib based on published data and their own clinical experience. One key difference between the two pivotal studies was the criteria used to assess BCC severity. ERIVANCE (a single-arm phase II trial) used the conventional Response Evaluation Criteria in Solid Tumors (RECIST), while the more recent double-blind randomized BOLT trial used the stringent modified RECIST. A preplanned analysis adjusted the outcomes from BOLT with RECIST-like criteria, and this enabled the experts to discuss relative efficacy outcomes for the two treatments. Centrally reviewed objective response rate (ORR) for vismodegib was 47.6% (95% CI: 35.5-60.6) at 21-month follow-up using RECIST. After adjusting with RECIST-like criteria, the ORR for sonidegib according to central review at 18-month follow-up was 60.6% (95% CI: 47.8-72.4). Both treatments were associated with similar patterns of adverse events. Sonidegib and vismodegib share the same efficacy and tolerability profiles, but their pharmacokinetic profiles show several differences, such as volume of distribution and half-life. Further studies are needed to understand how these differences may impact clinical practice.

Designing a Clinical Trial to Determine the Effect of Conventional Physiotherapy Plus Ankle KinesioTaping® on Walking and Balance in Children with Spastic Diplegia Cerebral Palsy: A Protocol for a Double-Blind Randomized Clinical Trial

Introduction: This study is a protocol of a double-blind randomized clinical trial with the aim of determining the effect of ankle KinesioTape® in addition to the routine physiotherapy approach on walking and balance of children with cerebral palsy (CP) suffering from spastic diplegia. Materials and Methods: The present clinical trial was performed on 20 children who were randomly divided into the two groups of control and intervention. 4 weeks of routine physiotherapy program was carried out for all the participants in both groups. In the intervention group, the KinesioTape® was applied to the ankles of the patients for 4 weeks in addition to the routine treatment. After completing this course, a 6-week follow-up phase was conducted for both groups, in which both groups received routine physiotherapy treatment. The treatment program was repeated twice a week. The outcome measures included modified Timed Up and Go (TUG) test, Gross Motor Function Measure (GMFM), and Pediatric Balance Scale (PBS). The normal distribution of the data was determined using the Shapiro-Wilks test. Paired-sample t-test and Wilcoxon nonparametric test were employed to analyze the data and check for changes before and after the treatment in each group. Additionally, the repeated measures analysis of variance (ANOVA) was used to compare between the two groups (P < 0.05). Conclusion: KinesioTape® improves voluntary movement, coordination and balance, and functional independence in children with CP. According to the comprehensive search of literature, it seems that no study to date has examined the effect of ankle equinus corrective KinesioTaping® on walking and balance in children with spastic diplegia. The results of the study can be used to examine the effectiveness of the addition of ankle Kinesio Taping® to physiotherapy on the function and balance of these children.

Comparison of quadratus lumborum block and caudal block for postoperative analgesia in pediatric patients undergoing inguinal hernia repair and orchiopexy surgeries: a randomized controlled trial

Background and objectivesCaudal epidural anesthesia is a widely used popular technique for postoperative analgesia but it has potential side effects and duration of analgesia is short. Quadratus lumborum block (QLB)...

Effects of Viola odorata as an Add-On Therapy on Insomnia in Patients with Obsession or Depression: A Pilot Randomized Double-Blind Placebo-Controlled Trial.

Objective: The present study was conducted to investigate the effect of Viola odorata extracted syrup on the quality and patterns of sleep in patients with depression or obsessive-compulsive disorder (OCD) as add-on therapy. Design: A pilot double-blind randomized placebo-controlled trial. Settings/Location: Psychiatric Clinic of Imam Hossein Hospital, Tehran, Iran. Subjects: Participants were 16-15 years of age with mild and moderate depression or OCD having insomnia. Interventions: This pilot study was conducted on patients with insomnia divided into two groups with depression (40 patients) or OCD (43 patients). Each group randomly assigned into two arms with the same conditions at baseline. The intervention arm daily received 5 mL V. odorata syrup every 12 h for 4 weeks, and the control arm received 5 mL placebo syrup every 12 h for 4 weeks. None of the participants was deprived of their routine treatment for depression or OCD. Outcome measures: The scores of insomnia symptoms were evaluated using total score of the Pittsburgh Sleep Quality Index (PSQI) and the scores of its components, the depression score using the final Beck depression inventory-II (BDI-II) score, and OCD score using the Yale-Brown Obsessive-Compulsive Scale (YBOCS). Results: The total PSQI score was found to be improved significantly in the intervention arms with depression or OCD (p < 0.001) compared with the corresponding control arms. Significant improvements were also observed in the final mean difference of BDI-II (p = 0.009) and YBOCS (p = 0.001) scores in the intervention arms. Conclusions: V. odorata syrup significantly improved insomnia symptoms and the scores of depression and OCD.

A Double Blind, Randomised, Four Arm Clinical Study to Evaluate the Safety, Efficacy and Tolerability of Collagen Peptide as a Nutraceutical Therapy in the Management of Type II Diabetes Mellitus

Dipeptidyl peptidase-4 (DPP-4) inhibitors constitute an innovative class of oral agents for the treatment of Type 2 Diabetes Mellitus (T2DM). DPP-4 inhibitors increase glucagon-like peptide-1 (GLP-1) availability and correct the “incretin defect” seen in T2DM patients. Peptides derived from collagen have been reported to have DPP-4 inhibitory properties. A double blind randomized trial has been conducted to evaluate the effectiveness of Collagen peptides (CPT) as nutritional supplement in subjects with T2DM. Resistant dextrin (RD), a non-digestible dietary polymer, has been used as active comparator in this study. The clinical study was conducted over a total duration of 12 weeks of treatment period. The study was conducted on 66 enrolled subjects randomized in a 2:2:1:1 ratio as a four arm clinical study design. The subjects consumed either CPT (2.5/5 g) or resistant dextrin (2.5/5 g) for 90 days. The results showed that the consumption of 5 g CPT resulted in significant reduction in fasting blood glucose (FBG) and Glycosylated Haemoglobin (HbA1c) in three months study period in subjects. Insulin sensitivity measured in as HOMA IR has also been improved significantly in the group. Thus this study demonstrates the potential role of CPT as add on nutritional supplement for the management of T2DM.

Trial protocol: preoperative administration of tranexamic acid in sleeve gastrectomy (PATAS) to reduce haemorrhage rates. A randomised controlled trial

IntroductionFast-track protocols often include short-term thromboprophylaxis and short length of hospital stay. These treatment strategies may negatively affect the occurrence and diagnosis of postoperative haemorrhage. Over the years, the rates...

Informed consent procedure in a double blind randomized anthelminthic trial on Pemba Island, Tanzania: do pamphlet and information session increase caregivers knowledge?

BackgroundIn clinical research, obtaining informed consent from participants is an ethical and legal requirement. Conveying the information concerning the study can be done using multiple methods yet this step commonly relies exclusively on the informed consent form alone. While this is legal, it does not ensure the participant’s true comprehension. New effective methods of conveying consent information should be tested. In this study we compared the effect of different methods on the knowledge of caregivers of participants of a clinical trial on Pemba Island, Tanzania.MethodsA total of 254 caregivers were assigned to receive (i) a pamphlet (n = 63), (ii) an oral information session (n = 62) or (iii) a pamphlet and an oral information session (n = 64) about the clinical trial procedures, their rights, benefits and potential risks. Their post-intervention knowledge was assessed using a questionnaire. One group of caregivers had not received any information when they were interviewed (n = 65).ResultsIn contrast to the pamphlet, attending an information session significantly increased caregivers’ knowledge for some of the questions. Most of these questions were either related to the parasite (hookworm) or to the trial design (study procedures).ConclusionsIn conclusion, within our trial on Pemba Island, a pamphlet was found to not be a good form of conveying clinical trial information while an oral information session improved knowledge. Not all caregivers attending an information session responded correctly to all questions; therefore, better forms of communicating information need to be found to achieve a truly informed consent.

A Comparative Study on Safety and Efficacy of Caudal, Thoracic Epidural and Intra Venous Analgesia in Paediatric Cardiac Surgery: A Double Blind Randomised Trial

Introduction:Regional anaesthesia combined with general anaesthesia reduces stress response to surgery, duration of ventilation, intensive care unit (ICU) stay and promotes early recovery. Studies on thoracic epidural, caudal analgesia along with general anaesthesia (GA) in paediatric cardiac surgery are limited hence we aimed to compare efficacy and safety of caudal, thoracic epidural and intravenous analgesia in paediatric cardiac surgery. Methodology: This study was conducted in the Department of Anaesthesiology in a tertiary care teaching hospital in southern India from February 2019 to December 2019. 90 children were randomised into group A, group B, group C. Children in group A received caudal analgesia along with GA. Group B children received thoracic epidural along with GA. Group C patients received intravenous analgesia along with GA. Rescue analgesia 1 mcg/kg fentanyl given in all 3 groups if pain score is more than 4. Primary outcome assessed was post-op pain scores. Secondary outcome assessed was duration of ventilation, duration of intensive care unit stay. Results: All patients were comparable in terms of age, sex, weight, mean RACHS score, baseline heart rate and blood pressure. Pain scores were significantly lower in thoracic epidural group compared to other two grou ps. Duration of ventilation was lower in thoracic epidural group (91.17± 43.85) minutes and caudal (199.6 ± 723.59) minutes compared to intravenous analgesia groups (436.37 ± 705.51) minutes. Duration of ICU stay was significantly low in thoracic epidural group (2.73 ± 0.69) days compared to caudal (3.7 ± 2.8) and intravenous analgesia groups (4.33 ± 0.920). We didn’t have any complications like hematoma, transient or permanent neurological sequelae in regional anesthesia groups. Conclusion: Regional anaesthesia along with general anaesthesia was more effective in pain relief than intravenous analgesia with general anaesthesia in paediatric cardiac surgery.

Comparative Study of Two Nebulized Preparations of Salbutamol in Children

Aim: Salbutamol is the main treatment for asthma attacks. It can be given via inhaler, nebulizer or oral route. Nebulization is mainly used at emergency departments. The aim of our study is to compare the clinical efficacy of two nebulized salbutamol preparations Ventolin® GSK and Asthalin® CIPLA. Methods: We conducted a prospective double blind randomized trial between April and December 2017 in which 30 children with asthma were included. Children were assigned randomly to receive nebulized Asthalin® or Ventolin®, with 15 patients included in each study arm. For each patient, oxygen saturation, presence of wheezing, retractions and thoraco-abdominal asynchrony, before and after Salbutamol nebulization were recorded. The effect of each treatment dose on oxygen saturation and respiratory rate after stratification of the initial population was analyzed. Results: Ventolin® increased oxygen saturation by 1.87% and decreased respiratory rate by 10.87 breaths per minute, while Asthalin® improved oxygen saturation by 1.8% and decreased respiratory rate by 9.53 breaths per minute. However, the difference was not significant as it was not significant for respiratory symptoms improvement and need for oxygenation and hospitalization rates. Conclusion: There is no significant difference between Ventolin® and Asthalin® when given via nebulization. Both treatments improved oxygen saturation, respiratory rate and respiratory symptoms similarly.

LBA86 - Mirtazapine in cancer-associated anorexia cachexia: A randomised, double-blind, placebo-controlled trial

BackgroundThe available options to manage cancer-associated anorexia-cachexia syndrome (CACS) are limited. At standard doses, the tetracyclic antidepressant mirtazapine causes appetite stimulation and weight gain. Based on limited evidence, it is used in cancer-associated anorexia. This trial was conducted to assess the efficacy and safety of mirtazapine in patients with CACS. MethodsA double-blind randomized placebo-controlled trial. Included patients were adults with advanced solid tumors, weight loss ≥5%, appetite loss score ≥ 4 on 0 to 10 scale (10 = maximum appetite loss), and depression ≤3 on 0 to 6 scale (6 = extreme feelings of depression). Patients were randomized to receive mirtazapine 15mg /day or placebo. The primary end-point was the change in appetite on a 0 to 10 appetite scale (where 10 is the best appetite possible) at week 4. Other assessed outcomes included changes in body weight, lean body mass, handgrip strength, depression (measured by the Hospital Anxiety and Depression Scale [HADS]), and quality of life (measured by Functional Assessment of Anorexia/Cachexia Therapy [FAACT] questionnaire). ResultsFrom 120 allocated patients, 100 completed 4 weeks treatment (48 in the mirtazapine arm and 52 in the placebo). After 4 weeks of treatment there was no significant difference between the two arms in the change from baseline in appetite or other outcome measures (Table 1). The change in the HADS depression score differed significantly in favour of mirtazapine. Sleepiness was significantly more prevalent in the mirtazapine arm (p=0.01) and only one patient discontinued treatment due to excess sleepiness.Table: LBA86Change in outcome measures from baseline to day 28Table: LBA86MirtazapinePlacebopMedian (Interquartile range)Appetite score2 (0-2)2 (0-2)0.401Body weight (kg)-0.8 (-1.5 – 0.9)-0.6 (-1.4 – 0.2)0.94Lean body mass (kg)-0.16 (-1.1 – 1.1)-0.37 (-1 – 0.4)0.411Handgrip strength (kg)-0.76 (-1.5 – 0.8)0 (-1 – 0.8)0.376FAACT Anorexia-cachexia scale4 (1 – 5.8)4 (0 – 6)0.997HADS Depression score1 (0.3 – 2)2 (1 – 2)0.022 ConclusionsCompared to placebo, mirtazapine 15mg at night did not improve appetite, body weight, hand-grip strength or quality of life in advanced cancer patients with anorexia cachexia. Clinical trial identificationNCT03254173. Legal entity responsible for the studyThe authors. FundingCairo University. DisclosureAll authors have declared no conflicts of interest.

Effects of Executive Function Training on Attentional, Behavioral and Emotional Functioning and Self-Perceived Competence in Very Preterm Children: A Randomized Controlled Trial.

ObjectiveVery preterm children have poorer attentional, behavioral and emotional functioning than term-born children. Problems on these domains have been linked to poorer executive function (EF). This study examined effects of a game-formatted, comprehensive EF training on attentional, behavioral and emotional functioning and self-perceived competence in very preterm children.Study DesignEighty-five children participated in a multi-center, double-blind, placebo and waitlist-controlled randomized trial. Children were recruited from neonatal follow-up units of two academic medical centers in The Netherlands. Eligible for inclusion were 8–12 year old children born very preterm (<30 weeks of gestation) and/or with extremely low birthweight (<1000 g) with parent reported attention problems. Children were randomly assigned to one of three treatment arms: EF training, placebo training or waitlist. The EF and placebo training involved a 6 weeks, 25 (30–45 min) sessions training program. Attentional functioning (Attention Network Test), behavioral and emotional functioning (parent and teacher Strengths and Difficulties questionnaire) and self-perceived competence (Self-Perception Profile for Children) were assessed at baseline, at the end of the training program and 5 months after the training was finished. Data analyses involved linear mixed model analyses.ResultsChildren in the EF training arm significantly improved on all training tasks over the course of the EF training program. Despite these improvements on the EF training tasks, there were no significant differences over time on any of the outcome measures between the three treatment arms, indicating that this computerized EF training program had no beneficial effects.ConclusionAlthough there were significant improvements in the EF training tasks, there was no generalization of these improvements to any of the outcome measures. Thus, our findings do not support the use of computerized EF training programs. Future research should investigate effectivity of more ecologically valid, real-world like EF training programs.

Transcranial direct current stimulation for nonspecific low back pain: double-blind randomized sham-controlled trial

Introduction: Low back pain is recognized as a major cause of morbidity worldwide. Between 70 and 80% of adults experience at least one occasion of low back pain with duration of 3 months or longer in their lifetime. Aside from the classic treatment methods, there are other new techniques yet to be clinically investigated. Transcranial direct current stimulation (tDCS) has been reported to alleviate pain by affecting the central nervous system. To date only a small number of studies have been published on the effects of tDCS on chronic low back pain. Some of these were pilot studies and others were low-powered in terms of their inference. Therefore the clinical application of tDCS requires further careful evaluation. Objective: To assess the efficacy of transcranial direct current stimulation for treatment of chronic nonspecific low back pain. Materials and methods: We carried out a double-blind randomized sham-controlled trial in a University Hospital. In total 70 people (15 women) with low back pain were randomized to either active or sham stimulation. The primary outcome was intensity of low back pain on the Visual Analog Scale. We also used the Oswestry Disability Questionnaire to evaluate the effects of back pain on daily activities. For the active stimulation group we administered 2 mA tDCS, 20 minutes for each session, once daily, 5 days per week for 2 weeks, totaling 10 sessions. For the sham stimulation group a similar program was followed with no stimulation. Both groups used analgesic medication. Results: Within-group analysis showed that an initial decrease in pain intensity was significant in both groups (both p &lt; 0.001). However, pain reduction became stable only in the active treatment group. There was a significant difference in the pattern of change in mean pain scores in favor of tDCS (p &lt; 0.001). Active treatment also significantly reduced disability scores (all p values &lt; 0.001), whereas participants in the sham treatment group did not experience functional recovery. Mixed ANOVA indicated that the pattern of change in mean scores of disability differed between the two groups throughout the study course, in favor of active stimulation (p &lt; 0.001). Conclusion: Transcranial direct current stimulation is an effective and safe initial treatment for chronic nonspecific low back pain, and the benefits remain for at least several months.

Including 60 mg Elemental Iron in a Multiple Micronutrient Supplement Blunts the Increase in Serum Zinc after 12 Weeks of Daily Supplementation in Predominantly Anemic, Nonpregnant Cambodian Women of Reproductive Age

Multiple micronutrient (MMN) supplementation may result in interaction effects due to competing absorptive pathways of trace elements. The aim of this study was to investigate the effect of MMN supplementation with or without iron on serum zinc, selenium, and copper concentrations in Cambodian women. In a 2×2 factorial double-blind randomized 12-wk trial, predominantly anemic, nonpregnant women (aged 18-45 y) received daily 60 mg of iron (Fe; n=201); 14 other micronutrients including zinc (15 mg), selenium (65 μg), and copper (2 mg), but no iron (MMN; n=202); 60 mg iron plus MMN (Fe+MMN; n=206); or a placebo (n=200). Fasting morning blood was collected at baseline and 12 wk from women in 26 villages in Kampong Chhnang province. Serum zinc, selenium, and copper concentrations (secondary outcomes of the randomized controlled trial) were measured using inductively coupled plasma mass spectrometry. Generalized linear regression was used to estimate intervention effects [β coefficient (95% CI)] for Fe (with or without MMN) and MMN (with or without Fe) after testing for the presence of an Fe×MMN interaction. A total of 760 women completed the trial. Zinc deficiency prevalence at baseline was 45% (inflammation-adjusted serum zinc <10.7 μmol/L). A significant Fe × MMN interaction (P=0.02) was detected in the 2×2 analysis with serum zinc concentration as the outcome: the MMN group had a higher mean serum zinc concentration at 12 wk (12.3 μmol/L; 95% CI: 12.2, 12.4 μmol/L) compared with all other groups, and the Fe+MMN group had a higher mean serum zinc concentration (11.6 μmol/L; 95% CI: 11.5, 11.7 μmol/L) compared with the Fe group (11.0 μmol/L; 95% CI: 10.9, 11.0 μmol/L) and the placebo group (11.2 μmol/L; 95% CI: 11.1, 11.4 μmol/L). The inclusion of 60 mg iron in the daily MMN formulation may be interfering with the absorption and/or metabolism of supplemental zinc in Cambodian women. This is of particular concern when MMN supplementation is implemented in populations with risk of zinc deficiency. This trial was registered at clinicaltrials.gov as NCT-02481375.

PT06.1: Effects Of Krill Oil on Omega-3 Index and Cardiometabolic Risk Factors in Patients with Non-Alcoholic Fatty Liver Disease (NAFLD): Pilot Randomized Double-Blind Trial

PT06.1: Effects Of Krill Oil on Omega-3 Index and Cardiometabolic Risk Factors in Patients with Non-Alcoholic Fatty Liver Disease (NAFLD): Pilot Randomized Double-Blind Trial

Bacterial colonization of seromas after breast cancer surgery with and without local steroid prophylaxis

BackgroundSeroma formation is a frequent postoperative sequela after mastectomy for primary breast cancer. We investigated the role of bacterial colonization of seroma fluid with three different culture methods and the effect of intracavitary steroids.MethodsThe study group consisted of 212 patients scheduled for mastectomy from a previously performed double-blind randomized placebo-controlled intervention trial. The patients were allocated to a single dose of 80 mg of steroids (methylprednisolone) or saline, and the effect on seroma formation was investigated. From each aspiration, an equal volume of seroma fluid (10 mL) was distributed into one sterile transport tube (conventional method), one aerobic blood culture bottle and one anaerobic blood culture bottle.ResultsThere was significant variation in the number of bacterial species detected in seroma samples among the three culture methods, ranging from 18 species with the conventional culture tubes to 40 species with aerobic blood culture bottles. Patients receiving prophylactic steroids had significantly more frequent colonization than those in the saline group. Nevertheless, the clinical surgical site infection rate of 7.0% was equal between the two groups.ConclusionsIn general, data analysis of the entire set of case material did not succeed in demonstrating a relationship between a specific bacterial species or a combination of species and seroma formation. However, in the few patients with growth of a pathogenic species, both the duration of seroma formation and volume of seroma fluid were more pronounced.Trial registration: Ethics Committee of Copenhagen (H-4-2009-137), (EudraCT number 2009-016650-40), the Danish Data Protection Agency (code J. no. F.750.75-2), and the Danish Health and Medicines Authority (sponsor protocol code number 23837). Start date November 2010.