Search results for: placebo

Authors: Sara Nasiri Semnani, Alireza Ramzani

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Background and Aims: Sodium bicarbonate is a supplementation that used to reduce fatigue and increase power output in short-term training. On the other hand, the Ischemic Reperfusion Preconditioning (IRPC) is an appropriate stimulus to increase the submaximal contractile response. Materials and methods: 9 female student-athletes in double-blind randomized crossover design were three mode, sodium bicarbonate + IRPC, sodium bicarbonate and placebo+ IRPC. Participants moved forward single arm dumbbell hand with a weight of 2 kg can be carried out most frequently. Results: The results showed that plasma lactate concentration and records of sodium bicarbonate + IRPC and sodium bicarbonate conditions were significantly different compared to placebo + IRPC (Respectively p=0.001, p=0/02). Conclusion: According to the research findings, bicarbonate supplementation in IRPC training condition increased force and delay fatigue in submaximal dynamic contraction.

Keywords: ischemic reperfusion, preconditioning, sodium bicarbonate, submaximal dynamic force

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Authors: Sara Ataei, Molouk Hadjibabaie, Amirhossein Moslehi, Maryam Taghizadeh-Ghehi, Asieh Ashouri, Elham Amini, Kheirollah Gholami, Alireza Hayatshahi, Mohammad Vaezi, Ardeshir Ghavamzadeh

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Acute kidney injury (AKI) is one of the complications of hematopoietic stem cell transplantation and is associated with increased mortality. N-acetylcysteine (NAC) is a thiol compound with antioxidant and vasodilatory properties that has been investigated for the prevention of AKI in several clinical settings. In the present study, we evaluated the effects of intravenous NAC on the prevention of AKI in allogeneic hematopoietic stem cell transplantation patients. A double-blind randomized placebo-controlled trial was conducted, and 80 patients were recruited to receive 100 mg/kg/day NAC or placebo as intermittent intravenous infusion from day -6 to day +15. AKI was determined on the basis of the Risk-Injury-Failure-Loss-Endstage renal disease and AKI Network criteria as the primary outcome. We assessed urine neutrophil gelatinase-associated lipocalin (uNGAL) on days -6, -3, +3, +9, and +15 as the secondary outcome. Moreover, transplant-related outcomes and NAC adverse reactions were evaluated during the study period. Statistical analysis was performed using appropriate parametric and non-parametric methods including Kaplan–Meier for AKI and generalized estimating equation for uNGAL. At the end of the trial, data from 72 patients were analyzed (NAC: 33 patients and placebo: 39 patients). Participants of each group were not different considering baseline characteristics. AKI was observed in 18% of NAC recipients and 15% of placebo group patients, and the occurrence pattern was not significantly different (p = 0.73). Moreover, no significant difference was observed between groups for uNGAL measures (p = 0.10). Transplant-related outcomes were similar for both groups, and all patients had successful engraftment. Three patients did not tolerate NAC because of abdominal pain, shortness of breath and rash with pruritus and were dropped from the intervention group before transplantation. However, the frequency of adverse reactions was not significantly different between groups. In conclusion, our findings could not show any clinical benefits from high-dose NAC particularly for AKI prevention in allogeneic hematopoietic stem cell transplantation patients.

Keywords: acute kidney injury, N-acetylcysteine, hematopoietic stem cell transplantation, urine neutrophil gelatinase-associated lipocalin, randomized controlled trial

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Authors: Mohammad Khazaei, Reza Rostami, Hassan Gharayagh Zandi, Ruhollah Basatnia, Mahboubeh Ghayour Najafabadi

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Introduction: This study delves into the influence of diverse interventions on brain functional connectivity among young male basketball players. Given the significance of understanding how interventions affect cognitive functions in athletes, particularly in the context of basketball, this research contributes to the growing body of knowledge in sports neuroscience. Methods: Three distinct groups were selected for comprehensive investigation: the Motivational Interview Group, Placebo Consumption Group, and Ritalin Consumption Group. The study involved assessing brain functional connectivity using various frequency bands (Delta, Theta, Alpha, Beta1, Beta2, Gamma, and Total Band) before and after the interventions. The participants were subjected to specific interventions corresponding to their assigned groups. Results: The findings revealed substantial differences in brain functional connectivity across the studied groups. The Motivational Interview Group exhibited optimal outcomes in PLI (Total Band) connectivity. The Placebo Consumption Group demonstrated a marked impact on PLV (Alpha) connectivity, and the Ritalin Consumption Group experienced a considerable enhancement in imCoh (Total Band) connectivity. Discussion: The observed variations in brain functional connectivity underscore the nuanced effects of different interventions on young male basketball players. The enhanced connectivity in specific frequency bands suggests potential cognitive and performance improvements. Notably, the Motivational Interview and Placebo Consumption groups displayed unique patterns, emphasizing the multifaceted nature of interventions. These findings contribute to the understanding of tailored interventions for optimizing cognitive functions in young male basketball players. Conclusion: This study provides valuable insights into the intricate relationship between interventions and brain functional connectivity in young male basketball players. Further research with expanded sample sizes and more sophisticated statistical analyses is recommended to corroborate and expand upon these initial findings. The implications of this study extend to the broader field of sports neuroscience, aiding in the development of targeted interventions for athletes in various disciplines.

Keywords: electroencephalography, Ritalin, Placebo effect, motivational interview

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Authors: Emad Kouhestani

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Background: Despite the enormous success of anterior cruciate ligament (ACL) reconstruction, acute neuropathic pain can develop postoperatively and is both distressing and difficult to treat once established. Pregabalin, as an anticonvulsant agent that selectively affects the nociceptive process, has been used as a pain relief agent. The purpose of this systematic review of randomized controlled trials (RCTs) was to evaluate the pain control effect of pregabalin versus placebo after ACL reconstruction. Method: A search of the literature was performed from inception to June 2022, using PubMed, Scopus, Google Scholar, Web of Science, Cochrane, and EBSCO. Studies considered for inclusion were RCTs that reported relevant outcomes (postoperative pain scores, or cumulative opioid consumption, adverse events) following the administration of pregabalin in patients undergoing ACL reconstruction. Result: Five placebo-controlled RCTs involving 272 participants met the inclusion criteria. 75 mg and 150 mg of oral pregabalin were used in included trials. Two studies used a single dose of pregabalin one hour before anesthesia induction. Two studies used pregabalin 1 hour before anesthesia induction and 12 hours after. One study used daily pregabalin 7 days before and 7 days after surgery. Out of five papers, three papers found significantly lower pain intensity and cumulative opioid consumption in the pregabalin group compared with the placebo group. However, a decrease in pain scores was found in all trials. Pregabalin administration was associated with dizziness and nausea. Conclusion: The use of pregabalin may be a valuable asset in pain management after ACL reconstruction. However, future studies with larger sample sizes and longer follow-up periods are required.

Keywords: pregabalin, anterior cruciate ligament, postoperative pain, clinical trial

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Authors: Jawaher F. Alsharef, Abdullah A. Ghaddaf, Mohammed S. Alomari, Abdullah A. Al Qurashi, Ahmed S. Abdulhamid, Mohammed S. Alshehri, Majed Alosaimi

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Botulinum toxin type A (BTX-A) is the most popular therapeutic agent for muscle relaxation and pain control. Lately, BTX-A injection received great interest as a part of multimodal pain management for lower limb lengthening and deformity correction. This systematic review aimed to determine the role of BTX-A injection in pain management for during lower limb lengthening and/or deformity correction. We searched Medline, Embase, and CENTRAL. We included randomized controlled trials (RCTs) that compared the BTX-A injection to placebo for individuals undergoing lower limb lengthening and/or deformity correction. We sought to evaluate the following outcomes: pain on visual analogue scale (VAS), range of motion parameters, average opioid consumption, and adverse events. The standardized mean difference (SMD) was used to represent continuous outcomes while risk ratio (RR) was used to represent dichotomous outcomes. A total of 4 RCTs that enrolled 257 participants (337 limbs) deemed eligible. Adjuvant BTX-A injection showed a significant reduction in post-operative pain compared to placebo (SMD=–0.28, 95% CI –0.53 to –0.04). No difference was found between BTX-A injection and placebo in terms of range of motion parameters, average opioid consumption, or adverse events after surgical limb lengthening and/or deformity correction (RR= 0.77, 95% CI –0.58 to 1.03). Conclusions: Adjuvant BTX-A injection conferred a discernible reduction in post-operative pain during surgical limb lengthening and/or deformity without increasing the risk of adverse events.

Keywords: botulinum toxin type A, limb lengthening, distraction osteogenesis, deformity correction, pain management

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Authors: Ashti Morovati, Hushyar Azari, Bahram Pourghassem Gargari

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Objectives and goals: The prevalence of metabolic syndrome (MetS), as a major health burden for societies, is increasing. This clinical trial was conducted to evaluate the effects of CuEO supplementation on anthropometric indices, systolic and diastolic blood pressure, blood glucose level, insulin resistance and serum lipid level in patients suffering from MetS. Methods: This was a randomized, triple‐blind, placebo‐controlled clinical trial in which 56 patients with MetS aged 18–60 years who fulfilled the eligibility criteria were randomly allocated to an intervention or a control group. Inclusion criteria for the study were comprised of diagnosis of MetS according to the new International Federation of Diabetes. The exclusion criteria were defined as: taking herbal supplements, use of drugs having evident interaction with cumin such as anti‐depressant drugs, vitamin D, omega 3, selenium, zinc, smoking, pregnancy, or breastfeeding, suffering from cancer, having any history of gastrointestinal and hepatic, cardiovascular, thyroid and kidney disorders, and menopause. 75 mg CuEO or placebo soft gels were administered three times daily to the participants for eight weeks. The soft gel consumption was checked by asking the participants to bring the medication containers in the follow‐up visits at the 4th and the 8th weeks of the study. Data pertaining to blood pressure, height, weight, waist circumference, hip circumference and BMI, as well as food consumption were collected at the beginning and end of the study. Fasting blood samples ( glucose, triglyceride, total cholesterol, HDL-cholesterol and LDL-cholesterol) were obtained and biochemical measurements were assessed at the beginning and end of the study. Results: At eight weeks, a total of 44 patients completed this study. Except for diastolic blood pressure (DBP), the other assessed variables were not significantly different between the two groups. In intra group analysis, placebo and CuEO groups both had insignificant decrements in DBP (mean difference [MD] with 95% CI: −3.31 [−7.11, 0.47] and −1.77 [−5.95, 2.40] mmHg, respectively). However, DBP was significantly lower in CuEO compared with the placebo group at the end of study (81.41 ± 5.88 vs. 84.09 ± 5.54 mmHg, MD with 95% CI: −3.98 [−7.60, −0.35] mmHg, p < .05). Conclusions: The results of this study indicated that CuEO does not have any effect on MetS components, except for DBP in patients with MetS.

Keywords: blood pressure, fasting blood glucose, lipid profile, waist circumference

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Authors: M. G. Nasuruddin, S. Ishak

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In anthropological medicine (traditional therapeutic healing) symbolic interface are used to connect with the cognitive and metacognitive mechanisms to activate conscious and unconscious response of patients or other recipients. At the same time they are used to communicate with the inhabitants of the nether world to whom are ascribed almost all cases of psychosomatic illness. The symbols, which are cultural specific, are divided into verbal and non-verbal forms of communication. The verbal forms are chanting of mantra and doa and the invocation to invoke the spirits while the non-verbal ones are the physical materials such as the offerings, props and decorative elements, music, movements, olfactory sensation and the performance space. The process of communication through these symbols is affected by the Shaman who is a link or intermediary between the healer (Shaman) and the patients and between the healer and the spirits of the nether world. The paper also examines the scientific perspective of the traditional healing through the use of these symbols. The response to these symbols as external stimuli is embedded in the genes that are linked to the hereditary factor in the person’s DNA. When the patients are tuned in to external stimuli such as music, chanting and singing (sonic orders), it can triggers a response from the brain, which may activate its inner pharmacy by releasing drugs such as dopamine and/or opiodsto ameliorate pain and counter depression, anxiety and create a feel good feeling. These symbols act like placebo, evoking the power of the mind over the body and triggering the innate self-healing energy. At the same time they could also be used as nocebo, for example black magic, which has the opposite effect of placebo. In whatever capacity they operate these symbols, which are either visual or auditory, is an integral part of anthropological medicine. For they communicate and conjure emotional responses that are conducive to healing by activating the internal brain pharmacy.

Keywords: communication, healing, placebo, nacebo, symbol

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Authors: Samaneh Rahsepar, Mehrzad Moghadasi

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To evaluate the effect of Test Pump supplement on the physiological and functional performance of futsal women, twenty female futsal subjects were divided into two groups: placebo (n = 10) and supplement (n = 10) and were given buccal tablets for 7 days and 12 g daily supplement each day. The placebo group used starch powder during this period. Speed, agility with ball, agility without ball and dribbling time were measured before and after supplementation. In addition, the rate of heart rate and blood pressure changes were measured before and after the YOYO test. The results showed that the test pump had no significant effect on improving speed, agility with ball, agility without ball, dribbling time and heart rate changes and diastolic blood pressure, and only affect the maximum oxygen consumption and systolic blood pressure (P <0.05). In general, the use of the test-pump supplement does not have a significant effect on the physiological and functional performance of futsal women. The results of this study showed that the use of supplementary pump tests on women's futsal heart rate changes after loading period had a significant difference between the two groups in resting heart rate with heart rate after exercise and 5 minutes after exercise. However, it did not have a significant effect on the increase in heart rate. Supplementation significantly increased systolic blood pressure after exercise compared to resting blood pressure, as well as a significant increase in systolic blood pressure after exercise compared to resting systolic blood pressure and 5 minutes after exercise in both groups from the loading period. On the other hand, there was a significant difference in systolic blood pressure in both placebo and supplemented groups.

Keywords: test pump supplement, women, speed, dribble, agility, maximum oxygen consumption, cardiovascular

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Authors: M. Varmaziar

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Magnesium (Mg) is an essential mineral that plays a crucial role in the human body. Certain types of foods, including nuts, grains, fruits, vegetables, and whole grains, are rich sources of magnesium. Mg serves as an essential cofactor for numerous enzymatic reactions, including energy metabolism, cellular growth, glycolysis, and protein synthesis. The Mg-ATP complex serves as an energy source and is vital for many physiological functions, including nerve conduction, muscle contraction, and blood pressure regulation. Despite the vital role of magnesium in energy metabolism, maintaining adequate magnesium intake is often overlooked among the general population and athletes. The aim of this study was to investigate the effect of magnesium supplementation on the physical activities of field athletes. Field athletes were divided into two groups: those who consumed magnesium supplements and those who received a placebo. These two groups received either 500 mg of magnesium oxide or a placebo daily for 8 weeks. At the beginning and end of the study, athletes completed ISI questionnaires and physical activity assessments. Nutritional analyses were performed using N4 software, and statistical analyses were conducted using SPSS19 software. The results of this study revealed a significant difference between the two study groups. Athletes who received magnesium supplements experienced less fatigue related to field athletic activities and muscle soreness. In contrast, athletes who received the placebo reported more significant fatigue and muscle soreness. A concerning finding in these results is that the performance of athletic activities may be at risk with low magnesium levels. Therefore, magnesium is essential for maintaining health and plays a crucial role in athletic performance. Consuming a variety of magnesium-rich foods ensures that individuals receive an adequate amount of this essential nutrient in their diet. The consumption of these foods improves performance parameters in athletic exercises.

Keywords: athletic performance, effect, field athletes, magnesium supplement

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Authors: Maryam Rafraf, Aida Ghaffari

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Objectives: Nonalcoholic fatty liver disease (NAFLD) is considered as an independent risk factor for cardiovascular disease (CVD). Dyslipidemia contributes to the enhanced risk of CVD in persons with NAFLD. This study aimed to investigate the effects of turmeric supplementation on serum lipids levels in patients with NAFLD. Methods: In this double-blind, randomized, controlled clinical trial, 46 NAFLD patients (21 males and 25 females; age range, 20 – 60 years) were randomly assigned in the two groups. The intervention and control groups received 3g of turmeric (n = 23) and placebo (n = 23), daily for 12 weeks. Fasting blood samples were collected at baseline and at the end of the trial. Results: Turmeric supplementation significantly increased serum levels of HDL-C compared with the placebo group at the end of the study (by 12.73%, P < 0.05). Serum levels of triglyceride, total cholesterol, and low-density lipoprotein cholesterol were significantly reduced within turmeric group at the end of the study (P < 0.05). Conclusions: Turmeric consumption had beneficial effects on serum lipids levels of subjects and may be useful in controlling of CVD risk factors in NAFLD patients.

Keywords: nonalcoholic fatty liver, serum lipids, supplementation, turmeric

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Authors: Wanvipa Thongborisute, Punyaphat Sirithanabadeekul, Pichit Suvanprakorn, Anan Jiraviroon

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Background: Acne vulgaris is one of the most common dermatologic problems, and can have a significant psychological and physical effect on patients. Propionibacterium acnes' roles in acne vulgaris involve the activation of toll-like receptor 4 (TLR4), and toll-like receptor 2 (TLR2) pathways. By activating these pathways, inflammatory events of acne lesions, comedogenesis and sebaceous lipogenesis can occur. Currently, there are several topical agents commonly use in treating acne vulgaris that are known to have an effect on TLRs, such as retinoic acid and adapalene, but these drugs still have some irritating effects. At present, there is an alarming increase in rate of bacterial resistance due to irrational used of antibiotics both orally and topically. For this reason, acne treatments should contain bioactive molecules targeting at the site of action for the most effective therapeutic effect with the least side effects. Sparganium stoloniferumis a Chinese aquatic herb containing a compound called Sparstolonin B (SsnB), which has been reported to selectively blocks Toll-like receptor 2 (TLR2) and Toll-like receptor 4 (TLR4)-mediated inflammatory signals. Therefore, this topical TLR2 and TLR4 antagonist, in a form of Sparganium stoloniferum-derived compound containing SsnB, should give a benefit in reducing inflammation of acne vulgaris lesions and providing an alternative treatments for patients with this condition. Materials and Methods: The objectives of this randomized double blinded split faced placebo controlled trial is to study the safety and efficacy of the Sparganium stoloniferum-derived compound. 32 volunteered patients with mild to moderate degree of acne vulgaris according to global acne grading system were included in the study. After being informed and consented the subjects were given 2 topical treatments for acne vulgaris, one being topical 2.40% Sparganium stoloniferum extraction (containing Sparstolonin B) and the other, placebo. The subjects were asked to apply each treatment to either half of the face daily morning and night by randomization for 8 weeks, and come in for a weekly follow up. For each visit, the patients went through a procedure of lesion counting, including comedones, papules, nodules, pustules, and cystic lesions. Results: During 8 weeks of experimentation, the result shows a reduction in total lesions number between the placebo and the treatment side show statistical significance starting at week 4, where the 95% confidence interval begin to no longer overlap, and shows a trend of continuing to be further apart. The decrease in the amount of total lesions between week 0 and week 8 of the placebo side shows no statistical significant at P value >0.05. While the decrease in the amount of total lesions of acne vulgaris of the treatment side comparing between week 0 and week 8 shows statistical significant at P value <0.001. Conclusion: The data demonstrates that 2.40% Sparganium stoloniferum extraction (containing Sparstolonin B) is more effective in treating acne vulgaris comparing to topical placebo in treating acne vulgaris, by showing significant reduction in the total numbers of acne lesions. Therefore, this topical Sparganium stoloniferum extraction could become a potential alternative treatment for acne vulgaris.

Keywords: acne vulgaris, sparganium stoloniferum, sparstolonin B, toll-like receptor 2, toll-like receptor 4

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Authors: Muhammad Imran Hussain, Ramisha Ibtisam, Tayyaba Fatima, Huba Khalid, Ayesha Aziz, Khansa, Adan Sitara, Anam Shahzad, Aymen Jabeen

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Vitamin D supports the immune system fight TB by inhibiting Interferon-gamma (IFN-γ) and lowering host inflammation. The purpose of the research was to see if giving the vitamin D supplements to TB patients affected their prognosis. A randomized placebo control study of 200 TB patients was performed among which 106 received 400,000 IU of injectable vitamin D3 and 94 received placebo for 2 doses. Assessment was carried out at the end of every month for 3 months. IFN-γ responses to whole blood stimulation generated by the Mycobacterium tuberculosis sonicate (MTBs) antigen and early secreted and T cell activated 6 kDa (ESAT6) were assessed at 0 and 12 weeks. The statistical analysis used descriptive statistics (mean and standard deviation), Friedman's test and Fisher's test. The vitamin D group gained significantly more weight (+3.90 pounds) and had less persistent lung disease on imaging (1.33 zones vs. 1.84 zones). They also had a 50% decrease in cavity size. Additionally, patients with low baseline serum concentrations of 25-(OH)D had a significant increase in MTB-induced IFN-γ production after taking vitamin D supplements. Vitamin D administration in large amounts can hasten the recovery of TB patients. The findings point is a therapeutically useful activity of Vitamin D's in the management for tuberculosis.

Keywords: tuberculosis, vitamin D, interferon gamma, protein, infection

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Authors: Alireza Barari, Saeed Shirali

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The etiology of obesity is heterogeneous with several factors, and the pathophysiology of obesity has recently related to leptin, oxidative damage, and inflammation. Silybum marianum have a health-promoting perspective and has shown that bioactive molecules of silymarin have the antioxidant and antitumor properties and can affect secretion of hormones and enzyme activity in animal. This study aimed to evaluate the antioxidant effects and changes in hormonal levels and body composition after silymarin consumption. Forty-five healthy untrained colleges male take part in the 4-week investigation. The subjects were assigned to 5 groups: endurance training, Silymarin with endurance training, strength training with placebo, Silymarin with strength training or placebo. Body fat percentage and Blood sample analysis were measured before and after the intervention to assay leptin, adiponectin and paraoxonase in the sample of subject's serum. There was a considerable decrease in body fat percent and a significant increase in VO2 max in 'Strength training' and 'Strength training with Silymarin' groups. But, no significant changes in levels of leptin, adiponectinin, and paraoxanase (PON) that were observed between exercise and exercise with Silymarin in these groups. We observed reduction in body fat% and increase in adiponectin induced by exercise for 4 weeks in untrained healthy men. Silybin, could not effectively improve all parameters and don’t prevent the progression of cell damage by antioxidant activity of PON.

Keywords: anti-inflammatory activity, antioxidant activity, silymarin, body composition, paraoxonase (PON)

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Authors: Camila Lemos Pinto, Juliana Alves Carneiro, Patrícia Borges Botelho, João Felipe Mota

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Sarcopenia, a syndrome characterized by progressive and generalized loss of skeletal muscle mass and strength, currently affects over 50 million people and increases the risk of adverse outcomes such as physical disability, poor quality of life and death. The aim of this study was to examine the efficacy of creatine supplementation associated with resistance training on muscle mass in the elderly. A 12-week, double blind, randomized, parallel group, placebo controlled trial was conducted. Participants were randomly allocated into one of the following groups: placebo with resistance training (PL+RT, n=14) and creatine supplementation with resistance training (CR + RT, n=13). The subjects from CR+RT group received 5 g/day of creatine monohydrate and the subjects from the PL+RT group were given the same dose of maltodextrin. Participants were instructed to ingest the supplement on non-training days immediately after lunch and on training days immediately after resistance training sessions dissolved in a beverage comprising 100 g of maltodextrin lemon flavored. Participants of both groups undertook a supervised exercise training program for 12 weeks (3 times per week). The subjects were assessed at baseline and after 12 weeks. The primary outcome was muscle mass, assessed by dual energy X-ray absorptiometry (DXA). The secondary outcome included diagnose participants with one of the three stages of sarcopenia (presarcopenia, sarcopenia and severe sarcopenia) by skeletal muscle mass index (SMI), handgrip strength and gait speed. CR+RT group had a significant increase in SMI and muscle (p<0.0001), a significant decrease in android and gynoid fat (p = 0.028 and p=0.035, respectively) and a tendency of decreasing in body fat (p=0.053) after the intervention. PL+RT only had a significant increase in SMI (p=0.007). The main finding of this clinical trial indicated that creatine supplementation combined with resistance training was capable of increasing muscle mass in our elderly cohort (p=0.02). In addition, the number of subjects diagnosed with one of the three stages of sarcopenia at baseline decreased in the creatine supplemented group in comparison with the placebo group (CR+RT, n=-3; PL+RT, n=0). In summary, 12 weeks of creatine supplementation associated with resistance training resulted in increases in muscle mass. This is the first research with elderly of both sexes that show the same increase in muscle mass with a minor quantity of creatine supplementation in a short period. Future long-term research should investigate the effects of these interventions in sarcopenic elderly.

Keywords: creatine, dietetic supplement, elderly, resistance training

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Authors: Seyyed Javad Ziaolhagh

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Background: The purpose of present study was to investigate, the effects of anabolic steroid Boldenone (BOL) with eight weeks of resistance training on structural changes in rat liver. Method: 21 Male adult Wistar rats, 12 weeks old and 228/53±7/94 g initial body weight were randomly assigned to three groups: group1: Control+ Placebo (C), group2: training+ Placebo (T), group3: Boldenone intramuscular injections 5mg/kg (B). The endurance training protocol consisted three exercise sessions weekly started by a 30-minute run with the speed of 12 m/min and lasted by 60min run with the speed of 30 m/min in 8 weeks. At the end of the experiment, for light microscopic study Slides were prepared. Results: Sections stained of rat's livers showed no any cell degeneration and cytoplasmic lipid vacuoles in all groups, but few samples were seen. Indeed, congested blood sinusoids, cell infiltration and degeneration were seen in the Boldenone-treated group. Hepatotoxic effects were severe in group treatment received 5 mg/kg and directly depended on the doses. Indeed, training group was no any hepatocyte degeneration, inflammation and congestion. Conclusion: The present results showed that BOL has a marked adverse effect on the liver tissue, even with low– dose and endurance training. As a result, athletes should aware of Boldenone dosage consumption.

Keywords: anabolic androgenic steroids, Boldenone, blood congestion, cellular inflammation, cellular degeneration, lipid vocuolations, endurance training

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Authors: Giannis Arnaoutis, Dimitra Efthymiopoulou, Maria-Foivi Nikolopoulou, Yannis Manios

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AIM: Nitrate-containing supplements have been used extensively as ergogenic in many sports. However, extract fractions from plant-based nutritional sources high in nitrate and their effect on athletic performance, has not been systematically investigated. The purpose of the present study was to examine the possible effect of acute consumption of a “smart mixture” from beetroot and rocket on exercise capacity. MATERIAL & METHODS: 12 healthy, nonsmoking, recreationally active, males (age: 25±4 years, % fat: 15.5±5.7, Fat Free Mass: 65.8±5.6 kg, VO2 max: 45.46.1 mL . kg -1 . min -1) participated in a double-blind, placebo-controlled trial study, in a randomized and counterbalanced order. Eligibility criteria for participation in this study included normal physical examination, and absence of any metabolic, cardiovascular, or renal disease. All participants completed a time to exhaustion cycling test at 75% of their maximum power output, twice. The subjects consumed either capsules containing 360 mg of nitrate in total or placebo capsules, in the morning, under fasted state. After 3h of passive recovery the performance test followed. Blood samples were collected upon arrival of the participants and 3 hours after the consumption of the corresponding capsules. Time until exhaustion, pre- and post-test lactate concentrations, and rate of perceived exertion for the same time points were assessed. RESULTS: Paired-sample t-test analysis found a significant difference in time to exhaustion between the trial with the nitrate consumption versus placebo [16.1±3.0 Vs 13.5±2.6 min, p=0.04] respectively. No significant differences were observed for the concentrations of lactic acid as well as for the values in the Borg scale between the two trials (p>0.05). CONCLUSIONS: Based on the results of the present study, it appears that a nutritional supplement derived from vegetable extracts rich in nitrate, improves athletic performance in recreationally active young males. However, the precise mechanism is not clear and future studies are needed. Acknowledgment: This research has been co‐financed by the European Regional Development Fund of the European Union and Greek national funds through the Operational Program Competitiveness, Entrepreneurship and Innovation, under the call RESEARCH – CREATE – INNOVATE (project code:T2EDK-00843).

Keywords: sports performance, ergogenic supplements, nitrate, extract fractions

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Authors: Joe Collins, Matthias Rother

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Background: Oral non-steroidal anti-inflammatory drugs (NSAIDs) are widely used for the relief of joint pain during and post-exercise. However, oral NSAIDs increase the risk of systemic side effects, even in healthy individuals, and retard recovery from muscle soreness. TDT 064 (Flexiseq®), a topical formulation containing ultra-deformable drug-free Sequessome™ vesicles, has demonstrated equivalent efficacy to oral celecoxib in reducing osteoarthritis-associated joint pain and stiffness. TDT 064 does not cause NSAID-related adverse effects. We describe clinical study data and a case report on the effectiveness of TDT 064 in reducing joint pain after exercise. Methods: Participants with a pain score ≥3 (10-point scale) 12–16 hours post-exercise were randomized to receive TDT 064 plus oral placebo, TDT 064 plus oral ketoprofen, or ketoprofen in ultra-deformable phospholipid vesicles plus oral placebo. Results: In the 168 study participants, pain scores were significantly higher with oral ketoprofen plus TDT 064 than with TDT 064 plus placebo in the 7 days post-exercise (P = 0.0240) and recovery from muscle soreness was significantly longer (P = 0.0262). There was a low incidence of adverse events. These data are supported by clinical experience. A 24-year-old male professional rugby player suffered a traumatic lisfranc fracture in March 2014 and underwent operative reconstruction. He had no relevant medical history and was not receiving concomitant medications. He had undergone anterior cruciate ligament reconstruction in 2008. The patient reported restricted training due to pain (score 7/10), stiffness (score 9/10) and poor function, as well as pain when changing direction and running on consecutive days. In July 2014 he started using TDT 064 twice daily at the recommended dose. In November 2014 he noted reduced pain on running (score 2-3/10), decreased morning stiffness (score 4/10) and improved joint mobility and was able to return to competitive rugby without restrictions. No side effects of TDT 064 were reported. Conclusions: TDT 064 shows efficacy against exercise- and injury-induced joint pain, as well as that associated with osteoarthritis. It does not retard muscle soreness recovery after exercise compared with an oral NSAID, making it an alternative approach for the treatment of joint pain during and post-exercise.

Keywords: exercise, joint pain, TDT 064, phospholipid vesicles

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Authors: Mohammad Soltani, Ayoub Saeidi, Nikoo Khosravi, Hanieh Nohbaradar, Seyedeh Parya Barzanjeh, Hassane Zouhal

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Exercise training and herbs supplement represent have role in the treatment for patients with type 2 diabetes (T2D). However, it is unclear combined effects of exercise training and herbs supplements on diabetic risk markers. This study aimed to determine the effect of 12 weeks of combined exercise and broccoli supplementation on decitin-1 and insulin resistance in men with type 2 diabetes. Forty-four type 2 diabetes men (age, 48.52 ± 4.36) were randomly allocated to training -supplement (TS, n = 11), training- placebo (TP, n = 11), supplement (S, n = 11) and control- placebo (CP, n = 11) groups. The combined exercise program included 12 weeks, three sessions per week, that each session contained 45 minutes of resistance training with intensity 60-70% of one maximal repetition and 30 minutes aerobic training (running) with intensity 60-70% of maximum heart rate. In addition supplement groups consumed 10 grams of Broccoli per day for 12 weeks. Plasma Decitin-1, HOMA-IR, Insulin, glucose and body composition were assessed before and after training. Plasma Dectin-1, HOMA-IR, glucose and BMI significantly decreased in TS, TP and S groups compared with CP group (P < .05). In addition Insulin and skeletal muscles mass showed significant increase in TS and TP groups compared with S and CP groups (P < .05). It is concluded that both combined exercise training (aerobic-resistance) or broccoli supplement can improve plasma Decitin-1 and insulin resistance in two diabetic patients however combine of exercise training and broccoli supplement have more effective on these markers.

Keywords: broccoli supplements, combined training, decitin-1, insulin resistance, type 2 diabetes

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Authors: M. A. Abdel-Wahed, Nayera Elmorsi Hassan, Safaa Shafik Imam, Ola G. El-Farghali, Khadija M. Alian

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Low-birth-weight is a challenging public health problem. Aim: to clarify role of zinc on enhancing catch-up growth of low-birth-weight and find out a proposed relationship between zinc effect on growth and the main growth hormone mediator, IGF-1. Methods: Study is a double-blind-randomized-placebo-controlled trial conducted on low-birth-weight-neonates delivered at Ain Shams University Maternity Hospital. It comprised 200 Low-birth-weight-neonates selected from those admitted to NICU. Neonates were randomly allocated into one of the following two groups: group I: low-birth-weight; AGA or SGA on oral zinc therapy at dose of 10 mg/day; group II: Low-birth-weight; AGA or SGA on placebo. Anthropometric measurements were taken including birth weight, length; head, waist, chest, mid-upper arm circumferences, triceps and sub-scapular skin-fold thicknesses. Results: At 12-month-old follow-up visit, mean weight, length; head (HC), waist, chest, mid-upper arm circumferences and triceps; also, infant’s proportions had values ≥ 10th percentile for weight, length and HC were significantly higher among infants of group I when compared to those of group II. Oral zinc therapy was associated with 24.88%, 25.98% and 19.6% higher proportion of values ≥ 10th percentile regarding weight, length and HC at 12-month-old visit, respectively [NNT = 4, 4 and 5, respectively]. Median IGF-1 levels measured at 6 months were significantly higher in group I compared to group II (median (range): 90 (19 – 130) ng/ml vs. 74 (21 – 130) ng/ml, respectively, p=0.023). Conclusion: Oral zinc therapy in low-birth-weight neonates was associated with significantly more catch-up growth at 12-months-old and significantly higher serum IGF-1 at 6-month-old.

Keywords: low-birth-weight, zinc, catch-up growth, neonates

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Authors: Masoumeh Khailghi Sikaroudi, Mohsen Masoodi, Fazad Shidfar, Meghdad Sedaghat

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Background: The hypertonicity of internal anal sphincter resting pressure is one of the main reasons for chronic anal fissures. The aim of this study is to assess the effect of oral administration of L-arginine on anal fissure symptom improvement by relaxation of the internal anal sphincter. Method: Seventy-six chronic anal fissure patients (age: 18-65 years) took part in this randomized, double-blind, placebo-controlled trial study from February 2019 to October 2020 at Rasoul-e-Akram Hospital, Tehran, Iran. Participants were allocated into treatment (L-arginine) or placebo groups. They took a 1000 mg capsule three times a day for one month and were followed up at the end of the first and third months after receiving the intervention. Clinical symptoms, anal sphincter resting pressure, and quality of life (QoL) were completed at baseline and the end of the study. Result: The analysis of data was shown significant improvement in bleeding, fissure size, and pain within each group; however, this effect was more seen in the arginine group compared to the control group at the end of the study (P-values<0.001). Following that, a significant increase in QoL was seen just in patients who were treated with arginine (P-value=0.006). Also, the comparison of anal pressures to baseline and between groups at the end of the study showed a significant reduction in sphincter pressure in treated patients (P-value<0.001, =0.049; respectively). Conclusion: Oral administration of 3000 mg L-arginine can heal chronic anal fissures by reducing anal internal sphincter pressure with fewer side effects. However, a long-term study with more follow-up is recommended.

Keywords: L-arginine, anal fissure, sphincter pressure, clinical symptoms, quality of life

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Authors: Neil Singla, Derek Muse, Karen DiDonato, Pamela Palmer

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Introduction: Pain is the most common reason people visit emergency rooms. Studies indicate however, that Emergency Department (ED) physicians often do not provide adequate analgesia to their patients as a result of gender and age bias, opiophobia and insufficient knowledge of and formal training in acute pain management. Novel classes of analgesics have recently been introduced, but many patients suffer from acute pain in settings where the availability of intravenous (IV) access may be limited, so there remains a clinical need for rapid-acting, potent analgesics that do not require an invasive route of delivery. A sublingual sufentanil tablet (SST), dispensed using a single-dose applicator, is in development for treatment of moderate-to-severe acute pain in a medically-supervised setting. Objective: The primary objective of this study was to demonstrate the repeat-dose efficacy, safety and tolerability of sufentanil 20 mcg and 30 mcg sublingual tablets compared to placebo for the management of acute pain as determined by the time-weighted sum of pain intensity differences (SPID) to baseline over the 12-hour study period (SPID12). Key secondary efficacy variables included SPID over the first hour (SPID1), Total pain relief over the 12-hour study period (TOTPAR12), time to perceived pain relief (PR) and time to meaningful PR. Safety variables consisted of adverse events (AE), vital signs, oxygen saturation and early termination. Methods: In this Phase 2, double-blind, dose-finding study, an equal number of male and female patients were randomly assigned in a 2:2:1 ratio to SST 20 mcg, SS 30 mcg or placebo, respectively, following bunionectomy. Study drug was dosed as needed, but not more frequently than hourly. Rescue medication was available as needed. The primary endpoint was the Summed Pain Intensity Difference to baseline over 12h (SPIDI2). Safety was assessed by continuous oxygen saturation monitoring and adverse event reporting. Results: 101 patients (51 Male/50 Female) were randomized, 100 received study treatment (intent-to-treat [ITT] population), and 91 completed the study. Reasons for early discontinuation were lack of efficacy (6), adverse events (2) and drug-dosing error (1). Mean age was 42.5 years. For the ITT population, SST 30 mcg was superior to placebo (p=0.003) for the SPID12. SPID12 scores in the active groups were superior for both male (ANOVA overall p-value =0.038) and female (ANOVA overall p-value=0.005) patients. Statistically significant differences in favour of sublingual sufentanil were also observed between the SST 30mcg and placebo group for SPID1(p<0.001), TOTPAR12(p=0.002), time to perceived PR (p=0.023) and time to meaningful PR (p=0.010). Nausea, vomiting and somnolence were more frequent in the sufentanil groups but there were no significant differences between treatment arms for the proportion of patients who prematurely terminated due to AE or inadequate analgesia. Conclusions: Sufentanil tablets dispensed sublingually using a single-dose applicator is in development for treatment of patients with moderate-to-severe acute pain in a medically-supervised setting where immediate IV access is limited. When administered sublingually, sufentanil’s pharmacokinetic profile and non-invasive delivery makes it a useful alternative to IM or IV dosing.

Keywords: acute pain, pain management, sublingual, sufentanil

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Authors: Hazel Ann Gianelli Cu, Stephanie Co, Radcliff Cobankiat

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Objectives: TRC101/Veverimer is an orally administered, non absorbed, sodium- and counterion-free hydrochloric acid binder for the treatment of metabolic acidosis associated with chronic kidney disease. The main objective of this study is to determine the efficacy of TRC 101/ Veverimer 6g/day in increasing serum bicarbonate levels of chronic kidney disease patients with metabolic acidosis. In this meta analysis, we also aim to look at safety outcomes, adverse effects and if the level of serum bicarbonate reached metabolic alkalosis when given TRC101/Veverimer. Methodology: Pubmed, Cochrane, Google Scholar and Science direct were used to search for randomized controlled trials about TRC101/Veverimer use in Chronic kidney disease patients with metabolic acidosis. Search strategy according to the Prisma checklist was done with evaluation of biases and synthesis of results using the Cochrane Review Manager software 5.4. Results: Two randomized controlled trials involving 371 chronic kidney disease patients were included in this study. Results show there was a significant increase in the serum bicarbonate level when given TRC101/Veverimer compared to the placebo. Both studies had a significant number of participants who completed the studies until the end. P value of <0.00001 was used in both studies with a confidence interval of 95%. Conclusion: TRC101/Veverimer 6g/day was shown to effectively and safely increase serum bicarbonate or achieve normalization in chronic kidney disease patients with metabolic acidosis as compared with a placebo. This was associated with delayed progression of kidney disease with improvement of physical functioning, however longer duration of future studies is ideal in order to assess further the long advantages and consequences of TRC 101/Veverimer.

Keywords: chronic kidney disease, metabolic acidosis, Veverimer, TRC101

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Authors: Saeed Abbasi, Davood Farsi, Soudabeh Shafiee Ardestani, Neda Valizadeh

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Objectives: Peripheral vertigo is a common complaint of patients who are visited in emergency departments. In our study, we wanted to evaluate the effect of betahistine as an oral drug vs. intravenous diazepam for the treatment of acute peripheral vertigo. We also wanted to see the possibility of substitution of parenteral drug with an oral one with fewer side effects. Materials and Methods: In this randomized, double-blind study, 101 patients were enrolled in the study. The patients were divided in two groups in a double-blind randomized manner. Group A took oral placebo and 10 mg of intravenous diazepam. Group B received 8mg of oral betahistine and intravenous placebo. Patients’ symptoms and signs (Vertigo severity, Nausea, Vomiting, Nistagmus and Gate) were evaluated after 0, 2, 4, 6 hours by emergency physicians and data were collected by a questionnaire. Results: In both groups, there was significant improvement in vertigo (betahistine group P=0.02 and Diazepam group P=0.03). Analysis showed more improvement in vertigo severity after 4 hours of treatment in betahistine group comparing to diazepam group (P=0.02). Nausea and vomiting were significantly lower in patients receiving diazepam after 2 and 6 hours (P=0.02 & P=0.03).No statistically significant differences were found between the groups in nistagmus, equilibrium & vertigo duration. Conclusion: The results of this randomized trial showed that both drugs had acceptable therapeutic effects in peripheral vertigo, although betahistine was significantly more efficacious after 4 hours of drug intake. As for higher nausea and vomiting in betahistine group, physician should consider these side effects before drug prescription.

Keywords: acute peripheral vertigo, betahistine, diazepam, emergency department

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Authors: Vahab Behmanesh

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Metabolic syndrome is defined as having at least three of the five metabolic risk factors, including abdominal obesity, high blood pressure, high triglycerides, low HDL, and insulin resistance. Lifestyle changes towards reducing physical activity, unhealthy eating habits Especially the high-fat and high-carbohydrate diet is directly related to metabolic syndrome, and due to the epidemic of overweight and sedentary life, metabolic syndrome is a serious problem worldwide. On the other hand, vitamin D deficiency is considered as one of the most common problems in the world, which is related to the dysfunction of beta cells and insulin resistance, and therefore, vitamin D deficiency is considered as a factor in the occurrence of metabolic syndrome. 40 subjects (age: 16.12 ± 4.4 years and body mass index 25.61 ± 4.4 kg/m2) were randomly assigned to groups of aerobic exercise and placebo, aerobic exercise and vitamin D and placebo (no exercise) were divided. Vitamin D was taken at a dose of 50,000 units per week in a double-blind format for eight weeks, and the daily aerobic exercise program was performed for 50 to 60 minutes, three doses per week, with an intensity of 50-60% of the maximum heart rate. From one-way analysis of variance, Factorial variance analysis (2x2) repeated measurement and correlated t-test were used for data analysis. Aerobic exercise and vitamin D intake reduced all metabolic risk indicators and blood insulin (P < 0.05). However, the subjective feeling of hunger did not change significantly (P < 0.05). Regarding waist circumference and blood glucose, the effect of exercise combined with vitamin D consumption was greater than the corresponding effect in the vitamin D group (P < 0.05). Aerobic exercises and vitamin D intake are safe and effective for improving cardiometabolic health, Imam adds vitamin D to the exercise program has more benefits for weight and blood sugar control, which suggests prescribing it for patients with metabolic syndrome.

Keywords: vitamin D, aerobic exercise, metabolic control, adolescents

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Authors: Lubna M. Zakaryia Mahmoud, Mohammed A. Dawood, Doaa A. Heiba

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A prospective double-blind placebo controlled trial carried out on 60 children known to be asthmatic who presented to the emergency department at Alexandria University of Children’s Hospital at El-Shatby with acute asthma exacerbations to assess the efficacy of adding inhaled magnesium sulfate to β-agonist, compared with β-agonist in saline, in the management of acute asthma exacerbations in children. The participants in the study were divided in two groups; Group A (study group) received inhaled salbutamol solution (0.15 ml/kg) plus isotonic magnesium sulfate 2 ml in a nebulizer chamber. Group B (control group): received nebulized salbutamol solution (0.15 ml/kg) diluted with placebo (2 ml normal saline). Both groups received inhaled solution every 20 minutes that was repeated for three doses. They were evaluated using the Pediatric Asthma Severity Score (PASS), oxygen saturation using portable pulse oximetry and peak expiratory flow rate using a portable peak expiratory flow meter at initially recorded as zero-minute assessment and every 20 minutes from the end of each nebulization (nebulization lasts 5-10 minutes) recorded as 20, 40 and 60-minute assessments. Regarding PASS, comparison showed non-significant difference with p-value 0.463, 0.472, 0.0766 at 20, 40 and 60 minutes. Regarding oxygen saturation, improvement was more significant towards group A starting from 40 min with significant p-value=0.000. At 60 min p-value=0.000. Although mean PEFR significantly improved from zero-min in both groups; however, improvement was more significant in group A with significant p-value = 0.015, 0.001, 0.001 at 20 min, 40 min and 60 min, respectively. The conclusion this study suggests is that inhaled magnesium sulfate is an efficient add on drug to standard β- agonist inhalation used in the treatment of moderate to severe asthma exacerbations.

Keywords: nebulized, magnesium sulfate, acute asthma , pediatric

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Authors: Hadeel Seraj, Mohammed Khoshhal, Mustafa Alhamoud, Hassan Alhashim, Anas Alsaif, Amro Abukhashabah

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Central serous chorioretinopathy (CSCR) is an idiopathic retinal disease characterized by localized serous detachment of the neurosensory retina at the macula. To date, there is no high-quality evidence of recent updates on treating acute CSCR, focusing on photodynamic therapy (PDT) and anti-vascular endothelial growth factor (anti-VEGF). Hence, this review aims to systematically review the latest treatment strategies for acute CSCR. Methodology: The following electronic databases were used for a comprehensive and systematic literature review: MEDLINE, EMBASE, and Cochrane. In addition, we analyzed studies comparing PDT with placebo, anti-VEGF with placebo, or PDT with anti-VEGF in treating acute CSC eyes with no previous intervention. Results: Seven studies were included, with a total of 292 eyes. The overall positive results were significantly higher among patients who received PDT compared to control groups (OR = 7.96, 95% CI, 3.02 to 20.95, p < 0.001). The proportions of positive results were 81.0% and 97.1% among patients who received anti-VEGF and PDT, respectively, with no statistically significant differences between the groups. In addition, there were no significant differences between anti-VEGF and control groups. In contrast, PDT was significantly associated with lower recurrence odds than the control groups (OR = 0.12, 95% CI, 0.04 to 0.39, p = 0.042). Conclusion: According to our findings, PDT showed higher positive results than Anti-VEGF in acute CSCR. In addition, PDT was significantly associated with a lower recurrence rate than the control group. However, the analysis needs to be confirmed and updated by large-scale, well-designed RCTs.

Keywords: central serous chorioretinopathy, Acute CSCR, photodynamic therapy, anti-vascular endothelial growth factor

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Authors: Daniela V. Bavaresco, Tamy Colonetti, Antonio Jose Grande, Francesc Colom, Joao Quevedo, Samira S. Valvassori, Maria Ines da Rosa

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Objective: Performed a systematic review and meta-analysis to evaluated the potential effect of the cyclo-oxygenases (Cox)-2 inhibitor Celecoxib adjunct treatment in Bipolar Disorder (BD), through of randomized controlled trials. Method: A search of the electronic databases was proceeded, on MEDLINE, EMBASE, Scopus, Cochrane Central Register of Controlled Trials (CENTRAL), Biomed Central, Web of Science, IBECS, LILACS, PsycINFO (American Psychological Association), Congress Abstracts, and Grey literature (Google Scholar and the British Library) for studies published from January 1990 to February 2018. A search strategy was developed using the terms: 'Bipolar disorder' or 'Bipolar mania' or 'Bipolar depression' or 'Bipolar mixed' or 'Bipolar euthymic' and 'Celecoxib' or 'Cyclooxygenase-2 inhibitors' or 'Cox-2 inhibitors' as text words and Medical Subject Headings (i.e., MeSH and EMTREE) and searched. The therapeutic effects of adjunctive treatment with Celecoxib were analyzed, it was possible to carry out a meta-analysis of three studies included in the systematic review. The meta-analysis was performed including the final results of the Young Mania Rating Scale (YMRS) at the end of randomized controlled trials (RCT). Results: Three primary studies were included in the systematic review, with a total of 121 patients. The meta-analysis had significant effect in the YMRS scores from patients with BD who used Celecoxib adjuvant treatment in comparison to placebo. The weighted mean difference was 5.54 (95%CI=3.26-7.82); p < 0.001; I2 =0%). Conclusion: The systematic review suggests that adjuvant treatment with Celecoxib improves the response of major treatments in patients with BD when compared with adjuvant placebo treatment.

Keywords: bipolar disorder, Cox-2 inhibitors, Celecoxib, systematic review, meta-analysis

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Authors: Annis Lai Chu Fung

Abstract:

While aggression had high stability throughout developmental stages and across generations, it should be the top priority of researchers and frontline helping professionals to develop prevention and intervention programme for aggressive children and children at risk of developing aggressive behaviours. Although there is a substantial amount of anti-bullying programmes, they gave disappointingly small effect sizes. The neglectful practical significance could be attributed to the overly simplistic categorisation of individuals involved as bullies or victims. In the past three decades, the distinction between reactive and proactive aggression has been well-proved. As children displaying reactively aggressive behaviours have distinct social-information processing pattern with those showing proactively aggressive behaviours, it is critical to identify the unique needs of the two subtypes accordingly when designing an intervention. The onset of reactive aggression and proactive aggression was observed at earliest in 4.4 and 6.8 years old respectively. Such findings called for a differential early intervention targeting these high-risk children. However, to the best of the author’s knowledge, the author was the first to establish an evidence-based intervention programme against reactive and proactive aggression. With the largest samples in the world, the author, in the past 10 years, explored three different approaches and their effectiveness against aggression quantitatively and qualitatively with longitudinal design. The three approaches presented are (a) cognitive-behavioral approach, (b) moral education, with Chinese marital arts and ethics as the medium, and (c) bioneurological measures (omega-3 supplementation). The studies adopted a multi-informant approach with repeated measures before and after the intervention, and follow-up assessment. Participants were recruited from primary and secondary schools in Hong Kong. In the cognitive-behavioral approach, 66 reactive aggressors and 63 proactive aggressors, aged from 11 to 17, were identified from 10,096 secondary-school children with questionnaire and subsequent structured interview. Participants underwent 10 group sessions specifically designed for each subtype of aggressor. Results revealed significant declines in aggression levels from the baseline to the follow-up assessment after 1 year. In moral education through the Chinese martial arts, 315 high-risk aggressive children, aged 6 to 12 years, were selected from 3,511 primary-school children and randomly assigned into four types of 10-session intervention group, namely martial-skills-only, martial-ethics-only, both martial-skills-and-ethics, and physical fitness (placebo). Results showed only the martial-skills-and-ethics group had a significant reduction in aggression after treatment and 6 months after treatment comparing with the placebo group. In the bioneurological approach, 218 children, aged from 8 to 17, were randomly assigned to the omega-3 supplement group and the placebo group. Results revealed that compared with the placebo group, the omega-3 supplement group had significant declines in aggression levels at the 6-month follow-up assessment. All three approaches were effective in reducing proactive and reactive aggression. Traditionally, intervention programmes against aggressive behaviour often adapted the cognitive and/or behavioural approach. However, cognitive-behavioural approach for children was recently challenged by its demanding requirement of cognitive ability. Traditional cognitive interventions may not be as beneficial to an older population as in young children. The present study offered an insightful perspective in aggression reduction measures.

Keywords: intervention, outcome effectiveness, proactive aggression, reactive aggression

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Authors: Keng H. Kong, Louis C. Tan, Wing L. Aw, Kay Y. Tay

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Background: Fatigue is a common problem in patients with Parkinson's disease, with reported prevalence of up to 70%. Fatigue can be disabling and has adverse effects on patients' quality of life. There is currently no satisfactory treatment of fatigue. Acupuncture is effective in the treatment of fatigue, especially that related to cancer. Its role in Parkinson's disease-related fatigue is uncertain. Aims: To evaluate the clinical efficacy of acupuncture treatment in Parkinson's disease-related fatigue. Hypothesis: We hypothesize that acupuncture is effective in alleviating Parkinson's disease-related fatigue. Design: A single center, randomized, controlled study with two parallel arms. Participants: Forty participants with idiopathic Parkinson's disease will be enrolled. Interventions: Participants will be randomized to receive verum (real) acupuncture or placebo acupuncture. The retractable non-invasive sham needle will be used in the placebo group. The intervention will be administered twice a week for five weeks. Main outcome measures: The primary outcome will be the change in general fatigue score of the multidimensional fatigue inventory at week 5. Secondary outcome measures include other subscales of the multidimensional fatigue inventory, movement disorders society-unified Parkinson's disease rating scale, Parkinson's disease questionnaire-39 and geriatric depression scale. All outcome measures will be assessed at baseline (week 0), completion of intervention (week 5) and 4 weeks after completion of intervention (week 9). Results: To date, 23 participants have been recruited and nine have completed the study. The mean age is 63.5±14.2 years, mean duration of Parkinson’s disease is 6.4±1.8 years and mean MDS-UPDRS score is 8.3±2.8. The mean general fatigue score of the multidimensional fatigue inventory is 13.5±4.6. No significant adverse event related to acupuncture is noted. Potential significance: If the results are as expected, this study will provide preliminary scientific evidence for the efficacy of acupuncture in Parkinson's Disease-related fatigue, and opens the door for a larger multicentre trial to be performed. In the longer term, it may lead to the integration of acupuncture in the care of patients with Parkinson's disease.

Keywords: acupuncture, fatigue, Parkinson's disease, trial

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Authors: Doua AlSaad, Ahmed Awaisu, Samah Elsalem, Palli Valapila Abdulrouf, Binny Thomas, Moza AlHail

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Background: It has been suggested that pyridoxine has an anti-lactogenic effect. Studies of the efficacy of pyridoxine in suppressing lactation have reported conflicting results. The aim of this review is to evaluate the effectiveness and safety of high-dose pyridoxine in postpartum lactation inhibition. Methods: This systematic review included published trials that compared the efficacy and/or safety of pyridoxine to placebo or to other pharmacological agents for the inhibition of postpartum lactation. We searched PubMed, Embase, ScienceDirect, CINAHL, AMED, the Cochrane library, and the clinical trials registry to identify relevant literature. No limit was imposed on the year of publication of the studies, and the review included studies published until 15 January 2016. Two reviewers independently extracted data and assessed the risk of bias. Results: Seven studies were included, with a total of 1155 women, of which 471 women received pyridoxine. Three studies were randomized controlled trials, while the remaining four studies were non-randomized controlled trials. All of the included studies were relatively small (n = 18 – 482). The studies compared pyridoxine with placebo, bromocriptine, and/or stilboestrol. Pyridoxine was given orally, with a total daily dose of 450 – 600 mg for 5 to 7 days. Two trials (n = 349 participants) indicated that pyridoxine was effective in inhibiting lactation in approximately 95% of the enrolled patients. All other studies failed to demonstrate pyridoxine efficacy through either clinical assessment or prolactin level measurements. Pyridoxine safety was assessed by two trials in which no serious untoward side-effects were reported. Overall, the risk of bias for most of the studies was low to moderate. Conclusion: Current evidence supporting the effectiveness of high dose pyridoxine in the inhibition of postpartum lactation is inconsistent and insufficient. Larger randomized trials are needed to confirm the efficacy of pyridoxine in postpartum lactation inhibition. Acknowledgment: This review received a grant from the Medical Research Center of Hamad Medical Corporation in Qatar (grant number: 15100/15).

Keywords: pyridoxine, safety, effectiveness, lactation inhibition

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