The effect of Nigella sativa L. supplementation on serum C-reactive protein: A systematic review and meta‐analysis of randomized controlled trials

ObjectiveEvidence on the efficacy ofNigella sativa supplementation is equivocal, thus the aim of this systematic review and meta-analysis of randomized clinical trials (RCTs) was to examine the effect of Nigella sativa (N. sativa) supplementation on plasma C-reactive protein (CRP) concentrations.MethodsPubMed, Scopus, ISI Web of Science, Cochrane library, and Google Scholar databases were searched (up to April 2019) to identify RCTs investigating the effects of N. sativa seed and seed oil supplementation on CRP. Weighted mean differences (WMD) was pooled using a random-effects model. Standard methods were also used for assessment of heterogeneity, sensitivity analysis, and publication bias.ResultsEventually only five articles which reported data of interest entered for data analysis. The meta-analysis showed a significant reduction in serum CRP (WMD: -0.55 mg/L, 95% CI: -1.02, -0.08, P = 0.02), with significant heterogeneity between selected studies (I² = 77.3%). Between-study heterogeneity disappeared following subgroup analysis, stratified by baseline BMI (≥30 kg/m²: I² = 2.8%). However, the effect of N. sativa seed and seed oil supplementation on CRP was only significant in studies that were conducted on participants with BMI ≥ 30 kg/m² (WMD: -0.50 mg/L, 95% CI: -0.85, -0.15).ConclusionsThis meta-analysis suggests thatN. sativa seed and seed oil supplementation can significantly reduce serum CRP level. However, RCTs with a larger sample size and longer follow-up periods should be conducted for future investigations to confirm the veracity of these results.     

Outcomes of OROS® methylphenidate compared with atomoxetine in children with ADHD: A multicenter, randomized prospective study

This community-based study was designed to evaluate treatment outcomes with OROS methylphenidate (MPH) and atomoxetine in children with attentiondeficit/hyperactivity disorder (ADHD), as assessed by physicians and parents in a setting that resembles clinical practice. In a multicenter, prospective, open-label study, children 6 to 12 years of age with ADHD were randomized (2:1, respectively) to 3 weeks of treatment with once-daily OROS MPH or atomoxetine. Investigatorrated measures of symptoms included the ADHD Rating Scale (ADHD-RS) and the Clinical Global Impression-Improvement of Illness scale (CGI-I). Assessments were made at baseline and during a telephone interview in week 1, a clinic visit in week 2, and a final clinic visit in week 3. In total, 1323 patients received OROS MPH (n = 850) or atomoxetine (n = 473). Significant reductions from baseline in investigator-evaluated ADHD-RS scores were observed among patients receiving OROS MPH and those receiving atomoxetine. At the end of the study, mean decreases from baseline ADHD-RS scores were 20.24 for OROS MPH and 16 for atomoxetine (P < .001). Between-treatment differences appeared to increase over time (2.77, 3.44, and 4.24 at weeks 1, 2, and 3, respectively; P < .001). Treatment response (ie, 25% reduction from baseline ADHD-RS scores) was significantly greater at each evaluation for patients taking OROS MPH than for those taking atomoxetine (P < .001). Similar percentages of patients taking OROS MPH (4.8%) and atomoxetine (5.5%) withdrew because of adverse events. Although community-based studies often lack the control of randomized, placebo-controlled trials, these results nevertheless suggest greater ADHD symptom improvement with OROS MPH compared with atomoxetine.     

Music intervention during daily weaning trials—A 6 day prospective randomized crossover trial

PurposeTo examine the effect of patient-selected music intervention during daily weaning trials for patients on prolonged mechanical ventilation.MethodsUsing a crossover repeated measures design, patients were randomized to music vs no music on the first intervention day. Provision of music was alternated for 6 days, resulting in 3 music and 3 no music days. During weaning trials on music days, data were obtained for 30 min prior to music listening and continued for 60 min while patients listened to selected music (total 90 min). On no music days, data were collected for 90 min. Outcome measures were heart rate (HR), respiratory rate (RR), oxygen saturation (SpO₂), blood pressure (BP), dyspnea and anxiety assessed with a visual analog scale (VAS-D, VAS-A) and weaning duration (mean h per day on music and non-music days).ResultsOf 31 patients randomized, 23 completed the 6-day intervention. When comparisons were made between the 3 music and 3 no music days, there were significant decreases in RR and VAS-D and a significant increase in daily weaning duration on music days (p < 0.05). A multivariate mixed-effects model analysis that included patients who completed ≥2 days of the intervention (n = 28) demonstrated significant decreases in HR, RR, VAS-A, and VAS-D and a significant increase in daily weaning duration on music days (p < 0.05).ConclusionsProviding patient selected music during daily weaning trials is a simple, low-cost, potentially beneficial intervention for patients on prolonged mechanical ventilation. Further study is indicated to test ability of this intervention to promote weaning success and benefits earlier in the weaning process.     

Effectiveness and safety of acupuncture in the treatment of Parkinson’s disease: A systematic review and meta-analysis of randomized controlled trials

ObjectiveThis study aimed to examine the effectiveness and safety of acupuncture in the treatment of Parkinson’s disease (PD).MethodsEnglish, Chinese, and Korean electronic databases were searched up to June 2016. Randomized controlled trials (RCTs) were eligible. The methodological quality was assessed using Cochrane’s risk of bias tool. Meta-analysis was performed using RevMan 5.3.ResultsIn total, 42 studies involving 2625 participants were systematically reviewed. Participants treated using combined acupuncture and conventional medication (CM) showed significant improvements in total Unified PD Rating Scale (UPDRS), UPDRS I, UPDRS II, UPDRS III, and the Webster scale compared to those treated using CM alone. The combination of electroacupuncture and CM was significantly superior to CM alone in total UPDRS, UPDRS I, UPDRS II, and UPDRS IV. Similarly, the combination of scalp electroacupuncture, acupuncture, and CM was significantly more effective than CM alone in total UPDRS. However, our meta-analysis showed that the combination of electroacupuncture and CM was not significantly more effective than CM alone in UPDRS III, the Webster, and the Tension Assessment Scale. The results also failed to show that acupuncture was significantly more effective than placebo acupuncture in total UPDRS. Overall, the methodological quality of the RCTs was low. No serious adverse events were reported.ConclusionsWe found that acupuncture might be a safe and useful adjunctive treatment for patients with PD. However, because of methodological flaws in the included studies, conclusive evidence is still lacking. More rigorous and well-designed placebo-controlled trials should be conducted.     

Soy milk: A functional beverage with hypocholesterolemic effects? A systematic review of randomized controlled trials

ObjectiveCurrent guidelines have highlighted the role of diet in conjunction with drug therapy in the management of dyslipidemia. Over the last two decades, the effect of soy milk, a derivative of soybean, on blood lipids has been the focus of nutritional researches. The present study aimed to provide a comprehensive review of clinical trials investigating the effect of soy milk on blood lipids.MethodsAn electronic database searching including PubMed, EMBASE, Scopus, and CENTRAL was performed to extract all the records that were published up to May 2018 using MeSH terms and relevant keywords. Randomized clinical trials that had evaluated the effect of soy milk consumption on serum lipids including total cholesterol (TC), triglycerides (TG), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C) were eligible for inclusion to this systematic review.ResultsEight eligible trials comprising a total of 263 subjects were included in this review. Three studies reported no significant improvement in any of the serum lipid parameters following soy milk consumption. A significant decrease in serum TG, TC, and LDL-C was reported by 1, 1 and 3 trials. Also, 1 trial found that soy milk consumption was accompanied by a significant increase in HDL-C.ConclusionEvidence from clinical trials regarding the hypolipidemic effect of soy milk is limited and controversial. More well-designed clinical trials with large sample size and longer duration are warranted.     

Complementary and alternative medicine therapies for uremic pruritus – A systematic review of randomized controlled trials

IntroductionUremic pruritus (UP) is one of the most bothersome symptoms among chronic kidney disease (CKD) patients. The pathophysiology of UP remains elusive, resulting in limited treatment options. The inability of standard medical treatments to provide effective relief has piqued interest in complementary and alternative medicine (CAM).MethodologyA systematic review of randomized controlled trials (RCTs) summarizing the efficacy and safety profile of CAM used for UP in CKD patients was performed. CAM interventions were classified using categories proposed by the National Center for Complementary and Integrative Health. The efficacy of each CAM was determined from changes in UP severity and all reported adverse effects were extracted.ResultsOf 5242 articles screened, 34 RCTs were included, with 15 (44.1 %) studies having a sample size greater than 50. The studies considered 21 treatments including omega-3 fatty acid supplementation (n=5), acupuncture (n=5), topical capsaicin (n=4) and acupressure (n=3). Acupuncture, acupressure and topical capsaicin were shown to be effective in improving uremic pruritus. Interventions which include oral omega-3 fatty acid and zinc supplementation demonstrated mixed efficacy. Other therapies such as evening primrose oil, turmeric, vitamin B3, vitamin D and thermal therapy were not effective for treatment of UP. Common adverse effects reported with topical capsaicin included mild burning sensations (50.0–88.2 %) or erythema (6.7–22.7%) while that of acupuncture included soreness (7.5 %), bleeding (6.0–7.5%) and hematoma (1.9 %).ConclusionsAcupuncture, acupressure and topical capsaicin have the largest body of evidence for efficacy in the treatment of UP. Larger and higher quality RCTs are required to examine the efficacy and safety of promising CAM.     

Differences in blood pressure: does the length of time between measurements have an effect?

Taking blood pressure measurements correctly is essential in order to successfully evaluate a patient's blood pressure from the initial measurement and subsequent measurements over time. With the purpose to determine if the time between blood pressure measurements in an office or clinic bears an influence on any variation in measurement, a study was carried out under which two blood pressure measurements five minutes apart were taken using an automatic instrument in order to evaluate the existence of any differences as well as to identify which arm should be the control arm and to evaluate the absolute measurements between both arms. During this study, the authors observed a decrease in the mean for the repeated blood pressure measurement of 7.7 mmHg (IC 95%: 4.7-10.7 mmHg, p < 0.0001) for the systolic measurement and of 2.9 mmHg (IC 95%: 1.6-4.2 mmHg) for the diastolic measurement. 78% of the patients in this study registered a difference between the two measurements, either systolic or diastolic > or = 5 mmHg. It was not possible to establish a significant relationship between the decrease in these blood pressure measurements and factors such as age, sex, cardiac frequency or hypertension. The control arm was the right arm in 59.3% of the patients. The absolute mean of the differences between both arms was 8.4 mmHg (IC 95%: 6.8-10 mmHg) for the systolic measurements and 5 mmHg (IC 95%: 3.9-6.1 mmHg) for the diastolic measurements. 26 patients, 44.1%, registered a difference in pressure between their arms > or = 10 mmHg.     

Adverse effects of homeopathy,what do we know? A systematic review and meta-analysis of randomized controlled trials

ObjectivesHomeopathy is a popular treatment modality among patient, however there is sparse research about adverse effects of homeopathy. A concept unique for homeopathy, is homeopathic aggravation that is understood as a transient worsening of the patients’ symptoms before an expected improvement occurs. From a risk perspective it is vital that a distinction between homeopathic aggravations and adverse effects is established. There is a lack of systematic information on how frequent adverse effects and homeopathic aggravations are reported in studies. Therefore, a systematic review and meta-analysis were performed.Design and settingSixteen electronic databases were searched for Randomized Controlled Trials (RCTs). The searches were limited from the year 1995 to January 2011. Forty-one RCTs, with a total of 6.055 participants were included. A subtotal of 39 studies was included in the additional meta-analysis.ResultsA total of 28 trials (68%) reported adverse effects and five trials (12%) reported homeopathic aggravations. The meta-analysis (including six subgroup comparisons) demonstrated that no significant difference was found between homeopathy and control with OR 0.99, 95% CI 0.86–1.14, I² = 54%. More than two third of the adverse effects were classified as grade 1 (68%) and two third were classified as grade 2 (25%) and grade 3 (6%) according to the Common Terminology Criteria for Adverse Effects. Homeopathic aggravation was classified as grade 1 (98%) and grade 3 (2%), suggesting that homeopathic aggravations were reported to be less severe than adverse effects. The methodological quality according to a method recommended in the Cochrane handbook for RCTs, was high.ConclusionAdverse effects including the concept of homeopathic aggravations are commonly reported in trials. The meta-analysis demonstrated that the proportion of patients experiencing adverse effects to be similar for patients randomized to homeopathic treatment compared to patients randomized to placebo and conventional medicine.     

Is yoga effective for pain? A systematic review of randomized clinical trials

Objective

The objective of this systematic review was to assess the effectiveness of yoga as a treatment option for any type of pain.

Method

Seven databases were searched from their inception to February 2011. Randomized clinical trials were considered if they investigated yoga in patients with any type of pain and if they assessed pain as a primary outcome measure. The 5-point Jadad scale was used to assess methodological quality of studies. The selection of studies, data extraction and quality assessment were performed independently by two reviewers.

Results

Ten randomized clinical trials (RCTs) met the inclusion criteria. Their methodological quality ranged between 1 and 4 on the Jadad scale. Nine RCTs suggested that yoga leads to a significantly greater reduction in pain than various control interventions such as standard care, self care, therapeutic exercises, relaxing yoga, touch and manipulation, or no intervention. One RCT failed to provide between group differences in pain scores.

Conclusions

It is concluded that yoga has the potential for alleviating pain. However, definitive judgments are not possible.     

Effects of curcumin/turmeric supplementation on lipid profile: A GRADE-assessed systematic review and dose–response meta-analysis of randomized controlled trials

IntroductionNumerous approaches have been assigned to treat dyslipidemia (DLP). Turmeric/curcumin have been widely investigated with this regard. In the current study, we explored the effect of curcumin/turmeric supplementation on lipid profile.MethodsOnline databases were searched up to October 2022. The outcomes included triglyceride (TG), total cholesterol (TC), low-density lipoprotein cholesterol (LDL-c), high-density lipoprotein cholesterol (HDL-c), apolipoprotein B (Apo-B), and apolipoprotein A (Apo-A). We used the Cochrane quality assessment tool to evaluate the risk of bias. The effect sizes were estimated as weighted mean difference (WMD) and 95% confidence intervals (CIs).ResultsOut of 4182 articles retrieved from the initial search, 64 randomized clinical trials (RCTs) were included in the study. Between-study heterogeneity was significant. Meta-analysis showed that turmeric/curcumin supplementation exerts statistically significant improvements on blood levels of TC (WMD = −3.99 mg/dL; 95% CI = −5.33, −2.65), TG (WMD = −6.69 mg/dL; 95% CI = −7.93, −5.45), LDL-c (WMD = −4.89 mg/dL; 95% CI = −5.92, −3.87), and HDL-c (WMD = 1.80 mg/dL; 95% CI = 1.43, 2.17). However, turmeric/curcumin supplementation was not associated with improvements in blood levels of Apo-A or Apo-B. The studies did not thoroughly address the issues of potency, purity, or consumption with other foods.ConclusionTurmeric/curcumin supplementation seems to be effective in improving blood levels of TC, TG, LDL-c, and HDL-c; but may not be capable of improving their pertinent apolipoproteins. Since the evidence was assessed to be low and very low concerning the outcomes, these findings should be dealt with caution.     

Effect of aromatherapy with Damask rose on alleviating adults’ acute pain severity: A systematic review and meta-analysis of randomized controlled trials

Background and purposeAlthough recent studies have investigated the analgesic activity of Damask rose using aromatherapy in different painful conditions, the results are inconclusive. Hence, this systematic review and meta-analysis aimed to clarify the effect of aromatherapy with Damask rose on adults’ acute pain.Material and methodsThe online databases of MEDLINE/PubMed, Scopus, ISI web of science, Embase, ProQuest, CENTRAL, CINAHL, SID, and MagIran were searched up to August 10, 2020. The aim of this study was to find randomized controlled trials on the effect of aromatherapy with Damask rose in any form of administration (inhalation, vapor diffusion, and massage) on different types of acute pain in adults. The Cochrane risk of bias tool was used to assess the methodological quality of the included studies. Moreover, the quality of the evidence was evaluated by the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Random effects model was applied to pool data using Stata.ResultsA total of 16 studies met the inclusion criteria, of which only one was not included in the meta-analysis. Pooled analysis revealed that aromatherapy with Damask rose reduced the pain severity significantly (WMD: -2.12; 95% CI [-2.85, -1.40]; P < 0.001). Inhalation aromatherapy (WMD: -2.39; 95% CI [-3.31, -1.48]; P < 0.001) and aromatherapy massage (WMD: -1.16; 95% CI [-1.57, -0.75]; P < 0.001) also had significant effects on pain reduction. The quality of evidence was low.ConclusionAromatherapy with Damask rose had a favourable effect on reducing the severity of acute pain in adults. However, there is insufficient evidence for the clinical benefits of aromatherapy with Damask rose due to the low-quality evidence. Accordingly, more high quality randomized clinical trials are needed to make an evidence-based conclusion.     

Assessing the quality of reports of randomized clinical trials: Is blinding necessary?

It has been suggested that the quality of clinical trials should be assessed by blinded raters to limit the risk of introducing bias into meta-analyses and systematic reviews, and into the peer-review process. There is very little evidence in the literature to substantiate this. This study describes the development of an instrument to assess the quality of reports of randomized clinical trials (RCTs) in pain research and its use to determine the effect of rater blinding on the assessments of quality. A multidisciplinary panel of six judges produced an initial version of the instrument. Fourteen raters from three different backgrounds assessed the quality of 36 research reports in pain research, selected from three different samples. Seven were allocated randomly to perform the assessments under blind conditions. The final version of the instrument included three items. These items were scored consistently by all the raters regardless of background and could discriminate between reports from the different samples. Blind assessments produced significantly lower and more consistent scores than open assessments. The implications of this finding for systematic reviews, meta-analytic research and the peer-review process are discussed.     

The effect of quercetin on iron overload and inflammation in β-thalassemia major patients: A double-blind randomized clinical trial

ObjectivesThe aim of this study was to determine whether quercetin can reduce iron overload and inflammation in thalassemic patients.MethodsEighty four patients were recruited to this study and randomly assigned to two groups: 42 patients received a 500 mg/day quercetin tablet and 42 others took a 500 mg/day starch placebo for 12 weeks. Demographic, anthropometric and biochemical evaluation were performed.ResultsANCOVA analysis revealed that compared to the control group, quercetin could reduce high sensitivity C-reactive protein (hs-CRP) (P = 0.046), iron (p = 0.036), ferritin (p = 0.043), and transferrin saturation (TS) (p = 0.008) and increase transferrin (p = 0.045) significantly, but it had no significant effect on total iron binding capacity (TIBC) (p = 0.734) and tumor necrosis factor α (TNF-α) (p = 0.310).ConclusionsQuercetin could ameliorate the iron status in thalassemia major, but its effect on inflammation is indistinctive.