The effects of Nigella sativa L. on obesity: A systematic review and meta-analysis.

ETHNOPHARMACOLOGICAL RELEVANCE: Nigella sativa L. (N.sativa) is a traditional herbal medicine that has been used for centuries to treat rheumatoid arthritis, diabetes, asthma, and other metabolic disorders. Recently, anti-obesity characteristics of N.sativa have been indicated. AIM OF THE STUDY: The effects of N. sativa as a complementary therapy in obesity management remains controversial. We aimed to perform a meta-analysis on the effects of supplementation with N. sativa on some anthropometric indices in adult subjects. MATERIALS AND METHODS: We searched PubMed/Medline, Cochrane Library, ISI Web of Science, and Scopus databases until June 2017 to identify relevant placebo-controlled clinical trials. Data was reported as weighted mean differences and standard deviations to show the magnitude of effects for N. sativa on body weight, body mass index (BMI) and waist circumference (WC). RESULTS: Findings of 11 studies revealed that N. sativa supplement reduced body weight (-2.11 kg, 95% CI: -3.61, -0.61, I2:72.4%), BMI (-1.16 kg/m2; 95%CI: -1.81, -0.51; I2: 40.1%) and WC (-3.52 cm, 95%CI: -4.10, -2.92, I2 =0%) significantly compared to placebo groups. CONCLUSION: Supplementation with N. sativa exerts a moderate effect on reduction in body weight, BMI and WC. However, due to the high heterogeneity for body weight and limited high quality studies, the findings should be declared by caution. No serious side effects were also reported following N. sativa supplementation. Further studies are needed to clarify the effects of N. sativa on other anthropometric indices.

¿Cómo podemos obtener información más confiable de los estudios de las patogenesias? Una crítica a las experimentaciones puras / How can e get more reliable information studies of the pathogenesis ? A critique of pure experimentation

Ciertamente, un medicamento debe ser administrado en un cuerpo sano sin ninguna sustancia extraña; cuando el olor y el sabor hayan sido examinados debe tomarse una pequeña dosis y llevar un registro de cada uno de los cambios que se pudieran presentar, tanto en el pulso, la temperatura, la respiración y las secreciones.Una vez analizados los síntomas encontrados en una persona se puede entonces proceder a probarse en el cuerpo de una persona enferma. (AU)

Certainly, a drug must be administered in a healthy body without any foreign substance; when the smell and taste have been examined must take a small dose and keep a record of each of the changes that may arise, both the pulse, temperature, breathing and secreciones.Una after analyzing the symptoms found in a person can then proceed to try on in the body of a sick person. (AU)

¿Cómo podemos obtener información más confiable de los estudios de las patogenesias? Una crítica a las experimentaciones puras / How can e get more reliable information studies of the pathogenesis ? A critique of pure experimentation

Ciertamente, un medicamento debe ser administrado en un cuerpo sano sin ninguna sustancia extraña; cuando el olor y el sabor hayan sido examinados debe tomarse una pequeña dosis y llevar un registro de cada uno de los cambios que se pudieran presentar, tanto en el pulso, la temperatura, la respiración y las secreciones.Una vez analizados los síntomas encontrados en una persona se puede entonces proceder a probarse en el cuerpo de una persona enferma.

Certainly, a drug must be administered in a healthy body without any foreign substance; when the smell and taste have been examined must take a small dose and keep a record of each of the changes that may arise, both the pulse, temperature, breathing and secreciones.Una after analyzing the symptoms found in a person can then proceed to try on in the body of a sick person.

Evening -versus morning- dosing drug therapy for chronic kidney disease patients with hypertension: a systematic review.

BACKGROUND/AIMS: There is a strong correlation between non-dipping status and cardiovascular events in chronic kidney disease (CKD) patients. Our study is designed to identify the effect of evening administration of antihypertensive drugs to hypertensive CKD patients. METHODS: A comprehensive search of Medline, Embase, the Chinese Biomedical Literature Database, Wanfang Data, Chinese National Knowledge Infrastructure, and the Cochrane Central Register of Controlled Trials was performed in July 2014. Concurrent controlled or crossover trials (including randomized and non-randomized experimental trials) designed to evaluate the effects of evening- versus morning-dosing hypertensive drug regimens on clinical outcomes in CKD patients with hypertension were included. All statistical analyses were performed using the RevMan software, which is available free from the Cochrane Collaboration. RESULTS: Seven trials involving 1277 patients were identified, and the randomized controlled trials (RCTs) and non-randomized controlled trials (non-RCTs) were classified into two groups. Taking at least one blood pressure-lowering medication at bedtime was not shown to reduce total death (P=0.056) or cardiovascular death (P=0.059) but was shown to reduce total events (P<0.001) and major cardiovascular events (P<0.001) in both RCTs and non-RCTs. Compared with a morning dosing regimen, taking antihypertensive drug in the evening significantly lowered nighttime systolic blood pressure (SBP) (P<0.0001) and diastolic blood pressure (P<0.05) in patients in the RCTs but did not affect blood pressure in patients in the non-RCTs (P<0.05). There is limited evidence from one non-RCT that taking an antihypertensive drug (benazepril 10 mg) in the evening did not increase adverse events (P=0.72) or withdrawals due to adverse events (P=0.64). CONCLUSIONS: A regimen of antihypertensive drugs in the evening should be considered for CKD patients with hypertension to lower nighttime blood pressure and help prevent total events and cardiovascular mortality. More studies are needed to verify the results of this study.

Descripción de los resultados y costes de una intervención preventiva a nivel respiratorio en el anciano institucionalizado: ensayo controlado aleatorizado / Cost-consequence analysis of respiratory preventive intervention among institutionalized older people: Randomized controlled trial

Introducción. En el anciano institucionalizado con limitación funcional se evidencia una mayor reducción de la funcionalidad de la musculatura respiratoria (MR). Los objetivos de este estudio son evaluar los resultados y costes de una intervención de entrenamiento de la MR mediante Pranayama en población anciana institucionalizada con limitación funcional. Material y métodos. Estudio controlado aleatorizado desarrollado en ancianos institucionalizados con limitación para la deambulación (n = 54). La intervención consistió en el entrenamiento de la MR mediante Pranayama, durante 6 semanas (5 sesiones/semana). Los resultados se midieron en relación con la función de la MR mediante las presiones inspiratoria y espiratoria máximas y la ventilación máxima voluntaria, en 4 tiempos. También se valoró la satisfacción percibida por el grupo experimental (GE) a través de un cuestionario ad hoc. Se estimaron los costes directos e indirectos de la intervención desde la perspectiva social. Resultados. El GE reveló una mejora significativa de la fuerza (presiones inspiratoria y espiratoria máximas) y de la resistencia (ventilación máxima voluntaria) de la MR. Además, un 92% del GE refirió una satisfacción alta. Los costes sociales totales, directos e indirectos, ascendieron a 21.678 Euros. Conclusiones. Esta evaluación revela que los resultados en términos de la función de la MR son significativos, que la intervención es bien tolerada y valorada por el residente, y los costes de la intervención son moderados (AU)

Introduction. The institutionalized elderly with functional impairment show a greater decline in respiratory muscle (RM) function. The aims of the study are to evaluate outcomes and costs of RM training using Pranayama in institutionalized elderly people with functional impairment. Material and methods. A randomized controlled trial was conducted on institutionalized elderly people with walking limitation (n = 54). The intervention consisted of 6 weeks of Pranayama RM training (5 times/week). The outcomes were measured at 4 time points, and were related to RM function: the maximum respiratory pressures and the maximum voluntary ventilation. Perceived satisfaction in the experimental group (EG) was assessed by means of an ad hoc questionnaire. Direct and indirect costs were estimated from the social perspective. Results. The GE showed a significant improvement related with strength (maximum respiratory pressures) and endurance (maximum voluntary ventilation) of RM. Moreover, 92% of the EG reported a high satisfaction. The total social costs, direct and indirect, amounted to Euros 21,678. Conclusions. This evaluation reveals that RM function improvement is significant, that intervention is well tolerated and appreciated by patients, and the intervention costs are moderate (AU)

[Thinking on controlled setting of plarebo acupuncture in clinical trial of acupuncture and moxibustion].

Differences and relations between effects of acupuncture therapy and sham acupuncture are systematically analyzed in this article through the influential factors of acupuncture effect. And it is held that sham acupuncture effect is not exactly equal to placebo effect. The effects of both acupuncture and sham acupuncture are composed by specific effects and non-specific effects, and the differences of non-specific effects between acupunc ture and sham acupuncture can be minimized furthest with blinding and randomized method. Therefore, the difference of acupuncture and sham acupuncture treatment rests with the degree of differences of the specific effects. Only when both of the specific effect of acupuncture and the effect of acupuncture are minimized, can it be applied as the ideal placebo control. Consequently when placebo acupunture are setted up, factors such as the body condition, site of stimulation and stimulation parameters which can influence the specific effect of acupuncture should be taken into consideration to produce the relatively minimum specific effect.

Educational games in geriatric medicine education: a systematic review.

OBJECTIVE: To systematically review the medical literature to assess the effect of geriatric educational games on the satisfaction, knowledge, beliefs, attitudes and behaviors of health care professionals. METHODS: We conducted a systematic review following the Cochrane Collaboration methodology including an electronic search of 10 electronic databases. We included randomized controlled trials (RCT) and controlled clinical trials (CCT) and excluded single arm studies. Population of interests included members (practitioners or students) of the health care professions. Outcomes of interests were participants' satisfaction, knowledge, beliefs, attitude, and behaviors. RESULTS: We included 8 studies evaluating 5 geriatric role playing games, all conducted in United States. All studies suffered from one or more methodological limitations but the overall quality of evidence was acceptable. None of the studies assessed the effects of the games on beliefs or behaviors. None of the 8 studies reported a statistically significant difference between the 2 groups in terms of change in attitude. One study assessed the impact on knowledge and found non-statistically significant difference between the 2 groups. Two studies found levels of satisfaction among participants to be high. We did not conduct a planned meta-analysis because the included studies either reported no statistical data or reported different summary statistics. CONCLUSION: The available evidence does not support the use of role playing interventions in geriatric medical education with the aim of improving the attitudes towards the elderly.

Effects of Ginkgo biloba in dementia: systematic review and meta-analysis.

BACKGROUND: The benefit of Ginkgo biloba has been discussed controversially. The aim of this review was to assess the effects of Ginkgo biloba in Alzheimer's disease as well as vascular and mixed dementia covering a variety of outcome domains. METHODS: We searched MEDLINE, EMBASE, the Cochrane databases, CINAHL and PsycINFO for controlled trials of ginkgo for Alzheimer's, vascular or mixed dementia. Studies had to be of a minimum of 12 weeks duration with at least ten participants per group. Clinical characteristics and outcomes were extracted. Meta-analysis results were expressed as risk ratios or standardized mean differences (SMD) in scores. RESULTS: Nine trials using the standardized extract EGb761(R) met our inclusion criteria. Trials were of 12 to 52 weeks duration and included 2372 patients in total. In the meta-analysis, the SMDs in change scores for cognition were in favor of ginkgo compared to placebo (-0.58, 95% confidence interval [CI] -1.14; -0.01, p = 0.04), but did not show a statistically significant difference from placebo for activities in daily living (ADLs) (SMD = -0.32, 95% CI -0.66; 0.03, p = 0.08). Heterogeneity among studies was high. For the Alzheimer subgroup, the SMDs for ADLs and cognition outcomes were larger than for the whole group of dementias with statistical superiority for ginkgo also for ADL outcomes (SMD = -0.44, 95% CI -0.77; -0.12, p = 0.008). Drop-out rates and side effects did not differ between ginkgo and placebo. No consistent results were available for quality of life and neuropsychiatric symptoms, possibly due to the heterogeneity of the study populations. CONCLUSIONS: Ginkgo biloba appears more effective than placebo. Effect sizes were moderate, while clinical relevance is, similar to other dementia drugs, difficult to determine.

The effect of calcium supplementation on bone loss in 32 controlled trials in postmenopausal women.

SUMMARY: In 32 controlled trials of calcium supplementation (700-2000 mg) in 3,169 postmenopausal women, mean bone loss in the controls was -1.07% p.a. and in the treated subjects -0.27% p.a. (P for difference <0.001). The effect was similar at all measured sites and at all doses of 700 mg or more but became weaker after 4 years. INTRODUCTION: We have reviewed 32 trials of calcium supplementation in 3,169 postmenopausal women. METHODS: We found 24 publications reporting 32 controlled trials lasting at least 1 year, which provided annual percentage changes in bone mass or density at one or more sites in the calcium-treated and control subjects. RESULTS: The median calcium supplement was 1,000 mg, median duration of the trials 2 years and total number of sites measured 79. The average of the mean rates of change in bone mass or density was -1.07% p.a. (P < 0.001) in the controls and -0.27% p.a. (ns) in the treated subjects (P for difference < 0.001). The effect of calcium was much the same at all measured sites (forearm/hand, proximal femur, spine, and total body and others). Supplements of less than 700 mg were not effective, but there was no significant beneficial effect of higher doses. There was significantly faster bone loss at total calcium intakes below 1,150 mg than on intakes over 1,350 mg. The effect of calcium appeared to be lost after 4 years of treatment. CONCLUSION: Calcium supplementation of about 1,000 mg daily has a significant preventive effect on bone loss in postmenopausal women for at least 4 years.

Assessing proarrhythmic potential of drugs when optimal studies are infeasible.

Assessing the potential for a new drug to cause life-threatening arrhythmias is now an integral component of premarketing safety assessment. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use Guideline (ICH) E14 recommends the "Thorough QT Study" (TQT) to assess clinical QT risk. Such a study calls for careful evaluation of drug effects on the electrocardiographic QT interval at multiples of therapeutic exposure and with a positive control to confirm assay sensitivity. Yet for some drugs and diseases, elements of the TQT Study may be impractical or unethical. In these instances, alternative approaches to QT risk assessment must be considered. This article presents points to consider for evaluation of QT risk when alternative approaches are needed.

Sham acupuncture may be as efficacious as true acupuncture: a systematic review of clinical trials.

OBJECTIVE: This study sought to determine whether sham acupuncture is as efficacious as true acupuncture, as defined by traditional acupuncture theories. METHODS: A systematic review was conducted of clinical trials that used sham acupuncture controls with needle insertion at wrong points (points not indicated for the condition) or non-points (locations that are not known acupuncture points). This study used a convenience sample of 229 articles resulting from a PubMed search using the keyword "acupuncture" and limited to "clinical trials" published in English in 2005 or 2006. Studies were categorized by use of wrong points versus non-points and the use of normal insertion and stimulation versus superficial insertion or minimal stimulation. RESULTS: Thirty-eight acupuncture trials were identified. Most studies (22/38 = 58%) found no statistically significant difference in outcomes, and most of these (13/22 = 59%) found that sham acupuncture may be as efficacious as true acupuncture, especially when superficial needling was applied to non-points. CONCLUSIONS: The findings cast doubt on the validity of traditional acupuncture theories about point locations and indications. Scientific rationales for acupuncture trials are needed to define valid controls, and the theoretical basis for traditional acupuncture practice needs to be re-evaluated.

Effects of potentised substances on growth rate of the water plant Lemna gibba L.

OBJECTIVES: This study investigated, whether the growth rate of Lemna gibba L. (duckweed) can be influenced by the application of homeopathic potencies of gibberellic acid, kinetin, argentum nitricum, and lemna minor. METHODS: Duckweed was grown in either potencies (14x-30x, decimal steps) or water controls (unsuccussed and succussed) over seven days. Frond (leaf-like structure) growth was measured using a non-destructive image analysis system. Growth rates were calculated for three time intervals (0-7, 0-3, 3-7 days). Five to six independent, randomized and blinded experiments were analysed for each of the four tested substances. Water control experiments were performed repeatedly to test the reliability of the experimental set-up (systematic negative controls). RESULTS: The systematic negative control experiments did not yield any significant effects. Hence, false positive results could be excluded. The test system had a low coefficient of variation (1.5%). Out of the four tested substances gibberellic acid had the most pronounced effect (p=0.0002, F-test) on the main outcome parameter frond growth rate (r(area) day 0-7). Potency levels 15x, 17x, 18x, 23x and 24x reduced growth rate of Lemna gibba (p<0.05 against the pooled water control, LSD test). CONCLUSIONS: Lemna gibba may be considered as a suitable test organism for further studies on the efficacy of homeopathic potencies. Evidence accumulates, that adjacent potency levels may strongly differ in their biological activity. Potential consequences for therapeutical application might be worth investigating.