Response to Comment on “Nicotinamide mononucleotide increases muscle insulin sensitivity in prediabetic women”

Science ◽  
2021 ◽  
Vol 373 (6554) ◽  
pp. eabj7375
Author(s):  
Samuel Klein ◽  
Mihoko Yoshino
Keyword(s):  
Clinical Trial ◽  
Insulin Sensitivity ◽  
Randomized Clinical Trial ◽  
Primary Outcome ◽  
Nicotinamide Mononucleotide ◽  
Triglyceride Content

In evaluating any randomized clinical trial, it is important to determine whether baseline differences between groups could have affected the primary outcome. In our study, muscle insulin sensitivity, which was identical in both groups at baseline, improved after nicotinamide mononucleotide (NMN), not placebo, therapy. Differences in baseline intrahepatic triglyceride content between groups do not negate the effects of NMN observed in muscle.

scholarly journals Tepid sponging plus dipyrone versus dipyrone alone for reducing body temperature in febrile children

2008 ◽  
Vol 126 (2) ◽  
pp. 107-111 ◽  
Author(s):  
João Guilherme Bezerra Alves ◽  
Natália Dornelas Câmara Marques de Almeida ◽  
Camila Dornelas Câmara Marques de Almeida
Keyword(s):  
Clinical Trial ◽  
Body Temperature ◽  
Randomized Clinical Trial ◽  
Primary Outcome ◽  
Control Group ◽  
Emergency Ward ◽  
Axillary Temperature ◽  
Secondary Outcomes ◽  
To Receive

CONTEXT AND OBJECTIVE: The role of tepid sponging to promote fever control in children is controversial. We did not find any studies reporting on the effectiveness of tepid sponging in addition to dipyrone. The aim of this study was to compare the effects of tepid sponging plus dipyrone with dipyrone alone for reducing fever. DESIGN AND SETTING: A randomized clinical trial was undertaken at Instituto Materno-Infantil Professor Fernando Figueira, Recife, Pernambuco. METHODS: Children from six months to five years old with axillary temperature greater than 38 ºC in the emergency ward between January and July 2006 were eligible. One hundred and twenty children were randomly assigned to receive oral dipyrone (20 mg/kg) or oral dipyrone and tepid sponging for 15 minutes. The primary outcome was mean temperature reduction after 15, 30, 60, 90 and 120 minutes. Secondary outcomes were crying and irritability. RESULTS: 106 children finished the study. After the first 15 minutes, the fall in axillary temperature was significantly greater in the sponged group than in the control group (p < 0.001). From 30 to 120 minutes, better fever control was observed in the control group. Crying and irritability were observed respectively in 52% and 36% of the sponged children and in none and only two of the controls. CONCLUSIONS: Tepid sponging plus dipyrone cooled faster during the first 15 minutes, but dipyrone alone presented better fever control over the two-hour period. Tepid sponging caused mild discomfort, crying and irritability for most of the children.

scholarly journals PERMA model vs. integrative-behavioral couple therapy for fertility problems: A randomized clinical trial protocol

2021 ◽  
Author(s):  
Mahsa Sadeghi ◽  
Tahmineh Farajkhoda ◽  
Mahdi Khanabadi ◽  
Maryam Eftekhar
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Couple Therapy ◽  
Primary Outcome ◽  
Cognitive Intervention ◽  
Infertility Treatment ◽  
Problem Solving Skills ◽  
Face To Face ◽  
Integrative Behavioral Couple Therapy ◽  
Fertility Problems

Background: Psychological interventions may reduce fertility problems. Positive emotion, engagement, meaning, positive relationship and accomplishment (PERMA) is a cognitive intervention and integrative-behavioral couple therapy (IBCT) is a behavioral intervention. Appropriate mental interventions are important in infertility treatment. Objective: To investigate the effect of the PERMA model vs. IBCT in reducing the fertility problems of couples. Materials and Methods: The content of the interventions was developed and adjusted based on a literature review and the opinions of experts. In this three-arm parallel randomized clinical trial, 42 couples undergoing infertility treatment will be allocated randomly into three groups (n = 14 couples/each). Group 1 will receive the PERMA intervention, group 2 will receive the IBCT intervention, and group 3 as the control group will receive an infertility treatment training program intervention. The primary outcome will be the fertility problems, which will be measured by completing a fertility problem inventory at baseline, as well as in the 5th and 9th wk as a follow-up. Another primary outcome, satisfaction with the intervention, will also be assessed in the 5th and 9th wk. The secondry outcome will be a positive pregnancy test at wk 12. The interventions will be conducted through a combination of face-to-face and online via WhatsApp. Conclusion: This study will assess social, sexual, and parenthood concerns. A combination of online and face-to-face interventions will be appropriate given the COVID-19 pandemic. Couple’s counseling may provide better counseling outcomes for fertility problems in comparison with group counseling. This study will try to optimize resilience during infertility treatment through learning better relationship and problem-solving skills, and may have an indirect impact on pregnancy rate, burden of infertility, and costs of treatment due to increased effectiveness. Key words: Online, Face-to-face, Infertility, Integrative-behavioral couple therapy, PERMA model, RCT, Positive psychology, Protocol study, COVID-19.

scholarly journals Acupuncture at a Single Acupoint, BL1 (Jingming), Compared to Artificial Tears in Moderate to Severe Dry Eye Disease: A Randomized Controlled Trial

2021 ◽  
Author(s):  
xue zhang ◽  
Bo Zhang ◽  
Siyang Peng ◽  
Guoliang Zhang ◽  
Jumei Ma ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Dry Eye ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Dry Eye Disease ◽  
Eye Disease ◽  
Artificial Tears ◽  
Artificial Tear ◽  
Randomized Controlled

Abstract BackgroundThe global incidence of dry eye disease (DED) is very high. DED seriously affects the quality of life of patients; however, the current curative effect of medicine for moderate to severe DED is poor. This randomized clinical trial was planned to investigate the effect of acupuncture compared with artificial tears on moderate to severe DED.MethodsA randomized clinical trial was performed at 2 hospitals in China. 120 DED patients were randomly equally divided into an acupuncture and an artificial tear group. Either acupuncture or artificial tears was performed for an 8-week period, and a 32-week follow-up was performed. The primary outcome measure was the Schirmer-I test (SIT) value. The secondary outcome measures included the numerical rating scale (NRS) for improvement in ocular symptoms, the ocular surface disease index (OSDI), the tear-film break-up time (TBUT), corneal fluorescein staining (CFS), and acupuncture acceptability. Adverse events also were monitored and documented.ResultsFor the primary outcome, the mean changes in the SIT values were significantly different between the acupuncture (5.75 [2.53‒9.75]) and artificial tear (0.52 [-1.18‒2.46]) groups at week 8 (P = 0.01). The OSDI decreased by -16.14 (-35.40‒16.30) and − 7.65 (-19.25‒15.05) from baseline to week 8 in the acupuncture and artificial tear groups, respectively (P < 0.05). A significant decrease was found in the NRS score for eye dryness, eye pain, and blurred vision in the acupuncture group, as compared to the artificial tear group. However, the change in the average symptom NRS score, TBUT, and CFS did not differ significantly at week 8. Five cases experienced acupuncture-related adverse events.ConclusionsThis randomized clinical trial found that acupuncture at a single acupoint, BL1, significantly promoted tear secretion and improved multiple eye discomfort symptoms. Acupuncture showed greater benefits than artificial tears for moderate to severe DED. However, the study findings warrant verification.Trial registrationRegistration number: ChiCTR1800015831. Name of trial registry: Efficacy and safety of acupuncture in the treatment of moderate to severe dry eye disease: a randomized controlled trial.

scholarly journals Effects of Pitavastatin on Insulin Sensitivity and Liver Fat: A Randomized Clinical Trial

2018 ◽  
Vol 103 (11) ◽  
pp. 4176-4186 ◽  
Author(s):  
Laurie R Braun ◽  
Meghan N Feldpausch ◽  
Natalia Czerwonka ◽  
Julian Weiss ◽  
Karen Branch ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Insulin Sensitivity ◽  
Randomized Clinical Trial ◽  
Liver Fat

scholarly journals A Randomized Clinical Trial of the Efficacy and Safety of Interferon β-1a in Treatment of Severe COVID-19

2020 ◽  
Vol 64 (9) ◽  
Author(s):  
Effat Davoudi-Monfared ◽  
Hamid Rahmani ◽  
Hossein Khalili ◽  
Mahboubeh Hajiabdolbaghi ◽  
Mohamadreza Salehi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Response ◽  
Randomized Clinical Trial ◽  
Primary Outcome ◽  
Discharge Rate ◽  
Control Group ◽  
Efficacy And Safety ◽  
Interferon Β ◽  
Mortality Effect ◽  
Overall Mortality

ABSTRACT To the best of our knowledge, there is no published study on the use of interferon β-1a (IFN β-1a) in the treatment of severe COVID-19. In this randomized clinical trial, the efficacy and safety of IFN β-1a were evaluated in patients with severe COVID-19. Forty-two patients in the interferon group received IFN β-1a in addition to the national protocol medications (hydroxychloroquine plus lopinavir-ritonavir or atazanavir-ritonavir). Each 44-μg/ml (12 million IU/ml) dose of interferon β-1a was subcutaneously injected three times weekly for two consecutive weeks. The control group consisted of 39 patients who received only the national protocol medications. The primary outcome of the study was time to reach clinical response. Secondary outcomes were duration of hospital stay, length of intensive care unit stay, 28-day mortality, effect of early or late administration of IFN on mortality, adverse effects, and complications during the hospitalization. Between 29 February and 3 April 2020, 92 patients were recruited, and a total of 42 patients in the IFN group and 39 patients in the control group completed the study. As the primary outcome, time to the clinical response was not significantly different between the IFN and the control groups (9.7 ± 5.8 versus 8.3 ± 4.9 days, respectively, P = 0.95). On day 14, 66.7% versus 43.6% of patients in the IFN group and the control group, respectively, were discharged (odds ratio [OR], 2.5; 95% confidence interval [CI], 1.05 to 6.37). The 28-day overall mortality was significantly lower in the IFN than the control group (19% versus 43.6%, respectively, P = 0.015). Early administration significantly reduced mortality (OR, 13.5; 95% CI, 1.5 to 118). Although IFN did not change the time to reach the clinical response, adding it to the national protocol significantly increased discharge rate on day 14 and decreased 28-day mortality. (This study is in the Iranian Registry of Clinical Trials under identifier IRCT20100228003449N28.)

scholarly journals Lateral Extra-Articular Tenodesis Reduces Failure of Hamstring Tendon Autograft ACL Reconstruction -Two Year Outcomes from the STABILITY Study Randomized Clinical Trial

2019 ◽  
Vol 7 (7_suppl5) ◽  
pp. 2325967119S0028 ◽  
Author(s):  
Alan M. Getgood ◽  
Dianne Bryant ◽  
Robert B. Litchfield ◽  
Robert Gordon McCormack ◽  
Mark Heard ◽  
...  
Keyword(s):  
Clinical Trial ◽  
High Risk ◽  
Randomized Clinical Trial ◽  
Graft Failure ◽  
Primary Outcome ◽  
Pivot Shift ◽  
Hamstring Tendon ◽  
Rotatory Laxity ◽  
Ligamentous Laxity

Objectives: Persistent anterolateral rotatory laxity following anterior cruciate ligament reconstruction (ACLR) has been correlated with poor outcome and graft failure. We hypothesized that anterolateral complex reconstruction by way of a Lateral Extra-articular Tenodesis (LET) in combination with single bundle ACLR would reduce the risk of persistent rotatory laxity in young individuals who are deemed as being at high risk of failure. Methods: This is a pragmatic, multicenter, randomized clinical trial comparing standard hamstring tendon ACLR with combined ACLR and LET, utilizing a strip of iliotibial band (Modified Lemaire). Patients aged 25 years or less with an ACL deficient knee were included. They also had to have two of the following three criteria: 1) Grade 2 pivot shift or greater; 2) Returning to high risk/pivoting sports; 3) Generalized ligamentous laxity. The primary outcome was graft failure defined as either the need for revision ACLR or symptomatic instability associated with a positive asymmetric pivot shift, indicating persistent rotational laxity. Secondary outcome measures included the P4 pain scale, KOOS, IKDC. Patients were followed for two years with visits at 3, 6, 12 and 24 months postoperatively. A sample size of 300 per group was calculated based on a relative reduction in graft failure by 40%, with type 1 error of 5%, 80% power and 15% loss to follow-up rate. Results: 624 patients were randomized with a mean age of 18.9 (range: 14-25), 293 male. 436 (87.9%) patients presented pre-operatively with high-grade rotatory laxity (grade 2 pivot or greater) and 215 (42.1%) were diagnosed as having generalized ligamentous laxity (Beighton Score of 4 or greater). 523 of the 624 patients are at least 2 years postoperative; 29 lost to follow-up (˜5%). In the ACLR group 104/252 (41%) of patients suffered the primary outcome compared to 61/242 (25%) of the ACLR+LET patients (RR=0.61, 95%CI 0.47 to 0.79), p<0.0001. 39 patients suffered graft rupture, 28/252 (11%) in the ACLR group compared to 11/242 (4.5%) in the ACL+LET group (RR=0.41, 95%CI 0.21 to 0.80, p<0.001). At 3 months postoperative, patients in the ACLR group had less pain (p=0.004); at 3 and 6 months all KOOS subdomains, the IKDC favored the ACLR alone group (p=0.03). At 12 and 24 months, no important between-group differences were observed in any patient reported outcome. Conclusion: The addition of LET to a hamstring autograft ACLR in young active patients significantly reduces graft failure and persistent anterolateral rotatory laxity at 2 years post operatively.

scholarly journals Selenium supplementation and insulin resistance in a randomized, clinical trial

2019 ◽  
Vol 7 (1) ◽  
pp. e000613 ◽  
Author(s):  
Elizabeth Theresa Jacobs ◽  
Peter Lance ◽  
Lawrence J Mandarino ◽  
Nathan A Ellis ◽  
H-H Sherry Chow ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Insulin Sensitivity ◽  
Randomized Clinical Trial ◽  
Cell Function ◽  
Controlled Trial ◽  
Fasting Blood Glucose ◽  
Oral Glucose ◽  
Model Assessment ◽  
Β Cell ◽  
Β Cell Function

ObjectiveWhile controversial, observational and randomized clinical trial data implicate the micronutrient selenium (Se) in the development of type 2 diabetes (T2D). The aim of this study was to test the hypothesis that Se supplementation adversely affects pancreatic β-cell function and insulin sensitivity.Research design and methodsIn a subset of 400 individuals participating in a randomized, placebo-controlled trial of Se at 200 µg/day for colorectal adenomatous polyps, fasting plasma glucose and insulin were measured before randomization and within 6 months of completing intervention. Change in the homeostasis model assessment-β cell function (HOMA2-%β) and insulin sensitivity (HOMA2-%S) were compared between arms. A subgroup of 175 (79 Se and 96 placebo) participants underwent a modified oral glucose tolerance test (mOGTT) at the end of intervention and change in glucose values was assessed.ResultsNo statistically significant differences were observed for changes in HOMA2-%β or HOMA2-%S between those who received Se compared with placebo. After a mean of 2.9 years on study, mean HOMA2-%β values were 3.1±24.0 and 3.1±29.8 for the Se and placebo groups, respectively (p=0.99). For HOMA2-%S, the values were −0.5±223.2 and 80.9±1530.9 for the Se and placebo groups, respectively (p=1.00). Stratification by sex or age did not reveal any statistically significant effects on insulin sensitivity by treatment group. For mOGTT, mean baseline fasting blood glucose concentrations were significantly higher among participants in the placebo group compared with the Se group (96.6±14.6 and 92.3±12.0, respectively; p=0.04), a trend which remained through the 20 min assessment.ConclusionsThese findings do not support a significant adverse effect of daily Se supplementation with 200 µg/day of selenized yeast on β-cell function or insulin sensitivity as an explanation for previously reported associations between Se and T2D. Further clarification of longer term effects of Se is needed.Clinical trial registryNIH Clinical Trials.gov numberNCT00078897.

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