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Incidence and Determinants of Spontaneous Normalization of Subclinical Hypothyroidism in Older Adults.
van der Spoel, E, van Vliet, NA, Poortvliet, RKE, Du Puy, RS, den Elzen, WPJ, Quinn, TJ, Stott, DJ, Sattar, N, Kearney, PM, Blum, MR, et al
The Journal of clinical endocrinology and metabolism. 2024;109(3):e1167-e1174
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With increasing age, circulating levels of thyroid stimulating hormone (TSH) generally rise, accompanied by a higher prevalence of subclinical hypothyroidism. Subclinical hypothyroidism is defined as an elevated TSH level while the serum free T4 (fT4) concentration is within the normal range. The aim of this study was to investigate the incidence of spontaneous normalisation of TSH levels and identify determinants of normalisation in a large group of adults aged 65 years and older with (persistent) subclinical hypothyroidism. This study was a longitudinal study that pooled data from 2 randomised, double-blind, placebo-controlled parallel-group clinical trials. Results showed that 60.8% of the older adults with biochemical subclinical hypothyroidism based on at least 1 elevated TSH measurement, TSH levels had returned to the normal range without intervention after a median follow-up of 1 year. Subsequently, TSH levels had still normalised after 1 year in 39.9% of older adults with persistent subclinical hypothyroidism. Younger age, female sex, lower initial TSH level, higher normal initial fT4 level, the absence of thyroid peroxidase antibodies, and a second measurement in summer were independent determinants for TSH normalisation. Authors concluded that since TSH levels spontaneously normalised in a large proportion of older adults with subclinical hypothyroidism, a third measurement is recommended before considering treatment.
Abstract
CONTEXT With age, the prevalence of subclinical hypothyroidism rises. However, incidence and determinants of spontaneous normalization remain largely unknown. OBJECTIVE To investigate incidence and determinants of spontaneous normalization of TSH levels in older adults with subclinical hypothyroidism. DESIGN Pooled data were used from the (1) pretrial population and (2) in-trial placebo group from 2 randomized, double-blind, placebo-controlled trials (Thyroid Hormone Replacement for Untreated Older Adults With Subclinical Hypothyroidism Trial and Institute for Evidence-Based Medicine in Old Age thyroid 80-plus thyroid trial). SETTING Community-dwelling 65+ adults with subclinical hypothyroidism from the Netherlands, Switzerland, Ireland, and the United Kingdom. PARTICIPANTS The pretrial population (N = 2335) consisted of older adults with biochemical subclinical hypothyroidism, defined as ≥1 elevated TSH measurement (≥4.60 mIU/L) and a free T4 within the laboratory-specific reference range. Individuals with persistent subclinical hypothyroidism, defined as ≥2 elevated TSH measurements ≥3 months apart, were randomized to levothyroxine/placebo, of which the in-trial placebo group (N = 361) was included. MAIN OUTCOME MEASURES Incidence of spontaneous normalization of TSH levels and associations between participant characteristics and normalization. RESULTS In the pretrial phase, TSH levels normalized in 60.8% of participants in a median follow-up of 1 year. In the in-trial phase, levels normalized in 39.9% of participants after 1 year of follow-up. Younger age, female sex, lower initial TSH level, higher initial free T4 level, absence of thyroid peroxidase antibodies, and a follow-up measurement in summer were independent determinants for normalization. CONCLUSION Because TSH levels spontaneously normalized in a large proportion of older adults with subclinical hypothyroidism (also after confirmation by repeat measurement), a third measurement may be recommended before considering treatment. TRIAL REGISTRATION ClinicalTrials.gov, NCT01660126 and Netherlands Trial Register, NTR3851.
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The effect of melatonin on irritable bowel syndrome patients with and without sleep disorders: a randomized double-blinded placebo-controlled trial study.
Faghih Dinevari, M, Jafarzadeh, F, Jabbaripour Sarmadian, A, Abbasian, S, Nikniaz, Z, Riazi, A
BMC gastroenterology. 2023;23(1):135
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Previous research has shown that the use of melatonin by individuals with irritable bowel syndrome (IBS) has improved symptoms and quality of life (QoL) but did not affect sleep. This research has been shown to have some limitations in that it has been conducted in a small number of individuals and did not use the latest IBS diagnostic criteria. This randomised control trial aimed to determine in 136 individuals with IBS with and without sleep disorders the effects of melatonin on IBS score, gastrointestinal (GI) symptoms, QoL, and sleep. The results showed that compared to placebo, the use of melatonin for 8 weeks resulted in improved IBS score and GI symptoms in individuals with and without sleep disorders. Severity and frequency of abdominal pain, satisfaction with bowel habits, disease impacts on life, and stool consistency were all improved, however frequency of defecations was unaffected. Sleep was improved in those with sleep disorders, but not those without. It was concluded that melatonin can be used to improve IBS and QoL in individuals with or without sleep disorders and may also improve sleep in those with sleep disorders and IBS. This study could be used by healthcare professionals to recommend the use of melatonin to individuals with IBS to improve symptoms and QoL.
Abstract
BACKGROUND Irritable bowel syndrome (IBS) is one of the world's most common gastrointestinal (GI) disorders, and current treatments do not meet patients' demands. This study aimed to investigate melatonin's therapeutic effects on IBS score, GI symptoms, quality of life, and sleep parameters in both groups of IBS patients with and without sleep disorders. METHODS In this randomized double-blinded placebo-controlled trial study, 136 patients with a diagnosis of IBS based on ROME IV criteria were enrolled and then divided into two groups respecting having sleep disorders or not. Patients of each group were randomized in a 1:1 ratio to receive melatonin 6 mg daily (3 mg fasting and 3 mg at bedtime) for 2 months (8 weeks). Blocked randomization was used in this process. All patients were evaluated both at the beginning and the end of the trial regarding IBS score, GI symptoms, quality of life, and sleep parameters through valid questionnaires. RESULTS In both groups of patients with and without sleep disorders, a significant improvement was observed in IBS score and GI symptoms, including the severity and the frequency of abdominal pain, the severity of abdominal bloating, satisfaction with bowel habits, disease's impact on patient's life, and stool consistency; however, there was no significant improvement in the frequency of defecations per week. In patients with sleep disorders, significant improvement in sleep parameters, including subjective sleep quality, sleep latency, sleep duration, sleep efficiency, and daytime dysfunction, was observed, while in patients without sleep disorders, there was no significant improvement in sleep parameters. In addition, quality-of-life improvement was observed in a significant number of melatonin recipients compared to placebo in both groups of patients. CONCLUSION Melatonin can be considered an effective treatment for improving IBS score, GI symptoms, and quality of life in IBS patients with and without sleep disorders. It is also effective to improve sleep parameters in IBS patients with sleep disorders. TRIAL REGISTRATION This study has been registered to the Iranian Registry of Clinical Trials (IRCT) with the approval number IRCT20220104053626N2 on the date of 13/02/2022.
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Effects of Different Types of Front-of-Pack Labelling Information on the Healthiness of Food Purchases-A Randomised Controlled Trial.
Neal, B, Crino, M, Dunford, E, Gao, A, Greenland, R, Li, N, Ngai, J, Ni Mhurchu, C, Pettigrew, S, Sacks, G, et al
Nutrients. 2017;9(12)
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Nutrition labelling on the front of packaged food is a policy tool to help promote healthier food choices. Current research on the effectiveness of package labelling food-purchasing behaviour is both limited and mixed in results. The aim of this large-scale randomised trial was to compare Australia's new Health Star Rating (HSR) with five other front-of-pack labelling schemes with a focus on usability and impact on food choices. The 1578 participants were randomised to one of six experimental groups or the control group and food purchases were tracked by a smartphone application for four weeks. This study demonstrated that the HSR system was as good as other front-of-pack labelling schemes in many outcomes, and superior in terms of usefulness, however there was no evidence to show HSR improved food purchasing behaviour. Based on these results, the authors conclude that various package labelling systems are effective and HSR is one they would recommend.
Abstract
BACKGROUND Front-of-pack nutrition labelling may support healthier packaged food purchases. Australia has adopted a novel Health Star Rating (HSR) system, but the legitimacy of this choice is unknown. OBJECTIVE To define the effects of different formats of front-of-pack labelling on the healthiness of food purchases and consumer perceptions. DESIGN Individuals were assigned at random to access one of four different formats of nutrition labelling-HSR, multiple traffic light labels (MTL), daily intake guides (DIG), recommendations/warnings (WARN)-or control (the nutrition information panel, NIP). Participants accessed nutrition information by using a smartphone application to scan the bar-codes of packaged foods, while shopping. The primary outcome was healthiness defined by the mean transformed nutrient profile score of packaged foods that were purchased over four weeks. RESULTS The 1578 participants, mean age 38 years, 84% female recorded purchases of 148,727 evaluable food items. The mean healthiness of the purchases in the HSR group was non-inferior to MTL, DIG, or WARN (all p < 0.001 at 2% non-inferiority margin). When compared to the NIP control, there was no difference in the mean healthiness of purchases for HSR, MTL, or DIG (all p > 0.07), but WARN resulted in healthier packaged food purchases (mean difference 0.87; 95% confidence interval 0.03 to 1.72; p = 0.04). HSR was perceived by participants as more useful than DIG, and easier to understand than MTL or DIG (all p < 0.05). Participants also reported the HSR to be easier to understand, and the HSR and MTL to be more useful, than NIP (all p < 0.03). CONCLUSIONS These real-world data align with experimental findings and provide support for the policy choice of HSR. Recommendation/warning labels warrant further exploration, as they may be a stronger driver of healthy food purchases.