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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.