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Corticosteroids are extremely potent and have potent anti-inflammatory properties. The downside is that they have an array of adverse effects including hypertension, hyperglycaemia, diabetes, osteoporosis, decreased muscle mass, increased appetite and early satiety, and increased risk of infection. This risk is largely independent of dose and duration of treatment, but may be prevented or delayed by appropriate pre-treatment risk stratification. A recent international consensus report on the use of glucocorticoids in the treatment of inflammatory bowel disease highlighted the potential harm from glucocorticoid therapy and the distinction between useful, non-beneficial and harmful steroids [ 247 ]. Although the effectiveness of lower doses of glucocorticoids on short-term outcomes is similar to higher doses, lower doses of glucocorticoids increase the safety profile, allowing for the more rapid discontinuation of glucocorticoids once clinical remission is achieved or sustained, and improvement in physical function. Combination therapy, as is frequently used in inflammatory arthritis, has the potential to decrease glucocorticoid dosages [ 248 ]. In particular, combination of methotrexate and prednisone was found to be associated with a 32% decrease in prednisone dose over a 6-month period compared with prednisone alone in a 16-week, controlled, randomized trial of glucocorticoid-dependent RA patients [ 249 ]. Similarly, continuous glucocorticoid therapy is associated with a high risk of serious infections, bone loss and fractures.
Alkaline water can neutralize and remove contaminants in drinking water and has many reported health benefits, including reduced cancer risk, infections, inflammation, and other disease markers [ 207 – 209 ]. The oxidation process destroys harmful free radicals as well as preventing the uptake of toxins and pathogens, and is thought to be the reason alkaline water can reduce inflammation, aid digestion, and support immune function [ 210 – 212 ]. Smaller trials suggest that alkaline water increases BMI in low-risk overweight women, but larger trials did not find a significant difference between placebo and alkaline water-treated groups [ 213 – 215 ]. Alkaline water was associated with modest benefits on lung function and reductions in fecal bacterial load in cases of HRS after paracetamol overdose in four randomized studies [ 216, 217 ], and studies of respiratory infection in the elderly and patients with asthma also found a reduction in the number of respiratory infections in treated groups [ 218, 219 ]. More recently, a randomized trial of healthy adults compared alkaline water to carbonated water and found that alkaline water increased total antioxidant capacity in serum and colonic tissue, and significantly increased calcium absorption [ 220 ].
in a clinical trial, scientists will strive to minimize bias, maximize internal validity, and minimize external validity [ 2 ]. internal validity refers to the extent to which the treatment group is comparable to the control group on observed variables that could affect the results of the study. for example, a non-inferiority trial is evaluated with respect to a specific comparison of a new intervention vs. a placebo (or a different intervention). in order to reduce the risk of bias, a randomized controlled trial (rct) of a treatment must be considered the "gold standard" of clinical research [ 3 ]. rcts generally exhibit high internal validity and generate results that are generalizable to the target population. they are considered the best available evidence, and are the most reliable and valid research designs [ 4 ]. a randomized controlled trial is an experiment where participants are randomly assigned to receive one of the treatment options under study or a control or placebo group. randomized controlled trials use randomization to reduce the impact of selection bias. in most cases, the researcher does not know in advance who will receive the treatment and who will receive the placebo or control. the principal difference between a rct and a non-randomized controlled trial (or a cohort study) is that in a rct the subjects are randomly assigned to the treatment or control group. this is called randomization. randomization has several advantages: it ensures that the groups are comparable, and it reduces the effect of selection bias. thus, probiotics may function by positively influencing energy metabolism (i.e., by reducing the levels of circulating free fatty acids and improving insulin sensitivity) and reducing inflammation in the muscle. further, there is evidence that probiotics can reduce the production of tnf-α [ 110, 111 ], a cytokine that is released during exercise and has been shown to negatively impact skeletal muscle regeneration. however, the available evidence regarding the impact of probiotics on inflammatory markers in humans is not as robust as the evidence in animal models. human clinical trials that have examined the effects of probiotics on inflammatory markers are less clear regarding the potential benefit. 5ec8ef588b
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