Background: Chronic kidney disease with metabolic acidosis is common in older people, but the effectiveness of oral sodium bicarbonate therapy in this group is unclear. We tested whether oral sodium bicarbonate provides net health benefit for older people with advanced chronic kidney disease and serum bicarbonate concentrations < 22 mmol/L. Methods: Pragmatic multicentre, parallel group, double-blind, placebo-controlled randomised trial. We recruited adults aged ≥ 60 years with estimated glomerular filtration rate of < 30 mL/min/1.73 m 2 , not receiving dialysis, with serum bicarbonate concentration < 22 mmol/L, from 27 nephrology and geriatric medicine departments in the UK. Participants received oral sodium bicarbonate (up to 3 g/day) or matching placebo given for up to 2 years, randomised in a 1:1 ratio. The primary outcome was between-group difference in the Short Physical Performance Battery (SPPB) at 12 months, adjusted for baseline values, analysed by intention to treat. Secondary outcomes included generic and disease-specific quality of life (EQ-5D and KDQoL tools), anthropometry, renal function, walk distance, blood pressure, bone and vascular health markers, and incremental cost per quality-adjusted life year gained.
Summary
Background
Actinic keratosis (AK) is a common premalignant skin lesion that can progress to cutaneous squamous cell carcinoma (cSCC). Microwave therapy is an established cancer treatment and has been used for plantar viral warts.
Objectives
To evaluate the efficacy and feasibility of microwave as a treatment for AK.
Methods
Stage I was a dose‐setting study, in which seven participants had the dielectric properties of 12 thick and 22 thin AKs assessed for optimization of the microwave dose used for treatment in Stage II. Stage II was a randomized, internally controlled trial evaluating 179 AKs in 11 patients (93 treated, 86 untreated controls) on the scalp/forehead or dorsal hand. Participants received one treatment initially and a repeat treatment to unresolved AKs at week 4. The response was assessed at six visits over 4 months. The primary outcome was partial or complete resolution of the treated AKs.
Results
A significantly higher proportion of treated AK areas responded than untreated (90% vs. 15%; P < 0·001). Thin AKs were more responsive than thick AKs. The site did not affect efficacy. Pain was severe, but brief (80% reported pain lasting ‘a few seconds only’). Adverse effects were minimal (erythema, n = 6; flaking, n = 3; itch, n = 3). All participants who would chose microwave therapy over their current treatment cited the shorter discomfort period.
Conclusions
Microwave therapy is a portable, safe and effective treatment for AK. An easy‐to‐deliver, acceptable therapy for AK is attractive as a prevention strategy. While these results are promising, a larger randomized controlled trial is needed against an effective comparator to confirm clinical efficacy and patient acceptability.
What is already known about this topic?
Actinic keratoses (AKs) are common precancerous skin lesions.
Successful treatment of AK can prevent cutaneous squamous cell carcinoma (cSCC).
Most topical therapies for AK require repeated application over weeks and drive local skin inflammation, leading to poor compliance.
An easy‐to‐deliver and effective treatment for AK, suitable for use in primary care, could reduce cSCC.
What does this study add?
Microwave therapy is a feasible, effective treatment for AK.
Ninety per cent of treated AKs showed full or partial resolution at 120 days post‐treatment.
Microwave therapy was painful, but the pain was short‐lived (seconds) and this short discomfort period was cited as the main reason that microwave was preferred to their current treatment.
Linked Comment: Samimi and Kelleners-Smeets. Br J Dermatol 2020; 183:197–199.
The derived CPR provides quantitative estimates of post-test probability for LVSD. This rule requires further validation in other populations and settings because of the difficulties encountered in the validation cohort.
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