Circadian variations in clinical symptoms and concentrations of inflammatory cytokines, melatonin, and cortisol in polymyalgia rheumatica before and during prednisolone treatment: a controlled, observational, clinical experimental study

Galbo, H.; Kall, Lisbeth

doi:10.1186/s13075-016-1072-4

Cited by 33 publications

(24 citation statements)

References 46 publications

(94 reference statements)

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“…Cross reaction with N‐acetyl serotonin was 1% and 0.07% for 5‐methoxy tryptamine. A study using this assay reported daytime levels of approximately 5 pg/mL and 10 pg/mL …”

Section: Melatonin Measurementmentioning

confidence: 99%

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A critical review of melatonin assays: Past and present

Kennaway

2019

Journal of Pineal Research

106

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There has been increased interest in the measurement of melatonin in plasma and saliva recently either as a marker of circadian phase or to understand the physiological role of melatonin. For both situations, there is a need for a specific assay for melatonin that is sensitive enough to detect low concentrations (<2 pg/mL). Since the mid‐1970s, there have been many assays developed to measure melatonin in blood and saliva. Radioimmunoassays and ELISA have predominated because of their relative simplicity and high throughput. In this review, I show that the early radioimmunoassays while providing valuable information about nocturnal melatonin levels in humans, generally produced inaccurate basal (daytime) levels. Mass spectrometry assays, however, have provided us with the target values that immunoassays need to achieve, that is, daytime plasma melatonin levels <1 pg/mL. There are now many contemporary commercial assays available utilising both RIA and ELISA technologies, but not all achieve the standards set by the mass spectrometry assays. The performance of these assays is reviewed. I conclude with recommendations on issues researchers need to consider when conducting melatonin studies, including the importance of time of day of collection, validation of assays, the potential causes of poor assay specificity at low levels, the advantages/disadvantages of using saliva vs plasma and extraction assays vs direct assays, kit manufacturers responsibilities and the reporting requirements when publishing melatonin studies.

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“…Cross reaction with N‐acetyl serotonin was 1% and 0.07% for 5‐methoxy tryptamine. A study using this assay reported daytime levels of approximately 5 pg/mL and 10 pg/mL …”

Section: Melatonin Measurementmentioning

confidence: 99%

“…Cross reaction with N-acetyl serotonin was 1% and 0.07% for 5-methoxy tryptamine. A study using this assay reported daytime levels of approximately 5 pg/mL 51 Circadian melatonin secretion (pg/mL, mean ± SD) was measured in the plasma samples of 12 healthy subjects using GC-NCI-MS…”

Section: Serum/plasma Riasmentioning

confidence: 99%

A critical review of melatonin assays: Past and present

Kennaway

2019

Journal of Pineal Research

106

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“…A recent clinical experimental study further supports the use of chronotherapy in PMR. 9 Although the formal criteria of non-inferiority were not met, our study showed a clear trend for a favourable clinical effect of MR prednisone over IR prednisone in patients with PMR. Further confirmation should be sought from a large clinical trial in patients with PMR, with careful consideration of inclusion and response criteria, based on the present study experience.…”

Section: Discussionmentioning

confidence: 53%

Modified-release prednisone for polymyalgia rheumatica: a multicentre, randomised, active-controlled, double-blind, parallel-group study

et al. 2017

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ObjectiveTo assess the efficacy and safety of modified-release (MR) versus immediate-release (IR) prednisone in newly diagnosed glucocorticoid (GC)-naïve patients with polymyalgia rheumatica (PMR).MethodsPatients were randomised to double-blind MR prednisone (taken at approximately 22:00) or IR prednisone (taken in the morning), 15 mg/day for 4 weeks. The primary end point was complete response rate (≥70% reduction in PMR visual analogue scale, duration of morning stiffness and C reactive protein (CRP) (or CRP <2× upper limit of normal (ULN))) at week 4. Non-inferiority was decided if the lower 95% confidence limit (MR vs IR prednisone) was above −15%. 400 patients were planned but only 62 were enrolled due to difficulties in recruiting GC-naïve patients with PMR with CRP ≥2×ULN.ResultsThe percentage of complete responders at week 4 was numerically greater for MR prednisone (53.8%) than for IR prednisone (40.9%). Non-inferiority of MR versus IR prednisone was not proven in the primary analysis on the per protocol population (N=48; treatment difference: 12.22%; 95% CI −15.82% to 40.25%). However, sensitivity analysis on the full analysis population showed an evident trend favouring MR prednisone (N=62; treatment difference: 15.56%; 95% CI −9.16% to 40.28%). Adverse events were generally mild and transient with no unexpected safety observations.ConclusionsThe study showed a clear trend for favourable short-term efficacy of MR prednisone versus IR prednisone in early treatment of PMR. Further studies are warranted.Trial registration numberEudraCT number 2011-002353-57; Results.

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“…The relationship between MS and sleep impairment is bi-directional, with inflammation as only one of the involved factors. The abrupt onset of PMR during nighttime rest that is much more frequent in PMR patients than in SEORA patients and the possible role of other, different inflammation mediators can explain the discrepancy between MS and CRP concentrations [39].…”

Section: Discussionmentioning

confidence: 99%

Subjective sleep disturbances at the time of diagnosis in patients with polymyalgia rheumatica and in patients with seronegative elderly-onset rheumatoid arthritis. A pilot study

Manzo¹,

Castagna²

2020

Reumatologia

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Objectives: To investigate subjective sleep disturbances in patients with recent-onset polymyalgia rheumatica (PMR) and in patients with recent-onset seronegative elderly-onset rheumatoid arthritis (SEORA). Material and methods: The study involved patients consecutively referred to two outpatient clinics from January to June 2018, with a diagnosis of PMR according to 2012 European League Against Rheumatism and American College of Rheumatology provisional criteria, and patients with a diagnosis of SEORA according to 1987 American Rheumatism Association criteria + age + absence of rheumatoid factor and anti-citrullinated peptide antibodies. All patients were naive to glucocorticoid (GC) therapy. After informed consent, we asked the patients to fill out a questionnaire including the Medical Outcomes Study-Sleep Scale (MOS-SS), pain Visual Analogic Scale (VAS), Cumulative Illness Rating Scale (CIRS), Neuropsychiatric Inventory (NPI), and how many minutes their morning stiffness (MS) lasted, at baseline and after 1 (T1) and 12 (T2) months. Differences between groups were calculated with the t-test; all p-values were two-sided and p < 0.05 was used to determine statistical significance. The study was approved by the local ethics committee and carried out in accordance with the Helsinki Declaration. Results: The MOS-SS scores and MS duration were the only variables to show at T0 a significant difference between the two groups. In particular, MOS-SS scores were 47.6 ±8.4 (PMR) and 28.26 ±12.4 (SEORA), with p-values = 0.000. The MS duration was 90 ±9.9 minutes and 45 ±5.5 minutes, with p-value = 0.000. At T1 and T2, MOS-SS scores and MS duration decreased in the two groups, and no significant differences were found. Conclusions: The study suggests that the assessment of subjective sleep disturbances can be useful in the differential diagnosis between recent-onset PMR and SEORA.

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Circadian variations in clinical symptoms and concentrations of inflammatory cytokines, melatonin, and cortisol in polymyalgia rheumatica before and during prednisolone treatment: a controlled, observational, clinical experimental study

Cited by 33 publications

References 46 publications

A critical review of melatonin assays: Past and present

A critical review of melatonin assays: Past and present

Modified-release prednisone for polymyalgia rheumatica: a multicentre, randomised, active-controlled, double-blind, parallel-group study

Subjective sleep disturbances at the time of diagnosis in patients with polymyalgia rheumatica and in patients with seronegative elderly-onset rheumatoid arthritis. A pilot study

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