Systemic exertion intolerance disease/chronic fatigue syndrome is common in sleep centre patients with hypersomnolence: A retrospective pilot study

Maness, Caroline; Saini, Prabhjyot; Bliwise, Donald L.; Olvera, Victoria; Rye, David B.; Trotti, Lynn Marie

doi:10.1111/jsr.12689

Cited by 14 publications

(11 citation statements)

References 39 publications

(35 reference statements)

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“…ESS change values were comparable, but baseline and follow-up values between diagnostic groups were noticeably different, following a predictable pattern with more severe symptoms in NT1and less in IH. 23 Significant fatigue in patients with CNS hypersomnolence has also been reported in prior studies, 26 but to our knowledge, ours is the first to evaluate FSS outcomes across NT1, NT2, and IH patient groups. Depressive symptoms are common as well in CNS hypersomnias at similar rates to those seen in our study, 27,28 but most use other scales for depression.…”

Section: Discussionsupporting

confidence: 57%

Effects of Pharmacotherapy Treatment on Patient-Reported Outcomes in a Narcolepsy and Idiopathic Hypersomnia Cohort

Pascoe

Bena

Foldvary‐Schaefer

2019

Journal of Clinical Sleep Medicine

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Study Objective: We aimed to evaluate the association between patient-reported outcomes (PROs) and treatment regimen/standardized dose (STD), a measure of drug burden, in patients with narcolepsy type 1 (NT1)/type 2 (NT2) and idiopathic hypersomnia (IH). Methods: Patients age 18 years or older with NT1/NT2 and IH with baseline and ≥ 6-month follow-up during 2008-2010 were included. Changes in PROs (Epworth Sleepiness Scale [ESS], Fatigue Severity Scale [FSS], Patient Health Questionnaire 9 [PHQ-9], total sleep time [TST]) by diagnosis, treatment regimen (monotherapy versus polytherapy, sodium oxybate [SO] use), and STD were assessed by t tests and univariable/multivariable linear regressions, adjusting for patient characteristics. Results: A total of 92 patients (26 [28.3%] NT1, 27 [29.3%] NT2, 39 [42.4%] IH) were included (age 43.8 ± 14.8 years; 66 [71.7%] female). Baseline PROs suggested excessive daytime sleepiness (ESS 14.2 ± 5.2 [74% patients > 10]), significant fatigue (FSS 47.5 ± 12.9), and mild depression (PHQ-9 9.0 [4.0, 14.0] [49.4% ≥ 10]). At follow-up, ESS and PHQ-9 improved significantly overall and within diagnostic, monotherapy/polytherapy, and SO use groups (all P <.01). FSS improved significantly overall (P = .016), but improvements were not significant for IH, monotherapy, polytherapy, and non-SO using groups. In multivariable models, PRO changes were not significantly different between groups, but baseline STD was associated with worsening PHQ-9 across PHQ-9 change models, and ESS worsened with increasing STD at follow-up (P = .056). Conclusions: Significant improvements in sleep-related PROs were seen with pharmacotherapy use, regardless of diagnosis or treatment type, highlighting the importance of individualized prescribing decisions for this population.

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Section: Discussionsupporting

confidence: 57%

Effects of Pharmacotherapy Treatment on Patient-Reported Outcomes in a Narcolepsy and Idiopathic Hypersomnia Cohort

Pascoe

Bena

Foldvary‐Schaefer

2019

Journal of Clinical Sleep Medicine

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“…The post hoc subgroup analysis gives a general limitation of the clinical study (Schühlen, 2014). 2) At present, the Multidimensional Fatigue Inventory (MFI) is well applied in many clinical studies worldwide (Arnold et al, 2015; Maness et al, 2019). The MFI has five categories to evaluate multidimensional aspects such as reduced activity, cognitive impairment, and declining motivation, and the Korean version of MFI has been verified for its reliability and validity (Song et al, 2018).…”

Section: Discussionmentioning

confidence: 99%

The Efficacy and Safety of Myelophil, an Ethanol Extract Mixture of Astragali Radix and Salviae Radix, for Chronic Fatigue Syndrome: A Randomized Clinical Trial

et al. 2019

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Background: There is a strong demand for therapeutics to treat chronic fatigue syndrome (CFS), although there are limitations. Myelophil, which is a combination of extracts from Astragali Radix and Salviae Miltiorrhizae Radix, has been clinically used to treat fatigue-related disorders in South Korea. We conducted a randomized controlled clinical trial of Myelophil in patients with CFS and evaluated its efficacy and safety in two hospitals. Methods: We enrolled 98 participants (M: 38, F: 60) with CFS in a phase 2 trial of oral Myelophil (2 g daily) or placebo for 12 weeks. The primary end point was a change in the Chalder fatigue scale, as scored by a numeric rating scale (NRS). The secondary end points included changes in the visual analogue scale, fatigue severity scale (FSS), and 36-item short-form health survey (SF-36). Biomarkers of oxidative stress and cytokines were evaluated by blood tests. Results: Ninety-seven participants (48 in the Myelophil group and 49 in the placebo group) completed the trial. An analysis of all participants showed that Myelophil slightly improved fatigue symptoms compared with those of the placebo, but this effect was not statistically significant (p > 0.05 for the NRS, VAS, FSS, and SF-36). By contrast, an analysis of the subpopulation (53 participants, M: 24, F: 29) with severe symptoms (≥63, median NRS value of total participants) showed a statistically significant improvement in fatigue symptoms in the Myelophil group compared with the placebo (p < 0.05 for NRS, FSS, and SF-36). There were no significant changes in the biomarkers for oxidative stress and cytokines before or after the treatment. No Myelophil-related adverse response was observed during the trial. Conclusion: These results support the hypothesis that Myelophil can be a therapeutic candidate to manage CFS and provide the rationale for its progression to a phase 3 clinical trial. Clinical Trial Registration: , identifier KCT0002317.

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“…Differentiating between fatigue and sleepiness may be challenging, in particular in children (86). Individuals with fatigue demonstrate sleepiness, and vice versa implying that there may be a shared biological basis between fatigue and sleepiness, or that there might be overlap of symptoms (113). Although further documentation is still needed, there are studies showing that the majority of patients with narcolepsy suffer from severe fatigue (14,86,114).…”

Section: Fatiguementioning

confidence: 99%

“…There is a positive relation between disturbed nocturnal sleep and fatigue in healthy subjects (158). However, the direction of the association between nocturnal sleep disturbances and daytime fatigue remains unclear (113) (14). The authors discussed whether fatigue was just an equivalent of depression in the narcolepsy population.…”

Section: Fatiguementioning

confidence: 99%

Obesity and other medical comorbidities among NT1 patients after the Norwegian H1N1 influenza epidemic and vaccination campaign

Nordstrand

Juvodden

Viste

et al. 2019

Sleep

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Study Objectives Narcolepsy type 1 (NT1) may be complicated by comorbidities. We aimed to study the extent of obesity and other medical comorbidities in a Norwegian population of NT1 patients with debut of symptoms after the 2009 H1N1 influenza epidemic and vaccination campaign. We also aimed to explore factors associated with obesity. Methods Ninety-one patients (48 children and 43 adults) were included in this cross-sectional study, 80 of whom were H1N1-vaccinated. All participants were hospitalized and underwent sleep investigation and physical examination, and completed a semi-structured clinical interview. Results In children, 16 females (70%) and 10 males (40%) were classified as overweight or obese. Twenty children (42%) had a co-existing medical disorder. Medical comorbidity was significantly positively associated with BMI in children (p = .032). In adults, 19 females (58%) and 7 males (70%) were classified as overweight or obese. Twenty-six adults (61%) had a co-existing medical disorder. We found no factors significantly associated with BMI in adults. On a fatigue scale from 0 to 100, lower scores indicating more fatigue, we found a mean (SD) total fatigue score of 50 (17) in children and 39 (16) in adults. Conclusion In a cohort of predominantly H1N1-vaccinated NT1 patients, we found a high prevalence of overweight or obesity. Half of the cohort presented with one or more additional medical comorbidities, and patients reported a clinically relevant degree of fatigue. Our findings highlight the importance of carefully monitoring patients with NT1 with regard to the development of obesity, which is a significant risk factor for cardiovascular disorders.

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Systemic exertion intolerance disease/chronic fatigue syndrome is common in sleep centre patients with hypersomnolence: A retrospective pilot study

Cited by 14 publications

References 39 publications

Effects of Pharmacotherapy Treatment on Patient-Reported Outcomes in a Narcolepsy and Idiopathic Hypersomnia Cohort

Effects of Pharmacotherapy Treatment on Patient-Reported Outcomes in a Narcolepsy and Idiopathic Hypersomnia Cohort

The Efficacy and Safety of Myelophil, an Ethanol Extract Mixture of Astragali Radix and Salviae Radix, for Chronic Fatigue Syndrome: A Randomized Clinical Trial

Obesity and other medical comorbidities among NT1 patients after the Norwegian H1N1 influenza epidemic and vaccination campaign

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