Effectiveness a herbal medicine ( Sipjeondaebo-tang) on adults with chronic fatigue syndrome: A randomized, double-blind, placebo-controlled trial

Abstract:

Background: Sipjeondaebo-tang (SJDBT, Shi-quan-da-bu-tang in Chinese) is a widely prescribed herbal medicine in traditional Korean medicine. This study aimed to evaluate the effectiveness and safety of SJDBT for treating chronic fatigue syndrome (CFS).

Methods: Ninety-six eligible participants were randomly allocated to either the SJDBT or placebo groups in a 1:1 ratio. Nine grams of SJDBT or placebo granules were administered to the patients for 8 weeks. The primary outcome was the response rate, defined as the proportion of participants with a score of 76 or higher in the Checklist Individual Strength assessment. Other measurements for fatigue severity, quality of life, and qi/blood/yin/yang deficiency were included. Safety was assessed throughout the trial.

Results: At week 8, the response rate did not significantly differ between the groups (SJDBT: 35.4%; placebo: 54.2%; P = 0.101, effect size [95% confidence interval] = 0.021 [-0.177, 0.218]). However, the scores of the visual analogue scale (P = 0.001, -0.327 [-0.506, -0.128]), Fatigue Severity Scale (P = 0.020, 0.480 [0.066, 0.889]), and Chalder fatigue scale (P = 0.004, -0.292 [-0.479, -0.101]) for the SJDBT group showed significant improvements in fatigue severity at the endpoint. Quality of life was not significantly different. Furthermore, SJDBT significantly ameliorated the severity of qi deficiency compared to that in the placebo group. No serious adverse events were observed.

Conclusion: This trial failed to show a significant improvement in fatigue severity, as assessed by the CIS-deprived response rate. It merely showed that SJDBT could alleviate the severity of fatigue and qi deficiency in patients with CFS. However, the further study is needed to confirm the details.

Source: Shin S, Park SJ, Hwang M. Effectiveness a herbal medicine (Sipjeondaebo-tang) on adults with chronic fatigue syndrome: A randomized, double-blind, placebo-controlled trial. Integr Med Res. 2021 Jun;10(2):100664. doi: 10.1016/j.imr.2020.100664. Epub 2020 Sep 22. PMID: 33101925; PMCID: PMC7578262.  https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7578262/ (Full study)

The case of Chronic Fatigue Syndrome-Myalgic Encephalomyelitis

Overview:

Chronic fatigue syndrome (CFS) and myalgic encephalomyelitis (ME) affect approximately 1 million Americans (Jason, Richman, Rademaker, Jordan, Plioplys, Taylor, et al., 199%); while some individuals believe that CFS and ME refer to the same illness, others characterize ME as a more severe, neurological disorder that is discrete from CES (Twisk, 2013). This controversy will be reviewed in detail. The widespread, debilitating symptoms of the illnesses include but are not limited to feeling sick after activity (known as post-exertional malaise), memory and concentration problems, and unrefreshing sleep (IOM, 2015).

Some researchers suggest that ME and CFS were first conceptualized under the diagnostic label ‘newrasthenia,’ defined as a neurological disease characterized by muscle weakness or fatigue. Notably, neurasthenia was one of the most frequently diagnosed illnesses in the late nineteenth century. However, use of this term had substantially decreased by the mid-twentieth century (Wessely, 1994)

Throughout the twentieth century, several outbreaks of idiopathic, fatigue-related illneses occurred, including ‘atypical poliomyelitis’ at Los Angeles County Hospital in 1934 (Meals, Hauser, & Bowe 1938), ‘encephalomyelits’ at the Royal Free Hospital in London in 1955 (Crowley, Nelon, & Stovi 1957), and ‘chronic mononucleosis-like syndrome’ in Lake Tahoe, Nevada, in 1984 (Barnes, 1986). After the Lake Tahoe outbreak, national attention began to focus on this illness (Wessely, 1994), and in 1988, it was named donc fatigue syndrome by the Centers for Disease Control and Prevention (CDC; Holmes, Kaplan, Gantz, Komaroff, Schonberger, Straus, ct al, 1988). For over two decades, the ease definition that the CDC developed (Fukuda, Straus, Hickic, Sharpe, Dobbins, & Komaroff, 1994) has bbeen prominently used in research and clinical practice; however, the Institute of Medicine (10M) recently developed an updated clinical case definition (IOM, 2015).

The annual direct and indirect costs of ME and CFS in the United States are estimated to be between $19 and $24 billion (Jason, Benton, Johnson, & Valentine, 2008). Individuals with ME and CES have an increased risk of cardiovascular-related mortality and a lower mean age of death by suicide and cancer in comparison to the general US population (McManimen, Devendorf, Brow Moore, Moore, & son, 2016).

In addition, arthritis, high blood pressure, fibromyalgia, and multiple chemical sensitivities are commonly comorbid (Jason, Porter, Hunnell, Brown, Rademaker, & Richman, 2011). Although no virus has been identified as the cause of ME and CFS, the immune system may be overactive (Fischer, William, Strauss, Unger, Jason, Marshall, etl, 2014), and there is and fibromyalgia using regression tree analysis and artificial neural network analysis, composed of computer-based models used to evaluate complex correlations. The patients were randomly divided into two groups. One group served to derive classification criteria sets by sophisticated procedures, including artificial neural networks in parallel. These criteria were then validated with the second group. Symptoms that best differentiated patients with ME and CES from the other patients were acute onset of fatigue and sore throat.

Additionally, a recent study highlighted that the duration of post-exertional malaise symptoms can distinguish ME and CFS from other chronic illnesses (Cotler, Holtzman, Dudun, & Jason, 2018). The lesson that is apparent from this section is that it is essential for a consensus on a case definition among investigators for establishing a solid empiric foundation in any illness or disease.

Source: Handbook of Research Methods in Health Psychology, Chapter 17: Chronic Illness, pp 228-241, Date:  November 29, 2020 and January 2021 URL: https://books.google.com/books?id=fPQCEAAAQBAJ&pg=PA228  Ref: https://www.routledge.com/Handbook-of-Research-Methods-in-Health-Psychology/Ragin-Keenan/p/book/9780429488320

 

Chronic fatigue syndrome/myalgic encephalomyelitis in children aged 5 to 11 years: A qualitative study

Abstract:

Treatments for paediatric chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) have not been designed or evaluated for younger children (5-11-years). The development of a complex intervention for this population requires an in-depth understanding of the perspectives and psychosocial context of children and families. Children with CFS/ME (5-11-years) and their families were recruited from a specialist CFS/ME service, and interviewed using semi-structured topic guides. Data were analysed thematically. Twenty-two participants were interviewed; eight parents, two children (aged nine and ten) and six parent-child dyads (aged 5-11-years).

Theme 1: CFS/ME in younger children is complex and disabling. Theme 2: Children aged eight and over (in comparison to those under eight) were more able to describe their illness, engage in clinical consultation, understand diagnosis and self-manage. Theme 3: Parents of children under eight took full responsibility for their child’s treatment. As children got older, this increasingly became a joint effort between the parent and child. Parents felt unsupported in their caring role. Clinicians should consider different treatment approaches for children under eight, focusing on: parent-only clinical sessions, training parents to deliver treatment, and increasing support for parents. Children over eight may benefit from tools to help them understand diagnosis, treatment and aids for self-management.

Source: Brigden A, Shaw A, Anderson E, Crawley E. Chronic fatigue syndrome/myalgic encephalomyelitis in children aged 5 to 11 years: A qualitative study. Clin Child Psychol Psychiatry. 2020 Oct 22:1359104520964528. doi: 10.1177/1359104520964528. Epub ahead of print. PMID: 33092395. https://pubmed.ncbi.nlm.nih.gov/33092395/

The Lonely, Isolating, and Alienating Implications of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Abstract:

This article provides a narrative review on myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) through a psychosocial lens and examines how this impairment affects its sufferers during adolescence and adulthood, as well as how it impacts family caregivers and healthcare professionals’ mental health. Since there has been a lack of investigation in the literature, the primary psychosocial stressor that this review focuses on is loneliness. As such, and in an attempt to help establish a theoretical framework regarding how loneliness may impact ME/CFS, loneliness is comprehensively reviewed, and its relation to chronic illness is described. We conclude by discussing a variety of coping strategies that may be employed by ME/CFS individuals to address their loneliness. Future directions and ways with which the literature may investigate loneliness and ME/CFS are discussed.

Source: Boulazreg S, Rokach A. The Lonely, Isolating, and Alienating Implications of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. Healthcare (Basel). 2020 Oct 20;8(4):E413. doi: 10.3390/healthcare8040413. PMID: 33092097. https://pubmed.ncbi.nlm.nih.gov/33092097/

Cardiac Dimensions and Function Are Not Altered among Females with the Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Abstract:

Background: Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a debilitating condition associated with several negative health outcomes. A hallmark of ME/CFS is decreased exercise capacity and often profound exercise intolerance. The causes of ME/CSF and its related symptoms are unknown, but there are indications of a dysregulated metabolism with impaired glycolytic vs oxidative energy balance. In line with this, we recently demonstrated abnormal lactate accumulation among ME/CFS patients compared with healthy controls after exercise testing. Here we examined if cardiac dimensions and function were altered in ME/CFS, as this could lead to increased lactate production.

Methods: We studied 16 female ME/CFS patients and 10 healthy controls with supine transthoracic echocardiography, and we assessed cardiac dimensions and function by conventional echocardiographic and Doppler analysis as well as novel tissue Doppler and strain variables.

Results: A detailed analyses of key variables of cardiac dimensions and cardiac function revealed no significant differences between the two study groups.

Conclusion: In this cohort of well-described ME/CFS patients, we found no significant differences in echocardiographic variables characterizing cardiac dimensions and function compared with healthy controls.

Source: Iversen PO, von Lueder TG, Kardel KR, Lien K. Cardiac Dimensions and Function Are Not Altered among Females with the Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. Healthcare (Basel). 2020 Oct 16;8(4):E406. doi: 10.3390/healthcare8040406. PMID: 33081294. https://pubmed.ncbi.nlm.nih.gov/33081294/

Characterization of Post-exertional Malaise in Patients With Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Abstract:

Background: Myalgic encephalomyelitis/chronic fatigue syndrome is characterized by persistent and disabling fatigue, exercise intolerance, cognitive difficulty, and musculoskeletal/joint pain. Post-exertional malaise is a worsening of these symptoms after a physical or mental exertion and is considered a central feature of the illness. Scant observations in the available literature provide qualitative assessments of post-exertional malaise in patients with myalgic encephalomyelitis/chronic fatigue syndrome. To enhance our understanding, a series of outpatient focus groups were convened.

Methods: Nine focus groups totaling 43 patients who reported being diagnosed with myalgic encephalomyelitis/chronic fatigue syndrome were held between November 2016 and August 2019. Focus groups queried post-exertional malaise in daily life and participants’ retrospective memory of post-exertional malaise that followed an exercise provocation with a cardiopulmonary exercise test. Data analysis followed the grounded theory method to systematically code and categorize the data to find meaningful patterns. A qualitative software package was used to move text into categories during data coding.

Results: A wide range of symptoms were attributed to exertion both in daily lives and following cardiopulmonary exercise testing. While three core symptoms emerged (exhaustion, cognitive difficulties, and neuromuscular complaints), participants’ descriptions were notable for their unique individual variations. Of 18 participants who responded to questions centered around symptoms following a cardiopulmonary exercise test, 17 reported that symptoms started within 24 h and peaked in severity within 72 h following the cardiopulmonary exercise test. Patients described post-exertional malaise as interfering with their ability to lead a “normal” life.

Conclusion: The experience of post-exertional malaise in myalgic encephalomyelitis/chronic fatigue syndrome varies greatly between individuals and leads to a diminished quality of life. myalgic encephalomyelitis/chronic fatigue syndrome patients describe post-exertional malaise as all-encompassing with symptoms affecting every part of the body, difficult to predict or manage, and requiring complete bedrest to fully or partially recover. Given the extensive variability in patients, further research identifying subtypes of post-exertional malaise could lead to better targeted therapeutic options.

Source: Stussman B, Williams A, Snow J, Gavin A, Scott R, Nath A, Walitt B. Characterization of Post-exertional Malaise in Patients With Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. Front Neurol. 2020 Sep 18;11:1025. doi: 10.3389/fneur.2020.01025. PMID: 33071931; PMCID: PMC7530890. https://www.frontiersin.org/articles/10.3389/fneur.2020.01025/full  (Full text)

Scraping on head and face combined with stepping technique of tuina along lower limbs for chronic fatigue syndrome

Abstract:

Objective: To observe the effect of scraping on head and face combined with stepping technique of tuina along lower limbs on fatigue symptom and mental state in patients with chronic fatigue syndrome.

Methods: A total of 100 patients with chronic fatigue syndrome were randomized into an observation group (50 cases, 2 cases dropped off) and a control group (50 cases, 2 cases dropped off). In the control group, oryzanol tablets and compound vitamin B tablets were taken orally, both 2 tablets every time, 3 times every day for 30 days. On the basis of the treatment in the control group, scraping on head and face combined with stepping technique of tuina along lower limbs of three yin meridians of foot were applied in the observation group, once every 3 days, 10 times were required. Before and after treatment, the scores of fatigue scale-14 (FS-14) and somatic and psychological health report (SPHERE) were observed, and the clinical therapeutic effect was evaluated in the two groups.

Results: After treatment, the scores of FS-14 and SPHERE were reduced in the two groups (P<0.05), and the changes of those indexes in the observation group were larger than the control group (P<0.05). The total effective rate was 91.7% (44/48) in the observation group, which was superior to 54.2% (26/48) in the control group (P<0.05).

Conclusion: Scraping on head and face combined with stepping technique of tuina along lower limbs can improve fatigue symptom and mental state in patients with chronic fatigue syndrome.

Source: Lei LM, Wu QY, He YF. [Scraping on head and face combined with stepping technique of tuina along lower limbs for chronic fatigue syndrome]. Zhongguo Zhen Jiu. 2020 Oct 12;40(10):1057-60. Chinese. doi: 10.13703/j.0255-2930.20190801-k0006. PMID: 33068345. https://pubmed.ncbi.nlm.nih.gov/33068345/

Acupuncture of the Beishu acupoint participates in regulatory effects of ginsenoside Rg1 on T cell subsets of rats with chronic fatigue syndrome

Abstract:

Background: There are close relationships between the spleen and limb muscles and thoughts. The study aims to test the effects of ginsenoside Rg1 in combination with acupuncture of the Beishu acupoint on T cell subsets of rats with chronic fatigue syndrome (CFS).

Methods: The model was set up by combining forced cold-water swimming with chronic restraint. The rats were randomly divided into blank control, model, ginsenoside, acupuncture, and ginsenoside plus acupuncture groups (n=10). For the acupuncture group, the Beishu acupoint was acupunctured on the 2nd day after modeling. For the ginsenoside group, the ginsenoside Rg1 solution was injected into the tail vein on the 2nd day after modeling. For the combination group, both processes were conducted. These groups were compared regarding exhausted swimming time, number of struggles, resting time, serum levels of IgA, IgG, IgM, IFN-α, IFN-β, and IFN-γ, lymphocyte transformation rate, T cell subsets, and skeletal muscle activities of malondialdehyde (MDA), total antioxidative capacity (T-AOC) and acetylcholinesterase (Ache).

Results: The exhausted swimming time, number of struggles, and resting time of combination group surpassed those in the ginsenoside and acupuncture groups significantly (P<0.05). The serum levels of IgA, IgG, IgM, IFN-β, IFN-γ, T-AOC, and Ache, together with CD3+ and CD8+ T cell percentages of combination groups, were significantly higher than those of ginsenoside and acupuncture groups. However, the IFN-α level, MDA activity, and CD4+ T cell percentage were significantly lower (P<0.05). Compared with the model group, the CD4+/CD8+ T cell ratios of acupuncture, ginsenoside, and combination groups decreased significantly (P<0.05). Compared with the combination group, the ratio of the ginsenoside group increased significantly (P<0.05).

Conclusions: Both acupuncture of the Beishu acupoint and intravenous injection of ginsenoside Rg1 have anti-fatigue effects, and their combination works synergistically. This study supplies an experimental basis for joint therapy using acupuncture and drugs to combat fatigue synergistically.

Source: He J, Yu Q, Wu C, Sun Z, Wu X, Liu R, Zhang H. Acupuncture of the Beishu acupoint participates in regulatory effects of ginsenoside Rg1 on T cell subsets of rats with chronic fatigue syndrome. Ann Palliat Med. 2020 Sep;9(5):3436-3446. doi: 10.21037/apm-20-1714. PMID: 33065794. http://apm.amegroups.com/article/view/52609/html (Full text)

Reduced Heart Rate Variability in Patients with Medically Unexplained Physical Symptoms: A Meta-Analysis of HF-HRV and RMSSD

Abstract:

Objectives: Medically unexplained physical symptoms (MUPS) and related syndromes are common and place a substantial burden on both patients and society. Chronic psychological distress and dysregulation of the autonomic nervous system may be common factors associated with MUPS, although previous studies have reported mixed results. The aim of this meta-analysis is to provide an updated synthesis of studies investigating heart rate variability (HRV) indices associated with autonomic nervous system functioning in three common MUPS-syndromes and to explain inconsistencies in previous study findings.

Method: Literature search yielded 58 studies comparing HRV indices of reduced parasympathetic activity of healthy individuals to patients with chronic fatigue syndrome (Npatients = 271), irritable bowel syndrome (Npatients = 1005), and fibromyalgia (Npatients = 534). Separate random-effects meta-analyses were conducted on studies measuring root mean square of successive differences (RMSSD) and high frequency HRV (HF-HRV).

Results: Regardless of syndrome type, patients had significantly lower RMSSD (k = 22, Hedges’ g = – 0.37 [-0.53; -0.21], p < .001) and HF-HRV (k = 52, Hedges’ g = -0.69 [-1.03; -0.36], p < .001) than healthy individuals. Sample age and publication year explained substantial variation in RMSSD, whereas controlling for confounders in statistical analyses explained variation in HF-HRV.

Conclusions: Lower RMSSD and HF-HRV in patients with MUPS versus healthy controls indicates that autonomic nervous system dysregulation, particularly lower parasympathetic activity, may play a role in patients with these conditions. This conclusion may have important implications for the underlying mechanisms and treatment of MUPS and related syndromes.

Source: Vreijling SR, Troudart Y, Brosschot JF. Reduced Heart Rate Variability in Patients with Medically Unexplained Physical Symptoms: A Meta-Analysis of HF-HRV and RMSSD. Psychosom Med. 2020 Oct 14. doi: 10.1097/PSY.0000000000000874. Epub ahead of print. PMID: 33065584. https://pubmed.ncbi.nlm.nih.gov/33065584/

Oxidative stress caused by a dysregulated Wnt/β-catenin signalling pathway is involved in abnormal placenta formation in pregnant mice with chronic fatigue syndrome

Abstract:

Chronic fatigue syndrome (CFS) is characterized by extreme fatigue and disabling symptoms. Women with CFS often have a high risk of gynaecological problems such as irregular menstruation, endometriosis and pelvic pain and sexual dysfunction. Our previous results have shown that, in pregnant mice, CFS significantly decreased the progestational hormone level in serum, as well as learning and memory, and the function of the hypothalamus-pituitary-gonadal axis. In addition, the F1 generation also suffered from congenital hypothyroidism. At present, there has been no report about placenta formation and embryonic development in pregnant mice with CFS. The aim of the present study was to investigate the influence of CFS on the morphology, oxidative stress and Wnt/β-catenin signalling pathway during placenta formation.

In this study, we found that CFS decreased the number of implantation sites for blastocysts, and increased the number of absorbed, stillborn and malformed fetuses. The morphology and structure of the placenta were abnormal in pregnant mice with CFS. Further study found that the oxidative stress in serum, uterus and placenta was increased in pregnant mice with CFS, while the levels of antioxidase were decreased. CFS also inhibited the Wnt/β-catenin signalling pathway in the placenta. These results suggested that inhibition of the Wnt/β-catenin signalling pathway and enhanced oxidative stress play an important role in abnormal placentation in pregnant mice with CFS.

Source: Zhao H, Zhang J, Qian N, Wu S, Wu Y, Yao G. Oxidative stress caused by a dysregulated Wnt/β-catenin signalling pathway is involved in abnormal placenta formation in pregnant mice with chronic fatigue syndrome. Zygote. 2020 Oct 15:1-8. doi: 10.1017/S096719942000057X. Epub ahead of print. PMID: 33054899. https://pubmed.ncbi.nlm.nih.gov/33054899/