Chronic fatigue syndrome post-COVID-19: triple-blind randomised clinical trial of Astragalus root extract 2024 Banihashemi et al

[Andy]

Abstract

Objective
This study aimed to evaluate the effect of Astragalus root extract on nurses suffering from post-COVID-19 chronic fatigue syndrome.

Materials and methods
The study was designed as a triple-blind, randomised, controlled trial in Iran in 2023. 64 chronic fatigue syndrome nurses were randomly assigned to one of two groups: an intervention group (n=32) that received Astragalus root extract (500 mg two times per day) or a control group (n=32) that received a placebo. Changes in chronic fatigue syndrome scores were measured before to, at the end of and 1 month after the intervention. Data were analysed using descriptive and analytical statistics (T-tests, χ2, analysis of variances, Cochran’s Q tests, McNemar and generalised estimating equations).

Results
In comparison to before, chronic fatigue prevalence decreased statistically significantly at the end of the intervention group (13.8%) and 1 month later (17.2%). Further, the frequency differed between before and after (p=0.0001) and 1 month later (p=0.0001). In the control group, chronic fatigue was statistically significantly different before and after the intervention (72.2%; p=0.003). Having an underlying disease (B=0.84, OR=2.33; p=0.04) and being in the control group (B=2.15, OR=12.36; p=0.01) increased the risk of chronic fatigue, whereas increasing the length of time decreased it (B=−0.67, OR=0.50; p=0.0001).

Conclusion
Astragalus root extract has been shown to reduce chronic fatigue in nurses. Therefore, this herbal extract can be used to reduce the incidence and treatment of chronic fatigue in nurses.

Paywall, https://spcare.bmj.com/content/early/2024/06/04/spcare-2023-004595

 

[Andy]

Being paywalled, I am unable to determine how "chronic fatigue syndrome" was specified. Given that they then refer only to chronic fatigue in the later part of the abstract I doubt they used any criteria that screened for PEM.

 

[SNT Gatchaman]

Nursing is linked to a high incidence of health issues, such as fatigue, which may result from work-related stressors. Chronic fatigue syndrome (CFS)/ myalgic encephalomyelitis is a debilitating disorder characterised by fatigue lasting over 6 months that is unrelieved by rest, cognitive impairment, autonomic dysfunction and/or muscle and joint pain. There was a prevalence of 6.76% for CFS in the population.

According to studies conducted in Iran, CSF affects 17%–39% of nurses. In addition, it has been reported that only 5%–10% of patients suffering from CFS will experience a full recovery, which is a very low percentage. Among nurses, fatigue is associated with burnout, sickness/absenteeism, medical errors, injury-related work performance and reduced safety, health and well-being. Fatigued nurses tend to lack accurate concentration and have poor decision-making skills, which can have irreparable effects on both the nurse and the patient.

The inclusion criteria include having the desire to participate in the study, having a history of being infected with COVID-19, having CFS based on the DePaul symptom questionnaire, working in a hospital as a nurse, not using anticoagulants, not experiencing orthostatic hypotension, not having any allergic reactions to legumes or beans, not being under the influence of antipsychotics or antidepressants and not having thyroid disorders.

Inclusion criteria include not having the exclusion criteria...

The exclusion criteria include unwillingness to continue participating in the study, discontinuation of medication for four consecutive days, inaccessibility of samples during the study, occurrence of drug allergy symptoms, pregnancy or a hypotensive reaction.

 

[SNT Gatchaman]

It continues on. It's laughable, but not really any different to the prime BPS papers: predisposing to, precipitating and perpetuating their circular diagrams.

An additional finding of the study is that CFS decreases over time, either at the end of the intervention or even 1 month after it has ended. According to these findings, the root extract has long-term effects that persist even after the intervention has ended. On the other hand, in explaining this finding, it can be said that removing CFS has been able to reduce the harmful effects of CFS in a person, thus interrupting the vicious cycle caused by the presence of CFS and its complications, and thus resulting in improved health. It has been been demonstrated that fatigue is associated with other complications, such as a decline in physical, mental and psychological abilities, which contribute to the aggravation of fatigue.

According to the same study, chronic fatigue is more likely to occur if an underlying disease is present. It confirms the explanation above that fatigue results from both the underlying disease as well as disorders that affect the physical and mental well-being of the individual. If this vicious circle is not broken, it continues to occur.

Also true of BPS: a vicious cycle which if not broken continues to occur.

 

[Hutan]

It's laughable

I actually did laugh out loud when I saw how well they did in not extrapolating beyond their sample population.

Astragalus root extract has been shown to reduce chronic fatigue in nurses. Therefore, this herbal extract can be used to reduce the incidence and treatment of chronic fatigue in nurses.

Presumably, never mind ongoing exposure to Covid-19, never mind probably inadequate protective equipment and ventilation. Just have some astragalus.

 

[Hutan]

In comparison to before, chronic fatigue prevalence decreased statistically significantly at the end of the intervention group (13.8%) and 1 month later (17.2%). Further, the frequency differed between before and after (p=0.0001) and 1 month later (p=0.0001). In the control group, chronic fatigue was statistically significantly different before and after the intervention (72.2%; p=0.003). Having an underlying disease (B=0.84, OR=2.33; p=0.04) and being in the control group (B=2.15, OR=12.36; p=0.01) increased the risk of chronic fatigue, whereas increasing the length of time decreased it (B=−0.67, OR=0.50; p=0.0001).

What are they actually saying here? It looks like there was 13.8% less chronic fatigue in the treatment group after one month of treatment. But was the incidence of chronic fatigue in the control group after the treatment 72.2% of what it was before? So 27.8% less chronic fatigue in the control group?
I assume I don't have it right. But I don't know what they are saying.

 

[SNT Gatchaman]

Yes. #in-nurses instead of #in-mice.

I don't think it's worth spending any time on. The Canadian taurine paper is of more interest.

 

[Hutan]

(I have a soft spot for astragalus. I don't know why. I've boiled up astragalus roots and drunk the tea sometimes, just because. I can't say that I noticed it did anything, good or bad, but if someone gave me an astragalus tonic from a reputable brand, I'd probably drink it. Which is to say, I am a receptive audience. But these researchers, they give me nothing upon which my unfounded faith in this plant can rest.)

 

[forestglip]

Based on just the objective results claimed in the abstract, I'm not sure why you guys are dismissing this so easily.

@SNT Gatchaman Can you paste any charts showing effect size?

Also, do they go into more detail on the DePaul questionnaire? MEpedia says:

In response to these concerns the DePaul research group has recently revised the DSQ PEM subscale to include 5 new items that can be used after the initial screening. An analysis showed that these supplementary questions (especially those asking about the duration of PEM) helped to differentiate ME/CFS patients from controls with MS or post-polio syndrome.[9]

 

[Yann04]

Based on just the objective results claimed in the abstract, I'm not sure why you guys are dismissing this so easily.

I think given they mismatch between chronic fatigue and ME/CFS, gives a first hint why this might not be referring to what we see as ME/CFS.

According to studies conducted in Iran, CSF affects 17%–39% of nurses.

Would be the second hint

also the depaul questionnaire is not used to diagnose alone and ME has many symptoms that would flag up in “Chronic fatigue”.

From me-pedia

follow-up medical examination is necessary to confirm the diagnosis and identify possible exclusionary medical and psychiatric disorders

 

[forestglip]

What are they actually saying here? It looks like there was 13.8% less chronic fatigue in the treatment group after one month of treatment. But was the incidence of chronic fatigue in the control group after the treatment 72.2% of what it was before? So 27.8% less chronic fatigue in the control group?
I assume I don't have it right. But I don't know what they are saying.

If you're correct that there was more improvement in the control but they decided to claim the herb helps because the intervention group did improve from baseline, I might cry.

 

[Yann04]

If you skim through the de-paul questionnaire, you can see why without proper testing it could identify someone with chronic fatigue who has some chronic pain.

 

[Kitty]

According to studies conducted in Iran, CSF affects 17%–39% of nurses.

Would be the second hint

Exactly. If that proportion of any profession were shown to have ME/CFS, (a) there'd be an enormous amount of interest, and (b) the profession would be in crisis with so many unable to work.

 

[forestglip]

If you skim through the de-paul questionnaire, you can see why without proper testing it could identify someone with chronic fatigue who has some chronic pain.

The five items they later added seem to help a bit:



A Brief Questionnaire to Assess Post-Exertional Malaise

The five supplementary DSQ PEM duration items correctly categorized patients with ME or CFS 81.7% of the time, while incorrectly categorizing multiple sclerosis (MS) and post-polio syndrome (PPS) as ME or CFS only 16.6% of the time.

 

[Yann04]

The five supplementary DSQ PEM duration items correctly categorized patients with ME or CFS 81.7% of the time, while incorrectly categorizing multiple sclerosis (MS) and post-polio syndrome (PPS) as ME or CFS only 16.6% of the time.

I’m assuming this is referring to the CCC?

Given the CCC finds population prevalence of under 1%, and DePaul is based on the CCC. The findings of 17-39% are extremely suspect.

 

[Yann04]

Sadly, every single one of the PEM questions are related to fatigue. So it is not hard to imagine why someone with depression or burnout (but without ME) might get flagged here.

 

[forestglip]

I’m assuming this is referring to the CCC?

Diagnoses were obtained from the online questionnaire through participant self-reports.

Hmm..

Given the CCC finds population prevalence of under 1%, and DePaul is based on the CCC. The findings of 17-39% are extremely suspect.

I agree.

 

[Jonathan Edwards]

If you're correct that there was more improvement in the control but they decided to claim the herb helps because the intervention group did improve from baseline, I might cry.

I wouldn't bother crying. I don't think these figures are what we call statistically significant at all. They are just differences between before and after. Not between groups.

 

[Trish]

(I have a soft spot for astragalus. I don't know why. I've boiled up astragalus roots and drunk the tea sometimes, just because. I can't say that I noticed it did anything, good or bad, but if someone gave me an astragalus tonic from a reputable brand, I'd probably drink it. Which is to say, I am a receptive audience. But these researchers, they give me nothing upon which my unfounded faith in this plant can rest.)

Reminded me of Alice in Wonderland and the bottle labelled 'Drink me'.

 

[SNT Gatchaman]

Hypotheses
When compared with the placebo, the Astragalus root extract group will have a significantly lower proportion of nurses without CFS at 1 and 2 months after the start of the intervention.

Recruitment, randomisation and blinding
The researchers first visited two educational hospitals and obtained a list of nurses from the nursing office. Then, all nurses were informed about the study and invited to participate. Those interested completed a chronic fatigue questionnaire in a specific hall. Nurses who met the criteria for chronic fatigue were selected while the rest were thanked and informed that they did not meet the criteria for chronic fatigue, and therefore, could not participate in the study.
...

Instrument
The instruments used in this study included a clinicodemographic information form and a self-report scale for assessing CFS. The first part had questions on the participant’s age, sex, work experience, marital status, department, working hours per month, number of children, level of education, history of COVID-19, systolic and diastolic blood pressure, and work shift.

A second part of the study was a questionnaire based on the DePaul symptom which measures CFS in people, and the content validity ratio (0.91) and content validity index (0.92) were measured in Iran. Also, its reliability was determined through Cronbach’s alpha by separating the questions related to the severity of symptoms (α=0.869) and questions related to the frequency of symptoms (α=0.837) were obtained. There are 14 questions in 8 domains including fatigue, postexertional malaise, sleep, neurocognitive impairment, pain, autonomic, neuroendocrine and immune system. [...] A participant is considered to have the symptom if they endorse ratings of 2 or higher for both frequencies (about half the time, most of the time or all the time) and severity (moderate, severe or very severe). If a participant has at least one symptom with a grading of frequency and severity ≥2 from the domains of fatigue, discomfort after exercise, sleep problems, neurological/cognitive problems and at least one symptom with a grading of frequency and severity ≥2 from the domains of pain, autonomous, neuroendocrine and safety dimensions is diagnosed with CFS.

Data collection
If they agreed to participate in the study, they were provided with the research tools for completion. The research tool was provided to the nurses in the hospital environment and in a quiet environment to complete it. They could take the tool home with them and complete it there. Based on the research tool, they were then included in the study if they were diagnosed with CFS.

A first assessment was carried out prior to the administration of Astragalus root extract, a second assessment 30 days after the start of the administration, and a third assessment 60 days after the start of the administration of Astragalus root extract.

Data analysis
...
A Cochran’s Q test was used to analyse the primary outcome (CFS) at the end of the study and 1 month after the end of the study. In this study, the parameters for group and time effects, as well as groupby-time interactions on secondary outcome measures were evaluated using a generalised estimating equation (GEE), which can account for missing data completely at random. The level of significance for statistical tests was set at p<0.05 (two tailed).