A Botanical; Containing Cistanche & Ginkgo Extracts; Improves CFS Symptoms in Adults: A Randomized, Double-Blind, Placebo-Controlled study,2021,Kan

[Sly Saint]

A Botanical Product Containing Cistanche and Ginkgo Extracts Potentially Improves Chronic Fatigue Syndrome Symptoms in Adults: A Randomized, Double-Blind, and Placebo-Controlled Study

Juntao Kan1†,

Junrui Cheng1,2†,

Chun Hu3†, Liang Chen1,

Siyu Liu1,

Dawna Venzon3,

Mary Murray3,

Shuguang Li4* and Jun Du1*

Dietary therapy may be beneficial in alleviating symptoms of chronic fatigue syndrome (CFS), a disorder that is characterized by extreme fatigue and other symptoms, but the cause of which remains unclear. The aim of this study was to evaluate the protective effect of a botanical product containing cistanche (Cistanche tubulosa [Schenk] Wight) and ginkgo (Ginkgo biloba L.) extracts on adults with CFS in a randomized, double-blind, placebo-controlled clinical trial.

A total of 190 subjects (35–60 years old, non-obese) with CFS were randomized to receive one tablet of a low dose (120-mg ginkgo and 300-mg cistanche), a high dose (180-mg ginkgo and 450-mg cistanche) or a placebo once daily for 60 days. Blood samples and responses on the Chalder fatigue scale (CFQ 11), the World Health Organization's quality of life questionnaire (WHOQOL), and the sexual life quality questionnaire (SLQQ) were collected at baseline and post-intervention. CFS symptoms of impaired memory or concentration, physical fatigue, unrefreshing sleep, and post-exertional malaise were significantly improved (p < 0.001) in both of the treatment groups.

The botanical intervention significantly decreased physical and mental fatigue scores of CFQ 11 and improved WHOQOL and SLQQ scores of the subjects (p < 0.01). Levels of blood ammonia and lactic acid in the treatment groups were significantly lower than those of the placebo group (low-dose: p < 0.05; high-dose: p < 0.01).

In addition, the change in lactic acid concentration was negatively associated with the severity of CFS symptoms (p = 0.0108) and was correlated with the change in total physical fatigue score of the CFQ (p = 0.0302).

Considering the trivial effect size, the results may lack clinical significance. In conclusion, this botanical product showed promising effects in ameliorating the symptoms of CFS. Clinical trials with improved assessment tools, an expanded sample size, and an extended follow-up period are warranted to further validate the findings.

https://www.frontiersin.org/articles/10.3389/fnut.2021.658630/full

 

[CRG]

I have major trust issues with this paper.

Author affiliations:

• 1Nutrilite Health Institute, Shanghai, China
• 2Plants for Human Health Institute, North Carolina State University, Kannapolis, NC, United States
• 3Nutrilite Health Institute, Buena Park, CA, United States
• 4School of Public Health, Fudan University, Shanghai, China
  

Nutrilite https://en.wikipedia.org/wiki/Nutrilite

Carl F. Rehnborg developed his vitamin products in the 1930s. His time in China between the end of 1915 and 1927 exposed him to experiences which lead him to realize the impact vitamins and nutrients have on general health. He began selling his vitamins as the California Vitamin company. In 1939 the company was renamed Nutrilite. In 1945, Rehnborg invented the multi-level marketing selling system to distribute his vitamins. Also in 1945 Lee S. Mytinger and William S. Casselberry became exclusive national distributors and operated a company to distribute the vitamins.[1]

The founders of Amway, Jay Van Andel and Richard DeVos, began as independent distributors selling Nutrilite products in 1949, at a time when the product's previous distributors (Mytinger and Casselberry, Inc.) were involved in a dispute with the U.S. Food and Drug Administration (FDA), which accused them of false advertising. Van Andel and DeVos rose rapidly, becoming top-selling distributors. Concerned about the FDA dispute, they launched a new company, the American Way, (later known as Amway), to use the multi-level marketing system for other household products. The FDA/Mytinger-Cassleberry dispute, which went to the United States Supreme Court, was resolved in favor of the FDA in the 1960s.[2]

In 1972, Amway bought a controlling interest in the company. In 1994 they took over complete ownership.

NUTRILITE™ Health Institute is a part of the Amway MLM operation https://en.wikipedia.org/wiki/Amway

 

[5vforest]

Interesting, thanks for posting.

I’m sure someone will pick out all the details.

The thing that struck me post is that the study was conducted 5 years ago.

It actually looks quite rigorous in design, especially compared to some of the junk that gets published.

They used Fukuda, unfortunately.

The difference between the treatment and placebo groups was very striking.

I know many people who have taken Gingko Biloba, myself included. Not sure about Cistanche tubulosa, but looks like it’s sold as a supplement and may be worth a try too.

 

[Trish]

What a very odd choice of the third questionnaire -the sexual life quality questionnaire (SLQQ).
The questions are shown in a table in the paper. It's all sorts of intrusive stuff asking details of the individual's sex life and satisfaction with it.

Edit: They explain the choice on the basis that one of the herbs is supposed to improve sexual function in men. So nothing to do with ME/CFS itself.

 

[Trish]

They admit that thier results were statistically significant but not clinically significant. On the Chalder questionnaire, the between group difference was less than 1. Here's what they say:

Multiple questionnaires have been previously employed to measure fatigue quantitatively (26), among which the Chalder fatigue questionnaire is the most widely used (20, 21). The 11-item Chalder fatigue questionnaire consists of two sections, one evaluating physical fatigue and the other evaluating mental fatigue, and both sections were included in the current study. These components of the questionnaire were validated by a study involving 361 CFS patients and 1,615 healthy individuals (21). This questionnaire has been shown to have high internal consistency, as indicated by a Cronbach alpha that ranged between 0.86–0.92 (20, 21, 27). One notable limitation of the Chalder fatigue questionnaire is ceiling effects, meaning that patients often record the maximum score on most of the 11 items, leaving no space to indicate a worsening of their fatigue symptoms (28) and making the reliability of the Likert scale questionable. Therefore, we employed a professional physician to validate the severity of CFS to verify the observation of deterioration. By using the Chalder fatigue questionnaire, we observed marginal but statistically significant improvement in the fatigue scores in the product group. However, such improvement may not be clinically meaningful, since according to the PACE trial, an efficacious treatment for CFS should present a difference of 2–4 using a Likert scale (29, 30), but the difference in our current study was <1. Such a small effect size might be due to the fluctuating nature of CFS and the limited time points used to assess CFS in the current study. Therefore, the efficacy of the product against CFS is promising but needs further validation./QUOTE]

 

[FMMM1]

I have major trust issues with this paper.

Author affiliations:

• 1Nutrilite Health Institute, Shanghai, China
• 2Plants for Human Health Institute, North Carolina State University, Kannapolis, NC, United States
• 3Nutrilite Health Institute, Buena Park, CA, United States
• 4School of Public Health, Fudan University, Shanghai, China

Nutrilite https://en.wikipedia.org/wiki/Nutrilite
NUTRILITE™ Health Institute is a part of the Amway MLM operation https://en.wikipedia.org/wiki/Amway

Yea and if you read @Trish posts below, you'll see that it's the usual approach of assessing outcomes based on questionnaires (mind ou some of them are a bit different!).

Check out @strategist post here* looks like these folks have managed to provide evidence that homeopathy works and without GRADE! Mind you a few more of these studies, and a GRADE systematic review, and you'd have all of the evidence you need to recommend it as a treatment!

EDIT - OK I've just (briefly) checked and it is a double blinded study. However, I still think that it's pretty inexcusable not to include objective activity measurement (actimetry - FitBit type devices) and if that showed something then that would be more informative.

@Caroline Struthers

*https://www.s4me.info/threads/indep...ed-by-hilda-bastian.13645/page-80#post-390309

 

[Solstice]

What a very odd choice of the third questionnaire -the sexual life quality questionnaire (SLQQ).
The questions are shown in a table in the paper. It's all sorts of intrusive stuff asking details of the individual's sex life and satisfaction with it.

Edit: They explain the choice on the basis that one of the herbs is supposed to improve sexual function in men. So nothing to do with ME/CFS itself.

I saw a shampoo here with Ginkgo extracts and took a spoonful, gotta say it did the trick.