fatigue
Sure, the LP is dangerous nonsense, but this begs the question of whether so-called alternative medicine (SCAM) has anything to offer for patients suffering from ME/CFS. If the LP story tells us anything, then it must be this: we should not trust single trials, particularly if they seem dodgy. In other words, we should look at systematic reviews that synthesize ALL clinical trials and evaluate them critically.
To locate this type of evidence I conducted several Medline searches and found several recent systematic reviews that address the issue:
Context: A variety of interventions have been used in the treatment and management of chronic fatigue syndrome (CFS). Currently, debate exists among health care professionals and patients about appropriate strategies for management.
Objective: To assess the effectiveness of all interventions that have been evaluated for use in the treatment or management of CFS in adults or children.
Data sources: Nineteen specialist databases were searched from inception to either January or July 2000 for published or unpublished studies in any language. The search was updated through October 2000 using PubMed. Other sources included scanning citations, Internet searching, contacting experts, and online requests for articles.
Study selection: Controlled trials (randomized or nonrandomized) that evaluated interventions in patients diagnosed as having CFS according to any criteria were included. Study inclusion was assessed independently by 2 reviewers. Of 350 studies initially identified, 44 met inclusion criteria, including 36 randomized controlled trials and 8 controlled trials.
Data extraction: Data extraction was conducted by 1 reviewer and checked by a second. Validity assessment was carried out by 2 reviewers with disagreements resolved by consensus. A qualitative synthesis was carried out and studies were grouped according to type of intervention and outcomes assessed.
Data synthesis: The number of participants included in each trial ranged from 12 to 326, with a total of 2801 participants included in the 44 trials combined. Across the studies, 38 different outcomes were evaluated using about 130 different scales or types of measurement. Studies were grouped into 6 different categories. In the behavioral category, graded exercise therapy and cognitive behavioral therapy showed positive results and also scored highly on the validity assessment. In the immunological category, both immunoglobulin and hydrocortisone showed some limited effects but, overall, the evidence was inconclusive. There was insufficient evidence about effectiveness in the other 4 categories (pharmacological, supplements, complementary/alternative, and other interventions).
Conclusions: Overall, the interventions demonstrated mixed results in terms of effectiveness. All conclusions about effectiveness should be considered together with the methodological inadequacies of the studies. Interventions which have shown promising results include cognitive behavioral therapy and graded exercise therapy. Further research into these and other treatments is required using standardized outcome measures.
Introduction: Chronic fatigue syndrome (CFS) affects between 0.006% and 3% of the population depending on the criteria of definition used, with women being at higher risk than men.
Methods and outcomes: We conducted a systematic review and aimed to answer the following clinical question: What are the effects of treatments for chronic fatigue syndrome? We searched: Medline, Embase, The Cochrane Library, and other important databases up to March 2010 (Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
Results: We found 46 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
Conclusions: In this systematic review we present information relating to the effectiveness and safety of the following interventions: antidepressants, cognitive behavioural therapy (CBT), corticosteroids, dietary supplements, evening primrose oil, galantamine, graded exercise therapy, homeopathy, immunotherapy, intramuscular magnesium, oral nicotinamide adenine dinucleotide, and prolonged rest.
Background: Throughout the world, patients with chronic diseases/illnesses use complementary and alternative medicines (CAM). The use of CAM is also substantial among patients with diseases/illnesses of unknown aetiology. Chronic fatigue syndrome (CFS), also termed myalgic encephalomyelitis (ME), is no exception. Hence, a systematic review of randomised controlled trials of CAM treatments in patients with CFS/ME was undertaken to summarise the existing evidence from RCTs of CAM treatments in this patient population.
Methods: Seventeen data sources were searched up to 13th August 2011. All randomised controlled trials (RCTs) of any type of CAM therapy used for treating CFS were included, with the exception of acupuncture and complex herbal medicines; studies were included regardless of blinding. Controlled clinical trials, uncontrolled observational studies, and case studies were excluded.
Results: A total of 26 RCTs, which included 3,273 participants, met our inclusion criteria. The CAM therapy from the RCTs included the following: mind-body medicine, distant healing, massage, tuina and tai chi, homeopathy, ginseng, and dietary supplementation. Studies of qigong, massage and tuina were demonstrated to have positive effects, whereas distant healing failed to do so. Compared with placebo, homeopathy also had insufficient evidence of symptom improvement in CFS. Seventeen studies tested supplements for CFS. Most of the supplements failed to show beneficial effects for CFS, with the exception of NADH and magnesium.
Conclusions: The results of our systematic review provide limited evidence for the effectiveness of CAM therapy in relieving symptoms of CFS. However, we are not able to draw firm conclusions concerning CAM therapy for CFS due to the limited number of RCTs for each therapy, the small sample size of each study and the high risk of bias in these trials. Further rigorous RCTs that focus on promising CAM therapies are warranted.
Background: There is no curative treatment for chronic fatigue syndrome (CFS). Traditional Chinese medicine (TCM) is widely used in the treatment of CFS in China.
Objective: To evaluate the effectiveness and safety of TCM for CFS.
Methods: The protocol of this review is registered at PROSPERO. We searched six main databases for randomized clinical trials (RCTs) on TCM for CFS from their inception to September 2013. The Cochrane risk of bias tool was used to assess the methodological quality. We used RevMan 5.1 to synthesize the results.
Results: 23 RCTs involving 1776 participants were identified. The risk of bias of the included studies was high. The types of TCM interventions varied, including Chinese herbal medicine, acupuncture, qigong, moxibustion, and acupoint application. The results of meta-analyses and several individual studies showed that TCM alone or in combination with other interventions significantly alleviated fatigue symptoms as measured by Chalder’s fatigue scale, fatigue severity scale, fatigue assessment instrument by Joseph E. Schwartz, Bell’s fatigue scale, and guiding principle of clinical research on new drugs of TCM for fatigue symptom. There was no enough evidence that TCM could improve the quality of life for CFS patients. The included studies did not report serious adverse events.
Conclusions: TCM appears to be effective to alleviate the fatigue symptom for people with CFS. However, due to the high risk of bias of the included studies, larger, well-designed studies are needed to confirm the potential benefit in the future.
Background: As the etiology of chronic fatigue syndrome (CFS) is unclear and the treatment is still a big issue. There exists a wide range of literature about acupuncture and moxibustion (AM) for CFS in traditional Chinese medicine (TCM). But there are certain doubts as well in the effectiveness of its treatment due to the lack of a comprehensive and evidence-based medical proof to dispel the misgivings. Current study evaluated systematically the effectiveness of acupuncture and moxibustion treatments on CFS, and clarified the difference among them and Chinese herbal medicine, western medicine and sham-acupuncture.
Methods: We comprehensively reviewed literature including PubMed, EMBASE, Cochrane library, CBM (Chinese Biomedical Literature Database) and CNKI (China National Knowledge Infrastructure) up to May 2016, for RCT clinical research on CFS treated by acupuncture and moxibustion. Traditional direct meta-analysis was adopted to analyze the difference between AM and other treatments. Analysis was performed based on the treatment in experiment and control groups. Network meta-analysis was adopted to make comprehensive comparisons between any two kinds of treatments. The primary outcome was total effective rate, while relative risks (RR) and 95% confidence intervals (CI) were used as the final pooled statistics.
Results: A total of 31 randomized controlled trials (RCTs) were enrolled in analyses. In traditional direct meta-analysis, we found that in comparison to Chinese herbal medicine, CbAM (combined acupuncture and moxibustion, which meant two or more types of acupuncture and moxibustion were adopted) had a higher total effective rate (RR (95% CI), 1.17 (1.09 ~ 1.25)). Compared with Chinese herbal medicine, western medicine and sham-acupuncture, SAM (single acupuncture or single moxibustion) had a higher total effective rate, with RR (95% CI) of 1.22 (1.14 ~ 1.30), 1.51 (1.31-1.74), 5.90 (3.64-9.56). In addition, compared with SAM, CbAM had a higher total effective rate (RR (95% CI), 1.23 (1.12 ~ 1.36)). In network meta-analyses, similar results were recorded. Subsequently, we ranked all treatments from high to low effective rate and the order was CbAM, SAM, Chinese herbal medicine, western medicine and sham-acupuncture.
Conclusions: In the treatment of CFS, CbAM and SAM may have better effect than other treatments. However, the included trials have relatively poor quality, hence high quality studies are needed to confirm our finding.
Objectives: This meta-analysis aimed to assess the effectiveness and safety of Chinese herbal medicine (CHM) in treating chronic fatigue syndrome (CFS). Methods: Nine electronic databases were searched from inception to May 2022. Two reviewers screened studies, extracted the data, and assessed the risk of bias independently. The meta-analysis was performed using the Stata 12.0 software. Results: Eighty-four RCTs that explored the efficacy of 69 kinds of Chinese herbal formulas with various dosage forms (decoction, granule, oral liquid, pill, ointment, capsule, and herbal porridge), involving 6,944 participants were identified. This meta-analysis showed that the application of CHM for CFS can decrease Fatigue Scale scores (WMD: -1.77; 95%CI: -1.96 to -1.57; p < 0.001), Fatigue Assessment Instrument scores (WMD: -15.75; 95%CI: -26.89 to -4.61; p < 0.01), Self-Rating Scale of mental state scores (WMD: -9.72; 95%CI:-12.26 to -7.18; p < 0.001), Self-Rating Anxiety Scale scores (WMD: -7.07; 95%CI: -9.96 to -4.19; p < 0.001), Self-Rating Depression Scale scores (WMD: -5.45; 95%CI: -6.82 to -4.08; p < 0.001), and clinical symptom scores (WMD: -5.37; 95%CI: -6.13 to -4.60; p < 0.001) and improve IGA (WMD: 0.30; 95%CI: 0.20-0.41; p < 0.001), IGG (WMD: 1.74; 95%CI: 0.87-2.62; p < 0.001), IGM (WMD: 0.21; 95%CI: 0.14-0.29; p < 0.001), and the effective rate (RR = 1.41; 95%CI: 1.33-1.49; p < 0.001). However, natural killer cell levels did not change significantly. The included studies did not report any serious adverse events. In addition, the methodology quality of the included RCTs was generally not high. Conclusion: Our study showed that CHM seems to be effective and safe in the treatment of CFS. However, given the poor quality of reports from these studies, the results should be interpreted cautiously. More international multi-centered, double-blinded, well-designed, randomized controlled trials are needed in future research.
What does all that tell us?
Disappointingly, it tells me that SCAM has preciously little to offer for ME/CFS patients.
But what about the TCM treatments? Aren’t the above reviews quite positive TCM?
Yes, they are but I nevertheless recommend taking them with a healthy pinch of salt.
Why?
Because we have seen many times before that, for a range of reasons, Chinese researchers of TCM draw false positive conclusions. That may sound unfair, harsh, or even racist, but I think it’s true. If you disagree, please show me a couple of systematic reviews of TCM for any human disease by Chinese researchers that have drawn negative conclusions.
And what is my advice to patients suffering from ME/CSF?
I think the best I can offer is this: be very cautious about the many claims made by SCAM enthusiasts; if it sounds too good to be true, it probably is!
The UK medical doctor, Sarah Myhill, has a website where she tells us:
Everyone should follow the general approach to maintaining and restoring good health, which involves eating a paleo ketogenic diet, taking a basic package of nutritional supplements, ensuring a good night’s sleep on a regular basis and getting the right balance between work, exercise and rest. Because we live in an increasingly polluted world, we should probably all be doing some sort of detox regime.
She also happens to sell dietary supplements of all kinds which must surely be handy for all who want to follow her advice. Dr. Myhill boosted her income even further by putting false claims about Covid-19 treatments online. And that got her banned from practicing for nine months after a medical tribunal.
She posted videos and articles advocating taking vitamins and other substances in high doses, without evidence they worked. The General Medical Council (GMC) found her recommendations “undermined public health” and found some of her recommendations had the potential to cause “serious harm” and “potentially fatal toxicity”. The tribunal was told she uploaded a series of videos and articles between March and May 2020, describing substances as “safe nutritional interventions” which she said meant vaccinations were “rendered irrelevant”. But the substances she promoted were not universally safe and have potentially serious health risks associated with them, the panel was told. The tribunal found Dr. Myhill “does not practice evidence-based medicine and may encourage false reassurance in her patients who may believe that they will not catch Covid-19 or other infections if they follow her advice”.
Dr. Myhill previously had a year-long ban lifted after a General Medical Council investigation into her claims of being a “pioneer” in the treatment of chronic fatigue syndrome. In fact, the hearing was told there had been 30 previous GMC investigations into Dr. Myhill, but none had resulted in findings of misconduct.
Dr. Myhill is also a vocal critic of the PACE trial and biopsychosocial model of ME/CFS. Dr. Myhill’s GMC complaint regarding a number of PACE trial authors was first rejected without investigation by the GMC, after Dr. Myhill appealed the GMC stated they would reconsider. Dr. Myhill’s action against the GMC for failing to provide reasoning for not investigating the PACE trial authors is still continuing and began a number of months before the most recent GMC instigation of her practice started.
The recent tribunal concluded: “Given the circumstances of this case, it is necessary to protect members of the public and in the public interest to make an order suspending Dr. Myhill’s registration with immediate effect, to uphold and maintain professional standards and maintain public confidence in the profession.”
Bioenergy (or energy healing) therapies are among the popular alternative treatment options for many diseases, including cancer. Many studies deal with the advantages and disadvantages of bioenergy therapies as an addition to established treatments such as chemotherapy, surgery, and radiation in the treatment of cancer. However, a systematic overview of this evidence is thus far lacking. For this reason, German authors reviewed and critically examined the evidence to determine what benefits the treatments have for patients.
In June 2022, a systematic search was conducted searching five electronic databases (Embase, Cochrane, PsychInfo, CINAHL and Medline) to find studies concerning the use, effectiveness, and potential harm of bioenergy therapies including the following modalities:
- Reiki,
- Therapeutic Touch,
- Healing Touch,
- Polarity Therapy.
From all 2477 search results, 21 publications with a total of 1375 patients were included in this systematic review. The patients treated with bioenergy therapies were mainly diagnosed with breast cancer. The main outcomes measured were:
- anxiety,
- depression,
- mood,
- fatigue,
- quality of life (QoL),
- comfort,
- well-being,
- neurotoxicity,
- pain,
- nausea.
The studies were predominantly of moderate quality and, for the most part, found no effect. In terms of QoL, pain, and nausea, there were some positive short-term effects of the interventions, but no long-term differences were detectable. The risk of side effects from bioenergy therapies appears to be relatively small.
The authors concluded that considering the methodical limitations of the included studies, studies with high study quality could not find any difference between bioenergy therapies and active (placebo, massage, RRT, yoga, meditation, relaxation training, companionship, friendly visit) and passive control groups (usual care, resting, education). Only studies with a low study quality were able to show significant effects.
Energy healing is as popular as it is implausible. What these ‘healers’ call ‘energy’ is not how it is defined in physics. It is an undefined, imagined entity that exists only in the imagination of its proponents. So why should it have an effect on cancer or any other condition?
My team conducted 2 RCT of energy healing (pain and warts); both failed to show positive effects. And here is what I stated in my recent book about energy healing for any ailment:
Energy healing is an umbrella term for a range of paranormal healing practices. Their common denominator is the belief in a mystical ‘energy’ that can be used for therapeutic purposes.
- Forms of energy healing have existed in many ancient cultures. The ‘New Age’ movement has brought about a revival of these ideas, and today energy healing systems are amongst the most popular alternative therapies in the US as well as in many other countries. Popular forms of energy healing include those listed above. Each of these are discussed and referenced in separate chapters of this book.
- Energy healing relies on the esoteric belief in some form of ‘energy’ which is distinct from the concept of energy understood in physics and refers to some life force such as chi in Traditional Chinese Medicine, or prana in Ayurvedic medicine.
- Some proponents employ terminology from quantum physics and other ‘cutting-edge’ science to give their treatments a scientific flair which, upon closer scrutiny, turns out to be but a veneer of pseudo-science.
- The ‘energy’ that energy healers refer to is not measurable and lacks biological plausibility.
- Considering its implausibility, energy healing has attracted a surprisingly high level of research activity. Its findings are discussed in the respective chapters of each of the specific forms of energy healing.
- Generally speaking, the methodologically best trials of energy healing fail to demonstrate that it generates effects beyond placebo.
- Even though energy healing is per se harmless, it can do untold damage, not least because it significantly undermines rational thought in our societies.
As you can see, I do not entirely agree with my German friends on the issue of harm. I think energy healing is potentially dangerous and should be discouraged.
Yes, it is hot! Very hot. Where I live – Cambridge, UK – we expect records to be broken today and tomorrow, and we are predicted to reach as much as 40 degrees Celsius.
But do not despair – there is help!
As so often, homeopathy comes to our rescue.
I found this source giving us advice about “BEST HOMEOPATHY MEDICINE FOR SUMMER HEAT“:
Homeopathic remedies are non-toxic and a safe way to help the body to replenish its store of the cell salts and nutrients it needs in warmer periods and help to relieve cramps, aches, and fatigue. Some of the most common homeopathic medicines to deal with summer heat are:
-
- Calendula: This is an all-purpose medicine for many kinds of skin damage that many of us face during the summer season. When the skin gets damaged due to wounds, infection, prolonged sun exposure, and even excessive pollution and dirt, one can try using calendula.
- Arnica: All that running around on the beach can easily give you sore muscles, while the heat can sap up your energy and leave you fatigued. In such cases, Arnica is the perfect homeopathic answer to your maladies. This homeopathic remedy can be used for topical application if bought in its cream or gel form.
- Belladonna: Sun strokes, dehydration, and over-exposure to the sun, in general, can give you a host of problems and conditions including heat headaches. In order to treat such conditions, one can use homeopathic medicine Belladonna used for sun-stroke related ailments and symptoms.
- Rhus Toxicodendron: This Homeopathy remedy used for Hot Weather Symptom is also known as Rhus Tox. It is made from poison ivy extracts and is an effective drug when it comes to dealing with itchy rashes. These rashes may be caused because of exposure to oak, sumac, and even poison ivy.
- Ledum: Ledum or Ledum Palustre is one of the best homeopathic drugs when it comes to treating insect bites during summers.
- Euphrasia Officinalis: This homeopathic medicine is most commonly used for eye-related problems that may come about due to sun exposure or excessive sweating in prickly heat and other heat-related factors.
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So, now we know. All you need to do is go to a homeopathic pharmacy and buy the remedies (please do not run, this might aggravate your symptoms!).
Which potency?
Good question!
The author of the advice – Dr. Bela Chaudhry, BHMS, MD – Homeopathy, Homeopathy Doctor, Delhi, India – does not disclose this important information. As some of these ingredients are toxic, I would urge you to buy an ultra-molecular dilution – a C30, for instance – this way, you are sure that not a single molecule of what is printed on the package is contained in the actual remedy.
Alternatively, you could save quite a bit of money by staying where you are, taking a cool drink of water (put a pinch of salt in it, if you think you are getting dehydrated), and considering the evidence. It clearly shows that homeopathic remedies are pure placebos. They do not work against the symptoms of overheating nor against anything else.
PS
I suspect, there will be some who disagree with me. To them, I say: please show me the evidence that any of the above-listed homeopathic remedies are effective against the named conditions. If you do that, I promise that I will change my post accordingly. Thank you.
Two million people in UK are estimated to be currently suffering from long COVID, says the Office for National Statistics. Fatigue continues to be the most common symptom – experienced by 55% of those with self-reported long COVID – followed by 32% with shortness of breath, 23% with a cough, and 23% with muscle ache. The problem is only going to increase in the near future. Thus, many people are frantically looking for an effective therapy. Practitioners of so-called alternative medicine (SCAM) are no exception.
This study aimed to evaluate the potential for inhalation of essential oils to improve energy levels among otherwise healthy female survivors of acute COVID-19 who experience a lack of energy more than five months after recovery.
This was a randomized double-blind, placebo-controlled trial to evaluate the potential for inhalation of Longevity™, a proprietary essential oil blend manufactured by Young Living Essential Oils (Lehi, Utah, USA), on energy levels among female survivors of COVID-19 who continue to experience fatigue more than 5 months recovery from the acute infection. Forty women were randomized to two groups: intervention and placebo. The placebo product contained an inert, odorless fractionated coconut oil. Both groups inhaled the assigned product twice daily for fourteen consecutive days. Fatigue scores were measured using the Multidimensional Fatigue Symptom Inventory (MFSI). Secondary outcomes included scores on each of the MFSI’s ten subscales.
Individuals who inhaled the essential oil blend for 2 weeks had significantly lower fatigue scores after controlling for baseline scores, employment status, BMI, olfactory function, and time since diagnosis, with a large effect size (F (1,39) = 6.15, p = .020, partial eta squared = 0.198). Subscale analysis identified subscales of vigor, as well as global, behavioral, general, and mental fatigue as benefiting from the intervention. This study provides evidence that a proprietary aromatherapy blend can significantly improve energy levels among women who are experiencing fatigue after recovering from COVID-19.
The authors concluded that the use of aromatherapy with Longevity™ essential oil blend to boost energy levels in women who have recovered from COVID-19 provides a novel, non-invasive approach to improving quality of life in this population. This intervention is particularly beneficial for global and mental fatigue, as well as vigor. Other subdomains may experience improvements to energy levels with a smaller effect size; future studies should be conducted to explore this potential.
This trial was funded by Young Living Essential Oils. Perhaps, this explains why there is no mention of the elephant in the room: the trial was not blind! Participants in the verum group knew that they received aromatherapy. Likewise, participants in the placebo group knew that they received the placebo.
Could this fact have influenced the outcome? Certainly!
Could the trial have been designed better? Certainly!
All the investigators needed to do is to use a nice-smelling oil that, according to aromatherapists, does not boost energy, as the placebo.
As it stands, we have no idea whether the authors’ assumption that the verum oil caused the effect is true.
Pity!
Or maybe not?
Perhaps Young Living Essential Oils, the sponsor of the study and producer of the oil never wanted to know the truth. Maybe they are happy to abuse science as a marketing tool?
Ginseng plants belong to the genus Panax and include:
- Panax ginseng (Korean ginseng),
- Panax notoginseng (South China ginseng),
- and Panax quinquefolius (American ginseng).
They are said to have a range of therapeutic activities, some of which could render ginseng a potential therapy for viral or post-viral infections. Ginseng has therefore been used to treat fatigue in various patient groups and conditions. But does it work for chronic fatigue syndrome (CFS), also often called myalgic encephalomyelitis (ME)? This condition is a complex, little-understood, and often disabling chronic illness for which no curative or definitive therapy has yet been identified.
This systematic review aimed to assess the current state of evidence regarding ginseng for CFS. Multiple databases were searched from inception to October 2020. All data was extracted independently and in duplicates. Outcomes of interest included the effectiveness and safety of ginseng in patients with CFS.
A total of two studies enrolling 68 patients were deemed eligible: one randomized clinical trial and one prospective observational study. The certainty of evidence in the effectiveness outcome was low and moderate in both studies, while the safety evidence was very low as reported from one study.
The authors concluded that the study findings highlight a potential benefit of ginseng therapy in the treatment of CFS. However, we are not able to draw firm conclusions due to limited clinical studies. The paucity of data warrants limited confidence. There is a need for future rigorous studies to provide further evidence.
To get a feeling of how good or bad the evidence truly is, we must of course look at the primary studies.
The prospective observational study turns out to be a mere survey of patients using all sorts of treatments. It included 155 subjects who provided information on fatigue and treatments at baseline and follow-up. Of these subjects, 87% were female and 79% were middle-aged. The median duration of fatigue was 6.7 years. The percentage of users who found a treatment helpful was greatest for coenzyme Q10 (69% of 13 subjects), dehydroepiandrosterone (DHEA) (65% of 17 subjects), and ginseng (56% of 18 subjects). Treatments at 6 months that predicted subsequent fatigue improvement were vitamins (p = .08), vigorous exercise (p = .09), and yoga (p = .002). Magnesium (p = .002) and support groups (p = .06) were strongly associated with fatigue worsening from 6 months to 2 years. Yoga appeared to be most effective for subjects who did not have unclear thinking associated with fatigue.
The second study investigated the effect of Korean Red Ginseng (KRG) on chronic fatigue (CF) by various measurements and objective indicators. Participants were randomized to KRG or placebo group (1:1 ratio) and visited the hospital every 2 weeks while taking 3 g KRG or placebo for 6 weeks and followed up 4 weeks after the treatment. The fatigue visual analog score (VAS) declined significantly in each group, but there were no significant differences between the groups. The 2 groups also had no significant differences in the secondary outcome measurements and there were no adverse events. Sub-group analysis indicated that patients with initial fatigue VAS below 80 mm and older than 50 years had significantly greater reductions in the fatigue VAS if they used KRG rather than placebo. The authors concluded that KRG did not show absolute anti-fatigue effect but provided the objective evidence of fatigue-related measurement and the therapeutic potential for middle-aged individuals with moderate fatigue.
I am at a loss in comprehending how the authors of the above-named review could speak of evidence for potential benefit. The evidence from the ‘observational study’ is largely irrelevant for deciding on the effectiveness of ginseng, and the second, more rigorous study fails to show that ginseng has an effect.
So, is ginseng a promising treatment for ME?
I doubt it.
Brite is an herbal energy drink that is currently being marketed aggressively. It is even for sale in one leading UK supermarket. It comes in various flavors the ingredients of which vary slightly.
The pineapple/mango drink, for instance, contains:
- guarana extract,
- green tea extract,
- guayusa extract,
- ashwagandha extract,
- matcha tea,
- ascorbic acid (vitamin C),
- natural caffeine.
The website of the manufacturer tells us that Brite uses ingredients and dosages that are safe and effective, utilising the power of nootropic superfoods organic Matcha, Guarana and Guayusa to provide a long-lasting boost.
Brite is based on peer reviewed, double-blind, placebo-controlled clinical trials and studies that can be found here.
It does not tell us the dosages of the ingredients, and I am puzzled by the claim that the drink is safe. A quick search seems to cast considerable doubt on it.
_____________________________
Guarana (Paullinia cupana) is a plant from the Amazon region with a high content of bioactive compounds. It is by no means free of adverse effects. It is known to interact with:
- armodafinil
- caffeine
- dexmethylphenidate
- dextroamphetamine
- green tea
- lisdexamfetamine
- methamphetamine
- methylenedioxymethamphetamine
- methylphenidate
- modafinil
- phentermine
- yohimbine
And it can cause the following adverse effects:
- Abdominal spasms (from overdose)
- Agitation
- Anxiety
- Convulsions
- Delirium
- Dependence
- Diarrhea
- Dizziness
- Fast heart rate
- Gastrointestinal (GI) upset
- Headache
- High blood pressure (hypertension)
- High blood sugar (hyperglycemia)
- Increased respiration
- Increased urination
- Insomnia
- Irregular heartbeats (arrhythmias)
- Irritability
- Muscle spasms
- Nausea/vomiting
- Nervousness
- Painful urination (from overdose)
- Rapid breathing
- Restlessness
- Ringing in the ears (tinnitus)
- Stomach cramps or irritation
- Tremors
- Withdrawal symptoms
Green tea is made from the leaves of the Camellia sinensis plant. It can cause the following adverse effects:
- headache,
- nervousness,
- sleep problems,
- vomiting,
- diarrhea,
- irritability,
- irregular heartbeat,
- tremor,
- heartburn,
- dizziness,
- ringing in the ears,
- convulsions,
- confusion.
Guayusa is a plant native to the Amazon rainforest that contains plenty of caffeine. Its adverse effects include:
- High Blood Pressure
- Rapid Heartbeat
- Anxiety
- Jitters
- Energy Crashes
- Insomnia
- Headaches
- Upset Stomach
Ashwagandha is a plant from India; the root and berry are used in Ayurvedic medicine. Its adverse effects include:
- stomach upset,
- diarrhea,
- vomiting.
Matcha tea also contains a high amount of caffeine. It is associated with the following adverse effects:
- nervousness,
- irritability,
- dizziness,
- anxiety,
- digestive disorders such as irritable bowel syndrome, or diarrhea,
- sleeping disorders,
- cardiac arrhythmia.
Caffeine is a chemical found in coffee, tea, cola, guarana, mate, and other products. Adverse effects include:
- insomnia,
- nervousness,
- restlessness,
- stomach irritation,
- nausea and vomiting,
- increased heart rate and respiration,
- headache,
- anxiety,
- agitation,
- chest pain,
- ringing in the ears.
A case report documented a case of myocardial infarction in a 25-year-old man who presented to the emergency department with chest pain. The patient had been consuming massive quantities of caffeinated energy drinks daily for the past week. This case report and previously documented studies support a possible connection between caffeinated energy drinks and myocardial infarction.
________________________
Yes, the adverse effects are predominantly (but not exclusively) caused by high doses. Yet, the claim that Brite is safe should nevertheless be taken with a very large pinch of salt. If I like the taste of the drink and thus consume a few bottles per day, the dosages of the ingredients would surely be high!
And what about the claim that it is effective? Here the pinch of salt must be even larger, I am afraid. I could not find a single trial that confirmed the notion. For backing up their claims, the manufacturers offer a few references, but if you look them up, you will find that they were not done with the mixture of ingredients contained in Brite.
So, what is the conclusion?
Based on the evidence that I have seen, the herbal drink ‘Brite’ has not been shown to be an effective nootropic. In addition, there are legitimate concerns about the safety of the product. I for one will therefore not purchase the (rather expensive) drink.
Yes, Today is ‘WORLD SLEEP DAY‘ and you are probably in bed hoping this post will put you back to sleep.
I’ll do my best!
This study aimed to synthesise the best available evidence on the safety and efficacy of using moxibustion and/or acupuncture to manage cancer-related insomnia (CRI).
The PRISMA framework guided the review. Nine databases were searched from its inception to July 2020, published in English or Chinese. Randomised clinical trials (RCTs) of moxibustion and or acupuncture for the treatment of CRI were selected for inclusion. The methodological quality was assessed using the method suggested by the Cochrane collaboration. The Cochrane Review Manager was used to conduct a meta-analysis.
Fourteen RCTs met the eligibility criteria; 7 came from China. Twelve RCTs used the Pittsburgh Sleep Quality Index (PSQI) score as continuous data and a meta-analysis showed positive effects of moxibustion and or acupuncture (n = 997, mean difference (MD) = -1.84, 95% confidence interval (CI) = -2.75 to -0.94, p < 0.01). Five RCTs using continuous data and a meta-analysis in these studies also showed significant difference between two groups (n = 358, risk ratio (RR) = 0.45, 95% CI = 0.26-0.80, I 2 = 39%).
The authors concluded that the meta-analyses demonstrated that moxibustion and or acupuncture showed a positive effect in managing CRI. Such modalities could be considered an add-on option in the current CRI management regimen.
Even at the risk of endangering your sleep, I disagree with this conclusion. Here are some of my reasons:
- Chinese acupuncture trials invariably are positive which means they are as reliable as a 4£ note.
- Most trials were of poor methodological quality.
- Only one made an attempt to control for placebo effects.
- Many followed the A+B versus B design which invariably produces (false-) positive results.
- Only 4 out of 14 studies mentioned adverse events which means that 10 violated research ethics.
Sorry to have disturbed your sleep!
Kratom (Mitragyna speciosa, Korth.) is an evergreen tree that is indigenous to Southeast Asia. It is increasingly being used as a recreational drug, to help with opium withdrawal, and as a so-called alternative medicine (SCAM) for pain, erectile dysfunction, as a mood stabilizer, and for boosting energy or concentration. When ingested, Kratom leaves produce stimulant and opioid-like effects (see also my previous post).
Kratom contains 7‑hydroxymitragynine, which is active on opioid receptors. The use of kratom carries significant risks, e.g. because there is no standardized form of administration as well as the possibility of direct damage to health and of addiction.
There are only very few clinical trials of Kratom. One small placebo-controlled study concluded that the short-term administration of the herb led to a substantial and statistically significant increase in pain tolerance. And a recent review stated that Kratom may have drug interactions as both a cytochrome P-450 system substrate and inhibitor. Kratom does not appear in normal drug screens and, especially when ingested with other substances of abuse, may not be recognized as an agent of harm. There are numerous cases of death in kratom users, but many involved polypharmaceutical ingestions. There are assessments where people have been unable to stop using kratom therapy and withdrawal signs/symptoms occurred in patients or their newborn babies after kratom cessation. Both banning and failure to ban kratom places people at risk; a middle-ground alternative, placing it behind the pharmacy counter, might be useful.
In Thailand, Kratom had been outlawed since 1943 but now it has become (semi-)legal. Earlier this year, the Thai government removed the herb from the list of Category V narcotics. Following this move, some 12,000 inmates who had been convicted when Kratom was still an illegal drug received amnesty. However, Kratom producers, traders, and even researchers will still require licenses to handle the plant. Similarly, patients looking for kratom-based supplements will need a valid prescription from licensed medical practitioners. Thai law still prohibits bulk possession of Kratom. Users are encouraged to handle only minimum amounts of the herb to avoid getting prosecuted for illegal possession.
In 2018, the US Food and Drug Administration stated that Kratom possesses the properties of an opioid, thus escalating the government’s effort to slow usage of this alternative pain reliever. The FDA also wrote that the number of deaths associated with Kratom use has increased to a total of 44, up from a total of 36 since the FDA’s November 2017 report. In the majority of deaths that the FDA attributes to Kratom, subjects ingested multiple substances with known risks, including alcohol.
In most European countries, Kratom continues to be a controlled drug. In the UK the sale, import, and export of Kratom are prohibited. Yet, judging from a quick look, it does not seem to be all that difficult to obtain Kratom via the Internet.
Multiple sclerosis (MS) causes a range of different symptoms. Patients with MS have looked for alternative therapies to control their MS progress and treat their symptoms. Non-invasive therapeutic approaches such as massage can have benefits to mitigate some of these symptoms. However, there is no rigorous review of massage effectiveness for patients suffering from MS.
The present systematic review was aimed at examining the effectiveness of different massage approaches on common MS symptoms, including fatigue, pain, anxiety, depression, and spasticity.
A total of 12 studies met the inclusion criteria. The authors rated 5 studies as being of fair and 7 studies of good methodological quality. Fatigue was improved by different massage styles, such as reflexology, nonspecific therapeutic massage, and Swedish massage. Pain, anxiety, and depression were effectively improved by reflexology techniques. Spasticity was reduced by Swedish massage and reflexology techniques.
The authors concluded that different massage approaches effectively improved MS symptoms such as fatigue, pain, anxiety, depression, and spasticity.
Clinical trials of massage therapy face formidable obstacles including:
- difficulties in obtaining funding,
- difficulties in finding expert researchers who are interested in the subject,
- difficulties to control for placebo effects,
- difficulties in blinding patients,
- impossibility of blinding therapists,
- confusion about the plethora of different massage techniques.
Thus, the evidence is often less convincing than one would hope. This, however, does not mean that massage therapy does not have considerable potential for a range of indications. One could easily argue that this situation is similar to spinal manipulation. Yet, there are at least three important differences:
- massage therapy is not as heavily burdened with frequent adverse effects and potentially life-threatening complications,
- massage therapy has a rational basis,
- the existing evidence is more uniformly encouraging.
Consequently, massage therapy (particularly, classic or Swedish massage) is more readily being accepted even in the absence of solid evidence. In fact, in some countries, e.g. Germany and Austria, massage therapy is considered to be a conventional treatment.
