MD, PhD, FMedSci, FSB, FRCP, FRCPEd

fatigue

Cancer-related fatigue (CRF) is one of the most common symptoms reported by cancer patients, and it is a symptom that is often difficult to treat. As always in such a situation, there are lots of alternative therapies on offer. Yet the evidence for most is flimsy, to put it mildly.

But perhaps there is hope? The very first RCT with a 2016 date to be reviewed on this blog investigated the efficacy of the amino acid jelly Inner Power(®) (IP), a semi-solid, orally administrable dietary supplement containing coenzyme Q10 and L-carnitine, in controlling CRF in breast cancer patients in Japan.

Breast cancer patients with CRF undergoing chemotherapy were randomly assigned to receive IP once daily or regular care for 21 days. The primary endpoint was the change in the worst level of fatigue during the past 24 h (Brief Fatigue Inventory [BFI] item 3 score) from day 1 (baseline) to day 22. Secondary endpoints were change in global fatigue score (GFS; the average of all BFI items), anxiety and depression assessed by the Hospital Anxiety and Depression Scale (HADS), quality of life assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and EORTC Breast Cancer-Specific QLQ (EORTC QLQ-BR23), and adverse events.

Fifty-nine patients were enrolled in the study, of whom 57 were included in the efficacy analysis. Changes in the worst level of fatigue, GFS, and current feeling of fatigue were significantly different between the intervention and control groups, whereas the change in the average feeling of fatigue was not significantly different between groups. HADS, EORTC QLQ-C30, and EORTC QLQ-BR23 scores were not significantly different between the two groups. No severe adverse events were observed.

The authors concluded that ‘IP may control moderate-severe CRF in breast cancer patients.’

The website of the manufacturer provides the following information on IP:

Inner Power is a functional food that provides various nutrients, such as zinc and copper. Zinc is a nutrient that your body needs to maintain your sense of taste. Zinc is also vital in keeping the skin and mucous membranes healthy and in regulating metabolism of proteins and nucleic acids. Copper helps the body form red blood cells and bones and regulates many enzymes that are found in the body. One pouch of Inner Power each day is the recommended daily serving.

  • Consuming a large amount of the product will not cure any underlying disease or improve your health condition.
  • Do not consume too much of the product because excessive zinc intake may inhibit the absorption of copper.
  • Observe the recommended daily serving of the product. This product should not be given to infants or children.

The recommended daily serving of the product (1 pouch/day) contains 43% of the reference daily intake of zinc and 50% of the reference daily intake of copper. Inner Power is neither categorized as a food for special dietary use nor approved individually by the Ministry of Health, Labour, and Welfare. You should eat well-balanced meals consisting of staple foods, including a main dish and side dishes.

I cannot say that this inspires me with confidence.

What about the trial itself?

To be honest, I am not impressed. The most obvious flaw is, I think, that there was not the slightest attempt to control for placebo effects. As I pointed out so many times before: with the ‘A+B versus B’ design, one can make any old placebo appear to be effective.

Lyme disease, also known as Lyme borreliosis, is an infectious disease caused by Borrelia infection transmitted by ticks. The most common early sign is an expanding area of redness beginning at the site of a bite about a week after a tick-bite. Fever, tiredness and headaches often follow. Later stages are characterised by more severe and remarkably variable illness.

Patients with medically unexplained or vague symptoms are sometimes told that they suffer from Lyme disease. These patients are commonly targeted by providers of alternative therapies who promise hope by claiming that their particular brand of quackery is effective for this chronic condition.

A recent review was designed to identify and characterize the range of unorthodox alternative therapies advertised to patients with a diagnosis of Lyme disease.

Internet searches using the Google search engine were performed to identify the websites of clinics and services that marketed non-antimicrobial therapies for Lyme disease. Subsequently the PubMed search engine was employed to identify any scientific studies evaluating such treatments for Lyme disease. Websites were included in this review, if they advertised a commercial, non-antimicrobial product or service that specifically mentioned utility for Lyme disease. Websites with patient testimonials (such as discussion groups) were excluded unless the testimonial appeared as marketing on a commercial site.

More than 30 different alternative treatments were identified. They fell into several broad categories: these included oxygen and reactive oxygen therapy; energy and radiation-based therapies; nutritional therapies; chelation and heavy metal therapies; and biological and pharmacological therapies ranging from certain medications without recognized therapeutic effects on Borrelia burgdorgeri to stem cell transplantation. The review of the medical literature did not substantiate efficacy or, in most cases, any rationale for the advertised treatments.

The authors concluded that providers of alternative therapies commonly target patients who believe they have Lyme disease. The efficacy of these unconventional treatments for Lyme disease is not supported by scientific evidence, and in many cases they are potentially harmful.

Being a bacterial infection, Lyme disease can be successfully treated with oral or intra-venous antibiotics. But, of course, patients need to have the infection in order to benefit from antibiotic treatment. Those patients who don’t are easy targets for charlatans promising help from bogus treatments. It seems that an entire, profitable industry has developed around this situation.

I regularly used to ask alternative practitioners what diseases they are good at treating. In fact, we once ran an entire research project dedicated to this question and found that their own impressions were generally based on wishful thinking rather than on evidence. The libel case of the BCA versus Simon Singh then brought this issue into the focus of the public eye, and consequently several professional organisations of alternative practitioners seem to have advised their members to be cautious about making unsubstantiated therapeutic claims. This could have been an important step into the right direction – unless, of course, a clever trick had not been devised to bypass the need for evidence. Today, when I ask alternative practitioners ‘what do you treat effectively?’ I tend to get answers like:

  • Alternative practitioners, unlike conventional clinicians, do not treat diseases.
  • I treat the whole person, not just the disease.
  • I treat people and their specific set of signs and symptoms, rather than disease labels (this actually is a quote from the comments section of one of my recent posts).
  • I focus on the totality of the symptoms; disease labels are irrelevant in the realm of my therapy.
  • Chiropractors adjust subluxations which are the root cause for most diseases.
  • Acupuncturists re-balance life energies which is a precondition for healing to commence irrespective of the disease.
  • Homeopaths treat the totality of symptoms so that the patient’s vital force can do the healing.
  • etc. etc.

All of these statements are deeply rooted in the long obsolete notions of vitalism, i.e. the assumption that a vital energy flows in all living organisms and is responsible for our health irrespective of the disease we happen to suffer from. But what do the answers to my question ‘what do you treat?’ really mean? If we analyse the above responses critically, they seem to imply that:

  1. Conventional clinicians do not treat patients but merely disease labels.
  2. Alternative practitioners can successfully treat any disease or condition.

Ad 1 In my view, it is arrogant and grossly unfair to claim that alternative practitioners work holistically, while conventional health care professionals do not. I have pointed out repeatedly that any good medicine always has been and always will be holistic. High-jacking holism as a specific characteristic for alternative medicine is misleading and an insult to all conventional clinicians who do their best to practice good medicine.

Ad 2 By claiming that they treat the whole person irrespective of her disease, alternative practitioners effectively try to give themselves a ‘carte blanche’ for treating any disease or any condition or any symptom. If a child has asthma, a chiropractor will find a subluxation, adjust it with spinal manipulation, and claim that the child’s condition will improve as a consequence of his treatment – NEVER MIND THE EVIDENCE. If a person wants to give up smoking, an acupuncturist will use acupuncture to re-balance her yin and yang claiming that this intervention will make smoking cessation more successful – NEVER MIND THE EVIDENCE. If a patient suffers from cancer, a homeopath might find a remedy that promotes her vital energy claiming that the cancer will subsequently be cured – NEVER MIND THE EVIDENCE which in all of the three cases is negative.

The claim of alternative practitioners to not treat disease labels but the whole patient is doubtlessly attractive to consumers and it is also extremely good for business. On closer inspection, however, it turns out to be a distraction from the fact that alternative practitioners treat everything and anything, usually without the slightest evidence that their interventions generates more good than harm. It allows alternative practitioners to live in a fool’s paradise of quackery where they believe themselves to be protected from any challenges and demands for evidence.

Many cancer patients will suffer from severe, debilitating fatigue during the course of their illness. The exact cause of this common symptom is not entirely clear. Most likely it is due to a combination of the cancer and the treatments used to cure it. Managing cancer-related fatigue (CRF) is thus an important part of the palliative and supportive care of cancer patients. Acupuncture is often advocated for this purpose and many centres use it routinely. The question therefore is, does it work?

The most recent trial on this subject was aimed at assessing the effectiveness of maintenance acupuncture in the management of CRF; acupuncture or self-acupuncture/self-needling was compared with no such treatment. Breast cancer patients who previously had received acupuncture were randomized to have 4 acupuncturist-delivered weekly sessions, 4 self-administered weekly acupuncture sessions (self-needling); or no acupuncture at all. The primary outcome-measure was general fatigue, while mood, quality of life and safety served as secondary endpoints. In total, 197 patients were randomized: 65 to therapist-delivered sessions, 67 to self-acupuncture/self-needling and 65 to no further acupuncture. The results failed to demonstrate significant inter-group differences in any of the parameters evaluated. The authors concluded that “maintenance acupuncture did not yield important improvements beyond those observed after an initial clinic-based course of acupuncture“.

But this is just one single of several available studies. Acupuncture-fans might suspect me of cherry-picking a largely negative study. If we want a fair verdict, we must consider the totality of the evidence. The aim of our systematic review was therefore to critically evaluate the effectiveness of acupuncture (AT) for CRF based on all the trial data available to us.

Fourteen databases were searched from their respective inception to November 2012. Randomized clinical trials (RCTs) of AT for the treatment of CRF were considered for inclusion. The risk of bias/methodological quality was assessed using the method suggested by the Cochrane Collaboration. Seven RCTs met the eligibility criteria. Most were small pilot studies with serious methodological flaws. Four of them showed effectiveness of AT or AT in addition to usual care (UC) over sham AT, UC, enhanced UC, or no intervention for alleviating CRF. Three RCTs failed to demonstrate an effect of AT over sham treatment.

Our conclusion had to be cautious: “Overall, the quantity and quality of RCTs included in the analysis were too low to draw meaningful conclusions. Even in the positive trials, it remained unclear whether the observed outcome was due to specific effects of AT or nonspecific effects of care. Further research is required to investigate whether AT demonstrates specific effects on CRF

There will, of course, be those who claim that no trial evidence is needed in this case; if a cancer-patient benefits from the treatment, she should have it regardless of whether it works as a placebo or has effects beyond that. I do sympathize with this attitude but should point out that there are a number of points to consider when making it:

1) Acupuncture is not risk-free.

2) There are other treatments against CRF; if we blindly advocate acupuncture, we might not offer the best option to our patients.

3) If we spend our limited resources on acupuncture, we might not afford treatments which are more effective.

4) If we are happy using acupuncture because it conveys a sizable placebo-effect, how will we make progress in finding treatments that are more effective?

It is therefore difficult to decide whether or not to recommend acupuncture for CRF. There are some arguments for both sides. Skeptics or critical thinkers or clinicians adhering to the principles of evidence-based medicine are unlikely to condone it, and some people might accuse them for cruelly  and heartlessly denying severely ill patients help which they so badly need. Personally, I fail to see what is cruel or heartless in insisting that these patients receive the treatment which demonstrably works best – and that does not seem to be acupuncture.

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