MD, PhD, MAE, FMedSci, FRSB, FRCP, FRCPEd.

fatigue

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:

    1. 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.
    2. 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.
    3. 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.
    4. 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.
    5. Ledum: Ledum or Ledum Palustre is one of the best homeopathic drugs when it comes to treating insect bites during summers.
    6. 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.

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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:

And it can cause the following adverse effects:

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:

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.

Acupuncture is a veritable panacea; it cures everything! At least this is what many of its advocates want us to believe. Does it also have a role in supportive cancer care?

Let’s find out.

This systematic review evaluated the effects of acupuncture in women with breast cancer (BC), focusing on patient-reported outcomes (PROs).

A comprehensive literature search was carried out for randomized controlled trials (RCTs) reporting PROs in BC patients with treatment-related symptoms after undergoing acupuncture for at least four weeks. Literature screening, data extraction, and risk bias assessment were independently carried out by two researchers. The authors stated that they followed the ‘Preferred Reporting Items for Systematic Review and Meta-Analyses’ (PRISMA) guidelines.

Out of the 2, 524 identified studies, 29 studies representing 33 articles were included in this meta-analysis. The RCTs employed various acupuncture techniques with a needle, such as hand-acupuncture and electroacupuncture. Sham/placebo acupuncture, pharmacotherapy, no intervention, or usual care were the control interventions. About half of the studies lacked adequate blinding.

At the end of treatment (EOT), the acupuncture patients’ quality of life (QoL) was measured by the QLQ-C30 QoL subscale, the Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES), the Functional Assessment of Cancer Therapy–General/Breast (FACT-G/B), and the Menopause-Specific Quality of Life Questionnaire (MENQOL), which depicted a significant improvement. The use of acupuncture in BC patients lead to a considerable reduction in the scores of all subscales of the Brief Pain Inventory-Short Form (BPI-SF) and Visual Analog Scale (VAS) measuring pain. Moreover, patients treated with acupuncture were more likely to experience improvements in hot flashes scores, fatigue, sleep disturbance, and anxiety compared to those in the control group, while the improvements in depression were comparable across both groups. Long-term follow-up results were similar to the EOT results. Eleven RCTs did not report any information on adverse effects.

The authors concluded that current evidence suggests that acupuncture might improve BC treatment-related symptoms measured with PROs including QoL, pain, fatigue, hot flashes, sleep disturbance and anxiety. However, a number of included studies report limited amounts of certain subgroup settings, thus more rigorous, well-designed and larger RCTs are needed to confirm our results.

This review looks rigorous on the surface but has many weaknesses if one digs only a little deeper. To start with, it has no precise research question: is any type of acupuncture better than any type of control? This is not a research question that anyone can answer with just a few studies of mostly poor quality. The authors claim to follow the PRISMA guidelines, yet (as a co-author of these guidelines) I can assure you that this is not true. Many of the included studies are small and lacked blinding. The results are confusing, contradictory and not clearly reported. Many trials fail to mention adverse effects and thus violate research ethics, etc., etc.

The conclusion that acupuncture might improve BC treatment-related symptoms could be true. But does this paper convince me that acupuncture DOES improve these symptoms?

No!

Many experts doubt that acupuncture generates the many positive health effects that are being claimed by enthusiasts. Yet, few consider that acupuncture might not be merely useless but could even make things worse. Here is a trial that seems to suggest exactly that.

This study evaluated whether combining two so-called alternative medicines (SCAMs), acupuncture and massage, reduce postoperative stress, pain, anxiety, muscle tension, and fatigue more than massage alone.

Patients undergoing autologous tissue breast reconstruction were randomly assigned to one of two postoperative SCAMs for three consecutive days. All participants were observed for up to 3 months. Forty-two participants were recruited from January 29, 2016 to July 11, 2018. Twenty-one participants were randomly assigned to massage alone and 21 to massage and acupuncture. Stress, anxiety, relaxation, nausea, fatigue, pain, and mood (score 0-10) were measured at enrollment before surgery and postoperative days 1, 2, and 3 before and after the intervention. Patient satisfaction was evaluated.

Stress decreased from baseline for both Massage-Only Group and Massage+Acupuncture Group after each treatment intervention. Change in stress score from baseline decreased significantly more in the Massage-Only Group at pretreatment and posttreatment. After adjustment for baseline values, change in fatigue, anxiety, relaxation, nausea, pain, and mood scores did not differ between groups. When patients were asked whether they would recommend the study, 100% (19/19) of Massage-Only Group and 94% (17/18) of Massage+Acupuncture Group responded yes.

The authors concluded tha no additive beneficial effects were observed with addition of acupuncture to massage for pain, anxiety, relaxation, nausea, fatigue, and mood. Combined massage and acupuncture was not as effective in reducing stress as massage alone, although both groups had significant stress reduction. These findings indicate a need for larger studies to explore these therapies further.

I recently went to the supermarket to find out whether combining two bank notes (£10 + £5) can buy more goods than one £10 note alone. What I found was interesting: the former did indeed purchase more than the latter. Because I am a scientist, I did not stop there; I went to a total of 10 shops and my initial finding was confirmed each time: A+B results in more than A alone.

It stands to reason that the same thing happens with clinical trials. We even tested this hypothesis in a systematic review entitled ‘A trial design that generates only ”positive” results‘. Here is our abstract:

In this article, we test the hypothesis that randomized clinical trials of acupuncture for pain with certain design features (A + B versus B) are likely to generate false positive results. Based on electronic searches in six databases, 13 studies were found that met our inclusion criteria. They all suggested that acupuncture is effective (one only showing a positive trend, all others had significant results). We conclude that the ‘A + B versus B’ design is prone to false positive results and discuss the design features that might prevent or exacerbate this problem.

But why is this not so with the above-mentioned study?

Why is, in this instance, A even more that A+B?

There are, of course, several possible answers. To use my supermarket example again, the most obvious one is that B is not a £5 note but a negative amount, a dept note, in other words: A + B can only be less than A alone, if B is a minus number. In the context of the clinical trail, this means acupuncture must have caused a negative effect.

But is that possible? Evidently yes! Many patients don’t like needles and experience stress at the idea of a therapist sticking one into their body. Thus acupuncture would cause stress, and stress would have a negative effect on all the other parameters quantified in the study (pain, anxiety, muscle tension, and fatigue).

My conclusion: in certain situations, acupuncture is more than just useless; it makes things worse.

The aim of this RCT was to examine symptom responses resulting from a home-based reflexology intervention delivered by a friend/family caregiver to women with advanced breast cancer undergoing chemotherapy, targeted, and/or hormonal therapy.

Patient-caregiver dyads (N = 256) were randomized to 4 weekly reflexology sessions or attention control. Caregivers in the intervention group were trained by a reflexology practitioner in a 30-min protocol. During the 4 weeks, both groups completed telephone symptom assessments using the M. D. Anderson Symptom Inventory. Those who completed at least one weekly call were included in this secondary analysis (N = 209). Each symptom was categorized as mild, moderate, or severe using established interference-based cut-points. Symptom response meant an improvement by at least one category or remaining mild. Symptom responses were treated as multiple events within patients and analysed using generalized estimating equations technique.

Reflexology was more successful than attention control in producing responses for pain with no significant differences for other symptoms. In the reflexology group, greater probability of response across all symptoms was associated with lower number of comorbid condition and lower depressive symptomatology at baseline. Compared to odds of responses on pain (chosen as a referent symptom), greater odds of symptom response were found for disturbed sleep and difficulty remembering with older aged participants.

Adjusted odds ratios (ORs) of symptom responses for reflexology arm versus control (adjusted for age, number of comorbid conditions, depressive symptoms at baseline, and treatment type: chemotherapy with or without hormonal therapy versus hormonal therapy alone)
Symptom                                 OR      (95% CI)        p value
Fatigue                                    1.76      (0.99, 3.12)       0.06
Pain                                         1.84      (1.05, 3.23)       0.03
Disturbed sleep                         1.45      (0.76, 2.77)       0.26
Shortness of breath                   0.58      (0.26, 1.30)       0.19
Remembering                           0.96      (0.51, 1.78)       0.89
Lack of appetite                        1.05      (0.45, 2.49)       0.91
Dry mouth                               1.84      (0.86, 3.94)       0.12
Numbness and tingling              1.40     (0.75, 2.64)        0.29
Depression                              1.38      (0.78, 2.43)       0.27

The authors concluded that home-based caregiver-delivered reflexology was helpful in decreasing patient-reported pain. Age, comorbid conditions, and depression are potentially important tailoring factors for future research and can be used to identify patients who may benefit from reflexology.

This is certainly one of the more rigorous studies of reflexology. It is well designed and reported. How valid are its findings? To a large degree, this seems to depend on the somewhat unusual statistical approach the investigators employed:

Baseline characteristics were summarized by study group for outcome values and potential covariates. The unit of analysis was patient symptom; multiple symptoms were treated as nested within the patient being analyzed, using methodology described by Given et al. [24] and Sikorskii et al. [17]. Patient symptom responses were treated as multiple events, and associations among responses to multiple symptoms within patients were accounted for by specifying the exchangeable correlation structure in the generalized estimating equations (GEE) model. The GEE model was fitted using the GENMOD procedure in SAS 9.4 [25]. A dummy symptom variable with 9 levels was included in the interaction with the trial arm to differentiate potentially different effects of reflexology on different symptoms. Patient-level covariates included age, number of comorbid conditions, type of treatment (chemotherapy or targeted therapy with or without
hormonal therapy versus hormonal therapy only), and the CES-D score at baseline. Odds ratios (ORs) and their 95% confidence intervals (CIs) were obtained for the essential parameter of study group for each symptom.

Another concern is the fact that the study crucially depended on the reliability of the 256 carers. It is conceivable, even likely, I think, that many carers from both groups were less than strict in adhering to the prescribed protocol. This might have distorted the results in either direction.

Finally, the study was unable to control for the possibly substantial placebo response that a reflexology massage unquestionably provokes. Therefore, we are not able to tell whether the observed effect is due to the agreeable, non-specific effects of touch and foot massages, or to the postulated specific effects of reflexology.

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