WARNING: after reading this, you might no longer enjoy your favorite breakfast cereal!
‘Biologic living’ is the name John Harvey Kellogg (1852-1943), an influential medical doctor and best-known as the inventor of the cornflakes gave to his health reforms. Biologic living was practiced in Kellogg’s Battle Creek Sanatorium, an institution for re-educating Americans and training of healthcare professionals. Kellogg’s religious beliefs bled into his medicinal practices and the Battle Creek Sanatorium was as much health spar as it was a rehabilitation facility. 
In the sanatorium, there was a strict focus on diet which was meant to cure a person of practically all ills, leading to a kind of purity of the soul. Meat and certain spicy, overly flavourful foods, as well as alcoholic beverages, were thought to overexcite the mind and lead to sinful behavior. A bland dull diet was thus recommended. Kellogg intended for ‘cornflakes’ to become the staple of this diet. Other treatments included the following :
- Vegetarian diet; Kellogg invented an artificial meat substitute based mainly on peanuts, called ‘nuttose’
- ‘Light bath’, a bath under lights lasting hours, days, sometimes even weeks
- Regular exercise
- Various forms of electrotherapy
- Vibrational therapy
- Massage therapy
- Breathing techniques
- Colonic irrigation delivered by specially designed machines that could deliver 14 liters of water followed by a pint of yogurt, half of which was to be eaten, while the other half would be delivered via a second enema
- Water cures of various types
- Sexual abstinence, including various measures to avoid masturbation. For boys, he recommended circumcision without anesthetic, thinking the trauma it caused and several weeks of pain that would follow would curb masturbation. If that did not suffice, Kellogg recommended sewing the foreskin shut, preventing an erection. For girls, he applied carbolic acid to the clitoris as ‘an excellent means of allaying the abnormal excitement.’ He would also recommend binding people’s hands, covering genitalia in specially designed cages, or electroshock therapy, such was his hatred of masturbation.
Biologic living was centered around purity, not merely of the soul but racial purity too. Meat and alcohol were not just bad, they were considered ‘race poisons’. He was a staunch advocate of ‘race suicide’, a term that summed up the fear of white America that their racial purity would be eroded, and they would disappear into ‘inferior races’. Kellogg helped implement a law whereby genetically ‘inferior’ humans such as epileptics or people with a learning disability could be a target. Michigan’s forced sterilization law, which Kellogg himself had a hand in, would not be repealed until 1974.
Today, Kellogg’s biologic living is mostly of historical interest. Yet, it is relevant for understanding some of the more extreme trends in the US related to so-called alternative medicine (SCAM).
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.
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.
A case report was published of a 35-year-old Chinese man with no risk factors for stroke. He presented with a 2-day history of expressive dysphasia and a 1-day history of right-sided weakness. The symptoms were preceded by multiple sessions of the neck, shoulder girdle, and upper back massage for pain relief in the prior 2 weeks. A CT-scan of the brain demonstrated an acute left middle cerebral artery infarct and left internal carotid artery dissection. The MRI cerebral angiogram confirmed left carotid arterial dissection and intimal oedema of bilateral vertebral arteries. In the absence of other vascular comorbidities and risk factors, massage-induced internal carotid arterial dissection was deemed to be the most likely cause of the near-fatal cerebrovascular event.
INSIDER reported further details of the case: the patient told the doctors who treated him that he had seen the chiropractor for two weeks before he experienced trouble reading, writing and talking. After experiencing those symptoms for two days and one day of pain on his right side, a friend convinced the patient to consult a neurologist. This led to the hospital admission, the above-named tests, and diagnosis. After three months of therapy and rehab, the patient showed “significant improvement,” according to the doctors.
What remains unclear is the exact nature of the neck treatment that is believed to have caused the arterial dissection. A massage is mentioned but massages have rarely been associated with such problems. Neck manipulations, on the other hand, are the hallmark therapy of chiropractors and have, as I have pointed out regularly, often been reported to cause arterial dissections.
Chiropractors usually deny this fact; alternatively, they claim that only poorly trained practitioners cause these adverse events or that their frequency is exceedingly small. However, without a proper post-marketing surveillance system, this argument is hardly convincing.
I recently came across this paper by Prof. Dr. Chad E. Cook, a physical therapist, PhD, a Fellow of the American Physical Therapy Association (FAPTA), and a professor as well as director of clinical research in the Department of Orthopaedics, Department of Population Health Sciences at the Duke Clinical Research Institute at Duke University in North Carolina, USA. The paper is entitled ‘The Demonization of Manual Therapy‘.
Cook introduced the subject by stating: “In medicine, when we do not understand or when we dislike something, we demonize it. Well-known examples throughout history include the initial ridicule of antiseptic handwashing, percutaneous transluminal coronary angioplasty (i. e., balloon angioplasty), the relationships between viruses and cancer, the contribution of bacteria in the development of ulcers, and the role of heredity in the development of disease. In each example, naysayers attempted to discredit the use of each of the concepts, despite having no evidence to support their claims. The goal in each of the aforementioned topics: demonize the concept.”
Cook then discussed 8 ‘demonizations’ of manual therapy. Number 7 is entitled “Causes as Much Harm as Help“. Here is this section in full:
By definition, harms include adverse reactions (e. g., side effects of treatments), and other undesirable consequences of health care products and services. Harms can be classified as “none”, minor, moderate, serious and severe . Most interventions have some harms, typically minor, which are defined as a non-life-threatening, temporary harm that may or may not require efforts to assess for a change in a patient’s condition such as monitoring .
There are harms associated with a manual therapy intervention, but they are generally benign (minor). Up to 20 –40 % of individuals will report adverse events after the application of manual therapy. The most common adverse events were soreness in muscles, increased pain, stiffness and tiredness . There are rare occasions of several harms associated with manual therapy and these include spinal or neurological problems as well as cervical arterial strokes . It is critical to emphasize how rare these events are; serious adverse event incidence estimates ranged from 1 per 2 million manipulations to 13 per 10,000 patients .
Cook then concludes that “manual therapy has been inappropriately demonized over the last decade and has been associated with inaccurate assumptions and false speculations that many clinicians have acquired over the last decade. This paper critically analyzed eight of the most common assumptions that have belabored manual therapy and identified notable errors in seven of the eight. It is my hope that the physiotherapy community will carefully re-evaluate its stance on manual therapy and consider a more evidence-based approach for the betterment of our patients.
REFERENCES Ernst E. Adverse effects of spinal manipulation: a systematic review. J R Soc Med 2007; 100: 330–338.
doi:10.1177/014107680710000716  Paanalahti K, Holm LW, Nordin M et al. Adverse events after manual therapy among patients seeking care for neck and/or back pain: a randomized controlled trial. BMC Musculoskelet Disord 2014; 15: 77. doi:10.1186/1471-2474-15-77  Swait G, Finch R. What are the risks of manual treatment of the spine? A scoping review for clinicians. Chiropr Man Therap 2017; 25: 37. doi:10.1186/s12998-017-0168-5
Here are a few things that I find odd or wrong with Cook’s text:
- The term ‘demonizing’ seems to be a poor choice. The historical examples chosen by Cook were not cases of demonization. They were mostly instances where new discoveries did not fit into the thinking of the time and therefore took a long time to get accepted. They also show that sooner or later, sound evidence always prevails. Lastly, they suggest that speeding up this process via the concept of evidence-based medicine is a good idea.
- Cook then introduces the principle of risk/benefit balance by entitling the cited section “Causes as Much Harm as Help“. Oddly, however, he only discusses the risks of manual therapies and omits the benefit side of the equation.
- This omission is all the more puzzling since he quotes my paper (his reference ) states that “the effectiveness of spinal manipulation for most indications is less than convincing.5 A risk-benefit evaluation is therefore unlikely to generate positive results: with uncertain effectiveness and finite risks, the balance cannot be positive.”
- In discussing the risks, he seems to assume that all manual therapies are similar. This is clearly not true. Massage therapies have a very low risk, while this cannot be said of spinal manipulations.
- The harms mentioned by Cook seem to be those of spinal manipulation and not those of all types of manual therapy.
- Cook states that “up to 20 –40 % of individuals will report adverse events after the application of manual therapy.” Yet, the reference he uses in support of this statement is a clinical trial that reported an adverse effect rate of 51%.
- Cook then states that “there are rare occasions of several harms associated with manual therapy and these include spinal or neurological problems as well as cervical arterial strokes.” In support, he quotes one of my papers. In it, I emphasize that “the incidence of such events is unknown.” Cook not only ignores this fact but states in the following sentence that “it is critical to emphasize how rare these events are…”
Cook concludes that “manual therapy has been inappropriately demonized over the last decade and has been associated with inaccurate assumptions and false speculations …” He confuses, I think, demonization with critical assessment.
Cook’s defence of manual therapy is clumsy, inaccurate, ill-conceived, misleading and often borders on the ridiculous. In the age of evidence-based medicine, therapies are not ‘demonized’ but evaluated on the basis of their effectiveness and safety. Manual therapies are too diverse to do this wholesale. They range from various massage techniques, some of which have a positive risk/benefit balance, to high-velocity, low-amplitude thrusts, for which the risks do not demonstrably outweigh the benefits.
Myofascial release (also known as myofascial therapy or myofascial trigger point therapy) is a type of low-load stretch therapy that is said to release tightness and pain throughout the body caused by the myofascial pain syndrome, a chronic muscle pain that is worse in certain areas known as trigger points. Various types of health professionals provide myofascial release, e.g. osteopaths, chiropractors, physical or occupational therapists, massage therapists, or sports medicine/injury specialists. The treatment is usually applied repeatedly, but there is also a belief that a single session of myofascial release is effective. This study was a crossover clinical trial aimed to test whether a single session of a specific myofascial release technique reduces pain and disability in subjects with chronic low back pain (CLBP).
A total of 41 participants were randomly enrolled into 3 situations in a balanced and crossover manner:
The subjects underwent a single session of myofascial release on thoracolumbar fascia and the results were compared with the control and placebo groups. A single trained and experienced therapist applied the technique.
For the control treatment, the subjects were instructed to remain in the supine position for 5 minutes. For the muscle release session, the subjects were in a sitting position with feet supported and the thoracolumbar region properly undressed. The trunk flexion goniometry of each participant was performed and the value of 30° was marked with a barrier to limit the necessary movement during the technique. The trained researcher positioned their hands on all participants without sliding over the skin or forcing the tissue, with the cranial hand close to the last rib and at the T12–L1 level on the right side of the individual’s body and the caudal hand on the ipsilateral side between the iliac crest and the sacrum. Then, the researcher caused slight traction in the tissues by moving their hands away from each other in a longitudinal direction. Then, the participant was instructed to perform five repetitions of active trunk flexion-extension (30°), while the researcher followed the movement with both hands simultaneously positioned, without losing the initial tissue traction and position. The same technique and the same number of repetitions of active trunk flexion-extension were repeated with the researcher’s hands positioned on the opposite sides. This technique lasted approximately five minutes.
For the placebo treatment, the subjects were not submitted to the technique of manual thoracolumbar fascia release, but they slowly performed ten repetitions of active trunk flexion-extension (30°) in the same position as the experimental situation. Due to the fact that touch can provide not only well-recognized discriminative input to the brain, but also an affective input, there was no touch from the researcher at this stage.
The outcomes, pain, and functionality, were evaluated using the numerical pain rating scale (NPRS), pressure pain threshold (PPT), and Oswestry Disability Index (ODI).
The results showed no effects between-tests, within-tests, nor for interaction of all the outcomes, i.e., NPRS (η 2 = 0.32, F = 0.48, p = 0.61), PPT (η2 = 0.73, F = 2.80, p = 0.06), ODI (η2 = 0.02, F = 0.02, p = 0.97).
The authors concluded that a single trial of a thoracolumbar myofascial release technique was not enough to reduce pain intensity and disability in subjects with CLBP.
This study describes the use of so-called alternative medicine (SCAM) among older adults who report being hampered in daily activities due to musculoskeletal pain. Cross-sectional European Social Survey (EES) Round 7 (2014) data from 21 countries were examined for participants aged 55 years and older, who reported musculoskeletal pain that hampered daily activities in the past 12months. From a total of 35,063 individuals who took part in the ESS study, 13,016 (37%) were aged 55 or older; of which 8183 (63%) reported the presence of pain, with a further 4950 (38%) reporting that this pain hampered their daily activities in any way.
Of the 4950 older adult participants reporting musculoskeletal pain that hampered daily activities, the majority (63.5%) were from the West of Europe, reported secondary education or less (78.2%), and reported at least one other health-related problem (74.6%). In total, 1657 (33.5%) reported using at least one SCAM treatment in the previous year. Manual body-based therapies (MBBTs) were most used, including massage therapy (17.9%) and osteopathy (7.0%). Alternative medicinal systems (AMSs) were also popular with 6.5% using homeopathy and 5.3% reporting herbal treatments. A general trend of higher SCAM use in younger participants was noted.
SCAM usage was associated with
- physiotherapy use,
- female gender,
- higher levels of education,
- being in employment,
- living in West Europe
- having multiple health problems.
The authors concluded that a third of older Europeans with musculoskeletal pain report SCAM use in the previous
12 months. Certain subgroups with higher rates of SCAM use could be identified. Clinicians should comprehensively and routinely assess SCAM use among older adults with musculoskeletal pain.
Such studies have the advantage of large sample sizes, and therefore one is inclined to consider their findings to be reliable and informative. Yet, they resemble big fishing operations where all sorts of important and unimportant stuff is caught in the net. When studying such papers, it is wise to remember that associations do not necessarily reveal causal relationships!
Having said this, I find very little information in these already outdated results (they originate from 2014!) that I would not have expected. Perhaps the most interesting aspect is the nature of the most popular SCAMs used for musculoskeletal problems. The relatively high usage of MBBTs had to be expected; in most of the surveyed countries, massage therapy is considered to be not SCAM but mainstream. The fact that 6.5% used homeopathy to ease their musculoskeletal pain is, however, quite remarkable. I know of no good evidence to show that homeopathy is effective for such problems (in case some homeopathy fans disagree, please show me the evidence).
In my view, this indicates that, in 2014, much needed to be done in terms of informing the public about homeopathy. Many consumers mistook homeopathy for herbal medicine (which btw may well have some potential for musculoskeletal pain), and many consumers had been misguided into believing that homeopathy works. They had little inkling that homeopathy is pure placebo therapy. This means they mistreated their conditions, continued to suffer needlessly, and caused an unnecessary financial burden to themselves and/or to society.
Since 2014, much has happened (as discussed in uncounted posts on this blog), and I would therefore assume that the 6.5% figure has come down significantly … but, as you know:
I am an optimist.
I believe in progress.
This systematic review assessed the effects and reliability of sham procedures in manual therapy (MT) trials in the treatment of back pain (BP) in order to provide methodological guidance for clinical trial development.
Different databases were screened up to 20 August 2020. Randomized controlled trials involving adults affected by BP (cervical and lumbar), acute or chronic, were included. Hand contact sham treatment (ST) was compared with different MT (physiotherapy, chiropractic, osteopathy, massage, kinesiology, and reflexology) and to no treatment. Primary outcomes were BP improvement, the success of blinding, and adverse effects (AE). Secondary outcomes were the number of drop-outs. Dichotomous outcomes were analyzed using risk ratio (RR), continuous using mean difference (MD), 95% CIs. The minimal clinically important difference was 30 mm changes in pain score.
A total of 24 trials were included involving 2019 participants. Most of the trials were of chiropractic manipulation. Very low evidence quality suggests clinically insignificant pain improvement in favor of MT compared with ST (MD 3.86, 95% CI 3.29 to 4.43) and no differences between ST and no treatment (MD -5.84, 95% CI -20.46 to 8.78).ST reliability shows a high percentage of correct detection by participants (ranged from 46.7% to 83.5%), spinal manipulation is the most recognized technique. Low quality of evidence suggests that AE and drop-out rates were similar between ST and MT (RR AE=0.84, 95% CI 0.55 to 1.28, RR drop-outs=0.98, 95% CI 0.77 to 1.25). A similar drop-out rate was reported for no treatment (RR=0.82, 95% 0.43 to 1.55).
The authors concluded that MT does not seem to have clinically relevant effect compared with ST. Similar effects were found with no treatment. The heterogeneousness of sham MT studies and the very low quality of evidence render uncertain these review findings. Future trials should develop reliable kinds of ST, similar to active treatment, to ensure participant blinding and to guarantee a proper sample size for the reliable detection of clinically meaningful treatment effects.
The optimal therapy for back pain does not exist or has not yet been identified; there are dozens of different approaches but none has been found to be truly and dramatically effective. Manual therapies like chiropractic and osteopathy are often used, and some data suggest that they are as good (or as bad) as most other options. This review confirms what we have discussed many times previously (e.g. here), namely that the small positive effect of MT, or specifically spinal manipulation, is largely due to placebo.
Considering this information, what is the best treatment for back pain sufferers? The answer seems obvious: it is a therapy that is as (in)effective as all the others but causes the least harm or expense. In other words, it is not chiropractic nor osteopathy but exercise.
avoid therapists who use spinal manipulation for back pain.
Tuina is a massage therapy that originates from Traditional Chinese Medicine. Many of the techniques used in tuina resemble those of a western massage like gliding, kneading, vibration, tapping, friction, pulling, rolling, pressing, and shaking. Tuina involves a range of manipulations usually performed by the therapist’s finger, hand, elbow, knee, or foot. They are applied to muscle or soft tissue at specific locations of the body.
The aim of Tuina is to enhance the flow of the ‘vital energy’ or ‘chi’, that is alleged to control our health. Proponents of the therapy recommend Tuina for a range of conditions, including paediatric ones. Paediatric Tuina has been widely used in children with acute diarrhea in China. However, due to a lack of high-quality clinical evidence, the benefit of Tuina is not clear.
This study aimed to assess the effect of paediatric Tuina compared with sham Tuina as add-on therapy in addition to usual care for 0-6-year-old children with acute diarrhea.
Eighty-six participants aged 0-6 years with acute diarrhea were randomized to receive Tuina plus usual care (n = 43) or sham Tuina plus usual care (n = 43). The primary outcomes were days of diarrhea from baseline and times of diarrhea on day 3. Secondary outcomes included a global change rating (GCR) and the number of days when the stool characteristics returned to normal. Adverse events were assessed.
Tuina treatment in the intervention group was performed on the surface of the children’s body using moderate pressure (Fig. 1a). Tuina treatment in the control group was different: the therapist used one hand to hold the child’s hand or put one hand on the child’s body, while the other hand performed manipulations on the therapist’s own hand instead of the child’s hand or body (Fig. (Fig.11b).
Tuina was associated with a reduction in times of diarrhea on day 3 compared with sham Tuina in both ITT and per-protocol analyses. However, the results were not significant when adjusted for social-demographic and clinical characteristics. No significant difference was found between groups in days of diarrhea, global change rating, or number of days when the stool characteristics returned to normal.
The authors concluded that in children aged 0-6 years with acute diarrhea, pediatric Tuina showed significant effects in terms of reducing times of diarrhea compared with sham Tuina. Studies with larger sample sizes and adjusted trial designs are warranted to further evaluate the effect of pediatric Tuina therapy.
This study was well-reported and has interesting features, such as the attempt to use a placebo control and blinding (whether blinding was successful is a different matter and was not tested in the trial). It is, therefore, all the more surprising that the essentially negative result is turned into a positive one. After adjustment, the differences disappear (a fact which the authors hardly mention in the paper), which means they are not due to the treatment but to group differences and confounding. This, in turn, means that the study shows not the effectiveness but the ineffectiveness of Tuina.
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.  and Sikorskii et al. . 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 . 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.