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.
This recent Cochrane review assessed the effects of so-called alternative medicine (SCAM) for post-caesarean pain. Randomised clinical trials (RCTs), including quasi-RCTs and cluster-RCTs, comparing SCAM, alone or associated with other forms of pain relief, versus other treatments or placebo or no treatment, for the treatment of post-CS pain were included.
A total of 37 studies (3076 women) investigating 8 different SCAM therapies for post-CS pain relief were found. There was substantial heterogeneity among the trials. The primary outcome measures were pain and adverse effects. Secondary outcome measures included vital signs, rescue analgesic requirement at 6 weeks after discharge; all of which were poorly reported or not reported at all.
The quality of the RCTs was low. Whether acupuncture or acupressure (versus no treatment) or acupuncture or acupressure plus analgesia (versus placebo plus analgesia) have any effect on pain. Acupuncture or acupressure plus analgesia (versus analgesia) may reduce pain at 12 hours (standardised mean difference (SMD) -0.28, 95% confidence interval (CI) -0.64 to 0.07; 130 women; 2 studies; low-certainty evidence) and 24 hours (SMD -0.63, 95% CI -0.99 to -0.26; 2 studies; 130 women; low-certainty evidence). It is uncertain whether acupuncture or acupressure (versus no treatment) or acupuncture or acupressure plus analgesia (versus analgesia) have any effect on the risk of adverse effects.
Aromatherapy plus analgesia may reduce pain when compared with placebo plus analgesia at 12 hours (mean difference (MD) -2.63 visual analogue scale (VAS), 95% CI -3.48 to -1.77; 3 studies; 360 women; low-certainty evidence) and 24 hours (MD -3.38 VAS, 95% CI -3.85 to -2.91; 1 study; 200 women; low-certainty evidence). The authors were uncertain whether aromatherapy plus analgesia has any effect on adverse effects (anxiety) compared with placebo plus analgesia.
Electromagnetic therapy may reduce pain compared with placebo plus analgesia at 12 hours (MD -8.00, 95% CI -11.65 to -4.35; 1 study; 72 women; low-certainty evidence) and 24 hours (MD -13.00 VAS, 95% CI -17.13 to -8.87; 1 study; 72 women; low-certainty evidence).
There were 6 RCTs (651 women), 5 of which were quasi-RCTs, comparing massage (foot and hand) plus analgesia versus analgesia. All the evidence relating to pain, adverse effects (anxiety), vital signs and rescue analgesic requirement was very low-certainty.
Music therapy plus analgesia may reduce pain when compared with placebo plus analgesia at one hour (SMD -0.84, 95% CI -1.23 to -0.46; participants = 115; studies = 2; I2 = 0%; low-certainty evidence), 24 hours (MD -1.79, 95% CI -2.67 to -0.91; 1 study; 38 women; low-certainty evidence), and also when compared with analgesia at one hour (MD -2.11, 95% CI -3.11 to -1.10; 1 study; 38 women; low-certainty evidence) and at 24 hours (MD -2.69, 95% CI -3.67 to -1.70; 1 study; 38 women; low-certainty evidence). It is uncertain whether music therapy plus analgesia has any effect on adverse effects (anxiety), when compared with placebo plus analgesia because the quality of evidence is very low.
The investigators were uncertain whether Reiki plus analgesia compared with analgesia alone has any effect on pain, adverse effects, vital signs or rescue analgesic requirement because the quality of evidence is very low (one study, 90 women). Relaxation Relaxation may reduce pain compared with standard care at 24 hours (MD -0.53 VAS, 95% CI -1.05 to -0.01; 1 study; 60 women; low-certainty evidence).
Transcutaneous electrical nerve stimulation (TENS)
TENS (versus no treatment) may reduce pain at one hour (MD -2.26, 95% CI -3.35 to -1.17; 1 study; 40 women; low-certainty evidence). TENS plus analgesia (versus placebo plus analgesia) may reduce pain compared with placebo plus analgesia at one hour (SMD -1.10 VAS, 95% CI -1.37 to -0.82; 3 studies; 238 women; low-certainty evidence) and at 24 hours (MD -0.70 VAS, 95% CI -0.87 to -0.53; 108 women; 1 study; low-certainty evidence). TENS plus analgesia (versus placebo plus analgesia) may reduce heart rate (MD -7.00 bpm, 95% CI -7.63 to -6.37; 108 women; 1 study; low-certainty evidence) and respiratory rate (MD -1.10 brpm, 95% CI -1.26 to -0.94; 108 women; 1 study; low-certainty evidence). The authors were uncertain whether TENS plus analgesia (versus analgesia) has any effect on pain at six hours or 24 hours, or vital signs because the quality of evidence is very low (two studies, 92 women).
The authors concluded that some SCAM therapies may help reduce post-CS pain for up to 24 hours. The evidence on adverse events is too uncertain to make any judgements on safety and we have no evidence about the longer-term effects on pain. Since pain control is the most relevant outcome for post-CS women and their clinicians, it is important that future studies of SCAM for post-CS pain measure pain as a primary outcome, preferably as the proportion of participants with at least moderate (30%) or substantial (50%) pain relief. Measuring pain as a dichotomous variable would improve the certainty of evidence and it is easy to understand for non-specialists. Future trials also need to be large enough to detect effects on clinical outcomes; measure other important outcomes as listed in this review, and use validated scales.
I feel that the Cochrane Collaboration does itself no favours by publishing such poor reviews. This one is both poorly conceived and badly reported. In fact, I see little reason to deal with pain after CS differently than with post-operative pain in general. Some of the modalities discussed are not truly SCAM. Most of the secondary endpoints are irrelevant. The inclusion of adverse effects as a primary endpoint seems nonsensical considering that SCAM studies are notoriously bad at reporting them. Many of the allegedly positive findings rely on trial designs that cannot control for placebo effects (e.g A+B versus B); therefore they tell us nothing about the effectiveness of the therapy.
Most importantly, the conclusions are not helpful. I would have simply stated that none of the SCAM modalities are supported by convincing evidence as treatments for pain control after CS.
This Cochrane review assessed the efficacy and safety of aromatherapy for people with dementia. The researchers included randomised controlled trials which compared fragrance from plants in an intervention defined as aromatherapy for people with dementia with placebo aromatherapy or with treatment as usual. All doses, frequencies and fragrances of aromatherapy were considered. Participants in the included studies had a diagnosis of dementia of any subtype and severity.
The investigators included 13 studies with 708 participants. All participants had dementia and in the 12 trials which described the setting, all were resident in institutional care facilities. Nine trials recruited participants because they had significant agitation or other behavioural and psychological symptoms in dementia (BPSD) at baseline. The fragrances used were:
- lavender (eight studies);
- lemon balm (four studies);
- lavender and lemon balm,
- lavender and orange,
- cedar extracts (one study each).
For six trials, assessment of risk of bias and extraction of results was hampered by poor reporting. Four of the other seven trials were at low risk of bias in all domains, but all were small (range 18 to 186 participants; median 66). The primary outcomes were:
- overall behavioural,
- psychological symptoms,
- adverse effects.
Ten trials assessed agitation using various scales. Among the 5 trials for which the confidence in the results was moderate or low, 4 trials reported no significant effect on agitation and one trial reported a significant benefit of aromatherapy. The other 5 trials either reported no useable data or the confidence in the results was very low. Eight trials assessed overall BPSD using the Neuropsychiatric Inventory and there was moderate or low confidence in the results of 5 of them. Of these, 4 reported significant benefit from aromatherapy and one reported no significant effect.
Adverse events were poorly reported or not reported at all in most trials. No more than two trials assessed each of our secondary outcomes of quality of life, mood, sleep, activities of daily living, caregiver burden. There was no evidence of benefit on these outcomes. Three trials assessed cognition: one did not report any data and the other two trials reported no significant effect of aromatherapy on cognition. The confidence in the results of these studies was low.
The authors reached the following conclusions: We have not found any convincing evidence that aromatherapy (or exposure to fragrant plant oils) is beneficial for people with dementia although there are many limitations to the data. Conduct or reporting problems in half of the included studies meant that they could not contribute to the conclusions. Results from the other studies were inconsistent. Harms were very poorly reported in the included studies. In order for clear conclusions to be drawn, better design and reporting and consistency of outcome measurement in future trials would be needed.
This is a thorough review. It makes many of the points that I so often make regarding SCAM research:
- too many of the primary studies are badly designed;
- too many of the primary studies are too small;
- too many of the primary studies are poorly reported;
- too many of the primary studies fail to mention adverse effects thus violating research ethics;
- too many of the primary studies are done by pseudo-scientists who use research for promotion rather than testing hypotheses.
It is time that SCAM researchers, ethic review boards, funders, editors and journal reviewers take these points into serious consideration – if only to avoid clinical research getting a bad reputation and losing the support of patients without which it cannot exist.
My new book has just been published. Allow me to try and whet your appetite by showing you the book’s introduction:
“There is no alternative medicine. There is only scientifically proven, evidence-based medicine supported by solid data or unproven medicine, for which scientific evidence is lacking.” These words of Fontanarosa and Lundberg were published 22 years ago. Today, they are as relevant as ever, particularly to the type of healthcare I often call ‘so-called alternative medicine’ (SCAM), and they certainly are relevant to chiropractic.
Invented more than 120 years ago by the magnetic healer DD Palmer, chiropractic has had a colourful history. It has now grown into one of the most popular of all SCAMs. Its general acceptance might give the impression that chiropractic, the art of adjusting by hand all subluxations of the three hundred articulations of the human skeletal frame, is solidly based on evidence. It is therefore easy to forget that a plethora of fundamental questions about chiropractic remain unanswered.
I wrote this book because I feel that the amount of misinformation on chiropractic is scandalous and demands a critical evaluation of the evidence. The book deals with many questions that consumers often ask:
- How well-established is chiropractic?
- What treatments do chiropractors use?
- What conditions do they treat?
- What claims do they make?
- Are their assumptions reasonable?
- Are chiropractic spinal manipulations effective?
- Are these manipulations safe?
- Do chiropractors behave professionally and ethically?
Am I up to this task, and can you trust my assessments? These are justified questions; let me try to answer them by giving you a brief summary of my professional background.
I grew up in Germany where SCAM is hugely popular. I studied medicine and, as a young doctor, was enthusiastic about SCAM. After several years in basic research, I returned to clinical medicine, became professor of rehabilitation medicine first in Hanover, Germany, and then in Vienna, Austria. In 1993, I was appointed as Chair in Complementary Medicine at the University of Exeter. In this capacity, I built up a multidisciplinary team of scientists conducting research into all sorts of SCAM with one focus on chiropractic. I retired in 2012 and am now an emeritus professor. I have published many peer-reviewed articles on the subject, and I have no conflicts of interest. If my long career has taught me anything, it is this: in the best interest of consumers and patients, we must insist on sound evidence; not opinion, not wishful thinking; evidence.
In critically assessing the issues related to chiropractic, I am guided by the most reliable and up-to-date scientific evidence. The conclusions I reach often suggest that chiropractic is not what it is often cracked up to be. Hundreds of books have been published that disagree. If you are in doubt who to trust, the promoter or the critic of chiropractic, I suggest you ask yourself a simple question: who is more likely to provide impartial information, the chiropractor who makes a living by his trade, or the academic who has researched the subject for the last 30 years?
This book offers an easy to understand, concise and dependable evaluation of chiropractic. It enables you to make up your own mind. I want you to take therapeutic decisions that are reasonable and based on solid evidence. My book should empower you to do just that.
In my never-ending search for novel so-called alternative medicines (SCAMs) I came across WATSU. If you had never heard of WATSU, you are in good company (for instance mine). WATSU (water and shiatsu) is a form of passive hydrotherapy in chest-deep thermoneutral water. It was created in the early 1980s by the California-based Shiatsu teacher Harold Dull and combines elements of myofascial stretching, joint mobilization, massage, and shiatsu and is used to address physical and mental issues.
To me, this sounds as though an old physiotherapeutic approach has been re-vamped in order to seem more attractive to the affluent sections of the SCAM brigade. My suspicion seems to be confirmed by SCAM ueber-guru Dr Andrew Weil’s comments:
Dr. Weil has received the therapy many times and often recommends it.
While other bodywork modalities are based on touch in a stationary, two-dimensional world, Watsu offers a different experience. A three-dimensional environment, nearly free from gravity, within a warm and comforting fluid-space and the opportunity to connect with another person all have obvious therapeutic potential.
Achieving states of deep relaxation combined with the therapeutic benefits of good massage therapy can be of great benefit in controlling pain, relieving stress, and recovering from emotional and physical trauma.
But never mind the one-dimensional Dr Weil. The question is: does WATSU work? According to a recent paper, it is effective for a wide range of conditions.
The objective of this systematic review and meta-analyses was to assess the applications, indications, and the effects of WATSU to form a basis for further studies.
Literature searches for “WATSU OR watershiatsu OR (water AND shiatsu)” were conducted without any restrictions in 32 databases. Peer reviewed original articles addressing WATSU as a stand-alone hydrotherapy were assessed for risk of bias. Quantitative data of effects on pain, physical function, and mental issues were processed in random model meta-analyses with subgroup analyses by study design.
Of 1,906 unique citations, 27 articles regardless of study design were assessed for risk of bias. WATSU has been applied to individuals of all ages. Indications covered acute (e.g. pregnancy related low back pain) and chronic conditions (e.g. cerebral palsy) with beneficial effects of WATSU regarding e.g. relaxation or sleep quality. Meta-analyses suggest beneficial effect sizes of WATSU on pain, physical function, and mental issues.
The authors concluded that various applications, indications and beneficial effects of WATSU were identified. The grade of this evidence is estimated to be low to moderate at the best. To strengthen the findings of this study, high-quality RCTs are needed.
Of the 27 studies included in this review, most were case-reports or case series, and only 5 were RCTs. Of these RCTs, none was robust. Some, for instance compared WATSU against no treatment at all, thus not controlling for placebo effects. All of these RCTs had small sample sizes, and all had been published in odd journals of dubious repute.
So, is it justified to categorically conclude that beneficial effects of WATSU were identified?
No, I don’t think so.
That physiotherapy in water can have positive effects on some symptoms would hardly be surprising. But, to convince people who think more critically than Dr Weil, better evidence would be needed.
Spinal epidural haematoma (SEH) is an uncommon but serious emergency condition. A team of emergency physicians reported the case of a SEH associated with traditional massage initially presenting with delayed lower paraplegia.
A 20-year-old man was seen with bilateral lower extremity weakness and numbness, symptoms that had started three hours prior to presentation. He had received a Thai massage by a friend three days before. Magnetic resonance imaging revealed a spinal epidural lesion suspicious for haematoma extending from C6 to T2 levels. Emergent surgical intervention for cord decompression was performed. An epidural haematoma with cord compression at C6-T2 levels was identified intra-operatively. No evidence of abnormal vascular flow or AV malformations was identified. The authors concluded that, similar to chiropractic manipulation, massage may be associated with spinal trauma. Emergency physicians must maintain a high index of suspicion for spinal epidural haematomas in patients with a history of massage or chiropractic manipulation with neurologic complaints, because delays in diagnosis may worsen clinical outcome.
Thai massage therapists typically use no lubricants. The patient remains clothed during a treatment. There is constant body contact between the therapist – who, in the above case, was a lay person – and the patient.
The authors of this case report rightly stress that such adverse events are rare – but they are by no means unknown. In 2003, I reviewed the risks and found 16 reports of adverse effects as well as 4 case series on the subject (like for all other manual therapies, there is no reporting system of adverse effects). The majority of adverse effects were – like the above case – associated with exotic types of manual massage or massage delivered by laymen. Professionally trained massage therapists were rarely implicated. The reported adverse events include cerebrovascular accidents, displacement of a ureteral stent, embolization of a kidney, haematoma, leg ulcers, nerve damage, posterior interosseous syndrome, pseudoaneurism, pulmonary embolism, ruptured uterus, strangulation of neck, thyrotoxicosis and various pain syndromes. In the majority of these instances, there was little doubt about a cause-effect relationship. Serious adverse effects were associated mostly with massage techniques other than ‘Swedish’ massage.
For patients, this means that massage is still amongst the safest form of manual therapy (best to employ qualified therapists and avoid the exotic versions of massage because they are not supported by evidence and carry the highest risks). For doctors, it means to be vigilant, if patients present with neurological problems after having enjoyed a massage.
Back pain is a huge problem: it affects many people, causes much suffering and leads to extraordinary high cost for all of us. Considering these facts, it would be excellent to identify a treatment that truly works. However, at present, we do not have found the ideal therapy; instead we have dozens of different approaches that are similarly effective/ineffective. Two of these therapies are massage and acupuncture.
Is one better than the other?
This study compared the efficacy of classical massage (KMT, n = 66) with acupuncture therapy (AKU, n = 66) in patients with chronic back pain. The primary endpoint was the non-inferiority of classical massage compared with the acupuncture treatment in respect of the impairment in everyday life, with the help of the Hannover function questionnaire (HFAQ) and the reduction in pain (“Von Korff”-Questionnaire) at the follow-up after one month.
In the per-protocol analysis during the period between enrollment in the study and follow-up, the responder rate of the KMT was 56.5% and thus tended to be inferior to the responder rate of the AKU with 62.5% (Δ = - 6%; KIΔ: - 23.5 to + 11.4%).
The authors concluded that classical massage therapy is not significantly inferior to acupuncture therapy in the period from admission to follow-up. Thus, the non-inferiority of the KMT to the AKU cannot be proven in the context of the defined irrelevance area.
I find such studies oddly useless.
To conduct a controlled trial, one needs an experimental treatment (the therapy that is not understood) and compare it with an intervention that is understood (such as a placebo that has no specific effects, or a treatment that has been shown to work). In comparative studies like the one above, one compares one unknown with another unknown. I do not see how such a comparison can ever produce a meaningful result.
In a way, it is like an equation with two unknowns: x + 5 = y. It is simply not possible to define either x nor y, and the equation is unsolvable.
For comparative studies of two back-pain treatments to make sense, we would need one of which the effect size is well-established. I do not think that we currently have identified such a therapy. Certainly, we cannot say that we know it for massage or acupuncture.
In other words, comparative studies like the one above are a waste of resources that cannot possibly make a meaningful contribution to our knowledge.
To put it even more bluntly: we ought to stop such pseudo-research.
In this RCT tested the effectiveness of foot reflexology and slow stroke back massage on the severity of fatigue in 52 patients treated with hemodialysis. Foot massage and slow stroke back massage were performed during three weeks, two sessions each week, 5 sessions in total. At the end of intervention, data of two groups were collected and compared.
The results show that the fatigue in the group receiving foot reflexology massage decreased significantly more compared to slow stroke back massage group.
The authors concluded that reflexology massage is a safe and economical nursing intervention for decreasing fatigue in hemodialysis patients.
At first glance, this might be a fairly straight forward study comparing two different interventions. One treatment yields better results than the other one, and therefore, this therapy is deemed to be the more effective one.
So far, so good.
The problem is, however, that the authors did not draw the conclusion. Instead they stated that:
- Reflexology is safe.
- Reflexology is economical.
The first point is perhaps true but cannot be concluded from the data presented. Adverse effects were not mentioned; and even if they had been noted, 52 patients is a wholly inadequate size to say anything about safety.
The second point might also be correct, but cannot be named as a conclusion, because the study was not a cost evaluation.
All of this would be hardly worth mentioning – except for the fact that such sloppy errors and illogical conclusions happen with such embarrassing regularity in the realm of alternative medicine. I feel strongly that the ‘Journal of Complementary and Integrative Medicine‘ and all similar publications must get their act together. Publishing articles such as the one discussed here only makes them the laughing stock of real scientists.
The authors of this paper wanted to establish and compare the effectiveness of Healing Touch (HT) and Oncology Massage (OM) therapies on cancer patients’ pain. They conducted pre-test/post-test, observational, retrospective study. A total of 572 outpatient oncology were recruited and asked to report pain before and after receiving a single session of either HT or OM from a certified practitioner.
Both HT and OM significantly reduced pain. Unadjusted rates of clinically significant pain improvement (defined as ≥2-point reduction in pain score) were 0.68 HT and 0.71 OM. Adjusted for pre-therapy pain, OM was associated with increased odds of pain improvement. For patients with severe pre-therapy pain, OM was not more effective in yielding clinically significant pain reduction when adjusting for pre-therapy pain score.
The authors concluded that both HT and OM provided immediate pain relief. Future research should explore the duration of pain relief, patient attitudes about HT compared with OM, and how this may differ among patients with varied pretherapy pain levels.
This paper made me laugh out loud; no, not because of the ‘certified’ practitioners (in the UK, we use this term to indicate that someone is not quite sane), but because of the admission that the authors aimed at establishing the effectiveness of their therapies. Most researchers of alternative medicine have exactly this motivation, but few make the mistake to write it into the abstract of their papers. Little do they know that this admission discloses a fatal amount of bias. Science is supposed to test hypotheses, and researchers who aim at establishing the effectiveness of their pet-therapy oust themselves as pseudo-researchers.
It comes therefore as no surprise that the study turns out to be a pseudo-study. As there was no adequate control group, these outcomes cannot be attributed to the interventions administered. The results could therefore be due to:
- the time that has passed;
- regression to the mean;
- the attention provided by the therapists;
- the expectation of the patient;
- social desirability;
- all of the above.
It follows that – just as with the study discussed in the previous post – the conclusion is wholly misleading. In fact, the data are consistent with the hypothesis that HT and OM both aggravated the pain (the results might have been better without HT and OM). The devils advocate concludes that both HT and OM provided an immediate increase in pain.