Charles has a well-documented weakness for so-called alternative medicine (SCAM) – not just any SCAM but predominantly the type of SCAM that is both implausible and ineffective. Therefore, nobody can be all that surprised to read in THE TIMES that he has decided to use SCAM for helping women who have difficulties getting pregnant.
If one really wanted to employ SCAM for this aim one is spoilt for choice. In fact, there are only few SCAMs that don’t claim to be useful for this purpose.
A recent review, for instance, suggested that some supplements might be helpful. Other authors advocate SCAMs such as acupuncture, moxibustion, Chinese herbal medicine, psychological intervention, biosimilar electrical stimulation, homeopathy, or hyperbaric oxygen therapy.
Yes, I know! The evidence for these treatments is lousy, and I would never issue a recommendation based on such flimsy evidence.
Yet, the SCAM project at Dumfries House, the Scottish stately home Charles restored in 2007, offers acupuncture, reflexology, massage, yoga, and hypnotherapy for infertile women.
Reflexology, also called zone therapy, is a manual treatment where pressure is applied usually to the sole of the patient’s foot and sometimes also to other areas such as the hands or ears. According to its proponents, foot reflexology is more than a simple foot massage that makes no therapeutic claims beyond relaxation. It is based on the idea that the human body is divided into 10 zones each of which is represented on the sole of the foot. Reflexologists employ maps of the sole of the foot where the body’s organs are depicted. By massaging specific zones which are assumed to be connected to specific organs, reflexologists believe to positively influence the function of these organs. While reflexology is mostly used as a therapy, some therapists also claim they can diagnose health problems through feeling tender or gritty areas on the sole of the foot which, they claim, correspond to specific organs.
Reflexology is not merely implausible as a treatment for infertility, it also boasts of some fairly rigorous trial evidence. A clinical trial (perhaps even the most rigorous of all the trials of SCAM for female fertility problems) testing whether foot reflexology might have a positive effect on the induction of ovulation stated that “the results suggest that any effect on ovulation would not be clinically relevant”.
So, as so often before in the realm of SCAM, Charles has demonstrated that his lack of critical thinking leads him to the least promising options.
Well done, Your Majesty!
This study investigated the potential benefits of auricular point acupressure on cerebrovascular function and stroke prevention among adults with a high risk of stroke.
A randomized controlled study was performed with 105 adults at high risk for stroke between March and July 2021. Participants were randomly allocated to receive either
- auricular point acupressure with basic lifestyle interventions (n = 53) or
- basic lifestyle interventions alone (n = 52) for 2 weeks.
The primary outcome was the kinematic and dynamic indices of cerebrovascular function, as well as the CVHP score at week 2, measured by the Doppler ultrasonography and pressure transducer on carotids.
Of the 105 patients, 86 finished the study. At week 2, the auricular point acupressure therapy with lifestyle intervention group had higher kinematic indices, cerebrovascular hemodynamic parameters score, and lower dynamic indices than the lifestyle intervention group.
The authors concluded that ccerebrovascular function and cerebrovascular hemodynamic parameters score were greater improved among the participants undergoing auricular point acupressure combined with lifestyle interventions than lifestyle interventions alone. Hence, the auricular point acupressure can assist the stroke prevention.
Acupuncture is a doubtful therapy.
Acupressure is even more questionable.
Ear acupressure is outright implausible.
The authors discuss that the physiological mechanism underlying the effect of APA therapy on cerebrovascular hemodynamic function is not fully understood at present. There may be two possible explanations.
- First, a previous study has demonstrated that auricular acupuncture can directly increase mean blood flow velocity in the middle cerebral artery.
- Second, cerebrovascular hemodynamic function is indirectly influenced by the effect of APA therapy on blood pressure.
I think there is a much simpler explanation: the observed effects are directly or indirectly due to placebo. As regular listeners of this blog know only too well by now, the A+B versus B study design cannot account for placebo effects. Sadly, the authors of this study hardly discuss this explanation – that’s why they had to publish their findings in just about the worst SCAM journal of them all: EBCAM.
The Sunday Times reported yesterday reported that five NHS trusts currently offer moxibustion to women in childbirth for breech babies, i.e. babies presenting upside down. Moxibustion is a form of Traditional Chinese Medicine (TCM) where mugwort is burned close to acupuncture points. The idea is that this procedure would stimulate the acupuncture point similar to the more common way using needle insertion. The fifth toe is viewed as the best traditional acupuncture point for breech presentation, and the treatment is said to turn the baby in the uterus so that it can be delivered more easily.
At least four NHS trusts are offering acupuncture and reflexology with aromatherapy to help women with delayed pregnancies, while 15 NHS trusts offer hypnobirthing classes. Some women are asked to pay fees of up to £140 for it. These treatments are supposed to relax the mother in the hope that this will speed up the process of childbirth.
The Nice guidelines on maternity care say the NHS should not offer acupuncture, acupressure, or hypnosis unless specifically requested by women. The reason for the Nice warning is simple: there is no convincing evidence that these therapies are effective.
Campaigner Catherine Roy who compiled the list of treatments said: “To one degree or another, the Royal College of Midwives, the Care Quality Commission and parts of the NHS support these pseudoscientific treatments.
“They are seen as innocuous but they carry risks, can delay medical help and participate in an anti-medicalisation stance specific to ‘normal birth’ ideology and maternity care. Nice guidelines are clear that they should not be offered by clinicians for treatment. NHS England must ensure that pseudoscience and non-evidence based treatments are removed from NHS maternity care.”
Birte Harlev-Lam, executive director of the Royal College of Midwives (RCM), said: “We want every woman to have as positive an experience during pregnancy, labour, birth and the postnatal period as possible — and, most importantly, we want that experience to be safe. That is why we recommend all maternity services to follow Nice guidance and for midwives to practise in line with the code set out by the Nursing and Midwifery Council.”
A spokeswoman for Nice said it was reviewing its maternity guidelines. NHS national clinical director for maternity and women’s health, Dr Matthew Jolly, said: “All NHS services are expected to offer safe and personalised clinical care and local NHS areas should commission core maternity services using the latest NICE and clinical guidance. NHS trusts are under no obligation to provide complementary or alternative therapies on top of evidence-based clinical care, but where they do in response to the wishes of mothers it is vital that the highest standards of safety are maintained.”
On this blog, we have repeatedly discussed the strange love affair of midwives with so-called alternative medicine (SCAM), for instance, here. In 2012, we published a summary of 19 surveys on the subject. It showed that the prevalence of SCAM use varied but was often close to 100%. Much of it did not seem to be supported by strong evidence for efficacy. We concluded that most midwives seem to use SCAM. As not all SCAMs are without risks, the issue should be debated openly. Today, there is plenty more evidence to show that the advice of midwives regarding SCAM is not just not evidence-based but also often dangerous. This, of course, begs the question: when will the professional organizations of midwifery do something about it?
In so-called alternative medicine (SCAM) we have an amazing number of ‘discoveries’ which – IF TRUE – should have changed the world. Here I list of 10 of my favorites:
- Diluting and shaking a substance makes it not weaker but stronger.
Homeopaths call this process ‘potentisation’. They use it to produce highly ‘potent’ remedies that contain not a single molecule of the original substance. The assumption is that potentisation transfers energy or information. Therefore, they claim, molecules are no longer required for achieving a clinical effect.
2. A substance that causes a certain symptom in a healthy person can be used to cure that symptom when it occurs in a patient.
The ‘like cures like’ principle of homeopathy is based on the notion that the similimum provokes an artificial disease which in turn defeats the condition the patient is suffering from.
3. Subluxations of the spine are the cause of most diseases that affect us humans.
DD Palmer, the inventor of chiropractic, insisted that almost all diseases are due to subluxations. These misplaced vertebrae, he claimed, are the root cause of any disease by inhibiting the flow of the ‘innate’ which in turn caused ill health.
4. Adjusting such subluxations is the best way to restore health.
Palmer, therefore, was sure that only adjustments of these subluxations were able to restore health. All other medical interventions were useless or even dangerous, in his view. Thus Palmer opposed medicines or vaccinations.
5. An imbalance of two life forces is the cause of all illnesses.
Practitioners of TCM believe that all illnesses originate from an energetic imbalance. Harmony between the two life forces ‘yin and yang’ means health.
6. Balance can be restored by puncturing the skin at specific points.
Acupuncturists are convinced that their needling is nothing less than attacking the root cause of his or her problem. Therefore, they are convinced that acupuncture is a cure-all.
7. Our organs are represented in specific areas on the sole of our feet.
Reflexologists have maps of the sole of a foot where specific organs of the body are located. They palpate the foot and when they feel a gritty area, they conclude that the corresponding organ is in trouble.
8. Massaging these areas will positively influence the function of specific organs.
Once the diseased or endangered organ is identified, the area in question needs to be massaged until the grittiness disappears. This intervention, in turn, will have a positive influence on the organ in question.
9. Healing energy can be sent into our body where it stimulates the self-healing process and restores health.
Various types of energy healers are convinced that they can transmit energy that comes from a divine or other source into a patient’s body. The energy enables the body to heal itself. Thus, energy healing is a panacea and does not even require a proper diagnosis to be effective.
10. Toxins accumulate in our bodies and must be eliminated through a wide range of SCAMs.
The toxins in question can originate from within the body and/or from the outside. They accumulate and make us sick. Therefore, we need to eliminate them, and the best way to achieve this is to use this or that SCAM
I could, of course, list many more such ‘discoveries’ – SCAM is full of them. They are all quite diverse but have one important thing in common: they are false (i.e. there is no good evidence for them and they fly in the face of science).
If they were true, they would have changed the world by revolutionizing science, physics, physiology, anatomy, pathology, therapeutics, etc.
ALL THESE UGLY FACTS DESTROYING SUCH BEAUTIFUL THEORIES!
WHAT A SHAME!!!
The objective of this systematic review was to assess 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. Randomised clinical 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 effect (AE). Secondary outcomes were the number of drop-outs. Dichotomous outcomes were analysed 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. Different manual treatments were provided:
- SM/chiropractic (7 studies, 567 participants).
- Osteopathy (5 trials, 645 participants).
- Kinesiology (1 trial, 58 participants).
- Articular mobilisations (6 trials, 445 participants).
- Muscular release (5 trials, 304 participants).
Very low evidence quality suggests clinically insignificant pain improvement in favour 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 being the most recognised 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).
Forest plot of comparison ST versus MT in back pain outcome at short term. MT, manual therapy; ST, sham treatment.
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.
Essentially these findings suggest that the effects patients experience after MT are not due to MT per see but to placebo effects. The review could be criticised because of the somewhat odd mix of MTs lumped together in one analysis. Yet, I think it is fair to point out that most of the studies were of chiropractic and osteopathy. Thus, this review implies that chiropractic and osteopathy are essentially placebo treatments.
The authors of the review also provide this further comment:
Similar findings were found in other reviews conducted on LBP. Ruddock et al included studies where SM was compared with what authors called ‘an effective ST’, namely a credible sham manipulation that physically mimics the SM. Pooled data from four trials showed a very small and not clinically meaningful effect in favour of MT.52
Rubinstein et al 53 compared SM and mobilisation techniques to recommended, non-recommended therapies and to ST. Their findings showed that 5/47 studies included attempted to blind patients to the assigned intervention by providing an ST. Of these five trials, two were judged at unclear risk of participants blinding. The authors also questioned the need for additional studies on this argument, as during the update of their review they found recent small pragmatic studies with high risk of bias. We agree with Rubinstein et al that recent studies included in this review did not show a higher quality of evidence. The development of RCT with similar characteristic will probably not add any proof of evidence on MT and ST effectiveness.53
If we agree that chiropractic and osteopathy are placebo therapies, we might ask whether they should have a place in the management of BP. Considering the considerable risks associated with them, I feel that the answer is obvious and simple:
Reflexology (originally called ‘zone therapy’ by its inventor) is a manual technique where pressure is applied to the sole of the patient’s foot. Reflexology is said to have its roots in ancient cultures. Its current popularity goes back to the US doctor William Fitzgerald (1872-1942) who did some research in the early 1900s and thought to have discovered that the human body is divided into 10 zones each of which is represented on the sole of the foot. Reflexologists thus drew maps of the sole of the foot where all the body’s organs are depicted. Numerous such maps have been published and, embarrassingly, they do not all agree with each other as to the location of our organs on the sole of our feet. By massaging specific zones which are assumed to be connected to specific organs, reflexologists believe to positively influence the function of these organs.
So, does reflexology do more good than harm?
The aim of this review was to conduct a systematic review, meta-analysis, and metaregression to determine the current best available evidence of the efficacy and safety of foot reflexology for adult depression, anxiety, and sleep quality.
Twenty-six studies could be included. The meta-analyses showed that foot reflexology intervention significantly improved adult depression, anxiety, and sleep quality. Metaregression revealed that an increase in total foot reflexology time and duration can significantly improve sleep quality.
The authors concluded that foot reflexology may provide additional nonpharmacotherapy intervention for adults suffering from depression, anxiety, or sleep disturbance. However, high quality and rigorous design RCTs in specific population, along with an increase in participants, and a long-term follow-up are recommended in the future.
Finally a so-called alternative medicine (SCAM) that is backed by soild evidence!
Or perhaps not?
Here are a few concerns that lead me to doubt these conclusions:
- Most of the primary studies were of poor methodological quality.
- Most studies failed to mention adverse effects.
- Very few studies controlled for placebo effects.
- There was evidence of publication bias (negative studies tended to remain unpublished).
- Studies published in languages other than English were not considered.
- The authors fail to point out that a foot massage is, of course, agreeable (and thus may relieve a range of symptoms), but reflexology with all its weird assumptions is less than plausible.
- Many of the studies located by the authors were excluded for reasons that are less than clear.
The last point seems particularly puzzling. Our own trial, for instance, was excluded because, according to the review authors, it did not include relevant outcomes. However, our method secion makes it clear that the primary focus for this study was the subscores for anxiety and depression, which comprise four and seven items, respectively. As it happens, our study was negative.
Also cuirous is the fact that the authors did not mention our own 2011 systematic review of reflexology:
Reflexology is a popular form of complementary and alternative medicine (CAM). The aim of this update is to critically evaluate the evidence for or against the effectiveness of reflexology in patients with any type of medical condition. Six electronic databases were searched to identify all relevant randomised clinical trials (RCTs). Their methodological quality was assessed independently by the two reviewers using the Jadad score. Overall, 23 studies met all inclusion criteria. They related to a wide range of medical conditions. The methodological quality of the RCTs was often poor. Nine high quality RCTs generated negative findings; and five generated positive findings. Eight RCTs suggested that reflexology is effective for the following conditions: diabetes, premenstrual syndrome, cancer patients, multiple sclerosis, symptomatic idiopathic detrusor over-activity and dementia yet important caveats remain. It is concluded that the best clinical evidence does not demonstrate convincingly reflexology to be an effective treatment for any medical condition.
I wonder why!
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 study investigated the effects of reflexology and homeopathy as an addition to conventional treatment on different markers of airway inflammation in asthma. Eighty-four patients with asthma were randomized to receive one to three different treatments:
- conventional treatment alone,
- conventional treatment with addition of homeopathy,
- conventional treatment plus reflexology.
The study was a single centre, investigator-blinded, controlled trial with a treatment period of one year.
During the study period, patients regularly consulted their general practitioner for evaluation and asthma treatment. At randomization, and after 6 and 12 months, methacholine challenge test and measurement of exhaled nitric oxide were performed. Blood samples were collected for eosinophil count and measurement of serum eosinophil cationic protein.
No significant differences were found between groups for any of the inflammatory markers were demonstrated. Methacholine responsiveness improved in all three groups but improvements were not statistically significant within and between groups.
The authors concluded that this randomized controlled study of reflexology and homeopathy failed to show significant improvement on selected markers of inflammation and airway hyperresponsiveness in asthma.
I would argue that the results imply that homeopathy and reflexology are not merely ineffective but have negative effects on the outcome. As this trial followed the infamous ‘A+B versus B’ design, one would have expected that the two add on treatments generate a placebo response – at least in terms of subjective endpoints. The only such measure is the medication use in this particular trial; it showed no inter-group differences. To me, this implies that homeopathy and reflexology might have generated slightly detrimental effects on subjective outcomes.
Ah yes, do I hear the fans of so-called alternative medicine (SCAM) claim that this study must have been conducted by the enemies of SCAM in order to defame it? For them, this acknowledgement might be enlightening:
This study was supported by The Knowledge and Research Centre for Alternative Medicine, Denmark. The authors thank registered homeopath Anne Hammer Langgaard for homeopathic treatments, registered reflexologists Pia Løbner Jeppesen and Pia Stolarzcyk for reflexology treatments, Pia Pedersen for secretarial assistance and randomization procedure, laboratory technician Anne-Marie Toft for handling blood samples, specialist nurses Anne Dorte Vindelev Kristensen and Jytte Møller Kjemtrup for help with clinical procedures.
As reported previously the NHS NATURAL HEALTH SCHOOL in Harrogate, is a service that offered a range of free complementary therapy treatments to patients and their relatives who are affected by a cancer diagnosis and are either receiving their cancer treatment at Harrogate or live in the Harrogate and Rural District.
This NHS school offered alternative treatments to cancer patients and claim that they know from experience, that when Complementary Therapies are integrated into patient care we are able to deliver safe, high quality care which fulfils the needs of even the most complex of patients.
In addition, they also ran courses for alternative practitioners. Their reflexology course, for instance, covered all of the following:
- Explore the history and origins of Reflexology
- Explore the use of various mediums used in treatment including waxes, balms, powders and oils
- Explore the philosophy of holism and its role within western bio medicine
- Reading the feet/hands and mapping the reflex points
- Relevant anatomy, physiology and pathology
- Managing a wide range of conditions
- Legal implications
- Cautions and contraindications
- Assessment and client care
- Practical reflexology skills and routines
- Treatment planning
I imagine that the initiators of the school are full of the very best, altruistic intentions. I therefore had considerable difficulties in criticising them. Yet, I do strongly feel that the NHS should be based on good evidence; and that much of the school’s offerings seemed to be the exact opposite. In fact, the NHS-label was being abused for giving undeserved credibility to outright quackery.
Therefore, I did something I do rarely: I filed an official complaint in September 2019.
What happened next?
I sent several reminders; and what happened then?
I got several assurances that a response was imminent.
And then I forgot all about it.
So, I was surprised to receive this email yesterday from the chief executive of the HARROGATE AND DISTRICT NHS FOUNDATION TRUST (I did not change or correct anything):
Thank you for contacting our Chair about the Natural Health School and my apologies for the extended delay in replying to you. We have reflected on the points you raised and I have set out a summary of this below in respect of the key issues.
- As a result of colleagues who set up the service having moved on to other posts outside of the Trust we have not been able to understand how the service was named. However, I agree that the terminology “NHS Natural Health School” could be interpreted in a certain way and as such we have agreed it should instead be referred to as the Natural Health School only to avoid any interpretation that it has national NHS endorsement. We will amend the information on the website and other material to reflect that the service is endorsed by the Trust.
- The service is hosted by HDFT, in that staff are employed by the Trust, but it is funded through charitable contributions. No NHS resources are used in providing the school, or the complementary therapies which are provided to patients receiving treatment at the Sir Robert Ogden Centre.
- There is no intention to assert that the services provided (ie the complementary therapies) are treatment for cancer. The ‘treatments’ referred to are complementary therapy treatments and are described as such. They are focused on wellbeing concurrently to the medical treatment of cancer, and we are satisfied that this is clear in the current description.
- Whilst recognising the differences of views on the complementary therapy treatments, the service regularly secures feedback from patients and this has been positive and as such we continue to offer it to those patients who would wish to take it up.
- The school provides training to allow participants to achieve a qualification which is awarded at level 3 by the International Therapies Examination Council.
I hope this provides clarity on the context to the service.
… … …
I find this response more than a little unsatisfactory; here are just a few points I find worth mentioning:
- As far as I can see, apart of the actual name of the school (it is now called ‘NATURAL HEALTH SCHOOL’), very little has changed. In particular, a NHS link is still implied in multiple different ways.
- To claim that ‘we have not been able to understand how the service was named’ seems like someone is taking the Mikey.
- So is the remark that ‘the terminology “NHS Natural Health School” could be interpreted in a certain way’.
- The statement ‘there is no intention to assert that the services provided (ie the complementary therapies) are treatment for cancer’ is simply untrue; symptomatic treatment of cancer is still a treatment for cancer!
- If the treatments are focussed on wellbeing, they nevertheless should be backed by evidence to show that they improve wellbeing. The label ‘complementary’ does not absolve a therapy from the need to be evidence-based.
- There may be ‘different views’ on complementary therapies; yet, there is only one set of evidence – and that fails to support several of the treatments on offer.
- Positive feedback from patients is no substitute for evidence.
I am not sure whether I should reply to the above letter. I take little pleasure in embarrassing chief excecutives.
WHAT DO YOU THINK I SHOULD DO?