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

systematic review

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Many forms of so-called alternative medicine (SCAM) involve touch, and touch is of critical importance: many studies have shown that it promotes mental and physical well-being.

A team of researchers conducted a pre-registered (PROSPERO: CRD42022304281) systematic review and multilevel meta-analysis encompassing 137 studies in the meta-analysis and 75 additional studies in the systematic review (n = 12,966 individuals, search via Google Scholar, PubMed and Web of Science until 1 October 2022) to identify critical factors moderating touch intervention efficacy.

Included studies always featured a touch versus no touch control intervention with diverse health outcomes as dependent variables. Risk of bias was assessed via small study, randomization, sequencing, performance and attrition bias.

The results show that touch interventions were especially effective in:

  • regulating cortisol levels (Hedges’ g = 0.78, 95% confidence interval (CI) 0.24 to 1.31),
  • increasing weight (0.65, 95% CI 0.37 to 0.94) in newborns,
  • reducing pain (0.69, 95% CI 0.48 to 0.89),
  • reducing feelings of depression (0.59, 95% CI 0.40 to 0.78),
  • reducing state (0.64, 95% CI 0.44 to 0.84) or trait anxiety (0.59, 95% CI 0.40 to 0.77) for adults.

Comparing touch interventions involving objects or robots resulted in similar physical (0.56, 95% CI 0.24 to 0.88 versus 0.51, 95% CI 0.38 to 0.64) but lower mental health benefits (0.34, 95% CI 0.19 to 0.49 versus 0.58, 95% CI 0.43 to 0.73). Adult clinical cohorts profited more strongly in mental health domains compared with healthy individuals (0.63, 95% CI 0.46 to 0.80 versus 0.37, 95% CI 0.20 to 0.55).

The authors found no difference in health benefits in adults when comparing touch applied by a familiar person or a health care professional (0.51, 95% CI 0.29 to 0.73 versus 0.50, 95% CI 0.38 to 0.61), but parental touch was more beneficial in newborns (0.69, 95% CI 0.50 to 0.88 versus 0.39, 95% CI 0.18 to 0.61). Small but significant small study bias and the impossibility to blind experimental conditions need to be considered.

The authors concluded that leveraging factors that influence touch intervention efficacy will help maximize the benefits of future interventions and focus research in this field.

It seems obvious to me that these findings are relevant to several SCAMs, e.g.:

  • acupuncture,
  • Alexander technique,
  • applied kinesiology,
  • aromatherapy,
  • Bowen technique,
  • chiropractic,
  • craniosacral therapy,
  • cupping,
  • Dorn method,
  • Feldenkrais method,
  • gua sha,
  • kinesiology taping,
  • lymph drainage,
  • massage in all its variations,
  • naprapathy,
  • osteopathy,
  • rebirthing,
  • reflexology,
  • Rolfing,
  • shiatsu,
  • slapping therapy,
  • therapeutic touch.

This also means that the effects of these SCAMs will be at least to some extend non-specific, i.e. not related to the treatment per se but to touch. Finally, it means that clinical trials testing these SCAMs need to be designed such that the touch element is adequately accounted for.

This systematic review and meta-analysis investigated the effectiveness and safety of manual therapy (MT) interventions compared to oral or topical pain medications in the management of neck pain.
The investigators searched from inception to March 2023, in Cochrane Central Register of Controller Trials (CENTRAL), MEDLINE, EMBASE, Allied and Complementary Medicine (AMED) and Cumulative Index to Nursing and Allied Health Literature (CINAHL; EBSCO) for randomized controlled trials that examined the effect of manual therapy interventions for neck pain when compared to oral or topical medication in adults with self-reported neck pain, irrespective of radicular findings, specific cause, and associated cervicogenic headaches. Trials with usual care arms were also included if they prescribed medication as part of the usual care and they did not include a manual therapy component. The authors used the Cochrane Risk of Bias 2 tool to assess the potential risk of bias in the included studies, and the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) approach to grade the quality of the evidence.

Nine trials  with a total of 779 participants were included in the meta-analysis.

  • low certainty of evidence was found that MT interventions may be more effective than oral pain medication in pain reduction in the short-term (Standardized Mean Difference: -0.39; 95% CI -0.66 to -0.11; 8 trials, 676 participants),
  • moderate certainty of evidence was found that MT interventions may be more effective than oral pain medication in pain reduction in the long-term (Standardized Mean Difference: −0.36; 95% CI −0.55 to −0.17; 6 trials, 567 participants),
  • low certainty evidence that the risk of adverse events may be lower for patients who received MT compared to the ones that received oral pain medication (Risk Ratio: 0.59; 95% CI 0.43 to 0.79; 5 trials, 426 participants).

The authors conluded that MT may be more effective for people with neck pain in both short and long-term with a better safety profile regarding adverse events when compared to patients receiving oral pain medications. However, we advise caution when interpreting our safety results due to the different level of reporting strategies in place for MT and medication-induced adverse events. Future MT trials should create and adhere to strict reporting strategies with regards to adverse events to help gain a better understanding on the nature of potential MT-induced adverse events and to ensure patient safety.

Let’s have a look at the primary studies. Here they are with their conclusions (and, where appropriate, my comments in capital letters):

  1. For participants with acute and subacute neck pain, spinal manipulative therapy (SMT) was more effective than medication in both the short and long term. However, a few instructional sessions of home exercise with (HEA) resulted in similar outcomes at most time points. EXERCISE WAS AS EFFECTIVE AS SMT
  2.  Oral ibuprofen (OI) pharmacologic treatment may reduce pain intensity and disability with respect to neural mobilization (MNNM and CLG) in patients with CP during six weeks. Nevertheless, the non-existence of between-groups ROM differences and possible OI adverse effects should be considered. MEDICATION WAS BETTER THAN MT
  3. It appears that both treatment strategies (usual care + MT vs usual care) can have equivalent positive influences on headache complaints. Additional studies with larger study populations are needed to draw firm conclusions. Recommendations to increase patient inflow in primary care trials, such as the use of an extended network of participating physicians and of clinical alert software applications, are discussed. MT DOES NOT IMPROVE OUTCOMES
  4. The consistency of the results provides, in spite of several discussed shortcomings of this pilot study, evidence that in patients with chronic spinal pain syndromes spinal manipulation, if not contraindicated, results in greater improvement than acupuncture and medicine. THIS IS A PILOT STUDY, A TRIAL TESTING FEASIBILITY, NOT EFFECTIVENESS
  5. The consistency of the results provides, despite some discussed shortcomings of this study, evidence that in patients with chronic spinal pain, manipulation, if not contraindicated, results in greater short-term improvement than acupuncture or medication. However, the data do not strongly support the use of only manipulation, only acupuncture, or only nonsteroidal antiinflammatory drugs for the treatment of chronic spinal pain. The results from this exploratory study need confirmation from future larger studies.
  6. In daily practice, manual therapy is a favorable treatment option for patients with neck pain compared with physical therapy or continued care by a general practitioner.
  7. Short-term results (at 7 weeks) have shown that MT speeded recovery compared with GP care and, to a lesser extent, also compared with PT. In the long-term, GP treatment and PT caught up with MT, and differences between the three treatment groups decreased and lost statistical significance at the 13-week and 52-week follow-up. MT IS NOT SUPERIOR [SAME TRIAL AS No 6]
  8. In this randomized clinical trial, for patients with chronic neck pain, Chuna manual therapy was more effective than usual care in terms of pain and functional recovery at 5 weeks and 1 year after randomization. These results support the need to consider recommending manual therapies as primary care treatments for chronic neck pain.
  9. In patients with chronic spinal pain syndromes, spinal manipulation, if not contraindicated, may be the only treatment modality of the assessed regimens that provides broad and significant long-term benefit. SAME TRIAL AS No 5
  10. An impairment-based manual physical therapy and exercise (MTE) program resulted in clinically and statistically significant short- and long-term improvements in pain, disability, and patient-perceived recovery in patients with mechanical neck pain when compared to a program comprising advice, a mobility exercise, and subtherapeutic ultrasound. THIS STUDY DID NOT TEST MT ALONE AND SHOULD NOT HAVE BEEN INCLUDED

I cannot bring myself to characterising this as an overall positive result for MT; anyone who can is guilty of wishful thinking, in my view. The small differences in favor of MT that (some of) the trials report have little to do with the effectiveness of MT itself. They are almost certainly due to the fact that none of these studies were placebo-controlled and double blind (even though this would clearly be possible). In contrast to popping a pill, MT involves extra attention, physical touch, empathy, etc. These factors easily suffice to bring about the small differences that some studies report.

It follows that the main conclusion of the authors of the review should be modified:

There is no compelling evidence to show that MT is more effective for people with neck pain in both short and long-term when compared to patients receiving oral pain medications.

 

This systematic review and meta-analysis aimed to evaluate the effectiveness of spiritually based interventions on blood pressure (BP) among adults. A systematic search was performed using the PubMed, Scopus, and Cochrane databases to identify studies evaluating spiritual interventions, including:

  • meditation,
  • transcendental meditation,
  • mindfulness meditation,
  • yoga,

for high BP among adults up to January 1, 2022.

The inclusion criteria were:

  • (a) randomized controlled trials (RCTs),
  • (b) studies in English or Persian,
  • (c) studies conducted among adults (≥ 18 years),
  • (d) studies reporting systolic or diastolic BP.

Given the high heterogeneity of these studies, a random effect model was used to calculate the effect sizes for the RCTs.

In total, the systematic review included 24 studies and the meta-analysis included 23 studies. As some of studies reported two or more outcome measurements, separate estimates of each outcome were extracted for that study (24 datasets). Fifteen trials reported the mean (SD) systolic blood pressure (SBP), and 13 trials reported the mean (SD) diastolic blood pressure (DBP). In addition, 13 studies reported means (SDs) and six trials reported mean changes in DBP. A significant decrease was found in systolic BP following intervention ((WMD (weighted mean difference) =  − 7.63 [− 9.61 to − 5.65; P < 0.001]). We observed significant heterogeneity among the studies (I2 = 96.9; P < 0.001). A significant decrease was observed in DBP following the interventions (WMD =  − 4.75 [− 6.45 to − 3.05; P < 0.001]).

The authors concluded that spiritually based interventions including meditation and yoga had beneficial effects in reducing both SBP and DBP. Reducing BP can be expected to reduce the risk of cardiovascular diseases.

Q: What do the RCTs of these interventions have in common?

A: They cannot normally be placebo-controlled because no adequate placebos exist for these therapies.

Q: What does that mean?

A: It means that patients could not be blinded and that patient expectations influenced the outcome.

In view of the fact that blood pressure is an endpoint that is extremely sensitive to expectation, I think, the conclusions of this paper might need to be re-formulated:

This analysis confirms that expectation can have beneficial effects in reducing both SBP and DBP. Reducing BP can be expected to reduce the risk of cardiovascular diseases.

‘WORLD HOMEOPATHY DAY’ is upon us and the Internet is awash with pro-homeopathy comments, e.g.:

  • World Homeopathy Day is observed annually on April 10th to commemorate the birth anniversary of Samuel Hahnemann, a prominent figure in the development of homeopathy. This day celebrates the principles and practices of homeopathy, an alternative medicinal approach that emphasizes treating ailments by utilizing natural substances and stimulating the body’s inherent healing abilities.
  • The theme for World Homeopathy Day 2024 is ‘Empowering Research, Enhancing Proficiency: A Homeopathy Symposium”. This theme underscores the significance of continuous research in homeopathy and the need to upgrade capability in its training to give better medical care results.

Even slightly less biased sources cannot bring themselves to a more realistic approach, e.g.:

The significance of the World Homeopathy Day is said to be as follows:

  • Raising Awareness: World Homeopathy Day has successfully brought homeopathy to the forefront of public attention, generating dialogue and interest in its principles and practices.
  • Bridging Communities: The Day serves as a platform for bringing together homeopaths, practitioners, researchers, and individuals interested in alternative medicine, fostering collaboration and knowledge exchange.
  • Focus on Education: World Homeopathy Day emphasizes the importance of education and ethical practices within the field, promoting responsible usage and informed choices for individuals seeking homeopathic care.

World Homeopathy Day is about understanding and exploring the potential of this alternative medicine system while keeping an open mind and prioritizing evidence-based healthcare practices.

So, let me try to counter-balance these texts by showing you what my recently published 7 key points about homeopathy tell us:

Homeopathy is popular, particularly in India, Germany, France and parts of South America. It was invented more than 200 years ago and still divides opinions like few other subjects in alternative medicine.

  1. Homeopathy was invented by the German physician, Samuel Hahnemann (1755–1843). At the time, our understanding of the laws of nature was woefully incomplete, and therefore Hahnemann’s ideas seemed less implausible than today. The conventional treatments of this period were often more dangerous than the disease they were supposed to cure. Consequently, homeopathy was repeatedly shown to be superior to ‘allopathy’ (a term coined by Hahnemann to denigrate conventional medicine) and Hahnemann’s treatments were an almost instant, worldwide success.[1]
  2. Many consumers confuse homeopathy with herbal medicine; yet the two are fundamentally different. Herbal medicines are plant extracts that contain potentially active ingredients. Homeopathic remedies are based on plants or any other material and they are typically so dilute that they contain not a single molecule of the substance advertised on the bottle. The most frequently used dilution (homeopaths call them ‘potencies’) is a ‘C30’; a C30-potency has been diluted 30 times at a ratio of 1:100. This means that one drop of the staring material is dissolved in 1 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 drops of diluent (usually a water/alcohol mixture)—and that equates to less than one molecule of the original substance per all the molecules of the universe.
  3. Homeopaths claim that their remedies work via some ‘energy’ or ‘vital force’ and that the process of preparing the homeopathic dilutions (it involves vigorous shaking the mixtures at each dilution step) transfers this ‘energy’ or information from one to the next dilution. They also believe that the process of diluting and agitating their remedies, which they call potentisation, renders them not less or not more potent. Homeopathic remedies are usually prescribed according to the ‘like cures like’ principle: if, for instance, a patient suffers from runny eyes, a homeopath might prescribe a remedy made of onion, because onion make a healthy person’s eyes water. This and all other assumptions of homeopathy contradict the known laws of nature. In other words, we do not fail to comprehend how homeopathy works, but we understand that it cannot work unless the known laws of nature are wrong.
  4. According to Hahnemann’s classical homeopathy, homeopaths are focussed on the symptoms and characteristics of the patient. They conduct a lengthy medical history, and they show little or no interest in a physical examination of their patient or other diagnostic procedures. Once they are confident to have all the information they need, they try to find the optimal homeopathic remedy. This is done by matching the symptoms with the drug pictures of homeopathic remedies. Any homeopathic drug picture is essentially based on what has been noted in homeopathic provings where healthy volunteers take a remedy and monitor all that symptoms, sensations and feelings they experience subsequently. Thus, the optimal homeopathic remedy can be seen as a diagnosis which makes homeopathy also a diagnostic method.[2]
  1. Today, around 500 clinical trials of homeopathy have been published. The totality of this evidence fails to show that homeopathic remedies are more than placebos.[3] Numerous official statements from various countries confirm the absurdity of homeopathy, for instance:
  • “The principles of homeopathy contradict known chemical, physical and biological laws and persuasive scientific trials proving its effectiveness are not available” (Russian Academy of Sciences, Russia)
  • “Homeopathy should not be used to treat health conditions that are chronic, serious, or could become serious. People who choose homeopathy may put their health at risk if they reject or delay treatments for which there is good evidence for safety and effectiveness.” (National Health and Medical Research Council, Australia)
  • “Homeopathic remedies don’t meet the criteria of evidence-based medicine.” (Hungarian Academy of Sciences, Hungary)
  • “The incorporation of anthroposophical and homeopathic products in the Swedish directive on medicinal products would run counter to several of the fundamental principles regarding medicinal products and evidence-based medicine.” (Swedish Academy of Sciences, Sweden)
  • “There is no good-quality evidence that homeopathy is effective as a treatment for any health condition” (National Health Service, England)
  1. Yet, many patients undeniably do get better after taking homeopathic remedies. The best evidence available today clearly shows that this improvement is unrelated to the homeopathic remedy per se. It is the result of a lengthy, empathetic, compassionate encounter with a homeopath, a placebo-response or other factors which experts often call ‘context effects’.[4]
  2. Whenever homeopaths advise their patients (as they often do) to forgo effective conventional treatments, they are likely to do harm. This phenomenon is best documented in relation to the advice of many homeopaths against immunisations.[5]
[For references, see the original text]

I do not expect fans of homeopathy to be impressed by my evidence-based assessment of their cult. In fact, just looking what is currently being posted on ‘X’ today about the ‘WORLD HOMEOPATHY DAY’ seems to justify my expectation. Here are the 10 first postings that appeared on my screen about an hour ago:

  1. Today, on #WorldHomeopathyDay, we celebrate the birth anniversary of Dr. Samuel Hahnemann, the founder of homeopathy. Let’s embrace the principles of natural healing and holistic well-being.
  2. On #WorldHomeopathyDay President #DroupadiMurmu to inaugurate 2-day Homeopathic Symposium at Yashobhoomi Convention Centre Dwarka, New Delhi. Organized by Central Council for Research in Homoeopathy (CCRH) based on theme of ‘Empowering Research, Enhancing Proficiency.’
  3. Dr. Ashvini Kumar Dwivedi, Member, Scientific Advisory Board, Central Council for Research in Homeopathy, Ministry of Ayush, Government of India, and #ASSOCHAM Ayush task force member, underlined the significance of #WorldHomeopathyDay, observed on April 10th each year
  4. Today, we celebrate #WorldHomeopathyDay 2024, embracing the gentle healing power of nature.
  5. Happy #WorldHomeopathyDay!  Let’s celebrate the holistic approach to health that homeopathy offers, honoring its contributions to alternative medicine and its focus on individualized care. Here’s to exploring natural remedies and supporting wellness for all! #HolisticHealth
  6. Happy World Homeopathy Day Embracing the gentle yet powerful healing of homeopathy, let’s cherish its holistic essence, promoting balance and well-being worldwide. Here’s to the harmony it brings to mind, body, and spirit.
  7. #WorldHomeopathyDay: President #DroupadiMurmu to inaugurate 2-day Homeopathic Symposium at Yashobhoomi Convention Centre Dwarka, New Delhi. Organized by Central Council for Research in Homoeopathy (CCRH) based on theme of ‘Empowering Research, Enhancing Proficiency.’
  8. Celebrate #WorldHomeopathyDay with us & enter to win these two enlightening reads by renowned homeopath Dr. Mukesh Batra. What inspired you to explore homeopathy? Share your story in the comments section & get a chance to win a copy of #HealWithHomeopathy and #FeelGoodHealGood!
  9. #WorldHomeopathyDay is celebrated on April 10th, promoting awareness of the principles and benefits of homeopathic medicine. It aims to address the whole body, including hereditary predispositions and disease history, and encourages people to pursue homeopathy as a profession.…
  10. On World Homeopathy Day, we celebrate Dr. Samuel Hahnemann, the pioneer of homeopathy. His gentle remedies, made from natural substances, have helped countless people heal without side effects.

_______________________

In view of this volume of pure BS, I encourage everyone to post (here, or on ‘X’, or elsewhere) some evidence-based comments on homeopathy, Hahnemann and the ‘World Homeopathy Day’.

Let me make a start:

Homeopaths are as deluded as their remedies are diluted

In the realm of so-called alternative medicine (SCAM), we see a lot of papers that are bizarre to the point of being disturbing and often dangerous nonsense. Yesterday, I came across an article that fits this bill well; in fact, I have not seen such misleading BS for quite a while. Let me present to you the abstract of this paper:

Introduction

There has been accumulating interest in the application of biofield therapy as complementary and alternative medicine (CAM) to treat various diseases. The practices include reiki, qigong, blessing, prayer, distant healing, known as biofield therapies. This paper aims to state scientific knowledge on preclinical and clinical studies to validate its potential use as an alternative medicine in the clinic. It also provides a more in-depth context for understanding the potential role of quantum entanglement in the effect of biofield energy therapy.

Content

A comprehensive literature search was performed using the different databases (PubMed, Scopus, Medline, etc.). The published English articles relevant to the scope of this review were considered. The review gathered 45 papers that were considered suitable for the purpose. Based on the results of these papers, it was concluded that biofield energy therapy was effective in treating different disease symptoms in preclinical and clinical studies.

Summary

Biofield therapies offer therapeutic benefits for different human health disorders, and can be used as alternative medicine in clinics for the medically pluralistic world due to the growing interest in CAM worldwide.

Outlook

The effects of the biofield energy therapies are observed due to the healer’s quantum thinking, and transmission of the quantum energy to the subject leads to the healing that occurs spiritually through instantaneous communication at the quantum level via quantum entanglement.

The authors of this article are affiliated with Trivedi Global, an organisation that states this about ‘biofield energy’:

Human Biofield EBnergy has subtle energy that has the capacity to work in an effective manner. This energy can be harnessed and transmitted by the gifted into living and non-living things via the process of a Biofield Energy Healing Treatment or Therapy.

If they aleady know that “Biofield EBnergy has subtle energy that has the capacity to work in an effective manner”, I wonder why they felt the need to conduct this review. Even more wonderous is the fact that their review showed such a positive result.

How did they manage this?

The answer might lie in their methodology: they “gathered 45 papers that were considered suitable”. While scientists gather the totality of the available evidence (and assess it critically), they merely selected what was suitable for the purpose of generating a positive result. This must be the reason our two studies on the subject were discretely omitted:

Our 1st study

Purpose: Distant healing, a treatment that is transmitted by a healer to a patient at another location, is widely used, although good scientific evidence of its efficacy is sparse. This trial was aimed at assessing the efficacy of one form of distant healing on common skin warts.

Subjects and methods: A total of 84 patients with warts were randomly assigned either to a group that received 6 weeks of distant healing by one of 10 experienced healers or to a control group that received a similar preliminary assessment but no distant healing. The primary outcomes were the number of warts and their mean size at the end of the treatment period. Secondary outcomes were the change in Hospital Anxiety and Depression Scale and patients’ subjective experiences. Both the patients and the evaluator were blinded to group assignment.

Results: The baseline characteristics of the patients were similar in the distant healing (n = 41) and control groups (n = 43). The mean number and size of warts per person did not change significantly during the study. The number of warts increased by 0.2 in the healing group and decreased by 1.1 in the control group (difference [healing to control] = -1.3; 95% confidence interval = -1.0 to 3.6, P = 0.25). Six patients in the distant healing group and 8 in the control group reported a subjective improvement (P = 0.63). There were no significant between-group differences in the depression and anxiety scores.

Conclusion: Distant healing from experienced healers had no effect on the number or size of patients’ warts.

Our 2nd study

Spiritual healing is a popular complementary and alternative therapy; in the UK almost 13000 members are registered in nine separate healing organisations. The present randomized clinical trial was designed to investigate the efficacy of healing in the treatment of chronic pain. One hundred and twenty patients suffering from chronic pain, predominantly of neuropathic and nociceptive origin resistant to conventional treatments, were recruited from a Pain Management Clinic. The trial had two parts: face-to-face healing or simulated face-to-face healing for 30 min per week for 8 weeks (part I); and distant healing or no healing for 30 min per week for 8 weeks (part II). The McGill Pain Questionnaire was pre-defined as the primary outcome measure, and sample size was calculated to detect a difference of 8 units on the total pain rating index of this instrument after 8 weeks of healing. VASs for pain, SF36, HAD scale, MYMOP and patient subjective experiences at week 8 were employed as secondary outcome measures. Data from all patients who reached the pre-defined mid-point of 4 weeks (50 subjects in part I and 55 subjects in part II) were included in the analysis. Two baseline measurements of outcome measures were made, 3 weeks apart, and no significant differences were observed between them. After eight sessions there were significant decreases from baseline in McGill Pain Questionnaire total pain rating index score for both groups in part I and for the control group in part II. However, there were no statistically significant differences between healing and control groups in either part. In part I the primary outcome measure decreased from 32.8 (95% CI 28.5-37.0) to 23.3 (16.8-29.7) in the healing group and from 33.1 (27.2-38.9) to 26.1 (19.3-32.9) in the simulated healing group. In part II it changed from 29.6 (24.8-34.4) to 24.0 (18.7-29.4) in the distant healing group and from 31.0 (25.8-36.2) to 21.0 (15.7-26.2) in the no healing group. Subjects in healing groups in both parts I and II reported significantly more ‘unusual experiences’ during the sessions, but the clinical relevance of this is unclear. It was concluded that a specific effect of face-to-face or distant healing on chronic pain could not be demonstrated over eight treatment sessions in these patients.

In addition, they, of course, also omitted many further studies by other investigators that failed to be positive. Considering this amount of cherry-picking, it is easy to understand how they arrived at their conclusion. It is all a question of chosing the right methodology!

A few decades ago, the cigarette industry employed this technique to show that smoking did not cause cancer! Luckily, we have since moved away from such pseudo-scientific ‘research’ – except, of course, in the realm of SCAM where it is still hughely popular.

These days, it has become a rare event – I am speaking of me publishing a paper in the peer-reviewed medical literature. But it has just happened: Spanish researchers and I published a meta-analysis on the effectiveness of craniosacral therapy. Here is its abstract:

The aim of this study was to evaluate the clinical effectiveness of craniosacral therapy (CST) in the management of any conditions. Two independent reviewers searched the PubMed, Physiotherapy Evidence Database, Cochrane Library, Web of Science, and Osteopathic Medicine Digital Library databases in August 2023, and extracted data from randomized controlled trials (RCT) evaluating the clinical effectiveness of CST. The PEDro scale and Cochrane Risk of Bias 2 tool were used to assess the potential risk of bias in the included studies. The certainty of the evidence of each outcome variable was determined using GRADEpro. Quantitative synthesis was carried out with RevMan 5.4 software using random effect models.

Fifteen RCTs were included in the qualitative and seven in the quantitative synthesis. For musculoskeletal disorders, the qualitative and quantitative synthesis suggested that CST produces no statistically significant or clinically relevant changes in pain and/or disability/impact in patients with headache disorders, neck pain, low back pain, pelvic girdle pain, or fibromyalgia. For non-musculoskeletal disorders, the qualitative and quantitative synthesis showed that CST was not effective for managing infant colic, preterm infants, cerebral palsy, or visual function deficits.

We concluded that the qualitative and quantitative synthesis of the evidence suggest that CST produces no benefits in any of the musculoskeletal or non-musculoskeletal conditions assessed. Two RCTs suggested statistically significant benefits of CST in children. However, both studies are seriously flawed, and their findings are thus likely to be false positive.

So, CST is not really an effective option for any condition.

Not a big surprise! After all, the assumptions on which CST is based fly in the face of science.

Since CST is nonetheless being used by many healthcare professionals, it is, I feel, important to state and re-state that CST is an implausible intervention that is not supported by clinical evidence. Hopefully then, one day, these practitioners will remember that their ethical obligation is to treat their patients not according to their beliefs but according to the best available evidence. And, hopefully, our modest paper will have helped rendering healthcare a little less irrational and somewhat more effective.

A recent post of mine started an interesting discussion about the research of the NCCIH. Richard Rasker made the following comment:

The NCCIH was initially established as the Office for Alternative Medicine (OAM) for mostly the same reason that Edzard’s department at Exeter was founded, i.e. to study alternative modalities, and determine once and for all which ones were effective and which ones weren’t. Unfortunately, OAM and its subsequent incarnations were taken over by SCAM proponents almost right away, with its core mission changed into validating (NOT ‘studying’) SCAM modalities – a small but crucial difference that will all but guarantee that even long-obsolete and totally ineffective quackery will continue to be ‘researched’ and promoted.

So what’s the score now, after more than 30 years and well over 4 billion dollars in taxpayers’ money? How many SCAM modalities have they managed to ‘validate’, i.e. definitively proven to be effective? The answer is: none, for all intents and purposes. Even their research into herbal medicine – one of the most effective (or should I say: least ineffective) SCAMs out there – is best described as woefully lacking. Their list of herbs and plants names just 55 species of plants, and the individual descriptions are mostly to the tune of ‘a lot of research was done, but we can’t say anything definite’.

I think I can contribute meaningfully to this important comment and topic. Several years ago, my Exeter team – together with several other researches – systematically reviewed the NCCIH (formerly NCCAM)-sponsored clinical trials. Specifically, we focussed on 4 different subject areas. Here are the conclusions of our articles reporting the findings:

      1. ACUPUNCTURE

Seven RCTs had a low risk of bias. Numerous methodological shortcomings were identified. Many NCCAM-funded RCTs of acupuncture have important limitations. These findings might improve future studies of acupuncture and could be considered in the ongoing debate regarding NCCAM-funding. [Focus on Alternative and Complementary Therapies Volume 17(1) March 2012 15–21]

       2. HERBAL MEDICINE

This independent assessment revealed a plethora of serious concerns related to NCCAM studies of herbal medicine. [Perfusion 2011; 24: 89-102]

       3. ENERGY MEDICINE

In conclusion, the NCCAM-funded RCTs of energy medicine are prime examples of misguided investments into research. In our opinion, NCCAM should not be funding poor-quality studies of implausible practices. The impact of any future studies of energy medicine would be negligible or even detrimental. [Focus on Alternative and Complementary Therapies Volume 16(2) June 2011 106–109 ]

       4. CHIROPRACTIC

In conclusion, our review demonstrates that several RCTs of chiropractic have been funded by the NCCAM. It raises numerous concerns in relation to these studies; in particular, it suggests that many of these studies are seriously flawed. [https://www.ncbi.nlm.nih.gov/pubmed/21207089]

The overall conclusion that comes to my mind is this:

The NCCIH has managed to spend more money on SCAM research than any other institution in the world (in the 20 years that I ran the Exeter research unit, we spent around £2 million in total). The NCCIH has wasted precious funds on plenty of dubious studies; arguably, this is unethical. It has misappropriated its role from testing to validating SCAMs. And it has validated none.

PS

As some of the above-cited papers are not easily accessible, I offer to send copies to interested individuals on request.

The aim of this systematic review and network meta-analysis was to identify the optimal dose and modality of exercise for treating major depressive disorder, compared with psychotherapy, antidepressants, and control conditions.

The screening, data extraction, coding, and risk of bias assessment were performed independently and in duplicate. Bayesian arm based, multilevel network meta-analyses were performed for the primary analyses. Quality of the evidence for each arm was graded using the confidence in network meta-analysis (CINeMA) online tool. All randomised trials with exercise arms for participants meeting clinical cut-offs for major depression were included.

A total of 218 unique studies with a total of 495 arms and 14 170 participants were included. Compared with active controls (eg, usual care, placebo tablet), moderate reductions in depression were found for

  • walking or jogging,
  • strength training,
  • mixed aerobic exercises,
  • and tai chi or qigong.

The effects of exercise were proportional to the intensity prescribed. Strength training and yoga appeared to be the most acceptable modalities. Results appeared robust to publication bias, but only one study met the Cochrane criteria for low risk of bias. As a result, confidence in accordance with CINeMA was low for walking or jogging and very low for other treatments.

The authors concluded that exercise is an effective treatment for depression, with walking or jogging, yoga, and strength training more effective than other exercises, particularly when intense. Yoga and strength training were well tolerated compared with other treatments. Exercise appeared equally effective for people with and without comorbidities and with different baseline levels of depression. To mitigate expectancy effects, future studies could aim to blind participants and staff. These forms of exercise could be considered alongside psychotherapy and antidepressants as core treatments for depression.

As far as I can see, there are two main problems with these findings:

  1. Because too many of the studies are less than rigorous, the results are not quite as certain as the conclusions would seem to imply.
  2. Patients suffering from a major depressive disorder are often unable (too fatigued, demotivated, etc.) to do and/or keep up vigorous excerise over any length of time.

What I find furthermore puzzling is that, on the one hand, the results show that – as one might expect – the effects are proportional to the intensity of the excercise but, on the other hand tai chi and qugong which are both distinctly low-intensity turn out to be effective.

Nonetheless, this excellent paper is undoubtedly good news and offers hope for patients who are in desperate need of effective, safe and economical treatments.

These days – 11 years after the closure of my department at Exeter – it is not often that I co-author a peer-reviewed paper. All the more reason, I think, to celebrate when it does happen:

Our review was aimed at determining the effectiveness of meditation, primarily mindfulness-based interventions (MBIs) and transcendental meditation (TM), for the primary and secondary prevention of CVD.

We searched CENTRAL, MEDLINE, Embase, three other databases, and two trials registers on 14 November 2021, together with reference checking, citation searching, and contact with study authors to identify additional studies. We included randomised controlled trials (RCTs) of 12 weeks or more in adults at high risk of CVD and those with established CVD. We explored four comparisons: MBIs versus active comparators (alternative interventions); MBIs versus non-active comparators (no intervention, wait list, usual care); TM versus active comparators; TM versus non-active comparators. We used standard Cochrane methods. Our primary outcomes were CVD clinical events (e.g. cardiovascular mortality), blood pressure, measures of psychological distress and well-being, and adverse events. Secondary outcomes included other CVD risk factors (e.g. blood lipid levels), quality of life, and coping abilities. We used GRADE to assess the certainty of evidence.

We included 81 RCTs (6971 participants), with most studies at unclear risk of bias. MBIs versus active comparators (29 RCTs, 2883 participants) Systolic (SBP) and diastolic (DBP) blood pressure were reported in six trials (388 participants) where heterogeneity was considerable (SBP: MD -6.08 mmHg, 95% CI -12.79 to 0.63, I2 = 88%; DBP: MD -5.18 mmHg, 95% CI -10.65 to 0.29, I2 = 91%; both outcomes based on low-certainty evidence). There was little or no effect of MBIs on anxiety (SMD -0.06 units, 95% CI -0.25 to 0.13; I2 = 0%; 9 trials, 438 participants; moderate-certainty evidence), or depression (SMD 0.08 units, 95% CI -0.08 to 0.24; I2 = 0%; 11 trials, 595 participants; moderate-certainty evidence). Perceived stress was reduced with MBIs (SMD -0.24 units, 95% CI -0.45 to -0.03; I2 = 0%; P = 0.03; 6 trials, 357 participants; moderate-certainty evidence). There was little to no effect on well-being (SMD -0.18 units, 95% CI -0.67 to 0.32; 1 trial, 63 participants; low-certainty evidence). There was little to no effect on smoking cessation (RR 1.45, 95% CI 0.78 to 2.68; I2 = 79%; 6 trials, 1087 participants; low-certainty evidence). None of the trials reported CVD clinical events or adverse events. MBIs versus non-active comparators (38 RCTs, 2905 participants) Clinical events were reported in one trial (110 participants), providing very low-certainty evidence (RR 0.94, 95% CI 0.37 to 2.42). SBP and DBP were reduced in nine trials (379 participants) but heterogeneity was substantial (SBP: MD -6.62 mmHg, 95% CI -13.15 to -0.1, I2 = 87%; DBP: MD -3.35 mmHg, 95% CI -5.86 to -0.85, I2 = 61%; both outcomes based on low-certainty evidence). There was low-certainty evidence of reductions in anxiety (SMD -0.78 units, 95% CI -1.09 to -0.41; I2 = 61%; 9 trials, 533 participants; low-certainty evidence), depression (SMD -0.66 units, 95% CI -0.91 to -0.41; I2 = 67%; 15 trials, 912 participants; low-certainty evidence) and perceived stress (SMD -0.59 units, 95% CI -0.89 to -0.29; I2 = 70%; 11 trials, 708 participants; low-certainty evidence) but heterogeneity was substantial. Well-being increased (SMD 0.5 units, 95% CI 0.09 to 0.91; I2 = 47%; 2 trials, 198 participants; moderate-certainty evidence). There was little to no effect on smoking cessation (RR 1.36, 95% CI 0.86 to 2.13; I2 = 0%; 2 trials, 453 participants; low-certainty evidence). One small study (18 participants) reported two adverse events in the MBI group, which were not regarded as serious by the study investigators (RR 5.0, 95% CI 0.27 to 91.52; low-certainty evidence). No subgroup effects were seen for SBP, DBP, anxiety, depression, or perceived stress by primary and secondary prevention. TM versus active comparators (8 RCTs, 830 participants) Clinical events were reported in one trial (201 participants) based on low-certainty evidence (RR 0.91, 95% CI 0.56 to 1.49). SBP was reduced (MD -2.33 mmHg, 95% CI -3.99 to -0.68; I2 = 2%; 8 trials, 774 participants; moderate-certainty evidence), with an uncertain effect on DBP (MD -1.15 mmHg, 95% CI -2.85 to 0.55; I2 = 53%; low-certainty evidence). There was little or no effect on anxiety (SMD 0.06 units, 95% CI -0.22 to 0.33; I2 = 0%; 3 trials, 200 participants; low-certainty evidence), depression (SMD -0.12 units, 95% CI -0.31 to 0.07; I2 = 0%; 5 trials, 421 participants; moderate-certainty evidence), or perceived stress (SMD 0.04 units, 95% CI -0.49 to 0.57; I2 = 70%; 3 trials, 194 participants; very low-certainty evidence). None of the trials reported adverse events or smoking rates. No subgroup effects were seen for SBP or DBP by primary and secondary prevention. TM versus non-active comparators (2 RCTs, 186 participants) Two trials (139 participants) reported blood pressure, where reductions were seen in SBP (MD -6.34 mmHg, 95% CI -9.86 to -2.81; I2 = 0%; low-certainty evidence) and DBP (MD -5.13 mmHg, 95% CI -9.07 to -1.19; I2 = 18%; very low-certainty evidence). One trial (112 participants) reported anxiety and depression and found reductions in both (anxiety SMD -0.71 units, 95% CI -1.09 to -0.32; depression SMD -0.48 units, 95% CI -0.86 to -0.11; low-certainty evidence). None of the trials reported CVD clinical events, adverse events, or smoking rates.

We concluded that despite the large number of studies included in the review, heterogeneity was substantial for many of the outcomes, which reduced the certainty of our findings. We attempted to address this by presenting four main comparisons of MBIs or TM versus active or inactive comparators, and by subgroup analyses according to primary or secondary prevention, where there were sufficient studies. The majority of studies were small and there was unclear risk of bias for most domains. Overall, we found very little information on the effects of meditation on CVD clinical endpoints, and limited information on blood pressure and psychological outcomes, for people at risk of or with established CVD. This is a very active area of research as shown by the large number of ongoing studies, with some having been completed at the time of writing this review. The status of all ongoing studies will be formally assessed and incorporated in further updates.

Some people will say that meditation is not a form of so-called alternative medicine (SCAM) but rather an aspect of lifestyle used for relaxation and well-being. As such, it should not be scrutinized like a therapy. This might be partly true, but as soon as proper health claims are made for meditation or similar modalities, they do need to be tested like any other therapy, in my view.

As our review demonstrates, meditation and similar treatments are not nearly as well supported by evidence as their proponents try to make us believe. In other words, the often-voiced claims that such therapies are effective for the primary and secondary prevention of cardiovascular disease are largely unfounded.

This systematic review aimed to investigate the effectiveness of cupping therapy on low back pain (LBP). Medline, Embase, Scopus and WANFANG databases were searched for relevant cupping RCTs on low back pain articles up to 2023. A complementary search was manually made on 27 September for update screening. Full-text English and Chinese articles on all ethnic adults with LBP of cupping management were included. Studies looking at acute low back pain only were excluded. Two independent reviewers screened and extracted data, with any disagreement resolved through consensus by a third reviewer. The methodological quality of the included studies was evaluated independently by two reviewers using an adapted tool. Change-from-baseline outcomes were treated as continuous variables and calculated according to the Cochrane Handbook. Data were extracted and pooled into the meta-analysis by Review Manager software (version 5.4, Nordic Cochrane Centre).

Eleven trials involving 921 participants were included. Five studies were assessed as being at low risk of bias, and six studies were of acceptable quality. The findings reveal:

  • High-quality evidence demonstrated cupping significantly improves pain at 2-8 weeks endpoint intervention (d=1.09, 95% CI: [0.35-1.83], p=0.004).
  • There was no continuous pain improvement observed at one month (d=0.11, 95% CI: [-1.02-1.23], p=0.85) and 3-6 months (d=0.39, 95% CI: [-0.09-0.87], p=0.11).
  • Dry cupping did not improve pain (d=1.06, 95% CI: [-0.34, 2.45], p=0.14) compared with wet cupping (d=1.5, 95% CI: [0.39-2.6], p=0.008) at the endpoint intervention.
  • There was no evidence indicating the association between pain reduction and different types of cupping (p=0.2).
  • Moderate- to low-quality evidence showed that cupping did not reduce chronic low back pain (d=0.74, 95% CI: [-0.67-2.15], p=0.30) and non-specific chronic low back pain (d=0.27, 95% CI: [-1.69-2.24], p=0.78) at the endpoint intervention.
  • Cupping on acupoints showed a significant improvement in pain (d=1.29, 95% CI: [0.63-1.94], p<0.01) compared with the lower back area (d=0.35, 95% CI: [-0.29-0.99], p=0.29).
  • A potential association between pain reduction and different cupping locations (p=0.05) was found.
  • Meta-analysis showed a significant effect on pain improvement compared to medication therapy (n=8; d=1.8 [95% CI: 1.22 – 2.39], p<0.001) and usual care (n=5; d=1.07 [95% CI: 0.21- 1.93], p=0.01).
  • Two studies demonstrated that cupping significantly mediated sensory and emotional pain immediately, after 24 hours, and 2 weeks post-intervention (d= 5.49, 95% CI [4.13-6.84], p<0.001).
  • Moderate evidence suggested that cupping improved disability at the 1-6 months follow-up (d=0.67, 95% CI: [0.06-1.28], p=0.03).
  • There was no immediate effect observed at the 2-8 weeks endpoint (d=0.40, 95% CI: [-0.51-1.30], p=0.39).
  • A high degree of heterogeneity was noted in the subgroup analysis (I2 >50%).

The authors concluded that high- to moderate-quality evidence indicates that cupping significantly improves pain and disability. The effectiveness of cupping for LBP varies based on treatment durations, cupping types, treatment locations, and LBP classifications. Cupping demonstrated a superior and sustained effect on pain reduction compared with medication and usual care. The notable heterogeneity among studies raises concerns about the certainty of these findings. Further research should be designed with a standardized cupping manipulation that specifies treatment sessions, frequency, cupping types, and treatment locations. The real therapeutic effects of cupping could be confirmed using a sham device or objective outcome measurements. Studies with at least six- to twelve-month follow-ups are needed to investigate the long-term efficacy of cupping in managing LBP.

Confused?

No need, it’s really quite simple: cupping can, according to this review, be shown to have some short-lasting effect, provided the study is flawed and does not control for placebo effects.

Surprised?

No need! There is hardly a form of so-called alternative medicine (SCAM) that does not have a similarly small effect of back pain, if tested in equally dodgy studies. This is particularly true for those treatments that can act as a theatrical placebo, e.g. acupuncture or chiropractic.

So, should a back pain sufferer try cupping?

If he/she insists, why not? But please don’t use wet cupping (which can do quite a bit of harm). Dry cupping (without injuring the skin) is arguably better (less risk, less expense, possibility of home treatment by your partner) than chiropractic, osteopathy, acupuncture, or many other SCAMs.

My conclusions – as mentioned many times previously – are as follows:

  1. Most SCAMs help a little with back pain (and similar conditions) because they can have a powerful placebo effect.
  2. Conventional medicine is also not convincingly effective for back pain.
  3. If you insist on SCAM, it is best to use one that is relatively harmless and inexpensive.
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