causation
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):
- 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
- 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
- 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
- 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
- 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.
- 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.
- 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]
- 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.
- 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
- 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.
This study evaluated and compared the effectiveness of Reiki and Qi-gong therapy techniques in improving diabetic patients’ negative emotional states. This quas-experimental research design was carried out at the National Institute of Diabetes and Endocrinology’s Hospital in Cairo, Egypt. It included 200 Type 2 diabetes patients randomized into two equal groups, one for Qigong and one for Reiki techniques. A self-administered questionnaire with a standardized tool (Depression Anxiety Stress Scales [DASS[) was used in data collection. The intervention programs were administered in the form of instructional guidelines through eight sessions for each group.
The results showed that the two study groups had similar socio-demographic characteristics. After implementation of the intervention, most patients in the two groups were having no anxiety, no depression, and no stress. Statistically significant improvements were seen in all three parameters in both groups (p<0.001). The multivariate analysis identified the study intervention as the main statistically significant independent negative predictor of the patients’ scores of anxiety, depression, and stress. Reiki technique was also a statistically significant independent negative predictor of these scores.
The authors conclused that both Reiki and Qi-gong therapy techniques were effective in improving diabetic patients’ negative emotional states of anxiety, depression, and stress, with slight superiority of the Reiki technique. The inclusion of these techniques in the management plans of Type-2 diabetic patients is recommended.
This is an excellent example of how NOT to design a clinical trial!
- If your aim is to test the efficacy of Reiki, conduct a trial of Reiki versus sham-Reiki.
- If your aim is to test the efficacy of Qi-gong, conduct a trial of Qi-gong versus sham-Qi-gong.
- If you compare two therapies in one trial, one has to be of proven and undoubted efficacy.
- Comparing two treatments of unproven efficacy cannot normally lead to a meaningful result.
- It is like trying to solve a mathematical equasion with two unknowns.
- A study that cannot produce a meaningful result is a waste of resorces.
- It arguably also is a neglect of research ethics.
- Even if we disregarded all these flaws and problems, recommending therapies for routine use on the basis of one single study is irresponsible nonsense.
All this is truly elementary and should be known by any researcher (not to mention research supervisor). Yet, in the realm of so-called alternative medicine (SCAM), it needs to be stressed over and over again. The ‘National Institute of Diabetes and Endocrinology’s Hospital in Cairo’ (and all other institutions that produce such shameful pseudoscience) urgently need to get their act together:
you are doing nobody a favour!
Spinal manipulation is usually performed by a therapist (chiropractor, osteopath, physiotherpist, doctor, etc.). But many people do it themselves. Self-manipulation is by no means safer than the treatment by a therapist, it seems. We have previously seen cases where the results were dramatic:
- Spinal epidural haematoma after neck manipulation (edzardernst.com)
- A ‘Self-Chiropractic Spinal Manipulation’ that resulted in death (edzardernst.com)
Now, a further case has been reported. In this paper, American pathologists present a tragic case of fatal vertebral artery dissection that occurred as the result of self-manipulation of the cervical spine.
The decedent was a 40-year-old man with no significant past medical history. He was observed to “crack his neck” while at work. Soon after, he began experiencing neck pain, then developed stroke-like symptoms and became unresponsive. He was transported to a local medical center, where imaging showed bilateral vertebral artery dissection. His neurological status continued to decline, and brain death was pronounced several days later.
An autopsy examination showed evidence of cerebellar and brainstem infarcts, herniation, and diffuse hypoxic-ischemic injury. A posterior neck dissection was performed to expose the vertebral arteries, which showed grossly visible hemorrhage and dilation. There was no evidence of traumatic injury to the bone or soft tissue of the head or neck. Bilateral dissection tracts were readily appreciated on microscopic examination. Death was attributed to self-manipulation of the neck, which in turn led to bilateral vertebral artery dissection, cerebellar and brainstem infarcts, herniation, hypoxic-ischemic injury, and ultimately brain death.
It seems clear to me that only few and spectacular cases of this nature are being published. In other words, the under-reporting of adverse effects of self-manipulation must be close to 100%. It follows that the risk of sel-manipulation is impossible to quantify. I suspect it is substancial. In any case, the precautionary principle compells me to re-issue my warning:
do not allow anybody to manipulate your neck, not even yourself!
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:
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.
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.
In spite of the safety and efficiency of the COVID-19 vaccines and the many promotion efforts of political and expert authorities, a fair portion of the population remained hesitant if not opposed to vaccination. Public debate and the available literature point to the possible role of people’s attitudes towards medical institutions as well as their preference for so-called alternative medicine (SCAM) on their motivations and intentions to be vaccinated. Other potential ideological factors are beliefs about environmental laissez-faire and divine providence insofar as they encourage people to let the pandemic unfold without human interference.
In three cross-sectional samples (total N = 8214), collected at successive moments during the Belgian vaccination campaign, the present research examines the distal role of these psychological and ideological factors on vaccination intentions via motivational processes.
- Study 1 gauges the relation between trust in medical institutions and preference for SCAM on intentions to get vaccinated via motivations.
- Study 2 examines the role of beliefs in the desirability of letting nature take its course (‘environmental laissez-faire beliefs’) on vaccination intention via motivations.
- Study 3 tests whether people’s adherence to environmental laissez-faire and beliefs about divine providence are linked to their motivations for vaccination via trust in the medical institutions and SCAM.
The results show that adherence to SCAM has a deleterious effect on vaccination intentions, whereas trust in medical institutions has a positive effect. Both ideological factors pertaining to external control are only moderately related, with environmental laissez-faire beliefs having stronger effects on SCAM, medical trust and vaccination motivations.
The evidence of an association between SCAM and willingness to get vaccinated is undeniable. On this blog, we have discussed it repeatedly, e.g.:
- Use of so-called alternative medicine (SCAM) and its association with SARS-CoV-2 vaccination status
- Intelligence, Religiosity, SCAM, Vaccination Hesitancy – are there links?
- Andrew Wakefield, Donald Trump, SCAM, and the anti-vaccination cult
- Measles are back – not least thanks to so-called alternative medicine (SCAM), I fear
- Reasons for parental hesitancy or refusal of childhood vaccination
- Endorsement of so-called alternative medicine (SCAM) and vaccine hesitancy among physicians
- Are people who oppose COVID-19 vaccinations intellectually challenged?
- So-called alternative medicine (SCAM) and vaccine hesitancy among physicians: findings from Germany, Finland, Portugal, and France
- Interest in so-called alternative medicine is linked to vaccination coverage
- Misinformation and conspiratorial thinking are at the heart of so-called alternative medicine(SCAM)
- Vaccination rates of Canadian healthcare professionals: those of chiropractors and naturopaths are at the lowest
- Echo chambers of vaccine hesitancy and so-called alternative medicine (SCAM)
- Preference of so-called alternative medicine predicts negative attitudes to vaccination
- What are the reasons for opposing COVID vaccinations?
- Anti-vax arguments used by proponents of SCAM are stupid, or wrong, or both
But what exactly is the nature of this association?
- Does SCAM-use predispose to vaccination hesitancy?
- Does Vaccination hesitancy predispose to SCAM use?
- Is both true?
After reading all this research that has emerged on the subject, I get the impression that we are mostly dealing here with a cross-correlation where a certain mind-set of being
- prone to conspiracy theories,
- anti-establishment,
- anti-science,
- irrational,
- of low intelligence,
- unable of critical thinking,
- etc., etc,
determines both the SCAM-use and the vaccination hesitancy.
It has been reported that 5 people who took a Japanese health supplement have died and more than 100 have been hospitalized as of Friday, a week after a pharmaceutical company issued a recall of the products, officials said. Osaka-based Kobayashi Pharmaceutical Co. came under fire for not going public quickly with problems known internally as early as January. Yet the first public announcement came only on 22 March. Company officials said 114 people were being treated in hospitals after taking products — including Benikoji Choleste Help meant to lower cholesterol — that contain an ingredient called benikoji, a red species of mold. Some people developed kidney problems after taking the supplements, but the exact cause was still under investigation in cooperation with government laboratories, according to the manufacturer.
“We apologize deeply,” President Akihiro Kobayashi told reporters last Friday, bowing for a long time to emphasize the apology alongside three other top company officials. He expressed remorse to those who have died and have been taken ill and to their families. He also apologized for the troubles caused to the entire health food industry and the medical profession, adding that the company was working to prevent further damage and improve crisis management.
The company’s products have been recalled — as have dozens of other products that contain benikoji, including miso paste, crackers, and a vinegar dressing. Japan’s health ministry put up a list on its official site of all the recalled products, including some that use benikoji for food coloring. The ministry warned the deaths could keep growing. The supplements could be bought at drug stores without a prescription from a doctor, and some may have been purchased or exported before the recall, including by tourists who may not be aware of the health risks.
Kobayashi Pharmaceutical had been selling benikoji products for years, with a million packages sold over the past 3 fiscal years, but a problem crept up with the supplements produced in 2023. Kobayashi Pharmaceutical said it produced 18.5 tons of benikoji last year. Some analysts blame the recent deregulation initiatives, which simplified and sped up approval for health products to spur economic growth.
________________________
Anouther source reported that Japanese authorities on Saturday raided a drug factory after a pharmaceutical company reported at least five deaths and 114 hospitalizations possibly linked to a health supplement. About a dozen Japanese health officials walked into the Osaka plant of the Kobayashi Pharmaceutical Co., as seen in footage of the raid widely telecasted on Japanese news. The health supplement in question is a pink pill called Benikoji Choleste Help. It is said to help lower cholesterol levels. A key ingredient is benikoji, a type of red mold. The company has said it knows little about the cause of the sickness, which can include kidney failure. It is currently investigating the effects in cooperation with Japan’s government.
___________________________
More recent reports update the figure of affected individuals: Japanese dietary supplements at the center of an expanding health scare have now been linked to at least 157 hospitalizations, a health ministry official said Tuesday.The figure reflects an increase from the 114 hospitalization cases that Kobayashi Pharmaceutical said on Friday were linked to its products containing red yeast rice, or beni kōji.
A Kobayashi Pharmaceutical spokeswoman confirmed the latest hospitalization cases without elaborating further.
Benikoji is widely sold and used; not just in Japan. It comes under a range of different names:
- red yeast rice,
- red fermented rice,
- red kojic rice,
- red koji rice,
- anka,
- angkak,
- Ben Cao Gang Mu.
It is a bright reddish purple fermented rice which acquires its color from being cultivated with the mold Monascus purpureus. Red yeast rice is used as food and as a medicine in Asian cultures, such as Kampo and TCM.
It contains lovastatin which, of course, became patented and is marketed as the prescription drug, Mevacor. Red yeast rice went on to become a non-prescription dietary supplement in the United States and other countries. In 1998, the U.S. FDA banned a dietary supplement containing red yeast rice extract, stating that red yeast rice products containing monacolin K are identical to a prescription drug, and thus subject to regulation as a drug.
Cervical spondylosis is a chronic degenerative process of the cervical spine characterized by pain in neck, degenerative changes in intervertebral disc and osteophyte formation. The present study was aimed at evaluating the effect of wet cupping (Ḥijāma Bish Sharṭ) in the pain management of cervical spondylosis.
This Open, randomized, clinical study was conducted on 44 patients.
- Subjects in the test group (n = 22) received a series of three-staged wet cupping treatment, performed on 0, 7th and 14th day.
- Subjects in the control group (n = 22) received 12 sittings of Transcutaneous Electrical Nerve Stimulation (TENS): 6 sittings per week for two weeks.
The outcomes were assessed with the help of VAS, Neck Disability Index (NDI) and Cervical range of motion.
Intra group comparison in test group from baseline to 21st day were found highly significant (p < 0.001) in terms of VAS, NDI, Flexion, Extension and Left rotation score. While in Right rotation, Left rotation and Left lateral flexion score were found moderately significant (p < 0.01). Statistically significant difference was observed between two groups at 21st day in VAS scale, NDI, and Cervical range of motion score (p < 0.001).
The authors concluded that Ḥijāma Bish Sharṭ was found better in the management of pain due to cervical spondylosis than TENS. It can be concluded that Ḥijāma Bish Sharṭ may a better option for the pain management of cervical spondylosis.
Wet cupping is the use of a vacuum cup applied to the skin which has previously been lacerated. It draws blood and can thus be seen as a form of blood letting. It has been used in various cultures for the treatment of joint pain and many other conditions since antiquity.
The authors point out that, in Unani medicine, it is believed to reduce pain and other symptoms by diverting and evacuating the causative pathological humours (akhlāṭ-e-fasida). Galen (Jalinoos) mentioned wet cupping as a very useful modality in evacuating the thick humours (akhlāṭ-e-Ghaleez) (Nafeesi, 1954; Qamri, 2008). Wet cupping works on the principle of diversion and evacuation of morbid matter (imala wa tanqiya-i-mawād-i-fasida). It opens the pores of the skin, enhances the blood circulation, nourishes the affected area with fresh blood, improves the eliminative function and facilitates the evacuation of morbid matter from the body.
There are several studies of wet cupping, most of which are as flawed as the one above. This new trial has several limitations, e.g.:
- It makes no attempt to control for placebo effects which could well be more prominent for wet cupping than for TENS.
- It did not inhibit the influence of verbal or non-verbal communications between therapists and patients which are likely to influence the results.
- The sample size is far too small, particularly as the study was designed as an equivalence study.
But some might say that my arguments a petty and argue that, regardless of a flimsy study, wet cupping is still worth a try. I would disagree – not because of the flaws of this study, nor the implausibility of the long-obsolete assumptions that underpin the therapy, but because wet cupping is associaated with infections of the skin lacerations which occasionally can be serious.
Lumbar stabilization exercises (LSEs) are said to be beneficial for chronic mechanical low back pain (CMLBP). However, further research focusing on intervention combinations is recommended. This study examined the effect of kinesio tape (KT) with LSEs on CMLBP adult patients.
A randomized blinded clinical trial was conducted. Fifty CMLBP patients of both genders were assigned into one of two groups and received 8 weeks of treatment:
- group A (control): LSEs only,
- group B (experimental): KT with LSEs.
The primary outcome was back disability, measured by the Oswestry disability index. Secondary outcomes included pain intensity, trunk extensor endurance, and sagittal spinal alignment, as indicated by the visual analog scale, Sorensen-test, and C7–S1 sagittal vertical axis, respectively. The reported data was analyzed by a two-way MANOVA using an intention-to-treat procedure.
Multivariate tests indicate statistically significant effects for group (F = 4.42, p = 0.005, partial η2 = 0.148), time (F = 219.55, p < 0.001, partial η2 = 0.904), and group-by-time interaction (F = 3.21, p = 0.01, partial η2 = 0.149). Univariate comparisons between groups revealed significant reductions in the experimental group regarding disability (p = 0.029, partial η2 = 0.049) and pain (p = 0.001, partial η2 = 0.102) without a significant difference in the Sorensen test (p = 0.281) or C7–S1 SVA (p = 0.491) results. All within-group comparisons were statistically significant (p < 0.001).
The authors concluded that the combination of KT and LSEs is an effective CMLBP treatment option. Although patients in both groups displayed significant changes in all outcomes, the combined interventions induced more significant reductions in back disability and pain intensity.
One of the main reason for conducting a controlled clinical trial is to determine whether the intervention, rather than some other factor, was the cause of the observed outcome. Yet, these trials can be designed in such a way that they mislead us on precisely this point. The present study is an example for such a case.
The authors leave us in no doubt that the KT was the cause of the positive outcome. However, they might be entirely wrong. Here are some other possibilities:
- the extra attention might have done the trick;
- the ritual of applying KT must have an effect;
- the expectation of the patient could have influenced the outcome;
- verbal or non-verbal communication between the patient and the therapist would have had an effect.
I know, it is often difficult to control for such influences in clinical trials. But, if it proves to be impossible [and in the case of KT it probably is possible], one should at the very least be cautious when drawing conclusions from the results. I suggest something like this:
The combination of KT and LSEs generated better outcomes than LSE alone. Whether this is due to specific effects of KT or non-specific context effects remains unclear.
Whenever a journalist wants to discuss the subject of acupuncture with me, he or she will inevitably ask one question:
DOES ACUPUNCTURE WORK?
It seems a legitimate, obvious and simple question, particularly during ‘Acupuncture Awareness Week‘, and I have heard it hundreds of times. Why then do I hesitate to answer it?
Journalists – like most of us – would like a straight answer, like YES or NO. But straight answers are in short supply, particularly when we are talking about acupuncture.
Let me explain.
Acupuncture is part of ‘Traditional Chinese Medicine’ (TCM). It is said to re-balance the life forces that determine our health. As such it is seen as a panacea, a treatment for all ills. Therefore, the question, does it work?, ought to be more specific: does it work for pain, obesity, fatigue, hair-loss, addiction, anxiety, ADHA, depression, asthma, old age, etc.etc. As we are dealing with virtually thousands of ills, the question, does it work?, quickly explodes into thousands of more specific questions.
But that’s not all!
The question, does acupuncture work?, assumes that we are talking about one therapy. Yet, there are dozens of different acupuncture traditions and sites:
- body acupuncture,
- ear acupuncture,
- tongue acupuncture,
- scalp acupuncture,
- etc., etc.
Then there are dozens of different ways to stimulate acupuncture points:
- needle acupuncture,
- electroacupuncture,
- acupressure,
- moxibustion,
- ultrasound acupuncture,
- laser acupuncture,
- etc., etc.
And then there are, of course, different acupuncture ‘philosophies’ or cultures:
- TCM,
- ‘Western’ acupuncture,
- Korean acupuncture,
- Japanese acupuncture,
- etc., etc.
If we multiply these different options, we surely arrive at thousands of different variations of acupuncture being used for thousands of different conditions.
But this is still not all!
To answer the question, does it work?, we today have easily around 10 000 clinical trials. One might therefore think that, despite the mentioned complexity, we might find several conclusive answers for the more specific questions. But there are very significant obstacles that are in our way:
- most acupuncture trials are of lousy quality;
- most were conducted by lousy researchers who merely aim at showing that acupuncture works rather that testing whether it is effective;
- most originate from China and are published in Chinese which means that most of us cannot access them;
- they get nevertheless included in many of the systematic reviews that are currently being published without non-Chinese speakers ever being able to scrutinise them;
- TCM is a hugely important export article for China which means that political influence is abundant;
- several investigators have noted that virtually 100% of Chinese acupuncture trials report positive results regardless of the condition that is being targeted;
- it has been reported that about 80% of studies emerging from China are fabricated.
Now, I think you understand why I hesitate every time a journalist asks me:
DOES ACUPUNCTURE WORK?
Most journalists do not have the patience to listen to all the complexity this question evokes. Many do not have the intellectual capacity to comprehend an exhaustive reply. But all want to hear a simple and conclusive answer.
So, what do I say in this situation?
Usually, I respond that the answer would depend on who one asks. An acupuncturist is likely to say: YES, OF COURSE, IT DOES! An less biased expert might reply:
IT’S COMPLEX, BUT THE MOST RELIABLE EVIDENCE IS FAR FROM CONVINCING.
