The US ‘Public Citizen‘ is an American non-profit, progressive consumer rights advocacy group, and think tank based in Washington, D.C. They recently published an article entitled “FDA Guidance on Homeopathic Drugs: An Ongoing Public Health Failure“. Here are a few excerpts:
In December 2022, the U.S. Food and Drug Administration (FDA) issued new guidance on homeopathic drug products. The guidance states that the agency now “intends to apply a risk-based enforcement approach to the manufacturing, distribution and marketing of homeopathic drug products.”
Under this new risk-based approach, the agency plans to target its enforcement actions against homeopathic drug products marketed without FDA approval that fall within the following limited categories:
- products with reports of injury that, after evaluation, raise potential safety concerns
- products containing or purportedly containing ingredients associated with potentially significant safety concerns (for example, infectious agents or controlled substances)
- products that are not administered orally or topically (for example, injectable drug products and ophthalmic drug products)
- products intended to be used to prevent or treat serious or life-threatening diseases
- products for vulnerable populations, such as immunocompromised individuals, infants and the elderly
- products with significant quality issues (for example, products that are contaminated with foreign materials or objectionable microorganisms)
But this new FDA guidance fails to adequately address the public health threat posed by the agency’s decades-long permissive approach to these illegal drug products.
Under FDA regulations, prescription and over-the-counter (OTC) homeopathic products are considered drugs and are supposed to be subject to the same review and approval requirements as all other prescription and OTC medications. However, under a flawed enforcement policy issued in 1988, the FDA has allowed these drug products to be marketed in the U.S. without agency review or approval. Thus, all products labeled as homeopathic are being marketed without the FDA having evaluated their safety, effectiveness or quality…
… there is no plausible physiologic or medical basis to support the theory underlying homeopathy, nor is there evidence from well-designed, rigorous clinical trials showing that homeopathic drugs are safe and effective.
The FDA should declare unequivocally that all unapproved homeopathic drug products are illegal and direct all manufacturers to immediately remove such products from the market. In the meantime, as we have recommended for many years, consumers should not use homeopathic products. At best, the products are a waste of money, given the lack of any evidence that they are effective. At worst, they could cause serious harm because of the lack of FDA oversight to ensure safety.
I fully agree with these sentiments. The harm caused by homeopathy is considerable and multi-facetted. Many previous posts have discudded these problems, e.g.:
- Nine cases of severe homeopathy-induced liver injuries
- Another death by homeopathy
- HOMEOPATHY – “It is not just irresponsible, it’s downright dangerous.”
- Adverse effects of homeopathy and aggravations at NAFKAM
- Homeopathy: it’s time to stop the double standards
- Homeopathy can cause serious harm – and finally, the NHS England has realised it
- Vidatox, homeopathy’s answer to cancer or outright fraud?
- Another child has died because of homeopathy
- Doctor homeopaths violate fundamental rules of ethics when practising homeopathy
- ‘Best homeopathy doctor in Delhi’ offers treatment for HIV/AIDS
- DIY-Homeopathy: how to kill your entire family
- The risks of homeopathy?
- The FDA has warned 4 manufacturers of unapproved injectable homeopathic drugs
- Is this the crown of the Corona-idiocy? Nosodes In Prevention And Management Of COVID -19
- The FDA has sent more warning letters to homeopathic manufacturers
- Walmart is being sued for selling homeopathic products
- Homoeopathic remedies may be safe, but do all homeopaths merit this attribute?
- Recommending homeoprophylaxis is unethical, irresponsible and possibly even criminal
- FDA: homeopathic teething remedies were toxic
- “Homeoprophylaxis, the homeopathic vaccine alternative, prevents disease through nosodes.”
- A truly dangerous homeopath
- The scandalous attitude of some homeopaths and their supporters towards immunisations
- Oh yes, let’s have homeopaths as primary care practitioners! But only in a parallel universe,please.
Having warned about the dangers of homeopathy for decades, I feel it is high time for regulators across the world to take appropriate action.
So-called alternative medicine (SCAM) is widely used in Saudi Arabia. One of the common practices is the use of camel urine alone or mixed with camel milk for the treatment of cancer, which is often supported by religious beliefs.
This study observed cancer patients who insisted on using camel urine, and to offer some clinically relevant recommendations. The authors observed 20 cancer patients (15 male, 5 female) from September 2020 to January 2022 who insisted on using camel urine for treatment. They documented the demographics of each patient, the method of administering the urine, reasons for refusing conventional treatment, period of follow-up, and the outcome and side effects.
All the patients had radiological investigations before and after their treatment with camel urine. All of them used a combination of camel urine and camel milk, and their treatment ranged from a few days to 6 months. They consumed an average of 60 ml urine/milk per day. No clinical benefit was observed after the treatment; 2 patients developed brucellosis. Eleven patients changed their mind and accepted conventional antineoplastic treatment and 7 were too weak to receive further treatment; they died from the disease.
The authors concluded that camel urine had no clinical benefits for any of the cancer patients, it may even have caused zoonotic infection. The promotion of camel urine as a traditional medicine should be stopped because there is no scientific evidence to support it.
If you suspected that this was a hoax, you were wrong!
Here is a recent paper on the ‘therapeutic potentials of camel urine’:
Camel urine has traditionally been used to treat multiple human diseases and possesses the most beneficial effects amongst the urine of other animals. However, scientific review evaluating the anticancer, antiplatelet, gastroprotective and hepatoprotective effects of camel urine is still scarce. Thus, this scoping review aimed to provide scientific evidence on the therapeutic potentials of camel urine. Three databases were searched to identify relevant articles (Web of Science, PubMed and Scopus) up to September 2020. Original articles published in English that investigated the effects of camel urine in various diseases were included. The literature search identified six potential articles that met all the inclusion criteria. Three articles showed that camel urine possesses cytotoxic activities against different types of cancer cells. Two studies revealed camel urine’s protective effects against liver toxicity and gastric ulcers, whilst another study showed the role of camel urine as an antiplatelet agent. All studies demonstrated significant positive effects with different effective dosages. Thus, camel urine shows promising therapeutic potential in treating human diseases, especially cancer. However, the standardised dosage and potential side effects should be determined before camel urine could be offered as an alternative treatment.
I have often asked myself the question whether some SCAMs are too absurd to merit scientific study. Over the years, I changed my mind on it; while initially I tended to answer it in the negative, I now think that YES: some ideas – even those that are ancient and, as Charles Windsor would argue, have thus stood the ‘test of time’ – are not worth the effort. Camel urine as a therapy might well be one of them.
This systematic review and meta-analysis was aimed at analyzing the effectiveness of craniosacral therapy in improving pain and disability among patients with headache disorders.
PubMed, Physiotherapy Evidence Database, Scopus, Cochrane Library, Web of Science, and Osteopathic Medicine Digital Library databases were searched in March 2023. Two independent reviewers searched the databases and extracted data from randomized clinical trials comparing craniosacral therapy with control or sham interventions. The same reviewers assessed the methodological quality and the risk of bias using the PEDro scale and the Cochrane Collaboration tool, respectively. Grading of recommendations, assessment, development, and evaluations was used to rate the certainty of the evidence. Meta-analyses were conducted using random effects models using RevMan 5.4 software.
The searches retrieved 735 papers, and 4 studies were finally included. The craniosacral therapy provided statistically significant but clinically unimportant change on pain intensity (Mean difference = –1.10; 95% CI: –1.85, –0.35; I2: 44%), and no change on disability or headache effect (Standardized Mean Difference = –0.34; 95% CI –0.70, 0.01; I2: 26%). The certainty of the evidence was downgraded to very low.
The authors concluded that very low certainty of evidence suggests that craniosacral therapy produces clinically unimportant effects on pain intensity, whereas no significant effects were observed in disability or headache effect.
I find it strange that researchers seem so frequently unable to formulate their conclusions clearly. Is it political correctness? Or are they somehow favorably inclined (i.e. biased) towards the treatment that they pretend to critically evaluate?
Let’s look at the facts related to this review:
- Craniosacral therapy (CST) is utterly implausible.
- Only 4 RCTs were found.
- They were of poor quality.
- They were published mostly by people who want to promote CST.
- Therefore the overall statistically significant effect is most likely a false-positive result.
- This means that the conclusion should be much more straight forward.
I suggest something along the following lines:
A critical evaluation of the existing RCTs failed to find convincing evidence that CST is an effective treatment for headache disorders.
Charles III is about to pay his first visit to France, his second visit to any state. Earlier this year, he has already visited Germany. Originally, France had been first on his list but the event was cancelled in view of the violent protests that rocked the country at the time. Now he is definitely expected and the French are exited. I am currently in France and have been asked to give several interviews on the king’s love affair with so-called alternative medicine (SCAM).
The French have long been fascinated by our royal family which seems a bit odd considering what they did to their own. Now that Charles and Camilla are about to appear with an entourage of about 50 servants between them, the press is full with slightly bemused reports and comments:
Since childhood, Charles has been accustomed to a luxurious, gilded life, which is reproduced on every trip outside the royal palaces, to ensure maximum service, comfort and security… The new king always travels with his private secretary, Sir Clive Alderton, his press advisor, his steward, his doctor, his personal valets, his security guards, and his private chauffeur, Tim Williams… And, of course, his regular osteopath to relieve his lower back. Since he’s had a lot of falls playing polo, Charles regularly suffers from back pain…”.
Really, just an osteopath?
What about all the other SCAM-practitioners whose businesses Charles so regularly supported in the past:
- · Acupuncture
- · Aromatherapy
- · Ayurveda
- · Chiropractic
- · Detox
- · Gerson therapy
- · Herbal medicine
- · Homeopathy
- · Iridology
- · Marma massage
- · Massage therapy
- · Pulse diagnosis
- · Reflexology
- · Tongue diagnosis
- · Traditional Chinese Medicine
- · Yoga
Will they not be disappointed?
I do wonder who Charles’ osteopath and doctor are. Are they competent? I am sure they both must be well-informed and evidence-based experts. If that is the case, they will have, of course, told Charles that osteopathy is hardly an optimal solution for an injured back.
In any case, now I am concerned about the royal back and therefore urgently recommend that HIS MAJESTY reads some of my previous posts on the subject, e.g.:
- Manual therapy (mainly chiropractic and osteopathy) does not have clinically relevant effects on back pain compared with sham treatment
- Spinal manipulative therapy for older adults with chronic low back pain fails to generate convincing results
- NICE no longer recommends acupuncture, chiropractic or osteopathy for low back pain
- The Effects of Yoga, Naturopathy, and Conventional Medical Treatment in Managing Low Back Pain
- Chronic non-specific low back pain: comparing cognitive functional therapy and movement system impairment (MSI)-based treatment
- Cognitive functional therapy for chronic low back pain
- Meditation for Chronic Low Back Pain Management?
Let’s hope all goes well here in France, and please let’s not be so akward as to ask about the environmental aspects – we all know how worried Charles truly is about not just his health but also the health of the planet – of moving such an entourage for a two-day visit.
Charles flew in a private jet from London to Paris and took his Bentley with him.
Exercise is often cited as a major factor contributing to improved cognitive functioning. As a result, the relationship between exercise and cognition has received much attention in scholarly literature. Systematic reviews and meta-analyses present varying and sometimes conflicting results about the extent to which exercise can influence cognition. The aim of this umbrella review was to summarize the effects of physical exercise on cognitive functions (global cognition, executive function, memory, attention, or processing speed) in healthy adults ≥ 55 years of age.
This review of systematic reviews with meta-analyses invested the effect of exercise on cognition. Databases (CINAHL, Cochrane Library, MEDLINE, PsycInfo, Scopus, and Web of Science) were searched from inception until June 2023 for reviews of randomized or non-randomised controlled trials. Full-text articles meeting the inclusion criteria were reviewed and methodological quality assessed. Overlap within included reviews was assessed using the corrected covered area method (CCA). A random effects model was used to calculate overall pooled effect size with sub-analyses for specific cognitive domains, exercise type and timing of exercise.
A total of 20 met the inclusion criteria. They were based on 332 original primary studies. Overall quality of the reviews was considered moderate with most meeting 8 or more of the 16 AMSTAR 2 categories. Overall pooled effects indicated that exercise in general has a small positive effect on cognition (d = 0.22; SE = 0.04; p < 0.01). Mind–body exercise had the greatest effect with a pooled effect size of (d = 0.48; SE = 0.06; p < 0.001). Exercise had a moderate positive effect on global cognition (d = 0.43; SE = 0,11; p < 0,001) and a small positive effect on executive function, memory, attention, and processing speed. Chronic exercise was more effective than acute exercise. Variation across studies due to heterogeneity was considered very high.
The authors concluded that mind–body exercise has moderate positive effects on the cognitive function of people aged 55 or older. To promote healthy aging, mind–body exercise should be used over a prolonged period to complement other types of exercise. Results of this review should be used to inform the development of guidelines to promote healthy aging.
It seems to me that the umbrella review hides the crucial fact that many of the primary studies had major flaws, e.g. in terms of:
- lack of randomisation,
- lack of blinding.
Eleven studies investigated the effects of aerobic exercise on cognition. Only three studies investigated the effects of mind body exercise on cognition, two analysed the effects of resistance exercise, and five investigated the effects of mixed exercise interventions. I am therefore mystified how the authors managed to arrive at such a hyped conclusion in favour of the effectiveness of mind body exercises. Even an optimistic interpretation of the data would allow merely a weak indication that a positive effect might exist. To state that mind body exercises should be promoted for ‘healthy aging’ borders on the irresponsible, in my view. Surely even the most naive researcher must see that, for such a far-reaching recommendation, we would need much more solid evidence.
I strongly suspect that a proper review of the primary studies of mind body exercise with a critical evaluation of the quality of the primary studies would lead to dramatically different conclusion.
It has been reported that a UK Conservative candidate for the next general election reportedly claimed she healed a man’s hearing through the power of prayer. Kristy Adams has been chosen to represent the Conservatives in Mid Sussex at the next general UK election, which is expected to take place in May or the autumn of next year. Mrs Adams previously stood as the Tory candidate in Hove in 2017, placing a distant second behind Labour MP Peter Kyle.
In a recording from 2010, the Conservative hopeful reportedly told the King’s Arms Church in Bedford how she healed a deaf man by placing her hands over his ears and saying: “Be healed in Jesus’s name”. Mrs Adams is reported to have said: “He had hearing aids in both ears and I just thought that wasn’t right. It just annoyed me. I said ‘can I pray for you?’ and his eyes lit up, which is unusual when you offer to pray for someone’s healing.” After removing her hands, she claims the man could hear without his hearing aids. “I don’t know if he was more surprised or me,” she reportedly said.
Speaking to The Argus during her 2017 election campaign, Mrs Adams said she had asked the Daily Mirror to remove a story about the alleged recording but refused to answer whether she believed non-scientific medical miracles can happen. She said: “Millions of Christians around the world pray every day to help people.”
- Daily prayer against severe COVID – an update of a study started two years ago
- Resolution of blindness after prayer?
- Prayer as a therapy: a new randomised study
- Prayer as a medical therapy? Time to stop this nonsense!
- When an undercover journalist tests alternative cancer healers
- Biblical Naturopathy, another SCAM that is new to me
- The ‘Association of Catholic Doctors’ and homeopathic conversion therapy
- Prof Harald Walach’s new ground breaking study of praying the Rosary
- Higher religiousness/spirituality is associated with a more frequent use of so-called alternative medicine (SCAM)
- ‘The power of all religions’ is being tested in a study with severely ill corona-virus patients
- Does religiosity influence post-operative survival?
- Daniel P Wirth, his dubious research, and the remarkable apathy of some medical journals
Suffice to say, perhaps, that the evidence for prayer as a therapy is not positive.
Homeopathic remedies are highly diluted formulations without proven clinical benefits, traditionally believed not to cause adverse events. Nonetheless, published literature reveals severe local and non–liver-related systemic side effects. Here is the first series on homeopathy-related severe drug-induced liver injury (DILI) from a single center.
A retrospective review of records from January 2019 to February 2022 identified 9 patients with liver injury attributed to homeopathic formulations. Competing causes were comprehensively excluded. Chemical analysis was performed on retrieved formulations using triple quadrupole gas chromatography-mass spectrometry and inductively coupled plasma atomic emission spectroscopy.
Males predominated with a median age of 54 years. The most typical clinical presentation was acute hepatitis, followed by acute or chronic liver failure. All patients developed jaundice, and ascites were notable in one-third of the patients. Five patients had underlying chronic liver disease. COVID-19 prevention was the most common indication for homeopathic use. Probable DILI was seen in 77.8%, and hepatocellular injury predominated (66.7%). Four (44.4%) patients died (3 with chronic liver disease) at a median follow-up of 194 days. Liver histopathology showed necrosis, portal and lobular neutrophilic inflammation, and eosinophilic infiltration with cholestasis. A total of 29 remedies were consumed between 9 patients, and 15 formulations were analyzed. Toxicology revealed industrial solvents, corticosteroids, antibiotics, sedatives, synthetic opioids, heavy metals, and toxic phyto-compounds, even in ‘supposed’ ultra-dilute formulations.
The authors concluded that homeopathic remedies potentially result in severe liver injury, leading to death in those with underlying liver disease. The use of mother tinctures, insufficient dilution, poor manufacturing practices, adulteration and contamination, and the presence of direct hepatotoxic herbals were the reasons for toxicity. Physicians, the public, and patients must realize that Homeopathic drugs are not ‘gentle placebos.’
The authors also cite our own work on this subject:
A detailed systematic review of homeopathic remedies-induced adverse events from published case reports and case series by Posadzski and colleagues showed that severe side effects, some leading to fatality, are possible with classic and unspecified homeopathic formulations. The total number of patients included was 1159, of which 1142 suffered adverse events directly related to homeopathy. The direct adverse events had acute pancreatitis, severe allergic reactions, arsenical keratosis, bullous pemphigoid, neurocognitive disorders, sudden cardiac arrest and coma, severe dyselectrolytemia, interstitial nephritis, kidney injury, thallium poisoning, syncopal attacks, and focal neurological deficits as well as movement disorders. Fatal events involved advanced renal failure requiring dialysis, toxic polyneuropathy, and quadriparesis. The duration of adverse events ranged from a few hours to 7 months, and 4 patients died. The authors state that in most cases, the mechanism of action for side effects of homeopathy involved allergic reactions or the presence of toxic substances—the use of strong mother tinctures, drug contaminants, adulterants, or poor manufacturing (incorrect dilutions).
When we published our paper back in 2012, it led to a seies of angry responses from defenders of homeopathy who claimed that one cannot ‘have the cake and eat it’; either homeopathic remedies are placebos and thus harmless, or they have effects and thus also side-effects, they claimed. As the new publication by Indian researchers yet again shows, they were mistaken. In fact, homeopathy is dangerous in more than one way:
- the homeopathic remedies can do harm if not diluted or wrongly manufactured;
- the homeopaths can do harm through their often wrong advice in health matters;
- homeopathy erodes rational thinking (as, for instance, the resopnses to our 2012 paper demonstrated).
Many community pharmacies in Switzerland provide so-called alternative medicine (SCAM) approaches in addition to providing biomedical services, and a few pharmacies specialise in SCAM. A common perception is that SCAM providers are sceptical towards, or opposed to, vaccination.
The key objectives of this study were to examine the potential roles of biomedically oriented and SCAM-specialised pharmacists regarding vaccine counselling and to better understand the association between vaccine hesitancy and SCAM. The researchers thus conducted semistructured, qualitative interviews. Transcripts were coded and analysed using thematic analysis. Interview questions were related to:
- type of pharmaceutical care practised,
- views on SCAM and biomedicine,
- perspectives on vaccination,
- descriptions of vaccination consultations in community pharmacies,
- and views on vaccination rates.
Qualitative interviews in three language regions of Switzerland (German, French and Italian). A total of 18 pharmacists (N=11 biomedically oriented, N=7 SCAM specialised) were invited.
Pharmacist participants expressed generally positive attitudes towards vaccination. Biomedically oriented pharmacists mainly advised customers to follow official vaccination recommendations but rarely counselled vaccine-hesitant customers. SCAM-specialised pharmacists were not as enthusiastic advocates of the Swiss vaccination recommendations as the biomedically oriented pharmacists. Rather, they considered that each customer should receive individualised, nuanced vaccination advice so that customers can reach their own decisions. SCAM-specialised pharmacists described how mothers in particular preferred getting a second opinion when they felt insufficiently advised by biomedically oriented paediatricians.
The authors concluded that vaccination counselling in community pharmacies represents an additional option to customers who have unmet vaccination consultation needs and who seek reassurance from healthcare professionals (HCPs) other than physicians. By providing individualised vaccination counselling to vaccine-hesitant customers, SCAM-specialised pharmacists are likely meeting specific needs of vaccine-hesitant customers. As such, research and implementation efforts should more systematically involve pharmacists as important actors in vaccination provision. SCAM-specialised pharmacists particularly should not be neglected as they are important HCPs who counsel vaccine-hesitant customers.
I must say that I find these conclusions odd, perhaps even wrong. Here are my reasons:
- Pharmacists are well-trained healthcare professionals.
- As such, they have ethical obligations towards their customers.
- These obligations include behaving in a way that is optimal for the health of their customers and follows the rules of evidence-based practice.
- This includes explaining to vaccine-hesitant customers why the recommended vaccinations make sense and advising them to follow the official vaccination guidelines.
- SCAM-specialised pharmacist should ask themselves whether offering SCAM is in line with their ethical obligation to provide optimal care and advice to their customers.
I fear that this paper suggests that SCAM-specialised pharmacists might be a danger to the health of their customers. If that is confirmed, they should consider re-training, in my view.
This randomised, double blind controlled trial compared the efficacy of curcumin versus omeprazole in improving patient reported outcomes in people with dyspepsia.
The interventions were:
- curcumin alone (C),
- omeprazole alone (O),
- curcumin plus omeprazole (C+O).
Patients in the combination group received two capsules of 250 mg curcumin, four times daily, and one capsule of 20 mg omeprazole once daily for 28 days.
Main outcome measure was unctional dyspepsia symptoms on days 28 and 56, assessed using the Severity of Dyspepsia Assessment (SODA) score. Secondary outcomes were the occurrence of adverse events and serious adverse events.
A total of 206 patients were enrolled in the study and randomly assigned to one of the three groups; 151 patients completed the study. Demographic data (age 49.7±11.9 years; women 73.4%), clinical characteristics and baseline dyspepsia scores were comparable between the three groups. Significant improvements were observed in SODA scores on day 28 in the pain (−4.83, –5.46 and −6.22), non-pain (−2.22, –2.32 and −2.31) and satisfaction (0.39, 0.79 and 0.60) categories for the C+O, C, and O groups, respectively. These improvements were enhanced on day 56 in the pain (−7.19, –8.07 and −8.85), non-pain (−4.09, –4.12 and −3.71) and satisfaction (0.78, 1.07, and 0.81) categories in the C+O, C, and O groups, respectively. No significant differences were observed among the three groups and no serious adverse events occurred.
The authors concluded that curcumin and omeprazole had comparable efficacy for functional dyspepsia with no obvious synergistic effect.
This study, which was funded by the Thai Traditional and Alternative Medicine Fund, has been picked up by the press and is being lauded as a solid proof of efficacy. Its authors too are not half proud of their splendid trial:
This multicentre randomised controlled trial provides highly reliable evidence for the treatment of functional dyspepsia. PPIs, widely used and approved for over-the-counter use, were compared with curcumin, a popular herbal remedy. The study design, including double blind randomisation, minimised biases. Participants met strict criteria, underwent endoscopy and were tested for H pylori infection. Furthermore, we implemented measures to minimise biases by ensuring that the individuals administering the drugs, participants receiving the drugs and individuals conducting the assessment remained blinded to the type of medications administered to the participants. The trial was carried out in hospitals, and certified individuals used standardised questionnaires for assessments. Statistical methods were appropriate and followed accepted principles.
Two follow-up appointments were scheduled, and blood tests showed no abnormal symptoms or liver function abnormalities. However, participants with high body mass index indicated a trend towards liver function impairment in the curcumin group, suggesting the need for larger studies. Some participants did not provide follow-up information, which is a study weakness. However, the number of participants who provided this information was sufficient for statistical analysis and the majority of the participants attended the follow-up visit. Therefore, it can be deduced from the results that even if the number of participants followed after drug administration increased, the study findings would not be significantly different. Another limitation of this study was the absence of long term follow-up data for all patients after treatment. This is a question that will require further investigation.
The strength of the study lies in its relevance to daily clinical practice, providing additional drug options in addition to PPIs alone, without added side effects. The study was unbiased, partially funded by government organisations and the first well designed trial comparing curcumin with PPI for functional dyspepsia, with confirmation through endoscopy and ruling out H pylori infection. Limitations of this study included the small number of patients who were lost to follow-up and the lack of long term follow-up data.
However, I am far less impressed.
Curcumin is bright yellow and has a very distinct taste/smell. Even though curumin was given in capsules, patients can easily tell what they are taking. I therefore doubt that they were adequately blinded. In fact, the authors seem to agree when they state the following:
We observed that despite improvements in pain and non-pain scores, there was no significant improvement in the SODA satisfaction scores in the O and C+O groups (table 3). A possible explanation for this observation could be related to the taste and/or smell of curcumin, which might have caused reduced pleasantness for the participants while ingesting it. This potential discomfort could offset the improvements in pain and non-pain symptoms, leading to the non-significant change in satisfaction score. Further studies may be needed to explore this hypothesis as well as to improve the palatability of curcumin.
Sadly, the success of blinding (which under such circumstances should always be tested) was not reported and probably not even quantified. If many patients were de-blinded, it seems inevitable that their expectation influenced the results. In other words, the much-lauded effect of curcumin might just be due to placebo and curcumin might be entirely useless. Or, to put it bluntly, the trial was not nearly as good as many made it out to be.
Sad to see that the reviewers of a reputable journal failed to pick up on this significant flaw.
The aim of this systematic review was to update the current level of evidence for spinal manipulation in influencing various biochemical markers in healthy and/or symptomatic population.
Various databases were searched (inception till May 2023) and fifteen trials (737 participants) that met the inclusion criteria were included in the review. Two authors independently screened, extracted and assessed the risk of bias in included studies. Outcome measure data were synthesized using standard mean differences and meta-analysis for the primary outcome (biochemical markers). The Grading of Recommendations, Assessment, Development and Evaluation (GRADE) was used for assessing the quality of the body of evidence for each outcome of interest.
There was low-quality evidence that spinal manipulation influenced various biochemical markers (not pooled). There was low-quality evidence of significant difference that spinal manipulation is better (SMD -0.42, 95% CI – 0.74 to -0.1) than control in eliciting changes in cortisol levels immediately after intervention. Low-quality evidence further indicated (not pooled) that spinal manipulation can influence inflammatory markers such as interleukins levels post-intervention. There was also very low-quality evidence that spinal manipulation does not influence substance-P, neurotensin, oxytocin, orexin-A, testosterone and epinephrine/nor-epinephrine.
The authors concluded that spinal manipulation may influence inflammatory and cortisol post-intervention. However, the wider prediction intervals in most outcome measures point to the need for future research to clarify and establish the clinical relevance of these changes.
The majority of the studies were of low or very low quality. This means that the collective evidence is less than reliable. In turn, this means, I think, that the conclusions are misleading. A more honest conclusion would be this:
There is no reliable evidence that spinal manipulation influences inflammatory and cortisol levels.
As for the clinical relevance, I would like to point out that it would not be surprising if chiropractors could one day convincingly show that spinal manipulation do influence various biochemical markers. Many things do! If you fall down a staircase, for instance, plenty of biochemical markers will be affected. This, however, does not mean that throwing our patients down the stairs is of therapeutic value.