Monthly Archives: April 2023
This single-blind, randomized, clinical trial was aimed at determining the long-term clinical effects of spinal manipulative therapy (SMT) or mobilization (MOB) as an adjunct to neurodynamic mobilization (NM) in the management of individuals with Lumbar Disc Herniation with Radiculopathy (DHR).
Forty participants diagnosed as having a chronic DHR (≥3 months) were randomly allocated into two groups with 20 participants each in the SMT and MOB groups.
Participants in the SMT group received high-velocity, low-amplitude manipulation, while those in the MOB group received Mulligans’ spinal mobilization with leg movement. Each treatment group also received NM as a co-intervention, administered immediately after the SMT and MOB treatment sessions. Each group received treatment twice a week for 12 weeks.
The following outcomes were measured at baseline, 6, 12, 26, and 52 weeks post-randomization; back pain, leg pain, activity limitation, sciatica bothersomeness, sciatica frequency, functional mobility, quality of life, and global effect. The primary outcomes were pain and activity limitation at 12 weeks post-randomization.
The results indicate that the MOB group improved significantly better than the SMT group in all outcomes (p < 0.05), and at all timelines (6, 12, 26, and 52 weeks post-randomization), except for sensory deficit at 52 weeks, and reflex and motor deficits at 12 and 52 weeks. These improvements were also clinically meaningful for neurodynamic testing and sensory deficits at 12 weeks, back pain intensity at 6 weeks, and for activity limitation, functional mobility, and quality of life outcomes at 6, 12, 26, and 52 weeks of follow-ups. The risk of being improved at 12 weeks post-randomization was 40% lower (RR = 0.6, CI = 0.4 to 0.9, p = 0.007) in the SMT group compared to the MOB group.
The authors concluded that this study found that individuals with DHR demonstrated better improvements when treated with MOB plus NM than when treated with SMT plus NM. These improvements were also clinically meaningful for activity limitation, functional mobility, and quality of life outcomes at long-term follow-up.
Yet again, I find it hard to resist playing the devil’s advocate: had the researchers added a third group with sham-MOB, they would have perhaps found that this group would have recovered even faster. In other words, this study might show that SMT is no good for DHR (which I find unsurprising), but it does NOT demonstrate MOB to be an effective therapy.
Low back pain (LBP) affects almost all of us at some stage. It is so common that it has become one of the most important indications for most forms of so-called alternative medicine (SCAM). In the discussions about the value (or otherwise) of SCAMs for LBP, we sometimes forget that there are many conventional medical options to treat LBP. It is therefore highly relevant to ask how effective they are. This overview aimed to summarise the evidence from Cochrane Reviews of the efficacy, effectiveness, and safety of systemic pharmacological interventions for adults with non‐specific LBP.
The Cochrane Database of Systematic Reviews was searched from inception to 3 June 2021, to identify reviews of randomised controlled trials (RCTs) that investigated systemic pharmacological interventions for adults with non‐specific LBP. Two authors independently assessed eligibility, extracted data, and assessed the quality of the reviews and certainty of the evidence using the AMSTAR 2 and GRADE tools. The review focused on placebo comparisons and the main outcomes were pain intensity, function, and safety.
Seven Cochrane Reviews that included 103 studies (22,238 participants) were included. There was high confidence in the findings of five reviews, moderate confidence in one, and low confidence in the findings of another. The reviews reported data on six medicines or medicine classes: paracetamol, non‐steroidal anti‐inflammatory drugs (NSAIDs), muscle relaxants, benzodiazepines, opioids, and antidepressants. Three reviews included participants with acute or sub‐acute LBP and five reviews included participants with chronic LBP.
Acute LBP
Paracetamol
There was high‐certainty evidence for no evidence of difference between paracetamol and placebo for reducing pain intensity (MD 0.49 on a 0 to 100 scale (higher scores indicate worse pain), 95% CI ‐1.99 to 2.97), reducing disability (MD 0.05 on a 0 to 24 scale (higher scores indicate worse disability), 95% CI ‐0.50 to 0.60), and increasing the risk of adverse events (RR 1.07, 95% CI 0.86 to 1.33).
NSAIDs
There was moderate‐certainty evidence for a small between‐group difference favouring NSAIDs compared to placebo at reducing pain intensity (MD ‐7.29 on a 0 to 100 scale (higher scores indicate worse pain), 95% CI ‐10.98 to ‐3.61), high‐certainty evidence for a small between‐group difference for reducing disability (MD ‐2.02 on a 0‐24 scale (higher scores indicate worse disability), 95% CI ‐2.89 to ‐1.15), and very low‐certainty evidence for no evidence of an increased risk of adverse events (RR 0.86, 95% CI 0. 63 to 1.18).
Muscle relaxants and benzodiazepines
There was moderate‐certainty evidence for a small between‐group difference favouring muscle relaxants compared to placebo for a higher chance of pain relief (RR 0.58, 95% CI 0.45 to 0.76), and higher chance of improving physical function (RR 0.55, 95% CI 0.40 to 0.77), and increased risk of adverse events (RR 1.50, 95% CI 1. 14 to 1.98).
Opioids
None of the included Cochrane Reviews aimed to identify evidence for acute LBP.
Antidepressants
No evidence was identified by the included reviews for acute LBP.
Chronic LBP
Paracetamol
No evidence was identified by the included reviews for chronic LBP.
NSAIDs
There was low‐certainty evidence for a small between‐group difference favouring NSAIDs compared to placebo for reducing pain intensity (MD ‐6.97 on a 0 to 100 scale (higher scores indicate worse pain), 95% CI ‐10.74 to ‐3.19), reducing disability (MD ‐0.85 on a 0‐24 scale (higher scores indicate worse disability), 95% CI ‐1.30 to ‐0.40), and no evidence of an increased risk of adverse events (RR 1.04, 95% CI ‐0.92 to 1.17), all at intermediate‐term follow‐up (> 3 months and ≤ 12 months postintervention).
Muscle relaxants and benzodiazepines
There was low‐certainty evidence for a small between‐group difference favouring benzodiazepines compared to placebo for a higher chance of pain relief (RR 0.71, 95% CI 0.54 to 0.93), and low‐certainty evidence for no evidence of difference between muscle relaxants and placebo in the risk of adverse events (RR 1.02, 95% CI 0.67 to 1.57).
Opioids
There was high‐certainty evidence for a small between‐group difference favouring tapentadol compared to placebo at reducing pain intensity (MD ‐8.00 on a 0 to 100 scale (higher scores indicate worse pain), 95% CI ‐1.22 to ‐0.38), moderate‐certainty evidence for a small between‐group difference favouring strong opioids for reducing pain intensity (SMD ‐0.43, 95% CI ‐0.52 to ‐0.33), low‐certainty evidence for a medium between‐group difference favouring tramadol for reducing pain intensity (SMD ‐0.55, 95% CI ‐0.66 to ‐0.44) and very low‐certainty evidence for a small between‐group difference favouring buprenorphine for reducing pain intensity (SMD ‐0.41, 95% CI ‐0.57 to ‐0.26).
There was moderate‐certainty evidence for a small between‐group difference favouring strong opioids compared to placebo for reducing disability (SMD ‐0.26, 95% CI ‐0.37 to ‐0.15), moderate‐certainty evidence for a small between‐group difference favouring tramadol for reducing disability (SMD ‐0.18, 95% CI ‐0.29 to ‐0.07), and low‐certainty evidence for a small between‐group difference favouring buprenorphine for reducing disability (SMD ‐0.14, 95% CI ‐0.53 to ‐0.25).
There was low‐certainty evidence for a small between‐group difference for an increased risk of adverse events for opioids (all types) compared to placebo; nausea (RD 0.10, 95% CI 0.07 to 0.14), headaches (RD 0.03, 95% CI 0.01 to 0.05), constipation (RD 0.07, 95% CI 0.04 to 0.11), and dizziness (RD 0.08, 95% CI 0.05 to 0.11).
Antidepressants
There was low‐certainty evidence for no evidence of difference for antidepressants (all types) compared to placebo for reducing pain intensity (SMD ‐0.04, 95% CI ‐0.25 to 0.17) and reducing disability (SMD ‐0.06, 95% CI ‐0.40 to 0.29).
The authors concluded as follows: we found no high‐ or moderate‐certainty evidence that any investigated pharmacological intervention provided a large or medium effect on pain intensity for acute or chronic LBP compared to placebo. For acute LBP, we found moderate‐certainty evidence that NSAIDs and muscle relaxants may provide a small effect on pain, and high‐certainty evidence for no evidence of difference between paracetamol and placebo. For safety, we found very low‐ and high‐certainty evidence for no evidence of difference with NSAIDs and paracetamol compared to placebo for the risk of adverse events, and moderate‐certainty evidence that muscle relaxants may increase the risk of adverse events. For chronic LBP, we found low‐certainty evidence that NSAIDs and very low‐ to high‐certainty evidence that opioids may provide a small effect on pain. For safety, we found low‐certainty evidence for no evidence of difference between NSAIDs and placebo for the risk of adverse events, and low‐certainty evidence that opioids may increase the risk of adverse events.
This is an important overview, in my opinion. It confirms what I and others have been stating for decades: WE CURRENTLY HAVE NO IDEAL SOLUTION TO LBP.
This is regrettable but true. It begs the question of what one should recommend to LBP sufferers. Here too, I have to repeat myself: (apart from staying as active as possible) the optimal therapy is the one that has the most favourable risk/benefit profile (and does not cost a fortune). And this option is not drugs, chiropractic, osteopathy, acupuncture, or any other SCAM – it is (physio)therapeutic exercise which is cheap, safe, and (mildly) effective.
Guided imagery is said to distract patients from disturbing feelings and thoughts, positively affects emotional well-being, and reduce pain by producing pleasing mental images.
This study aimed to determine the effects of guided imagery on postoperative pain management in patients undergoing lower extremity surgery. This randomized controlled study was conducted between April 2018 and May 2019. It included 60 patients who underwent lower extremity surgery. After using guided imagery, the posttest mean Visual Analog Scale score of patients in the intervention group was found to be 2.56 (1.00 ± 6.00), whereas the posttest mean score of patients in the control group was 4.10 (3.00 ± 6.00), and the difference between the groups was statistically significant (p <.001).
The authors concluded that guided imagery reduces short-term postoperative pain after lower extremity surgery.
I did not want to spend $52 to access the full article. Therefore, I can only comment on what the abstract tells me – and that is regrettably not a lot.
In fact, we don’t even learn what treatment was given to the control group. I guess that both groups receive standard post-op care and the control group received nothing in addition. This would mean that the observed effect might be entirely due to placebo and other non-specific effects. If that is so, the authors’ conclusion is not accurate.
I happen to think that guided imagery is a promising albeit under-researched therapy. Therefore, I am particularly frustrated to see that the few trials that do emerge of this option are woefully inadequate to determine its value.
During the coronavirus disease 2019 pandemic, Ayurvedic herbal supplements and homeopathic remedies were promoted as immune boosters (IBs) and disease-preventive agents. This happened in most parts of the world but nowhere more intensely than in India.
The present study examined the clinical outcomes among patients with chronic liver disease who presented with complications of portal hypertension or liver dysfunction temporally associated with the use of IBs in the absence of other competing causes. This Indian single-center retrospective observational cohort study included patients with chronic liver disease admitted for the evaluation and management of jaundice, ascites, or hepatic encephalopathy temporally associated with the consumption of IBs and followed up for 180 days. Chemical analysis was performed on the retrieved IBs.
From April 2020 to May 2021, 1022 patients with cirrhosis were screened, and 178 (19.8%) were found to have consumed complementary and alternative medicines. Nineteen patients with cirrhosis (10.7%), jaundice, ascites, hepatic encephalopathy, or their combination related to IBs use were included. The patients were predominantly male (89.5%). At admission, 14 (73.75%) patients had jaundice, 9 (47.4%) had ascites, 2 (10.5%) presented with acute kidney injury, and 1 (5.3%) had overt encephalopathy. Eight patients (42.1%) died at the end of the follow-up period. Hepatic necrosis and portal-based neutrophilic inflammation were the predominant features of liver biopsies.
Ten samples of IBs, including locally made ashwagandha powder, giloy juice, Indian gooseberry extracts, pure giloy tablets, multiherbal immune-boosting powder, other multiherbal tablets, and the homeopathic remedy, Arsenicum album 30C, were retrieved from our study patients. Samples were analyzed for potential hepatotoxic prescription drugs, known hepatotoxic adulterants, pesticides, and insecticides, which were not present in any of the samples. Detectable levels of arsenic (40%), lead (60%), and mercury (60%) were found in the samples analyzed. A host of other plant-derived compounds, industrial solvents, chemicals, and anticoagulants was identified using GC–MS/MS. These include glycosides, terpenoids, phytosteroids, and sterols, such as sitosterol, lupeol, trilinolein, hydroxy menthol, methoxyphenol, butyl alcohol, and coumaran derivatives.
The authors concluded that Ayurvedic and Homeopathic supplements sold as IBs potentially cause the worsening of preexisting liver disease. Responsible dissemination of scientifically validated, evidence-based medical health information from regulatory bodies and media may help ameliorate this modifiable liver health burden.
The authors comment that Ayurvedic herbal supplements and homeopathic remedies sold as IBs, potentially induce idiosyncratic liver injury in patients with preexisting liver disease. Using such untested advertised products can lead to the worsening of CLD in the form of liver failure or portal hypertension events, which are associated with a high risk of mortality compared to those with severe AH-related liver decompensation in the absence of timely liver transplantation. Severe mixed portal inflammation and varying levels of hepatic necrosis are common findings on liver histopathology in IB-related liver injury. Health regulatory authorities and print and visual media must ensure the dissemination of responsible and factual scientific evidence-based information on herbal and homeopathic “immune boosters” and health supplements to the public, specifically to the at-risk patient population.
Research by the Milner Center for Evolution at the University of Bath, U.K., along with colleagues at the Universities of Oxford and Aberdeen, found that trust in scientists has hugely increased since the COVID-19 pandemic. The study also found that people were more likely to take the COVID-19 vaccine if their trust in the science had increased.
Using data from a survey of more than 2,000 U.K. adults commissioned by the Genetics Society, the team asked individuals whether their trust in scientists had gone up, down, or stayed the same.
- A third of people reported that their trust in scientists had gone up.
- When Pfizer, a company that made COVID-19 vaccines, was used as an example of the pharma industry, more people reported a positive response than when GlaxoSmithKline, a company not associated with the COVID-19 vaccine, was mentioned.
- The researchers also found that people who reported holding a negative view of science before the pandemic had become even more negative.
- People reporting increased trust were most likely to take the COVID-19 vaccine.
- Those preferring not to do so reported a decline in trust.
This is an interesting study with relevance to many discussions we had on this blog. I recommend reading it in full. Here are the abstract and link to the paper:
While attempts to promote acceptance of well-evidenced science have historically focused on increasing scientific knowledge, it is now thought that for acceptance of science, trust in, rather than simply knowledge of, science is foundational. Here we employ the COVID-19 pandemic as a natural experiment on trust modulation as it has enabled unprecedented exposure of science. We ask whether trust in science has on the average altered, whether trust has changed the same way for all and, if people have responded differently, what predicts these differences? We 1) categorize the nature of self-reported change in trust in “scientists” in a random sample of over 2000 UK adults after the introduction of the first COVID vaccines, 2) ask whether any reported change is likely to be real through consideration of both a negative control and through experiment, and 3) address what predicts change in trust considering sex, educational attainment, religiosity, political attitude, age and pre-pandemic reported trust. We find that many more (33%) report increased trust towards “scientists” than report decreased trust (7%), effects of this magnitude not being seen in negative controls. Only age and prior degree of trust predict change in trust, the older population increasing trust more. The prior degree of trust effect is such that those who say they did not trust science prior to the pandemic are more likely to report becoming less trusting, indicative of both trust polarization and a backfire effect. Since change in trust is predictive of willingness to have a COVID-19 vaccine, it is likely that these changes have public health consequences.
