pain
Chiropractic is a complementary medicine that has been growing increasingly in different countries over recent decades. It addresses the prevention, diagnosis and treatment of the neuromusculoskeletal system disorders and their effects on the whole body health.
This review aimed to evaluate the effectiveness of chiropractic in the treatment of different diseases. To gather data, scientific electronic databases, such as Cochrane, Medline, Google Scholar, and Scirus were searched and all systematic reviews in the field of chiropractic were obtained. Reviews were included if they were specifically concerned with the effectiveness of chiropractic treatment, included evidence from at least one clinical trial, included randomized studies and focused on a specific disease. The articles were excluded if:
- – they were concerned with a combination of chiropractic and other treatments (not specifically chiropractic treatment);
- – they lacked at least one clinical trial;
- – they lacked at least one randomized study;
- – and they studied chiropractic in the treatment of multiple diseases.
The research data including the article’s first author’s name, type of disease, intervention type, number and types of research used, meta-analysis, number of participants, and overall results of the study, were extracted, studied and analyzed.
Totally, 23 chiropractic systematic reviews were found, and 11 articles met the defined criteria. The results showed the influence of chiropractic on improvement of neck pain, shoulder and neck trigger points, and sport injuries. In the cases of asthma, infant colic, autism spectrum disorder, gastrointestinal problems, fibromyalgia, back pain and carpal tunnel syndrome, there was no conclusive scientific evidence. There is heterogeneity in some of the studies and also limited number of clinical trials in the assessed systematic reviews. Thus, conducting comprehensive studies based on more reliable study designs are highly recommended.
The authors stressed that three points should be emphasized. Firstly, there is a discrepancy between the development of chiropractic in different countries of the world and the quality and quantity of studies regarding the effectiveness and safety of chiropractic in treatment of diseases. Secondly, some of the systematic reviews regarding the effectiveness of chiropractic in treatment of diseases had a minimum quality of research methodology and were not useful for evaluation. Some of the excluded articles are examples of this problem. Finally, a limited number of studies (11 systematic review articles and 10 diseases) had the required criteria and were assessed in the study.
Assessment and analysis of the studies showed the impact of chiropractic on improvement of some upper extremity conditions including shoulder and neck trigger points, neck pain and sport injuries. In the case of asthma, infant colic and other studied diseases, further clinical trials with larger sample sizes and high quality research methodology are recommended.
So, is chiroprctic of proven effectiveness for any disease?
The conditions for which there is tentatively positive evidence (btw: most rely on my research!!!) are arguably not diseases but symptoms of undelying conditions. Therefore, the answer to my question above is:
NO.
Cauda equina syndrome (CES) is a lumbosacral surgical emergency that has been associated with chiropractic spinal manipulation (CSM) in numerous case reports. However, identifying if there is a potential causal effect is complicated by the heightened incidence of CES among those with low back pain (LBP). This study‘s hypothesis was that there would be no increase in the risk of CES in adults with LBP following CSM compared to a propensity-matched cohort following physical therapy (PT) evaluation without spinal manipulation over a three-month follow-up period.
A query of a United States network (TriNetX, Inc.) was conducted, searching health records of more than 107 million patients attending academic health centers, yielding data ranging from 20 years prior to the search date (July 30, 2023). Patients aged 18 or older with LBP were included, excluding those with pre-existing CES, incontinence, or serious pathology that may cause CES. Patients were divided into two cohorts:
- (1) LBP patients receiving CSM,
- (2) LBP patients receiving PT evaluation without spinal manipulation.
Propensity score matching controlled for confounding variables associated with CES.
67,220 patients per cohort (mean age 51 years) remained after propensity matching. CES incidence was 0.07% (95% confidence intervals [CI]: 0.05–0.09%) in the CSM cohort compared to 0.11% (95% CI: 0.09–0.14%) in the PT evaluation cohort, yielding a risk ratio and 95% CI of 0.60 (0.42–0.86; p = .0052). Both cohorts showed a higher rate of CES during the first two weeks of follow-up.
The authors concluded that the present study involving over 130,000 propensity-matched patients found that CSM is not a risk factor for CES. The incidence of CES in both CSM and PT evaluation cohorts aligns with previous estimates of CES incidence among patients with LBP, indicating a heightened risk of CES compared to asymptomatic individuals regardless of intervention. Moreover, these findings underscore the increased CES incidence within the first two weeks after either CSM or PT evaluation, emphasizing the need for clinicians’ vigilance in identifying and emergently referring patients with CES for surgical evaluation. Further real-world evidence is needed to corroborate these findings using alternative case-control and case-crossover designs, and different clinician comparators.
This is an interesting and well-reported investigation. Its particular strength is the huge sample size. Its weakness, on the other hand, is the fact that, despite the researchers best efforts, the two groups might not have been entirely comparable and that there could be a host of relevant factors that the propensity matching was unable to control for.
It is, I think, to the credit of the authors that they abstain from overrating their results and correctly emphasize in their conclusions that: Further real-world evidence is needed to corroborate these findings using alternative case-control and case-crossover designs, and different clinician comparators.
Cupping is a from of so-called alternative medicine (SCAM) that has featured already many times on this blog, e.g.:
- Wet cupping in the management of cervical spondylosis? No!
- The effectiveness of cupping therapy for low back pain
- Cupping: “the propagation of ancient, scientifically unsound techniques that may cause more harm than benefit”
- Cupping therapy for non-specific chronic low back pain
- Cupping for Olympic swimmers. Or: why breaking your shoulder is not necessarily good for writing a successful book
- Wet cupping and dry humour
- Cupping for athletes: rubbish trials, rubbish review, rubbish journal
- The future of cupping: it’s bright, profitable and vacuous
Now a new and interesting paper has been published on the subject
This review aimed to investigate the effectiveness of cupping therapy on low back pain (LBP). Medline, Embase, Scopus and WANFANG databases were searched for relevant cupping RCTs on low back pain articles up to 2023. A complementary search was manually made on 27 September for update screening. Full-text English and Chinese articles on all ethnic adults with LBP of cupping management were included in this study. Studies looking at acute low back pain only were excluded. Two independent reviewers screened and extracted data, with any disagreement resolved through consensus by a third reviewer. The methodological quality of the included studies was evaluated independently by two reviewers using an adapted tool. Change-from-baseline outcomes were treated as continuous variables and calculated according to the Cochrane Handbook. Data were extracted and pooled into the meta-analysis by Review Manager software (version 5.4, Nordic Cochrane Centre).
Eleven trials involving 921 participants were included (6 on dry and 5 on wet cupping). Five studies were assessed as being at low risk of bias, and six studies were of acceptable quality. High-quality evidence demonstrated cupping significantly improves pain at 2-8 weeks endpoint intervention (d=1.09, 95% CI: [0.35-1.83], p = 0.004). There was no continuous pain improvement observed at one month (d=0.11, 95% CI: [-1.02-1.23], p = 0.85) and 3-6 months (d=0.39, 95% CI: [-0.09-0.87], p = 0.11). Dry cupping did not improve pain (d=1.06, 95% CI: [-0.34, 2.45], p = 0.14) compared with wet cupping (d=1.5, 95% CI: [0.39-2.6], p = 0.008) at the endpoint intervention. There was no evidence indicating the association between pain reduction and different types of cupping (p = 0.2). Moderate- to low-quality evidence showed that cupping did not reduce chronic low back pain (d=0.74, 95% CI: [-0.67-2.15], p = 0.30) and non-specific chronic low back pain (d=0.27, 95% CI: [-1.69-2.24], p = 0.78) at the endpoint intervention. Cupping on acupoints showed a significant improvement in pain (d=1.29, 95% CI: [0.63-1.94], p < 0.01) compared with the lower back area (d=0.35, 95% CI: [-0.29-0.99], p = 0.29). A potential association between pain reduction and different cupping locations (p = 0.05) was found. Meta-analysis showed a significant effect on pain improvement compared to medication therapy (n = 8; d=1.8 [95% CI: 1.22 – 2.39], p < 0.001) and usual care (n = 5; d=1.07 [95% CI: 0.21- 1.93], p = 0.01). Two studies demonstrated that cupping significantly mediated sensory and emotional pain immediately, after 24 h, and 2 weeks post-intervention (d= 5.49, 95% CI [4.13-6.84], p < 0.001). Moderate evidence suggested that cupping improved disability at the 1-6 months follow-up (d=0.67, 95% CI: [0.06-1.28], p = 0.03). There was no immediate effect observed at the 2-8 weeks endpoint (d=0.40, 95% CI: [-0.51-1.30], p = 0.39). A high degree of heterogeneity was noted in the subgroup analysis (I2 >50%).
The authors concluded that high- to moderate-quality evidence indicates that cupping significantly improves pain and disability. The effectiveness of cupping for LBP varies based on treatment durations, cupping types, treatment locations, and LBP classifications. Cupping demonstrated a superior and sustained effect on pain reduction compared with medication and usual care. The notable heterogeneity among studies raises concerns about the certainty of these findings. Further research should be designed with a standardized cupping manipulation that specifies treatment sessions, frequency, cupping types, and treatment locations. The actual therapeutic effects of cupping could be confirmed by using objective pain assessments. Studies with at least six- to twelve-month follow-ups are needed to investigate the long-term efficacy of cupping in managing LBP.
A crucial point here is that only 3 of the included studies were ‘patient-blind’, i.e. tried to control for placebo effects by using a sham procedure:
- The first of these used leaking vaccum cups that failed to create sucction. This would therefore not have resulted in the typical circular hematoma. In other words, patients were easily de-blinded.
- The second trial compared two different wet cupping techniques which involved different procedures. This would have been easily identifiable by the patients. In other words, patients were easily de-blinded.
- The third (which showed no effectiveness of cupping) supposedly patient-blind study used a similar method as the first. In other words, patients were easily de-blinded.
In addition, we ought to remember that in no study was it possible to blind the therapists. Thus there is a danger of verbal or non-verbal communications impacting on the outcomes.
In my view, it follows that the effectiveness of cupping is far lass certain than the authors of this paper try to make us believe.
This study aimed to determine the effects of Reiki on pain and biochemical parameters in patients undergoing bone marrow transplantation. This investigation was designed as a “single-blind, repeated measures, randomized prospective controlled study”. It was conducted between August 2022 and April 2023 with patients who underwent autologous bone marrow transplantation (BMT).
- In the Reiki group (n = 21), Reiki therapy was applied directly to the energy centers for 30 min on the 0th and 1st day of BMT, and from a distance for 30 min on the 2nd day.
- No intervention was performed on the control group (n = 21).
Data were collected using the Personal Information Form, Visual Analog Scale (VAS), and biochemical parameters. Pain and biochemical parameters were evaluated on days 0, 1, 2, and 10 before the Reiki application.
There were no statistically significant differences in pain scores between the groups before the intervention (p > .005). The Reiki group showed a significant improvement in the mean VAS score compared with the control group on days 1 and 2 (p = .002; p < .001, respectively). The measurement of procalcitonin showed a decrease in the Reiki group and an increase in the control group (p = .026, p = .001, p < .001, respectively). Although the Reiki group had better absolute neutrophil, thrombocyte, and C-reactive protein values than the control group, no significant difference was observed between the groups (p > .05).
The authors concluded that Reiki is effective for pain control and enhancing the immune system response.
For the following reasons, I beg to differ:
- The patients of the verum group were fully aware of receiving the therapy; thus they were expecting/hoping to benefit from it.
- The patients of the control group received no therapy; thus they were disappointed which may have influenced thie VAS ratings.
- The procalcitonin levels are of doubtful relevance; they changed only within the group which, in a controlled clinical trial that is supposed to compare groups is meaningless and most likely a chance finding.
- The only people who could have been blinded in this ‘single blind’ study were the evaluators of the results (even though the authors state that “patients were blinded to the group assignments”) which is meaningless if patients and therapists are not blinded.
Because of all this, I feel that the conclusions should be re-written:
Reiki is known to cause a placebo effect which most likely caused the observed outcomes.
“Is Chiropractic Worth the Taxpayer’s Expense?” is the interesting question asked in this article by Ikenna Idika Ogbu from the Department of Neurosurgery, University Hospitals of North Midlands, UK and Chandrasekaran Kaliaperumal from the Department of Clinical Neurosciences, Royal Infirmary of Edinburgh, UK. Here is the abstract:
Chiropractic remains a service provided outside the NHS in the United Kingdom and the argument for inclusion has been ongoing since the 90’s. There are significant patient-reported benefits from chiropractic backed by evidence in specific use-cases as cervicogenic headaches and there are significant potential cost-savings from the inclusion of chiropractic as an NHS service. The evidence, however, does not particularly favour the use case of chiropractic, especially in the context of Low Back Pain (LBP) and the benefits of chiropractic are unclear. Considering the potential cost-savings for the NHS and the society, there should be consideration for its inclusion. However, the evidence will need to be clearer to argue for inclusion of chiropractic in the NHS spectrum of services, especially for spinal services.
So, the authors confirm that, even for back pain, “the benefits of chiropractic are unclear”, and in the next sentence they advocate “consideration for its inclusion.”
Does that make sense?
No!
Let’s be clear: the least expensive way to proceed in the short term is usually to do nothing. No treatment is invariably less expensive than treatment! Yet, this logic obviously does not account for the two most important factors in this equation: risk and benefit.
- Not treating a condition can cause prolonged, needless suffering.
- Not treating a condition can cause significant follow-up costs.
- Treating it can cause adverse effects and additional suffering.
- Adverse effects can cause significant follow-up costs.
- Treating the condition effectively will result in less suffering.
- Treating the condition effectively will result in less follow-up costs.
It follows that we should treat health problems:
- effectively,
- with few risks of side-effects,
- as cheaply as possible.
It also follows that costs are by no means the only factor in this complex equation. Cost-effectiveness without effectiveness is not possible. Moreover, cost-effectiveness withoout an acceptable degree of safety is unlikely.
In the case of chiropractic, we have hardly reliable proof of effectiveness or safety. And this means that, before we can consider chiropractic to be paid for from public money, we first need solid evidence for its safey and efficacy – each for the relevant health problem to be treated. Once we have reliable data about all this – AND ONLY THEN – might we consider including chiropractic into the public healthcare budget.
In other words, the above cited paper is naive and ill-informed to the extreme.
This study aimed at examining the feasibility issues of comparing individualized homeopathic medicines (IHMs) with identical-looking placebos for treating knee osteoarthritis (OA).
Forty eligible patients participated in this double-blind, randomized (1:1), placebo-controlled feasibility trial in the outpatient clinics of a homeopathic hospital in West Bengal, India. Either IHMs or identical-looking placebos were administered, along with mutually agreed-upon concomitant care guidelines. The Knee Injury and Osteoarthritis Outcome Score (KOOS) was the primary outcome measure, along with derived Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores from KOOS. The EQ-5D-5L questionnaire and Visual Analog Scale (VAS) were the secondary outcomes. All were measured at baseline and after 2 months. Group differences and effect sizes (Cohen’s d) were estimated using an intention-to-treat approach. p-Values less than 0.05 (two-tailed) were considered statistically significant.
Enrolment/screening and trial retention rates were 43% and 85% respectively. Recruitment was difficult owing to the coronavirus disease 2019 (COVID-19) lockdown. Group differences were statistically significant, favoring IHMs against placebos in all the KOOS sub-scales: symptoms (p < 0.001), pain (p = 0.002), activities of daily living (p < 0.001), sports or recreation (p = 0.016), and quality of life (p = 0.002). Derived WOMAC scores from KOOS favored IHMs against placebos: stiffness (p < 0.001) and pain (p < 0.001). The EQ-5D-5L questionnaire score (p < 0.001) and EQ-5D-5L VAS scores (p < 0.001) also yielded significant results, favoring IHMs over placebos. All the effect sizes ranged from moderate to large. Sulphur was the most frequently prescribed homeopathic medication. Neither group reported any harm or serious adverse events.
The authors concluded that, although recruitment was sub-optimal due to prevailing COVID-19 conditions during the trial, the action of IHMs was found to be superior to that of placebos in the treatment of knee OA. Larger and more definitive studies, with independent replications, are warranted in order to substantiate the findings.
Sorry, but I don’t understand this: the authors stated multiple times that this was a feasibility study (which tests feasibility and not effectiveness), and then they promptly report effectiveness data for which the trial was grossly under-powered (i.e. too small). Why are they doing such nonsense? Perhaps their affiliations provide a hint?
- 1Department of Materia Medica, D. N. De Homoeopathic Medical College and Hospital, Kolkata; affiliated to The West Bengal University of Health Sciences, Kolkata, West Bengal, India.
- 2Department of Repertory, D.N. De Homoeopathic Medical College and Hospital, Kolkata, West Bengal, India.
- 3Department of Organon of Medicine and Homoeopathic Philosophy, D.N. De Homoeopathic Medical College and Hospital, Kolkata, West Bengal, India.
- 4Department of Practice of Medicine, D.N. De Homoeopathic Medical College and Hospital, Kolkata, West Bengal, India.
- 5Department of Surgery, D.N. De Homoeopathic Medical College and Hospital, Kolkata, West Bengal, India.
- 6Department of Homoeopathy, East Bishnupur State Homoeopathic Dispensary, Chandi Daulatabad Block Primary Health Centre, West Bengal, India.
- 7Department of Community Medicine, D.N. De Homoeopathic Medical College and Hospital, Kolkata, West Bengal, India.
I do symathise with the pressures of reporting positive findings, if your salary comes from homeopathic institutions. Yet, I cannot help but pointing out:
THESE FINDINGS ARE INVALID AND FALSE-POSITIVE!
After all these years, some homeopaths still manage to make me (almost) speechless. Here is the abstract of an article (Ravi Raghul.G, Shivaprasad J. Overuse Injuries in Children: A Homoeopathic Approach. Indian J Integr Med. 2024; Online First.) that achieved this rare feast of incompetence:
The increasing participation of children in organized competitive sports has led to a rise in overuse injuries, posing risks of limb deformity and impairment. This article explores the diagnostic, prognostic, and therapeutic applications of HOMOEOPATHY in addressing overuse injuries in children. Overuse injuries result from repetitive strain on musculoskeletal structures, particularly prevalent during periods of physical growth and immaturity. Common injuries include stress fractures, traction apophysitis, and chronic physeal damage. In the Indian context, lack of awareness and inappropriate self-treatment exacerbate these injuries. Recognition of warning signs, such as persistent soreness, is crucial for early intervention. Rehabilitative approaches involve rest, gradual strengthening, and attention to flexibility. HOMOEOPATHY offers personalized remedies targeting specific musculoskeletal entities, aiding in recovery and preventing recurrence. Remedies such as Rhus Toxicodendron, Ruta, and Bryonia address tendon and joint issues, while Arnica montana and Symphytum officinale target trauma-related injuries. Individualized homeopathic treatment, alongside appropriate rehabilitation regimens, facilitates faster recovery from overuse injuries in children.
As this does not provide any concrete insights into how to treat overuse injuries of kids, let me also show you the ‘results’ section of this paper:
Arnica Montana
Indications: Arnica is one of the most used homeopathic remedies for injuries. It is particularly effective for muscle soreness, bruising, and inflammation resulting from overexertion and trauma. Athletes often use Arnica to reduce pain and swelling associated with overuse injuries [6].
Rhus Toxicodendron
Indications: This remedy is beneficial for conditions characterized by stiffness and pain that improve with movement and worsen with rest. Rhus tox is particularly suitable for tendinitis and bursitis where the affected area feels better after initial movement but stiffens up after periods of inactivity [7].
Ruta graveolens
Indications: Ruta is indicated for injuries involving tendons and ligaments. It is particularly useful for conditions like tendinitis and sprains where there is a sensation of bruising and lameness. This remedy is also effective in promoting the healing of bones and connective tissues [8].
Bryonia alba
Indications: Bryonia is suitable for conditions where pain is aggravated by movement and relieved by rest. It is particularly helpful for joint and muscle pain that worsens with the slightest movement [9].
Symphytum officinale
Indications: Known as “knitbone” Symphytum is particularly effective for promoting the healing of fractures and bone injuries. It is also used for periosteal injuries where the covering of the bone is affected [10].
As in this section the authors (from Dept. of Homoeopathic Paediatrics, and Father Muller Homoeopathic Medical College, Mangaluru, India) do also not provide any real evidence, let’s have a look at their references 6 – 10:
6. Tveiten D, Bruset S. Effect of Arnica montana in marathon runners. Homeopathy. 2003; 92(4):187-189.
7. Ernst E. A systematic review of systematic reviews of homeopathy. Br J Clin Pharmacol. 2002; 54(6):577-582.
8. Oberbaum M, Schreiber R, Rosenthal C, et al. Homeopathic treatment in emergency medicine. A case series. Homeopathy.
2003; 92(1):44-47.
9. Bell IR, Schwartz GE, Boyer NN, et al. Advances in integrative nanomedicine for improving infectious disease treatment in
public health. Eur J Integr Med. 2013; 5(1):39-56.
10. Vickers AJ, Fisher P, Smith C, et al. Homeopathic Arnica 30X is ineffective in preventing pain after tooth extraction. Br J Clin
Pharmacol. 1998; 45(4):532-535.
I happen to know all of these papers well (particularly the one I authored myself!). And I can assure you that none of them backs up the notion that the listed homeopathic remedies are effective for overuse injuries of children.
So, what is this paper?
- Scientific misconduct?
- Fraud?
- Sloppy research?
- Pseudo-sciene?
- Wishful thinking?
- Stupidity?
- Or just normal behaviour of pseudo-researchers in homeopathy?
I let you decide.
Osteoarthritis of the knee (OAK) is a chronic degenerative musculoskeletal disorder that strongly affects the elderly population and decreases their quality of life. Pain, stiffness, and restricted knee movements are the major characteristic features of OAK. There are no studies available on the effect of the liver 7 (LR 7) acupuncture point on pain and range of motion. This study therefore tested the effectiveness of the LR 7 acupuncture point on pain and range of motion in chronic OAK patients.
Thirty-five subjects aged between 40 and 65 years were recruited from Government Yoga and Naturopathy Medical College, Chennai. Participants were included in the study after they fulfilled the eligibility criteria. The duration of acupuncture was 20 minutes (5 days/week) for 2 weeks. Baseline and post-intervention assessments were performed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and the degree of knee flexion and extension was measured using a goniometer.
Pre- and post-trial outcomes were compared using paired t-tests. LR 7 acupuncture reduced the WOMAC score from 49 to 30 (p < 0.001), indicating that pain was alleviated. Treatment increased the range of knee flexion from 110 to 115 degrees and reduced knee extension (p < 0.01) from 16 to 9 degrees (p < 0.001). These findings indicate that acupuncture treatment improved the range of knee movement.
The authors concluded that the present study showed that 10 sessions of LR 7 acupuncture for people with OAK significantly reduced pain and increased range of motion. We conclude that LR 7 acupuncture is an adjuvant therapy for alleviating pain and managing OAK.
On several levels, this is a shocking paper:
- There already are many controlled clinical trials of acupuncture for OAK; thus there is no reason whatsoever to conduct and publish a trial that is methodolagically inferior to this body of evidence.
- The conclusions are incorrect; as the study had no control group, it is impossible to establish causaality between the treatment and the outcome. The pain reduction might have been caused by phenomena that are unrelated to acupuncture, e.g. placebo effect, regression towards the mean, social desirability.
- The authors state that they are “grateful to principal and faculities of government of yoga and naturopathy medical college and hospital for their support”. This means that they were misguided by a governmental medical college and hospital in planning and running a study that is a waste of resources and thus arguably unethical.
Research of this nature is dangerous:
- It undermines the trust people put in science.
- It makes a laughing stock of more serious attempts to test the value of acupuncture.
- It misuses the cooperation of patients who give their time and good will to advance our knowledge.
- It wasts precious resources.
- It is an incentive for others to do similarly nonsensical pseudo-science.
- It misleads patients and carers into believing in quackery.
The only valid conclusion that can be drawn from this paper is, I think, this:
The people involed in planning, conducting, supporting and publishing this study have little understanding of clinical research and should receive adequate education and training before they are allowed to continue.
This study evaluated efficacy of krill oil supplementation, compared with placebo, on knee pain in people with knee osteoarthritis who have significant knee pain and effusion-synovitis. It was designed as a multicenter, randomized, double-blind, placebo-controlled clinical trial that took place in 5 Australian cities. Participants with clinical knee osteoarthritis, significant knee pain, and effusion-synovitis on magnetic resonance imaging were enrolled from December 2016 to June 2019; final follow-up occurred on February 7, 2020.
The patients received
- 2 g/d of krill oil (n = 130)
- or matching placebo (n = 132) for 24 weeks.
The primary outcome was change in knee pain as assessed by visual analog scale (range, 0-100; 0 indicating least pain; minimum clinically important improvement = 15) over 24 weeks.
Of 262 participants randomized (mean age, 61.6 [SD, 9.6] years; 53% women), 222 (85%) completed the trial. Krill oil did not improve knee pain compared with placebo (mean change in VAS score, -19.9 [krill oil] vs -20.2 [placebo]; between-group mean difference, -0.3; 95% CI, -6.9 to 6.4) over 24 weeks. One or more adverse events was reported by 51% in the krill oil group (67/130) and by 54% in the placebo group (71/132). The most common adverse events were musculoskeletal and connective tissue disorders, which occurred 32 times in the krill oil group and 42 times in the placebo group, including knee pain (n = 10 with krill oil; n = 9 with placebo), lower extremity pain (n = 1 with krill oil; n = 5 with placebo), and hip pain (n = 3 with krill oil; n = 2 with placebo).
The authors concluded that, among people with knee osteoarthritis who have significant knee pain and effusion-synovitis on magnetic resonance imaging, 2 g/d of daily krill oil supplementation did not improve knee pain over 24 weeks compared with placebo. These findings do not support krill oil for treating knee pain in this population.
This is a rigorous and well-presented study. Apart from the ineffectiveness of krill, it confirms two issues very clearly:
- Placebo effects plus regression to the mean can lead to symptomatic improvements.
- Adverse effects occur even with placebo therapy.
Krill is a small crustacean consumed by whales, penguins and other sea creatures. It is a source of omega 3 fatty acids. The alleged benefits of krill supplements include anti-inflammatory effects. So, it could theoretically help reducing the inflammation that is part of knee osteoarthritis.
A review including five trials with 700 patients using krill oil for knee pain was recently published. Results showed no significant difference between krill oil and placebo for knee pain, knee stiffness, and lipid profiles. However, krill oil demonstrated a significant small effect in improving knee physical function. Trial sequential analysis provided certainty that krill oil enhances knee physical function compared to placebo and indicated no improvement in knee pain, but the findings for knee stiffness need to be confirmed by further research. The authors concluded that krill oil supplementation did not significantly improve knee pain, stiffness, or lipid profile, although it may help knee physical function. Based on these findings, krill oil supplementation is not yet justified for knee pain.
The two papers should settle the issue: KRILL IS NOT EFFECTIVE FOR KNEE OSTEOARTHRITIS. Will this stop the many manufacturers of krill supplements selling their products to gullible consumers? I would not hold my breath.
To date, two open-label clinical trials have indicated that acupuncture may be more effective than standard medication for chronic migraine. However, drawing definitive conclusions from these trials is challenging. Studies employing a double-dummy design can eliminate the placebo effect and offer more unbiased estimates of efficacy.
This double-dummy, single-blind, randomized controlled trial compared the efficacy and safety of acupuncture and topiramate for chronic migraine. Participants, aged 18–65 years and diagnosed with chronic migraine, were randomly assigned (1:1) to receive:
- acupuncture (three sessions/week) plus topiramate placebo (acupuncture group),
- or topiramate (50–100 mg/day) plus sham acupuncture (topiramate group) over 12 weeks.
The primary outcome was the mean change in monthly migraine days during weeks 1–12.
Of 123 screened patients, 60 (mean age 45.8, 81.7% female) were randomly assigned to the acupuncture or topiramate groups. Acupuncture demonstrated significantly greater reductions in monthly migraine days than topiramate. No severe adverse events were reported.
The authors concluded that acupuncture may be safe and effective for treating chronic migraine. The efficacy of 12 weeks of acupuncture was sustained for 24 weeks and superior to that of topiramate. Acupuncture can be used as an optional preventive therapy for chronic migraine.
I beg to differ!
The authors claim that the participants, outcome assessors, and statistical analysts were blinded (masked) to the group allocations. However, the success of patient blinding was not tested. Why?
The authors state that, in the acupuncture group, “twirling, lifting, and thrusting were performed to produce deqi (a sensation of soreness, numbness, distention, or heaviness that indicates effective needling)… In the topiramate group, sham acupuncture was administered on non-effective acupoints, without manual deqi manipulations.” In other words, patients could very easily tell to which group they had been randomised.
This, in turn, means that a placebo effect – possibly enhanced by verbal or non-verbal communication from the (non-blinded) actupuncturists – has most likely caused the observed outcomes. I therefore feel the need to re-phrase the authors’ conclusions:
This study confirms that acupuncture produces a large placebo effect. Whether it has any effects beyond placebo cannot be determined by this study. Until this point has been clarified, acupuncture should not be used as a preventive therapy for chronic migraine.
