meta-analysis
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.
These days, it has become a rare event – I am speaking of me publishing a paper in the peer-reviewed medical literature. But it has just happened: Spanish researchers and I published a meta-analysis on the effectiveness of craniosacral therapy. Here is its abstract:
The aim of this study was to evaluate the clinical effectiveness of craniosacral therapy (CST) in the management of any conditions. Two independent reviewers searched the PubMed, Physiotherapy Evidence Database, Cochrane Library, Web of Science, and Osteopathic Medicine Digital Library databases in August 2023, and extracted data from randomized controlled trials (RCT) evaluating the clinical effectiveness of CST. The PEDro scale and Cochrane Risk of Bias 2 tool were used to assess the potential risk of bias in the included studies. The certainty of the evidence of each outcome variable was determined using GRADEpro. Quantitative synthesis was carried out with RevMan 5.4 software using random effect models.
Fifteen RCTs were included in the qualitative and seven in the quantitative synthesis. For musculoskeletal disorders, the qualitative and quantitative synthesis suggested that CST produces no statistically significant or clinically relevant changes in pain and/or disability/impact in patients with headache disorders, neck pain, low back pain, pelvic girdle pain, or fibromyalgia. For non-musculoskeletal disorders, the qualitative and quantitative synthesis showed that CST was not effective for managing infant colic, preterm infants, cerebral palsy, or visual function deficits.
We concluded that the qualitative and quantitative synthesis of the evidence suggest that CST produces no benefits in any of the musculoskeletal or non-musculoskeletal conditions assessed. Two RCTs suggested statistically significant benefits of CST in children. However, both studies are seriously flawed, and their findings are thus likely to be false positive.
So, CST is not really an effective option for any condition.
Not a big surprise! After all, the assumptions on which CST is based fly in the face of science.
Since CST is nonetheless being used by many healthcare professionals, it is, I feel, important to state and re-state that CST is an implausible intervention that is not supported by clinical evidence. Hopefully then, one day, these practitioners will remember that their ethical obligation is to treat their patients not according to their beliefs but according to the best available evidence. And, hopefully, our modest paper will have helped rendering healthcare a little less irrational and somewhat more effective.
The aim of this systematic review and network meta-analysis was to identify the optimal dose and modality of exercise for treating major depressive disorder, compared with psychotherapy, antidepressants, and control conditions.
The screening, data extraction, coding, and risk of bias assessment were performed independently and in duplicate. Bayesian arm based, multilevel network meta-analyses were performed for the primary analyses. Quality of the evidence for each arm was graded using the confidence in network meta-analysis (CINeMA) online tool. All randomised trials with exercise arms for participants meeting clinical cut-offs for major depression were included.
A total of 218 unique studies with a total of 495 arms and 14 170 participants were included. Compared with active controls (eg, usual care, placebo tablet), moderate reductions in depression were found for
- walking or jogging,
- strength training,
- mixed aerobic exercises,
- and tai chi or qigong.
The effects of exercise were proportional to the intensity prescribed. Strength training and yoga appeared to be the most acceptable modalities. Results appeared robust to publication bias, but only one study met the Cochrane criteria for low risk of bias. As a result, confidence in accordance with CINeMA was low for walking or jogging and very low for other treatments.
The authors concluded that exercise is an effective treatment for depression, with walking or jogging, yoga, and strength training more effective than other exercises, particularly when intense. Yoga and strength training were well tolerated compared with other treatments. Exercise appeared equally effective for people with and without comorbidities and with different baseline levels of depression. To mitigate expectancy effects, future studies could aim to blind participants and staff. These forms of exercise could be considered alongside psychotherapy and antidepressants as core treatments for depression.
As far as I can see, there are two main problems with these findings:
- Because too many of the studies are less than rigorous, the results are not quite as certain as the conclusions would seem to imply.
- Patients suffering from a major depressive disorder are often unable (too fatigued, demotivated, etc.) to do and/or keep up vigorous excerise over any length of time.
What I find furthermore puzzling is that, on the one hand, the results show that – as one might expect – the effects are proportional to the intensity of the excercise but, on the other hand tai chi and qugong which are both distinctly low-intensity turn out to be effective.
Nonetheless, this excellent paper is undoubtedly good news and offers hope for patients who are in desperate need of effective, safe and economical treatments.
These days – 11 years after the closure of my department at Exeter – it is not often that I co-author a peer-reviewed paper. All the more reason, I think, to celebrate when it does happen:
Our review was aimed at determining the effectiveness of meditation, primarily mindfulness-based interventions (MBIs) and transcendental meditation (TM), for the primary and secondary prevention of CVD.
We searched CENTRAL, MEDLINE, Embase, three other databases, and two trials registers on 14 November 2021, together with reference checking, citation searching, and contact with study authors to identify additional studies. We included randomised controlled trials (RCTs) of 12 weeks or more in adults at high risk of CVD and those with established CVD. We explored four comparisons: MBIs versus active comparators (alternative interventions); MBIs versus non-active comparators (no intervention, wait list, usual care); TM versus active comparators; TM versus non-active comparators. We used standard Cochrane methods. Our primary outcomes were CVD clinical events (e.g. cardiovascular mortality), blood pressure, measures of psychological distress and well-being, and adverse events. Secondary outcomes included other CVD risk factors (e.g. blood lipid levels), quality of life, and coping abilities. We used GRADE to assess the certainty of evidence.
We included 81 RCTs (6971 participants), with most studies at unclear risk of bias. MBIs versus active comparators (29 RCTs, 2883 participants) Systolic (SBP) and diastolic (DBP) blood pressure were reported in six trials (388 participants) where heterogeneity was considerable (SBP: MD -6.08 mmHg, 95% CI -12.79 to 0.63, I2 = 88%; DBP: MD -5.18 mmHg, 95% CI -10.65 to 0.29, I2 = 91%; both outcomes based on low-certainty evidence). There was little or no effect of MBIs on anxiety (SMD -0.06 units, 95% CI -0.25 to 0.13; I2 = 0%; 9 trials, 438 participants; moderate-certainty evidence), or depression (SMD 0.08 units, 95% CI -0.08 to 0.24; I2 = 0%; 11 trials, 595 participants; moderate-certainty evidence). Perceived stress was reduced with MBIs (SMD -0.24 units, 95% CI -0.45 to -0.03; I2 = 0%; P = 0.03; 6 trials, 357 participants; moderate-certainty evidence). There was little to no effect on well-being (SMD -0.18 units, 95% CI -0.67 to 0.32; 1 trial, 63 participants; low-certainty evidence). There was little to no effect on smoking cessation (RR 1.45, 95% CI 0.78 to 2.68; I2 = 79%; 6 trials, 1087 participants; low-certainty evidence). None of the trials reported CVD clinical events or adverse events. MBIs versus non-active comparators (38 RCTs, 2905 participants) Clinical events were reported in one trial (110 participants), providing very low-certainty evidence (RR 0.94, 95% CI 0.37 to 2.42). SBP and DBP were reduced in nine trials (379 participants) but heterogeneity was substantial (SBP: MD -6.62 mmHg, 95% CI -13.15 to -0.1, I2 = 87%; DBP: MD -3.35 mmHg, 95% CI -5.86 to -0.85, I2 = 61%; both outcomes based on low-certainty evidence). There was low-certainty evidence of reductions in anxiety (SMD -0.78 units, 95% CI -1.09 to -0.41; I2 = 61%; 9 trials, 533 participants; low-certainty evidence), depression (SMD -0.66 units, 95% CI -0.91 to -0.41; I2 = 67%; 15 trials, 912 participants; low-certainty evidence) and perceived stress (SMD -0.59 units, 95% CI -0.89 to -0.29; I2 = 70%; 11 trials, 708 participants; low-certainty evidence) but heterogeneity was substantial. Well-being increased (SMD 0.5 units, 95% CI 0.09 to 0.91; I2 = 47%; 2 trials, 198 participants; moderate-certainty evidence). There was little to no effect on smoking cessation (RR 1.36, 95% CI 0.86 to 2.13; I2 = 0%; 2 trials, 453 participants; low-certainty evidence). One small study (18 participants) reported two adverse events in the MBI group, which were not regarded as serious by the study investigators (RR 5.0, 95% CI 0.27 to 91.52; low-certainty evidence). No subgroup effects were seen for SBP, DBP, anxiety, depression, or perceived stress by primary and secondary prevention. TM versus active comparators (8 RCTs, 830 participants) Clinical events were reported in one trial (201 participants) based on low-certainty evidence (RR 0.91, 95% CI 0.56 to 1.49). SBP was reduced (MD -2.33 mmHg, 95% CI -3.99 to -0.68; I2 = 2%; 8 trials, 774 participants; moderate-certainty evidence), with an uncertain effect on DBP (MD -1.15 mmHg, 95% CI -2.85 to 0.55; I2 = 53%; low-certainty evidence). There was little or no effect on anxiety (SMD 0.06 units, 95% CI -0.22 to 0.33; I2 = 0%; 3 trials, 200 participants; low-certainty evidence), depression (SMD -0.12 units, 95% CI -0.31 to 0.07; I2 = 0%; 5 trials, 421 participants; moderate-certainty evidence), or perceived stress (SMD 0.04 units, 95% CI -0.49 to 0.57; I2 = 70%; 3 trials, 194 participants; very low-certainty evidence). None of the trials reported adverse events or smoking rates. No subgroup effects were seen for SBP or DBP by primary and secondary prevention. TM versus non-active comparators (2 RCTs, 186 participants) Two trials (139 participants) reported blood pressure, where reductions were seen in SBP (MD -6.34 mmHg, 95% CI -9.86 to -2.81; I2 = 0%; low-certainty evidence) and DBP (MD -5.13 mmHg, 95% CI -9.07 to -1.19; I2 = 18%; very low-certainty evidence). One trial (112 participants) reported anxiety and depression and found reductions in both (anxiety SMD -0.71 units, 95% CI -1.09 to -0.32; depression SMD -0.48 units, 95% CI -0.86 to -0.11; low-certainty evidence). None of the trials reported CVD clinical events, adverse events, or smoking rates.
We concluded that despite the large number of studies included in the review, heterogeneity was substantial for many of the outcomes, which reduced the certainty of our findings. We attempted to address this by presenting four main comparisons of MBIs or TM versus active or inactive comparators, and by subgroup analyses according to primary or secondary prevention, where there were sufficient studies. The majority of studies were small and there was unclear risk of bias for most domains. Overall, we found very little information on the effects of meditation on CVD clinical endpoints, and limited information on blood pressure and psychological outcomes, for people at risk of or with established CVD. This is a very active area of research as shown by the large number of ongoing studies, with some having been completed at the time of writing this review. The status of all ongoing studies will be formally assessed and incorporated in further updates.
Some people will say that meditation is not a form of so-called alternative medicine (SCAM) but rather an aspect of lifestyle used for relaxation and well-being. As such, it should not be scrutinized like a therapy. This might be partly true, but as soon as proper health claims are made for meditation or similar modalities, they do need to be tested like any other therapy, in my view.
As our review demonstrates, meditation and similar treatments are not nearly as well supported by evidence as their proponents try to make us believe. In other words, the often-voiced claims that such therapies are effective for the primary and secondary prevention of cardiovascular disease are largely unfounded.
Guest post by Udo Endruscheit
Switzerland is probably the European country with the strangest complementary and alternative medicine (CAM) regulations in the health insurance system. A total of five different CAM methods have been included in the benefits catalogue of basic insurance for several years. However, this is subject to a strange proviso. How did this come about?
As almost everywhere in Europe, there was a desire in Switzerland in the 1990s to include CAM in the public healthcare system, with homeopathy naturally once again taking pole position. Initially, the urge to include five CAM modalities in basic care was granted, but only provisionally. A major project called the “Complementary Medicine Evaluation Programme” (PEK) was launched in 1999 to evaluate the procedures. Even back then, the criteria of efficacy, appropriateness and cost-effectiveness were prerequisites for reimbursement in health insurance. PEK was intended to create clarity here.
One part of PEK has been the well-known Shang/Egger (2005) study on homeopathy “Are the clinical effects of homoeopathy placebo effects? Comparative study of placebo-controlled trials of homoeopathy and allopathy”, which was to become a bone of contention without precedent. However, this did not change the negative result for homeopathy.
In any case, clear conclusions were drawn in Switzerland not only from this study, but also from the results of the other evaluations: the provisional inclusion of the methods in statutory basic insurance was terminated.
This in turn enraged the supporters of CAM methods, who thought they had already reached their goal with the provisional decision in their favour. Apparently, they had not even considered the possibility that scientific evaluations could actually lead to a sudden end to their wishes, which they believed had already been fulfilled.
In fact, in 2009, the friends of ineffective methods succeeded in bringing about one of the referendums for which Switzerland is known under the catchphrase “direct democracy”. And they prevailed – around two thirds of the votes cast were in favour of CAM and its inclusion in the Swiss Federal Constitution. However, it should be borne in mind that the two-thirds figure is put into perspective if the approval, including the low voter turnout, is converted to the proportion of the total electorate. This leaves just 17 per cent who voted for the CAM. And a closer look at the issue of the constitution also reveals that no unconditional protection space has been created for CAM. This is more or less a kind of good behaviour clause for CAM methods, but not rules that could render laws null and void.
The Swiss government was faced with the question of how to avoid simply ignoring the result of the referendum, while at the same time complying with the still valid requirements for reimbursement in basic insurance. So the representatives of the five CAM directions were actually asked to come to the Federal Office of Public Health with their proof of efficacy and economic efficiency. This was done in 2011.
Of course, this was a little bizarre at this stage – and of course nothing came of it. Or actually it did: once again, no proof could be provided. Meanwhile, a lot of time had passed again and a new Federal Council was forced to take up the matter.
The latter, Alain Berset, came up with the plan that the necessary proof of efficacy could actually be postponed until after the methods had been included in the catalogue of basic insurance benefits. In other words, he gave the methods a governmental leap of faith (which, in view of the long-year history of the case, meant closing several eyes) and postulated that this should be the matter until someone applied for an evaluation of one of the methods.
This is what happened in the year of our Lord 2017. Apparently everyone was able to make their peace with it, which is hardly surprising after ten years of moving around and around. Only the umbrella organisation of health insurers, Santesuisse, grumbled about it and predicted that the announced cost neutrality of such a measure could hardly be expected. Which Santesuisse did indeed prove in a dossier two years later.
The exhausted Swiss have so far left it at that. Homeopathy remained untouched. This was also unfortunate for the reason that the fairy tale of the clever and innovative Switzerland, which knew how important the wishes and preferences of its patients were, was propagated in Germany. The rather strange result of more than ten years of struggle was even passed around by German homeopaths under the name “Swiss model”. Even the leading Swiss press was embarrassed by this and published a clarifying article. And unfortunately, the Swiss began to get used to the existence of hocus-pocus in their basic insurance and to take it for granted.
Until now. Even in Switzerland, the fact that homeopathy is coming under increasing criticism everywhere has probably not gone unnoticed. And the Swiss are actually a rather critical and resistant people. And so it happened that a single brave inhabitant of the country recently decided to exercise his right to demand a new evaluation of homeopathy. The Federal Office of Public Health must have been surprised – or perhaps they were desperately waiting for it? Perhaps. In any case, the application was accepted without hesitation. Meanwhile, a notification has been issued that the hearing procedure for the evaluation has been initiated. The representatives of homeopathy (the service providers), the representatives of the Swiss medical profession and the representatives of the health insurance companies – the aforementioned Santesuisse – will be heard. The final decision will then be made by the Swiss government’s Department of Home Affairs.
How many attempts at an evaluation has this actually been – the third? The fourth? We can’t keep up … We have seen the consequences of scientific questions being decided by majorities. It is to be hoped that Switzerland will not add another chapter to the drama that has been going on since 2005. Mr Berset’s successor, who has been in office since the beginning of the year, should only be given a brief reminder: in Switzerland, too, homeopathy has no effect beyond contextual effects. And that is not enough to prove efficacy, appropriateness and cost-effectiveness.
But cheers to the courageous descendant of William Tell, who is about to single-handedly bring down homeopathy in the Swiss healthcare system!
This systematic review aimed to investigate the effectiveness of cupping therapy on low back pain (LBP). Medline, Embase, Scopus and WANFANG databases were searched for relevant cupping RCTs on low back pain articles up to 2023. A complementary search was manually made on 27 September for update screening. Full-text English and Chinese articles on all ethnic adults with LBP of cupping management were included. Studies looking at acute low back pain only were excluded. Two independent reviewers screened and extracted data, with any disagreement resolved through consensus by a third reviewer. The methodological quality of the included studies was evaluated independently by two reviewers using an adapted tool. Change-from-baseline outcomes were treated as continuous variables and calculated according to the Cochrane Handbook. Data were extracted and pooled into the meta-analysis by Review Manager software (version 5.4, Nordic Cochrane Centre).
Eleven trials involving 921 participants were included. Five studies were assessed as being at low risk of bias, and six studies were of acceptable quality. The findings reveal:
- High-quality evidence demonstrated cupping significantly improves pain at 2-8 weeks endpoint intervention (d=1.09, 95% CI: [0.35-1.83], p=0.004).
- There was no continuous pain improvement observed at one month (d=0.11, 95% CI: [-1.02-1.23], p=0.85) and 3-6 months (d=0.39, 95% CI: [-0.09-0.87], p=0.11).
- Dry cupping did not improve pain (d=1.06, 95% CI: [-0.34, 2.45], p=0.14) compared with wet cupping (d=1.5, 95% CI: [0.39-2.6], p=0.008) at the endpoint intervention.
- There was no evidence indicating the association between pain reduction and different types of cupping (p=0.2).
- Moderate- to low-quality evidence showed that cupping did not reduce chronic low back pain (d=0.74, 95% CI: [-0.67-2.15], p=0.30) and non-specific chronic low back pain (d=0.27, 95% CI: [-1.69-2.24], p=0.78) at the endpoint intervention.
- Cupping on acupoints showed a significant improvement in pain (d=1.29, 95% CI: [0.63-1.94], p<0.01) compared with the lower back area (d=0.35, 95% CI: [-0.29-0.99], p=0.29).
- A potential association between pain reduction and different cupping locations (p=0.05) was found.
- Meta-analysis showed a significant effect on pain improvement compared to medication therapy (n=8; d=1.8 [95% CI: 1.22 – 2.39], p<0.001) and usual care (n=5; d=1.07 [95% CI: 0.21- 1.93], p=0.01).
- Two studies demonstrated that cupping significantly mediated sensory and emotional pain immediately, after 24 hours, and 2 weeks post-intervention (d= 5.49, 95% CI [4.13-6.84], p<0.001).
- Moderate evidence suggested that cupping improved disability at the 1-6 months follow-up (d=0.67, 95% CI: [0.06-1.28], p=0.03).
- There was no immediate effect observed at the 2-8 weeks endpoint (d=0.40, 95% CI: [-0.51-1.30], p=0.39).
- A high degree of heterogeneity was noted in the subgroup analysis (I2 >50%).
The authors concluded that high- to moderate-quality evidence indicates that cupping significantly improves pain and disability. The effectiveness of cupping for LBP varies based on treatment durations, cupping types, treatment locations, and LBP classifications. Cupping demonstrated a superior and sustained effect on pain reduction compared with medication and usual care. The notable heterogeneity among studies raises concerns about the certainty of these findings. Further research should be designed with a standardized cupping manipulation that specifies treatment sessions, frequency, cupping types, and treatment locations. The real therapeutic effects of cupping could be confirmed using a sham device or objective outcome measurements. Studies with at least six- to twelve-month follow-ups are needed to investigate the long-term efficacy of cupping in managing LBP.
Confused?
No need, it’s really quite simple: cupping can, according to this review, be shown to have some short-lasting effect, provided the study is flawed and does not control for placebo effects.
Surprised?
No need! There is hardly a form of so-called alternative medicine (SCAM) that does not have a similarly small effect of back pain, if tested in equally dodgy studies. This is particularly true for those treatments that can act as a theatrical placebo, e.g. acupuncture or chiropractic.
So, should a back pain sufferer try cupping?
If he/she insists, why not? But please don’t use wet cupping (which can do quite a bit of harm). Dry cupping (without injuring the skin) is arguably better (less risk, less expense, possibility of home treatment by your partner) than chiropractic, osteopathy, acupuncture, or many other SCAMs.
My conclusions – as mentioned many times previously – are as follows:
- Most SCAMs help a little with back pain (and similar conditions) because they can have a powerful placebo effect.
- Conventional medicine is also not convincingly effective for back pain.
- If you insist on SCAM, it is best to use one that is relatively harmless and inexpensive.
NICE helps practitioners and commissioners get the best care to patients, fast, while ensuring value for the taxpayer. Internationally, NICE has a reputation for being reliable and trustworthy. But is that also true for its recommendations regarding the use of acupuncture? NICE currently recommends that patients consider acupuncture as a treatment option for the following conditions:
- chronic (long-term) pain
- chronic tension-type headaches
- migraines
- prostatitis symptoms
- hiccups
Confusingly, on a different site, NICE also recommends acupuncture for retinal migraine, a very specific type of migraine that affect normally just one eye with symptoms such as vision loss lasting up to one hour, a blind spot in the vision, headache, blurred vision and seeing flashing lights, zigzag patterns or coloured spots or lines, as well as feeling nauseous or being sick.
I think this perplexing situation merits a look at the evidence. Here I quote the conclusions of recent, good quality, and (where possible) independent reviews:
- Chronic pain: Acupuncture is efficacious for reducing pain in patients with LBP… Further research needs to be done to evaluate acupuncture’s efficacy in these conditions, especially for abdominal pain, as many of the current studies have a risk of bias due to lack of blinding and small sample size.
- Chronic tension-type headaches (TTH): Acupuncture may be an effective and safe treatment for TTH patients. Due to low or very low certainty of evidence and high heterogeneity, more rigorous RCTs are needed to verify the effect and safety of acupuncture in the management of TTH.
- Migraines: Many studies suggest that acupuncture is a safe, helpful and available alternative therapy that may be beneficial to certain migraine patients. Nevertheless, further large-scale RCTs are warranted to further consolidate these findings and provide further support for the clinical value of acupuncture. Despite previous studies that have analyzed the effects of acupuncture on migraine, there is still a need for further investigation to ensure that the incorporation of acupuncture into migraine treatment management will have a positive outcome on patients.
- Prostatitis: This meta-analysis indicated that acupuncture has measurable benefits on CP/CPPS, and security has also been ensured. However, this meta-analysis only included 10 RCTs; thus, RCTs with a larger sample size and longer-term observation are required to verify the effectiveness of acupuncture further in the future.
- Hiccups: All of these studies sought to determine the effectiveness of different acupuncture techniques in the treatment of persistent and intractable hiccups. All four studies had a high risk of bias, did not compare the intervention with placebo, and failed to report side effects or adverse events for either the treatment or control groups.
- Retinal migraine: no evidence
So, what do we make of this? I think that, on the basis of the evidence:
- a positive recommendation for all types of chromic pain is not warranted;
- a positive recommendation for the treatment of TTH is questionable;
- a positive recommendation for migraine is questionable;
- a positive recommendation for prostatitis is questionable;
- a positive recommendation for hiccups is not warranted;
- a positive recommendation for retinal migraine is not warranted.
But why did NICE issue positive recommendations despite weak or even non-existent evidence?
SEARCH ME!
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Omega-3 fatty acids (fish oil) supplementation reduces the occurrence of cardiovascular disease (CVD) and CVD-related mortality in patients at high-risk of CVD and in patients with elevated plasma triglyceride level. Yet, some studies have found an increased risk of atrial fibrillation (AF). AF is the most common sustained cardiac arrhythmia worldwide. It is associated with high morbidity and mortality rates and significant public health burden. Previous studies of the effect of omega-3 fatty acids on AF occurrence have reported contradictory results.
This review evaluated the effect of omega-3 fatty acids on the risk of AF. The results suggest that omega-3 fatty acids supplementation is associated with increased AF risk, particularly in trials that used high doses. Therefore, several factors should be considered before prescribing omega-3 fatty acids, including their dose, type, and formulation (fish, dietary fish oil supplements, and purified fatty acids), as well as patient-related factors and atrial mechanical milieu. Because the benefits of omega-3 fatty acids are dose-dependent, the associated AF risk should be balanced against the benefit for CVD. Patients who take omega-3 fatty acids, particularly at high doses, should be informed of the risk of AF and followed up for the possible development of this common and potentially hazardous arrhythmia.
Another recent review included 54,799 participants from 17 cohorts. A total of 7,720 incident cases of AF were ascertained after a median 13.3 years of follow-up. In multivariable analysis, EPA levels were not associated with incident AF, HR per interquintile range (ie, the difference between the 90th and 10th percentiles) was 1.00 (95% CI: 0.95-1.05). HRs for higher levels of DPA, DHA, and EPA+DHA, were 0.89 (95% CI: 0.83-0.95), 0.90 (95% CI: 0.85-0.96), and 0.93 (95% CI: 0.87-0.99), respectively.
The authors concluded that in vivo levels of omega-3 fatty acids including EPA, DPA, DHA, and EPA+DHA were not associated with increased risk of incident AF. Our data suggest the safety of habitual dietary intakes of omega-3 fatty acids with respect to AF risk. Coupled with the known benefits of these fatty acids in the prevention of adverse coronary events, our study suggests that current dietary guidelines recommending fish/omega-3 fatty acid consumption can be maintained.
Faced with contradictory results based on non-RCT evidence, we clearly need an RCT. Luckily such a trial has recently been published. It was an ancillary study of a 2 × 2 factorial randomized clinical trial involving 25 119 women and men aged 50 years or older without prior cardiovascular disease, cancer, or AF. Participants were recruited directly by mail between November 2011 and March 2014 from all 50 US states and were followed up until December 31, 2017.
Participants were randomized to receive EPA-DHA (460 mg/d of EPA and 380 mg/d of DHA) and vitamin D3 (2000 IU/d) (n = 6272 analyzed); EPA-DHA and placebo (n = 6270 analyzed); vitamin D3 and placebo (n = 6281 analyzed); or 2 placebos (n = 6296 analyzed). The primary outcome was incident AF confirmed by medical record review.
Among the 25 119 participants who were randomized and included in the analysis (mean age, 66.7 years; 50.8% women), 24 127 (96.1%) completed the trial. Over a median 5.3 years of treatment and follow-up, the primary end point of incident AF occurred in 900 participants (3.6% of study population). For the EPA-DHA vs placebo comparison, incident AF events occurred in 469 (3.7%) vs 431 (3.4%) participants, respectively (hazard ratio, 1.09; 95% CI, 0.96-1.24; P = .19). For the vitamin D3 vs placebo comparison, incident AF events occurred in 469 (3.7%) vs 431 (3.4%) participants, respectively (hazard ratio, 1.09; 95% CI, 0.96-1.25; P = .19). There was no evidence for interaction between the 2 study agents (P = .39).
The authors concluded that among adults aged 50 years or older, treatment with EPA-DHA or vitamin D3, compared with placebo, resulted in no significant difference in the risk of incident AF over a median follow-up of more than 5 years. The findings do not support the use of either agent for the primary prevention of incident AF.
So, does the regular supplementation with omega-3 fatty acids increase the risk of atrial fibrillation? The evidence is not entirely clear but, on balance, I conclude that the risk is low or even non-existent.
The concept that the outcomes of spinal manipulation therapy (SMT) – the hallmark intervention of chiropractors which they use on practically every patient – are optimized when the treatment is aimed at a clinically relevant joint is commonly assumed and central to teaching and clinical use of chiropractic. But is the assumption true?
This systematic review investigated whether clinical effects are superior when this is the case compared to SMT applied elsewhere. Eligible study designs were randomized controlled trials that investigated the effect of SMT applied to candidate versus non-candidate sites for spinal pain.
The authors obtained studies from four different databases. Risk of bias was assessed using an adjusted Cochrane risk of bias tool, adding four items for study quality. Between-group differences were extracted for any reported outcome or, when not reported, calculated from the within-group changes. Outcomes were compared for SMT applied at a ‘relevant’ site to SMT applied elsewhere. The authors prioritized methodologically robust studies when interpreting results.
Ten studies were included. They reported 33 between-group differences; five compared treatments within the same spinal region and five at different spinal regions.
None of the nine studies with low or moderate risk of bias reported statistically significant between-group differences for any outcome. The tenth study reported a small effect on pain (1.2/10, 95%CI – 1.9 to – 0.5) but had a high risk of bias. None of the nine articles of low or moderate risk of bias and acceptable quality reported that “clinically-relevant” SMT has a superior outcome on any outcome compared to “not clinically-relevant” SMT. This finding contrasts with ideas held in educational programs and clinical practice that emphasize the importance of joint-specific application of SMT.
The authors concluded that the current evidence does not support that SMT applied at a supposedly “clinically relevant” candidate site is superior to SMT applied at a supposedly “not clinically relevant” site for individuals with spinal pain.
I came across this study when I searched for the published work of Prof Stephen Perle, a chiropractor and professor at the School of Chiropractic, College of Health Sciences, University of Bridgeport, US, who recently started trolling me on this blog. Against my expectation, I find his study interesting and worthwhile.
His data quite clearly show that the effects of SMT are non-specific and mainly due to a placebo response. That in itself is not hugely remarkable and has been suspected to some time, e.g.:
- Chiropractic manipulation for migraine is a placebo therapy
- Chiropractic treatments are placebos
- Chiropractic spinal manipulation = placebo!
- Manual therapy (mainly chiropractic and osteopathy) does not have clinically relevant effects on back pain compared with sham treatment
- Manual therapies for back pain: not better than a placebo
- Is spinal manipulation a placebo therapy?
What is remarkable, however, is the fact that Perle and his co-authors offer all sorts of other explanation for their findings without even seriously considering what is stareing in their faces:
SPINAL MANIPULATIONS ARE PLACEBOS
CHIROPRACTIC IS A PLACEBO THERAPY
This might be almost acceptable, if chiropractic would not also be burdened with significant risks (as we have discussed ad nauseam on this blog) – another fact of which chiros like Perle are in denial.
What does all that mean for patients?
The practical implication is fairly straight forward: the risk/benefit balance of chiropractic is negative. And this surely means the only responsible advice to patients is this:
NEVER CONSULT A CHIRO!
