Stable angina is a symptom of coronary heart disease which, in turn, is amongst the most frequent causes of death in developed countries. It is an alarm bell to any responsible clinician and requires causal, often life-saving treatments of which we today have several options. The last thing a patient needs in this condition is ACUPUNCTURE, I would say.
Yet acupuncture is precisely the therapy such patients might be tempted to employ.
Because irresponsible or criminally naïve acupuncturists advertise it!
Take this website, for instance; it informs us that a meta-analysis of eight clinical trials conducted between 2000 and 2014 demonstrates the efficacy of acupuncture for the treatment of stable angina. In all eight clinical trials, patients treated with acupuncture experienced a greater rate of angina relief than those in the control group treated with conventional drug therapies (90.1% vs 75.7%)….
I imagine that this sounds very convincing to patients and I fear that many might opt for acupuncture instead of potentially invasive/unpleasant but life-saving intervention. The original meta-analysis to which the above promotion referred to is equally optimistic. Here is its abstract:
Angina pectoris is a common symptom imperiling patients’ life quality. The aim of this study is to evaluate the efficacy and safety of acupuncture for stable angina pectoris. Clinical randomized-controlled trials (RCTs) comparing the efficacy of acupuncture to conventional drugs in patients with stable angina pectoris were searched using the following database of PubMed, Medline, Wanfang and CNKI. Overall odds ratio (ORs) and weighted mean difference (MD) with their 95% confidence intervals (CI) were calculated by using fixed- or random-effect models depending on the heterogeneity of the included trials. Total 8 RCTs, including 640 angina pectoris cases with 372 patients received acupuncture therapy and 268 patients received conventional drugs, were included. Overall, our result showed that acupuncture significantly increased the clinical curative effects in the relief of angina symptoms (OR=2.89, 95% CI=1.87-4.47, P<0.00001) and improved the electrocardiography (OR=1.83, 95% CI=1.23-2.71, P=0.003), indicating that acupuncture therapy was superior to conventional drugs. Although there was no significant difference in overall effective rate relating reduction of nitroglycerin between two groups (OR=2.13, 95% CI=0.90-5.07, P=0.09), a significant reduction on nitroglycerin consumption in acupuncture group was found (MD=-0.44, 95% CI=-0.64, -0.24, P<0.0001). Furthermore, the time to onset of angina relief was longer for acupuncture therapy than for traditional medicines (MD=2.44, 95% CI=1.64-3.24, P<0.00001, min). No adverse effects associated with acupuncture therapy were found. Acupuncture may be an effective therapy for stable angina pectoris. More clinical trials are needed to systematically assess the role of acupuncture in angina pectoris.
In the discussion section of the full paper, the authors explain that their analysis has several weaknesses:
Several limitations were presented in this meta-analysis. Firstly, conventional drugs in control group were different, this may bring some deviation. Secondly, for outcome of the time to onset of angina relief with acupuncture, only one trial included. Thirdly, the result of some outcomes presented in different expression method such as nitroglycerin consumption. Fourthly, acupuncture combined with traditional medicines or other factors may play a role in angina pectoris.
However, this does not deter them to conclude on a positive note:
In conclusion, we found that acupuncture therapy was superior to the conventional drugs in increasing the clinical curative effects of angina relief, improving the electrocardiography, and reducing the nitroglycerin consumption, indicating that acupuncture therapy may be effective and safe for treating stable angina pectoris. However, further clinical trials are needed to systematically and comprehensively evaluate acupuncture therapy in angina pectoris.
So, why do I find this irresponsibly and dangerously misleading?
Here a just a few reasons why this meta-analysis should not be trusted:
- There was no systematic attempt to evaluate the methodological rigor of the primary studies; any meta-analysis MUST include such an assessment, or else it is not worth the paper it was printed on.
- The primary studies all look extremely weak; this means they are likely to be false-positive.
- They often assessed not acupuncture alone but in combination with other treatments; consequently the findings cannot be attributed to acupuncture.
- All the primary studies originate from China; we have seen previously (see here and here) that Chinese acupuncture trials deliver nothing but positive results which means that their results cannot be trusted: they are false-positive.
My conclusion: the authors, editors and reviewers responsible for this article should be ashamed; they committed or allowed scientific misconduct, mislead the public and endangered patients’ lives.
I have blogged about the herbal antidepressant before; for instance about the fact that it can cause potentially dangerous herb-drug interactions. When taken alone, however, it seems to be both safe and efficacious in reducing the symptoms of depression. This notion has just been confirmed yet again.
A new systematic review evaluated St. John’s wort (SJW) for the treatment of Major Depressive Disorder (MDD). The objectives of this review were to (1) evaluate the efficacy and safety of SJW in adults with MDD compared to placebo and active comparator and (2) evaluate whether the effects vary by severity of MDD.
The authors searched 9 electronic databases and existing reviews to November 2014. Two independent reviewers screened the citations, abstracted the data, and assessed the risk of bias. They included randomized controlled trials (RCTs) examining the effect of at least a 4-week administration of SJW on depression outcomes against placebo or active comparator in adults with MDD. Risk of bias was assessed using the Cochrane Risk of Bias tool and USPSTF criteria. Quality of evidence (QoE) was assessed using the GRADE approach.
Thirty-five studies examining 6993 patients met inclusion criteria; 8 studies evaluated a SJW extract that combined 0.3 % hypericin and 1-4 % hyperforin. SJW was associated with more treatment responders than placebo (relative risk [RR] 1.53; 95 % confidence interval [CI] 1.19, 1.97; I(2) 79 %; 18 RCTs; N = 2922, moderate QoE; standardized mean differences [SMD] 0.49; CI 0.23, 0.74; 16 RCTs; I(2) 89 %, N = 2888, moderate QoE). Compared to antidepressants, SJW participants were less likely to experience adverse events (OR 0.67; CI 0.56, 0.81; 11 RCTs; moderate QoE) with no difference in treatment effectiveness (RR 1.01; CI 0.90, 1.14; 17 RCTs, I(2) 52 %, moderate QoE; SMD -0.03; CI -0.21, 0.15; 14 RCTs; I(2) 74 %; N = 2248, moderate QoE) in mild and moderate depression.
The authors concluded that SJW monotherapy for mild and moderate depression is superior to placebo in improving depression symptoms and not significantly different from antidepressant medication. However, evidence of heterogeneity and a lack of research on severe depression reduce the quality of the evidence. Adverse events reported in RCTs were comparable to placebo and fewer compared with antidepressants. However, assessments were limited due to poor reporting of adverse events and studies were not designed to assess rare events. Consequently, the findings should be interpreted with caution.
This is an excellent review from a reputable and independent team. The findings are therefore trustworthy.
Does that mean that we can now recommend SJW for patients suffering from depression?
Perhaps – but we need to keep an eye on the interaction issue. As a sole treatment, SJW is much safer than conventional antidepressants. But if a patient takes other medicines, we ought to be very careful.
Other currently unresolved issues are the questions of which extract and which dose. At present, there is not enough evidence to provide conclusive answers to either of these, and therefore the enthusiasm of many doctors for prescribing SJW is understandably limited.
Irrespective of these problems, I have to say that SJW is without question one of the biggest ‘success stories’ from the realm of alternative medicine. Pity that there are not more of them!
A website I recently came across promised to teach me 7 things about acupuncture. This sort of thing is always of interest to me; so I read them with interest and found them so remarkable that I decided to reproduce them here:
1. Addiction recovery
Acupuncture calms and relaxes the mind making it easier for people to overcome addictions to drugs, cigarettes, and alcohol by reducing the anxiety and stress they feel when quitting.
2. Helps the body heal itself
The body contains natural pain relief chemicals, such as endorphins and has an amazing capacity for self-healing. Acupuncture helps stimulate the natural healing mechanisms and causes the body to manufacture pain relieving chemicals.
3. Builds a stronger immune system
The body’s immune system is negatively affected by stress, poor diet, illness and certain medical treatments, but acupuncture targets the underlying imbalances naturally and helps it to regain balance.
4. Eliminate that killer hangover
While it may not have been the best choice to finish off that bottle of wine, acupuncture can help the body detox and flush out the morning side effects.
5. Mood stabilizer
If you find yourself snapping at friends, family, or co-workers for unexplained reasons, acupuncture can get to the root of the problem, find the imbalance and help your body return to a healthier state of mind.
6. Chronic stomach problems
Some people suffer from stomach problems and never find the cause. Acupuncture targets your whole body, including the digestive tract and helps it to work in harmony with the rest of the body’s systems.
7. Coping with death
Grief can have an overwhelming effect on the body and manifest itself physically. Acupuncture helps reduce the anxiety of dealing with loss and help you cope with the stress.
END OF QUOTE
The ‘7 things’ are remarkably mislabelled – they should be called 7 lies! Let me explain:
- There are several Cochrane reviews on the subject of acupuncture for various addictions. Here are their conclusions: There is currently no evidence that auricular acupuncture is effective for the treatment of cocaine dependence. The evidence is not of high quality and is inconclusive. Further randomised trials of auricular acupuncture may be justified. There is no clear evidence that acupuncture is effective for smoking cessation. There is currently no evidence that auricular acupuncture is effective for the treatment of cocaine dependence. The evidence is not of high quality and is inconclusive. Further randomised trials of auricular acupuncture may be justified.
- Even if the ‘endorphin story’ is true (in my view, it’s but a theory), there is no good evidence that acupuncture enhances our body’s self-healing mechanisms via endorphins or any other mechanism.
- Stronger immune system? My foot! I have no idea where this claim comes from, certainly not from anything resembling good evidence.
- Acupuncture for hangover or detox? This is just a stupid joke with no evidential support. I imagine, however, that it is superb marketing.
- The same applies to acupuncture to ‘stabilize’ your mood.
- Unexplained stomach problems? Go and see a doctor! Here is the conclusion of a Cochrane review related to IBS which is one of the more common unexplained stomach complaint: Sham-controlled RCTs have found no benefits of acupuncture relative to a credible sham acupuncture control for IBS symptom severity or IBS-related quality of life.
- I am not aware of any good evidence to show that acupuncture could ease the grieving process; I even doubt that this would be such a good or desirable thing: grieving is a necessary and essential process.
So, what we have here are essentially 7 fat lies. Yes, I know, the literature and the internet are full of them. And I suspect that they are a prominent reason why acupuncture is fairly popular today. Lies are a major marketing tool of acupuncturists – but that does not mean that we should let them get away with them!
Bogus claims may be good for the cash flow of alternative practitioners, but they are certainly not good for our health and well-being; in fact, they can cost lives!!!
IN THIS SPIRIT, LET ME ADD SEVEN THINGS YOU DO NEED TO KNOW ABOUT ACUPUNCTURE
- Traditional acupuncture is based on complete hocus pocus and is therefore implausible.
- ‘Western’ acupuncture is based on endorphin and other theories, which are little more than that and at best THEORIES.
- Acupuncture is often promoted as a ‘cure all’ which is implausible and not supported by evidence.
- Meridians, acupoints chi and all the other things acupuncturists claim to exist are pure fantasy.
- For a small list of symptoms, acupuncture is backed up by some evidence, but this is less than convincing and could well turn out to rely on little more than placebo.
- The claim of acupuncturists that acupuncture is entirely safe is false.
- Acupuncture studies from China cannot be trusted.
Low back pain (LBP) is a ‘minor complaint’ in the sense that it does not cost patients’ lives. At the same time, LBP is amongst the leading causes of disability and one of the most common reasons for patients to seek primary care. Chiropractors, osteopaths, physical therapists and general practitioners are among those treating LBP patients, but there is only limited evidence regarding the effectiveness offered by these provider groups.
The aim of this systematic review was to estimate the clinical effectiveness and to systematically review economic evaluations of chiropractic care compared to other commonly used approaches among adult patients with non-specific LBP.
A comprehensive search strategy was conducted to identify 1) pragmatic randomized clinical trials (RCTs) and/or 2) full economic evaluations of chiropractic care for low back pain compared to standard care delivered by other healthcare providers. Studies published between 1990 and 4th June 2015 were considered. The primary outcomes included pain, functional status and global improvement. Study selection, critical quality appraisal and data extraction were conducted by two independent reviewers. Data from RCTs with low risk of bias were included in a meta-analysis to determine estimates of effect sizes. Cost estimates of full economic evaluations were converted to 2015 USD and results summarized.
Six RCTs and three full economic evaluations were included. Five RCTs with low risk of bias compared chiropractic care to exercise therapy (n = 1), physical therapy (n = 3) and medical care (n = 1). The authors found similar effects for chiropractic care and the other types of care. Three low to high quality full economic evaluations studies (one cost-effectiveness, one cost-minimization and one cost-benefit) compared chiropractic to medical care. Highly divergent conclusions (favours chiropractic, favours medical care, equivalent options) were noted for economic evaluations of chiropractic care compared to medical care.
The authors drew the following conclusions: moderate evidence suggests that chiropractic care for LBP appears to be equally effective as physical therapy. Limited evidence suggests the same conclusion when chiropractic care is compared to exercise therapy and medical care although no firm conclusion can be reached at this time. No serious adverse events were reported for any type of care. Our review was also unable to clarify whether chiropractic or medical care is more cost-effective. Given the limited available evidence, the decision to seek or to refer patients for chiropractic care should be based on patient preference and values. Future studies are likely to have an important impact on our estimates as these were based on only a few admissible studies.
This is a thorough and timely review. Its results are transparent and clear, however, its conclusions are, in my view, more than a little odd.
Let me try to re-formulate them such that they are better supported by the actual data: There is no good evidence to suggest that chiropractic care is better or worse that conventional therapeutic approaches currently used for LBP. The pooled sample size dimensions too small to allow any statements about the risks of the various approaches. The data are also too weak for any pronouncements on the relative cost-effectiveness of the various options. Given these limitations, the decision which approach to use should be based on a more comprehensive analysis of the therapeutic risks.
The point I am trying to make is quite simple:
- The fact that RCTs fail to show adverse effects could be due to the small collective sample size and/or to the well-known phenomenon that, in well-controlled trials, adverse effects tend to be significantly rarer than in routine care.
- Hundreds of serious adverse events have been reported after chiropractic spinal manipulations; to these we have to add the fact that ~50% of all chiropractic patients suffer from transient, mild to moderate adverse effects after spinal manipulations.
- If we want to generate a realistic picture of the safety of a therapy, we need to include case-reports, case-series and other non-RCT evidence.
- Conventional treatments of LBP may not be free of adverse effects, but some are relatively safe.
- It seems reasonable, necessary and ethical to consider a realistic picture of the relative risks when deciding which therapy amongst equally (in)effective treatments might be best.
To me, all this seems almost painfully obvious, and I ask myself why the authors of this otherwise sound review failed to consider such thoughts. As one normally is obliged to, the authors included a section about the limitations of their review:
Our review has limitations. First, we did not search the grey literature for clinical effectiveness studies. McAuley et al. showed that the inclusion of results from the grey literature tend to decrease effectiveness estimates in meta-analyses because the unpublished studies tend to report smaller treatment effects. Second, critical appraisal requires scientific judgment that may vary among reviewers. This potential bias was minimized by training reviewers to use a standardized critical appraisal tool and using a consensus process among reviewers to reach decisions regarding scientific admissibility. Most of the original between-group differences and pooled estimates in our meta-analysis did not favour a specific provider group, and we believe it is unlikely that the inclusion of unpublished grey literature would change our conclusions. Third, the low number of clinical trials prevents us from conducting a meaningful investigation for publication bias. Fourth, the majority of the included clinical effectiveness studies (three out of five) and all three economic evaluations were conducted in the United States. Caution should therefore be used when generalizing our findings to other settings or jurisdictions. With respect to economic evaluations in particular, local healthcare systems and insurance plans may have a higher impact on cost than the type of healthcare provider.
Remarkably, this section does not mention their useless assessment of the risks with one word. Why? One answer might be found in the small-print of the paper:
The authors … have the following competing interests: MAB: Personal fees from Ordre des chiropraticiens du Québec for one teaching presentation, outside the submitted work. MJS: Position at the Nordic Institute of Chiropractic and Clinical Biomechanics is funded by the Danish Chiropractic Research Foundation. The Foundation had no role in the study design; in the design and conduct of the study, in the collection, management, analysis, and interpretation of data; in the preparation, review or approval of the manuscript; or in the decision to submit the article for publication. RBDS: Nothing to disclose. JB: Nothing to disclose. PH: Nothing to disclose. AB: Position at the School of Physical and Occupational Therapy at McGill University is funded by the Canadian Chiropractic Research Foundation. The Foundation had no role in the study design; in the design and conduct of the study, in the collection, management, analysis, and interpretation of data; in the preparation, review or approval of the manuscript; or in the decision to submit the article for publication.
In alternative medicine, good evidence is like gold dust and good evidence showing that alternative therapies are efficacious is even rarer. Therefore, I was delighted to come across a brand-new article from an institution that should stand for reliable information: the NIH, no less.
According to its authors, this new article “examines the clinical trial evidence for the efficacy and safety of several specific approaches—acupuncture, manipulation, massage therapy, relaxation techniques including meditation, selected natural product supplements (chondroitin, glucosamine, methylsulfonylmethane, S-adenosylmethionine), tai chi, and yoga—as used to manage chronic pain and related disability associated with back pain, fibromyalgia, osteoarthritis, neck pain, and severe headaches or migraines.”
The results of this huge undertaking are complex, of course, but in a nutshell they are at least partly positive for alternative medicine. Specifically, the authors state that “based on a preponderance of positive trials vs negative trials, current evidence suggests that the following complementary approaches may help some patients manage their painful health conditions: acupuncture and yoga for back pain; acupuncture and tai chi for OA of the knee; massage therapy for neck pain with adequate doses and for short-term benefit; and relaxation techniques for severe headaches and migraine. Weaker evidence suggests that massage therapy, SM, and osteopathic manipulation might also be of some benefit to those with back pain, and relaxation approaches and tai chi might help those with fibromyalgia.”
This is excellent news! Finally, we have data from an authoritative source showing that some alternative treatments can be recommended for common pain conditions.
Hold on, not so fast! Yes, the NIH is a most respectable organisation, but we must not blindly accept anything of importance just because it appears to come form a reputable source. Let’s look a bit closer at the actual evidence provided by the authors of this paper.
Reading the article carefully, it is impossible not to get troubled. Here are a few points that concern me most:
- the safety of a therapy cannot be evaluated on the basis of data from RCTs (particularly as it has been shown repeatedly that trials of alternative therapies often fail to report adverse effects); much larger samples are needed for that; any statements about safety in the aims of the paper are therefore misplaced;
- the authors talk about efficacy but seem to mean effectiveness;
- the authors only included RCTs from the US which must result in a skewed and incomplete picture;
- the article is from the National Center for Complementary and Integrative Health which is part of the NIH but which has been criticised repeatedly for being biased in favour of alternative medicine;
- not all of the authors seem to be NIH staff, and I cannot find a declaration of conflicts of interest;
- the discussion of the paper totally lacks any critical thinking;
- there is no assessment of the quality of the trials included in this review.
My last point is by far the most important. A summary of this nature that fails to take into account the numerous limitations of the primary data is, I think, as good as worthless. As I know most of the RCTs included in the analyses, I predict that the overall picture generated by this review would have changed substantially, if the risks of bias in the primary studies had been accounted for.
Personally, I find it lamentable that such a potentially worthy exercise ended up employing such lousy methodology. Perhaps even more lamentable is the fact that the NIH (or one of its Centers) can descend that low; to mislead the public in this way borders on scientific misconduct and is, in my view, unethical and unacceptable.
A new Cochrane review evaluated the effectiveness and safety of Chinese herbal medicines (CHM) in the treatment of menopausal symptoms. Its authors conducted a thorough search for randomised controlled trials (RCTs) comparing the effectiveness of CHM with placebo, hormone therapy (HT), pharmaceutical drugs, acupuncture, or another CHM formula in women suffering from menopausal symptoms.
Two review authors independently assessed 864 studies for eligibility. Data extractions were performed by them with disagreements resolved through group discussion and clarification of data or direct contact with the study authors. Data analyses were performed in accordance with Cochrane Collaboration guidelines.
In total, 22 RCTs (2902 women) could be included. When CHM was compared with placebo (8 RCTs), there was little or no evidence of a difference between the groups for the following outcomes: hot flushes per day (MD 0.00, 95% CI -0.88 to 0.89; 2 trials, 199 women; moderate quality evidence); hot flushes per day assessed by an overall hot flush score in which a difference of one point equates to one mild hot flush per day (MD -0.81 points, 95% CI -2.08 to 0.45; 3 RCTs, 263 women; low quality evidence); and overall vasomotor symptoms per month measured by the Menopause-Specific Quality of Life questionnaire (MENQOL, scale 0 to 6) (MD -0.42 points; 95% CI -1.52 to 0.68; 3 RCTs, 256 women; low quality evidence). In addition, results from individual studies suggested there was no evidence of a difference between the groups for daily hot flushes assessed by severity (MD -0.70 points, 95% CI -1.00, -0.40; 1 RCT, 108 women; moderate quality evidence); or overall monthly hot flushes scores (MD -2.80 points, 95% CI -8.93 to 3.33; 1 RCT, 84 women; very low quality evidence); or overall daily night sweats scores (MD 0.07 points, 95% CI -0.19 to 0.33, 1 RCT, 64 women; low quality evidence); or overall monthly night sweats scores (MD 1.30 points, 95% CI -1.76 to 4.36, 1 RCT, 84 women; very low quality evidence). However, one study reported that overall monthly vasomotor symptom scores were lower in the CHM group (MD -4.79 points, 95% CI -5.52 to -4.06; 1 RCT, 69 women; low quality evidence).
When CHM was compared with HT (10 RCTs), only two RCTs reported monthly vasomotor symptoms using MENQOL. It was uncertain whether CHM reduces vasomotor symptoms (MD 0.47 points, 95% CI -0.50 to 1.44; 2 RCTs, 127 women; very low quality evidence).
Adverse effects were not fully reported in the included studies. Adverse events reported by women taking CHM included mild diarrhoea, breast tenderness, gastric discomfort and an unpleasant taste. Effects were inconclusive because of imprecise estimates of effects: CHM versus placebo (RR 1.51; 95% CI 0.69 to 3.33; 7 trials, 705 women; I² = 40%); CHM versus HT (RR 0.96; 95% CI 0.66 to 1.39; 2 RCTs, 864 women; I² = 0%); and CHM versus specific conventional medications (such as Fluoxetine and Estazolam) (RR 0.20; 95% CI 0.03 to 1.17; 2 RCTs, 139 women; I² = 61%).
The authors concluded: We found insufficient evidence that Chinese herbal medicines were any more or less effective than placebo or HT for the relief of vasomotor symptoms. Effects on safety were inconclusive. The quality of the evidence ranged from very low to moderate; there is a need for well-designed randomised controlled studies.
This review seems well done and reports clear findings. The fact that there was insufficient evidence for CHM is probably no surprise to most readers of this blog. However, I would like to draw your attention to a finding that could easily be missed: most of the primary studies failed to mention adverse effects; to be perfectly clear: they did not state “there were no adverse effects”, but they simply did not mention the subject of adverse effects at all.
In my view, this is a breach of research ethics. I have been banging on about this phenomenon for some time now, because I think it is important. Many if not most clinical trials in this area neglect reporting adverse effects. This means that we get an entirely misleading impression about the safety of the treatments in question. Reviewers of such studies are bound to conclude that they seem to be safe, while, in fact, researchers have only been withholding crucial information from us.
The solution to this fast-growing problem would be simple: trialists must be forced to fully report adverse effects. This is less complicated that it might seem: journal editors must insist that all authors fully report adverse effects of alternative treatments. Even if there were none at all – a very unlikely proposition if you think about it – they must disclose this fact.
The aim of a new meta-analysis was to estimate the clinical effectiveness and safety of acupuncture for amnestic mild cognitive impairment (AMCI), the transitional stage between the normal memory loss of aging and dementia. Randomised controlled trials (RCTs) of acupuncture versus medical treatment for AMCI were identified using six electronic databases.
Five RCTs involving a total of 568 subjects were included. The methodological quality of the RCTs was generally poor. Participants receiving acupuncture had better outcomes than those receiving nimodipine with greater clinical efficacy rates (odds ratio (OR) 1.78, 95% CI 1.19 to 2.65; p<0.01), mini-mental state examination (MMSE) scores (mean difference (MD) 0.99, 95% CI 0.71 to 1.28; p<0.01), and picture recognition score (MD 2.12, 95% CI 1.48 to 2.75; p<0.01). Acupuncture used in conjunction with nimodipine significantly improved MMSE scores (MD 1.09, 95% CI 0.29 to 1.89; p<0.01) compared to nimodipine alone. Three trials reported adverse events.
The authors concluded that acupuncture appears effective for AMCI when used as an alternative or adjunctive treatment; however, caution must be exercised given the low methodological quality of included trials. Further, more rigorously designed studies are needed.
Meta-analyses like this one are, in my view, perfect examples for the ‘rubbish in, rubbish out’ principle of systematic reviews. This may seem like an unfair statement, so let me justify it by explaining the shortfalls of this specific paper.
The authors try to tell us that their aim was “to estimate the clinical effectiveness and safety of acupuncture…” While it might be possible to estimate the effectiveness of a therapy by pooling the data of a few RCTs, it is never possible to estimate its safety on such a basis. To conduct an assessment of therapeutic safety, one would need sample sizes that go two or three dimensions beyond those of RCTs. Thus safety assessments are best done by evaluating the evidence from all the available evidence, including case-reports, epidemiological investigations and observational studies.
The authors tell us that “two studies did not report whether any adverse events or side effects had occurred in the experimental or control groups.” This is a common and serious flaw of many acupuncture trials, and another important reason why RCTs cannot be used for evaluating the risks of acupuncture. Too many such studies simply don’t mention adverse effects at all. If they are then submitted to systematic reviews, they must generate a false positive picture about the safety of acupuncture. The absence of adverse effects reporting is a serious breach of research ethics. In the realm of acupuncture, it is so common, that many reviewers do not even bother to discuss this violation of medical ethics as a major issue.
The authors conclude that acupuncture is more effective than nimodipine. This sounds impressive – unless you happen to know that nimodipine is not supported by good evidence either. A Cochrane review provided no convincing evidence that nimodipine is a useful treatment for the symptoms of dementia, either unclassified or according to the major subtypes – Alzheimer’s disease, vascular, or mixed Alzheimer’s and vascular dementia.
The authors also conclude that acupuncture used in conjunction with nimodipine is better than nimodipine alone. This too might sound impressive – unless you realise that all the RCTs in question failed to control for the effects of placebo and the added attention given to the patients. This means that the findings reported here are consistent with acupuncture itself being totally devoid of therapeutic effects.
The authors are quite open about the paucity of RCTs and their mostly dismal methodological quality. Yet they arrive at fairly definitive conclusions regarding the therapeutic value of acupuncture. This is, in my view, a serious mistake: on the basis of a few poorly designed and poorly reported RCTs, one should never arrive at even tentatively positive conclusion. Any decent journal would not have published such misleading phraseology, and it is noteworthy that the paper in question appeared in a journal that has a long history of being hopelessly biased in favour of acupuncture.
Any of the above-mentioned flaws could already be fatal, but I have kept the most serious one for last. All the 5 RCTs that were included in the analyses were conducted in China by Chinese researchers and published in Chinese journals. It has been shown repeatedly that such studies hardly ever report anything other than positive results; no matter what conditions is being investigated, acupuncture turns out to be effective in the hands of Chinese trialists. This means that the result of such a study is clear even before the first patient has been recruited. Little wonder then that virtually all reviews of such trials – and there are dozens of then – arrive at conclusions similar to those formulated in the paper before us.
As I already said: rubbish in, rubbish out!
Several investigations have suggested that chiropractic care can be cost-effective. A recent review of 25 studies, for instance, concluded that cost comparison studies suggest that health care costs were generally lower among patients whose spine pain was managed with chiropractic care. However, its authors cautioned that the studies reviewed had many methodological limitations. Better research is needed to determine if these differences in health care costs were attributable to the type of HCP managing their care.
Better research might come from the US ‘Centers for Medicaid and Medicare Services’ (CMS); they conduced a two-year demonstration of expanded Medicare coverage for chiropractic services in the treatment of beneficiaries with neuromusculoskeletal (NMS) conditions affecting the back, limbs, neck, or head.
The demonstration was conducted in 2005–2007 in selected counties of Illinois, Iowa, and Virginia and the entire states of Maine and New Mexico. Medicare claims were compiled for the preceding year and two demonstration years for the demonstration areas and matched comparison areas. The impact of the demonstration was analyzed through multivariate regression analysis with a difference-in-difference framework.
Expanded coverage increased Medicare expenditures by $50 million or 28.5% in users of chiropractic services and by $114 million or 10.4% in all patients treated for NMS conditions in demonstration areas during the two-year period. Results varied widely among demonstration areas ranging from increased costs per user of $485 in Northern Illinois and Chicago counties to decreases in costs per user of $59 in New Mexico and $178 in Scott County, Iowa.
The authors concluded that the demonstration did not assess possible decreases in costs to other insurers, out-of-pocket payments by patients, the need for and costs of pain medications, or longer term clinical benefits such as avoidance of orthopedic surgical procedures beyond the two-year period of the demonstration. It is possible that other payers or beneficiaries saved money during the demonstration while costs to Medicare were increased.
In view of such results, I believe chiropractors should stop claiming that chiropractic care is cost-effective.
Turmeric (Curcuma longa) is a truly fascinating plant with plenty of therapeutic potential. It belongs to the ginger family, Zingiberaceae and is native to southern Asia. Its main active ingredients are curcumin (diferuloylmethane) and the related compounds, demethoxycurcumin and bis-demethoxycurcumin (curcuminoids) which are secondary metabolites. Turmeric has been used extensively in Ayurvedic medicine and has a variety of pharmacologic properties including antioxidant, analgesic, anti-inflammatory, and antiseptic activities.
In the often weird world of alternative medicine, turmeric is currently being heavily hyped as the new panacea. Take this website, for instance; it promotes turmeric for just about any ailment known to mankind. Here is a short excerpt to give you a flavour (pun intended, turmeric is, of course, a main ingredient in many curries):
It comes at a surprise to a lot of people that herbs can be highly effective, if not more effective, than conventional medications …
To date, turmeric is one of the top researched plants. It was involved in more than 5,600 peer-reviewed and published biomedical studies. In one research project that extended over a five year period, it was found that turmeric could potentially be used in preventive and therapeutic applications. It was also noted that it has 175 beneficial effects for psychological health…
The 14 Medications it Mimics
Or should we say the 14 medications that mimic turmeric, since turmeric has been around much longer than any chemical prescription drug. Here’s a quick look at some of them:
- Lipitor: This is a cholesterol drug that is used to reduce inflammation and oxidative stress inside of patients suffering from type 2 diabetes. When the curcuminoid component inside of turmeric is properly prepared, it can offer the same effects (according to a study published in 2008).
- Prozac: This is an antidepressant that has been overused throughout the past decade. In a study published back in 2011, turmeric was shown to offer beneficial effects that helped to reduce depressive behaviors (using animal models).
- Aspirin: This is a blood thinner and pain relief drug. In a study done in 1986, it was found that turmeric has similar affects, which makes it a candidate for patients that are susceptible to vascular thrombosis and arthritis.
- Metformin: This is a drug that treats diabetes. It is used to activate AMPK (to increase uptake of glucose) and helps to suppress the liver’s production of glucose. In a study published in 2009, it was found that curcumin was 500 to 100,000 times more effective at activating AMPK ad ACC.
- Anti-Inflammatory Drugs: This includes medications like ibuprofen, aspirin and dexamethasone, which are designed to reduce inflammation. Again, in 2004, it was proven that curcumin was an effective alternative option to these chemical drugs.
- Oxaliplatin: This is a chemotherapy drug. A study done in 2007 showed that curcumin is very similar to the drug, acting as an antiproliferative agent in colorectal cell lines.
- Corticosteroids: This is a steroid medication, which is used to treat inflammatory eye diseases. In 1999, it was found that curcumin was effective at managing this chronic condition. Then in 2008, curcumin was used in an animal model that proved it could also aid in therapy used to protect patients from lung transplantation-associated injuries by “deactivating” inflammatory genes.
Turmeric Fights Drug-Resistant Cancers… it’s been shown that curcumin can battle against cancers that are resistant to chemotherapy and radiation…
END OF QUOTE
As I said, turmeric is fascinating and promising, but such hype is clearly counter-productive and dangerous. As so often, the reality is much more sobering than the fantasy of uncritical quacks. Research is currently very active and has produced a host of interesting findings. Here are the conclusions (+links) of a few, recent reviews:
Overall, there is early evidence that turmeric/curcumin products and supplements, both oral and topical, may provide therapeutic benefits for skin health. However, currently published studies are limited and further studies will be essential to better evaluate efficacy and the mechanisms involved.
While statistical significant differences in outcomes were reported in a majority of studies, the small magnitude of effect and presence of major study limitations hinder application of these results.
The highlighted studies in the review provide evidence of the ability of curcumin to reduce the body’s natural response to cutaneous wounds such as inflammation and oxidation. The recent literature on the wound healing properties of curcumin also provides evidence for its ability to enhance granulation tissue formation, collagen deposition, tissue remodeling and wound contraction. It has become evident that optimizing the topical application of curcumin through altering its formulation is essential to ensure the maximum therapeutical effects of curcumin on skin wounds.
What emerges from a critical reading of the evidence is that turmeric has potential in several different areas. Generally speaking, clinical trials are still thin on the ground, not of sufficient rigor and therefore not conclusive. In other words, it is far too early to state or imply that we all should rush to the next health food store and buy the supplements.
On the contrary, at this stage, I would even warn people not to be seduced by the unprofessional hype and wait until we know more – much more. There might be risks associated with ingesting turmeric at high doses over long periods of time. And there are fundamental open questions about oral intake. One recent review cautioned: …its extremely low oral bioavailability hampers its application as therapeutic agent.
WATCH THIS SPACE!
The German Association of Homeopaths (Deutscher Zentralverein Homoeopathischer Aerzte) just issued a press-release explaining that they have recently determined that homeopathy works.
Well, aren’t we relieved!
Otherwise, we would have had to assume they are all quacks.
Their statement is based on what they consider a thorough analysis of the published evidence. As the whole document is about 60 pages long, I will not bother you with all the details. Instead, I will focus on what they say about systematic reviews/meta-analyses in the press-release:
Eine Betrachtung der Meta-Analysen zur Homöopathie zeigt überwiegend statistisch signifikante Ergebnisse gegenüber Placebo, die auf eine spezifische Wirksamkeit potenzierter Arzneien hinweisen. Je nach den verwendeten Selektionskriterien werden hierbei unterschiedliche Studien in die Auswertung eingeschlossen. Diese Befunde werden von den Autoren der jeweiligen Meta-Analysen zum Teil stark relativiert. Die angeführten Vorbehalte entsprechen hierbei nicht immer den üblichen wissenschaftlichen Standards.
Let me translate this for you: An assessment of the meta-analyses of homeopathy shows mostly significant results compared to placebo which indicates a specific effectiveness of potentised remedies. Depending on the selection criteria, various studies are included in the evaluation. These results are relativized by the authors of the respective meta-analyses. The listed caveats do not always reflect the usual scientific standards.
You think my English has deteriorated or my brain gone soft? No, it’s their German! It makes almost no sense at all.
Therefore, I am afraid, we need to briefly go into the hefty document after all. Their chapter on meta-analyses concludes as follows: Insgesamt ergibt sich hinsichtlich der bis dato publizierten maßgeblichen Meta-Analysen zur Homöopathie, dass in vier von fünf Fällen tendenziell eine spezifische Wirksamkeit potenzierter Arzneimittel über Placebo hinaus erkennbar ist. That makes (linguistically) a little more sense: Overall, it emerges that the currently published decisive meta-analyses show, in 4 of 5 cases, that a specific effectiveness of potentised remedies is noticeable.
In other words, it is now proven, homeopathic remedies work beyond placebo!!!
But how can this be?
Did the NHMRC not just do a similar analysis concluding that “the evidence from research in humans does not show that homeopathy is effective for treating the range of health conditions considered… homeopathy should not be used to treat health conditions that are chronic, serious, or could become serious. People who choose homeopathy may put their health at risk if they reject or delay treatments for which there is good evidence for safety and effectiveness. People who are considering whether to use homeopathy should first get advice from a registered health practitioner. Those who use homeopathy should tell their health practitioner and should keep taking any prescribed treatments.
Obviously ‘down under’ they don’t know how to evaluate published data!
Or could it be that the Germans are mistaken? Or are they perhaps joking?
Let’s have a look!
The Germans selected (cherry-picked) 5 meta-analyses which they believed to be ‘decisive’, while the Australian panel of independent experts (funded by government) assessed 57 meta-analyses and systematic reviews (all they found via extensive literature searches).
But the German evaluation was done by homeopaths (and financed by a homeopathic lobby group)! And they understand homeopathy best and would not have a bias or conflict of interest, would they?[FOR A MORE COMPLETE ANALYSIS, SEE HERE (in German)]