Acupuncture has remained one of the most controversial topics in the area of alternative medicine. Is it plausible? Is it safe? Is it effective? The arguments have been raging for decades and are by no means settled yet. The June issue of Anesth. Analg. is partly dedicated to this debate; the editor has invited two teams of experts to put forward their contrasting views.
The team of experts arguing in support of acupuncture conclude as follows: “clinical trials support the efficacy of acupuncture in reducing post-operative nausea and vomiting and postoperative pain; however, evidence supporting acupuncture as a treatment for chronic pain conditions is mixed. It should be noted that acupuncture trials in chronic pain have concluded that acupuncture treatment is often superior to standard of care or wait list controls and that acupuncture has minimal side effects and is cost effective. Brain imaging studies have demonstrated that there are different neural correlates between verum and sham acupuncture stimulation. Additionally, all clinical trials and many research studies have assumed that the acupuncture effect is equal to the “needle” effect, failing to recognize that factors in addition to specific effects of needling are also important contributors to the therapeutic effect of acupuncture in the setting of chronic pain.
Last, acupuncture is an ancient medical intervention first developed in an era when there were no laboratory tests, technology, or science of anatomy. The reason that the practice of acupuncture has survived for thousands of years is because it has evolved over time, with changes ranging from the number of acupuncture points to the practice techniques. Instead of criticizing this ancient art with arguments culled from modern medicine and science, physicians and scientists should try to integrate current knowledge into this ancient, yet ever-evolving practice so it may be used to treat conditions for which pharmaceutical interventions are ineffective and/or potentially dangerous. Over the last decade, there has been a growing green movement and eco-sustainability trend as well as an increased awareness that the same medication may not be effective in treating every patient with the same biomedical diagnosis. This “new age-integrative medicine” in Western culture promotes a patient-oriented medical practice that complements the ancient Chinese theory behind acupuncture practice. Overall, acupuncture practice should not be seen as a placebo intervention or merely a needle therapy, but a medical option that not only treats disorders but also fosters a greater awareness of how harmonic interactions between self, family, work, and environment play a role in promoting health and restoring order”.
The two experts arguing against the usefulness of acupuncture draw the following conclusions: “It is clear from meta-analyses that results of acupuncture trials are variable and inconsistent, even for single conditions. After thousands of trials of acupuncture and hundreds of systematic reviews,arguments continue unabated. In 2011, Pain published an editorial that summed up the present situation well.
“Is there really any need for more studies? Ernst et al. point out that the positive studies conclude that acupuncture relieves pain in some conditions but not in other very similar conditions. What would you think if a new pain pill was shown to relieve musculoskeletal pain in the arms but not in the legs? The most parsimonious explanation is that the positive studies are false positives. In his seminal article on why most published research findings are false, Ioannidis points out that when a popular but ineffective treatment is studied, false positive results are common for multiple reason, including bias and low prior probability.”
Since it has proved impossible to find consistent evidence after more than 3000 trials, it is time to give up. It seems very unlikely that the money that it would cost to do another 3000 trials would be well-spent.
A small excess of positive results after thousands of trials is most consistent with an inactive intervention. The small excess is predicted by poor study design and publication bias. Furthermore, Simmons et al. demonstrated that exploitation of “undisclosed flexibility in data collection and analysis” can produce statistically positive results even from a completely nonexistent effect. They say this is “… not driven by a willingness to deceive but by the self-serving interpretation of ambiguity, which enables us to convince ourselves that whichever decisions produced the most publishable outcome must have also been the most appropriate.”
With acupuncture, in particular, there is documented profound bias among proponents. Existing studies are also contaminated by variables other than acupuncture, such as the frequent inclusion of “electroacupuncture” which is essentially transdermal electrical nerve stimulation masquerading as acupuncture.
The best controlled studies show a clear pattern, with acupuncture the outcome does not depend on needle location or even needle insertion. Since these variables are those that define acupuncture, the only sensible conclusion is that acupuncture does not work. Everything else is the expected noise of clinical trials, and this noise seems particularly high with acupuncture research. The most parsimonious conclusion is that with acupuncture there is no signal, only noise.
The interests of medicine would be best-served if we emulated the Chinese Emperor Dao Guang and issued an edict stating that acupuncture and moxibustion should no longer be used in clinical practice.
No doubt acupuncture will continue to exist on the “High Streets” where they can be tolerated as a voluntary self-imposed tax on the gullible (as long as they do not make unjustified claims).”
The readers of this blog will no doubt make up their own mind as to which arguments are stronger, more logical, more convincing, and based on more reliable evidence. I recommend reading the full articles and studying the references.
Personally, I have no hesitation in agreeing with the second, more sceptical view, and I have to admit finding the pro-acupuncture arguments weak as well as full of clichés, fallacies and errors.
I look forward to a lively discussion.
Where I live, some of the old-fashioned, privately-owned shops that used to dominate our high streets have survived the onslaught of the supermarkets. Our bakery is such a quaint remnant from the past. Surprisingly, it also is more holistic and more therapeutic than any alternative health centre I have come across.
The first thing that strikes anyone who enters the premises is the irresistible smell. Customers’ well being hits the ceiling, and the local aromatherapists are in danger of going out of business. The intense stimulation of the customers’ olfactory system relaxes their mind and puts them into a meditative state as they patiently wait to be served. Everyone in the queue has a little word with the baker’s wife, and progress is therefore slow – but we don’t mind: the chat is holistic counselling at its best, and our slow movements towards the counter are healthier than tai chi.
“You are looking well today,” says the baker’s wife, thereby gently arousing me from my aroma-induced meditation and indicating that she is about to focus her shaman healing-energy on me. Her diagnosis is spot on; the alternative therapies I enjoyed while waiting have re-balanced my chakras and got my qi flowing nicely – no wonder I am looking well!
The whole-wheat scones are finely balanced and nutritious; so I order three—one for the walk home and two for tea later. Prices have gone up a bit but, as with all holistic therapies, the more you pay, the more it’s worth. “Here you are,” she says, handing me her dietary delights. As I pay, our hands touch ever so briefly, just long enough for me to experience the instant transfer of healing energy that is so characteristic of Therapeutic Touch.
“Take care now, and God bless”, she says. As I walk out of her aura, I contemplate her words full of empathetic spiritual guidance and ancient wisdom. “That was expensive”, my wife mutters back home. I beg to differ: not only did I get the most wholesome food for my physical body, but I received holistic and patient-centred aromatherapy, counselling, meditation, tai chi and energy healing for my emotional, psychological and spiritual needs.
If only our Health Secretary knew about this traditional, yet integrated and therefore cutting-edge approach to cost-effective health and holistic well-being. We could all have it for free, and it might even save the NHS from its current crisis!
Neck pain is a common problem which is often far from easy to treat. Numerous therapies are being promoted but few are supported by good evidence. Could yoga be the solution?
The aim of a brand-new RCT was to evaluate the effectiveness of Iyengar yoga for chronic non-specific neck pain. Patients were randomly assigned to either yoga or exercise. The yoga group attended a 9-week yoga course, while the exercise group received a self-care manual on home-based exercises for neck pain. The primary outcome measure was neck pain. Secondary outcome measures included functional disability, pain at motion, health-related quality of life, cervical range of motion, proprioceptive acuity, and pressure pain threshold. Fifty-one patients participated in the study: yoga (n = 25), exercise (n = 26). At the end of the treatment phase, patients in the yoga group reported significantly less neck pain compared as well as less disability and better mental quality of life compared with the exercise group. Range of motion and proprioceptive acuity were improved and the pressure pain threshold was elevated in the yoga group.
The authors draw the following conclusion: “Yoga was more effective in relieving chronic nonspecific neck pain than a home-based exercise program. Yoga reduced neck pain intensity and disability and improved health-related quality of life. Moreover, yoga seems to influence the functional status of neck muscles, as indicated by improvement of physiological measures of neck pain.”
I’d love to agree with the authors and would be more than delighted, if an effective treatment for neck pain had been identified. Yoga is fairly safe and inexpensive; it promotes a generally healthy life-style, and is attractive to many patients; it has thus the potential to help thousands of suffering individuals. However, I fear that things might not be quite as rosy as the authors of this trial seem to believe.
The principle of an RCT essentially is that two groups of patients receive two different therapies and that any difference in outcome after the treatment phase is attributable to the therapy in question. Unfortunately, this is not the case here. One does not need to be an expert in critical thinking to realise that, in the present study, the positive outcome might be unrelated to yoga. For instance, it could be that the unsupervised home exercises were carried out wrongly and thus made the neck pain worse. In this case, the difference between the two treatment groups might not have been caused by yoga at all. A second possibility is that the yoga-group benefited not from the yoga itself but from the attention given to these patients which the exercise-group did not have. A third explanation could be that the yoga teachers were very kind to their patients, and that the patients returned their kindness by pretending to have less symptoms or exaggerating their improvements. In my view the most likely cause of the results seen in this study is a complex mixture of all the options just mentioned.
This study thus teaches us two valuable lessons: 1) whenever possible, RCTs should be designed such that a clear attribution of cause and effect is possible, once the results are on the table; 2) if cause and effect cannot be clearly defined, it is unwise to draw conclusions that are definite and have the potential to mislead the public.
A stroke is a condition where brain cells get irreversibly damaged either by a haemorrhage in the brain or by a blood clot cutting off oxygen supply. This process leaves most patients with neurological deficits such as difficulties in moving, speaking, concentrating etc. As other parts of the brain learn to take over, these problems can partly or completely resolve themselves over time, but many patients are left with permanent handicaps. Stroke-rehabilitation can minimise these problems, and there is a long-standing debate as to which measures are most effective. Acupuncture has been discussed as a method to improve the results of stroke-rehabilitation, but the evidence is hotly disputed. This is why a new study in this area is an important contribution to our existing knowledge.
The aim of this randomised trial was to test the effectiveness of acupuncture in promoting the recovery of patients with ischaemic stroke and to determine whether the outcomes of combined physiotherapy and acupuncture are superior to those with physiotherapy alone. The Chinese investigators recruited 120 patients who received one of three daily treatments: 1) acupuncture, 2) physiotherapy, 3) physiotherapy combined with acupuncture. Motor function in the limbs was measured with the Fugl-Meyer assessment (FMA); the modified Barthel index (MBI) was used to rate activities of daily living; both of these measures are validated and well-established. All evaluations were performed by assessors blinded to treatment allocation.
At baseline, FMA and MBI scores did not significantly differ among the treatment groups. Compared with baseline, on day 28 of therapy, the mean FMA scores of the physiotherapy, acupuncture, and combined treatment groups had increased by 65.6%, 57.7%, and 67.2%, respectively; on day 56, FMA scores had increased by 88.1%, 64.5%, and 88.6%, respectively. The respective MBI scores in the three groups had increased by 85.2%, 60.4%, and 63.4% at day 28 and by 108.0%, 71.2%, and 86.2% at day 56, respectively. However, FMA scores did not significantly differ between the three treatment groups on the 28th day. By the day 56, the FMA and MBI scores of the physiotherapy group were 46.1% and 33.2% greater, respectively, than those in the acupuncture group. No significant differences were seen between the combined treatment group and the other groups. The FMA subscores for the upper extremities did not show significant improvements in any group on day 56.
The authors draw the following conclusion: “Acupuncture is less effective for the outcome measures studied than is physiotherapy. Moreover, the therapeutic effect of combining acupuncture with physiotherapy was not superior to that of physiotherapy alone. A larger-scale clinical trial is necessary to confirm these finding.”
Our own study arrived at similarly disappointing conclusions: “Acupuncture is not superior to sham treatment for recovery in activities of daily living and health-related quality of life after stroke, although there may be a limited effect on leg function in more severely affected patients“. Our review of all 10 sham-controlled RCTs in this area is also in line with the results of this new study: “Our meta-analyses of data from rigorous randomized sham-controlled trials did not show a positive effect of acupuncture as a treatment for functional recovery after stroke”
I am quite sure that some acupuncture-enthusiasts will dispute this evidence. They might argue that I am too critical, the trials were not done optimally, that acupuncturists have seen plenty of good results in their clinical practice, that acupuncture is a complex intervention that does not fit into the straight jacket of an RCT, that this or that “prestigious” organisation recommends acupuncture for stroke patients, that it would be wrong not to give acupuncture a try etc. etc. I would counter that the reliable evidence available to date is sufficiently conclusive to stop claiming that acupuncture is effective and thus give false hope to severely suffering, vulnerable patients. Moreover, I would advocate using the sparse available resources to help stroke victims with treatments that demonstrably work.
One of the best-selling supplements in the UK as well as several other countries is evening primrose oil (EPO). It is available via all sorts of outlets (even respectable pharmacies – or is that supposedly respectable?), and is being promoted for a wide range of conditions, including eczema. The NIH website is optimistic about its efficacy: “Evening primrose oil may have modest benefits for eczema.” Our brand-new Cochrane review was aimed at critically assessing the effects of oral EPO or borage oil (BO) on the symptoms of atopic eczema, and it casts considerable doubt on this somewhat uncritical view.
Here is what we did: We searched six databases as well as online trials registers and checked the bibliographies of included studies for further references to relevant trials. We corresponded with trial investigators and pharmaceutical companies to identify unpublished and ongoing trials. We also performed a separate search for adverse effects. All RCTs investigating oral intake of EPO or BO for eczema were included.
Two experts independently applied eligibility criteria, assessed risk of bias, and extracted data. We pooled dichotomous outcomes using risk ratios (RR), and continuous outcomes using the mean difference (MD). Where possible, we pooled study results using random-effects meta-analysis and tested statistical heterogeneity.
And here is what we found: 27 studies with a total of 1596 participants met our inclusion criteria: 19 studies tested EPO, and 8 studies assessed BO. A meta-analysis of results from 7 studies showed that EPO failed to improve global eczema symptoms as reported by participants and doctors. Treatment with BO also failed to improve global eczema symptoms. 67% of the studies had a low risk of bias for random sequence generation; 44%, for allocation concealment; 59%, for blinding; and 37%, for other biases.
Our conclusions were clear: Oral borage oil and evening primrose oil lack effect on eczema; improvement was similar to respective placebos used in trials. Oral BO and EPO are not effective treatments for eczema.
The very wide-spread notion that EPO is effective for eczema and a range of other conditions was originally promoted by the researcher turned entrepreneur, D F Horrobin, who claimed that several human diseases, including eczema, were due to a lack of fatty acid precursors and could thus be effectively treated with EPO. In the 1980s, Horrobin began to sell EPO supplements without having conclusively demonstrated their safety and efficacy; this led to confiscations and felony indictments in the US. As chief executive of Scotia Pharmaceuticals, Horrobin obtained licences for several EPO-preparations which later were withdrawn for lack of efficacy. Charges of mismanagement and fraud led to Horrobin being ousted as CEO by the board of the company. Later, Horrobin published a positive meta-analysis of EPO for eczema where he excluded the negative results of the largest published trial, but included results of 7 of his own unpublished studies. When scientists asked to examine the data, Horrobin’s legal team convinced the journal to refuse the request.
The evidence for EPO is negative not just for eczema. To the best of my knowledge, there is not a single disease or symptom for which it demonstrably works. Our own review of the data concluded ” EPO has not been established as an effective treatment for any condition”
Our new Cochrane review might help to put this long saga to rest. In my view, it is a fascinating tale of a scientist being blinded by creed and ambition. The results of such errors can be dramatic. Horrobin misled all of us: patients, health care professionals, scientists, regulators, decision makers, businessmen. This caused unnecessary expense and set back research efforts in a multitude of areas. I find the tale also fascinating from other perspectives; for instance, it begs the question why so many ‘respectable’ manufacturers and retailers are still allowed to make money on EPO. Is it not time to debunk the EPO-myth and say it as clearly as possible: EPO helps only those who financially profit from misleading the public?
In the UK, we have about 150000 practitioners of Spiritual Healing (SH). They treat all sorts of conditions claiming to channel ‘healing energy’ into the patient’s body which enables him/her to heal itself. The plausibility of SH is very close to zero and, despite numerous trials, its clinical effectiveness remains unproven. A new and, in my view, remarkable study of SH was aimed at investigating whether “SH could support patients with breast cancer”.
Spiritual Healing was provided by 4 healers registered with the National Federation of Spiritual Healers. Twelve patients with breast cancer undergoing long-term hormone treatment and experiencing its adverse-effects as onerous, self-referred themselves and were given ten weekly sessions of approximately 40 minutes each. Data collected included participant’s daily records, direct observations noted by the healers, the researcher’s field diary and a one-to-one semi-structured interview.
The alleged positive effects of SH included alleviation of the physical adverse-effects of their treatment, increased energy levels, enhanced well-being, emotional relaxation, and re-engagement with pre-cancer activities. Although one participant admitted considering a drug holiday prior to joining the study, none of the participants felt tempted to stop their hormonal treatments while receiving SH. The authors concluded that “these qualitative findings indicate that SH has the potential to support patients with breast cancer in the maintenance of their long-term orthodox treatments. Further research is needed to test SH as a cost-effective complementary therapy, for those undergoing long-term cancer treatments.”
As I already mentioned, I think this study is remarkable. Having done quite a bit of research into SH myself, I know how bizarre this intervention truly is. A typical treatment session might be with the patient lying on a couch in a relaxing atmosphere, often accompanied by soothing background music; the healer would talk gently but very little to enable the patient to be comfortable and relax; the SH itself might be performed by the healer moving his/her hands at a distance over the body of the patient; the healer would explain that this may cause the sensation of warmth as the ‘healing energy’ enters the body. Altogether, the experience is exotic to say the least.
It is therefore not surprising that SH generates a host of non-specific effects, including the most enormous placebo-response I have ever witnessed in any clinical trial which I have been involved in. I am mentioning this, of course, to point out that the above-noted effects are entirely compatible with those of placebo. As the study has no control group, there is no way of knowing what the effects of SH per se might have been. The fact that patients self-referred themselves to SH would only amplify this placebo-response. In the discussion of the paper, we find a further interesting pointer regarding patients’ prior experience with conventional health care professionals: “participants felt they were left to cope alone as their side-effects were trivialized.” This seems to suggest that the group of patients were indeed highly selected and all had suffered badly from previous experiences of poorly administered heath care. Thus their expectations of SH were probably high which, in turn, would exaggerate the placebo-response even further.
All of these phenomena might well be fascinating and could provide ample material for relevant research. They deserve to be analysed carefully and discussed openly and critically. Unfortunately none of this happened in the present study. The authors do not even consider the possibility that the observed effects could be related to anything else than their SH. Their stated aim to investigate whether SH supports cancer patients is not even approached; the authors simply assume a cause-effect relationship without demonstrating one. I find this is more than just a missed opportunity; in my view, it is pseudo-science. And this is the reason why I find this study remarkable.
If we believe homeopaths, we might get the impression that homeopathy is firmly established in mainstream health care. “They would say that, wouldn’t they?” To convince skeptics, we might want to have a bit more than wishful thinking.
We have just published a systematic review in order to instill some evidence into this debate. Our aim was to evaluate all the data from recent surveys of GPs and assess their involvement with and attitudes towards homeopathy. We searched 7 electronic databases to identify all relevant articles. Data extraction was conducted by three independent reviewers. Thirteen surveys met the inclusion criteria. Their findings suggest that less than 10% of GPs treated patients with homeopathy; referral rates varied hugely and ranged from 4.6% to 73%.
Two surveys also assessed GPs’ endorsement of homeopathy; they suggested that less than 15% of GPs were endorsing homeopathy. One survey asked about GPs’ personal usage of homeopathy and reported less than 10% had used this form of therapy on themselves.
Three surveys investigated adverse events (AEs) from homeopathic treatments. One was solely focussed on AEs which were classified as “serious” (either life threatening or likely to cause disability or sever morbidity) or non-serious. In total, 21 “indirect” serious AEs were reported (e.g., stopping medication, refusing immunisation, refusing cancer treatment, delaying diagnosis). Another survey found that 14% of GPs reported AEs following homeopathic treatment within a year. Other authors reported that the discontinuation of conventional asthma treatment in favour of a homeopathic remedy had led to cardiovascular arrest.
These data shed a much more sober light on the use of homeopathy in the UK. They fail to show that homeopathy is well-accepted by British GPs. More importantly perhaps they disclose serious problems with the use of homeopathy.
Whenever we consider alternative medicine, we think of therapeutic interventions and tend to forget that alternative practitioners frequently employ diagnostic methods which are alien to mainstream health care. Acupuncturists, iridologists, spiritual healers, massage therapists, reflexologists, applied kinesiologists, homeopaths, chiropractors, osteopaths and many other types of alternative practitioners all have their very own ways of diagnosing what might be wrong with their patients.
The purpose of a diagnostic test or technique is, of course, to establish the presence or absence of an abnormality, condition or disease. Conventional doctors use all sorts of validated diagnostic methods, from physical examination to laboratory tests, from blood pressure measurements to X-rays. Alternative practitioners use mostly alternative methods for arriving at a diagnosis, and we should ask: how reliable are these techniques?
Anyone trying to answer this question, will be surprised to find how very little reliable information on this topic exists. Scientific tests of the validity of alternative diagnostic tests are a bit like gold dust. And this is why a recently published article is, in my view, of particular importance and value.
The aim of this study was to evaluate the inter-rater reliability of pulse-diagnosis as performed by Traditional Korean Medicine (TKM) clinicians. A total 658 patients with stroke who were admitted into Korean oriental medical university hospitals were included. Each patient was seen by two TKM-experts for an examination of the pulse signs – pulse diagnosis is regularly used by practitioners of TKM and Traditional Chinese Medicine (TCM), and is entirely different from what conventional doctors do when they feel the pulse of a patient. Inter-observer reliability was assessed using three methods: simple percentage agreement, the kappa value, and the AC(1) statistic. The kappa value indicated that the inter-observer reliability in evaluating the pulse signs ranged from poor to moderate, whereas the AC(1) analysis suggested that agreement between the two experts was generally high (with the exception of ‘slippery pulse’). The kappa value indicated that the inter-observer reliability was generally moderate to good (with the exceptions of ‘rough pulse’ and ‘sunken pulse’) and that the AC(1) measure of agreement between the two experts was generally high.
Based on these findings, the authors drew the following conclusion: “Pulse diagnosis is regarded as one of the most important procedures in TKM… This study reveals that the inter-observer reliability in making a pulse diagnosis in stroke patients is not particularly high when objectively quantified. Additional research is needed to help reduce this lack of reliability for various portions of the pulse diagnosis.”
This indicates, I think, that the researchers (who are themselves practitioners of TCM!) are not impressed with the inter-rater reliability of the most commonly used diagnostic tool in TCM/TKM. Imagine this to be true for a commonly used test in conventional medicine; imagine, for instance, that one doctor measuring your blood pressure produces entirely different readings than the next one. Hardly acceptable, don’t you think?
And, of course, inter-rater reliability would be only one of several preconditions for their diagnostic methods to be valid. Other essential preconditions for diagnostic tests to be of value are their specificity and their sensitivity; do they discriminate between healthy and unhealthy, and are they capable of differentiating between severely abnormal findings and those that are just a little out of the normal range?
Until we have answers to all the open questions about each specific alternative diagnostic method, it would be unwise to pretend these tests are valid. Imagine a doctor prescribing a life-long anti-hypertensive therapy on the basis of a blood pressure reading that is little more than guess-work!
Since non-validated diagnostic tests can generate both false positive and false negative results, the danger of using them should not be under-estimated. In a way, invalid diagnostic tests are akin to bogus bomb-detectors (which made headlines recently): both are techniques to identify a problem. If the method generates a false positive result, an alert will be issued in vain, people will get anxious for nothing, time and money will be lost, etc. If the method generates a false negative result, we will assume to be safe while, in fact, we are not. In extreme cases, such an error will cost lives.
It is difficult to call those ‘experts’ who advocate using such tests anything else than irresponsible, I’d say. And it is even more difficult to have any confidence in the treatments that might be administered on the basis of such diagnostic methods, wouldn’t you agree?
I think I must have mentioned this once or twice before: I am constantly on the look-out for new evidence which shows or suggests that some form of alternative medicine works. Today, it seems, I have been lucky.
In this randomised, double-blind, placebo-controlled clinical trial, 200 patients suffering from chronic obstructive pulmonary disease (COPD) were randomly allocated to receive oral therapy with 3 × 30 drops/day of an extract of Pelargonium sidoides (EPs 7630) or placebo. Both treatments were administered in addition to standardised COPD- therapies, and the treatment period lasted 24 weeks. The primary endpoint of this study was the time to the next exacerbation of COPD. Secondary endpoints were the number of such exacerbations, consumption of antibiotics, quality of life, patient satisfaction, inability to work, and the tolerability of the treatment.
The results show that the median time to exacerbation was significantly prolonged with the herbal treatment compared to placebo (57 versus 43 days). The superiority of EPs 7630 over placebo was also confirmed in secondary endpoints, e.g., fewer exacerbations, less patients with antibiotic use, improved quality of life, higher patient satisfaction, and less days of inability to work. The incidence of minor gastrointestinal adverse events was higher in the EPs 7630 group.
The authors of the study conclude that “the results demonstrate a statistically significant and clinically relevant superiority of add-on therapy with EPs 7630 over placebo and a good long-term tolerability in the treatment of moderate to severe COPD. EPs 7630 prolonged time to exacerbations and reduced exacerbation frequency and antibiotic use.”
Chronic obstructive pulmonary disease, is a progressive and serious condition linked to smoking which makes breathing increasingly difficult. The symptoms of COPD typically include a productive cough, wheezing, shortness of breath and chest tightness. Long-term exposure to other lung irritants—such as air pollution, chemical fumes, or dust may contribute to COPD. The condition is a major cause of disability, and currently it is the third leading cause of death, which means that millions of people suffer from COPD.
There is no cure for COPD; the damage to the airways and lungs is not reversible. Various symptomatic treatments exist, for instance, antibiotics, bronchio-dilators, steroids and physiotherapy. Lifestyle changes can further improve the situation, help patients to stay more active, and slow the progress of the disease.
It is clear that COPD is a very serious condition, that the burden of suffering for individual patients can be immense, that therapeutic options are limited and often associated with adverse-effects. In this situation, any new effective and safe therapy would be more than welcome. Pelargonium has previously shown promise in the treatment of asthma, acute bronchitis as well as other respiratory infections. It seems generally safe but is not totally devoid of adverse-effects.
This new study gives hope to COPD-sufferers as it suggests that Pelargonium sidoides might alleviate their symptoms. The trial seems rigorous but the benefit is not huge and the treatment is not a cure of COPD. Moreover, I should point out that any new finding of this nature requires independent confirmations. I do think that the trial is an important step in the right direction, yet I feel that it is too early for issuing general recommendations.
This post has an odd title and addresses an odd subject. I am sure some people reading it will ask themselves “has he finally gone potty; is he a bit xenophobic, chauvinistic, or what?” I can assure you none of the above is the case.
Since many years, I have been asked to peer-review Chinese systematic reviews and meta-analyses of TCM-trials submitted to various journals and to the Cochrane Collaboration for publication, and I estimate that around 300 such articles are available today. Initially, I thought they were a valuable contribution to our knowledge, particularly for the many of us who cannot read Chinese languages. I hoped they might provide reliable information about this huge and potentially important section of the TCM-evidence. After doing this type of work for some time, I became more and more frustrated; now I have decided not to accept this task any longer – not because it is too much trouble, but because I have come to the conclusion that these articles are far less helpful than I had once assumed; in fact, I now fear that they are counter-productive.
In order to better understand what I mean, it might be best to use an example; this recent systematic review seems as good for that purpose as any.
Its Chinese authors “hypothesized that the eligible trials would provide evidence of the effect of Chinese herbs on bone mineral density (BMD) and the therapeutic benefits of Chinese medicine treatment in patients with bone loss“. Randomized controlled trials (RCTs) were thus retrieved for a systematic review from Medline and 8 Chinese databases. The authors identified 12 RCTs involving a total of 1816 patients. The studies compared Chinese herbs with placebo or standard anti-osteoporotic therapy. The pooled data from these RCTs showed that the change of BMD in the spine was more pronounced with Chinese herbs compared to the effects noted with placebo. Also, in the femoral neck, Chinese herbs generated significantly higher increments of BMD compared to placebo. Compared to conventional anti-osteoporotic drugs, Chinese herbs generated greater BMD changes.
In their abstract, the part on the paper that most readers access, the authors reached the following conclusions: “Our results demonstrated that Chinese herb significantly increased lumbar spine BMD as compared to the placebo or other standard anti-osteoporotic drugs.” In the article itself, we find this more detailed conclusion: “We conclude that Chinese herbs substantially increased BMD of the lumbar spine compared to placebo or anti-osteoporotic drugs as indicated in the current clinical reports on osteoporosis treatment. Long term of Chinese herbs over 12 months of treatment duration may increase BMD in the hip more effectively. However, further studies are needed to corroborate the positive effect of increasing the duration of Chinese herbs on outcome as the results in this analysis are based on indirect comparisons. To date there are no studies available that compare Chinese herbs, Chinese herbs plus anti-osteoporotic drugs, and anti-osteoporotic drug versus placebo in a factorial design. Consequently, we are unable to draw any conclusions on the possible superiority of Chinese herbs plus anti-osteoporotic drug versus anti-osteoporotic drug or Chinese herb alone in the context of BMD.“
Most readers will feel that this evidence is quite impressive and amazingly solid; they might therefore advocate routinely using Chinese herbs for the common and difficult to treat problem of osteoporosis. The integration of TCM might avoid lots of human suffering, prolong the life of many elderly patients, and save us all a lot of money. Why then am I not at all convinced?
The first thing to notice is the fact that we do not really know which of the ~7000 different Chinese herbs should be used. The article tells us surprisingly little about this crucial point. And even, if we manage to study this question in more depth, we are bound to get thoroughly confused; there are simply too many herbal mixtures and patent medicines to easily identify the most promising candidates.
The second and more important hurdle to making sense of these data is the fact that most of the primary studies originate from inaccessible Chinese journals and were published in Chinese languages which, of course, few people in the West can understand. This is entirely our fault, some might argue, but it does mean that we have to believe the authors, take their words at face value, and cannot check the original data. You may think this is fine, after all, the paper has gone through a rigorous peer-review process where it has been thoroughly checked by several top experts in the field. This, however, is a fallacy; like you and me, the peer-reviewers might not read Chinese either! (I don’t, and I reviewed quite a few of these papers; in some instances, I even asked for translations of the originals to do the job properly but this request was understandably turned down) In all likelihood, the above paper and most similar articles have not been properly peer-reviewed at all.
The third and perhaps most crucial point can only be fully appreciated, if we were able to access and understand the primary studies; it relates to the quality of the original RCTs summarised in such systematic reviews. The abstract of the present paper tells us nothing at all about this issue. In the paper, however, we do find a formal assessment of the studies’ risk of bias which shows that the quality of the included RCTs was poor to very poor. We also find a short but revealing sentence: “The reports of all trials mentioned randomization, but only seven described the method of randomization.” This remark is much more significant than it may seem: we have shown that such studies use such terminology in a rather adventurous way; reviewing about 2000 of these allegedly randomised trials, we found that many Chinese authors call a trial “randomised” even in the absence of a control group (one cannot randomise patients and have no control group)! They seem to like the term because it is fashionable and makes publication of their work easier. We thus have good reason to fear that some/many/most of the studies were not RCTs at all.
The fourth issue that needs mentioning is the fact that very close to 100% of all Chinese TCM-trials report positive findings. This means that either TCM is effective for every indication it is tested for (most unlikely, not least because there are many negative non-Chinese trials of TCM), or there is something very fundamentally wrong with Chinese research into TCM. Over the years, I have had several Chinese co-workers in my team and was invariably impressed by their ability to work hard and efficiently; we often discussed the possible reasons for the extraordinary phenomenon of 0% negative Chinese trials. The most plausible answer they offered was this: it would be most impolite for a Chinese researcher to produce findings which contradict the opinion of his/her peers.
In view of these concerns, can we trust the conclusions of such systematic reviews? I don’t think so – and this is why I have problems with research of this nature. If there are good reasons to doubt their conclusions, these reviews might misinform us systematically, they might not further but hinder progress, and they might send us up the garden path. This could well be in the commercial interest of the Chinese multi-billion dollar TCM-industry, but it would certainly not be in the interest of patients and good health care.