MD, PhD, FMedSci, FSB, FRCP, FRCPEd

systematic review

Pyruvate, a ketone and an alpha-keto acid, occurs naturally in the body when glucose is converted into energy. It is part of the Krebs cycle, the complex chain of reactions in which nutrients are metabolised to provide energy. High doses of pyruvate seem to stimulate the breakdown of fat in the body. It is therefore not surprising that pyruvate is used in all sorts of slimming aids; and if the advertising for ‘fat burners’ is to be believed, pyruvate is just the ticket for the desperate slimmer.

One such product advertisement, for instance, claims that sodium pyruvate and potassium pyruvate, which can act as a stimulant for the metabolism, adding to the thermogenesis process. Pyruvates have been found in studies to reduced the storage of fat in the body and convert the food source into calories which are then burned off in the production of heat. In one study, rats were injected with three fat burners, including pyruvates, and the rats given the pyruvates burned the greatest amount of fat by increasing the rat’s resting metabolic rate. With the elevated resting metabolic rate, the body burned more fat in individuals, which makes pyruvate an excellent source for weight maintenance.

So, maybe pyruvate works for rats – but does it really help those of us who would like to lose a few kilos? Some studies seem to say so, but others don’t. What do we conclude? There can only be one solution: we need a systematic review of the totality of the available trial evidence – and you probably guessed it: we have just published such an article.

The objective of our systematic review was to examine the efficacy of pyruvate in reducing body weight. Extensive literature searches identifies 9 RCTs of which 6 were met our inclusion criteria. All had methodological weaknesses. The meta-analysis revealed a statistically significant difference of 0.72 kg in body weight with pyruvate compared to placebo. The magnitude of the effect is small, and its clinical relevance is therefore uncertain. Adverse events included gas, bloating, diarrhoea, and increase in low-density lipoprotein cholesterol.

Our conclusion: The evidence from randomized clinical trials does not convincingly show that pyruvate is efficacious in reducing body weight. Limited evidence exists about the safety of pyruvate. Future trials involving the use of this supplement should be more rigorous and better reported.

Pyruvate supplements are popular; people who want to lose weight are misled into believing that they are effective. Bodybuilders as well as other athletes tend to take them because pyruvate is claimed to reduce body fat and enhance the ability to use energy more efficiently. None of these assumptions is based on sound evidence. Regardless of the evidence, a whole industry is exploiting the gullible and doing very well on it.

As these ‘fat burners’ are by no means cheap, I recommend a more efficient and more economical method for normalising body weight: eat a little less and move a bit more – I know it’s naff, but it works!

Irritable bowel syndrome (IBS) is common and often difficult to treat – unless, of course, you consult a homeopath. Here is just one of virtually thousands of quotes from homeopaths available on the Internet: Homeopathic medicine can reduce Irritable Bowel Syndrome (IBS) symptoms by lowering food sensitivities and allergies. Homeopathy treats the patient as a whole and does not simply focus on the disease. Careful attention is given to the minute details about the presenting complaints, including the severity of diarrhea, constipation, pain, cramps, mucus in the stools, nausea, heartburn, emotional triggers and conventional laboratory findings. In addition, the patient’s eating habits, food preferences, thermal attributes and sleep patterns are noted. The patient’s family history and diseases, along with the patient’s emotions are discussed. Then the homeopathic practitioner will select the remedy that most closely matches the symptoms.

Such optimism might be refreshing, but is there any reason for it? Is homeopathy really an effective treatment for IBS? To answer this question, we now have a brand-new Cochrane review. The aim of this review was to assess the effectiveness and safety of homeopathic treatment for treating irritable bowel syndrome (IBS). (This type of statement always makes me a little suspicious; how on earth can anyone truly assess the safety of a treatment by looking at a few studies? This is NOT how one evaluates safety!) The authors conducted extensive literature searches to identify all RCTs, cohort and case-control studies that compared homeopathic treatment with placebo, other control treatments, or usual care in adults with IBS. The primary outcome was global improvement in IBS.

Three RCTs with a total of 213 participants were included. No cohort or case-control studies were identified. Two studies compared homeopathic remedies to placebos for constipation-predominant IBS. One study compared individualised homeopathic treatment to usual care defined as high doses of dicyclomine hydrochloride, faecal bulking agents and a high fibre diet. Due to the low quality of reporting, the risk of bias in all three studies was unclear on most criteria and high for some criteria.

A meta-analysis of two studies with a total of 129 participants with constipation-predominant IBS found a statistically significant difference in global improvement between the homeopathic ‘asafoetida’ and placebo at a short-term follow-up of two weeks. Seventy-three per cent of patients in the homeopathy group improved compared to 45% of placebo patients. There was no statistically significant difference in global improvement between the homeopathic asafoetida plus nux vomica compared to placebo. Sixty-eight per cent of patients in the homeopathy group improved compared to 52% of placebo patients.

The overall quality of the evidence was very low. There was no statistically significant difference between individualised homeopathic treatment and usual care for the outcome “feeling unwell”. None of the studies reported on adverse events (which, by the way, should be seen as a breech in research ethics on the part of the authors of the three primary studies).

The authors concluded that a pooled analysis of two small studies suggests a possible benefit for clinical homeopathy, using the remedy asafoetida, over placebo for people with constipation-predominant IBS. These results should be interpreted with caution due to the low quality of reporting in these trials, high or unknown risk of bias, short-term follow-up, and sparse data. One small study found no statistically difference between individualised homeopathy and usual care (defined as high doses of dicyclomine hydrochloride, faecal bulking agents and diet sheets advising a high fibre diet). No conclusions can be drawn from this study due to the low number of participants and the high risk of bias in this trial. In addition, it is likely that usual care has changed since this trial was conducted. Further high quality, adequately powered RCTs are required to assess the efficacy and safety of clinical and individualised homeopathy compared to placebo or usual care.

THIS REVIEW REQUIRES A FEW FURTHER COMMENTS, I THINK

Asafoetida, the remedy used in two of the studies, is a plant native to Pakistan, Iran and Afghanistan. It is used in Ayurvedic herbal medicine to treat colic, intestinal parasites and irritable bowel syndrome. In the ‘homeopathic’ trials, asafoetida was used in relatively low dilutions, one that still contains molecules. It is therefore debatable whether this was really homeopathy or whether it is more akin to herbal medicine – it was certainly not homeopathy with its typical ultra-high dilutions.

Regardless of this detail, the Cochrane review does hardly provide sound evidence for homeopathy’s efficacy. On the contrary, my reading of its findings is that the ‘possible benefit’ is NOT real but a false positive result caused by the serious limitations of the original studies. The authors stress that the apparently positive result ‘should be interpreted with caution’; that is certainly correct.

So, if you are a proponent of homeopathy, as the authors of the review seem to be, you will claim that homeopathy offers ‘possible benefits’ for IBS-sufferers. But if you are not convinced of the merits of homeopathy, you might suggest that the evidence is insufficient to recommend homeopathy. I imagine that IBS-sufferers might get as frustrated with such confusion as most scientists will be. Yet there is hope; the answer could be imminent: apparently, a new trial is to report its results within this year.

IS THIS NEW TRIAL GOING TO CONTRIBUTE MEANINGFULLY TO OUR KNOWLEDGE?

It is a three-armed study (same 1st author as in the Cochrane review) which, according to its authors, seeks to explore the effectiveness of individualised homeopathic treatment plus usual care compared to both an attention control plus usual care and usual care alone, for patients with IBS. (Why “explore” and not “determine”, I ask myself.) Patients are randomly selected to be offered, 5 sessions of homeopathic treatment plus usual care, 5 sessions of supportive listening plus usual care or usual care alone. (“To be offered” looks odd to me; does that mean patients are not blinded to the interventions? Yes, indeed it does.) The primary clinical outcome is the IBS Symptom Severity at 26 weeks. Analysis will be by intention to treat and will compare homeopathic treatment with usual care at 26 weeks as the primary analysis, and homeopathic treatment with supportive listening as an additional analysis.

Hold on…the primary analysis “will compare homeopathic treatment with usual care“. Are they pulling my leg? They just told me that patients will be “offered, 5 sessions of homeopathic treatment plus usual care… or usual care alone“.

Oh, I see! We are again dealing with an A+B versus B design, on top of it without patient- or therapist-blinding. This type of analysis cannot ever produce a negative result, even if the experimental treatment is a pure placebo: placebo + usual care is always more than usual care alone. IBS-patients will certainly experience benefit from having the homeopaths’ time, empathy and compassion – never mind the remedies they get from them. And for the secondary analyses, things do not seem to be much more rigorous either.

Do we really need more trials of this nature? The Cochrane review shows that we currently have three studies which are too flimsy to be interpretable. What difference will a further flimsy trial make in this situation? When will we stop wasting time and money on such useless ‘research’? All it can possibly achieve is that apologists of homeopathy will misinterpret the results and suggest that they demonstrate efficacy.

Obviously, I have not seen the data (they have not yet been published) but I think I can nevertheless predict the conclusions of the primary analysis of this trial; they will read something like this: HOMEOPATHY PROVED TO BE SIGNIFICANTLY MORE EFFECTIVE THAN USUAL CARE. I have asked the question before and I do it again: when does this sort of ‘research’ cross the line into the realm of scientific misconduct?

If we ask how effective spinal manipulation is as a treatment of back pain, we get all sorts of answers. Therapists who earn their money with it – mostly chiropractors, osteopaths and physiotherapists – are obviously convinced that it is effective. But if we consult more objective sources, the picture changes dramatically. The current Cochrane review, for instance, arrives at this conclusion: SMT is no more effective in participants with acute low-back pain than inert interventions, sham SMT, or when added to another intervention. SMT also appears to be no better than other recommended therapies.

Such reviews tend to pool all studies together regardless of the nature of the practitioner. But perhaps one type of clinician is better than the next? Certainly many chiropractors are on record claiming that they are the best at spinal manipulations. Yet it is conceivable that physiotherapists who do manipulations without being guided by the myth of ‘adjusting subluxations’ have an advantage over chiropractors. Three very recent systematic reviews might go some way to answer these questions.

The purpose of the first systematic review was to examine the effectiveness of spinal manipulations performed by physiotherapists for the treatment of patients with low back pain. The authors found 6 RCTs that met their inclusion criteria. The most commonly used outcomes were pain rating scales and disability indexes. Notable results included varying degrees of effect sizes favouring spinal manipulations and minimal adverse events resulting from this intervention. Additionally, the manipulation group in one study reported significantly less medication use, health care utilization, and lost work time. The authors concluded that there is evidence to support the use of spinal manipulation by physical therapists in clinical practice. Physical therapy spinal manipulation appears to be a safe intervention that improves clinical outcomes for patients with low back pain.

The second systematic Review was of osteopathic intervention for chronic, non-specific low back pain (CNSLBP). Only two trials met the authors’ inclusion criteria. They had a lack of methodological and clinical homogeneity, precluding a meta-analysis. The trials used different comparators with regards to the primary outcomes, the number of treatments, the duration of treatment and the duration of follow-up. The authors drew the following conclusions: There are only two studies assessing the effect of the manual therapy intervention applied by osteopathic clinicians in adults with CNSLBP. One trial concluded that the osteopathic intervention was similar in effect to a sham intervention, and the other suggests similarity of effect between osteopathic intervention, exercise and physiotherapy. Further clinical trials into this subject are required that have consistent and rigorous methods. These trials need to include an appropriate control and utilise an intervention that reflects actual practice.

The third systematic review sought to determine the benefits of chiropractic treatment and care for back pain on well-being, and aimed to explore to what extent chiropractic treatment and care improve quality of life. The authors identified 6 studies (4 RCTs and two observational studies) of varying quality. There was a high degree of inconsistency and lack of standardisation in measurement instruments and outcome measures. Three studies reported reduced use of other/extra treatments as a positive outcome; two studies reported a positive effect of chiropractic intervention on pain, and two studies reported a positive effect on disability. The authors concluded that it is difficult to defend any conclusion about the impact of chiropractic intervention on the quality of life, lifestyle, health and economic impact on chiropractic patients presenting with back pain.

Yes, yes, yes, I know: the three reviews are not exactly comparable; so we cannot draw firm conclusions from comparing them. Five points seem to emerge nevertheless:

  1. The evidence for spinal manipulation as a treatment for back pain is generally not brilliant, regardless of the type of therapist.
  2. There seem to be considerable differences according to the nature of the therapist.
  3. Physiotherapists seem to have relatively sound evidence to justify their manipulations.
  4. Chiropractors and osteopaths are not backed by evidence which is as reliable as they so often try to make us believe.
  5. Considering that the vast majority of serious complications after spinal manipulation has occurred with chiropractors, it would seem that chiropractors are the profession with the worst track record regarding manipulation for back pain.

Some experts concede that chiropractic spinal manipulation is effective for chronic low back pain (cLBP). But what is the right dose? There have been no full-scale trials of the optimal number of treatments with spinal manipulation. This study was aimed at filling this gap by trying to identify a dose-response relationship between the number of visits to a chiropractor for spinal manipulation and cLBP outcomes. A further aim was to determine the efficacy of manipulation by comparison with a light massage control.

The primary cLBP outcomes were the 100-point pain intensity scale and functional disability scales evaluated at the 12- and 24-week primary end points. Secondary outcomes included days with pain and functional disability, pain unpleasantness, global perceived improvement, medication use, and general health status.

One hundred patients with cLBP were randomized to each of 4 dose levels of care: 0, 6, 12, or 18 sessions of spinal manipulation from a chiropractor. Participants were treated three times per week for 6 weeks. At sessions when manipulation was not assigned, the patients received a focused light massage control. Covariate-adjusted linear dose effects and comparisons with the no-manipulation control group were evaluated at 6, 12, 18, 24, 39, and 52 weeks.

For the primary outcomes, mean pain and disability improvement in the manipulation groups were 20 points by 12 weeks, an effect that was sustainable to 52 weeks. Linear dose-response effects were small, reaching about two points per 6 manipulation sessions at 12 and 52 weeks for both variables. At 12 weeks, the greatest differences compared to the no-manipulation controls were found for 12 sessions (8.6 pain and 7.6 disability points); at 24 weeks, differences were negligible; and at 52 weeks, the greatest group differences were seen for 18 visits (5.9 pain and 8.8 disability points).

The authors concluded that the number of spinal manipulation visits had modest effects on cLBP outcomes above those of 18 hands-on visits to a chiropractor. Overall, 12 visits yielded the most favorable results but was not well distinguished from other dose levels.

This study is interesting because it confirms that the effects of chiropractic spinal manipulation as a treatment for cLBP are tiny and probably not clinically relevant. And even these tiny effects might not be due to the treatment per se but could be caused by residual confounding and bias.

As for the optimal dose, the authors suggest that, on average, 18 sessions might be the best. But again, we have to be clear that the dose-response effects were small and of doubtful clinical relevance. Since the therapeutic effects are tiny, it is obviously difficult to establish a dose-response relationship.

In view of the cost of chiropractic spinal manipulation and the uncertainty about its safety, I would probably not rate this approach as the treatment of choice but would consider the current Cochrane review which concludes that “high quality evidence suggests that there is no clinically relevant difference between spinal manipulation and other interventions for reducing pain and improving function in patients with chronic low-back pain” Personally, I think it is more prudent to recommend exercise, back school, massage or perhaps even yoga to cLBP-sufferers.

This post was inspired by a shiatsu-practitioner who recently commented on this blog. As I have not yet written a post about shiatsu, I think this might be a good occasion to do so. On one of the websites of the said practitioner – who claimed to have such amazing powers that hewould be locked up or worse“, if he made them public explains that Shiatsu is a form of natural healing therapy that promotes health through finger pressure along energy meridians or channels – like acupuncture but with no needles and all your clothes on. Shiatsu is a combination of ancient theories of oriental medicine and ‘energy’, with modern knowledge of anatomy and physiology. Shiatsu originated in Japan where it is officially recognised and parents teach their children to treat them. Shiatsu is one of the fastest growing areas of complementary therapy in the UK. Shiatsu is safe and non-invasive. Shiatsu is a holistic therapy which means your whole body is treated. Work on your energy channels promotes well-being at the physical and emotional levels and stimulates your natural self-healing processes. The application of pressure and gentle stretching helps relieve muscle tension, joint stiffness and to realign body structures. Contact with the energy pathways helps to correct imbalance in the functioning of internal organs and to re-balance the effects of emotional disturbance. You don’t have to be ill to enjoy Shiatsu, many people enjoy it simply because it is deeply relaxing.

I also looked up another of his websites and found that he claims to treat the following conditions:

  • Anger Management
  • Anxiety and Stress
  • Arthritis
  • Back pain
  • Bipolar disorder
  • Breathing/respiratory problems
  • Cancer
  • Confidence issues
  • Depression
  • Digestive Disorders
  • Eating Disorders
  • Eczema
  • Emotional Issues
  • Fears and Phobias
  • Headache
  • Indigestion
  • Infertility
  • Insomnia
  • Irritable bowel syndrome (IBS)
  • Joint Pain
  • Low energy/Lethargy
  • Low Self-Esteem
  • ME/Chronic Fatigue Syndrome
  • Migraine
  • Muscular Tension
  • Nausea and sickness
  • Nightmares
  • Obesity
  • Pain
  • Panic Attacks
  • Sciatica
  • Sexual problems
  • Sinus problems
  • Skin conditions
  • Sleeping problems
  • Social anxiety disorder
  • Spiritual Issues
  • Stiffness/Tension
  • Weight problems

Impressed by this list, I looked at similar sites and found that such extravagant claims seem more the rule than the exception in the world of shiatsu. Such therapeutic claims came as a big surprise to me: the last time we reviewed the evidence, we had concluded: NO CONVINCING DATA AVAILABLE TO SUGGEST THAT SHIATSU IS EFFECTIVE FOR ANY CONDITION.

But that was 5 years ago; perhaps there have been major advances since? To find out, I did a quick Medline search and – BINGO! – found a recent systematic review entitled “The evidence for Shiatsu: a systematic review of Shiatsu and acupressure“. It was authored by proponents of this therapy and can therefore not be suspected to be riddled with ‘anti-shiatsu bias’ (I just love the give-away title THE EVIDENCE FOR SHIATSU….!). These authors found that “Shiatsu studies comprised 1 RCT, three controlled non-randomised, one within-subjects, one observational and 3 uncontrolled studies investigating mental and physical health issues. Evidence was of insufficient quantity and quality” The only RCT included in their review was not actually a study of shiatsu but of a complex mixture of treatments including shiatsu for back and neck pain. No significant effects compared to standard care were identified in this study.

So, what does that tell us about shiatsu? It clearly tells us that it is an unproven therapy. And what does that say about shiatsu-practitioners who make multiple claims about treating serious conditions? I think I can leave it to my readers to answer this question.

The fish oil (FO) story began when a young Danish doctor noticed that there were no heart attacks in Greenland. Large epidemiological studies were initiated, mechanistic investigations followed, and a huge amount of fascinating data emerged. Today, we know more about FO than most other dietary supplements.

Fish oil contains large amounts of omega-3 fatty acids which are thought to be beneficial in treating hypertriglyceridemia,  preventing heart disease.  In addition, FO is often recommended for a wide variety of other conditions, such as  cancer, depression, and macular degeneration. Perhaps the most compelling evidence exists in the realm of inflammatory diseases; the mechanism of action of FO is well-studied and includes powerful anti-inflammatory properties.

Australian rheumatologists just published a study of FO supplements for patients suffering from rheumatoid arthritis (RA). Specifically, they examined  the effects of high versus low dose FO in early RA employing a ‘treat-to-target’ protocol of combination disease-modifying anti-rheumatic drugs (DMARDs).

Patients with chronic RA <12 months’ who were DMARD-naïve were enrolled and randomised 2:1 to FO at a high dose or plaacebo (low dose FO for masking). These groups were given 5.5 or 0.4 g/day, respectively, of  eicosapentaenoic acid + docosahexaenoic acid. All patients received methotrexate (MTX), sulphasalazine and hydroxychloroquine, and DMARD doses were adjusted according to an algorithm taking disease activity and toxicity into account. DAS28-erythrocyte sedimentation rate, modified Health Assessment Questionnaire (mHAQ) and remission were assessed three monthly. The primary outcome measure was failure of triple DMARD therapy.

The results indicate that, the FO group, failure of triple DMARD therapy was lower (HR=0.28 (95% CI 0.12 to 0.63; p=0.002) unadjusted and 0.24 (95% CI 0.10 to 0.54; p=0.0006) following adjustment for smoking history, shared epitope and baseline anti–cyclic citrullinated peptide. The rate of first American College of Rheumatology (ACR) remission was significantly greater in the FO compared with the control group (HRs=2.17 (95% CI 1.07 to 4.42; p=0.03) unadjusted and 2.09 (95% CI 1.02 to 4.30; p=0.04) adjusted). There were no differences between groups in MTX dose, DAS28 or mHAQ scores, or adverse events.

The authors conclude that FO was associated with benefits additional to those achieved by combination ‘treat-to-target’ DMARDs with similar MTX use. These included reduced triple DMARD failure and a higher rate of ACR remission.

These findings are most encouraging, particularly as they collaborate those of systematic reviews which concluded that evidence is seen for a fairly consistent, but modest, benefit of marine n-3 PUFAs on joint swelling and pain, duration of morning stiffness, global assessments of pain and disease activity, and use of non-steroidal anti-inflammatory drugs and …there is evidence from 6 of 14 randomized controlled trials supporting a favourable effect of n-3 LCP supplementation in decreasing joint inflammation in RA. And you don’t need to buy the supplements either; regularly eating lots of fatty fish like mackerel, sardine or salmon has the same effects.

So, here we have an alternative, ‘natural’, dietary supplement or diet that is supported by reasonably sound evidence for efficacy, that has very few adverse effects (the main one being contamination of the supplement with toxins), that generates a host of potentially useful effects on other organ systems, that is affordable, that has a plausible mechanism of action…. Hold on, I hear some people interrupting me, FO is not an alternative medicine, it is mainstream! Exactly, an alternative medicine that works is called….MEDICINE.

Researchers from the ‘International Centre for Allied Health Evidence’, University of South Australia in Adelaide wanted to determine whether massage therapy is an effective intervention for back pain. They carried out extensive literature searches to identify all systematic reviews on the subject, analysed them critically and evaluated their methodological quality. Nine systematic reviews were found. Their methodological quality varied from poor to excellent. The primary research informing these systematic reviews was generally considered to be weak quality. The findings indicated that massage may be an effective treatment option when compared to placebo or active treatment options such as relaxation, especially in the short term. There were conflicting and contradictory findings for the effectiveness of massage therapy as a treatment of non-specific low back pain when compared against other manual therapies such as mobilization, standard medical care, and acupuncture.

The authors concluded that there is an emerging body of evidence, albeit small, that supports the effectiveness of massage therapy for the treatment of non-specific low back pain in the short term. Due to common methodological flaws in the primary research, which informed the systematic reviews recommendations arising from this evidence base should be interpreted with caution.

My own systematic review from 1999 (which the authors of this systematic review of systematic reviews seem to have missed) concluded that massage seems to have some potential as a therapy for low back pain. Indeed, there seems to be unanimous agreement that massage therapy is a promising treatment. Why then do massage therapists not finally get their act together and conduct a few more high quality primary studies? Currently, we have about as many reviews as trials! Doing even more reviews will not answer the question about effectiveness!!!

And it is a damn important question. Back pain is extremely common and extremely expensive for us all. At present, we have no optimal treatment. Chiropractors and osteopaths are claiming to have found a good solution, but many experts are not convinced by their evidence and argue that the risks of spinal manipulation might not outweigh its benefits. Massage, by contrast, is almost risk-free. Considering all this, I believe we need more trials with some urgency.

So, why are such trials not forthcoming? I realise that multiple hurdles have to be taken:

  • Clinical studies of that nature are expensive, and there is no obvious funding source.
  • Massage therapists usually do not have enough research expertise to pull off a sound study.
  • There are multiple methodological problems in conduction a definitive massage trial that might convince us all.

However, none of these obstacles are insurmountable. I suggest massage therapists team up with experts who know how to run clinical trials, hammer out a reasonable study design and approach government or other official funders for support. We need a definitive answers and we need them soon: is massage effective? which type of massage? for which patients? at which stage of non-specific low back pain?

Australian researchers wanted to know whether acupuncture is effective for alleviating the symptoms of fibromyalgia, a common painful condition for which no universally accepted treatment exists. For this purpose, they conducted a Cochrane review. After extensive literature searches, they identified 9 RCTs, extracted their data and assessed risk of bias.

The results show that all studies except one were at low risk of selection bias; five were at risk of selective reporting bias; two were subject to attrition bias (favouring acupuncture); three were subject to performance bias (favouring acupuncture) and one to detection bias (favouring acupuncture).

Three studies utilised electro-acupuncture (EA) and the remainder manual acupuncture (MA) without electrical stimulation.

Low quality evidence from one study (13 participants) showed EA improved symptoms with no adverse events at one month following treatment.

Moderate quality evidence from six studies (286 participants) indicated that acupuncture (EA or MA) was no better than sham acupuncture, except for less stiffness at one month. Subgroup analysis of two studies (104 participants) indicated benefits of EA. Mean pain was 70 points on 0 to 100 point scale with sham treatment; EA reduced pain by 13% (5% to 22%).

Low-quality evidence from one study suggested that MA resulted in poorer physical function: mean function in the sham group was 28 points (100 point scale); treatment worsened function by a mean of 6 points.

Moderate quality evidence from one study (58 participants) found that, compared with standard therapy alone (antidepressants and exercise), adjunct acupuncture therapy reduced pain at one month after treatment.

Low quality evidence from one study (38 participants) showed a short-term benefit of acupuncture over antidepressants in pain relief.

Moderate-quality evidence from one study (41 participants) indicated that deep needling with or without deqi did not differ in pain, fatigue, function or adverse events.

Four studies reported no differences between acupuncture and control or other treatments described at six to seven months follow-up.

No serious adverse events were reported, but there were insufficient adverse events to be certain of the risks.

The authors draw the following conclusions: There is low to moderate-level evidence that compared with no treatment and standard therapy, acupuncture improves pain and stiffness in people with fibromyalgia. There is moderate-level evidence that the effect of acupuncture does not differ from sham acupuncture in reducing pain or fatigue, or improving sleep or global well-being. EA is probably better than MA for pain and stiffness reduction and improvement of global well-being, sleep and fatigue. The effect lasts up to one month, but is not maintained at six months follow-up. MA probably does not improve pain or physical functioning. Acupuncture appears safe. People with fibromyalgia may consider using EA alone or with exercise and medication. The small sample size, scarcity of studies for each comparison, lack of an ideal sham acupuncture weaken the level of evidence and its clinical implications. Larger studies are warranted.

What does all that mean? In my view, it means that there is no sound evidence base for acupuncture as a treatment of fibromyalgia – or as we expressed it in our own systematic review of 2007: The notion that acupuncture is an effective symptomatic treatment for fibromyaligia is not supported by the results from rigorous clinical trials. On the basis of this evidence, acupuncture cannot be recommended for fibromyalgia.

In 2010, NICE recommended acupuncture for chronic low back pain (cLBP). Acupuncturists were of course delighted; the British Acupuncture Council, for instance, stated that they fully support NICE’s (National Institute for Health and Clinical Excellence) decision that acupuncture be made available on the NHS for chronic lower back pain. Traditional acupuncture has been used for over 2,000 years to alleviate back pain and British Acupuncture Council members have for many many years been successfully treating patients for this condition either in private practice or working within the NHS. In effect, therefore, these new guidelines are a rubber stamp of the positive work already being undertaken as well as an endorsement of the wealth of research evidence now available in this area.

More critical experts, however, tended to be surprised about this move and doubted that the evidence was strong enough for a positive recommendation. Now a brand-new meta-analysis sheds more light on this important issue.

Its aim was to determine the effectiveness of acupuncture as a therapy for cLBP. The authors found 13 RCTs which matched their inclusion criteria. Their results show that, compared with no treatment, acupuncture achieved better outcomes in terms of pain relief, disability recovery and better quality of life. These effects were, however, not observed when real acupuncture was compared to sham acupuncture. Acupuncture achieved better outcomes when compared with other treatments. No publication bias was detected.

The authors conclude that acupuncture is an effective treatment for chronic low back pain, but this effect is likely to be produced by the nonspecific effects of manipulation.

In plain English, this means that the effects of acupuncture on cLBP are most likely due to placebo. Should NICE be recommending placebo-treatments and have the tax payer foot the bill? I think I can leave it to my readers to answer this question.

Hot flushes are a big problem; they are not life-threatening, of course, but they do make life a misery for countless menopausal women. Hormone therapy is effective, but many women have gone off the idea since we know that hormone therapy might increase their risk of getting cancer and cardiovascular disease. So, what does work and is also risk-free? Acupuncture?

Together with researchers from Quebec, we wanted to determine whether acupuncture is effective for reducing hot flushes and for improving the quality of life of menopausal women. We decided to do this in form of a Cochrane review which was just published.

We searched 16 electronic databases in order to identify all relevant studies and included all RCTs comparing any type of acupuncture to no treatment/control or other treatments. Sixteen studies, with a total of 1155 women, were eligible for inclusion. Three review authors independently assessed trial eligibility and quality, and extracted data. We pooled data where appropriate.

Eight studies compared acupuncture versus sham acupuncture. No significant difference was found between the groups for hot flush frequency, but flushes were significantly less severe in the acupuncture group, with a small effect size. There was substantial heterogeneity for both these outcomes. In a post hoc sensitivity analysis excluding studies of women with breast cancer, heterogeneity was reduced to 0% for hot flush frequency and 34% for hot flush severity and there was no significant difference between the groups for either outcome. Three studies compared acupuncture with hormone therapy, and acupuncture turned out to be associated with significantly more frequent hot flushes. There was no significant difference between the groups for hot flush severity. One study compared electro-acupuncture with relaxation, and there was no significant difference between the groups for either hot flush frequency or hot flush severity. Four studies compared acupuncture with waiting list or no intervention. Traditional acupuncture was significantly more effective in reducing hot flush frequency, and was also significantly more effective in reducing hot flush severity. The effect size was moderate in both cases.

For quality of life measures, acupuncture was significantly less effective than HT, but traditional acupuncture was significantly more effective than no intervention. There was no significant difference between acupuncture and other comparators for quality of life. Data on adverse effects were lacking.

Our conclusion: We found insufficient evidence to determine whether acupuncture is effective for controlling menopausal vasomotor symptoms. When we compared acupuncture with sham acupuncture, there was no evidence of a significant difference in their effect on menopausal vasomotor symptoms. When we compared acupuncture with no treatment there appeared to be a benefit from acupuncture, but acupuncture appeared to be less effective than HT. These findings should be treated with great caution as the evidence was low or very low quality and the studies comparing acupuncture versus no treatment or HT were not controlled with sham acupuncture or placebo HT. Data on adverse effects were lacking.

I still have to meet an acupuncturist who is not convinced that acupuncture is not an effective treatment for hot flushes. You only need to go on the Internet to see the claims that are being made along those lines. Yet this review shows quite clearly that it is not better than placebo. It also demonstrates that studies which do suggest an effect do so because they fail to adequately control for a placebo response. This means that the benefit patients and therapists observe in routine clinical practice is not due to the acupuncture per se, but to the placebo-effect.

And what could be wrong with that? Quite a bit, is my answer; here are just 4 things that immediately spring into my mind:

1) Arguably, it is dishonest and unethical to use a placebo on ill patients in routine clinical practice and charge for it pretending it is a specific and effective treatment.

2) Placebo-effects are unreliable, small and usually of short duration.

3) In order to generate a placebo-effect, I don’t need a placebo-therapy; an effective one administered with compassion does that too (and generates specific effects on top of that).

4) Not all placebos are risk-free. Acupuncture, for instance, has been associated with serious complications.

The last point is interesting also in the context of our finding that the RCTs analysed failed to mention adverse-effects. This is a phenomenon we observe regularly in studies of alternative medicine: trialists tend to violate the most fundamental rules of research ethics by simply ignoring the need to report adverse-effects. In plain English, this is called ‘scientific misconduct’. Consequently, we find very little published evidence on this issue, and enthusiasts claim their treatment is risk-free, simply because no risks are being reported. Yet one wonders to what extend systematic under-reporting is the cause of that impression!

So, what about the legion of acupuncturists who earn a good part of their living by recommending to their patients acupuncture for hot flushes?

They may, of course, not know about the evidence which shows that it is not more than a placebo. Would this be ok then? No, emphatically no! All clinicians have a duty to be up to date regarding the scientific evidence in relation to the treatments they use. A therapist who does not abide by this fundamental rule of medical ethics is, in my view, a fraud. On the other hand, some acupuncturists might be well aware of the evidence and employ acupuncture nevertheless; after all, it brings good money! Well, I would say that such a therapist is a fraud too.

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