This pilot study tested the feasibility of using US Food and Drug Administration (FDA)–recommended endpoints to evaluate the efficacy of acupuncture in the treatment of IBS. It was designed as a multicenter randomized clinical trial, conducted in 4 tertiary hospitals in China from July 1, 2020, to March 31, 2021, and 14-week data collection was completed in March 2021. Individuals with a diagnosis of IBS with diarrhea (IBS-D) were randomized to 1 of 3 groups:
- acupuncture groups 1 (using specific acupoints [SA])
- acupuncture group 2 (using nonspecific acupoints [NSA])
- sham acupuncture group (non-acupoints [NA])
Patients in all groups received twelve 30-minute sessions over 4 consecutive weeks at 3 sessions per week, ideally every other day.
The primary outcome was the response rate at week 4, which was defined as the proportion of patients whose worst abdominal pain score (score range, 0-10, with 0 indicating no pain and 10 indicating unbearable severe pain) decreased by at least 30% and the number of type 6 or 7 stool days decreased by 50% or greater.
Ninety patients (54 male [60.0%]; mean [SD] age, 34.5 [11.3] years) were enrolled, with 30 patients in each group. There were substantial improvements in the primary outcomes for all groups
- response rates in the SA group = 46.7% [95% CI, 28.8%-65.4%]
- response rate in the NSA group = 46.7% [95% CI, 28.8%-65.4%]
- response rate in the NA group = 26.7% [95% CI, 13.0%-46.2%]
The difference between the groups was not statistically significant (P = .18). The response rates of adequate relief at week 4 were 64.3% (95% CI, 44.1%-80.7%) in the SA group, 62.1% (95% CI, 42.4%-78.7%) in the NSA group, and 55.2% (95% CI, 36.0%-73.0%) in the NA group (P = .76). Adverse events were reported in 2 patients (6.7%) in the SA group and 3 patients (10%) in NSA or NA group.
The authors concluded that acupuncture in both the SA and NSA groups showed clinically meaningful improvement in IBS-D symptoms, although there were no significant differences among the 3 groups. These findings suggest that acupuncture is feasible and safe; a larger, sufficiently powered trial is needed to accurately assess efficacy.
WHAT A LOAD OF TOSH!
Here are some of the most obvious issues I have with this new study:
- A pilot study is not about reporting effectiveness/efficacy but about testing the feasibility of a study.
- That acupuncture is feasible has been known for ~2000 years.
- The conclusion that acupuncture is safe is not warranted on the basis of the data; for that we would need a much larger investigation.
- The authors seem to have used our sham needle without acknowledging it.
- The authors are affiliated with the International Acupuncture and Moxibustion Innovation Institute, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, yet they state that they have no conflicts of interest.
- The results are clearly negative, yet the authors seem to attempt to draw a positive conclusion.
The main question that occurs to me is this: how low has the JAMA sunk to publish such junk?
Homeopaths believe that their remedies work for every condition imaginable and that naturally includes irritable bowel syndrome (IBS). But what does the evidence show?
The aim of this pilot study was to evaluate the efficacy of individualized homeopathic treatment in patients with IBS. The study was carried out at the National Homeopathic Hospital of the Secretary of Health, Mexico City, Mexico and included 41 patients: 3 men and 38 women, mean age 54 ± 14.89 years, diagnosed with IBS as defined by the Rome IV Diagnostic criteria. Single individualized homeopathics were prescribed for each patient, taking into account all presenting symptoms, clinical history, and personality via repertorization using RADAR Homeopathic Software. The homeopathic remedies were used at the fifty-millesimal (LM) potency per the Mexican Homeopathic Pharmacopoeia starting with 0/1 and increasing every month (0/2, 0/3, 0/6). Severity scales were applied at the beginning of treatment and every month for 4 months of treatment. The evaluation was based on comparing symptom severity scales during treatment.
The results demonstrated that 100% of patients showed some improvement and 63% showed major improvement or were cured. The study showed a significant decrease in the severity of symptom scores 3 months after the treatment, with the pain score showing a decrease already one month after treatment.
The authors state that the results highlight the importance of individualized medicine regimens using LM potency, although the early decrease in pain observed could also be due to the fact that Lycopodium clavatum and Nux vomica were the main homeopathic medicine prescribed, and these medicines contain many types of alkaloids, which have shown significant analgesic effects on pain caused by physical and chemical stimulation.
The authors concluded that this pilot study suggests that individualized homeopathic treatment using LM potencies benefits patients with IBS.
Where to begin?
Let me mention just a few rather obvious points:
- A pilot study is not for evaluating the efficacy, but for testing the feasibility of a definitive trial.
- The study has no control group, therefore the outcome cannot be attributed to the treatment but is most likely due to a mixture of placebo effects, regression towards the mean, and natural history of IBS.
- The conclusions are not warranted.
- The paper was published in the infamous Altern Ther Health Med.
Just to make sure that nobody is fooled into believing that homeopathy might nonetheless be effective for IBS. Here is what the Cochrane review on this subject tells us: no firm conclusions regarding the effectiveness and safety of homeopathy for the treatment of IBS can be drawn. Further high quality, adequately powered RCTs are required to assess the efficacy and safety of clinical and individualised homeopathy for IBS compared to placebo or usual care.
In my view, even the conclusion of the Cochrane review is odd and slightly misleading. The correct conclusion would have been something more to the point:
THE CURRENT TRIAL EVIDENCE FAILS TO INDICATE THAT HOMEOPATHY IS AN EFFECTIVE TREATMENT FOR IBS.
The aim of this update of a Cochrane review was to assess the effectiveness and safety of homeopathic treatment for irritable bowel syndrome (IBS). Hold on, the bit about safety is odd here and does not bode well: one cannot possibly assess the safety of an intervention on the basis of just a few trials.
Randomised controlled trials (RCTs), cohort and case-control studies that compared homeopathic treatment with placebo, other control treatments, or usual care, in adults with IBS were considered for inclusion. Two authors independently assessed the risk of bias and extracted data. The primary outcome was global improvement in IBS as measured by an IBS symptom severity score. Secondary outcomes included quality of life, abdominal pain, stool frequency, stool consistency, and adverse events. The overall certainty of the evidence supporting the primary and secondary outcomes was assessed using the GRADE criteria. The Cochrane risk of bias tool was used to assess risk of bias.
Four RCTs (307 participants) were included. Two studies compared clinical homeopathy (homeopathic remedy, asafoetida or asafoetida plus nux vomica) to placebo for IBS with constipation (IBS-C). One study compared individualised homeopathic treatment (consultation plus remedy) to usual care for the treatment of IBS in female patients. One study was a three armed RCT comparing individualised homeopathic treatment to supportive listening or usual care.
The risk of bias in three studies (the two studies assessing clinical homeopathy and the study comparing individualised homeopathic treatment to usual care) was unclear on most criteria and high for selective reporting in one of the clinical homeopathy studies. The three armed study comparing individualised homeopathic treatment to usual care and supportive listening was at low risk of bias in four of the domains and high risk of bias in two (performance bias and detection bias).
A meta-analysis of the studies assessing clinical homeopathy, (171 participants with IBS-C) was conducted. At short-term follow-up of two weeks, global improvement in symptoms was experienced by 73% (46/63) of asafoetida participants compared to 45% (30/66) of placebo participants (RR 1.61, 95% CI 1.18 to 2.18; 2 studies, very low certainty evidence).
In the other clinical homeopathy study at two weeks, 68% (13/19) of those in the asafoetida plus nux vomica arm and 52% (12/23) of those in the placebo arm experienced a global improvement in symptoms (RR 1.31, 95% CI 0.80 to 2.15; very low certainty evidence).
In the study comparing individualised homeopathic treatment to usual care (N = 20), the mean global improvement score (feeling unwell) at 12 weeks was 1.44 + 4.55 (n = 9) in the individualised homeopathic treatment arm compared to 1.41 + 1.97 (n=11) in the usual care arm (MD 0.03; 95% CI -3.16 to 3.22; very low certainty evidence).In the study comparing individualised homeopathic treatment to usual care, the mean IBS symptom severity score at 6 months was 210.44 + 112.4 (n = 16) in the individualised homeopathic treatment arm compared to 237.3 + 110.22 (n = 60) in the usual care arm (MD -26.86, 95% CI -88.59 to 34.87; low certainty evidence).
The mean quality of life score (EQ-5D) at 6 months in homeopathy participants was 69.07 (SD 17.35) compared to 63.41 (SD 23.31) in usual care participants (MD 5.66, 95% CI -4.69 to 16.01; low certainty evidence). In the study comparing individualised homeopathic treatment to supportive listening, the mean IBS symptom severity score at 6 months was 210.44 + 112.4 (n = 16) in the individualised homeopathic treatment arm compared to 262 + 120.72 (n = 18) in the supportive listening arm (MD -51.56, 95% CI -129.94 to 26.82; very low certainty evidence). The mean quality of life score at 6 months in homeopathy participants was 69.07 (SD 17.35) compared to 63.09 (SD 24.38) in supportive listening participants (MD 5.98, 95% CI -8.13 to 20.09; very low certainty evidence). None of the included studies reported on abdominal pain, stool frequency, stool consistency, or adverse events.
The authors concluded that the results for the outcomes assessed in this review are uncertain. Thus no firm conclusions regarding the effectiveness and safety of homeopathy for the treatment of IBS can be drawn. Further high quality, adequately powered RCTs are required to assess the efficacy and safety of clinical and individualised homeopathy for IBS compared to placebo or usual care.
[The previous version of this review was published in 2013 and concluded: 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 is a thorough review that is technically well-done (no wonder, as it had to comply with Cochrane standards!). However, as with some other Cochrane reviews of homeopathy, acupuncture and other SCAMs, one might object to the phraseology used in the conclusions (the part that most people would focus on). Don’t get me wrong, the conclusions are technically correct; however, they are not as clear as they should be and hide the essence of the evidence, in my view.
Systematic reviews have one main purpose: they need to inform the reader whether there is or is not good evidence that the treatment in question works for the condition in question. This question is not well addressed by stating THE RESULTS ARE UNCERTAIN. The truth is that a firm conclusion can very well be drawn: THERE IS NO GOOD EVIDENCE THAT ANY FORM OF HOMEOPATHY IS EFFECTIVE FOR IBS!
Surely that’s correct and firm enough!!!
Why do the authors not dare to put this clearly?
Probably because some of them are well-known, long-term proponents of homeopathy.
Why does the Cochrane Collaboration allow them to get away with their petty attempt of obfuscation?
You probably know what yoga is. But what is FODMAP? It stands for fermentable oligosaccharides, disaccharides, monosaccharides and polyols, more commonly known as carbohydrates. In essence, FODMAPs are carbohydrates found in a wide range of foods including onions, garlic, mushrooms, apples, lentils, rye and milk. These sugars are poorly absorbed, pass through the small intestine and enter the colon . There they are fermented by bacteria a process that produces gas which stretches the sensitive bowel causing bloating, wind and sometimes even pain. This can also cause water to move into and out of the colon, causing diarrhoea, constipation or a combination of both. Irritable bowel syndrome (IBS) makes people more susceptible to such problems.
During a low FODMAP diet these carbohydrates are eliminated usually for six to eight weeks. Subsequently, small amounts of FODMAP foods are gradually re-introduced to find a level of symptom-free tolerance. The question is, does the low FODMAP diet work?
This study examined the effect of a yoga-based intervention vs a low FODMAP diet on patients with irritable bowel syndrome. Fifty-nine patients with IBS undertook a randomised controlled trial involving yoga or a low FODMAP diet for 12 weeks. Patients in the yoga group received two sessions weekly, while patients in the low FODMAP group received a total of three sessions of nutritional counselling. The primary outcome was a change in gastrointestinal symptoms (IBS-SSS). Secondary outcomes explored changes in quality of life (IBS-QOL), health (SF-36), perceived stress (CPSS, PSQ), body awareness (BAQ), body responsiveness (BRS) and safety of the interventions. Outcomes were examined in weeks 12 and 24 by assessors “blinded” to patients’ group allocation.
No statistically significant difference was found between the intervention groups, with regard to IBS-SSS score, at either 12 or 24 weeks. Within-group comparisons showed statistically significant effects for yoga and low FODMAP diet at both 12 and 24 weeks. Comparable within-group effects occurred for the other outcomes. One patient in each intervention group experienced serious adverse events and another, also in each group, experienced nonserious adverse events.
The authors concluded that patients with irritable bowel syndrome might benefit from yoga and a low-FODMAP diet, as both groups showed a reduction in gastrointestinal symptoms. More research on the underlying mechanisms of both interventions is warranted, as well as exploration of potential benefits from their combined use.
Technically, this study is an equivalence study comparing two interventions. Such trials only make sense, if one of the two treatments have been proven to be effective. This is, however, not the case. Moreover, equivalence studies require much larger sample sizes than the 59 patients included here.
What follows is that this trial is pure pseudoscience and the positive conclusion of this study is not warranted. The authors have, in my view, demonstrated a remarkable level of ignorance regarding clinical research. None of this is all that unusual in the realm of alternative medicine; sadly, it seems more the rule than the exception.
What might make this lack of research know-how more noteworthy is something else: starting in January 2019, one of the lead authors of this piece of pseudo-research (Prof. Dr. med. Jost Langhorst) will be the director of the new Stiftungslehrstuhl “Integrative Medizin” am Klinikum Bamberg (clinic and chair of integrative medicine in Bamberg, Germany).
This does not bode well, does it?
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.
A recent meta-analysis evaluated the efficacy of acupuncture for treatment of irritable bowel syndrome (IBS) and arrived at bizarrely positive conclusions.
The authors state that they searched 4 electronic databases for double-blind, placebo-controlled trials investigating the efficacy of acupuncture in the management of IBS. Studies were screened for inclusion based on randomization, controls, and measurable outcomes reported.
Six RCTs were included in the meta-analysis, and 5 articles were of high quality. The pooled relative risk for clinical improvement with acupuncture was 1.75 (95%CI: 1.24-2.46, P = 0.001). Using two different statistical approaches, the authors confirmed the efficacy of acupuncture for treating IBS and concluded that acupuncture exhibits clinically and statistically significant control of IBS symptoms.
As IBS is a common and often difficult to treat condition, this would be great news! But is it true? We do not need to look far to find the embarrassing mistakes and – dare I say it? – lies on which this result was constructed.
The largest RCT included in this meta-analysis was neither placebo-controlled nor double blind; it was a pragmatic trial with the infamous ‘A+B versus B’ design. Here is the key part of its methods section: 116 patients were offered 10 weekly individualised acupuncture sessions plus usual care, 117 patients continued with usual care alone. Intriguingly, this was the ONLY one of the 6 RCTs with a significantly positive result!
The second largest study (as well as all the other trials) showed that acupuncture was no better than sham treatments. Here is the key quote from this trial: there was no statistically significant difference between acupuncture and sham acupuncture.
So, let me re-write the conclusions of this meta-analysis without spin, lies or hype: These results of this meta-analysis seem to indicate that:
- currently there are several RCTs testing whether acupuncture is an effective therapy for IBS,
- all the RCTs that adequately control for placebo-effects show no effectiveness of acupuncture,
- the only RCT that yields a positive result does not make any attempt to control for placebo-effects,
- this suggests that acupuncture is a placebo,
- it also demonstrates how misleading studies with the infamous ‘A+B versus B’ design can be,
- finally, this meta-analysis seems to be a prime example of scientific misconduct with the aim of creating a positive result out of data which are, in fact, negative.
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?
Alternative medicine thrives in the realm of common chronic conditions which conventional medicine cannot cure and which respond well to treatment with placebos. Irritable bowel syndrome (IBS) is such a condition, and IBS-sufferers who are often frustrated with the symptomatic relief conventional medicine has to offer are only too keen to try any therapy that promises help. There is hardly an alternative therapy which does not claim to be the solution to IBS-symptoms: herbal medicine, mind-body interventions, homeopathy (the subject of my next post), acupuncture, even ‘MOXIBUSTION‘.
Moxibustion is a derivative of acupuncture; instead of needles, this method employs heat to stimulate acupuncture points. Proponents believe that the effects of moxibustion are roughly equivalent to those of acupuncture but many acupuncturists feel that they are less powerful. One website explains: Moxibustion is a traditional Chinese medicine technique that involves the burning of mugwort, a small, spongy herb, to facilitate healing. Moxibustion has been used throughout Asia for thousands of years; in fact, the actual Chinese character for acupuncture, translated literally, means “acupuncture-moxibustion.” The purpose of moxibustion, as with most forms of traditional Chinese medicine, is to strengthen the blood, stimulate the flow of qi, and maintain general health.
Many proponents of moxibustion claim that their treatment works for IBS. The evidence is, however, far less clear. Two recent meta-analyses might tell us more.
The first systematic review and meta-analysis was published by Korean researchers and aimed at critically evaluating the current evidence on moxibustion for improving global symptoms of IBS. The authors conducted extensive searches and found a total of 20 RCTs to be included in their analyses. The risk of bias in these studies was generally high. Compared with pharmacological medications, moxibustion significantly alleviated overall IBS symptoms but there was a moderate inconsistency among the 7 RCTs. Moxibustion combined with acupuncture was more effective than pharmacological therapy but a moderate inconsistency among the 4 studies was found. When moxibustion was added to pharmacological medications or herbal medicine, no additive benefit of moxibustion was shown compared with pharmacological medications or herbal medicine alone. One small sham-controlled trial found no difference between moxibustion and sham control in symptom severity. Moxibustion appeared to be associated with few adverse events but the evidence is limited due to poor reporting.
The authors concluded that moxibustion may provide benefit to IBS patients although the risk of bias in the included studies is relatively high. Future studies are necessary to confirm whether this finding is reproducible in carefully-designed and conducted trials and to firmly establish the place of moxibustion in current practice.
The way I see it, these conclusions are far too optimistic. There was only one RCT that controlled for placebo-effects, and the results of that study were negative. Thus I would conclude that some studies report effectiveness of moxibustion for IBS, yet the effects seem not to be caused by the treatment per se but are most likely due to a placebo-effect.
The second systematic review and meta-analysis was published by Chinese researchers and aimed at evaluating the clinical efficacy and safety of moxibustion and acupuncture in treatment of IBS. The authors included randomized and quasi-randomized clinical trials in their analyses and were able to include 11 trials. Their meta analysis suggests that the effectiveness of the combined methods of acupuncture and moxibustion is superior to conventional western medication treatment. The authors concluded that acupuncture-moxibustion for IBS is better than the conventional western medication treatment.
While the first meta-analysis was at least technically sound, the second seems to have too many flaws to mention: the search methodology was flimsy, many available studies were not included, their risk of bias was not assessed critically, the conclusions are based more on wishful thinking than on the available data, etc.
If we consider that moxibustion is a method of stimulating acupoints, we have to assume that it can at best be as effective as acupuncture, quite possibly slightly less. Thus it is relevant to see what the evidence tells us about acupuncture for IBS. The current Cochrane review of acupuncture for IBS shows that 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 think I rest my case.