MD, PhD, FMedSci, FSB, FRCP, FRCPEd

clinical trial

Did I previously imply that osteopaths are not very research-active? Shame on me!

Here are two brand-new studies by osteopaths and they both seem to show that their treatments work.

Impressed?

Well, perhaps we better have a closer look at them before we start praising osteopathic research efforts.

THE FIRST STUDY

Researchers from the ‘European Institute for Evidence Based Osteopathic Medicine’ in Chieti, Italy, investigated the effect of  osteopathic manipulative therapy (OMT) on the length of hospital-stay (LOHS) in premature infants. They conducted an RCT on 110 preterm newborns admitted to a single specialised unit. Thus the subjects with a gestational age between 28 and 38 weeks were randomized to receive either just routine care, or routine care with OMT for the period of hospitalization. Endpoints were differences in LOHS and daily weight gain. The results showed a mean difference in LOHS between the OMT and the control group: -5.906 days (95% C.I. -7.944, -3.869; p<0.001). However, OMT was not associated with any change in daily weight gain.

The authors’ conclusion was bold: OMT may have an important role in the management of preterm infants hospitalization.

THE SECOND STUDY

The second investigation suggested similarly positive effects of OMT on LOHS in a different setting. Using a retrospective cohort study, US osteopaths wanted to determine whether there is a relationship between post-operative use of OMT and post-operative outcomes in gastrointestinal surgical patients, including time to flatus, clear liquid diet, and bowel movement [all indicators for the length of the post-operative ileus] as well as LOHS. They thus assessed the records of 55 patients who underwent a major gastrointestinal operation in a hospital that had been routinely offering OMT to its patients. The analyses showed that 17 patients had received post-operative OMT and 38 had not.The two groups were similar in terms of all variables the researchers managed to assess. The time to bowel movement and to clear liquid diet did not differ significantly between the groups. The mean time to flatus was 4.7 days in the non-OMT group and 3.1 days in the OMT group (P=.035). The mean post-operative hospital LOHS was also reduced significantly with OMT, from 11.5 days in the non-OMT group to 6.1 days in the OMT group (P=.006).

The authors concluded that OMT applied after a major gastrointestinal operation is associated with decreased time to flatus and decreased postoperative hospital LOHS.

WHAT SHOULD WE MAKE OF THESE RESULTS?

Some people may have assumed that OMT is for bad backs; these two studies imply, however, that it can do much more. If the findings are correct, they have considerable implications: shortening the time patients have to spend in hospital would not only decrease individual suffering, it would also save us all tons of money! But do these results hold water?

The devil’s advocate in me cannot help but being more than a little sceptical. I fail to see how OMT might shorten LOHS; it just does not seem plausible! Moreover, some of the results seem too good to be true. Could there be any alternative explanations for the observed findings?

The first study, I think, might merely demonstrate that more time spent handling  premature babies provides a powerful developmental stimulus. Therefore the infants are quicker ready to leave hospital compared to those children who did not receive this additional boost. But the effect might not at all be related to OMT per se; if, for instance, the parents had handled their children for the same amount of time, the outcome would probably have been quite similar, possibly even better.

The second study is not an RCT and therefore it tells us little about cause and effect. We might speculate, for instance, that those patients who elected to have OMT were more active, had lived healthier lives, adhered more rigorously to a pre-operative diet, or differed in other variables from those patients who chose not to bother with OMT. Again, the observed difference in the duration of the post-operative ileus and consequently the LOHS would be entirely unrelated to OMT.

I suggest therefore to treat these two studies with more than just a pinch of salt. Before hospitals all over the world start employing osteopaths right, left and centre in order to shorten their average LOHS, we might be well advised to plan and conduct a trial that avoids the pitfalls of the research so far. I would bet a fiver that, once we do a proper independent replication, we will find that both investigations did, in fact, generate false positive results.

My conclusion from all this is simple: RESEARCH CAN SOMETIMES BE MISLEADING, AND POOR QUALITY RESEARCH IS ALMOST INVARIABLY MISLEADING.

A recently published study by Danish researchers aimed at comparing the effectiveness of a patient education (PEP) programme with or without the added effect of chiropractic manual therapy (MT) to a minimal control intervention (MCI). Its results seem to indicate that chiropractic MT is effective. Is this the result chiropractors have been waiting for?

To answer this question, we need to look at the trial and its methodology in more detail.

A total of 118 patients with clinical and radiographic unilateral hip osteoarthritis (OA) were randomized into one of three groups: PEP, PEP+ MT or MCI. The PEP was taught by a physiotherapist in 5 sessions. The MT was delivered by a chiropractor in 12 sessions, and the MCI included a home stretching programme. The primary outcome measure was the self-reported pain severity on an 11-box numeric rating scale immediately following the 6-week intervention period. Patients were subsequently followed for one year.

The primary analyses included 111 patients. In the PEP+MT group, a statistically and clinically significant reduction in pain severity of 1.9 points was noted compared to the MCI of 1.90. The number needed to treat for PEP+MT was 3. No difference was found between the PEP and the MCI groups. At 12 months, the difference favouring PEP+MT was maintained.

The authors conclude that for primary care patients with osteoarthritis of the hip, a combined intervention of manual therapy and patient education was more effective than a minimal control intervention. Patient education alone was not superior to the minimal control intervention.

This is an interesting, pragmatic trial with a result suggesting that chiropractic MT in combination with PEP is effective in reducing the pain of hip OA. One could easily argue about the small sample size, the need for independent replication etc. However, my main concern is the fact that the findings can be interpreted in not just one but in at least two very different ways.

The obvious explanation would be that chiropractic MT is effective. I am sure that chiropractors would be delighted with this conclusion. But how sure can we be that it would reflect the truth?

I think an alternative explanation is just as (possibly more) plausible: the added time, attention and encouragement provided by the chiropractor (who must have been aware what was at stake and hence highly motivated) was the effective element in the MT-intervention, while the MT per se made little or no difference. The PEP+MT group had no less than 12 sessions with the chiropractor. We can assume that this additional care, compassion, empathy, time, encouragement etc. was a crucial factor in making these patients feel better and in convincing them to adhere more closely to the instructions of the PEP. I speculate that these factors were more important than the actual MT itself in determining the outcome.

In my view, such critical considerations regarding the trial methodology are much more than an exercise in splitting hair. They are important in at least two ways.

Firstly, they remind us that clinical trials, whenever possible, should be designed such that they allow only one interpretation of their results. This can sometimes be a problem with pragmatic trials of this nature. It would be wise, I think, to conduct pragmatic trials only of interventions which have previously been proven to work.  To the best of my knowledge, chiropractic MT as a treatment for hip OA does not belong to this category.

Secondly, it seems crucial to be aware of such methodological issues and to consider them carefully before research findings are translated into clinical practice. If not, we might end up with  therapeutic decisions (or guidelines) which are quite simply not warranted.

I would not be in the least surprised, if chiropractic interest groups were to use the current findings for promoting chiropractic in hip-OA. But what, if the MT per se was ineffective, while the additional care, compassion and encouragement was? In this case, we would not need to recruit (and pay for) chiropractors and put up with the considerable risks chiropractic treatments can entail; we would merely need to modify the PE programme such that patients are better motivated to adhere to it.

As it stands, the new study does not tell us much that is of any practical use. In my view, it is a pragmatic trial which cannot readily be translated into evidence-based practice. It might get interpreted as good news for chiropractic but, in fact, it is not.

Acupuncture is not just one single form of therapy, there are dozens of variations of this theme. For instance, acupuncture-points can, according to proponents of this form of treatment, be stimulated in a number of ways: needles, heat (moxibustion), electrical current, laser-light, ultrasound or pressure. In the latter case, the therapy is called acupressure. This therapy is popular and often recommended as a form of self-treatment, for instance, to alleviate nausea and vomiting of all causes.

Chemotherapy-induced nausea/vomiting can normally be successfully treated with standard anti-emetic drugs. Some patients, however, may not respond satisfactorily and others prefer a drug-free option such as acupressure for which there has been encouraging evidence. A brand-new study sheds new light on this issue.

Its objective was to assess the effectiveness and cost-effectiveness of self-administered acupressure using wristbands compared with sham acupressure wristbands and standard care alone in the management of chemotherapy-induced nausea. Secondary objectives included assessment of the effectiveness and cost-effectiveness of the wristbands in relation to vomiting and quality of life and exploration of any age, gender and emetogenic risk effects. The trial was conducted in outpatient chemotherapy clinics in three regions in the UK involving 14 different cancer units/centres. Chemotherapy-naïve cancer patients were included receiving chemotherapy of low, moderate and high emetogenic risk. The intervention were acupressure wristbands pressing the P6 point (anterior surface of the forearm), sham-wrist bands providing no pressure on acupuncture-points or no wrist-bands at all; all three groups had standard care in addition. The main outcome measures were the Rhodes Index for Nausea/Vomiting, the Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool and the Functional Assessment of Cancer Therapy – General (FACT-G). At baseline participants also completed measures of anxiety/depression, nausea/vomiting expectation and expectations from using the wristbands.

In total, 500 patients were randomised (166 standard care, 166 sham acupressure + standard care, and 168 acupressure + standard care). Data were available for 361 participants for the primary outcome. The primary outcome analysis (nausea in cycle 1) revealed no differences between the three arms. Women responded more favourably to the use of sham acupressure wristbands than men. No significant differences were detected in relation to vomiting outcomes, anxiety and quality of life. Some transient adverse effects were reported, including tightness in the area of the wristbands, feeling uncomfortable when wearing them and minor swelling in the wristband area.There were no statistically significant cost differences associated with the use of real acupressure bands.

In total, 26 patients took part in qualitative interviews. The qualitative data suggested that participants perceived the wristbands (both real and sham) as effective and helpful in managing their nausea during chemotherapy.

The authors concluded that there were no statistically significant differences between the three arms in terms of nausea, vomiting and quality of life.

Intriguingly, this study was published in two different journals; and the second article reporting the identical data concluded that no clear recommendations can be made about the use of acupressure wristbands in the management of chemotherapy-related nausea and vomiting.

A further equally new study tested acupressure for post-operative nausea/vomiting. One hundred and thirty-four healthy, non-smoking women scheduled for breast surgery were randomised either to P6 stimulation or to sham control. Wristbands were applied and covered with a dressing before induction of anaesthesia. Follow-up was carried out three times within 24 h postoperative. Primary outcomes were postoperative nausea and/or vomiting.

One hundred and twelve patients completed the study. There were no statistically significant differences in the incidence of nausea or vomiting. Approximately, one third of the patients reported adverse-effects caused by the wristband, for example, redness, swelling and tenderness.

The authors of this trial concluded as follows: We did not find the Vital-Band effective in preventing either nausea or vomiting after operation in women undergoing breast surgery.

There has been quite a bit of previous research on acupressure. The most recent summary included 2 meta-analyses, 6 systematic reviews and 39 RCTs of acupressure for various conditions. Its authors stated that the strongest evidence was for pain (particularly dysmenorrhoea, lower back and labour), post-operative nausea and vomiting.

So, is acupressure effective in reducing nausea and vomiting or not? The evidence is contradictory to a degree that is baffling. If we look closer at the existing trials, we are likely to find that the more rigorous studies and those published by researchers who do not have an axe to grind tend to produce negative findings. I am therefore not convinced that acupressure has any effects beyond placebo.

Some people will probably think that I am obsessed with writing about the risk of chiropractic. True, I have published quite a bit on this subject, both in the peer-reviewed literature as well as on this blog – but not because I am obsessed; on this blog, I will re-visit the topic every time a relevant new piece of evidence becomes available because it is indisputably such an important subject. Writing about it might prevent harm.

So far, we know for sure that mild to moderate as well as serious complications, including deaths, do occur after chiropractic spinal manipulations, particularly those of the upper spine.  What we cannot say with absolute certainty is whether they are caused by the treatment or whether they happened coincidentally. Our knowledge in this area relies mostly on case-reports and surveys which, by their very nature, do not allow causal inferences. Therefore chiropractors have, in the past, been able to argue that a causal link remains unproven.

A brand-new blinded parallel group RCT might fill this gap in our knowledge and might reject or establish the notion of causality once and for all. The authors’ objective was to establish the frequency and severity of adverse effects from short term usual chiropractic treatment of the spine when compared to a sham treatment group. They thus conducted the first ever RCT  with the specific aim to examine the occurrence of adverse events resulting from chiropractic treatment. It was conducted across 12 chiropractic clinics in Perth, Western Australia. The participants comprised 183 adults, aged 20-85, with spinal pain. Ninety two participants received individualized care consistent with the chiropractors’ usual treatment approach; 91 participants received a sham intervention. Each participant received two treatment sessions.

Completed adverse questionnaires were returned by 94.5% of the participants after the first appointment and 91.3% after the second appointment. Thirty three per cent of the sham group and 42% of the usual care group reported at least one adverse event. Common adverse events were increased pain (sham 29%; usual care 36%), muscle stiffness (sham 29%; usual care 37%), headache (sham 17%; usual care 9%). The relative risk was not significant for either adverse event occurrence (RR = 1.24 95% CI 0.85 to 1.81); occurrence of severe adverse events (RR = 1.9; 95% CI 0.98 to 3.99); adverse event onset (RR = 0.16; 95% CI 0.02 to 1.34); or adverse event duration (RR = 1.13; 95% CI 0.59 to 2.18). No serious adverse events were reported.

The authors concluded that a substantial proportion of adverse events following chiropractic treatment may result from natural history variation and non-specific effects.

If we want to assess causality of effects, we have no better option than to conduct an RCT. It is the study design that can give us certainty, or at least near certainty – that is, if the RCT is rigorous and well-made. So, does this study reject or confirm causality? The disappointing truth is that it does neither.

Adverse events were clearly more frequent with real as compared to sham-treatment. Yet the difference failed to be statistically significant. Why? There are at least two possibilities: either there was no true difference and the numerically different percentages are a mere fluke; or there was a true difference but the sample size was too small to prove it.

My money is on the second option. The number of patients was, in my view, way too small for demonstrating differences in frequencies of adverse effects. This applies to the adverse effects noted, but also, and more importantly, to the ones not noted.

The authors state that no serious adverse effects were observed. With less that 200 patients participating, it would have been most amazing to see a case of arterial dissection or stroke. From all we currently know, such events are quite rare and occur perhaps in one of 10 000 patients or even less often. This means that one would require a trial of several hundred thousand patients to note just a few of such events, and an RCT with several million patients to see a difference between real and sham treatment. It seems likely that such an undertaking will never be affordable.

So, what does this new study tell us? In my view, it is strong evidence to suggest a causal kink between chiropractic treatment and mild to moderate adverse effects. I dose not prove it, but merely suggests it – yet I am fairly sure that chiropractors, once again, will not agree with me.

Postoperative ileus (POI), the phenomenon that after an operation the intestines tend to be inactive for a few days, can cause intense pain and thus contributes significantly to human suffering. It also prolongs hospital stay and increases the risks of post-operative complications. There is no known effective treatment for POI.

In China, POI is often treated with acupuncture, and due to this fact acupuncture became known in the West: James Reston, a journalist who accompanied Nixon on his first trip to China, had to have an appendectomy in a Beijing hospital, he subsequently suffered from POI, was treated with acupuncture and moxibustion, experienced symptom-relief, and subsequently wrote about it in the New York Times. This was the beginning of the present acupuncture-boom.

Since then, thousands of acupuncture trials have been published but, intriguingly, very few have tested the effectiveness of acupuncture for POI. Now researchers from the Sloan Kettering Cancer Center in New York have conducted a randomized, sham-controlled trial to test whether acupuncture reduces POI more effectively than sham acupuncture.

Ninety colon cancer patients undergoing elective colectomy were randomized to receive 30 min of true or sham acupuncture twice daily during their first three postoperative days. GI-3 (the later of the following two events: time that the patient first tolerated solid food, AND time that the patient first passed flatus OR a bowel movement) and GI-2 (the later of the following two events: time patient first tolerated solid food AND time patient first passed a bowel movement) were determined. Pain, nausea, vomiting, and use of pain medications were evaluated daily for the first three postoperative days. Eighty-one patients received the allocated intervention: 39 the true acupuncture and 42 the sham acupuncture. The mean time to GI-3 was 149 hours and 146 hours for the acupuncture group and the sham acupuncture group. No significant differences were found between groups for secondary endpoints.

The authors’ conclusion was clear: True acupuncture as provided in this study did not reduce POI more significantly than sham acupuncture.

So, did a mere misunderstanding start the present acupuncture boom? POI inevitably normalises with time. Did the journalist just imagine that acupuncture helped, while nature cured the condition? It would seem so, according to this study. But perhaps things are not just black or white. Almost at the same time as the New York trial, another study was emerged.

Researchers from Hong Kong conducted an RCT with 165 patients undergoing elective laparoscopic surgery for colonic and upper rectal cancer. Patients were assigned randomly to receive electroacupuncture (n = 55) or sham acupuncture (n = 55), once daily from postoperative days 1-4, or no acupuncture (n = 55). The primary outcome was time to defecation. Secondary outcomes included postoperative analgesic requirement, time to ambulation, and length of hospital stay. The results showed that patients who received electroacupuncture had a shorter time to defecation than patients who received no acupuncture (85.9 ± 36.1 vs 122.1 ± 53.5 h) and length of hospital stay (6.5 ± 2.2 vs 8.5 ± 4.8 days). Patients who received electroacupuncture also had a shorter time to defecation than patients who received sham acupuncture (85.9 ± 36.1 vs 107.5 ± 46.2 h). Electroacupuncture was more effective than no or sham acupuncture in reducing postoperative analgesic requirement and time to ambulation.

The Chinese researchers’ conclusion is equally clear: electroacupuncture reduced the duration of postoperative ileus, time to ambulation, and postoperative analgesic requirement, compared with no or sham acupuncture, after laparoscopic surgery for colorectal cancer.

The only other trial I know in this area failed to show that acupuncture shortens POI. What should we make of these data? A systematic review would be nice, of course, but, to the best of my knowledge, none is currently available.

Is this a question of everyone being able to pick and chose the evidence they like? Is it a question of who we trust, the researchers in New York or those in China? Is it a question of where the treatment was done authentically? Is it a question of critically analysing which study had the higher risks of bias? Or is it a question of simply saying that two negative studies are more than one positive trial?

Confused? Me too, a little!

Whatever answers we chose, several things seems fairly certain to me. It would be wrong to say that there is good evidence for acupuncture as a treatment of POI. And the acupuncture-boom that ensued after Reston’s article was to a very large degree built on a simple misunderstanding: POI is a condition that resolves literally into thin air whether we treat it or not.

Tai Chi, as we know it in the West, is said to promote the smooth flow of “energy” throughout the body by performing postures, slow meditative movements and controlled breathing. Tai Chi is also supposed to help increasing flexibility, suppleness, balance and coordination. According to enthusiasts, the smooth, gentle movements of Tai Chi aid relaxation and help to keep the mind calm and focused.

Tai Chi has become popular in Western countries and is being considered for a surprisingly wide range of conditions. The patient/consumer is taught to perform postures, slow meditative movements and controlled breathing. The concepts underlying Tai Chi are strange, but that does not necessarily mean that the treatment is not effective for certain illnesses or symptoms.

There has been a surprising amount of research in this area, and some studies have generated encouraging results. A recent study which is unfortunately not available electronically ( Wu, WF; Muheremu, A; Chen, CH; Liu, WG; Sun, L. Effectiveness of Tai Chi Practice for Non-Specific Chronic Low Back Pain on Retired Athletes: A Randomized Controlled Study. JOURNAL OF MUSCULOSKELETAL PAIN 2013, 21:1, p.37-45) tested the effectiveness of Tai Chi for chronic back pain. Specifically, the researchers wanted to determine whether regular Tai Chi practice is superior to other means of sports rehabilitation in relieving non-specific chronic low back pain [LBP] in a younger population. They randomized 320 former athletes suffering from chronic LBP into a treatment [tai chi practice] and several control groups [regular sessions with swimming, backward walking or jogging, or no such interventions]. At the beginning, middle, and end of a six-month intervention, patients from all groups completed questionnaires assessing the intensity of LBP; in addition, a physical examination was conducted.

After 3 and 6 months, no statistically significant difference in the intensity of LBP was demonstrated between the Tai Chi and swimming. However, significant differences were demonstrated between the Tai Chi and backward walking, jogging, and no exercise groups.

The authors’ concluded that “Tai chi has better efficacy than certain other sports on the treatment of non-specific chronic LBP.”

This is only the second RCT of Tai chi for back pain. The first such study consisted of 160 volunteers between ages 18 and 70 years with persistent nonspecific low back pain. The experimental group (n = 80) had 18 Tai Chi sessions over a 10-week period. The waitlist control group continued with their usual health care. Bothersomeness of symptoms was the primary outcome, and secondary outcomes included pain intensity and pain-related disability. Tai Chi reduced bothersomeness of back symptoms by 1.7 points on a 0-10 scale, reduced pain intensity by 1.3 points on a 0-10 scale, and improved self-report disability by 2.6 points on the 0-24 Roland-Morris Disability Questionnaire scale. The authors of this RCT concluded that a 10-week Tai Chi program improved pain and disability outcomes and can be considered a safe and effective intervention for those experiencing long-term low back pain symptoms.

My own team have conducted their fair share of Tai Chi research. Specifically,we have published several systematic reviews of Tai Chi as an adjunctive or supportive treatment of various conditions, and the conclusions (in italics) have been mixed.

DIABETES: The existing evidence does not suggest that tai chi is an effective therapy for type 2 diabetes.

HYPERTENSION: The evidence for tai chi in reducing blood pressure in the elderly individuals is limited.

BREAST CANCER: the existing trial evidence does not show convincingly that tai chi is effective for supportive breast cancer care.

IMPROVEMENT OF AEROBIC EXCERCISE CAPACITY: the existing evidence does not suggest that regular tai chi is an effective way of increasing aerobic capacity.

PARKINSON’S DISEASE: the evidence is insufficient to suggest tai chi is an effective intervention for Parkinson’s Disease.

OSTEOPOROSIS: The evidence for tai chi in the prevention or treatment of osteoporosis is not convincing.

OSTEOARTHRITIS: there is some encouraging evidence suggesting that tai chi may be effective for pain control in patients with knee OA.

RHEUMATOID ARTHRITIS: Collectively this evidence is not convincing enough to suggest that tai chi is an effective treatment for RA.

Finally, an overview over all systematic reviews of Tai Chi suggested that the only area where the evidence is convincing is the prevention of falls in the elderly.

I think, this indicates that we should not pin our hopes too high as to the therapeutic value of Tai Chi. In particular, for back pain, the evidence might be optimistically judged as encouraging, but it is by no means convincing; the effect size seems to be small and two studies are not enough to issue general recommendations. On the other hand, considering that there is so little to offer to back pain patients, I concede that this is an area that should be studied further. Meanwhile, one could argue that Tai Chi can be fun and is devoid of risks – so, why not give it a try?

Lymph oedema in the arms or legs is a frequent complication after lymph-node dissections for cancer. Treatment or prevention can be difficult, and the results  are often unsatisfactory. Consequently, the burden of suffering of cancer patients affected by this problem is immense.

Amongst several options, a little-known massage technique, called lymph-drainage (or lymphatic drainage, LD), is sometimes recommended. It consists of gentle manual movements which lightly push the lymph fluid through the lymphatic vessels that eventually enter into the blood circulation. During a session of lymph-drainage, a specially trained massage therapist lightly moves his or her hands along the lymph vessels to facilitate the lymph flow. The treatment is agreeable and relaxing, but does it really reduce the oedema?

A recent systematic review and meta-analysis of RCTs evaluated the effectiveness of LD in the prevention and treatment of breast-cancer related lymph-oedema. The primary outcome for prevention was the incidence of postoperative lymph-oedema. The outcome for management of  was a reduction in oedema volume.

In total, 10 RCTs with altogether 566 patients were identified. Two studies evaluating the preventive outcome of LD found no significant difference in the incidence of lymph-oedema between the LD and standard treatments. Seven studies assessed the reduction in arm volume, and found no significant difference between the LD and standard treatments.

The authors conclusion was negative about the value of LD: The current evidence from RCTs does not support the use of LD in preventing or treating lymph-oedema. However, clinical and statistical inconsistencies between the various studies confounded our evaluation of the effect of LD on breast-cancer-related lymph-oedema.

Perhaps a brand-new clinical trial which had not been included in the above assessment would have persuaded the authors to be a little more optimistic. This study evaluated the effectiveness of LD in the prevention of lymph-oedema after treatment of breast cancer. The study-population consisted of 67 women, who had undergone surgery for breast cancer. From the second day of surgery, 33 randomly chosen women were given LD. The control group consisted of 34 women who did not receive LD. Measurements of the volumes of both arms were taken before surgery and on days 2, 7, 14, and at 3 and 6 months after surgery.

Among the women who did not have LD, a significant increase in the arm volume on the operated side was observed after 6 month. There was no statistically significant  increase in the volume of the upper limb on the operated side in women who underwent LD.

The authors conclude that regardless of the surgery type and the number of the lymph nodes removed, LD effectively prevented lymph-oedema of the arm on the operated side. Even in high risk breast cancer treatments (operation plus irradiation), LD was demonstrated to be effective against arm volume increase. Even though confirmatory studies are needed, this study demonstrates that LD administered early after operation for breast cancer should be considered for the prevention of lymph-oedema.

So, does LD reduce oedema or not? This does not seem to be such a difficult question that it should take decades to resolve! And who would doubt that it is an important one? Lymph-oedema has the potential to seriously impede the quality of life of many patients, and it can even contribute to unnecessary mortality. The fact that the few available studies are too small and too weak to generate reliable results is disappointing and shines a dim light on the supposedly patient-centred research in oncology, in my view.

The concept of LD is plausible, at least some of the findings from clinical trials are encouraging, and the problem of lymph-oedema is both prevalent and relevant. So what is stopping us from funding a large, well-designed and definitive study?

Indian homeopaths recently published a clinical trial aimed at evaluating homeopathic treatment in the management of diabetic polyneuropathy. The condition affects many diabetic patients; its symptoms include tingling, numbness, burning sensation in the feet and pain, particularly at night. The best treatment consists of adequate metabolic control of the underlying diabetes. The pain can be severe often does not respond adequately to conventional pain-killers. It is therefore obvious that any new, effective treatment would be more than welcome.

The new trial  is a prospective observational study which was carried out from October 2005 to September 2009 by the Indian Central Council for Research in Homeopathy at its five Institutes. Patients suffering diabetic polyneuropathy (DPN) were screened and enrolled in the study, if they fulfilled the inclusion and exclusion criteria. The Diabetic Distal Symmetric Polyneuropathy Symptom Score (DDSPSS), developed by the Council, served as the primary outcome measure.

A total of 15 homeopathic medicines were identified after repertorizing the nosological symptoms and signs of the disease. The appropriate constitutional medicine was selected and prescribed in the 30, 200 and 1 M potencies on an individualized basis. Patients were followed up for 12 months.

Of 336 diabetics enrolled in the study, 247 patients who attended at least three follow-up appointments and baseline nerve conduction studies were included in the analysis. A statistically significant improvement in DDSPSS total score was found at 12 months. Most objective measures did not show significant improvements. Lycopodium clavatum (n = 132), Phosphorus (n = 27) and Sulphur (n = 26) were the most frequently prescribed homeopathic remedies.

From these results, the authors concluded that: “homeopathic medicines may be effective in managing the symptoms of DPN patients.”

Does this study tell us anything worth knowing? The short answer to this question, I am afraid, is NO.

Its weaknesses are all too obvious:

1) There was no control group.

2) Patients who did not come back to the follow-up appointments – presumably because they were not satisfied – were excluded from the analyses. The average benefit reported is thus likely to be a cherry-picked false positive result.

3) The primary outcome measure was not validated.

4) The observed positive effect on subjective symptoms could be due to several factors which are entirely unrelated to the homeopathic treatments’ e.g. better metabolic control, regression towards the mean, or social desirability.

Anyone who had seen the protocol of this study would have predicted the result; I see no way that such a study does not generate an apparently positive outcome. In other words, conducting the investigation was superfluous, which means that the patients’ participation was in vain; and this, in turn, means that the trial was arguably unethical.

This might sound a bit harsh, but I am entirely serious: deeply flawed research should not happen. It is a waste of scarce resources and patients’ tolerance; crucially, it has a powerful potential to mislead us and to set back our efforts to improve health care. All of this is unethical.

The problem of research which is so poor that it crosses the line into being unethical is, of course, not confined to homeopathy. In my view, it is an important issue in much of alternative medicine and quite possibly in conventional medicine as well. Over the years, several mechanisms have been put in place to prevent or at least minimize the problem, for instance, ethic committees and peer-review. The present study shows, I think, that these mechanisms are fragile and that, sometimes, they fail altogether.

In their article, the authors of the new homeopathic study suggest that more investigations of homeopathy for diabetic polyneuropathy should be done. However, I suggest almost precisely the opposite: unethical research of this nature should be prevented, and the existing mechanisms to achieve this aim must be strengthened.

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.

Gravityscan Badge

Recent Comments

Note that comments can be edited for up to five minutes after they are first submitted.


Click here for a comprehensive list of recent comments.

Categories