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.
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.
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?
In the UK, we have about 150000 practitioners of Spiritual Healing (SH). They treat all sorts of conditions claiming to channel ‘healing energy’ into the patient’s body which enables him/her to heal itself. The plausibility of SH is very close to zero and, despite numerous trials, its clinical effectiveness remains unproven. A new and, in my view, remarkable study of SH was aimed at investigating whether “SH could support patients with breast cancer”.
Spiritual Healing was provided by 4 healers registered with the National Federation of Spiritual Healers. Twelve patients with breast cancer undergoing long-term hormone treatment and experiencing its adverse-effects as onerous, self-referred themselves and were given ten weekly sessions of approximately 40 minutes each. Data collected included participant’s daily records, direct observations noted by the healers, the researcher’s field diary and a one-to-one semi-structured interview.
The alleged positive effects of SH included alleviation of the physical adverse-effects of their treatment, increased energy levels, enhanced well-being, emotional relaxation, and re-engagement with pre-cancer activities. Although one participant admitted considering a drug holiday prior to joining the study, none of the participants felt tempted to stop their hormonal treatments while receiving SH. The authors concluded that “these qualitative findings indicate that SH has the potential to support patients with breast cancer in the maintenance of their long-term orthodox treatments. Further research is needed to test SH as a cost-effective complementary therapy, for those undergoing long-term cancer treatments.”
As I already mentioned, I think this study is remarkable. Having done quite a bit of research into SH myself, I know how bizarre this intervention truly is. A typical treatment session might be with the patient lying on a couch in a relaxing atmosphere, often accompanied by soothing background music; the healer would talk gently but very little to enable the patient to be comfortable and relax; the SH itself might be performed by the healer moving his/her hands at a distance over the body of the patient; the healer would explain that this may cause the sensation of warmth as the ‘healing energy’ enters the body. Altogether, the experience is exotic to say the least.
It is therefore not surprising that SH generates a host of non-specific effects, including the most enormous placebo-response I have ever witnessed in any clinical trial which I have been involved in. I am mentioning this, of course, to point out that the above-noted effects are entirely compatible with those of placebo. As the study has no control group, there is no way of knowing what the effects of SH per se might have been. The fact that patients self-referred themselves to SH would only amplify this placebo-response. In the discussion of the paper, we find a further interesting pointer regarding patients’ prior experience with conventional health care professionals: “participants felt they were left to cope alone as their side-effects were trivialized.” This seems to suggest that the group of patients were indeed highly selected and all had suffered badly from previous experiences of poorly administered heath care. Thus their expectations of SH were probably high which, in turn, would exaggerate the placebo-response even further.
All of these phenomena might well be fascinating and could provide ample material for relevant research. They deserve to be analysed carefully and discussed openly and critically. Unfortunately none of this happened in the present study. The authors do not even consider the possibility that the observed effects could be related to anything else than their SH. Their stated aim to investigate whether SH supports cancer patients is not even approached; the authors simply assume a cause-effect relationship without demonstrating one. I find this is more than just a missed opportunity; in my view, it is pseudo-science. And this is the reason why I find this study remarkable.
Many cancer patients will suffer from severe, debilitating fatigue during the course of their illness. The exact cause of this common symptom is not entirely clear. Most likely it is due to a combination of the cancer and the treatments used to cure it. Managing cancer-related fatigue (CRF) is thus an important part of the palliative and supportive care of cancer patients. Acupuncture is often advocated for this purpose and many centres use it routinely. The question therefore is, does it work?
The most recent trial on this subject was aimed at assessing the effectiveness of maintenance acupuncture in the management of CRF; acupuncture or self-acupuncture/self-needling was compared with no such treatment. Breast cancer patients who previously had received acupuncture were randomized to have 4 acupuncturist-delivered weekly sessions, 4 self-administered weekly acupuncture sessions (self-needling); or no acupuncture at all. The primary outcome-measure was general fatigue, while mood, quality of life and safety served as secondary endpoints. In total, 197 patients were randomized: 65 to therapist-delivered sessions, 67 to self-acupuncture/self-needling and 65 to no further acupuncture. The results failed to demonstrate significant inter-group differences in any of the parameters evaluated. The authors concluded that “maintenance acupuncture did not yield important improvements beyond those observed after an initial clinic-based course of acupuncture“.
But this is just one single of several available studies. Acupuncture-fans might suspect me of cherry-picking a largely negative study. If we want a fair verdict, we must consider the totality of the evidence. The aim of our systematic review was therefore to critically evaluate the effectiveness of acupuncture (AT) for CRF based on all the trial data available to us.
Fourteen databases were searched from their respective inception to November 2012. Randomized clinical trials (RCTs) of AT for the treatment of CRF were considered for inclusion. The risk of bias/methodological quality was assessed using the method suggested by the Cochrane Collaboration. Seven RCTs met the eligibility criteria. Most were small pilot studies with serious methodological flaws. Four of them showed effectiveness of AT or AT in addition to usual care (UC) over sham AT, UC, enhanced UC, or no intervention for alleviating CRF. Three RCTs failed to demonstrate an effect of AT over sham treatment.
Our conclusion had to be cautious: “Overall, the quantity and quality of RCTs included in the analysis were too low to draw meaningful conclusions. Even in the positive trials, it remained unclear whether the observed outcome was due to specific effects of AT or nonspecific effects of care. Further research is required to investigate whether AT demonstrates specific effects on CRF”
There will, of course, be those who claim that no trial evidence is needed in this case; if a cancer-patient benefits from the treatment, she should have it regardless of whether it works as a placebo or has effects beyond that. I do sympathize with this attitude but should point out that there are a number of points to consider when making it:
2) There are other treatments against CRF; if we blindly advocate acupuncture, we might not offer the best option to our patients.
3) If we spend our limited resources on acupuncture, we might not afford treatments which are more effective.
4) If we are happy using acupuncture because it conveys a sizable placebo-effect, how will we make progress in finding treatments that are more effective?
It is therefore difficult to decide whether or not to recommend acupuncture for CRF. There are some arguments for both sides. Skeptics or critical thinkers or clinicians adhering to the principles of evidence-based medicine are unlikely to condone it, and some people might accuse them for cruelly and heartlessly denying severely ill patients help which they so badly need. Personally, I fail to see what is cruel or heartless in insisting that these patients receive the treatment which demonstrably works best – and that does not seem to be acupuncture.
Many cancer patients use some form of complementary and alternative medicine (CAM), mostly as an adjunct to conventional cancer therapies to improve the symptoms of the disease or to alleviate the side-effects of the often harsh cancer-therapy. The hope is that this approach leads to less suffering and perhaps even longer survival – but is this really so?
In a recently published study, Korean researchers evaluated whether CAM-use influenced the survival and health-related quality of life (HRQOL) of terminal cancer patients. From July 2005 to October 2006, they prospectively studied a cohort study of 481 cancer patients. During a follow-up of 163.8 person-years, they identified 466 deceased patients. Their multivariate analyses of these data showed that, compared with non-users, CAM-users did not have better survival. Using mind-body interventions or prayer was even associated with significantly worse survival. CAM users reported significantly worse cognitive functioning and more fatigue than nonusers. In sub-group analyses, users of alternative medical treatments, prayer, vitamin supplements, mushrooms, or rice and cereal reported significantly worse HRQOL. The authors conclude that “CAM did not provide any definite survival benefit, CAM users reported clinically significant worse HRQOLs.”
Most proponents of CAM would find this result counter-intuitive and might think it is a one-off coincidental result or a fluke. But, in fact, it is not; similar data have been reported before. For instance, a Norwegian study from 2003 examined the association between CAM-use and cancer survival. Survival data were obtained with a follow-up of 8 years for 515 cancer patients. A total of 112 patients used CAM. During the follow-up period, 350 patients died. Death rates were higher in CAM-users (79%) than in those who did not use CAM (65%). The hazard ratio of death for CAM-use compared with no use was 1.30. The authors of this paper concluded that “use of CAM seems to predict a shorter survival from cancer.”
I imagine that, had the results been the opposite (i.e. showing that CAM-users live longer and have a better quality of life), most CAM-enthusiasts would not have hesitated in claiming a cause effect relationship (i.e. that the result was due to the use of alternative medicine). Critical thinkers, however, are more careful, after all, correlation is not causation! So, how can these findings be explained?
There are, of course, several possibilities, for example:
1) Some patients might use ineffective alternative therapies instead of effective cancer treatments thus shortening their life and reducing their quality of life.
2) Other patients might employ alternative treatments which cause direct harm; for this, there are numerous options; for instance, if they self-medicate St John’s Wort, they would decrease the effectiveness of many mainstream medications, including some cancer drugs.
3) Patients who elect to use alternative medicine as an adjunct to their conventional cancer treatment might, on average, be more sick than those who stay clear of alternative medicine.
The available data do not allow us to say which explanation applies. But things are rarely black or white, and I would not be surprised, if a complex combination of all three possibilities came closest to the truth.
Since weeks I have been searching for new (2013) studies which actually report POSITIVE results. I like good news as much as the next man but, in my line of business, it seems awfully hard to come by. Therefore I am all the more delighted to present these two new articles to my readers.
The first study is a randomized trial with patients suffering from metastatic cancer who received one of three interventions: massage therapy, no-touch intervention or usual care. Primary outcomes were pain, anxiety, and alertness; secondary outcomes were quality of life and sleep. The mean number of massage therapy sessions per patient was 2.8.
The results show significant improvement in the quality of life of the patients who received massage therapy after 1-week follow-up which was not observed in either of the other groups. Unfortunately, the difference was not sustained at 1 month. There were also trends towards improvement in pain and sleep of the patients after massage. No serious adverse events were noted.
The authors conclude that “providing therapeutic massage improves the quality of life at the end of life for patients and may be associated with further beneficial effects, such as improvement in pain and sleep quality. Larger randomized controlled trials are needed to substantiate these findings“.
The second study examined the effectiveness of a back massage for improving sleep quality in 60 postpartum women suffering from poor sleep. They were randomized to either the intervention or the control group. Participants in both groups received the same care except for the back massages. The intervention group received one 20-minutes back massage at the same time each evening for 5 consecutive days by a certified massage therapist. The outcome measure was the Pittsburgh Sleep Quality Index (PSQI). The results showed that the changes in mean PSQI were significantly lower in the intervention group than in controls indicating a positive effect of massage on sleep quality.
The authors’ conclusions were clear: “an intervention involving back massage in the postnatal period significantly improved the quality of sleep.”
Where I was trained (Germany), massage is not deemed to be an alternative but an entirely mainstream treatment. Despite this fact, there is precious little evidence to demonstrate that it is effective. Our own research has found encouraging evidence for a range of conditions, including autism, cancer palliation, constipation, DOMS and back pain. In addition, we have shown that massage is not entirely free of risks but that its potential for harm is very low (some might say that this was never in question but it is good to have a bit more solid evidence).
The new studies are, of course, not without flaws; this can hardly be expected in an area where logistical, financial and methodological problems abound. The fact that there are many different approaches to massage does not make things easier either. The new evidence is nevertheless encouraging and seems to suggest that massage has relaxing effects which are clinically relevant. In my view, massage is a therapy worth considering for more rigorous research.
Acupuncture remains a highly controversial treatment: its mechanism of action is less than clear and the clinical results are equally unconvincing. Of course, one ought to differentiate between different conditions; the notion that acupuncture is a panacea is most certainly nonsense.
In many countries, acupuncture is being employed mostly in the management of pain, and it is in this area where the evidence is perhaps most encouraging. Yet, even here the evidence from the most rigorous clinical trials seems to suggest that much, if not all of the effects of acupuncture might be due to placebo.
Moreover, we ought to be careful with generalisations and ask what type of pain? One very specific pain is that caused by aromatase inhibitors (AI), a medication frequently prescribed to women suffering from breast cancer. Around 50 % of these patients complain of AI-associated musculoskeletal symptoms (AIMSS) and 15 % discontinue treatment because of these complaints. So, can acupuncture help these women?
A recent randomised, sham-controlled trial tested whether acupuncture improves AIMSS. Postmenopausal women with early stage breast cancer, experiencing AIMSS were randomized to eight weekly real or sham acupuncture sessions. The investigators evaluated changes in the Health Assessment Questionnaire Disability Index (HAQ-DI) and pain visual analog scale (VAS). Serum estradiol, β-endorphin, and proinflammatory cytokine concentrations were also measured pre and post-intervention. In total, 51 women were enrolled of whom 47 were evaluable (23 randomized to real and 24 to sham acupuncture).
Baseline characteristics turned out to be balanced between groups with the exception of a higher HAQ-DI score in the real acupuncture group. The results failed to show a statistically significant difference in reduction of HAQ-DI or VAS between the two groups. Following eight weekly treatments, a significant reduction of IL-17 was noted in both groups. No significant modulation was seen in estradiol, β-endorphin, or other proinflammatory cytokine concentrations in either group. No difference in AIMSS changes between real and sham acupuncture was seen.
Even though this study was not large, it was rigorously executed and well-reported. As many acupuncturists claim that their treatment alleviates pain and as many women suffering from AM-induced pain experience benefit, acupuncture advocates will nevertheless claim that the findings of this study are wrong, misleading or irrelevant. The often remarkable discrepancy between experience and evidence will again be the subject of intense discussions. How can a tiny trial overturn the experience of so many?
The answer is: VERY EASILY! In fact, the simplest explanation is that both are correct. The trial was well-done and its findings are thus likely to be true. The experience of patients is equally true – yet it relies not on the effects of acupuncture per se, but on the context in which it is given. In simple language, the effects patients experience after acupuncture are due to a placebo-response.
This is the only simple explanation which tallies with both the evidence and the experience. Once we think about it carefully, we realise that acupuncture is highly placebo-genic:
It is exotic.
It is invasive.
It is slightly painful.
It involves time with a therapist.
It involves touch.
If anyone had the task to develop a treatment that maximises placebo-effects, he could not come up with a better intervention!
Ahhh, will acupuncture-fans say, this means that acupuncture is a helpful therapy. I don’t care how it works, as long as it does help. Did we not just cover this issues in some detail? Indeed we did – and I do not feel like re-visiting the three fallacies which underpin this sentence again.
Would it not be nice to have a world where everything is positive? No negative findings ever! A dream! No, it’s not a dream; it is reality, albeit a reality that exists mostly in the narrow realm of alternative medicine research. Quite a while ago, we have demonstrated that journals of alternative medicine never publish negative results. Meanwhile, my colleagues investigating acupuncture, homeopathy, chiropractic etc. seem to have perfected their strategy of avoiding the embarrassment of a negative finding.
Since several years, researchers in this field have adopted a study-design which is virtually sure to generate nothing but positive results. It is being employed widely by enthusiasts of placebo-therapies, and it is easy to understand why: it allows them to conduct seemingly rigorous trials which can impress decision-makers and invariably suggests even the most useless treatment to work wonders.
One of the latest examples of this type of approach is a trial where acupuncture was tested as a treatment of cancer-related fatigue. Most cancer patients suffer from this symptom which can seriously reduce their quality of life. Unfortunately there is little conventional oncologists can do about it, and therefore alternative practitioners have a field-day claiming that their interventions are effective. It goes without saying that desperate cancer victims fall for this.
In this new study, cancer patients who were suffering from fatigue were randomised to receive usual care or usual care plus regular acupuncture. The researchers then monitored the patients’ experience of fatigue and found that the acupuncture group did better than the control group. The effect was statistically significant, and an editorial in the journal where it was published called this evidence “compelling”.
Due to a cleverly over-stated press-release, news spread fast, and the study was celebrated worldwide as a major breakthrough in cancer-care. Finally, most commentators felt, research has identified an effective therapy for this debilitating symptom which affects so many of the most desperate patients. Few people seemed to realise that this trial tells us next to nothing about what effects acupuncture really has on cancer-related fatigue.
In order to understand my concern, we need to look at the trial-design a little closer. Imagine you have an amount of money A and your friend owns the same sum plus another amount B. Who has more money? Simple, it is, of course your friend: A+B will always be more than A [unless B is a negative amount]. For the same reason, such “pragmatic” trials will always generate positive results [unless the treatment in question does actual harm]. Treatment as usual plus acupuncture is more than treatment as usual, and the former is therefore moer than likely to produce a better result. This will be true, even if acupuncture is no more than a placebo – after all, a placebo is more than nothing, and the placebo effect will impact on the outcome, particularly if we are dealing with a highly subjective symptom such as fatigue.
I can be fairly confident that this is more than a theory because, some time ago, we analysed all acupuncture studies with such an “A+B versus B” design. Our hypothesis was that none of these trials would generate a negative result. I probably do not need to tell you that our hypothesis was confirmed by the findings of our analysis. Theory and fact are in perfect harmony.
You might say that the above-mentioned acupuncture trial does still provide important information. Its authors certainly think so and firmly conclude that “acupuncture is an effective intervention for managing the symptom of cancer-related fatigue and improving patients’ quality of life”. Authors of similarly designed trials will most likely arrive at similar conclusions. But, if they are true, they must be important!
Are they true? Such studies appear to be rigorous – e.g. they are randomised – and thus can fool a lot of people, but they do not allow conclusions about cause and effect; in other words, they fail to show that the therapy in question has led to the observed result.
Acupuncture might be utterly ineffective as a treatment of cancer-related fatigue, and the observed outcome might be due to the extra care, to a placebo-response or to other non-specific effects. And this is much more than a theoretical concern: rolling out acupuncture across all oncology centres at high cost to us all might be entirely the wrong solution. Providing good care and warm sympathy could be much more effective as well as less expensive. Adopting acupuncture on a grand scale would also stop us looking for a treatment that is truly effective beyond a placebo – and that surely would not be in the best interest of the patient.
I have seen far too many of those bogus studies to have much patience left. They do not represent an honest test of anything, simply because we know their result even before the trial has started. They are not science but thinly disguised promotion. They are not just a waste of money, they are dangerous – because they produce misleading results – and they are thus also unethical.
Guest Post by Louise Lubetkin
A study published last week in the New England Journal of Medicine (NEJM) has brought to light some stark differences in the way that physicians and their patients see the role of chemotherapy in the management of advanced (i.e., metastatic) cancer.
Physicians who treat patients with advanced cancer know only too well that while chemotherapy can sometimes be helpful in easing symptoms, and may temporarily slow tumor growth, it cannot reverse or permanently cure the disease. In other words, when chemotherapy is given to patients with advanced cancer it is always given with palliative rather than curative intent. However, this is a distinction that a sizeable majority of cancer patients apparently do not fully understand.
In the NEJM-study, which involved 1193 patients with advanced lung or colorectal cancer, only 20-30 percent of patients reported understanding that chemotherapy was not at all likely to cure their cancer. The remainder, a full 81 percent of patients with colorectal cancer and 69 percent of patients with lung cancer, continued to believe, even when told otherwise, that chemotherapy did indeed offer them a significant chance of cure.
The study raises important questions concerning possible lack of informed consent: would patients still accept chemotherapy if they knew that it stood no chance of curing them? The authors cite a study which revealed that patients – especially younger patients – would opt for chemotherapy if it offered even a 1 percent chance of cure, but would be considerably less willing to accept the same treatment if it offered only a significant increase in life expectancy. In the light of this, the authors write, “…an argument can be made that patients without a sustained understanding that chemotherapy cannot cure their cancer have not met the standard for true ongoing informed consent to their treatment.”
Because of the searching nature of the questions raised by the NEJM-study, and its potential ethical ramifications, it seems destined to be picked up by advocates of alternative medicine and used as a cudgel against standard medicine. To promoters of alt med, oncology represents a cynical institutionalized conspiracy to obstruct the use of purported “natural” cures, and chemotherapy is simply a license to poison patients in pursuit of profit. Take, for example this fevered headline and article from the Natural News website : “Chemo ‘benefits’ wildly over-hyped by oncologists; cancer patients actually believe they will be ‘cured’ by poison.”
“…chemotherapy is nothing but a sham “treatment” that puts cancer patients through needless pain and suffering while making the cancer industry rich,” continues the Natural News article.
“And perhaps the most disturbing part about this now-normalized form of medical quackery is that oncologists typically fail to disclose to their patients the fact that chemotherapy does not even cure cancer, which gives them false hope.”
(Which incidentally is pretty rich, coming from a website which carries, on the same page as this article, an ad which reads “How to CURE almost any cancer at home for $5.15 a day.”)
In fact, as more than one study has previously demonstrated, the majority of oncologists do indeed try their best to convey the incurable nature of metastatic cancer, and do mention the limited aims of chemotherapy in this setting. However, patients themselves are not always psychologically receptive, and are not always immediately able to confront the bleak truth. Neither, understandably, are physicians always eager to dwell on the negative aspects of the situation during “bad news” consultations. While two thirds of doctors tell patients at their initial visit that they have an incurable disease, only about a third explicitly state the prognosis. And even when prognosis is explained, more than one third of patients simply refuse to believe that treatment is unable to cure them (see Smith TJ, Dow LA, Virago EA, et al., here).
Moreover, patients’ initial reaction to the news that their cancer has recurred, or has metastasized, is typically “What can be done?” rather than “When will I die?” Similarly, physicians – who, contrary to the calumnies of alt med conspiracy-mongers, are just as human as the rest of us, and just as averse to being the bearer of awful news – are apt quickly to follow their patients’ lead away from the hopelessness and finality of the situation and towards a practical discussion of treatment options, a realm in which they feel far more at home.
Significantly, the NEJM-study found that the very physicians who most explicitly drummed home the message that chemotherapy would not cure advanced cancer were consistently given the lowest marks for empathy and communication skills by their patients. Conversely, those physicians who projected a more optimistic view of chemotherapy were perceived as better communicators.
“In an era of greater measurement and accountability in health care,” the study concludes, “we need to recognize that oncologists who communicate honestly with their patients, a marker of high quality of care, may be at risk for lower patient ratings.”
In an accompanying NEJM editorial titled “Talking with Patients about Dying” (unfortunately it’s behind a paywall but you can read a summary here), Thomas J. Smith, MD, and Dan L. Longo, MD, provide a trenchant commentary on this important subject.
“Chemotherapy near the end of life is still common, does not improve survival, and is one preventable reason why 25 percent of all Medicare funds are spent in the last year of life. Patients need truthful information in order to make good choices. If patients are offered truthful information – repeatedly – on what is going to happen to them, they can choose wisely. Most people want to live as long as they can, with a good quality of life, and then transition to a peaceful death outside the hospital. We have the tools to help patients make these difficult decisions. We just need the gumption and incentives to use them.”
As these uncompromisingly candid editorialists point out, chemotherapy is a crude and ineffective treatment for advanced cancer. But to claim, as do many proponents of alternative approaches to cancer, that palliative chemotherapy represents a highly lucrative business built on the deliberate deception of dying patients, is a clear-cut case of the pot calling the kettle black.
When advocates of alternative cancer therapies have subjected their own highly profitable nostrums to the same kind of scientific scrutiny and honest, unsparing self-criticism as the NEJM researchers and editorialists, and when they produce evidence that their remedies and regimens, their coffee enemas and latter-day reincarnations of laetrile offer greater efficacy, whether palliative or curative, than chemotherapy, then, and only then, will they will have earned the right to criticize rational medicine for its shortcomings.