The question whether chiropractic is a truly valuable option for people suffering from back pain has been addressed repeatedly on this blog. My answer was usually negative, but proponents of chiropractic tended to argue that I am biased. Therefore I find it constructive to see what an organisation that hardly can be accused of bias says on this topic. An article by ‘SHOW ME THE EVIDENCE’ has recently provided a comprehensive overview of treatments for back pain. This is what they wrote about chiropractic:
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Spinal manipulation, the cranking and tweaking on offer when you visit a traditional chiropractor, is among the most popular approaches to back pain. Practitioners lay their hands on the patient and move their joints to or beyond their range of motion — a technique that’s often accompanied by a pop or crack.
There is some evidence the approach can help people with chronic back pain — but not any more than over-the-counter painkillers or exercise, and you need to take precautions when seeking out a chiropractor.
First, a quick look at the evidence. There are two recent Cochrane reviews on spinal manipulation for low back pain: one focused on people with acute (again, episodic/short duration) pain and the other on chronic pain. The 2011 review on chronic low back pain found that spinal manipulation had small, short-term effects on reducing pain and improving the patient’s functional status — but this effect was about the same as other common therapies for chronic low back pain, such as exercise. That review was published in 2011; UpToDate reviewed the randomized trials that have come out since — and also found that spinal manipulation delivered modest, short-term benefits for chronic back pain sufferers.
The Cochrane review on acute pain found that spinal manipulation worked no better than placebo. So people with a short episode of back pain should probably not bother seeing a chiropractor.
“Based on the evidence,” University of Amsterdam assistant professor Sidney Rubinstein, who is the lead author on the Cochrane reviews, told me, “it would appear [spinal manipulation] works as well as other accepted conservative therapies for chronic low back pain, such as non-prescription medication or exercise, but less well for patients with acute low back pain.”
As a chiropractor himself, he had some advice for patients: They should avoid chiropractors who routinely make X-rays or do advanced diagnostics for low back pain because this adds nothing to the clinical picture, particularly in the case of nonspecific low back pain. Patients should also beware chiropractors who put them on extended programs of care.
“Patients who respond to chiropractic care traditionally respond rather quickly,” he said. “My advice is those patients who have not responded to a short course of chiropractic care or manipulation should consider another type of therapy.”
While the risks of serious side effects from spinal manipulation for back pain are rare — about one in 10 million — the risks associated with chiropractic therapy for neck pain tend to be slightly higher: 1.46 strokes for every million neck adjustments.
The issue is the vertebral artery, which travels from the neck down through the vertebrae. Manipulating the neck can put patients at a higher risk of arterial problems, including stroke or vertebral artery dissection, or the tearing of the vertebral artery (though Rubinstein noted that people in the initial stages of stroke or dissection may also seek out care for their symptoms, such as neck pain, which makes it difficult to untangle how many of health emergencies are brought on by the adjustments).
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This all seems fairly reasonable to me – except for the following not entirely unimportant points:
- I am not sure where the evidence about risks of spinal manipulation comes from. In my view, it is not entirely correct: as there is no effective post-marketing surveillance, we cannot possibly name the incidence figures.
- Neck manipulations are clearly more risky than manipulations lower down. But this does not necessarily mean that back patients are safer than those with neck pain. Chiropractors view the spine as a whole organ and will regularly manipulate the neck (if they sense ‘subluxations’ in this area), even if the patient comes with low back pain.
- There are also indirect risks with consulting a chiropractor; for instance, they often give incompetent advice about healthcare. This can include discouraging immunisations or treating serious diseases, such as asthma, colic etc., with chiropractic.
- I think the article should point out that exercise is not just as effective (or as ineffective) as chiropractic, but it is much safer and less expensive.
- What Rubinstein says about responders is debatable, in my view. In particular, most chiropractors will convince their patients to continue treatment, even if they do not ‘respond’. And ‘responding’ might be simply the natural history of the condition and therefore totally unrelated to the therapy.
The bottom line: Chiropractic is not the best treatment for back pain!
This overview by researchers from that Arthritis Research UK Primary Care Centre, Research Institute for Primary Care & Health Sciences, Keele University, UK, was aimed at summarising the current best evidence on treatment options for 5 common musculoskeletal pain presentations: back, neck, shoulder, knee and multi-site pain. Reviews and studies of treatments were considered of the following therapeutic options: self-management advice and education, exercise therapy, manual therapy, pharmacological interventions (oral and topical analgesics, local injections), aids and devices, other treatments (ultrasound, TENS, laser, acupuncture, ice / hot packs) and psychosocial interventions (such as cognitive-behavioural therapy and pain-coping skills).
Here are the findings for those treatments most relevant in alternative medicine (it is interesting that most alternative medicines were not even considered because of lack of evidence and that the team of researchers can hardly be accused of an anti-alternative medicine bias, since its senior author has a track record of publishing results favourable to alternative medicine):
Current evidence shows significant positive effects in favour of exercise on pain, function, quality of life and work related outcomes in the short and long-term for all the musculoskeletal pain presentations (compared to no exercise or other control) but the evidence regarding optimal content or delivery of exercise in each case is inconclusive.
The evidence from a good quality individual patient data meta-analysis suggests that acupuncture may be effective for short-term relief of back pain and knee pain with medium summary effect sizes respectively compared with usual care or no acupuncture. However, effects on function were reported to be minimal and not maintained at longer-term follow-up. Similarly for neck and shoulder pain, acupuncture was only found to be effective for short-term (immediately post-treatment and at short-term follow-up) symptom relief compared to placebo.
Current evidence regarding manual therapy is beset by heterogeneity. Due to paucity of high quality evidence, it is uncertain whether the efficacy of manual therapy might be different for different patient subgroups or influenced by the type and experience of professional delivering the therapy. On the whole, the available evidence suggests that manual therapy may offer some beneficial effects on pain and function, but it may not be superior to other non-pharmacological treatments (e.g. exercise) for patients with acute or chronic musculoskeletal pain.
Overall. the authors concluded that the best available evidence shows that patients with musculoskeletal pain problems in primary care can be managed effectively with non-pharmacological treatments such as self-management advice, exercise therapy, and psychosocial interventions. Pharmacological interventions such as corticosteroid injections (for knee and shoulder pain) were shown to be effective treatment options for the short-term relief of musculoskeletal pain and may be used in addition to non-pharmacological treatments. NSAIDs and opioids also offer short-term benefit for musculoskeletal pain, but the potential for adverse effects must be considered. Furthermore, the optimal treatment intensity, methods of application, amount of clinical contact, and type of provider or setting, are unclear for most treatment options.
These findings confirm what we have pointed out many times before on this blog. There is very little that alternative therapies have to offer for musculoskeletal pain. Whenever it is possible, I would recommend exercise therapy initiated by a physiotherapist; it is inexpensive, safe, and at least as effective as acupuncture or chiropractic or osteopathy.
Practitioners of alternative medicine will, of course, not like this solution.
Acupuncturists may not be that bothered by such evidence: their focus is not necessarily on musculoskeletal but on a range of other conditions (with usually little evidence, I hasten to add).
But for chiropractors and osteopaths, this is much more serious, in my view. Of course, some of them also claim to be able to treat a plethora of non-musculoskeletal conditions (but there the evidence is even worse than for musculoskeletal pain, and therefore this type of practice is clearly unethical). And those who see themselves as musculoskeletal specialists have to either accept the evidence that shows little benefit and considerable risk of spinal manipulation, or go in a state of denial.
In the former case, the logical conclusion is to look for another job.
In the latter case, the only conclusion is that their practice is not ethical.
Sorry, but something I stated in my last post was not entirely correct!
I wrote that “I could not find a single study on Schuessler Salts“.
Yet, I do know of a ‘study’ of Schuessler Salts after all; I hesitate to write about it because it is an exceedingly ugly story that goes back to the ‘Third Reich’, and some people do not seem to appreciate me reporting about my research on this period.
The truth, however, is that I already did mention the Schuessler salts before on this blog: “…in 1941 a research unit was established in ‘block 5’ [of the Dachau Concetration Camp] which, according to Rascher’s biographer, Sigfried Baer, contained his department and a homeopathic research unit led by Hanno von Weyherns and Rudolf Brachtel (1909-1988). I found the following relevant comment about von Weyherns: “Zu Jahresbeginn 1941 wurde in der Krankenabteilung eine Versuchsstation eingerichtet, in der 114 registrierte Tuberkulosekranke homöopathisch behandelt wurden. Leitender Arzt war von Weyherns. Er erprobte im Februar biochemische Mittel an Häftlingen.” My translation: At the beginning of 1941, an experimental unit was established in the sick-quarters in which 114 patients with TB were treated homeopathically. The chief physician was von Weyherns. In February, he tested Schuessler Salts [a derivative of homeopathy still popular in Germany today] on prisoners.”
Wikipedia provides further details: [Im Dritten Reich] konnten erstmals mit staatlicher Billigung und Förderung Untersuchungen durchgeführt werden, in denen die behauptete Wirksamkeit „biochemischer“ Arzneimittel überprüft wurde. Solche Versuche fanden auch in den Konzentrationslagern Dachau und Auschwitz statt, unter Leitung des Reichsarztes SS Ernst-Robert Grawitz. Dabei wurden unter anderem künstlich herbeigeführte Fälle von Blutvergiftung und Malaria weitgehend erfolglos behandelt. Für die Häftlinge nahmen diese Experimente in den meisten Fällen einen tödlichen Ausgang.
My translation: During the Third Reich, it became possible for the first time possible to conduct with governmental support investigations into the alleged effectiveness of ‘biochemical’ Schuessler Salts. Such tests were carried out in the concentration camps of Dachau and Auschwitz under the leadership of Reichsarzt SS Ernst-Robert Grawitz. They involved infecting prisoners with sepsis and malaria and treating them – largely without success. Most of the prisoners used for these experiments died.
I also found several further sources on the Internet. They confirm what was stated above and also mention the treatment of TB with Schuessler Salts. Furthermore, they state that the victims were mostly Polish priests:
- Versuchsstation im Krankenrevier des KZ Dachau, in der Tuberkulosekranke mit homöopathischen Mitteln behandelt werden. Leitender Arzt ist Dr. von Weyherns, 114 Versuchspersonen sind registriert.
- Zu Jahresbeginn 1941 wurde in der Krankenabteilung eine Versuchsstation eingerichtet, in der 114 registrierte Tuberkulosekranke homöopathisch behandelt wurden. Leitender Arzt war von Weyherns.
- Dr. Rudolph Kießwetter, (andere Schreibweise: Kiesewetter), Biochemiker aus Magdeburg, spritzte 10 Häftlingen Eiter in die Oberschenkel bzw. in die Venen, 7 starben. (Experimente mit Entzündungen: vgl. Sulfonamid-Experimente von Karl Gebhardt)
- Mitte Juni 1942 wurde Heinrich Schütz Leiter der Biochemischen Versuchsstation im Krankenrevier des Konzentrationslagers Dachau. Dort erprobte er biochemische Heilmittel an Häftlingen, die er mit bakteriellen Eitererregern infiziert hatte. Die Opfer waren vor allem polnische Priester im Pfarrerblock (KZ Dachau). Hintergrund war die These, dass Krankheiten auf einer Störung der Gewebesalze in den Körperzellen beruhen und durch Mineralzufuhr in homöopathischer Verdünnung geheilt werden könnten. Obwohl die meisten Versuche mit dem Tod der Erkrankten endeten, wurden die biochemischen Mittel weiter erprobt, ungeachtet der Tatsache, dass mit den Sulfonamiden wirksame Medikamente zur Verfügung standen. Bei diesen Versuchen halfen ihm unter anderem Waldemar Wolter und Karl Babor.
- Ab Mitte Juni 1942 waren Babor und Waldemar Wolter Assistenzärzte in der „Biochemischen Versuchsstation“ im KZ Dachau. Dort wurden unter der Leitung von Heinrich Schütz an Häftlingen Sepsisversuche durchgeführt, um die Wirksamkeit von biochemischen Heilmethoden gegenüber Sulfonamiden bei Infektionen zu testen. Insgesamt wurden zwischen Mitte und Ende 1942 vier Versuchsreihen durchgeführt. Bei den äußerst schmerzhaften und inhumanen Versuchen, bei denen Häftlingen auch der eigene Eiter injiziert wurde, starben mindestens 28 Häftlinge.
The last source claims that at least 28 prisoners died as a result of these unspeakably cruel experiments.
The most detailed account (and even there, it is just 2 or 3 pages) about these experiments that I could find is in the superb and extremely well-researched book ‘AUSCHWITZ, DIE NS MEDIZIN UND IHRE OPFER’ by Ernst Klee. In it (p 146), Klee cites Grawitz’s correspondence with Himmler where Grawitz discloses that, prior to the Dachau ‘Schuessler experiments’, there were also some in Auschwitz where all three victims had died. Apparently Grawitz tried to persuade Himmler to stop these futile and (even for his standards) exceedingly cruel tests; the prisoners suffered unimaginable pain before their deaths. However, Himmler reprimanded him sharply and instructed him to continue. Dr Kiesswetter was subsequently recruited to the team because he was considered to be an expert on the clinical use of Schuessler Salts.[Another book entitled ‘Der Deutsche Zentralverein homöopathischer Ärzte im Nationalsozialismus‘ also mentions these experiments. Its author claims that Weyherns was not a doctor but a Heilpraktiker (all other sources agree that he was a medic). In general, the book seems to down-play this deplorable story and reads like an attempt to white-wash German homeopathy during the Third Reich] .
Klee concludes his chapter by reporting the post-war fate of all the doctors involved in the ‘Schuessler experiments’:
Dr Waldemar Wolter was sentenced to death and executed.
Dr Hermann Pape disappeared.
Dr Rudolf Kiesswetter disappeared.
Dr Babor fled to Addis Abeba.
Dr Laue died.
Dr Heinrich Schuetz managed to become a successful consultant in Essen. Only in 1972, he was charged and tried by a German court to 10 years of jail. Several of his colleagues, however, certify that he was too ill to be imprisoned, and Schuetz thus escaped his sentence.
Why do I dwell on this most unpleasant subject?
Surely, this has nothing to do with today’s use of Schuessler Salts!
Do I do it to “smear homeopathy and other forms of complementary medicine with a ‘guilt by association’ argument, associating them with the Nazis“, as Peter Fisher once so stupidly put it?
I have other, more important reasons:
- I do not think that the evidence regarding Schuessler Salts is complete without these details.
- I believe that these are important historical facts.
- I feel that the history of alternative medicine during the Third Reich is under-researched and almost unknown (contrary to that of conventional medicine for which a very large body of published evidence is now available).
- I feel it should be known and ought to be much better documented than it is today.
- I fear that we live in times where the memory of such atrocities might serve as a preventative for a resurgence of fascism in all its forms.
Chiropractors are often proud of offering drugless treatments to their patients. Many even have an outright aversion against drugs which goes back to their founding father, DD Palmer, who disapproved of pharmaceuticals. On this background it seems surprising that, today, some chiropractors lobby hard to get prescription rights.
A recent article explains:
A legislative proposal that would allow Wisconsin chiropractors to prescribe narcotics has divided those in the profession and pitted those of them who support the idea against medical doctors. At a hearing on the bill Tuesday, representatives form the Wisconsin Chiropractic Association said back pain is a common reason people go see a medical doctor, but they argue that chiropractors with additional training could be helping those patients instead. Under the bill, chiropractors would be able to write prescriptions for painkillers and administer anesthesia under the direction of a physician.
Expanding the scope of practice, the WCA said, would give patients with pain faster relief when primary care physicians are busy. The Wisconsin Medical Society, though, has come out against the proposal. “This expands to something not seen anywhere else in the country,” said Don Dexter, chief medical officer for WMS.
Meanwhile, another chiropractic group, the Chiropractic Society of Wisconsin, is also skeptical. “We contend there is no public need or demand … to allow chiropractors to prescribe drugs,” said Dean Shepherd, the group’s president.
Opponents also pointed out that the changes could increase access to opioids at a time the state is trying to reduce abuse. “As you know, based on legislation passed in the last two sessions, we’re already dealing with an epidemic of opioid overuse,” Dexter said. “We don’t need new providers prescribing those medications.”
However, some practicing chiropractors like Jason Mackey, with Leutke Storm Mackey Chiropractic in Madison, argue that medical fields evolve: “We have always had change throughout the course of our professsion.” Mackey said there has been pushback with previous changes, like using X-ray or certain therapies and recommending vitamins.
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On this blog, we discussed the issue of chiropractic prescribing before. At the time, I argued against such a move and gave the following reasons:
- Patients might be put at risk by chiropractors who are less than competent in prescribing medicines.
- More unnecessary NAISDs would be prescribed.
- The vast majority of the drugs in question is already available OTC.
- Healthcare costs would increase.
- Prescribing rights would give more legitimacy to a profession that arguably does not deserve it.
- Chiropractors would then continue their lobby work and soon demand the prescription rights to be extended to other classes of drugs.
Considering the chiropractors’ arguments for prescribing rights stated in the above article, I see little reason to change my mind.
The goal of this study was to assess clinical outcomes observed among adult patients who received acupuncture treatments at a United States Air Force medical center.
This retrospective chart review was performed at the Nellis Family Medicine Residency in the Mike O’Callaghan Military Medical Center at Nellis Air Force Base in Las Vegas, NV. The charts were from 172 consecutive patients who had at least 4 acupuncture treatments within 1 year. These patients were suffering from a wide range of symptoms, including pain, anxiety and sleep problems. The main outcome measures were prescriptions for opioid medications, muscle relaxants, benzodiazepines, and nonsteroidal anti-inflammatory drugs (NSAIDS) in the 60 days prior to the first acupuncture session and in the corresponding 60 days 1 year later; and Measure Yourself Medical Outcome Profile (MYMOP2) values for symptoms, ability to perform activities, and quality of life.
The most common 10 acupuncture treatments in descending order were: (1) the Auricular Trauma Protocol; (2) Battlefield Auricular Acupuncture; (3) Chinese scalp acupuncture, using the upper one-fifth of the sensory area and the Foot Motor Sensory Area; (4) the Koffman Cocktail; (5) lumbar percutaneous electrical nerve stimulation (PENS); (6) various auricular functional points; (7) Chinese scalp acupuncture, using the frontal triangle pattern; (8) cervical PENS; (9) the Great American Malady treatment; and (10) tendinomuscular meridian treatment with surface release.
The results show that opioid prescriptions decreased by 45%, muscle relaxants by 34%, NSAIDs by 42%, and benzodiazepines by 14%. MYMOP2 values decreased 3.50–3.11 (P < 0.002) for question 1, 4.18–3.46 (P < 0.00001) for question 3, and 2.73–2.43 (P < 0.006) for question 4.
The authors concluded that in this military patient population, the number of opioid prescriptions decreased and patients reported improved symptom control, ability to function, and sense of well-being after receiving courses of acupuncture by their primary care physicians.
The phraseology used by the authors is intriguing; they imply that the clinical outcomes were the result of the acupuncture treatment without actually stating it. This is perhaps most obvious in the title of the paper: Reduction in Pain Medication Prescriptions and Self-Reported Outcomes Associated with Acupuncture in a Military Patient Population. Association is not causation! But the implication of a cause effect relationship is clearly there. Once we realise who is behind this research we understand why: This study was funded by the ACUS Foundation as part of a Cooperative Research and Development Agreement with the 99th Medical Group, at Nellis Air Force Base.
The mission of Acus Foundation is to educate military physicians in the science and art of medical acupuncture, and to facilitate its integration into conventional military care… we are the most experienced team of physician teachers and practitioners of acupuncture in the United States. If they are so experienced, they surely also know that there are many explanations for the observed outcomes which are totally unrelated to acupuncture, e. g.:
- the natural history of the conditions that were being treated;
- the conventional therapies the soldiers received;
- the regression to the mean;
- social desirability;
- placebo effects.
In fact the results could even indicate that acupuncture caused a delay of clinical improvement; without a control group, we cannot know either way. All we can safely assume from this study is that it is yet another example of promotion masquerading as research.
We have repeatedly discussed the fact that alternative medicine (AM) is by no means free of risks. I find it helpful to divide them into two broad categories:
- direct risks of the intervention (such as stroke due to neck manipulation, or cardiac tamponade caused by acupuncture, or liver damage due to a herbal remedy) and
- indirect risks usually due to the advice given by AM practitioners.
The latter category is often more important than the former. It includes delay of effective treatment due to treatment with an ineffective or less effective form of AM. It is clear that this will cause patients to suffer unnecessarily.
Several investigations have recently highlighted this important problem, including this study from Singapore which assessed the predictors of AM-use in patients with early inflammatory arthritis (EIA), and its impact on delay to initiation of disease-modifying anti-rheumatic drugs (DMARD). Data were collected prospectively from EIA patients aged ≥ 21 years. Current or prior AM-use was ascertained by face-to-face interviews. Predictors of AM-use and its effect on time to DMARD initiation were determined by multivariate logistic regression and Cox proportional hazards, respectively.
One hundred and eighty patients were included: 83.9% had rheumatoid arthritis, 57% were seropositive. Median (IQR). Chinese race, being non-English speaking, smoking and high DAS28 were independent predictors of AM-use. AM-users initiated DMARD later (median [IQR] 21.5 [13.1-30.4] vs. 15.6 [9.4-22.7] weeks in non-users, P = 0.005). AM-use and higher DAS28 were associated with a longer delay to DMARD initiation. Race, education level, being non-English speaking, smoking and sero-positivity were not associated.
The authors concluded that healthcare professionals should be aware of the unique challenges in treating patients with EIA in Asia. Healthcare beliefs regarding AM may need to be addressed to reduce treatment delay.
These findings are not dissimilar to results previously discussed, for instance:
- AM-use delays cancer diagnosis.
- The advice of non-medically qualified practitioners may delay cancer therapy.
- Chiropractic care may delay referral to effective treatment.
- Consultations with homeopaths can delay effective therapy.
The only solution to the problem I can think of would be to educate AM practitioners and the public such that they are aware of the issue and do everything possible to prevent such problems. But this is, of course, easier said than done, and it seems more than just optimistic to hope that such endeavours might be successful. The public is currently bombarded with misleading information and outright lies about AM (many of my previous post have addressed this problem). And practitioners would have to operate against their own financial interest to prevent these problems from occurring.
This means that treatment delays caused by AM-use and advice from AM practitioners are inevitable…
unless you have a better idea.
If so, please let me know.
On this blog, we have often discussed the risks of spinal manipulation. As I see it, the information we have at present suggests that
- mild to moderate adverse effects are extremely frequent and occur in about half of all patients;
- serious adverse effects are being reported regularly;
- the occur usually with chiropractic manipulations of the neck (which are not of proven efficacy for any condition) and often relate to vascular accidents;
- the consequences can be permanent neurological deficits and even deaths;
- under-reporting of such cases might be considerable and therefore precise incidence figures are not available;
- there is no system to accurately monitor the risks;
- chiropractors are in denial of these problems.
Considering the seriousness of these issues, it is important to do more rigorous research. Therefore, any new paper published on this subject is welcome. A recent article might shed new light on the topic.
The objective of this systematic review was to identify characteristics of 1) patients, 2) practitioners, 3) treatment process and 4) adverse events (AE) occurring after cervical spinal manipulation (CSM) or cervical mobilization. A systematic searches were performed in 6 electronic databases up to December 2014. Of the initial 1043 articles thus located, 144 were included, containing 227 cases. 117 cases described male patients with a mean age of 45 and a mean age of 39 for females. Most patients were treated by chiropractors (66%). Manipulation was reported in 95% of the cases, and neck pain was the most frequent indication for the treatment. Cervical arterial dissection (CAD) was reported in 57% of the cases and 45.8% had immediate onset symptoms. The overall distribution of gender for CAD was 55% for female. Patient characteristics were described poorly. No clear patient profile, related to the risk of AE after CSM, could be extracted, except that women seemed more at risk for CAD. The authors of this review concluded that there seems to be under-reporting of cases. Further research should focus on a more uniform and complete registration of AE using standardized terminology.
This article provides little new information; but it does confirm what I have been saying since many years: NECK MANIPULATIONS ARE ASSOCIATED WITH SERIOUS RISKS AND SHOULD THEREFORE BE AVOIDED.
This new RCT by researchers from the National Institute of Complementary Medicine in Sydney, Australia was aimed at ‘examining the effect of changing treatment timing and the use of manual, electro acupuncture on the symptoms of primary dysmenorrhea’. It had four arms:
- low frequency manual acupuncture (LF-MA),
- high frequency manual acupuncture (HF-MA),
- low frequency electro acupuncture (LF-EA)
- and high frequency electro acupuncture (HF-EA).
A total of 74 women were given 12 treatments over three menstrual cycles, either once per week (LF groups) or three times in the week prior to menses (HF groups). All groups received a treatment in the first 48 hours of menses. The primary outcome was the reduction in peak menstrual pain at 12 months from trial entry.
During the treatment period and 9 month follow-up all groups showed statistically significant reductions in peak and average menstrual pain compared to baseline. However, there were no differences between groups. Health related quality of life increased significantly in 6 domains in groups having high frequency of treatment compared to two domains in low frequency groups. Manual acupuncture groups required less analgesic medication than electro-acupuncture groups. HF-MA was most effective in reducing secondary menstrual symptoms compared to both–EA groups.
The authors concluded that acupuncture treatment reduced menstrual pain intensity and duration after three months of treatment and this was sustained for up to one year after trial entry. The effect of changing mode of stimulation or frequency of treatment on menstrual pain was not significant. This may be due to a lack of power. The role of acupuncture stimulation on menstrual pain needs to be investigated in appropriately powered randomised controlled trials.
If I were not used to reading rubbish research of alternative medicine in general and acupuncture in particular, this RCT would amaze me – not so much because of its design, execution, or write-up, but primarily because of its conclusion (why, oh why, I ask myself, did PLOS ONE publish this paper?). They are, I think, utterly barmy.
Let me explain:
- “acupuncture treatment reduced menstrual pain intensity” – oh no, it didn’t; at least this is not what the study proves; the fact that pain was perceived as less could be due to a host of factors, for instance regression towards the mean, or social desirability; as there was no proper control group, nobody can tell;
- the lack of difference between treatments “may be due to a lack of power”. Yes, but more likely it is due to the fact that all versions of a placebo therapy generate similar outcomes.
- “acupuncture stimulation on menstrual pain needs to be investigated in appropriately powered randomised controlled trials”. Why? Because the authors have a quasi-religious belief in acupuncture? And if they have, why did they not design their study ‘appropriately’?
The best conclusion I can suggest for this daft trial is this: IN THIS STUDY, THE PRIMARY ENDPOINT SHOWED NO DIFFERENCE BETWEEN THE 4 TREATMENT GROUPS. THE RESULTS ARE THEREFORE FULLY COMPATIBLE WITH THE NOTION THAT ACUPUNCTURE IS A PLACEBO THERAPY.
Something along these lines would, in my view, have been honest and scientific. Sadly, in acupuncture research, we very rarely get such honest science and the ‘National Institute of Complementary Medicine in Sydney, Australia’ has no track record of being the laudable exception to this rule.
It used to be called ‘good bedside manners’. The term is an umbrella for a range of attitudes and behaviours including compassion, empathy and conveying positive messages. What could be more obvious than the assumption that good bedside manners are better than bad ones?
But as sceptics, we need to doubt obvious assumptions! Where is the evidence? we need to ask. So, where is the evidence that positive messages have any clinical effects? A meta-analysis has tackled the issue, and the results are noteworthy.
The researchers aimed to estimate the efficacy of positive messages for pain reduction. They included RCTs of the effects of positive messages. Their primary outcome measures were differences in patient- or observer reported pain between groups who were given positive messages and those who were not. Of the 16 RCTs (1703 patients) that met the inclusion criteria, 12 trials had sufficient data for meta-analysis. The pooled standardized effect size was −0.31 (95% CI −0.61 to −0.01, P = 0.04, I² = 82%). The effect size remained positive but not statistically significant after we excluded studies considered to have a high risk of bias (standard effect size −0.17, 95% CI −0.54 to 0.19, P = 0.36, I² = 84%). The authors concluded that care of patients with chronic or acute pain may be enhanced when clinicians deliver positive messages about possible clinical outcomes. However, we have identified several limitations of the present study that suggest caution when interpreting the results. We recommend further high quality studies to confirm (or falsify) our result.
The 1st author of this paper published a comment in which he stated that our recent mega-study with 12 randomized trials confirmed that doctors who use positive language reduce patient pain by a similar amount to drugs. Other trials show that positive messages can:
• help Parkinson’s patients move their hands faster,
• increase ‘peak flow’ (a measure of how much air is breathed) in asthma patients,
• improve the diameter of arteries in heart surgery patients, and
• reduce the amount of pain medication patients use.
The way a positive message seems to help is biological. When a patient anticipates a good thing happening (for example that their pain will go away), this activates parts of the brain that help the body make its own drugs like endorphins. A positive doctor may also help a patient relax which can also improve health.
I am not sure that this is entirely correct. When the authors excluded the methodologically weak and therefore unreliable studies, the effect was no longer significant. That is to say, it was likely due to chance.
And what about the other papers cited above? I am not sure about them either. Firstly, they do not necessarily show that positive messages are effective. Secondly, there is just one study for each claim, and one swallow does not make a summer; we would need independent replications.
So, am I saying that being positive as a clinician is ineffective? No! I am saying that the evidence is too flimsy to be sure. And possibly, this means that the effect of positive messages is smaller than we all thought.
In the US, some right-wing politicians might answer this question in the affirmative, having suggested that American citizens don’t really need healthcare, if only they believed stronger in God. Here in the UK, some right-wing MPs are not that far from such an attitude, it seems.
A 2012 article in the ‘Plymouth Harald’ revealed that the Tory MP for South West Devon, Gary Streeter , has challenged the UK Advertising Standards Authority (ASA) for banning claims that ‘God can heal’. Mr Streeter was reported to have written to the ASA demanding it produce “indisputable scientific evidence” to prove that prayer does not work – otherwise they will raise the issue in Parliament, he threatened. Mr Streeter also accused the ASA of “poor judgement” after it banned a Christian group from using leaflets stating: “Need healing? God can heal today!… We believe that God loves you and can heal you from any sickness.”
The ASA said such claims were misleading and could discourage people from seeking essential medical treatment.
The letter to ASA was written on behalf of the all-party Christians in Parliament group, which Mr Streeter chairs. Here are a few quotes from this bizarre document:
“We write to express our concern at this decision and to enquire about the basis on which it has been made… It appears to cut across two thousand years of Christian tradition and the very clear teaching in the Bible. Many of us have seen and experienced physical healing ourselves in our own families and churches and wonder why you have decided that this is not possible. On what scientific research or empirical evidence have you based this decision?… You might be interested to know that I (Gary Streeter) received divine healing myself at a church meeting in 1983 on my right hand, which was in pain for many years. After prayer at that meeting, my hand was immediately free from pain and has been ever since. What does the ASA say about that? I would be the first to accept that prayed for people do not always get healed, but sometimes they do… It is interesting to note that since the traumatic collapse of the footballer Fabrice Muamba the whole nation appears to be praying for a physical healing for him. I enclose some media extracts. Are they wrong also and will you seek to intervene? … We invite your detailed response to this letter and unless you can persuade us that you have reached your ruling on the basis of indisputable scientific evidence, we intend to raise this matter in Parliament.”
Mr Streeter displays, of course, a profound and embarrassing ignorance of science, healthcare and common sense:
- ‘Indisputable’ evidence that something is ineffective is usually not obtainable in science.
- In healthcare it is also not relevant, because we try to employ treatments that are proven to work and avoid those for which this is not the case.
- It is common sense that those who make a claim must also prove it to be true; those who doubt it need not prove that it is untrue.
- Chronic pain disappearing spontaneously is not uncommon.
- The plural of anecdote is anecdotes, not evidence!
Personally, I find it worrying that a man with such views sits in parliament and exerts influence over me and our country.