The most regularly reported serious complication of chiropractic neck manipulation is a stroke due to arterial dissection. Atlantoaxial dislocation (a dislocations of the first and second vertebrae which means that the spinal cord is in danger of being compressed which, in turn, would have devastating consequences) has not been previously reported, but is just as serious.
This new case-report described an 83-year-old man with a history of old cerebellar infarction who presented to the emergency department with acute left hemiplegia after a chiropractic manipulation of the neck and back several hours before symptom onset. Mild hypoesthesia was observed on his left limbs. No speech disturbance, facial palsy, or neck or shoulder pain was observed.
Intravenous thrombolytic treatment was given 238 min after symptom onset. Brown-Sequard syndrome (damage to one side of the spinal cord causing paralysis and loss of feeling on one side) subsequently developed 6 h after thrombolysis with a hypo-aesthetic sensory level below the right C5 dermatome. An emergent brain magnetic resonance angiography did not reveal an acute cerebral infarct but rather an atlantoaxial dislocation causing upper cervical spinal cord compression.
Clinical symptoms did not deteriorate after thrombolysis. He received successful decompressive surgery 1 week later, and his muscle power gradually improved, with partial dependency when performing daily living activities two months later.
A literature review revealed that only 15 patients (including the patient mentioned here) with spinal disorder mimicking acute stroke who received thrombolytic therapy have been reported. Atlantoaxial dislocation may present as acute hemiplegia mimicking acute stroke, followed by Brown-Sequard syndrome. Inadvertent thrombolytic therapy is likely not harmful for patients with atlantoaxial dislocation-induced cervical myelopathy. The neurological deficits of patients should be carefully and continuously evaluated to differentiate between stroke and myelopathy.
The authors of this case report provide no detail about the exact treatment that caused this complication, nor do they elaborate on the type of healthcare professional who administered the cervical manipulation (they focus on the issue of non-indicated thrombolytic therapy). We also do not learn why the patient had neck manipulations in the first place. However, the authors seem confident that the ‘chiropractic manipulation’ was the cause of this atlantoaxial dislocation causing severe upper cervical spinal cord compression.
The patient was treated surgically, with corticosteroids and subsequent rehabilitation. Two months later, his neurological deficits were much improved.
This article reported the case of a woman from West Bengal who presented with generalised weakness, weight loss, intermittent diffuse pain abdomen, anorexia, nausea, off and on diarrhoea for eight months. She also noticed darkening of her complexion for six months. Since last 4 months, she had intermittent headache of varying duration, frequency and intensity with tingling and numbness of all four limbs.
Her past medical history was unremarkable except for a chronic anxiety disorder for which she was treated by homeopathy medicine. A neurological examination showed preserved higher mental function, bilateral papilledema with intact other cranial nerves. There was mild motor weakness in both lower limbs, both proximal and distal accompanied by hypotonia without any motor weakness in upper limbs. There was distal sensory deficit in the form of glove and stocking hypoesthesia with reduced deep reflexes in all 4 limbs and bilateral flexor planter response. Gastrointestinal examination revealed non-tender enlarged liver with 16 cm span, mild splenomegaly and mild ascites. Investigations showed mild microcytic hypochromic anaemia (Hb- 9.2 g/dl, MCV-78 fl, MCH-26 pg, MCHC- 31.3 g/dl), low serum iron (27.5 mcg/dl), low TIBC (84.4 mcg/ dl), high serum ferritin (808.6 ng/ml), raised transaminases (AST- 40 IU/L, ALT- 98 IU/L), low serum total protein (4.6 g/dl), low serum albumin (1.9g/dl), globulin (2.7 g/dl) and raised alkaline phosphatase (789 IU/L). Nerve conduction velocity of all four limbs was suggestive of sensorimotor neuropathy.
Unexplained, apparently unrelated multi-system involvement including chronic diarrhoea, presence of liver disease, peripheral neuropathy, idiopathic intracranial hypertension (pseudotumor cerebri ) and characteristic skin lesions suggested chronic arsenicosis. Arsenic level in hair was found to be 1.06 μg/g (N= 0.02-0.2 μg/g) and arsenic level in nail was 1.24 μg/g (N= 0.02-0.5 μg/g) with normal arsenic content (0.03 mg/l) of the drinking water of the locality.
Further questioning revealed that the patient was taking arsenicum album for her anxiety depressive disorder for last one year. The drug was discontinued. Six months later the patient had fully recovered. The authors concluded that an apparently harmless homeopathy medicine may cause multisystem involvement.
The only other case reports of homeopathic arsenic poisoning is this paper:
Case 1 presented with melanosis and keratosis following short-term use of Arsenic Bromide 1-X followed by long-term use of other arsenic-containing homeopathic preparations. Case 2 developed melanotic arsenical skin lesions after taking Arsenicum Sulfuratum Flavum-1-X (Arsenic S.F. 1-X) in an effort to treat his white skin patches. Case 3 consumed Arsenic Bromide 1-X for 6 days in an effort to treat his diabetes and developed an acute gastrointestinal illness followed by leukopenia, thrombocytopenia, and diffuse dermal melanosis with patchy desquamation. Within approximately 2 weeks, he developed a toxic polyneuropathy resulting in quadriparesis. Arsenic concentrations in all three patients were significantly elevated in integument tissue samples. In all three cases, arsenic concentrations in drinking water were normal but arsenic concentrations in samples of the homeopathic medications were elevated. CONCLUSION: Arsenic used therapeutically in homeopathic medicines can cause clinical toxicity if the medications are improperly used.
The authors of the new paper fail to mention the potency of the homeopathic arsenic preparation taken by the patient. As far as I know, in Europe, only high potencies of arsenic are prescribed and dispensed; these remedies contain no or very little arsenic and can thus be considered harmless. In India, however, the 1-X potency seems to be popular, according to the second paper cited above. It describes a dilution of 1: 10 only. It is clear that taking such a remedy would quickly lead to severe toxicity.
This begs the questions: Is it legal to prescribe and dispense such remedies in India or anywhere else? And, in case it is legal, why?
Here is the abstract of a paper that makes even the most senior assessor of quackery shudder:
The purpose of this report is to describe the manipulation under anesthesia (MUA) treatment of 6 infants with newborn torticollis with a segmental dysfunction at C1/C2.
Six infants aged 4 1/2 to 15 months previously diagnosed with newborn torticollis were referred to a doctor of chiropractic owing to a failure to respond adequately to previous conservative therapies. Common physical findings were limited range of motion of the upper cervical spine. Radiographs demonstrated rotational malpositions and translation of atlas on axis in all 6 infants, and 1 had a subluxation of the C1/C2 articulation.
Interventions and Outcome:
Selection was based on complexity and variety of different clinical cases qualifying for MUA. Treatment consisted of 1 mobilization and was performed in the operating room of a children’s hospital by a certified chiropractic physician with the author assisting. Along with the chiropractor and his assistant, a children’s anesthesiologist, 1 to 2 operating nurses, a children’s radiologist, and in 1 case a pediatric surgeon were present. Before the mobilization, plain radiographs of the cervico-occipital area were taken. Three infants needed further investigation by a pediatric computed tomography scan of the area because of asymmetric bony conditions on the plain radiographs. Follow-up consultations at 2, 3, 5, or 6 weeks were done. Patient records were analyzed for restriction at baseline before MUA compared with after MUA treatment for active rotation, passive rotation, and passive rotation in full flexion of the upper cervical spine. All 3 measurements showed significant differences. The long-term outcome data was collected via phone calls to the parents at 6 to 72 months. The initial clinical improvements were maintained.
These 6 infants with arthrogenic newborn torticollis, who did not respond to previous conservative treatment methods, responded to MUA.
After reading the full text, I see many very serious problems and questions with this paper; here are 14 of the most obvious ones.
1. A congenital torticollis (that’s essentially what these kids were suffering from) has a good prognosis and does not require such invasive treatments. There is thus no plausible reason to conduct a case series of this nature.
2. A retrospective case series does not allow conclusions about therapeutic effectiveness, yet in the article the author does just that.
3. The same applies to her conclusions about the safety of the interventions.
4. It is unclear how the 6 cases were selected; it seems possible or even likely that they are, in fact, 6 cases of many more treated over a long period of time.
5. If so, this paper is hardly a ‘retrospective case series’; at best it could be called a ‘best case series’.
6. The X-rays or CT scans are unnecessary and potentially harmful.
7. The anaesthesia is potentially very harmful and unjustifiable.
8. The outcome measure is unreliable, particularly if performed by the chiropractor who has a vested interest in generating a positive result.
9. The follow-up by telephone is inadequate.
10. The range of the follow-up period (6-72 months) is unacceptable.
11. The exact way in which informed consent was obtained is unclear. In particular, we would need to know whether the parents were fully informed about the futility of the treatment and its considerable risks.
12. The chiropractor who administered the treatments is not named. Why not?
13. Similarly, it is unclear why the other healthcare professionals involved in these treatments are not named as co-authors of the paper.
14. It is unclear whether ethical approval was obtained for these treatments.
The author seems inexperienced in publishing scientific articles; the present one is poorly written and badly constructed. A Medline research reveals that she has only one other publication to her name. So, perhaps one should not be too harsh in judging her. But what about her supervisors, the journal, its reviewers, its editor and the author’s institution? The author comes from the Department of Chiropractic Medicine, Medical Faculty University, Zurich, Switzerland. On their website, they state:
The Faculty of Medicine of the University of Zurich is committed to high quality teaching and continuing research-based education of students in health care professions. Excellent and internationally recognised scientists and clinically outstanding physicians are at the Faculty of Medicine devoted to patients and public health, to teaching, to the support of young researchers and to academic medicine. The interaction between research and teaching, and their connection to clinical practice play a central role for us…
The Faculty of Medicine of the University of Zurich promotes innovative research in the basic fields of medicine, in the clinical application of knowledge, in personalised medicine, in health care, and in the translational connection between all these research areas. In addition, it encourages the cooperation between primary care and specialised health care.
It seems that, with the above paper, the UZH must have made an exception. In my view, it is a clear case of scientific misconduct and child abuse.
The present trial evaluated the efficacy of homeopathic medicines of Melissa officinalis (MO), Phytolacca decandra (PD), and the combination of both in the treatment of possible sleep bruxism (SB) in children (grinding teeth during sleep).
Patients (n = 52) (6.62 ± 1.79 years old) were selected based on the parents report of SB. The study comprised a crossover design that included 4 phases of 30-day treatments (Placebo; MO 12c; PD 12c; and MO 12c + PD 12c), with a wash-out period of 15 days between treatments.
At baseline and after each phase, the Visual Analogic Scale (VAS) was used as the primary outcome measure to evaluate the influence of treatments on the reduction of SB. The following additional outcome measures were used: a children’s sleep diary with parent’s/guardian’s perceptions of their children’s sleep quality, the trait of anxiety scale (TAS) to identify changes in children’s anxiety profile, and side effects reports. Data were analyzed by ANOVA with repeated measures followed by Post Hoc LSD test.
Significant reduction of SB was observed in VAS after the use of Placebo (-1.72 ± 0.29), MO (-2.36 ± 0.36), PD (-1.44 ± 0.28) and MO + PD (-2.21 ± 0.30) compared to baseline (4.91 ± 1.87). MO showed better results compared to PD (p = 0.018) and Placebo (p = 0.050), and similar result compared to MO+PD (p = 0.724). The sleep diary results and TAS results were not influenced by any of the treatments. No side effects were observed after treatments.
The authors concluded that MO showed promising results in the treatment of possible sleep bruxism in children, while the association of PD did not improve MO results.
Even if one fully subscribed to the principles of homeopathy, this trial raises several questions:
- Why was it submitted and then published in the journal ‘Phytotherapy’. All the remedies were given as C12 potencies. This has nothing to do with phytomedicine.
- Why was a cross-over design chosen? According to homeopathic theory, a homeopathic treatment has fundamental, long-term effects which last much longer than the wash-out periods between treatment phases. This effectively rules out such a design as a means of testing homeopathy.
- MO is used in phytomedicine to induce sleep and reduce anxiety. According to the homeopathic ‘like cures like’ assumption, this would mean it ought to be used homeopathically to treat sleepiness or for keeping patients awake or for making them anxious. How can it be used for sleep bruxism?
Considering all this, I ask myself: should we trust this study and its findings?
What do you think?
A new update of the current Cochrane review assessed the benefits and harms of spinal manipulative therapy (SMT) for the treatment of chronic low back pain. The authors included all randomised controlled trials (RCTs) examining the effect of spinal manipulation or mobilisation in adults (≥18 years) with chronic low back pain with or without referred pain. Studies that exclusively examined sciatica were excluded.
The effect of SMT was compared with recommended therapies, non-recommended therapies, sham (placebo) SMT, and SMT as an adjuvant therapy. Main outcomes were pain and back specific functional status, examined as mean differences and standardised mean differences (SMD), respectively. Outcomes were examined at 1, 6, and 12 months.
Forty-seven RCTs including a total of 9211 participants were identified. Most trials compared SMT with recommended therapies. In 16 RCTs, the therapists were chiropractors, in 14 they were physiotherapists, and in 5 they were osteopaths. They used high velocity manipulations in 18 RCTs, low velocity manipulations in 12 studies and a combination of the two in 20 trials.
Moderate quality evidence suggested that SMT has similar effects to other recommended therapies for short term pain relief and a small, clinically better improvement in function. High quality evidence suggested that, compared with non-recommended therapies, SMT results in small, not clinically better effects for short term pain relief and small to moderate clinically better improvement in function.
In general, these results were similar for the intermediate and long term outcomes as were the effects of SMT as an adjuvant therapy.
Low quality evidence suggested that SMT does not result in a statistically better effect than sham SMT at one month. Additionally, very low quality evidence suggested that SMT does not result in a statistically better effect than sham SMT at six and 12 months. Low quality evidence suggested that SMT results in a moderate to strong statistically significant and clinically better effect than sham SMT at one month. Additionally, very low quality evidence suggested that SMT does not result in a statistically significant better effect than sham SMT at six and 12 months.
(Mean difference in reduction of pain at 1, 3, 6, and 12 months (0-100; 0=no pain, 100 maximum pain) for spinal manipulative therapy (SMT) versus recommended therapies in review of the effects of SMT for chronic low back pain. Pooled mean differences calculated by DerSimonian-Laird random effects model.)
About half of the studies examined adverse and serious adverse events, but in most of these it was unclear how and whether these events were registered systematically. Most of the observed adverse events were musculoskeletal related, transient in nature, and of mild to moderate severity. One study with a low risk of selection bias and powered to examine risk (n=183) found no increased risk of an adverse event or duration of the event compared with sham SMT. In one study, the Data Safety Monitoring Board judged one serious adverse event to be possibly related to SMT.
The authors concluded that SMT produces similar effects to recommended therapies for chronic low back pain, whereas SMT seems to be better than non-recommended interventions for improvement in function in the short term. Clinicians should inform their patients of the potential risks of adverse events associated with SMT.
This paper is currently being celebrated (mostly) by chiropractors who think that it vindicates their treatments as being both effective and safe. However, I am not sure that this is entirely true. Here are a few reasons for my scepticism:
- SMT is as good as other recommended treatments for back problems – this may be so but, as no good treatment for back pain has yet been found, this really means is that SMT is as BAD as other recommended therapies.
- If we have a handful of equally good/bad treatments, it stand to reason that we must use other criteria to identify the one that is best suited – criteria like safety and cost. If we do that, it becomes very clear that SMT cannot be named as the treatment of choice.
- Less than half the RCTs reported adverse effects. This means that these studies were violating ethical standards of publication. I do not see how we can trust such deeply flawed trials.
- Any adverse effects of SMT were minor, restricted to the short term and mainly centred on musculoskeletal effects such as soreness and stiffness – this is how some naïve chiro-promoters already comment on the findings of this review. In view of the fact that more than half the studies ‘forgot’ to report adverse events and that two serious adverse events did occur, this is a misleading and potentially dangerous statement and a good example how, in the world of chiropractic, research is often mistaken for marketing.
- Less than half of the studies (45% (n=21/47)) used both an adequate sequence generation and an adequate allocation procedure.
- Only 5 studies (10% (n=5/47)) attempted to blind patients to the assigned intervention by providing a sham treatment, while in one study it was unclear.
- Only about half of the studies (57% (n=27/47)) provided an adequate overview of withdrawals or drop-outs and kept these to a minimum.
- Crucially, this review produced no good evidence to show that SMT has effects beyond placebo. This means the modest effects emerging from some trials can be explained by being due to placebo.
- The lead author of this review (SMR), a chiropractor, does not seem to be free of important conflicts of interest: SMR received personal grants from the European Chiropractors’ Union (ECU), the European Centre for Chiropractic Research Excellence (ECCRE), the Belgian Chiropractic Association (BVC) and the Netherlands Chiropractic Association (NCA) for his position at the Vrije Universiteit Amsterdam. He also received funding for a research project on chiropractic care for the elderly from the European Centre for Chiropractic Research and Excellence (ECCRE).
- The second author (AdeZ) who also is a chiropractor received a grant from the European Chiropractors’ Union (ECU), for an independent study on the effects of SMT.
After carefully considering the new review, my conclusion is the same as stated often before: SMT is not supported by convincing evidence for back (or other) problems and does not qualify as the treatment of choice.
A recent blog-post pointed out that the usefulness of yoga in primary care is doubtful. Now we have new data to shed some light on this issue.
The new paper reports a ‘prospective, longitudinal, quasi-experimental study‘. Yoga group (n= 49) underwent 24-weeks program of one-hour yoga sessions. The control group had no yoga.
Participation was voluntary and the enrolment strategy was based on invitations by health professionals and advertising in the community (e.g., local newspaper, health unit website and posters). Users willing to participate were invited to complete a registration form to verify eligibility criteria.
The endpoints of the study were:
- quality of life,
- psychological distress,
- satisfaction level,
- adherence rate.
The yoga routine consisted of breathing exercises, progressive articular and myofascial warming-up, followed by surya namascar (sun salutation sequence; adapted to the physical condition of each participant), alignment exercises, and postural awareness. Practice also included soft twists of the spine, reversed and balance postures, as well as concentration exercises. During the sessions, the instructor discussed some ethical guidelines of yoga, as for example, non-violence (ahimsa) and truthfulness (satya), to allow the participant to have a safer and integrated practice. In addition, the participants were encouraged to develop their awareness of the present moment and their body sensations, through a continuous process of self-consciousness, keeping a distance between body sensations and the emotional experience. The instructor emphasized the connection between breathing and movement. Each session ended with a guided deep relaxation (yoga nidra; 5–10 min), followed by a meditation practice (5–10 min).
The results of the study showed that the patients in the yoga group experienced a significant improvement in all domains of quality of life and a reduction of psychological distress. Linear regression analysis showed that yoga significantly improved psychological quality of life.
The authors concluded that yoga in primary care is feasible, safe and has a satisfactory adherence, as well as a positive effect on psychological quality of life of participants.
Are the authors’ conclusions correct?
I think not!
Here are some reasons for my judgement:
- The study was far to small to justify far-reaching conclusions about the safety and effectiveness of yoga.
- There were relatively high numbers of drop-outs, as seen in the graph above. Despite this fact, no intention to treat analysis was used.
- There was no randomisation, and therefore the two groups were probably not comparable.
- Participants of the experimental group chose to have yoga; their expectations thus influenced the outcomes.
- There was no attempt to control for placebo effects.
- The conclusion that yoga is safe would require a sample size that is several dimensions larger than 49.
In conclusion, this study fails to show that yoga has any value in primary care.
Oh, I almost forgot: and yoga is also satanic, of course (just like reading Harry Potter!).
Crohn’s disease (CD) is an inflammatory bowel disease characterized by recurring flares altered by periods of inactive disease and remission, affecting physical and psychological aspects and quality of life (QoL). The aim of this study was to determine the therapeutic benefits of soft non-manipulative osteopathic techniques in patients with CD.
A randomized controlled trial was performed. It included 30 individuals with CD who were divided into 2 groups: 16 in the experimental group (EG) and 14 in the control group (CG). The EG was treated with the 6 manual techniques depicted below. All patients were advised to continue their prescribed medications and diets. The intervention period lasted 30 days (1 session every 10 days). Pain, global quality of life (GQoL) and QoL specific for CD (QoLCD) were assessed before and after the intervention. Anxiety and depression levels were measured at the beginning of the study.
A significant effect was observed of the treatment in both the physical and task subscales of the GQoL and also in the QoLCD but not in pain score. When the intensity of pain was taken into consideration in the analysis of the EG, there was a significantly greater increment in the QoLCD after treatment in people without pain than in those with pain. The improvements in GQoL were independent from the disease status.
The authors concluded that soft, non-manipulative osteopathic treatment is effective in improving overall and physical-related QoL in CD patients, regardless of the phase of the disease. Pain is an important factor that inversely correlates with the improvements in QoL.
Where to begin?
Here are some of the most obvious flaws of this study:
- It was far too small for drawing any far-reaching conclusions.
- Because the sample size was so small, randomisation failed to create two comparable groups.
- Sub-group analyses are based on even smaller samples and thus even less meaningful.
- The authors call their trial a ‘single-blind’ study but, in fact, neither the patients nor the therapists (physiotherapists) were blind.
- The researchers were physiotherapists, their treatments were mostly physiotherapy. It is therefore puzzling why they repeatedly call them ‘osteopathic’.
- It also seems unclear why these and not some other soft tissue techniques were employed.
- The CG did not receive additional treatment at all; no attempt was thus made to control for placebo effects.
- The stated aim to determine the therapeutic benefits… seems to be a clue that this study was never aimed at rigorously testing the effectiveness of the treatments.
My conclusion therefore is (yet again) that poor science has the potential to mislead and thus harm us all.
Osteopathic visceral manipulation (OVM) have been our subject several times before. The method has been developed by the French Osteopath and Physical Therapist Jean-Pierre Barral. According to uncounted Internet-sites, books and other promotional literature, OVM is a miracle cure for just about every disease imaginable. Most of us hearing such claims hear alarm bells ringing – rightly so, I think. The evidence for OVM is thin, to put it mildly. But now, there is a new study to consider.
Brazilian researchers designed a placebo-controlled study using placebo visceral manipulation as the control to evaluate the effect of OVM of the stomach and liver on pain, cervical mobility, and electromyographic activity of the upper trapezius (UT) muscle in individuals with nonspecific neck pain (NS-NP) and functional dyspepsia. Twenty-eight NS-NP patients were randomly assigned into two groups: treated with OVM (OVMG; n = 14) and treated with placebo visceral manipulation (PVMG; n = 14). The effects were evaluated immediately and 7 days after treatment through pain, cervical range, and electromyographic activity of the UT muscle.
Significant effects were confirmed immediately after treatment (OVMG and PVMG) for numeric rating scale scores and pain area. Significant increases in EMG amplitude were identified immediately and 7 days after treatment for the OVMG. No differences were identified between the OVMG and the PVMG for cervical range of motion.
The authors concluded that the results of this pilot study indicate that a single session of osteopathic visceral manipulation for the stomach and liver reduces cervical pain and increases the amplitude of the upper trapezius muscle EMG signal immediately and 7 days after treatment in patients with nonspecific neck pain and functional dyspepsia. Patients treated with placebo visceral mobilisation reported a significant decrease in pain immediately after treatment. The effect of this intervention on the cervical range of motion was inconclusive. The results of this study suggest that further investigation is necessary.
There are numerous problems with this study:
- The authors call it a pilot study. Such a trial is for exploring the feasibility of a proper study. With the introduction of a placebo-OVM, this would make sense. The relevant question would then be: is the placebo valid and indistinguishable from the real thing? Sadly, this issue is not even addressed in the trial.
- A pilot study certainly is not for evaluating the effectiveness of an intervention. Sadly, this is precisely what the authors used it for. The label ‘pilot’, it seems, was merely given to excuse the many methodological flaws of their trial.
- For an evaluation of treatment effects, the study was far too small. This means the reported results can be discarded as meaningless.
- If we nevertheless took them seriously, we would want to explain how the findings were generated. The authors believe that they were caused by OVM. I find this most unlikely.
- The more plausible explanation would be that patient-blinding was unsuccessful. In other words, the placebo is not indistinguishable from the real OVM. Looking at the pictures above, one can easily see that the patients were able to tell to which group they had been allocated.
- The failure to blind patients (and, of course, the therapists), in turn, would mean that the verum group were better motivated to out-perform the placebo group in the outcome measures.
- Finally, I disagree with the authors’ view that the results of this study suggest that further investigation is necessary. On the contrary, I think that any further investment into OVM is ill-advised.
My conclusion: OVM is an implausible, non-evidence-based SCAM, and dodgy science is not going to make it look any more convincing.
Acupuncture is all over the news today. The reason is a study just out in BMJ-Open.
The aim of this new RCT was to investigate the efficacy of a standardised brief acupuncture approach for women with moderate-tosevere menopausal symptoms. Nine Danish primary care practices recruited 70 women with moderate-to-severe menopausal symptoms. Nine general practitioners with accredited education in acupuncture administered the treatments.
The acupuncture style was western medical with a standardised approach in the pre-defined acupuncture points CV-3, CV-4, LR-8, SP-6 and SP-9. The intervention group received one treatment for five consecutive weeks. The control group received no acupuncture but was offered treatment after 6 weeks. Outcomes were the differences between the two groups in changes to mean scores using the scales in the MenoScores Questionnaire, measured from baseline to week 6. The primary outcome was the hot flushes scale; the secondary outcomes were the other scales in the questionnaire. All analyses were based on intention-to-treat analysis.
Thirty-six patients received the intervention, and 34 were in the control group. Four participants dropped out before week 6. The acupuncture intervention significantly decreased hot flushes, day-and-night sweats, general sweating, menopausal-specific sleeping problems, emotional symptoms, physical symptoms and skin and hair symptoms compared with the control group at the 6-week follow-up. The pattern of decrease in hot flushes, emotional symptoms, skin and hair symptoms was already apparent three weeks into the study. Mild potential adverse effects were reported by four participants, but no severe adverse effects were reported.
The authors concluded that the standardised and brief acupuncture treatment produced a fast and clinically relevant reduction in moderate-to-severe menopausal symptoms during the six-week intervention.
The only thing that I find amazing here is the fact the a reputable journal published such a flawed trial arriving at such misleading conclusions.
- The authors call it a ‘pragmatic’ trial. Yet it excluded far too many patients to realistically qualify for this characterisation.
- The trial had no adequate control group, i.e. one that can account for placebo effects. Thus the observed outcomes are entirely in keeping with the powerful placebo effect that acupuncture undeniably has.
- The authors nevertheless conclude that ‘acupuncture treatment produced a fast and clinically relevant reduction’ of symptoms.
- They also state that they used this design because no validated sham acupuncture method exists. This is demonstrably wrong.
- In my view, such misleading statements might even amount to scientific misconduct.
So, what would be the result of a trial that is rigorous and does adequately control for placebo-effects? Luckily, we do not need to rely on speculation here; we have a study to demonstrate the result:
Background: Hot flashes (HFs) affect up to 75% of menopausal women and pose a considerable health and financial burden. Evidence of acupuncture efficacy as an HF treatment is conflicting.
Objective: To assess the efficacy of Chinese medicine acupuncture against sham acupuncture for menopausal HFs.
Design: Stratified, blind (participants, outcome assessors, and investigators, but not treating acupuncturists), parallel, randomized, sham-controlled trial with equal allocation. (Australia New Zealand Clinical Trials Registry: ACTRN12611000393954)
Setting: Community in Australia.
Participants: Women older than 40 years in the late menopausal transition or postmenopause with at least 7 moderate HFs daily, meeting criteria for Chinese medicine diagnosis of kidney yin deficiency.
Interventions:10 treatments over 8 weeks of either standardized Chinese medicine needle acupuncture designed to treat kidney yin deficiency or noninsertive sham acupuncture.
Measurements: The primary outcome was HF score at the end of treatment. Secondary outcomes included quality of life, anxiety, depression, and adverse events. Participants were assessed at 4 weeks, the end of treatment, and then 3 and 6 months after the end of treatment. Intention-to-treat analysis was conducted with linear mixed-effects models.
Results: 327 women were randomly assigned to acupuncture (n = 163) or sham acupuncture (n = 164). At the end of treatment, 16% of participants in the acupuncture group and 13% in the sham group were lost to follow-up. Mean HF scores at the end of treatment were 15.36 in the acupuncture group and 15.04 in the sham group (mean difference, 0.33 [95% CI, −1.87 to 2.52]; P = 0.77). No serious adverse events were reported.
Limitation: Participants were predominantly Caucasian and did not have breast cancer or surgical menopause.
Conclusion: Chinese medicine acupuncture was not superior to noninsertive sham acupuncture for women with moderately severe menopausal HFs.
My conclusion from all this is simple: acupuncture trials generate positive findings, provided the researchers fail to test it rigorously.
Spinal epidural haematoma (SEH) is an uncommon but serious emergency condition. A team of emergency physicians reported the case of a SEH associated with traditional massage initially presenting with delayed lower paraplegia.
A 20-year-old man was seen with bilateral lower extremity weakness and numbness, symptoms that had started three hours prior to presentation. He had received a Thai massage by a friend three days before. Magnetic resonance imaging revealed a spinal epidural lesion suspicious for haematoma extending from C6 to T2 levels. Emergent surgical intervention for cord decompression was performed. An epidural haematoma with cord compression at C6-T2 levels was identified intra-operatively. No evidence of abnormal vascular flow or AV malformations was identified. The authors concluded that, similar to chiropractic manipulation, massage may be associated with spinal trauma. Emergency physicians must maintain a high index of suspicion for spinal epidural haematomas in patients with a history of massage or chiropractic manipulation with neurologic complaints, because delays in diagnosis may worsen clinical outcome.
Thai massage therapists typically use no lubricants. The patient remains clothed during a treatment. There is constant body contact between the therapist – who, in the above case, was a lay person – and the patient.
The authors of this case report rightly stress that such adverse events are rare – but they are by no means unknown. In 2003, I reviewed the risks and found 16 reports of adverse effects as well as 4 case series on the subject (like for all other manual therapies, there is no reporting system of adverse effects). The majority of adverse effects were – like the above case – associated with exotic types of manual massage or massage delivered by laymen. Professionally trained massage therapists were rarely implicated. The reported adverse events include cerebrovascular accidents, displacement of a ureteral stent, embolization of a kidney, haematoma, leg ulcers, nerve damage, posterior interosseous syndrome, pseudoaneurism, pulmonary embolism, ruptured uterus, strangulation of neck, thyrotoxicosis and various pain syndromes. In the majority of these instances, there was little doubt about a cause-effect relationship. Serious adverse effects were associated mostly with massage techniques other than ‘Swedish’ massage.
For patients, this means that massage is still amongst the safest form of manual therapy (best to employ qualified therapists and avoid the exotic versions of massage because they are not supported by evidence and carry the highest risks). For doctors, it means to be vigilant, if patients present with neurological problems after having enjoyed a massage.