The sale and promotion of a therapeutic drug in most countries require rigorous assessment and licencing by that country’s therapeutic regulatory body. However, a new surgical technique can escape such checks and overview unless the technique is subject to local medical ethics review in the context of a research trial. New medical devices in Australia such as carbon dioxide or Er-YAG lasers can be listed on its therapeutic register without critical review of their efficacy and safety. Thermal injury to the postmenopausal vaginal wall in the hope of rejuvenating it has become a lucrative fad for some surgeons outside formal well-conducted clinical trials.
There are many published studies of this technique but the large majority are small, uncontrolled and observational. The few randomised controlled trials using sham controls show a placebo effect and debatable clinical efficacy with limited follow-up of adverse effects. A review of these therapies in July 2020 published by The National Institute for Health and Care Excellence summarised apparent claims for some efficacy in terms of vaginal dryness, dyspareunia, sexual function, and incontinence but noted confounding in the study’s designs such as concurrent breast cancer treatments, local oestrogen therapy and lubricants (!). Most studies had very limited follow up for adverse events but elsewhere the literature has reported burns, infection, increased dyspareunia and scarring. There is no physiological mechanism by which burning atrophic vaginal epithelium will magically rejuvenate it.
A recent well-conducted randomised sham-controlled trial with a 12-month follow-up of Fractional Carbon Dioxide Laser for the treatment of vaginal symptoms associated with menopause has been published in JAMA by Li et al has shown no efficacy for this treatment(2).
At 12 months, there was no difference in overall symptom severity based on a 0-100 scale (zero equals no symptoms), with a reduction in symptom severity of 17.2 in the treatment group compared with 26.6 in the sham group.
The treatment had no impact on quality of life. “Sexual activity rates and quality of sex were not significantly different between the groups at baseline or 12 months”. The study compared 46 paired vaginal wall biopsies, taken at baseline and six months into treatment, and no significant histological improvement with laser was evident.
“The annual cost of laser treatment to the individual for management of vaginal menopausal symptoms was reported to be AUD$2,733, and because there is no demonstrable difference versus sham treatment, it cannot be considered to be cost-effective.”
Although one could still call for more quality sham-controlled randomised trials in different circumstances there is no justification for touting this therapy commercially. Complications following this therapy outside of ethical trials could become the next medico-legal mine-field.
Vaginal atrophy in the years after menopause is almost universal and is primarily due to oestrogen deficiency. The efficient solution is local vaginal oestrogen or systemic hormone replacement therapy. However, the misreporting of the Women’s Health Initiative and Million Women’s Study has created exaggerated fear of oestrogen therapies and thus a market for alternative and often unproven therapies (3). The way forward is education and tailoring of hormonal therapies to minimise risk and maximise efficacy and quality of life and not to resort to quackery.
2. Li FG, Maheux-Lacroix S, Deans R et al. Effect of Fractional Carbon Dioxide Laser vs Sham Treatment on Symptom Severity in Women With Postmenopausal Vaginal Symptoms A Randomized Clinical Trial. JAMA. 2021;326:1381-1389.
3. MacLennan AH. Evidence-based review of therapies at the menopause. Int J Evid Based Healthc 2009; 7: 112-123.
Kratom (Mitragyna speciosa, Korth.) is an evergreen tree that is indigenous to Southeast Asia. It is increasingly being used as a recreational drug, to help with opium withdrawal, and as a so-called alternative medicine (SCAM) for pain, erectile dysfunction, as a mood stabilizer, and for boosting energy or concentration. When ingested, Kratom leaves produce stimulant and opioid-like effects (see also my previous post).
Kratom contains 7‑hydroxymitragynine, which is active on opioid receptors. The use of kratom carries significant risks, e.g. because there is no standardized form of administration as well as the possibility of direct damage to health and of addiction.
There are only very few clinical trials of Kratom. One small placebo-controlled study concluded that the short-term administration of the herb led to a substantial and statistically significant increase in pain tolerance. And a recent review stated that Kratom may have drug interactions as both a cytochrome P-450 system substrate and inhibitor. Kratom does not appear in normal drug screens and, especially when ingested with other substances of abuse, may not be recognized as an agent of harm. There are numerous cases of death in kratom users, but many involved polypharmaceutical ingestions. There are assessments where people have been unable to stop using kratom therapy and withdrawal signs/symptoms occurred in patients or their newborn babies after kratom cessation. Both banning and failure to ban kratom places people at risk; a middle-ground alternative, placing it behind the pharmacy counter, might be useful.
In Thailand, Kratom had been outlawed since 1943 but now it has become (semi-)legal. Earlier this year, the Thai government removed the herb from the list of Category V narcotics. Following this move, some 12,000 inmates who had been convicted when Kratom was still an illegal drug received amnesty. However, Kratom producers, traders, and even researchers will still require licenses to handle the plant. Similarly, patients looking for kratom-based supplements will need a valid prescription from licensed medical practitioners. Thai law still prohibits bulk possession of Kratom. Users are encouraged to handle only minimum amounts of the herb to avoid getting prosecuted for illegal possession.
In 2018, the US Food and Drug Administration stated that Kratom possesses the properties of an opioid, thus escalating the government’s effort to slow usage of this alternative pain reliever. The FDA also wrote that the number of deaths associated with Kratom use has increased to a total of 44, up from a total of 36 since the FDA’s November 2017 report. In the majority of deaths that the FDA attributes to Kratom, subjects ingested multiple substances with known risks, including alcohol.
In most European countries, Kratom continues to be a controlled drug. In the UK the sale, import, and export of Kratom are prohibited. Yet, judging from a quick look, it does not seem to be all that difficult to obtain Kratom via the Internet.
Mesotherapy is a treatment where fine needles or a high-pressure ‘gun’ are used to inject vitamins, enzymes, hormones, plant extracts, etc. into the skin of a patient. Michel Pistor, a French doctor, developed the therapy in 1952. It was originally used to relieve pain. Today, mesotherapy is also employed for a range of further indications:
- remove fat in areas like the stomach, thighs, buttocks, hips, legs, arms, and face
- reduce cellulite
- fade wrinkles and lines
- tighten loose skin
- recontour the body
- lighten pigmented skin
- treat alopecia, a condition that causes hair loss
Mesotherapy is said to deliver drugs into the middle layer (mesoderm) of the skin. It is claimed to correct underlying issues like poor circulation and inflammation that cause skin damage.
Many different drugs can be used for mesotherapy, including:
- prescription medicines like vasodilators and antibiotics
- hormones such as calcitonin and thyroxin
- enzymes like collagenase and hyaluronidase
- herbal extracts
- homeopathic remedies
- vitamins and minerals
According to the Italian Mesotherapy Society, the mechanisms of action of mesotherapy can be summarised as follows:
But is there at all any sound evidence that mesotherapy works?
It turns out that there are few rigorous studies. The most recent review concluded that mesotherapy proved to be more effective than systemic therapy in the treatment of local pain and functional limitations caused by a variety of musculoskeletal conditions. However, because of the heterogeneity of the analysed studies in terms of injected drugs, administration technique, associated treatments, frequency and total number of sessions, more randomized controlled trials are needed, comparing a standardized mesotherapy protocol with a systemic treatments.
So, is mesotherapy a treatment that might be recommended?
- Its effectiveness remains unproven.
- It can cause serious adverse effects.
- It is by no means cheap.
I think these facts answer the question fairly well.
Kneipp therapy goes back to Sebastian Kneipp (1821-1897), a catholic priest who was convinced to have cured himself of tuberculosis by using various hydrotherapies. Kneipp is often considered by many to be ‘the father of naturopathy’. Kneipp therapy consists of hydrotherapy, exercise therapy, nutritional therapy, phototherapy, and ‘order’ therapy (or balance). Kneipp therapy remains popular in Germany where whole spa towns live off this concept.
The obvious question is: does Kneipp therapy work? A team of German investigators has tried to answer it. For this purpose, they conducted a systematic review to evaluate the available evidence on the effect of Kneipp therapy.
A total of 25 sources, including 14 controlled studies (13 of which were randomized), were included. The authors considered almost any type of study, regardless of whether it was a published or unpublished, a controlled or uncontrolled trial. According to EPHPP-QAT, 3 studies were rated as “strong,” 13 as “moderate” and 9 as “weak.” Nine (64%) of the controlled studies reported significant improvements after Kneipp therapy in a between-group comparison in the following conditions:
- chronic venous insufficiency,
- mild heart failure,
- menopausal complaints,
- sleep disorders in different patient collectives,
- as well as improved immune parameters in healthy subjects.
No significant effects were found in:
- depression and anxiety in breast cancer patients with climacteric complaints,
- quality of life in post-polio syndrome,
- disease-related polyneuropathic complaints,
- the incidence of cold episodes in children.
Eleven uncontrolled studies reported improvements in allergic symptoms, dyspepsia, quality of life, heart rate variability, infections, hypertension, well-being, pain, and polyneuropathic complaints.
The authors concluded that Kneipp therapy seems to be beneficial for numerous symptoms in different patient groups. Future studies should pay even more attention to methodologically careful study planning (control groups, randomisation, adequate case numbers, blinding) to counteract bias.
On the one hand, I applaud the authors. Considering the popularity of Kneipp therapy in Germany, such a review was long overdue. On the other hand, I am somewhat concerned about their conclusions. In my view, they are far too positive:
- almost all studies had significant flaws which means their findings are less than reliable;
- for most indications, there are only one or two studies, and it seems unwarranted to claim that Kneipp therapy is beneficial for numerous symptoms on the basis of such scarce evidence.
My conclusion would therefore be quite different:
Despite its long history and considerable popularity, Kneipp therapy is not supported by enough sound evidence for issuing positive recommendations for its use in any health condition.
Cannabis seems often to be an emotional subject where more heat than light is generated. Does it work for chronic pain? This cannot be such a difficult question to answer definitively. Yet, systematic reviews have provided conflicting results due, in part, to limitations of analytical approaches and interpretation of findings.
A new systematic review is therefore both necessary and welcome. It aimed at determining the benefits and harms of medical cannabis and cannabinoids for chronic pain. Included were all randomised clinical trials of medical cannabis or cannabinoids versus any non-cannabis control for chronic pain at ≥1-month follow-up.
A total of 32 trials with 5174 adult patients were included, 29 of which compared medical cannabis or cannabinoids with placebo. Medical cannabis was administered orally (n=30) or topically (n=2). Clinical populations included chronic non-cancer pain (n=28) and cancer-related pain (n=4). Length of follow-up ranged from 1 to 5.5 months.
Compared with placebo, non-inhaled medical cannabis probably results in a small increase in the proportion of patients experiencing at least the minimally important difference (MID) of 1 cm (on a 10 cm visual analogue scale (VAS)) in pain relief (modelled risk difference (RD) of 10% (95% confidence interval 5% to 15%), based on a weighted mean difference (WMD) of −0.50 cm (95% CI −0.75 to −0.25 cm, moderate certainty)). Medical cannabis taken orally results in a very small improvement in physical functioning (4% modelled RD (0.1% to 8%) for achieving at least the MID of 10 points on the 100-point SF-36 physical functioning scale, WMD of 1.67 points (0.03 to 3.31, high certainty)), and a small improvement in sleep quality (6% modelled RD (2% to 9%) for achieving at least the MID of 1 cm on a 10 cm VAS, WMD of −0.35 cm (−0.55 to −0.14 cm, high certainty)). Medical cannabis taken orally does not improve emotional, role, or social functioning (high certainty). Moderate certainty evidence shows that medical cannabis taken orally probably results in a small increased risk of transient cognitive impairment (RD 2% (0.1% to 6%)), vomiting (RD 3% (0.4% to 6%)), drowsiness (RD 5% (2% to 8%)), impaired attention (RD 3% (1% to 8%)), and nausea (RD 5% (2% to 8%)), but not diarrhoea; while high certainty evidence shows greater increased risk of dizziness (RD 9% (5% to 14%)) for trials with <3 months follow-up versus RD 28% (18% to 43%) for trials with ≥3 months follow-up; interaction test P=0.003; moderate credibility of subgroup effect).
The authors concluded that moderate to high certainty evidence shows that non-inhaled medical cannabis or cannabinoids results in a small to very small improvement in pain relief, physical functioning, and sleep quality among patients with chronic pain, along with several transient adverse side effects, compared with placebo.
This is a high-quality review. Its findings will disappoint the many advocates of cannabis as a therapy for chronic pain management. The bottom line, I think, seems to be that cannabis works but the effect is not very powerful, while we have treatments for managing chronic pain that are both more effective and arguably less risky. So, its place in clinical routine is debatable.
Cannabis is, of course, a herbal remedy and therefore belongs to so-called alternative medicine (SCAM). Yet, I am aware that the medical cannabis preparations used in most studies are based on single cannabinoids which makes them conventional medicines.
Bromelain, papain and chymotrypsin are proteolytic enzymes. They can be found in fruits such as pineapple or papaya, but also in the human body, namely in the pancreas. Besides their enzymatic functions, they have long been said to have a wide range of positive health effects. For instance, it is claimed that they reduce side effects and even improve the outcome of cancer therapies. This systematic review examined the existing evidence on the role that these enzymes which are available as food supplements might play in cancer treatment.
A total of 15 studies with 3,008 patients could be included in this systematic review. Patients treated with enzymes were diagnosed with various entities of gastrointestinal, gynecologic, head and neck, and lung cancer as well as hematological malignancies. The therapy concepts included mainly oral intake of enzymes in addition to conventional therapies. Investigated outcomes were:
- side-effects of anticancer therapy,
- quality of life,
- anticancer effects,
- survival rates.
Due to conflicting results and moderate quality of the included studies, the evidence is insufficient to attribute positive effects to enzymes in terms of better tolerability of the various antineoplastic therapies or even improvement in treatment efficacy. In most cases, enzyme therapy was well tolerated; side-effects were mainly gastrointestinal complaints such as diarrhea or meteorism.
The authors concluded that there is no clear therapeutic benefit of enzymes neither as supportive therapy nor as part of antineoplastic therapy.
I fully agree with this conclusion. In fact, in my new book that is just being published, I summarised the evidence for enzyme therapy (and many more alternative cancer therapies) in very similar terms: the evidence to suggest that enzyme therapy might be an effective treatment for any type of cancer is less than convincing.
I find it highly irresponsible to claim otherwise. Cancer patients are vulnerable and can easily be tempted to opt for one of the many quack treatments that are said to be both effective and free of nasty adverse effects. If they do try such options, they usually pay dearly, and not just in monetary terms.
In their 2019 systematic review of spinal manipulative therapy (SMT) for chronic back pain, Rubinstein et al included 7 studies comparing the effect of SMT with sham SMT.
They defined SMT as any hands-on treatment of the spine, including both mobilization and manipulation. Mobilizations use low-grade velocity, small or large amplitude passive movement techniques within the patient’s range of motion and control. Manipulation uses a high-velocity impulse or thrust applied to a synovial joint over a short amplitude near or at the end of the passive or physiological range of motion. Even though there is overlap, it seems fair to say that mobilization is the domain of osteopaths, while manipulation is that of chiropractors.
The researchers found:
- low-quality evidence suggesting that SMT does not result in a statistically better effect than sham SMT at one month,
- very low-quality evidence suggesting that SMT does not result in a statistically better effect than sham SMT at six and 12 months.
- low-quality evidence suggesting that, in terms of function, SMT results in a moderate to strong statistically significant and clinically better effect than sham SMT at one month. Exclusion of an extreme outlier accounted for a large percentage of the statistical heterogeneity for this outcome at this time interval (SMD −0.27, 95% confidence interval −0.52 to −0.02; participants=698; studies=7; I2=39%), resulting in a small, clinically better effect in favor of SMT.
- very low-quality evidence suggesting that, in terms of function, SMT does not result in a statistically significant better effect than sham SMT at six and 12 months.
This means that SMT has effects that are very similar to placebo (the uncertain effects on function could be interpreted as the result of residual de-blinding due to a lack of an optimal placebo or sham intervention). In turn, this means that the effects patients experience are largely or completely due to a placebo response and that SMT has no or only a negligibly small specific effect on back pain. Considering the facts that SMT is by no means risk-free and that less risky treatments exist, the inescapable conclusion is that SMT cannot be recommended as a treatment of chronic back pain.
This multicenter, randomized, sham-controlled trial was aimed at assessing the long-term efficacy of acupuncture for chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). Men with moderate to severe CP/CPPS were recruited, regardless of prior exposure to acupuncture. They received sessions of acupuncture or sham acupuncture over 8 weeks, with a 24-week follow-up after treatment. Real acupuncture treatment was used to create the typical de qi sensation, whereas the sham acupuncture treatment (the authors state they used the Streitberger needle, but the drawing looks more as though they used our device) does not generate this feeling.
The primary outcome was the proportion of responders, defined as participants who achieved a clinically important reduction of at least 6 points from baseline on the National Institutes of Health Chronic Prostatitis Symptom Index at weeks 8 and 32. Ascertainment of sustained efficacy required the between-group difference to be statistically significant at both time points.
A total of 440 men (220 in each group) were recruited. At week 8, the proportions of responders were:
- 60.6% (95% CI, 53.7% to 67.1%) in the acupuncture group
- 36.8% (CI, 30.4% to 43.7%) in the sham acupuncture group (adjusted difference, 21.6 percentage points [CI, 12.8 to 30.4 percentage points]; adjusted odds ratio, 2.6 [CI, 1.8 to 4.0]; P < 0.001).
At week 32, the proportions were:
- 61.5% (CI, 54.5% to 68.1%) in the acupuncture group
- 38.3% (CI, 31.7% to 45.4%) in the sham acupuncture group (adjusted difference, 21.1 percentage points [CI, 12.2 to 30.1 percentage points]; adjusted odds ratio, 2.6 [CI, 1.7 to 3.9]; P < 0.001).
Twenty (9.1%) and 14 (6.4%) adverse events were reported in the acupuncture and sham acupuncture groups, respectively. No serious adverse events were reported. No significant difference was found in changes in the International Index of Erectile Function 5 score at all assessment time points or in peak and average urinary flow rates at week 8.
The authors concluded that, compared with sham therapy, 20 sessions of acupuncture over 8 weeks resulted in greater improvement in symptoms of moderate to severe CP/CPPS, with durable effects 24 weeks after treatment.
The study was sponsored by the China Academy of Chinese Medical Sciences and the National Administration of Traditional Chinese Medicine. The trialists originate from the following institutions:
- 1Guang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China (Y.S., B.L., Z.Q., J.Z., J.W., X.L., W.W., R.P., H.C., X.W., Z.L.).
- 2Key Laboratory of Chinese Internal Medicine of Ministry of Education, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China (Y.L.).
- 3ThedaCare Regional Medical Center – Appleton, Appleton, Wisconsin (K.Z.).
- 4Hengyang Hospital Affiliated to Hunan University of Chinese Medicine, Hengyang, China (Z.Y.).
- 5The First Hospital of Hunan University of Chinese Medicine, Changsha, China (W.Z.).
- 6Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou, China (W.F.).
- 7The First Affiliated Hospital of Anhui University of Chinese Medicine, Hefei, China (J.Y.).
- 8West China Hospital of Sichuan University, Chengdu, China (N.L.).
- 9China Academy of Chinese Medical Sciences, Beijing, China (L.H.).
- 10Yantai Hospital of Traditional Chinese Medicine, Yantai, China (Z.Z.).
- 11Shaanxi Provincial Hospital of Traditional Chinese Medicine, Xi’an, China (T.S.).
- 12The Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, China (J.F.).
- 13Beijing Fengtai Hospital of Integrated Traditional and Western Medicine, Beijing, China (Y.D.).
- 14Xi’an TCM Brain Disease Hospital, Xi’an, China (H.S.).
- 15Dongfang Hospital Beijing University of Chinese Medicine, Beijing, China (H.H.).
- 16Luohu District Hospital of Traditional Chinese Medicine, Shenzhen, China (H.Z.).
- 17Guizhou University of Traditional Chinese Medicine, Guiyang, China (Q.M.).
These facts, together with the previously discussed notion that clinical trials from China are notoriously unreliable, do not inspire confidence. Moreover, one might well wonder about the authors’ claim that patients were blinded. As pointed out above, the real and sham acupuncture were fundamentally different: the former did generate de qi, while the latter did not! A slightly pedantic point is my suspicion that the trial did not test the efficacy but the effectiveness of acupuncture, if I am not mistaken. Finally, one might wonder what the rationale of acupuncture as a treatment of CP/CPPS might be. As far as I can see, there is no plausible mechanism (other than placebo) to explain the effects.
So, is the evidence that emerged from the new study convincing?
No, in my view, it is not!
In fact, I am surprised that a journal as reputable as the Annals of Internal Medicine published it.
I recently came across this paper by Prof. Dr. Chad E. Cook, a physical therapist, PhD, a Fellow of the American Physical Therapy Association (FAPTA), and a professor as well as director of clinical research in the Department of Orthopaedics, Department of Population Health Sciences at the Duke Clinical Research Institute at Duke University in North Carolina, USA. The paper is entitled ‘The Demonization of Manual Therapy‘.
Cook introduced the subject by stating: “In medicine, when we do not understand or when we dislike something, we demonize it. Well-known examples throughout history include the initial ridicule of antiseptic handwashing, percutaneous transluminal coronary angioplasty (i. e., balloon angioplasty), the relationships between viruses and cancer, the contribution of bacteria in the development of ulcers, and the role of heredity in the development of disease. In each example, naysayers attempted to discredit the use of each of the concepts, despite having no evidence to support their claims. The goal in each of the aforementioned topics: demonize the concept.”
Cook then discussed 8 ‘demonizations’ of manual therapy. Number 7 is entitled “Causes as Much Harm as Help“. Here is this section in full:
By definition, harms include adverse reactions (e. g., side effects of treatments), and other undesirable consequences of health care products and services. Harms can be classified as “none”, minor, moderate, serious and severe . Most interventions have some harms, typically minor, which are defined as a non-life-threatening, temporary harm that may or may not require efforts to assess for a change in a patient’s condition such as monitoring .
There are harms associated with a manual therapy intervention, but they are generally benign (minor). Up to 20 –40 % of individuals will report adverse events after the application of manual therapy. The most common adverse events were soreness in muscles, increased pain, stiffness and tiredness . There are rare occasions of several harms associated with manual therapy and these include spinal or neurological problems as well as cervical arterial strokes . It is critical to emphasize how rare these events are; serious adverse event incidence estimates ranged from 1 per 2 million manipulations to 13 per 10,000 patients .
Cook then concludes that “manual therapy has been inappropriately demonized over the last decade and has been associated with inaccurate assumptions and false speculations that many clinicians have acquired over the last decade. This paper critically analyzed eight of the most common assumptions that have belabored manual therapy and identified notable errors in seven of the eight. It is my hope that the physiotherapy community will carefully re-evaluate its stance on manual therapy and consider a more evidence-based approach for the betterment of our patients.
REFERENCES Ernst E. Adverse effects of spinal manipulation: a systematic review. J R Soc Med 2007; 100: 330–338.
doi:10.1177/014107680710000716  Paanalahti K, Holm LW, Nordin M et al. Adverse events after manual therapy among patients seeking care for neck and/or back pain: a randomized controlled trial. BMC Musculoskelet Disord 2014; 15: 77. doi:10.1186/1471-2474-15-77  Swait G, Finch R. What are the risks of manual treatment of the spine? A scoping review for clinicians. Chiropr Man Therap 2017; 25: 37. doi:10.1186/s12998-017-0168-5
Here are a few things that I find odd or wrong with Cook’s text:
- The term ‘demonizing’ seems to be a poor choice. The historical examples chosen by Cook were not cases of demonization. They were mostly instances where new discoveries did not fit into the thinking of the time and therefore took a long time to get accepted. They also show that sooner or later, sound evidence always prevails. Lastly, they suggest that speeding up this process via the concept of evidence-based medicine is a good idea.
- Cook then introduces the principle of risk/benefit balance by entitling the cited section “Causes as Much Harm as Help“. Oddly, however, he only discusses the risks of manual therapies and omits the benefit side of the equation.
- This omission is all the more puzzling since he quotes my paper (his reference ) states that “the effectiveness of spinal manipulation for most indications is less than convincing.5 A risk-benefit evaluation is therefore unlikely to generate positive results: with uncertain effectiveness and finite risks, the balance cannot be positive.”
- In discussing the risks, he seems to assume that all manual therapies are similar. This is clearly not true. Massage therapies have a very low risk, while this cannot be said of spinal manipulations.
- The harms mentioned by Cook seem to be those of spinal manipulation and not those of all types of manual therapy.
- Cook states that “up to 20 –40 % of individuals will report adverse events after the application of manual therapy.” Yet, the reference he uses in support of this statement is a clinical trial that reported an adverse effect rate of 51%.
- Cook then states that “there are rare occasions of several harms associated with manual therapy and these include spinal or neurological problems as well as cervical arterial strokes.” In support, he quotes one of my papers. In it, I emphasize that “the incidence of such events is unknown.” Cook not only ignores this fact but states in the following sentence that “it is critical to emphasize how rare these events are…”
Cook concludes that “manual therapy has been inappropriately demonized over the last decade and has been associated with inaccurate assumptions and false speculations …” He confuses, I think, demonization with critical assessment.
Cook’s defence of manual therapy is clumsy, inaccurate, ill-conceived, misleading and often borders on the ridiculous. In the age of evidence-based medicine, therapies are not ‘demonized’ but evaluated on the basis of their effectiveness and safety. Manual therapies are too diverse to do this wholesale. They range from various massage techniques, some of which have a positive risk/benefit balance, to high-velocity, low-amplitude thrusts, for which the risks do not demonstrably outweigh the benefits.
Spinal manipulation therapy (SMT) is widely used worldwide to treat musculoskeletal and many other conditions. The evidence that it works for any of them is weak, non-existent, or negative. What is worse, SMT can – as we have discussed so often on this blog – cause adverse events some of which are serious, even fatal.
Spinal epidural hematoma (SEH) caused by SMT is a rare emergency that can cause neurological dysfunction. Chinese researchers recently reported three cases of SEH after SMT.
- The first case was a 30-year-old woman who experienced neck pain and numbness in both upper limbs immediately after SMT. Her symptoms persisted after 3 d of conservative treatment, and she was admitted to our hospital. Magnetic resonance imaging (MRI) demonstrated an SEH, extending from C6 to C7.
- The second case was a 55-year-old man with sudden back pain 1 d after SMT, numbness in both lower limbs, an inability to stand or walk, and difficulty urinating. MRI revealed an SEH, extending from T1 to T3.
- The third case was a 28-year-old man who suddenly developed symptoms of numbness in both lower limbs 4 h after SMT. He was unable to stand or walk and experienced mild back pain. MRI revealed an SEH, extending from T1 to T2.
All three patients underwent surgery after failed conservative treatment and all recovered to ASIA grade E on day 5, 1 wk, and day 10 after surgery, respectively. All patients returned to normal after 3 mo of follow-up.
The authors concluded that SEH caused by SMT is very rare, and the condition of each patient should be evaluated in full detail before operation. SEH should be diagnosed immediately and actively treated by surgery.
These cases might serve as an apt reminder of the fact that SMT (particularly SMT of the neck) is not without its dangers. The authors’ assurance that SEH is VERY RARE is a little puzzling, in my view (the paper includes a table with all 17 previously published cases). There is, as we often have mentioned, no post-marketing surveillance, surgeons only see those patients who survive such complications long enough to come to the hospital, and they publish such cases only if they feel like it. Consequently, the true incidence is anyone’s guess.
As pointed out earlier, the evidence that SMT might be effective is shaky for most indications. In view of the potential for harm, this can mean only one thing:
The risk/benefit balance for SMT is not demonstrably positive.
In turn, this leads to the conclusion that patients should think twice before having SMT and should inquire about other therapeutic options that have a more positive risk/benefit balance. Similarly, the therapists proposing SMT to a patient have the ethical and moral duty to obtain fully informed consent which includes information about the risk/benefit balance of SMT and other options.