This systematic review with meta-analysis of randomized clinical trials (RCTs) estimated the benefits and harms of cervical spinal manipulative therapy (SMT) for treating neck pain. The authors searched the MEDLINE, Cochrane CENTRAL, EMBASE, CINAHL, PEDro, Chiropractic Literature Index bibliographic databases, and grey literature sources, up to June 6, 2022.
RCTs evaluating SMT compared to guideline-recommended and non-recommended interventions, sham SMT, and no intervention for adults with neck pain were eligible. Pre-specified outcomes included pain, range of motion, disability, health-related quality of life.
A total of 28 RCTs could be included. There was very low to low certainty evidence that SMT was more effective than recommended interventions for improving pain at short-term (standardized mean difference [SMD] 0.66; confidence interval [CI] 0.35 to 0.97) and long-term (SMD 0.73; CI 0.31 to 1.16), and for reducing disability at short-term (SMD 0.95; CI 0.48 to 1.42) and long-term (SMD 0.65; CI 0.23 to 1.06). Only transient side effects were found (e.g., muscle soreness).
The authors concluded that there was very low certainty evidence supporting cervical SMT as an intervention to reduce pain and improve disability in people with neck pain.
Harms cannot be adequately investigated on the basis of RCT data. Firstly, because much larger sample sizes would be required for this purpose. Secondly, RCTs of spinal manipulation very often omit reporting adverse effects (as discussed repeatedly on this bolg). If we extend our searches beyond RCTs, we find many cases of serious harm caused by neck manipulations (also as discussed repeatedly on this bolg). Therefore, the conclusion of this review should be corrected:
Low certainty evidence exists supporting cervical SMT as an intervention to reduce pain and improve disability in people with neck pain. The evidence of harm is, however, substantial. It follows that the risk/benefit ratio is not positive. Cervical SMT should therefore be discouraged.
In a video, Mr.Darkmoore speaks from a hospital bed and says the cause behind his visit to the emergency room stemmed from a chiropractor’s work on him. Three days ago, he had a ringing in his ear due to a long-term condition he knew as tinnitus. Thus, he decided to visit a chiropractor. “I figured $100 to a chiro, let them adjust a few things, if all else fails, I’ll go to a doctor,” explains Darkmoore.
This $100 visit led to several other complications and doctor’s bills worth thousands of dollars. The day after he was treated by the chiropractor, he experienced a headache that eventually led to dizzy spells. He decided to visit the emergency room where a CT scan was ordered which showed that the chiropractor had dissected an artery in his neck.
Next, Darkmoore was put on blood thinners to avoid blood clots that could result in a stroke or worse. Darkmoore explains that he will be on two blood thinners for the next three months to prevent clotting. If the dissection heals partially, he says he will need to take aspirin every day for the rest of his life. If it doesn’t heal, he claims that he will need surgery.
Many viewers of the video claimed they have had the same “chiropractor gone wrong” experience as Darkmoore.
- “Wow. How scary. I had a similar thing happen to me. Extremely bad headache after going one time. Haven’t gone since,” one commenter wrote.
- “I’m so sorry this happened to u,” another user echoed. “My chiropractor also caused an injury which required emergency surgery & I have permanent damage. I’m glad u survived.”
Darkmore captioned his last update video, “I appreciate the thoughts and prayers. Hopefully, I’ll be okay after 3 months of recovery.”
Let’s hope that he is correct and that he will make a speedy and full recovery.
Of course, chiros will queue up to stress that important details are missing in this case report. To them, I would merely say this:
THERE IS NO GOOD EVIDENCE THAT NECK MANIPULATIONS BRING ANY BENEFIT AND QUITE A BIT OF EVIDENCE THAT THEY CAN CAUSE SERIOUS HARM.
SO, WHY NOT JUST STOP OFFERING THE PROCEDURE?
Cervical spondylosis (CS) is a general term for wear and tear affecting the spinal disks in the neck. As these disks age, they shrink and signs of osteoarthritis can develop, including bony projections along the edges of bones (bone spurs). CS is very common and worsens with age. About 85% of people over 60 are affected by cervical spondylosis. For most of them, it causes no symptoms. When symptoms do occur, non-surgical treatments often are effective. I think there are not many so-called alternative treatments that are not being promoted as effective for CS – often with the support of some lousy clinical trials. Homeopathy does not seem to be an exception.
This trial attempted evaluating the efficacy of individualized homeopathic medicines (IHMs) against placebos in the treatment of CS.
A 3-month, double-blind, randomized, placebo-controlled trial was conducted at the Organon of Medicine outpatient department of the National Institute of Homoeopathy, India. Patients were randomized to receive either IHMs (n = 70) or identical-looking placebos (n = 70) in the mutual context of concomitant conservative and standard physiotherapeutic care. Primary outcome measures were 0-10 Numeric Rating Scales (NRSs) for pain, stiffness, numbness, tingling, weakness, and vertigo, and the secondary outcome was the Neck Disability Index (NDI), measured at baseline and every month until 3 months. The intention-to-treat sample was analyzed to detect group differences and effect sizes.
Overall, improvements were clinically significant and higher in the IHM group than in the placebo group, but group differences were statistically nonsignificant with small effect sizes (all p > 0.05, two-way repeated measure analysis of variance). After 2 months of time points, improvements observed in the IHM group were significantly higher than placebo on a few occasions (e.g., pain NRS: p < 0.001; stiffness NRS: p = 0.024; weakness NRS: p = 0.003). Sulfur (n = 21; 15%) was the most frequently prescribed medication. No harm, unintended effects, or any serious adverse events were reported from either group.
The authors concluded that an encouraging but nonsignificant direction of effect was elicited favoring IHMs against placebos in the treatment of CS.
I agree that it is encouraging that Indian homeopaths have recently dared to publish also negative findings! However, I do not agree that the findings are encouraging in the sense that they indicate anything other than that homeopathy is a placebo therapy.
Unfortunately, I cannot access the full article without paying for it. Thus I am unable to provide detailed criticism of this study – sorry.
Cervical radiculopathy is a common condition that is usually due to compression or injury to a nerve root by a herniated disc or other degenerative changes of the upper spine. The C5 to T1 levels are the most commonly affected. In such cases local and radiating pains, often with neurological deficits, are the most prominent symptoms. Treatment of this condition is often difficult.
The purpose of this systematic review was to assess the effectiveness and safety of conservative interventions compared with other interventions, placebo/sham interventions, or no intervention on disability, pain, function, quality of life, and psychological impact in adults with cervical radiculopathy (CR).
MEDLINE, CENTRAL, CINAHL, Embase, and PsycINFO were searched from inception to June 15, 2022, to identify studies that were randomized clinical trials, had at least one conservative treatment arm, and diagnosed participants with CR through confirmatory clinical examination and/or diagnostic tests. Studies were appraised using the Cochrane Risk of Bias 2 tool and the quality of the evidence was rated using the Grades of Recommendations, Assessment, Development, and Evaluation approach.
Of the 2561 records identified, 59 trials met our inclusion criteria (n = 4108 participants). Due to clinical and statistical heterogeneity, the findings were synthesized narratively. The results show very-low certainty evidence supporting the use of
- cervical manipulation,
- low-level laser therapy
for pain and disability in the immediate to short-term, and thoracic manipulation and low-level laser therapy for improvements in cervical range of motion in the immediate term.
There is low to very-low certainty evidence for multimodal interventions, providing inconclusive evidence for pain, disability, and range of motion. There is inconclusive evidence for pain reduction after conservative management compared with surgery, rated as very-low certainty.
The authors concluded that there is a lack of high-quality evidence, limiting our ability to make any meaningful conclusions. As the number of people with CR is expected to increase, there is an urgent need for future research to help address these gaps.
The fact that we cannot offer a truly effective therapy for CR has long been known – except, of course, to chiropractors, acupuncturists, osteopaths, and other SCAM providers who offer their services as though they are a sure solution. Sometimes, their treatments seem to work; but this could be just because the symptoms of CR can improve spontaneously, unrelated to any intervention.
The question thus arises what should these often badly suffering patients do if spontaneous remission does not occur? As an answer, let me quote from another recent systematic review of the subject: The 6 included studies that had low risk of bias, providing high-quality evidence for the surgical efficacy of Cervical Spondylotic Radiculopathy. The evidence indicates that surgical treatment is better than conservative treatment … and superior to conservative treatment in less than one year.
Yes, this post is yet again about the harm chiropractors do.
No, I am not obsessed with the subject – I merely consider it to be important.
This is a case presentation of a 44-year-old male who was transferred from another emergency department for left homonymous inferior quadrantanopia noted on an optometrist visit. He reported sudden onset left homonymous hemianopia after receiving a high-velocity cervical spine adjustment at a chiropractor appointment for chronic neck pain a few days prior.
The CT angiogram of the head and neck revealed bilateral vertebral artery dissection at the left V2 and right V3 segments. MRI brain confirmed an acute infarct in the right medial occipital lobe. His right PCA stroke was likely embolic from the injured right V3 but possibly from the left V2 as well. As the patient reported progression from a homonymous hemianopia to a quadrantanopia, he likely had a migrating embolus.
The authors discussed that arterial dissection accounts for about 2% of all ischemic strokes, but maybe between 8–25% in patients less than 45 years old. Vertebral artery dissection (VAD) can result from trauma from sports, motor vehicle accidents, and chiropractor neck manipulations to violent coughing/sneezing.
It is estimated that 1 in 20,000 spinal manipulation results in vertebral artery aneurysm/dissection. Patients who have multiple chronic conditions are reporting higher use of so-called alternative medicine (SCAM), including chiropractic manipulation. Education about the association between VAD and chiropractor maneuvers can be beneficial to the public as these are preventable acute ischemic strokes. In addition, VAD symptoms can be subtle and patients presenting to chiropractors may have distracting pain masking their deficits. Evaluating for appropriateness of cervical manipulation in high‐risk patients and detecting early clinical signs of VAD by chiropractors can be beneficial in preventing acute ischemic strokes in young patients.
Here we have a rare instance where the physicians who treated the chiro-victim were sufficiently motivated to present their findings and document them in the medical literature. Their report was published in 2021 as an abstract in conference proceedings. In other words, the report is not easy to find. Even though two years have passed, the full article does not seem to have emerged, and chances are that it will never be published.
The points I am trying to make are as follows:
- Complications after chiropractic manipulation do happen and are probably much more frequent than chiros want us to believe.
- They are only rarely reported in the medical literature because the busy clinicians who end up treating the victims do not consider this a priority and because many cases are settled in or out of court.
- Normally, it would be the ethical/moral duty of the chiros who have inflicted the damage to do the reporting.
- Yet, they seem too busy ripping off more patients by doing neck manipulations that do more harm than good.
- And then they complain that the evidence is insufficient!!!
I came across an article that seems highly relevant to our recurring debates about the dangers of chiropractic. Since few of us might be readers of the Louisville Courier, I take the liberty of reproducing here a shortened version of it:
Amber Burgess, then 33, had never set foot in a chiropractor’s office when she went to Dr. Adam Fulkerson’s Heartland Family Chiropractic in Elizabethtown on May 18, 2020. In contrast, Becca Barlow, 31, had seen Dr. Leah Wright at Louisville Family Chiropractic 29 times for adjustments over three years when she went there on Jan. 7, 2019, seeking relief for “nursing mother’s neck.” Both say they will never see a chiropractor again. “That visit was my first – and last,” said Burgess, a former utility bucket-truck assembler.
In separate lawsuits, they claim they suffered strokes after chiropractic adjustments; Barlow, herself a nurse, said she realized she was having one before she even left the office and told Wright’s staff to call 911.
Citing studies on human cadavers and other research, chiropractors claim adjustments are physically incapable of causing tears to arteries that in turn cause strokes by blocking the flow of blood to the brain and other organs. In an opening statement in the trial of Barlow’s suit last March, attorney John Floyd Jr., counsel for Wright and the National Chiropractic Mutual Insurance Co., said no one has ever proved adjustments cause the tears – known as dissection – only that there is an “association” between them. “We associate the crowing of roosters with sunrise,” he told the jury. “But that doesn’t mean roosters cause the sun to come up.” Floyd also cited studies he said prove that when a patient strokes out immediately after adjustments, like Barlow, it is because they already were suffering from artery injuries when they sought treatment from their chiropractor.
Louisville attorney Brian Clare, who represents both Barlow and Burgess, previously settled two cases in Jefferson County, and has another suit pending in Warren Circuit Court. He said in an interview that “every time chiropractors perform adjustments on the neck they are playing with fire. They can go too far, too fast, turning the neck past therapeutic limits,” he said.
The jury in Barlow’s case emphatically rejected the chiropractic profession’s defenses. “We found those claims to be unbelievable,” said jury foreman Joseph Tucker, a lawyer, who noted Barlow had no symptoms before her adjustments. By a 9-3 vote, the jury awarded her $1,130,800, including $380,000 in medical expenses and $750,000 for pain and suffering.
Witnesses testified that Barlow fell off the table and vomited almost immediately after her adjustment, showing classic stroke symptoms, including vertigo, dizziness, numbness, and nausea. She lost consciousness, had to be intubated in an ambulance, then raced to Norton Brownsboro Hospital, where she underwent emergency surgery to restore the flow of blood to her arteries and save her life. Three of the four arteries in her neck had been dissected.
Burgess, in Elizabethtown, suffered a stroke in her spine that her expert, Dr. Louis Caplan, a neurology professor at Harvard University, said also was caused by her cervical manipulations. Caplan says he’s cared for more than 15,000 stroke patients over 45 years.
Fulkerson has denied liability; his lawyer, James Grohman, said he couldn’t comment because the case is pending; the trial is set for Aug. 28 in Hardin Circuit Court Caplan said in a report that Burgess’s stroke left her with partial but permanent paralysis in her arms and legs. She uses a wheelchair and walker with wheels to get around. She said she can’t work, can’t drive, and that while she can dress herself, it takes hours to get ready. She fears they will have to give up their plans to have a baby.
By any measure, strokes associated with adjustments are rare, although their incidence is disputed. The American Chiropractic Association says arteries are damaged in only one to three adjustments out of 100,000 But a 2001 report in the New England Journal of Medicine estimated dissections occur in 1 of 20,000 adjustments. And Dr. Alan Brafman, an Atlanta chiropractor, has said they occur more often than that. Brafman wrote that he’s consulted in 1,100 cases, including Barlow’s, and found in most of them, chiropractors were at fault, causing vascular damage that is “a tragic, life-altering situation for all parties involved.” Wright’s experts themselves divulged they had been retained in 200 cases, according to Clare, which he said suggests chiropractic-related strokes are more common than suspected. A survey at Stanford University in 2008 of 177 neurologists found 55 had patients who suffered strokes after seeing chiropractors, while a 2018 study in West Virginia found one in 48 chiropractors experienced such an event. Neurologists and other physicians point to a 2001 study in STROKE of 582 stroke patients that found they were five times more likely to have seen a chiropractor in the previous five days before their artery dissection than a control group without such injuries. The American Heart Association and other medical groups recommend that patients also be warned about the risks; Barlow said she never would have undergone her final manipulation if she had been informed.
Yet again, I am impressed by the number of cases that go to court where a settlement of some sort is reached and further reporting of the incident is prevented. As a consequence, these cases are not published in the medical literature. In turn, this means that chiropractors can continue to claim that these complications do not exist or are exceedingly rare.
- The truth, however, is that NOBODY can provide accurate incidence figures.
- The truth is that, even if such complications were rare, they are devastating.
- The truth is that neck manipulations do not generate any or very little benefit.
- The truth is that their risk/benefit balance is not positive.
- The truth is that we, therefore, have an ethical duty to tell potential patients about it.
I feel that I cannot repeat my warning often enough:
THEY CAUSE MORE HARM THAN GOOD!
One of the numerous conditions chiropractors, osteopaths, and other manual therapists claim to treat effectively is tension-type headache (TTH). For this purpose, they (in particular, chiropractors) often use high-velocity, low-amplitude manipulations of the neck. They do so despite the fact that the evidence for these techniques is less than convincing.
This systematic review evaluated the evidence about the effectiveness of manual therapy (MT) on pain intensity, frequency, and impact of pain in individuals with tension-type headache (TTH).
Medline, Embase, Scopus, Web of Science, CENTRAL, and PEDro were searched in June 2020. Randomized clinical trials that applied MT not associated with other interventions for TTH were selected. The level of evidence was synthesized using GRADE, and Standardized Mean Differences (SMD) were calculated for meta-analysis.
Fifteen studies were included with a total sample of 1131 individuals. The analyses show that high-velocity, low-amplitude techniques were not superior to no treatment in reducing pain intensity (SMD = 0.01, low evidence) and frequency (SMD = -0.27, moderate evidence). Soft tissue interventions were superior to no treatment in reducing pain intensity (SMD = -0.86, low evidence) and frequency of pain (SMD = -1.45, low evidence). Dry needling was superior to no treatment in reducing pain intensity (SMD = -5.16, moderate evidence) and frequency (SMD = -2.14, moderate evidence). Soft tissue interventions were not superior to no treatment and other treatments on the impact of headache.
The authors concluded that manual therapy may have positive effects on pain intensity and frequency, but more studies are necessary to strengthen the evidence of the effects of manual therapy on subjects with tension-type headache. Implications for rehabilitation soft tissue interventions and dry needling can be used to improve pain intensity and frequency in patients with tension type headache. High velocity and low amplitude thrust manipulations were not effective for improving pain intensity and frequency in patients with tension type headache. Manual therapy was not effective for improving the impact of headache in patients with tension type headache.
So, this review shows that:
- soft tissue interventions are better than no treatment,
- dry needling is better than no treatment.
These two results fail to impress me. Due to a placebo effect, almost any treatment should be better than no therapy at all.
ALMOST, because high-velocity, low-amplitude techniques were not superior to no treatment in reducing the intensity and frequency of pain. This, I feel, is an important finding that needs an explanation.
As it is only logical that high-velocity, low-amplitude techniques must also produce a positive placebo effect, the finding can only mean that these manipulations also generate a negative effect that is strong enough to cancel the positive response to placebo. (In addition, they can also cause severe complications via arterial dissections, as discussed often on this blog.)
Perhaps; let me, therefore, put it simply and use the blunt words of a neurologist who once was quoted saying this:
DON’T LET THE BUGGARS TOUCH YOUR NECK!
Pancoast tumors, also called superior sulcus tumors, are a rare type of cancer affecting the lung apex. These tumors can spread to the brachial plexus and spine and present with symptoms that appear to be of musculoskeletal origin. Patients with an advanced Pancoast tumor may thus feel intense, constant, or radiating pain in their arms, around their chest wall, between their shoulder blades, or traveling into their upper back or armpit. In addition, a Pancoast tumor may cause the following symptoms:
- Swelling in the upper arm
- Chest tightness
- Weakness or loss of coordination in the hand muscles
- Numbness or tingling sensations in the hand
- Loss of muscle tissue in the arm or hand
- Unexplained weight loss
This case report details the story of a 59-year-old Asian man who presented to a chiropractor in Hong Kong with a 1-month history of neck and shoulder pain and numbness. His symptoms had been treated unsuccessfully with exercise, medications, and acupuncture. He had a history of tuberculosis currently treated with antibiotics and a 50-pack-year history of smoking.
Cervical magnetic resonance imaging (MRI) revealed a small cervical disc herniation thought to correspond with radicular symptoms. However, when the patient did not respond to a brief trial of chiropractic treatment, the chiropractor referred the patient back to the chest hospital for further testing, which confirmed the diagnosis of a Pancoast tumor. The patient was then referred for medical care and received radiotherapy and chemotherapy. At 2 months’ follow-up, the patient noted feeling lighter with less severe neck and shoulder pain and numbness. He also reported that he could sleep longer but still had severe pain upon waking for 2–3 hours, which subsided through the day.
A literature review identified six previously published cases in which a patient presented to a chiropractor with an undiagnosed Pancoast tumor. All patients had shoulder, spine, and/or upper extremity pain.
The authors concluded that patients with a previously undiagnosed Pancoast tumor can present to chiropractors given that these tumors may invade the brachial plexus and spine, causing shoulder, spine, and/or upper extremity pain. Chiropractors should be aware of the clinical features and risk factors of Pancoast tumors to readily identify them and refer such patients for medical care.
This is an important case report, in my view. It demonstrates that symptoms treated by chiropractors, osteopaths, and physiotherapists on a daily basis can easily be diagnosed wrongly. It also shows how vital it is that the therapist reacts responsibly to the fact that his/her treatments are unsuccessful. Far too often, the therapist has an undeniable conflict of interest and will say: “Give it more time, and, in my experience, symptoms will respond.”
The chiropractor in this story was brilliant and did the unusual thing of not continuing to treat his patient. However, I do wonder: might he be the exception rather than the rule?
If you go on Twitter you will find that chiropractors are keen like mustard to promote the idea that, after a car accident, you should consult a chiropractor. Here is just one Tweet that might stand for hundreds, perhaps even thousands:
Recovering from a car accident? If you have accident-related injuries such as whiplash, chiropractic care may provide relief. Treatments like spinal manipulation and soft tissue therapy can aid in your recovery.
In case you don’t like Twitter, you could also go on the Internet where you find hundreds of websites that promote the same idea. Here are just two examples:
A frequent injury arising from an automobile accident … is whiplash. After an accident, a chiropractor can help treat resulting issues and pain from the whiplash… Proceeding reduction in swelling and pain, treatment will then focus on manipulation of the spine and other areas.
There is no question, chiropractors earn much of their living by treating patients suffering from whiplash (neck injury caused by sudden back and forth movement of the neck often causing neck pain and stiffness, shoulder pain, and headache) after a car accident with spinal manipulation.
There are two not mutually exclusive possibilities:
- They think it is effective.
- It brings in good money.
I have no doubt about the latter notion, yet I think we should question the first. Is there really good evidence that chiropractic manipulations are effective for whiplash?
When I was head of the PMR department at the University of Vienna, treating whiplash was my team’s daily bread. At the time, our strategy was to treat each patient according to the whiplash stage and to his/her individual signs and symptoms. Manipulations were generally considered to be contra-indicated. But that was about 30 years ago. Perhaps the evidence has now changed. Perhaps manipulation therapy has been shown to be effective for certain types of whiplash injuries?
To find out, I did a few Medline searches. These did, however, not locate compelling evidence for spinal manipulation as a treatment of any stage of whiplash injuries. Here is an example of the evidence I found:
In 2008, the Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders (Neck Pain Task Force) found limited evidence on the effectiveness of manual therapies, passive physical modalities, or acupuncture for the management of whiplash-associated disorders (WAD) or neck pain and associated disorders (NAD). This review aimed to update the findings of the Neck Pain Task Force, which examined the effectiveness of manual therapies, passive physical modalities, and acupuncture for the management of WAD or NAD. Its findings show the following: Evidence from 15 evaluation studies suggests that for recent neck pain and associated disorders grades I-II, cervical and thoracic manipulation provides no additional benefit to high-dose supervised exercises.
But this is most puzzling!
Why do chiropractors promote their manipulations for whiplash, if there is no compelling evidence that it does more good than harm? Again, there are two possibilities:
- They erroneously believe it to be effective.
- They don’t care but are in it purely for the money.
Whatever it is – and obviously not all chiropractors would have the same reason – I must point out that, in both cases, they behave unethically. Not being informed about the evidence related to the interventions used clearly violates healthcare ethics, and so does financially not informing and exploiting patients.
Earlier this year, I started the ‘WORST PAPER OF 2022 COMPETITION’. You will ask what is there to win in this competition? I agree: a competition without a prize is no fun. Therefore, I suggest offering the winner (that is the author of the winning paper) one of my books that best fits his/her subject. I am sure this will over-joy him or her. And how do we identify the winner? I suggest that I continue blogging about nominated papers (I hope to identify about 10 in total), and towards the end of the year, I let my readers decide democratically.
In this spirit of democratic voting, let me suggest to you ENTRY No 6:
This study was to ascertain the efficacy of dry cupping therapy (DCT) and optimal cup application time duration for cervical spondylosis (CS). It was designed as a randomized clinical trial involving 45 participants with clinically diagnosed CS. The eligible subjects were randomly allocated into three groups, each having 15 participants. Each of the three groups, i.e., A, B, and C, received DCT daily for 15 days for 8 min, 10 min, and 12 min, respectively. All the participants were evaluated at the baseline, 7th, and 15th day of the trial using the neck disability index (NDI) as well as the visual analog scale (VAS).
The baseline means ± SD of NDI and VAS scores were significantly reduced in all three groups at the end of the trial. Although all three groups were statistically equal in terms of NDI, group C demonstrated greater efficacy in terms of VAS.
The authors concluded that the per-protocol analysis showed that dry cupping effectively alleviated neck pain across all treatment groups. Although this effect on neck disability index was statistically equal in all three groups, the 12-min protocol was more successful in reducing pain.
Who would design such a study and why?
- The authors claim they wanted to ascertain the efficacy of DCT. A trial is for testing, not ascertaining. And this study does certainly not test for efficacy.
- The groups were too small to generate a meaningful result of what, in fact, was an equivalence study.
- Intra-group changes in symptoms between baseline and time points during treatment are irrelevant in a controlled trial.
- The slightly better results of group C are most likely due to chance or non-specific effects (a longer application of a placebo would generate better outcomes that a shorter one).
- The study participants had cervical spondylosis, yet the conclusion is about neck pain. The two are not identical.
- The title of the paper promises that we learn something about the safety of DCT. Sadly, a trial with just 45 patients has no chance in hell to pick up adverse effects in a reliable way.
- As there is no control group, the study cannot tell us anything about possible specific effects of DCT.
The authors of the study have impressive affiliations:
- Department of Ilaj bil Tadbir, Luqman Unani Medical College Hospital and Research Center, Bijapur, India.
- Department of Ilaj bil Tadbir, National Institute of Unani Medicine, Bengaluru, India.
- Department of Moalajat, Luqman Unani Medical College Hospital and Research Center, Bijapur, India.
I would have hoped that researchers from national institutions and medical colleges should be able to design a trial that has at least a small chance to produce a meaningful finding. As it turns out, my hope was badly disappointed.