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.
Cupping is a so-called alternative medicine (SCAM) that has been around for millennia in many cultures. We have discussed it repeatedly on this blog (see, for instance, here, here, and here). This new study tested the effects of dry cupping on pain intensity, physical function, functional mobility, trunk range of motion, perceived overall effect, quality of life, psychological symptoms, and medication use in individuals with chronic non-specific low back pain.
Ninety participants with chronic non-specific low back pain were randomized. The experimental group (n = 45) received dry cupping therapy, with cups bilaterally positioned parallel to the L1 to L5 vertebrae. The control group (n = 45) received sham cupping therapy. The interventions were applied once a week for 8 weeks.
Participants were assessed before and after the first treatment session, and after 4 and 8 weeks of intervention. The primary outcome was pain intensity, measured with the numerical pain scale at rest, during fast walking, and during trunk flexion. Secondary outcomes were physical function, functional mobility, trunk range of motion, perceived overall effect, quality of life, psychological symptoms, and medication use.
On a 0-to-10 scale, the between-group difference in pain severity at rest was negligible: MD 0.0 (95% CI -0.9 to 1.0) immediately after the first treatment, 0.4 (95% CI -0.5 to 1.5) at 4 weeks and 0.6 (95% CI -0.4 to 1.6) at 8 weeks. Similar negligible effects were observed on pain severity during fast walking or trunk flexion. Negligible effects were also found on physical function, functional mobility, and perceived overall effect, where mean estimates and their confidence intervals all excluded worthwhile effects. No worthwhile benefits could be confirmed for any of the remaining secondary outcomes.
The authors concluded that dry cupping therapy was not superior to sham cupping for improving pain, physical function, mobility, quality of life, psychological symptoms or medication use in people with non-specific chronic low back pain.
These results will not surprise many of us; they certainly don’t baffle me. What I found interesting in this paper was the concept of sham cupping therapy. How did they do it? Here is their explanation:
For the experimental group, a manual suction pump and four acrylic cups size one (internal diameter = 4.5 cm) were used for the interventions. The cups were applied to the lower back, parallel to L1 to L5 vertebrae, with a 3-cm distance between them, bilaterally. The dry cupping application consisted of a negative pressure of 300 millibars (two suctions in the manual suction pump) sustained for 10 minutes once a week for 8 weeks.
In the control group, the exact same procedures were used except that the cups were prepared with small holes < 2 mm in diameter to release the negative pressure in approximately 3 seconds. Double-sided adhesive tape was applied to the border of the cups in order to keep them in contact with the participants’ skin.
So, sham-controlled trials of cupping are doable. Future trialists might now consider the inclusion of testing the success of patient-blinding when conducting trials of cupping therapy.
Bloodletting therapy (BLT) has been widely used for centuries until it was discovered that it is not merely useless for almost all diseases but also potentially harmful. Yet in so-called alternative medicine (SCAM) BLT is still sometimes employed, for instance, to relieve acute gouty arthritis (AGA). This systematic review aimed to evaluate the feasibility and safety of BLT in treating AGA.
Seven databases were searched from the date of establishment to July 31, 2020, irrespective of the publication source and language. BLT included fire needle, syringe, three-edged needle, and bloodletting followed by cupping. The included articles were evaluated for bias risk by using the Cochrane risk of bias assessment tool.
Twelve studies involving 894 participants were included in the final analysis. A meta-analysis suggested that BLT was highly effective in relieving pain (MD = -1.13, 95% CI [-1.60, -0.66], P < 0.00001), with marked alterations in the total effective (RR = 1.09, 95% [1.05, 1.14], P < 0.0001) and curative rates (RR = 1.37, 95%CI [1.17, 1.59], P < 0.0001). In addition, BLT could dramatically reduce serum C-reactive protein (CRP) level (MD = -3.64, 95%CI [-6.72, -0.55], P = 0.02). Both BLT and Western medicine (WM) produced comparable decreases in uric acid (MD = -18.72, 95%CI [-38.24, 0.81], P = 0.06) and erythrocyte sedimentation rate (ESR) levels (MD = -3.01, 95%CI [-6.89, 0.86], P = 0.13). Lastly, we demonstrated that BLT was safer than WM in treating AGA (RR = 0.36, 95%CI [0.13, 0.97], P = 0.04).
The authors concluded that BLT is effective in alleviating pain and decreasing CRP level in AGA patients with a lower risk of evoking adverse reactions.
This conclusion is optimistic, to say the least. There are several reasons for this statement:
- All the primary studies came from China (and we have often discussed that such trials need to be taken with a pinch of salt).
- All the studies had major methodological flaws.
- There was considerable heterogeneity between the studies.
- The treatments employed were very different from study to study.
- Half of all studies failed to mention adverse effects and thus violate medical ethics.
Since Gwyneth Paltrow, as well as US Olympic swimmers, were publicly sporting their cupping marks, cupping has repeatedly occupied the pages of this blog. Now, cupping is in the news yet again. It has been reported that an image of a self-proclaimed ‘cupping’ expert performing treatment on a newborn baby has caused a major outcry. The photo shows a three-month-old baby’s skin on its back being sucked into a cup with the skin deformed and bright red.
The man, known as Mustafa, who refers to himself as an ‘expert’ at a ’cupping centre’ in the city of Istanbul, recently shared the images on social media where he was apparently treating the baby for ‘gas’. “We provide cupping for everyone from three-month-old babies to 70-year-olds. We do it since it is an Islamic tradition and we believe that everyone should take part in it,“ Mustafa said. “I am not a swindler. I do not demand money from people. They give as much as they choose.”
Child and adolescent psychiatrist associate, Dr Veysi Ceri, slammed the parents who allowed the procedure to be performed on their children. “Children cannot be left at the mercy of their parents,” Dr Ceri said. “Cupping is something that is not based on scientific evidence and children are physically harmed from it.”
On social media, people expressed their fury, labelling the practice as “questionable”. One commenter wrote: “Are these people crazy? They don’t read or learn anything.” But there were also those who shared their positive experiences. “I congratulate the family who had cupping performed on their baby,” one person wrote. “I also do cupping regularly and I haven’t had a headache in years. I do not take any medicine either. It is also beneficial for children to have cupping.“
So, is there any reliable evidence about dry cupping for children?
Is it demonstrably effective for any paediatric condition?
Is it harmful?
Believe it or not, there has been at least one clinical trial of dry cupping as a treatment of constipation in children:
One hundred and twenty children (4-18 years old) diagnosed as functional constipation according to ROME III criteria were assigned to receive a traditional dry cupping protocol on the abdominal wall for 8 minutes every other day or standard laxative therapy (Polyethylene glycol (PEG) 40% solution without electrolyte), 0.4 g/kg once daily) for 4 weeks, in an open label randomized controlled clinical trial using a parallel design with a 1:1 allocation ratio. Patients were evaluated prior to and following 2, 4, 8 and 12 weeks of the intervention commencement in terms of the ROME III criteria for functional constipation.
Results: There were no significant differences between the two arms regarding demographic and clinical basic characteristics. After two weeks of the intervention, there was a significant better result in most of the items of ROME III criteria of patients in PEG group. In contrast, after four weeks of the intervention, the result was significantly better in the cupping group. There was no significant difference in the number of patients with constipation after 4 and 8 weeks of the follow-up period.
Conclusion: This study showed that dry cupping of the abdominal wall, as a traditional manipulative therapy, can be as effective as standard laxative therapy in children with functional constipation.
This study is squarely negative, yet the conclusions are clearly positive. I have stopped being amazed by such contradictions. After all, we are dealing with so-called alternative medicine (SCAM)!
For what it’s worth, here is our 2011 overview of all systematic reviews of cupping:
Several systematic reviews (SRs) have assessed the effectiveness of cupping for a range of conditions. Our aim was to provide a critical evaluation and summary of these data. Electronic searches were conducted to locate all SRs concerning cupping for any condition. Data were extracted by two authors according to predefined criteria. Five SRs met our inclusion criteria, which related to the following conditions: pain conditions, stroke rehabilitation, hypertension, and herpes zoster. The numbers of studies included in each SR were small. Relatively clear evidence emerged only for one indication, that cupping may be effective for reducing pain. Based on evidence from the currently available SRs, the effectiveness of cupping has been demonstrated only as a treatment for pain, and even for this indication doubts remain.
And here is our 2011 SR of cupping as a treatment of pain:
The objective of this study was to assess the evidence for or against the effectiveness of cupping as a treatment option for pain. Fourteen databases were searched. Randomized clinical trials (RCTs) testing cupping in patients with pain of any origin were considered. Trials using cupping with or without drawing blood were included, while trials comparing cupping with other treatments of unproven efficacy were excluded. Trials with cupping as concomitant treatment together with other treatments of unproven efficacy were excluded. Trials were also excluded if pain was not a central symptom of the condition. The selection of studies, data extraction and validation were performed independently by three reviewers. Seven RCTs met all the inclusion criteria. Two RCTs suggested significant pain reduction for cupping in low back pain compared with usual care (P < .01) and analgesia (P < .001). Another two RCTs also showed positive effects of cupping in cancer pain (P < .05) and trigeminal neuralgia (P < .01) compared with anticancer drugs and analgesics, respectively. Two RCTs reported favorable effects of cupping on pain in brachialgia compared with usual care (P = .03) or heat pad (P < .001). The other RCT failed to show superior effects of cupping on pain in herpes zoster compared with anti-viral medication (P = .065). Currently there are few RCTs testing the effectiveness of cupping in the management of pain. Most of the existing trials are of poor quality. Therefore, more rigorous studies are required before the effectiveness of cupping for the treatment of pain can be determined.
The included trials frequently were silent about adverse effects. Others reported no adverse effects and one mentioned three cases of vaso-vagal shock. None of the studies was on children.
So, here are my answers to the questions above:
- Is there any reliable evidence about dry cupping for children? No
- Is it demonstrably effective for any paediatric condition? No
- Is it harmful? Probably not that much (other than undermining common sense and rationality).
Bloodletting has been used for centuries in many cultures. Its principle, it was assumed, consisted in re-balancing the body’s four humours. Bloodletting had a detrimental effect on most diseases and must have killed millions. It is a good historical example of the harm that ensues, if healthcare adheres to dogma. Today, we know that bloodletting is useful only in rare conditions such as polycythaemia vera or haemochromatosis (and some 30 years ago, a variation of bloodletting, isovolaemic haemodilution, was being discussed as a treatment for circulatory diseases such as intermittent claudication or stroke).
Yet, in so-called alternative medicine (SCAM), there are some practitioners who seem to find it hard to concede that ancient treatments might be not as good as they think. Thus, bloodletting has survived in this realm as a therapy for a wide range of conditions. This study assessed the efficacy of bloodletting therapy (acupoint pricking and cupping) in patients with chronic idiopathic urticaria (CIU) in a randomized, control, parallel-group trial.
A total of 174 patients with CIU were randomized into three groups:
- group A was treated with bloodletting therapy and ebastine (an anti-histamine),
- group B was treated with placebo treatment (acupoint pseudopricking and cupping) and ebastine,
- group C was treated with ebastine only.
The treatment period lasted 4 weeks. An intention-to-treat analysis was conducted, and the primary outcome was the effective rate of UAS7 score being reduced to 7 or below after treatment phase.
The effective rates at the end of treatment phase were different among the three groups, which were
- 73.7% in group A,
- 45.6% in group B,
- and 42.9% in group C.
Multiple analysis indicated differences between groups A and B (P < 0.0125) and groups A and C (P < 0.0125) and no difference between groups B and C (P > 0.0125). No severe bloodletting therapy-related adverse events were observed.
The authors concluded that one month of bloodletting therapy combined with ebastine is clinically beneficial compared with placebo treatment combined with ebastine and treatment with ebastine only. Thus, bloodletting therapy can be an effective complementary treatment in CIU.
How on earth might bloodletting help for CIU? Luckily, the authors have an answer to this question:
The clinical feature of urticaria with wheals and pruritus coming and going quickly is the manifestation of wind-evil that lurks in and circulates with blood. Hence, in the treatment of urticaria, dispersing wind is the one of the principle methods, and treating blood before wind is an important procedure because when blood flows fluently , wind-evil will resolve spontaneously. Bloodletting therapy is a direct and effective way of regulating blood.
You see, it’s all perfectly clear!
In this case, the results must be true. And the argument that patients might have known in which treatment group they had ended up (and were thus not blinded) can be discarded.
Even the NEW SCIENTIST seems alarmed about Gwyneth and her activities:
Psychic readings, energy healing and vampire facials are just a few of the adventures had by actor and alternative health guru Gwyneth Paltrow and her team in her forthcoming Netflix series The Goop Lab. Goop, Paltrow’s natural health company, has already become a byword for unrestrained woo, but the TV series takes things to the next level.
Don’t make the mistake of thinking you can stick your fingers in your ears and pretend it isn’t happening. There is unlikely to be any escape from The Goop Lab after it is released on 24 January, judging by the current explosion of interest in Goop’s latest offering, a candle scented like Paltrow’s vagina, which has reportedly sold out…
Yet, I am sure we got her all wrong!
Good old Gwennie is really one of us – she is a true sceptic!
Think about it; it’s the only explanation.
When she first started dabbling in woo, she only wanted to test us. I’ll just display a few cupping marks and see how they react, she thought.
Then she saw that most people were so gullible that they bought it. Of course, she thought, if they buy it, I might as well take their money. In her attempt to see how far she can push her boat out, she decided to conduct a sceptical experiment and went further and further. This is when she started to focus on her vagina – jade eggs, steaming it, etc. Surely, she thought, eventually they must realise that I am a sceptic taking the Mikey!
But they never did realise it; at least not so far.
So, she decided to do something even more brazen and sell candles to dispense the smell of her vagina in the homes of her fans. That will do it, she felt, now they will realise what I want to achieve with all this.
But what happened? They sold out in no time (actually, both the candles and the gullible public)! That was a surprise even to our Gwennie. She thought she had seen it all, but she was wrong.
Now she is trying to think of something even more outrageous – but she admits, it’s not easy. What can be a more obvious and disgusting hoax than filling people’ homes with the smell of my genitals and let them pay through their noses for the pleasure? she asks herself.
Yes, poor old Gwennie is at loss! Stuck in her own vagina, so to speak.
Perhaps you can help her? Please suggest what vaginal gimmick she might sell next to make her position inescapably clear to even the dumbest of the gullible. Just mention your ideas in the comment section below; I have a feeling she is an avid reader of this blog. Gwennie might even show herself generous; if she likes your innovation, she will certainly make it worth your while.
Because, by Jove, she can afford to be generous. Apparently her business is now worth a quarter of a billion US$. But we must not be envious. Knowing that she did all this merely to stimulate sceptical thinking in the general public, you will not be surprised to learn what she intends to do with all this dosh: once she has succeeded in demonstrating to all the gullible pin heads and devotees that she really is on the side of the angles, she will donate all of it to sceptic organisations across the globe.
So, sceptics of the world: stop snarling at my friend Gwennie, rejoice and prepare for a major windfall.
Cupping is a so-called alternative medicine (SCAM) that has existed in several ancient cultures. It recently became popular when US Olympic athletes displayed cupping marks on their bodies, and it was claimed that cupping is used for enhancing their physical performance. There are two distinct forms: dry and wet cupping.
Wet cupping involves scarring the skin with a sharp instrument and then applying a cup with a vacuum to suck blood from the wound. It can thus be seen (and was traditionally used) as a form of blood-letting. Wet cupping is being recommended by enthusiasts for a wide range of conditions. But does it work?
This study compared the effects of wet-cupping therapy with conventional therapy on persistent nonspecific low back pain (PNSLBP). In this randomized clinical trial, 180 participants with the mean age of 45±10 years old, who had been suffering from PNSLBP were randomly assigned to wet-cupping or conventional treatment. The wet-cupping group was treated with two separate sessions (4 weeks in total) on the inter-scapular and sacrum area. In the conventional treatment group, patients were conservatively treated using rest (6 weeks) and oral medications (3 weeks). The primary and the secondary outcome were the quantity of disability using Oswestry Disability Index (ODI), and pain intensity using Visual Analogue Scale (VAS), respectively.
The results show that there was no significant difference in demographic characteristics (age, gender, and body mass index) between the two groups. Therapeutic effect of wet-cupping therapy was comparable to conventional treatment in the 1st month follow-up visits. The functional outcomes of wet-cupping at the 3rd and 6th month visits were significantly superior compared to the conventional treatment group. The final ODI scores in the wet-cupping and conventional groups were 16.7 ± 5.7 and 22.3 ± 4.5, respectively (P<0.01).
The authors concluded that wet-cupping may be a proper method to decrease PNSLBP without any conventional treatment. The therapeutic effects of wet-cupping can be longer lasting than conventional therapy.
Perhaps the authors were joking? In any case, their conclusions cannot be taken seriously. Why? There are several reasons, but the most obvious ones are:
- There was no adequate control of the presumably substantial placebo effects of wet cupping.
- The control group received a treatment that is known to be ineffective or even detrimental.
For people with acute low back pain, advice to rest in bed is less effective than advice to stay active. Thus comparing wet cupping to a control group treated with bed rest is bound to generate a false-positive outcome for wet cupping.
My final point is perhaps the most important: wet cupping can lead to serious complication, and I therefore do not recommend it to anyone – other than masochists, perhaps.
The authors of this systematic review aimed to summarize the evidence of clinical trials on cupping for athletes. Randomized controlled trials on cupping therapy with no restriction regarding the technique, or co-interventions, were included, if they measured the effects of cupping compared with any other intervention on health and performance outcomes in professionals, semi-professionals, and leisure athletes. Data extraction and risk of bias assessment using the Cochrane Risk of Bias Tool were conducted independently by two pairs of reviewers.
Eleven trials with n = 498 participants from China, the United States, Greece, Iran, and the United Arab Emirates were included, reporting effects on different populations, including soccer, football, and handball players, swimmers, gymnasts, and track and field athletes of both amateur and professional nature. Cupping was applied between 1 and 20 times, in daily or weekly intervals, alone or in combination with, for example, acupuncture. Outcomes varied greatly from symptom intensity, recovery measures, functional measures, serum markers, and experimental outcomes. Cupping was reported as beneficial for perceptions of pain and disability, increased range of motion, and reductions in creatine kinase when compared to mostly untreated control groups. The majority of trials had an unclear or high risk of bias. None of the studies reported safety.
The authors concluded that no explicit recommendation for or against the use of cupping for athletes can be made. More studies are necessary for conclusive judgment on the efficacy and safety of cupping in athletes.
Considering the authors’ stated aim, this conclusion seems odd. Surely, they should have concluded that THERE IS NO CONVINCING EVIDENCE FOR THE USE OF CUPPING IN ATHLETES. But this sounds rather negative, and the JCAM does not seem to tolerate negative conclusions, as discussed repeatedly on this blog.
The discussion section of this paper is bar of any noticeable critical input (for those who don’t know: the aim of any systematic review must be to CRITICALLY EVALUATE THE PRIMARY DATA). The authors even go as far as stating that the trials reported in this systematic review found beneficial effects of cupping in athletes when compared to no intervention. I find this surprising and bordering on scientific misconduct. The RCTs were mostly not on cupping but on cupping in combination with some other treatments. More importantly, they were of such deplorable quality that they allow no conclusions about effectiveness. Lastly, they mostly failed to report on adverse effects which, as I have often stated, is a violation of research ethics.
In essence, all this paper proves is that, if you have rubbish trials, you can produce a rubbish review and publish it in a rubbish journal.