MD, PhD, FMedSci, FRSB, FRCP, FRCPEd.

pain

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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.

Aromatherapy, the use of essential oils for medicinal purposes, exists in several guises. One of them is inhalation aromatherapy which is a complementary therapy used in different clinical settings. But is there any sound evidence about its effectiveness?

The aim of this review was to assess the effectiveness of inhalational aromatherapy in the care of hospitalized pediatric patients.

A systematic review of clinical trials and quasi-experimental studies was conducted, based on PRISMA recommendations, searching Medline, Web of ScienceScopus, SciELO, LILACS, CINAHLScience Direct, EBSCO, and updated databases. The Down and Black 2020, RoB 2020 CLARITY, and ROBINS-I 2020 scales were used through the Distiller SR software to verify the studies’ internal validity and risk of bias.

From 446 articles identified, 9 fulfilled the inclusion criteria. Seven were randomized controlled trials (RCTs), one pilot RCT, and one non-randomized quasi-experimental trial.

Different outcomes were analyzed, with pain being the most frequently measured variable. None of the 6 studies that evaluated pain showed significant effects with inhalation aromatherapy. Additionally, non-significant effects were found regarding nausea, vomiting, and behavioral/emotional variables.

The authors concluded that the findings are still inconclusive, and more evidence is required from future studies with high methodological quality, blinding, and adequate sample sizes.

Inconclusive?

Really?

Call me a skeptic, but I think the findings show quite clearly that there is no sound evidence to suggest that inhalation aromatherapy might be effective for kids.

The effectiveness of manipulation versus mobilization for the management of spinal conditions, including cervicogenic headache, is conflicting, and a pragmatic approach comparing manipulation to mobilization has not been examined in a patient population with cervicogenic headache.

This study evaluated the effectiveness of manipulation compared to mobilization applied in a pragmatic fashion for patients with cervicogenic headache.

Forty-five (26 females) patients with cervicogenic headache were randomly assigned to receive either pragmatically selected manipulation or mobilization. Outcomes were measured at baseline, the second visit, discharge, and 1-month follow-up. The endpoints of the study included the Neck Disability Index (NDI), Numeric Pain Rating Scale (NPRS), the Headache Impact Test (HIT-6), the Global Rating of Change (GRC), the Patient Acceptable Symptoms Scale (PASS). The primary outcome measures were the effects of treatment on disability and pain. They were examined with a mixed-model analysis of variance (ANOVA), with treatment group (manipulation versus mobilization) as the between-subjects variable and time (baseline, 48 hours, discharge, and follow-up) as the within-subjects variable.

The interaction for the mixed model ANOVA was not statistically significant for NDI (p = 0.91), NPRS (p = 0.81), or HIT (p = 0.89). There was no significant difference between groups for the GRC or PASS.

The authors concluded that manipulation has similar effects on disability, pain, GRC, and cervical range of motion as mobilization when applied in a pragmatic fashion for patients with cervicogenic headaches.

Essentially, this study is an equivalence trial comparing one treatment to another. As such it would need a much larger sample size than the 45 patients enrolled by the investigators. If, however, we ignored this major flaw and assumed the results are valid, they would be consistent with both manipulation and mobilization being pure placebos.

I can imagine that many chiropractors find this conclusion unacceptable. Therefore, let me offer an alternative: both approaches were equally effective. Therefore, mobilization, which is associated with far fewer risks, is preferable. This means that patients suffering from cervicogenic headache should see an osteopath who is less likely to use manipulation than a chiropractor.

And again, I can imagine that many chiropractors find this conclusion unacceptable.

It was only when I came across this recent paper that I realized that, apparently, I am THE WORLD CHAMPION in acupuncture reviews. The aim of this paper was to analyze the 100 most-cited systematic reviews or meta-analyses in the field of acupuncture research.

The Web of Science Core Collection was used to retrieve lists of 100 most-cited systematic reviews or meta-analyses in the field of acupuncture research. Two authors screened literature, extracted data, and analyzed the results.

The citation number of the 100 most-cited systematic reviews or meta-analyses varied from 65 to 577; they were published between 1989 and 2018. Fourteen authors published more than 1 study as the corresponding author and 10 authors published more than 1 study as the first author.

In terms of the corresponding authors, Edzard Ernst and Linde Klaus published the most systematic reviews/meta-analyses (n = 7). The USA published most of the systematic reviews or meta-analyses (n = 24), followed by England (n = 23) and China (n = 14). Most institutions with more than 1 study were from England (4/13). The institutions with the largest numbers of most-cited systematic reviews or meta-analyses were the Technical University of Munich in Germany, the University of Maryland School of Medicine in the USA (n = 8), the Universities of Exeter and Plymouth in England (n = 6), and the University of Exeter in England (n = 6). The journal with the largest number of most-cited systematic reviews or meta-analyses was the Cochrane Database of Systematic Reviews (n = 20), followed by Pain (n = 6). The majority of the 100 most-cited reviews are on pain or pain-related conditions. Only 4 of them focus on safety issues, and all of these are by my team.

The authors concluded that the 100 most-cited systematic reviews or meta-analyses in the acupuncture research field are mostly from high impact factor journals and developed countries. It will help researchers follow research hot spots, broaden their research scope, expand their academic horizons, and explore new research ideas, thereby improving the quality of acupuncture research.

The authors show that, both in the list of corresponding as well as first authors, I am in place number one! Not only that, they furthermore reveal that my department is also in place number 1 (as Universities of Exeter and Plymouth in England (n = 6), and the University of Exeter in England (n = 6) both refer to my unit [in the 19 years it existed the Exeter medical school changed affiliation twice]). This is remarkable, particularly because acupuncture was only one of several research foci of my team (the other 3 being herbal medicine, homeopathy, and spinal manipulation), and my department was closed almost 10 years ago.

When I write about acupuncture these days (mostly on this blog), I often get the impression that the true believers in this therapy don’t especially like what I have to say. I, therefore, fear that the concept of me being the WORLD CHAMPION of acupuncture reviews might cause some degree of displeasure to them.

What can I say?

Sorry guys!

Guest post by Emeritus Professor Alastair MacLennan AO, MB ChB, MD, FRCOG, FRANZCOG

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.

References

1. https://www.nice.org.uk/guidance/ipg697/documents/overview

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.

Static or motion manual palpation tests of the spine are commonly used by chiropractors and osteopaths to assess pain location and reproduction in low back pain (LBP) patients. But how reliable are they?

The purpose of this review was to evaluate the reliability and validity of manual palpation used for the assessment of LBP in adults. The authors systematically searched five databases from 2000 to 2019 and critically appraised the internal validity of studies using QAREL and QUADAS-2 instruments.

A total of 2023 eligible articles were identified, of which 14 were at low risk of bias. Evidence suggests that reliability of soft tissue structures palpation is inconsistent, and reliability of bony structures and joint mobility palpation is poor. Preliminary evidence was found to suggest that gluteal muscle palpation for tenderness may be valid in differentiating LBP patients with and without radiculopathy.

The authors concluded that the reliability of manual palpation tests in the assessment of LBP patients varies greatly. This is problematic because these tests are commonly used by manual therapists and clinicians. Little is known about the validity of these tests; therefore, their clinical utility is uncertain. High quality validity studies are needed to inform the clinical use of manual palpation tests.

I have repeatedly drawn attention to the fact that the diagnostic methods used by chiropractors and osteopaths are of uncertain or disproven validity (see for instance here, or here). Why is that important?

Imagine you consult a chiropractor or osteopath. Simply put, this is what is likely to happen:

  • They listen to your complaint.
  • They do a few tests which are of dubious validity.
  • They give you a diagnosis that is meaningless.
  • They treat you with manual therapies that are neither effective nor safe.
  • You pay.
  • They persuade you that you need many more sessions.
  • You pay regularly.
  • When eventually your pain has gone away, they persuade you to have useless maintenance treatment.
  • You pay regularly.

In a nutshell, they have very little to offer … which explains why they attack everyone who dares to disclose this.

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.

PS

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.

Diabetic polyneuropathy is a prevalent, potentially disabling condition. Evidence-based treatments include specific anticonvulsants and antidepressants for pain management. All current guidelines advise a personalized approach with a low-dose start that is tailored to the maximum response having the least side effects or adverse events. Homeopathy has not been shown to be effective, but it is nevertheless promoted by many homeopaths as an effective therapy.

This study assessed the efficacy of individualized homeopathic medicines in the management of diabetic polyneuropathy. A multi-centric double-blind, placebo-controlled, randomized clinical trial was conducted by the Indian Central Council for Research in Homoeopathy at six centers with a sample size of 84. Based on earlier observational studies and repertorial anamnesis of DDSP symptoms 15 homeopathic medicines were shortlisted and validated scales were used for evaluating the outcomes post-intervention. The primary outcome measure was a change in Neuropathy Total Symptom Score-6 (NTSS-6) from baseline to 12 months. Secondary outcomes included changes in peripheral nerve conduction study (NCS), World Health Organization Quality of Life BREF (WHOQOL-BREF) and Diabetic Neuropathy Examination (DNE) score at 12 months.

Data of 68 enrolled cases were considered for data analysis. A statistically significant difference (p<0.014) was found in NTSS-6 post-intervention in the Verum group. A positive trend was noted for the Verum group as per the graph plotted for DNE score and assessment done for NCS. No significant difference was found between the groups for WHOQOL-Bref. Out of 15 pre-identified homeopathic medicines, 11 medicines were prescribed in potencies in ascending order from 6C to 1M.

The authors refrain from drawing conclusions about the efficacy of their homeopathic treatment (which is more than a little odd, as their stated aim was to assess the efficacy of individualized homeopathic medicines in the management of diabetic polyneuropathy). So, please allow me to do it for them:

The findings of this study confirm that homeopathy is a useless treatment.

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