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

methodology

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Ovariohysterectomy (OH) is one of the most frequent elective surgical procedures in routine veterinary practice. The aim of this study was to evaluate analgesia with Arnica montana 30cH during the postoperative period after elective OH.

Thirty healthy female dogs, aged 1 to 3 years, weighing 7 to 14 kg, were selected at the Veterinary Hospital in Campo Mourão, Paraná, Brazil. The dogs underwent the surgical procedure with an anaesthetic protocol and analgesia that had the aim of maintaining the patient’s wellbeing. After the procedure, they were randomly divided into three groups of 10. One group received Arnica montana 30cH; another received 5% hydroalcoholic solution; and the third group, 0.9% NaCl saline solution. All animals received four drops of the respective solution sublingually and under blinded conditions, every 10 minutes for 1 hour, after the inhalational anaesthetic had been withdrawn. The Glasgow Composite Measure Pain Scale was used to analyse the effect of therapy. Analysis of variance (ANOVA) followed by the Tukey test was used to evaluate the test data. Statistical differences were deemed significant when p ≤0.05.

The results show that the Arnica montana 30cH group maintained analgesia on average for 17.8 ± 3.6 hours, whilst the hydroalcoholic solution group did so for 5.1 ± 1.2 hours and the saline solution group for 4.1 ± 0.9 hours (p ≤0.05).

The authors concluded that these data demonstrate that Arnica montana 30cH presented a more significant analgesic effect than the control groups, thus indicating its potential for postoperative analgesia in dogs undergoing OH.

I do not have access to the full article (I was fired by the late Peter Fisher from the editorial board of the journal ‘HOMEOPATHY’) which puts me in a somewhat difficult position:

  • not reporting this study could be construed as an anti-homeopathy bias,
  • and reporting it handicaps me as I cannot assess essential details.

So, if anyone has access, please send the full paper to me and I will then study it and revise this post accordingly.

Judging from the abstract, I have to say that the results seem far too good to be true. I doubt that any oral remedy can have the effect that is being described here – let alone one that has been diluted (sorry, potentised) at a rate of 1: 1000000000000000000000000000000000000000000000000000000000000. That fact alone reduces the plausibility of the finding to zero.

At this stage, I do wonder who peer-reviewed the study and ask myself whether the rough data have been checked for reliability.

Well-conducted systematic reviews (SRs) should in principle provide the most reliable evidence on the effectiveness of acupuncture. However, limitations on the methodological rigour of SRs may impact the trustworthiness of their conclusions. This cross-sectional study was aimed at evaluating the methodological quality of recent SRs of acupuncture.

The Cochrane Database of Systematic Reviews, MEDLINE, and EMBASE were searched for SRs focusing on manual acupuncture or electro-acupuncture published during January 2018 and March 2020. Eligible SRs needed to contain at least one meta-analysis and be published in the English language. Two independent reviewers extracted the bibliographical characteristics of the included SRs with a pre-designed questionnaire and appraised the methodological quality of the reviews with the validated AMSTAR 2 (A MeaSurement Tool to Assess systematic Reviews 2). The associations between bibliographical characteristics and methodological quality ratings were explored using Kruskal-Wallis rank tests and Spearman’s rank correlation coefficients.

A total of 106 SRs were appraised. The results were as follows:

  • one (0.9%) SR was of high methodological quality,
  • no review (0%) was of moderate quality,
  • six (5.7%) were of low quality,
  • 99 (93.4%) were of critically low quality.

Only ten (9.4%) provided an a priori protocol, only four (3.8%) conducted a comprehensive literature search, only five (4.7%) provided a list of excluded studies, and only six (5.7%) performed a meta-analysis appropriately. Cochrane SRs, updated SRs, and SRs that did not search non-English databases had relatively higher overall quality. The vast majority (87.7%) of the 106 reviews included in this analysis originated from Asia. Conflicts of interest of the review authors were declared in only 2 of the 106 reviews.

The authors concluded that the methodological quality of SRs on acupuncture is unsatisfactory. Future reviewers should improve critical methodological aspects of publishing protocols, performing comprehensive search, providing a list of excluded studies with justifications for exclusion, and conducting appropriate meta-analyses. These recommendations can be implemented via enhancing the technical competency of reviewers in SR methodology through established education approaches as well as quality gatekeeping by journal editors and reviewers. Finally, for evidence users, skills in SR critical appraisal remain to be essential as relevant evidence may not be available in pre-appraised formats.

On this blog, I have often complained about the lack of critical input and the poor quality of systematic reviews of so-called alternative medicine (SCAM), particularly of acupuncture, and especially of Chinese reviews, and even more especially Chinese reviews of (mostly) Chinese studies. This new paper is a valuable confirmation of this fast-growing deficit.

One does not need to be a prophet to predict that this pollution of the literature with complete rubbish will have detrimental effects. Because poor reviews almost always draw an over-optimistic picture of the value of acupuncture, this phenomenon must seriously mislead the public. The end result will be that the public believes acupuncture to be effective.

I cannot help thinking that this is, in fact, the intended aim of the authors of such poor, false-positive reviews. Moreover, a glance at the subject areas of the reviews in the list below gives the impression that China is heavily promoting the idea that acupuncture is a panacea. Yet there is good evidence to show that acupuncture is little more than placebo therapy.

In my last post, I have reported that I am an author of many of the frequently-cited systematic acupuncture reviews. You might thus assume that I am a significant part of this pollution by rubbish reviews. This would, however, be an entirely wrong conclusion. The above analysis covers a period when my unit had already been closed, and I am thus not responsible for a single of the papers included in the above analysis.

List of included systematic reviews

ID Included systematic reviews
1 Acupuncture for primary insomnia: An updated systematic review of randomized controlled trials
2 Efficacy and safety of acupuncture for essential hypertension: A meta-analysis
3 Acupuncture for the treatment of sudden sensorineural hearing loss: A systematic review and meta-analysis: Acupuncture for SSNHL
4 Effectiveness of Acupuncturing at the Sphenopalatine Ganglion Acupoint Alone for Treatment of Allergic Rhinitis: A Systematic Review and Meta-Analysis
5 Acupuncture and clomiphene citrate for anovulatory infertility: a systematic review and meta-analysis
6 Acupuncture for primary trigeminal neuralgia: A systematic review and PRISMA-compliant meta-analysis
7 Acupuncture as an adjunctive treatment for angina due to coronary artery disease: A meta-analysis
8 Conventional treatments plus acupuncture for asthma in adults and adolescent: A systematic review and meta-analysis
9 Optimizing acupuncture treatment for dry eye syndrome: A systematic review
10 Acupuncture using pattern-identification for the treatment of insomnia disorder: a systematic review and meta-analysis of randomized controlled trials
11 Efficacy and Safety of Auricular Acupuncture for Cognitive Impairment and Dementia: A Systematic Review
12 Acupuncture for cognitive impairment in vascular dementia, alzheimer’s disease and mild cognitive impairment: A systematic review and meta-analysis
13 Effectiveness of pharmacopuncture for cervical spondylosis: A systematic review and meta-analysis
14 Acupuncture combined with swallowing training for poststroke dysphagia: a meta-analysis of randomised controlled trials
15 Scalp acupuncture treatment for children’s autism spectrum disorders: A systematic review and meta-analysis
16 Acupuncture for Post-stroke Shoulder-Hand Syndrome: A systematic review and meta-analysis
17 Systematic review of acupuncture for the treatment of alcohol withdrawal syndrome
18 Acupuncture for hip osteoarthritis
19 Clinical Benefits of Acupuncture for the Reduction of Hormone Therapy-Related Side Effects in Breast Cancer Patients: A Systematic Review
20 Combination therapy of scalp electro-acupuncture and medication for the treatment of Parkinson’s disease: A systematic review and meta-analysis
21 Acupuncture for migraine: A systematic review and meta-analysis
22 Acupuncture to Promote Recovery of Disorder of Consciousness after Traumatic Brain Injury: A Systematic Review and Meta-Analysis
23 Acupuncture Compared with Intramuscular Injection of Neostigmine for Postpartum Urinary Retention: A Systematic Review and Meta-Analysis of Randomized Controlled Trials
24 Acupuncture for the relief of hot flashes in breast cancer patients: A systematic review and meta-analysis of randomized controlled trials and observational studies
25 Effectiveness and Safety of Acupuncture for Perimenopausal Depression: A Systematic Review and Meta-Analysis of Randomized Controlled Trials
26 Acupuncture plus Chinese Herbal Medicine for Irritable Bowel Syndrome with Diarrhea: A Systematic Review and Meta-Analysis
27 Electroacupuncture as an adjunctive therapy for motor dysfunction in acute stroke survivors: A systematic review and meta-analyses
28 Acupuncture for Acute Pancreatitis: A Systematic Review and Meta-analysis
29 Acupuncture for chronic fatigue syndrome: a systematic review and meta-analysis
30 Compare the efficacy of acupuncture with drugs in the treatment of Bell’s palsy: A systematic review and meta-analysis of RCTs
31 The effectiveness and safety of acupuncture for the treatment of myasthenia gravis: a systematic review and meta-analysis of randomized controlled trials
32 Acupuncture therapy for fibromyalgia: A systematic review and meta-analysis of randomized controlled trials
33 The effectiveness of acupuncture therapy in patients with post-stroke depression: An updated meta-analysis of randomized controlled trials
34 Fire needling for herpes zoster: A systematic review and meta-analysis of randomized clinical trials
35 Comparison between the Effects of Acupuncture Relative to Other Controls on Irritable Bowel Syndrome: A Meta-Analysis
36 Manual Acupuncture for Optic Atrophy: A Systematic Review and Meta-Analysis
37 Effect of warm needling therapy and acupuncture in the treatment of peripheral facial paralysis: A systematic review and meta-analysis
38 The Effect of Acupuncture in Breast Cancer-Related Lymphoedema (BCRL): A Systematic Review and Meta-Analysis
39 The Efficacy of Acupuncture in Chemotherapy-Induced Peripheral Neuropathy: Systematic Review and Meta-Analysis
40 The maintenance effect of acupuncture on breast cancer-related menopause symptoms: a systematic review
41 The effectiveness of acupuncture in the management of persistent regional myofascial head and neck pain: A systematic review and meta-analysis
42 Acupuncture for the Treatment of Adults with Posttraumatic Stress Disorder: A Systematic Review and Meta-Analysis
43 The effectiveness of superficial versus deep dry needling or acupuncture for reducing pain and disability in individuals with spine-related painful conditions: a systematic review with meta-analysis
44 Effects of dry needling trigger point therapy in the shoulder region on patients with upper extremity pain and dysfunction: a systematic review with meta-analysis
45 Is dry needling effective for low back pain?: A systematic review and PRISMA-compliant meta-analysis
46 The effectiveness and safety of acupuncture for patients with atopic eczema: a systematic review and meta-analysis
47 Comparing verum and sham acupuncture in fibromyalgia syndrome: a systematic review and meta-analysis
48 Acupuncture for symptomatic gastroparesis
49 The Efficacy and Safety of Acupuncture for the Treatment of Children with Autism Spectrum Disorder: A Systematic Review and Meta-Analysis
50 Acupuncture Versus Sham-acupuncture: A Meta-analysis on Evidence for Non-immediate Effects of Acupuncture in Musculoskeletal Disorders
51 Acupuncture Treatment for Post-Stroke Dysphagia: An Update Meta-Analysis of Randomized Controlled Trials
52 Effectiveness of Acupuncture Used for the Management of Postpartum Depression: A Systematic Review and Meta-Analysis
53 Clinical effects and safety of electroacupuncture for the treatment of post-stroke depression: a systematic review and meta-analysis of randomised controlled trials
54 Placebo effect of acupuncture on insomnia: a systematic review and meta-analysis
55 Acupuncture for Chronic Pain-Related Insomnia: A Systematic Review and Meta-Analysis
56 Evidence for Dry Needling in the Management of Myofascial Trigger Points Associated With Low Back Pain: A Systematic Review and Meta-Analysis
57 Warm needle acupuncture in primary osteoporosis management: a systematic review and meta-analysis
58 Acupuncture for overactive bladder in adults: a systematic review and meta-analysis
59 Traditional acupuncture for menopausal hot flashes: A systematic review and meta-analysis of randomized controlled trials
60 The effectiveness of acupuncture for osteoporosis: A systematic review and meta-analysis
61 Long-term effects of acupuncture for chronic prostatitis/chronic pelvic pain syndrome: Systematic review and single-Arm meta-Analyses
62 Does acupuncture the day of embryo transfer affect the clinical pregnancy rate? Systematic review and meta-analysis
63 Acupuncture treatments for infantile colic: a systematic review and individual patient data meta-analysis of blinding test validated randomised controlled trials
64 Acupuncture performed around the time of embryo transfer: a systematic review and meta-analysis
65 Is Acupuncture Effective for Improving Insulin Resistance? A Systematic Review and Meta-analysis
66 Efficacy of acupuncture in the management of post-apoplectic aphasia: A systematic review and meta-analysis of randomized controlled trials
67 Acupuncture for lumbar disc herniation: a systematic review and meta-analysis
68 Traditional Chinese acupuncture and postpartum depression: A systematic review and meta-analysis
69 Acupuncture for Chronic Pain: Update of an Individual Patient Data Meta-Analysis
70 Acupuncture Therapy for Functional Effects and Quality of Life in COPD Patients: A Systematic Review and Meta-Analysis
71 Electroacupuncture for Reflex Sympathetic Dystrophy after Stroke: A Meta-Analysis
72 The Effect of Patient Characteristics on Acupuncture Treatment Outcomes
73 The efficacy and safety of acupuncture in women with primary dysmenorrhea: A systematic review and meta-analysis
74 Role of acupuncture in the treatment of insulin resistance: A systematic review and meta-analysis
75 Appropriateness of sham or placebo acupuncture for randomized controlled trials of acupuncture for nonspecific low back pain: A systematic review and meta-analysis
76 Evidence of efficacy of acupuncture in the management of low back pain: a systematic review and meta-analysis of randomised placebo- or sham-controlled trials
77 The effects of acupuncture on pregnancy outcomes of in vitro fertilization: A systematic review and meta-analysis
78 Acupuncture for migraine without aura: a systematic review and meta-analysis
79 Acupuncture for acute stroke
80 Acupuncture at Tiaokou (ST38) for Shoulder Adhesive Capsulitis: What Strengths Does It Have? A Systematic Review and Meta-Analysis of Randomized Controlled Trials
81 Acupuncture for hypertension
82 The effect of acupuncture on Bell’s palsy: An overall and cumulative meta-analysis of randomized controlled trials
83 Effects of acupuncture on cancer-related fatigue: a meta-analysis
84 Acupuncture for adults with overactive bladder
85 Electroacupuncture for Postoperative Urinary Retention: A Systematic Review and Meta-Analysis
86 Meta-Analysis of Electroacupuncture in Cardiac Anesthesia and Intensive Care
87 Acupuncture therapy improves health-related quality of life in patients with chronic obstructive pulmonary disease: A systematic review and meta-analysis
88 The effect of acupuncture on the quality of life in patients with migraine: A systematic review and meta-analysis
89 Cognitive improvement effects of electro-acupuncture for the treatment of MCI compared with Western medications: A systematic review and Meta-analysis 11 Medical and Health Sciences 1103 Clinical Sciences
90 Oriental herbal medicine and moxibustion for polycystic ovary syndrome: A meta-analysis
91 The Effect of Acupuncture and Moxibustion on Heart Function in Heart Failure Patients: A Systematic Review and Meta-Analysis
92 Acupuncture therapy for the treatment of stable angina pectoris: An updated meta-analysis of randomized controlled trials
93 Traditional manual acupuncture combined with rehabilitation therapy for shoulder hand syndrome after stroke within the Chinese healthcare system: a systematic review and meta-analysis
94 Effects of moxibustion on pain behaviors in patients with rheumatoid arthritis: A meta-analysis
95 Acupuncture Treatment for Chronic Pelvic Pain in Women: A Systematic Review and Meta-Analysis of Randomized Controlled Trials
96 The effectiveness of dry needling for patients with orofacial pain associated with temporomandibular dysfunction: a systematic review and meta-analysis
97 Acupuncture for postherpetic neuralgia systematic review and meta-analysis
98 Acupoint selection for the treatment of dry eye: A systematic review and meta-analysis of randomized controlled trials
99 Warm-needle moxibustion for spasticity after stroke: A systematic review of randomized controlled trials
100 Acupuncture for menstrual migraine: a systematic review
101 The efficacy of acupuncture for stable angina pectoris: A systematic review and meta-analysis
102 Acupuncture and weight loss in Asians: A PRISMA-compliant systematic review and meta-analysis
103 Effects of Acupuncture on Breast Cancer-Related lymphoedema: A Systematic Review and Meta-Analysis
104 Acupuncture for infertile women without undergoing assisted reproductive techniques (ART): A systematic review and meta-analysis
105 Moxibustion for alleviating side effects of chemotherapy or radiotherapy in people with cancer
106 Acupuncture for stable angina pectoris: A systematic review and meta-analysis

Therapeutic touch (TT) is a form of paranormal or energy healing developed by Dora Kunz (1904-1999), a psychic and alternative practitioner, in collaboration with Dolores Krieger, a professor of nursing. TT is popular and practised predominantly by US nurses; it is currently being taught in more than 80 colleges and universities in the U.S., and in more than seventy countries. According to one TT-organisation, TT is a holistic, evidence-based therapy that incorporates the intentional and compassionate use of universal energy to promote balance and well-being. It is a consciously directed process of energy exchange during which the practitioner uses the hands as a focus to facilitate the process.

The question is: does TT work beyond a placebo effect?

This review synthesized recent (January 2009–June 2020) investigations on the effectiveness and safety of therapeutic touch  (TT) as a therapy in clinical health applications. A rapid evidence assessment (REA) approach was used to review recent TT research adopting PRISMA 2009 guidelines. CINAHL, PubMed, MEDLINE, Cochrane databases, Web of Science, PsychINFO, and Google Scholar were screened between January 2009-March 2020 for studies exploring TT therapies as an intervention. The main outcome measures were for pain, anxiety, sleep, nausea, and functional improvement.

Twenty-one studies covering a range of clinical issues were identified, including 15 randomized controlled trials, four quasi-experimental studies, one chart review study, and one mixed-methods study including 1,302 patients. Eighteen of the studies reported positive outcomes. Only four exhibited a low risk of bias. All others had serious methodological flaws, bias issues, were statistically underpowered, and scored as low-quality studies. Over 70% of the included studies scored the lowest score possible on the GSRS weight of evidence scale. No high-quality evidence was found for any of the benefits claimed.

The authors drew the following conclusions:

After 45 years of study, scientific evidence of the value of TT as a complementary intervention in the management of any condition still remains immature and inconclusive:

  • Given the mixed result, lack of replication, overall research quality and significant issues of bias identified, there currently exists no good quality evidence that supports the implementation of TT as an evidence‐based clinical intervention in any context.
  • Research over the past decade exhibits the same issues as earlier work, with highly diverse poor quality unreplicated studies mainly published in alternative health media.
  • As the nature of human biofield energy remains undemonstrated, and that no quality scientific work has established any clinically significant effect, more plausible explanations of the reported benefits are from wishful thinking and use of an elaborate theatrical placebo.

TT turns out to be a prime example of a so-called alternative medicine (SCAM) that enthusiastic amateurs, who wanted to prove TT’s effectiveness, have submitted to multiple trials. Thus the literature is littered with positive but unreliable studies. This phenomenon can create the impression – particularly to TT fans – that the treatment works.

This course of events shows in an exemplary fashion that research is not always something that creates progress. In fact, poor research often has the opposite effect. Eventually, a proper scientific analysis is required to put the record straight (the findings of which enthusiasts are unlikely to accept).

In view of all this, and considering the utter implausibility of TT, it seems an unethical waste of resources to continue researching the subject. Similarly, continuing to use TT in clinical settings is unethical and potentially dangerous.

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,
  • hypertension,
  • 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.

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.

This systematic review assessed the effect of spinal manipulative therapy (SMT), the hallmark therapy of chiropractors, on pain and function for chronic low back pain (LBP) using individual participant data (IPD) meta-analyses.

Of the 42 RCTs fulfilling the inclusion criteria, the authors obtained IPD from 21 (n=4223). Most trials (s=12, n=2249) compared SMT to recommended interventions. The analyses showed moderate-quality evidence that SMT vs recommended interventions resulted in similar outcomes on

  • pain (MD -3.0, 95%CI: -6.9 to 0.9, 10 trials, 1922 participants)
  • and functional status at one month (SMD: -0.2, 95% CI -0.4 to 0.0, 10 trials, 1939 participants).

Effects at other follow-up measurements were similar. Results for other comparisons (SMT vs non-recommended interventions; SMT as adjuvant therapy; mobilization vs manipulation) showed similar findings. SMT vs sham SMT analysis was not performed, because data from only one study were available. Sensitivity analyses confirmed these findings.

The authors concluded that sufficient evidence suggest that SMT provides similar outcomes to recommended interventions, for pain relief and improvement of functional status. SMT would appear to be a good option for the treatment of chronic LBP.

In 2019, this team of authors published a conventional meta-analysis of almost the same data. At this stage, they concluded as follows: SMT produces similar effects to recommended therapies for chronic low back pain, whereas SMT seems to be better than non-recommended interventions for improvement in function in the short term. Clinicians should inform their patients of the potential risks of adverse events associated with SMT.

Why was the warning about risks dropped in the new paper?

I have no idea.

But the risks are crucial here. If we are told that SMT is as good or as bad as recommended therapies, such as exercise, responsible clinicians need to decide which treatment they should recommend to their patients. If effectiveness is equal, other criteria come into play:

  • cost,
  • risk,
  • availability.

Can any reasonable person seriously assume that SMT would do better than exercise when accounting for costs and risks?

I very much doubt it!

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.

Previous studies of acupuncture for CP/CPPS have been unconvincing. Our own systematic review of 2012 included 9 RCTs and all suggested that acupuncture is as effective as a range of control interventions. Their methodologic quality was variable; most were associated with major flaws. Only one RCT had a Jadad score of more than 3. We concluded that the evidence that acupuncture is effective for chronic prostatitis/chronic pelvic pain syndrome is encouraging but, because of several caveats, not conclusive. Therefore, more rigorous studies seem warranted.
This new study looks definitely more rigorous than the previous ones. But is it convincing? To answer this question, we need to consider a few points.

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.

Chinese researchers evaluated the effect of Chinese medicine (CM) on survival time and quality of life (QoL) in patients with small-cell lung cancer (SCLC). They conducted an exploratory and prospective clinical observation. Patients diagnosed with SCLC receiving CM treatment as an add-on to conventional cancer therapies were included and followed up every 3 months. The primary outcome was overall survival (OS), and the secondary outcomes were progression-free survival (PFS) and QoL.

A total of 136 patients including 65 limited-stage SCLC (LS-SCLC) patients and 71 extensive-stage SCLC (ES-SCLC) patients were analyzed. The median OS of ES-SCLC patients was 17.27 months, and the median OS of LS-SCLC was 40.07 months. The survival time was 16.27 months for SCLC patients with brain metastasis, 9.83 months for liver metastasis, 13.43 months for bone metastasis, and 18.13 months for lung metastasis. Advanced age, pleural fluid, liver, and brain metastasis were risk factors, while longer CM treatment duration was a protective factor. QoL assessment indicated that after 6 months of CM treatment, scores increased in function domains and decreased in symptom domains.

The authors concluded that CM treatment might help prolong OS of SCLC patients. Moreover, CM treatment brought the trend of symptom amelioration and QoL improvement. These results provide preliminary evidence for applying CM in SCLC multi-disciplinary treatment.

Sorry, but these results provide NO evidence for applying CM in SCLC multi-disciplinary treatment! Even if the findings were a bit better than those reported for SCLC in the literature – and I am not sure they are – it is simply not possible to say with any degree of certainty what effect the CM had. For that, we would obviously need a proper control group.

The study was supported by the National Natural Science Foundation of China (No. 81673797), and Beijing Municipal Natural Science Foundation (No. 7182142). In my view, this paper is an example for showing how the relentless promotion of dubious Traditional Chinese Medicine by Chinese officials might cost lives.

I feel that it is time to do something about it.

But what precisely?

Any ideas anyone?

 

Myofascial release (also known as myofascial therapy or myofascial trigger point therapy) is a type of low-load stretch therapy that is said to release tightness and pain throughout the body caused by the myofascial pain syndrome, a chronic muscle pain that is worse in certain areas known as trigger points. Various types of health professionals provide myofascial release, e.g. osteopaths, chiropractors, physical or occupational therapists, massage therapists, or sports medicine/injury specialists. The treatment is usually applied repeatedly, but there is also a belief that a single session of myofascial release is effective. This study was a crossover clinical trial aimed to test whether a single session of a specific myofascial release technique reduces pain and disability in subjects with chronic low back pain (CLBP).

A total of 41 participants were randomly enrolled into 3 situations in a balanced and crossover manner:

  • experimental,
  • placebo,
  • control.

The subjects underwent a single session of myofascial release on thoracolumbar fascia and the results were compared with the control and placebo groups. A single trained and experienced therapist applied the technique.

For the control treatment, the subjects were instructed to remain in the supine position for 5 minutes. For the muscle release session, the subjects were in a sitting position with feet supported and the thoracolumbar region properly undressed. The trunk flexion goniometry of each participant was performed and the value of 30° was marked with a barrier to limit the necessary movement during the technique. The trained researcher positioned their hands on all participants without sliding over the skin or forcing the tissue, with the cranial hand close to the last rib and at the T12–L1 level on the right side of the individual’s body and the caudal hand on the ipsilateral side between the iliac crest and the sacrum. Then, the researcher caused slight traction in the tissues by moving their hands away from each other in a longitudinal direction. Then, the participant was instructed to perform five repetitions of active trunk flexion-extension (30°), while the researcher followed the movement with both hands simultaneously positioned, without losing the initial tissue traction and position. The same technique and the same number of repetitions of active trunk flexion-extension were repeated with the researcher’s hands positioned on the opposite sides. This technique lasted approximately five minutes.

For the placebo treatment, the subjects were not submitted to the technique of manual thoracolumbar fascia release, but they slowly performed ten repetitions of active trunk flexion-extension (30°) in the same position as the experimental situation. Due to the fact that touch can provide not only well-recognized discriminative input to the brain, but also an affective input, there was no touch from the researcher at this stage.

The outcomes, pain, and functionality, were evaluated using the numerical pain rating scale (NPRS), pressure pain threshold (PPT), and Oswestry Disability Index (ODI).

The results showed no effects between-tests, within-tests, nor for interaction of all the outcomes, i.e., NPRS (η 2 = 0.32, F = 0.48, p = 0.61), PPT (η2 = 0.73, F = 2.80, p = 0.06), ODI (η2 = 0.02, F = 0.02, p = 0.97).

The authors concluded that a single trial of a thoracolumbar myofascial release technique was not enough to reduce pain intensity and disability in subjects with CLBP.

Surprised?

I’m not!

Recently, I received this comment from a reader:

Edzard-‘I see you do not understand much of trial design’ is true BUT I wager that you are in the same boat when it comes to a design of a trial for LBP treatment: not only you but many other therapists. There are too many variables in the treatment relationship that would allow genuine , valid criticism of any design. If I have to pick one book of the several listed elsewhere I choose Gregory Grieve’s ‘Common Vertebral Joint Problems’. Get it, read it, think about it and with sufficient luck you may come to realize that your warranted prejudices against many unconventional ‘medical’ treatments should not be of the same strength when it comes to judging the physical therapy of some spinal problems as described in the book.

And a chiro added:

EE: I see that you do not understand much of trial design

Perhaps it’s Ernst who doesnt understand how to research back pain.

“The identification of patient subgroups that respond best to specific interventions has been set as a key priority in LBP research for the past 2 decades.2,7 In parallel, surveys of clinicians managing LBP show that there are strong views against generic treatment and an expectation that treatment should be individualized to the patient.6,22.”

Journal of Orthopaedic & Sports Physical Therapy
Published Online:January 31, 2017Volume47Issue2Pages44-48

Do I need to explain why the Grieve book (yes, I have it and yes, I read it) is not a substitute for evidence that an intervention or technique is effective? No, I didn’t think so. This needs to come from a decent clinical trial.

And how would one design a trial of LBP (low back pain) that would be a meaningful first step and account for the “many variables in the treatment relationship”?

How about proceeding as follows (the steps are not necessarily in that order):

  • Study the previously published literature.
  • Talk to other experts.
  • Recruit a research team that covers all the expertise you need (and don’t have yourself).
  • Formulate your research question. Mine would be IS THERAPY XY MORE EFFECTIVE THAN USUAL CARE FOR CHRONIC LBP? I know LBP is but a vague symptom. This does, however, not necessarily matter (see below).
  • Define primary and secondary outcome measures, e.g. pain, QoL, function, as well as the validated methods with which they will be quantified.
  • Clarify the method you employ for monitoring adverse effects.
  • Do a small pilot study.
  • Involve a statistician.
  • Calculate the required sample size of your study.
  • Consider going multi-center with your trial if you are short of patients.
  • Define chronic LBP as closely as you can. If there is evidence that a certain type of patient responds better to the therapy xy than others, that might be considered in the definition of the type of LBP.
  • List all inclusion and exclusion criteria.
  • Make sure you include randomization in the design.
  • Randomization should be to groups A and B. Group A receives treatment xy, while group B receives usual care.
  • Write down what A and B should and should not entail.
  • Make sure you include blinding of the outcome assessors and data evaluators.
  • Define how frequently the treatments should be administered and for how long.
  • Make sure all therapists employed in the study are of a high standard and define the criteria of this standard.
  • Train all therapists of both groups such that they provide treatments that are as uniform as possible.
  • Work out a reasonable statistical plan for evaluating the results.
  • Write all this down in a protocol.

Such a trial design does not need patient or therapist blinding nor does it require a placebo. The information it would provide is, of course, limited in several ways. Yet it would be a rigorous test of the research question.

If the results of the study are positive, one might consider thinking of an adequate sham treatment to match therapy xy and of other ways of firming up the evidence.

As LBP is not a disease but a symptom, the study does not aim to include patients that all are equal in all aspects of their condition. If some patients turn out to respond better than others, one can later check whether they have identifiable characteristics. Subsequently, one would need to do a trial to test whether the assumption is true.

Therapy xy is complex and needs to be tailored to the characteristics of each patient? That is not necessarily an unsolvable problem. Within limits, it is possible to allow each therapist the freedom to chose the approach he/she thinks is optimal. If the freedom needed is considerable, this might change the research question to something like ‘IS THAT TYPE OF THERAPIST MORE EFFECTIVE THAN THOSE EMPLOYING USUAL CARE FOR CHRONIC LBP?’

My trial would obviously not answer all the open questions. Yet it would be a reasonable start for evaluating a therapy that has not yet been submitted to clinical trials. Subsequent trials could build on its results.

I am sure that I have forgotten lots of details. If they come up in discussion, I can try to incorporate them into the study design.

 

 

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