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

systematic review

In 2013, Zuckerman et al. conducted a meta-analysis of 63 studies that showed a negative intelligence-religiosity relation (IRR). Now a new meta-analysis with an updated data set of 83 studies has re-addressed the issue.

The new analysis showed that the correlation between intelligence and religious beliefs in college and non-college samples ranged from -.20 to -.23. There was no support for mediation of the IRR by education but there was support for partial mediation by analytic cognitive style.

In 2012, Canadian scientists tested the hypothesis that an analytic cognitive style is associated with a history of questioning, altering, and rejecting (i.e., unbelieving) supernatural claims, both religious and paranormal. In two studies, they examined associations of God beliefs, religious engagement (attendance at religious services, praying, etc.), conventional religious beliefs (heaven, miracles, etc.), and paranormal beliefs (extrasensory perception, levitation, etc.) with performance measures of cognitive ability and analytic cognitive style. An analytic cognitive style negatively predicted both religious and paranormal beliefs when controlling for cognitive ability as well as religious engagement, sex, age, political ideology, and education. Participants more willing to engage in analytic reasoning were less likely to endorse supernatural beliefs. Further, an association between analytic cognitive style and religious engagement was mediated by religious beliefs, suggesting that an analytic cognitive style negatively affects religious engagement via lower acceptance of conventional religious beliefs.

Some time ago, I reported about a study concluding that a higher religiousness/spirituality is associated with a more frequent use of supplements or additional therapies in individuals with endocrinopathies or metabolic diseases. As so-called alternative medicine (SCAM) has been shown to be associated with worse outcome, addressing religiousness/spirituality which stresses the responsibility of the person for his life might offer an additional resource and should be further studied.

On this blog, we have discussed many times, that advocacy of SCAM is associated with vaccination hesitancy; see, for instance here, here, and here)

Finally, the findings of a recent study suggest that beliefs in an engaged God were associated with greater mistrust in the COVID-19 vaccine. This association was amplified for Hispanic and lower-educated Americans. The authors argued that beliefs in an engaged God may promote distrust of science, reduce motivation to get vaccinated, and derive comfort and strength by placing control over one’s life in the hands of a loving, involved deity.

There are, of course, other factors involved in the complex relationships between intelligence, religiosity, SCAM, and vaccination hesitancy. Yet, it seems clear that such links do exist. I agree that it is well worth investigating them in more detail.

Open-label placebos (OLPs) are placebos without deception in the sense that patients know that they are receiving an inert sugar pill with no activity of its own. Intuitively, we think that such treatments must be ineffective. Yet, there have been several studies that seemed to show otherwise.

The objective of this paper was to systematically review and analyze the effect of OLPs in comparison to no treatment in clinical trials. A systematic literature search was carried out in February 2020. Randomized controlled trials of any medical condition or mental disorder comparing OLPs to no treatment were included. Data extraction and risk of bias rating were independently assessed. 1246 records were screened and 13 studies were included in the systematic review. Eleven trials were eligible for meta-analysis.

These trials assessed the effects of OLPs on

  • back pain,
  • cancer-related fatigue,
  • attention deficit hyperactivity disorder,
  • allergic rhinitis,
  • major depression,
  • irritable bowel syndrome,
  • menopausal hot flushes.

The risk of bias was moderate among all studies.

Click to enlarge.

A significant overall effect (standardized mean difference = 0.72, 95% Cl 0.39–1.05, p < 0.0001, I2 = 76%) of OLP. Thus, OLPs appear to be a promising treatment in different conditions. Yet, the researchers spotted several caveats and discuss them in some detail.

First, we detected hints of a publication bias in the study sample, but the respective test was not significant. The quantitative basis of the meta-analysis is based on a small number of studies, reflecting the early state of research in this field. Moreover, the set of studies showed some heterogeneity. Finally, four studies were rated to have a high risk of bias, and nine to have some concerns.

In order to assess the impact of these high-risk studies we performed an exploratory best-evidence synthesis. We excluded the four studies with a high risk of bias. In this analysis, the heterogeneity could be reduced to a non-critical value and almost all variance in the set of studies could be explained by a sampling error (I2 = 4%). With the exclusion of these four studies the mean effect size was reduced to a more conservative SMD = 0.49.

Regardless of this reduction of the overall effect, the same conclusions about the treatment-effect of OLPs can be drawn, although the lack of robustness means that interpretations require some caution. The decrease of heterogeneity shows that methodological impairments might be responsible for the considerable unexplained variance in our results. We abstained from carrying out a further sensitivity analysis for explaining heterogeneity because of the small number of studies.

This is certainly an interesting subject. And the above findings are certainly counter-intuitive.

My impression is that the effect of OLPs is small and of doubtful value in clinical practice. My prediction is that, as more and better research emerges, it will diminish further, if not vanish totally. I think that there are several reasons for this:

  • The number of trials is still quite small.
  • The studies obviously lack patient blinding.
  • Positive messages can be included alongside open-label placebos.
  • The “time lag bias” is high.

This type of bias means that, due to initial enthusiasm in a new subject, negative results are published with some delay. I have observed this bias repeatedly in the past. A new treatment initially tends to generate nothing but positive results, and only after a while, when the researchers’ euphoria has subsided, more realistic findings emerge.

This review summarized the available evidence on so-called alternative medicine (SCAM) used with radiotherapy. Systematic literature searches identified studies on the use of SCAM during radiotherapy. Inclusion required the following criteria: the study was interventional, SCAM was for human patients with cancer, and SCAM was administered concurrently with radiotherapy. Data points of interest were collected from included studies. A subset was identified as high-quality using the Jadad scale. Fisher’s exact test was used to assess the association between study results, outcome measured, and type of SCAM.

Overall, 163 articles met inclusion. Of these, 68 (41.7%) were considered high-quality trials. Articles published per year increased over time. Frequently identified therapies were biologically based therapies (47.9%), mind-body therapies (23.3%), and alternative medical systems (13.5%). Within the subset of high-quality trials, 60.0% of studies reported a favorable change with SCAM while 40.0% reported no change. No studies reported an unfavorable change. Commonly assessed outcome types were patient-reported (41.1%) and provider-reported (21.5%). The rate of favorable change did not differ based on the type of SCAM or outcome measured.

The authors concluded that concurrent SCAM may reduce radiotherapy-induced toxicities and improve quality of life, suggesting that physicians should discuss SCAM with patients receiving radiotherapy. This review provides a broad overview of investigations on SCAM use during radiotherapy and can inform how radiation oncologists advise their patients about SCAM.

In my recent book, I have reviewed the somewhat broader issue of SCAM for palliative and supportive care. My conclusions are broadly in agreement with the above review:

… some forms of SCAM—by no means all— benefit cancer patients in multiple ways… four important points:
• The volume of the evidence for SCAM in palliative and supportive cancer care is currently by no means large.
• The primary studies are often methodologically weak and their findings are contradictory.
• Several forms of SCAM have the potential to be useful in palliative and supportive cancer care.
• Therefore, generalisations are problematic, and it is wise to go by the current best evidence …

One particular finding of the new review struck me as intriguing: The rate of favorable change did not differ based on the type of SCAM. Combined with the fact that most studies are less than rigorous and fail to control for non-specific effects, this indicates to me that, in cancer palliation (and perhaps in other areas as well), SCAM works mostly via non-specific effects. In other words, patients feel better not because the treatment per se was effective but because they needed the extra care, attention, and empathy.

If this is true, it carries an important reminder for oncology: cancer patients are very vulnerable and need all the empathy and compassion they can get. Seen from this perspective, the popularity of SCAM would be a criticism of conventional medicine for not providing enough of it.

Equine-assisted therapies (EAT) are sometimes used for improving the physical function and the quality of life (QoL) of people (often children) with disabilities through the practice of hippotherapy or therapeutic riding (TR). Yet, the effectiveness for or against these approaches has so far not been well documented.

This review aimed to systematically evaluate and meta-analyze the available data on the potential health benefits of EAT in patients with multiple sclerosis (PwMS).

Four electronic databases (MEDLINE/PubMed, Web of Science, SPORTDiscus, and Scopus) were searched systematically from their inception until June 2021 for randomized controlled trials (RCTs) and comparative studies that provided information regarding the effects of EAT on PwMS. The studies’ methodological quality assessment was performed using the PEDro and the MINORS scales. For the meta-analysis, heterogeneity across studies was quantified using the I2 statistic. Fixed-effect or random-effects models were applied to obtain the pooled results in the case of low (I2 < 30%) or high (I2 > 30%) heterogeneity values, respectively. Standardized mean differences (SMD) and 95% confidence intervals (CIs) were calculated to assess the change in each outcome.

After removing duplicated studies, 234 results were retrieved by the literature search and 11 were eligible for full text search. Finally, 9 studies with a methodological quality ranging from good to low quality met the inclusion criteria. Six of them focused on hippotherapy and 4 of them were included in the quantitative analysis.

In them, a total of 225 PwMS patients were evaluated. Findings from the meta-analysis indicated that this therapy improved static (SMD = 0.42; 95% CI: 0.05, 0.78) but not dynamic balance (SMD = 0.51; 95% CI: -0.04, 1.06), while significant benefits were observed on the patients’ QoL (SMD = 0.37; 95% CI: 0.00, 0.73). Hippotherapy showed effectiveness for reducing self-perceived fatigue (SMD = 0.70; 95% CI: 0.33, 1.07), while TR showed mixed effects on balance and QoL.

The authors concluded that the actual evidence on the effectiveness of EAT in PwMS is mainly limited to hippotherapy. This rehabilitation approach seems to have beneficial effects on static balance, QoL and fatigue, but not directly on gait and dynamic balance. Altogether, the findings suggest that hippotherapy could be incorporated as a complementary therapy when developing comprehensive care plans for PwMS.

These results are further supported by a new study concluding that Hippotherapy improved postural balance, functional mobility, fatigue, and quality of life in people with relapsing-remitting MS. This suggests that hippotherapy may be a useful approach for complementary treatment among people with MS.

EAT is, of course, one of those modalities which are difficult to research. What, for instance, is a good control intervention? And how can one blind the patient? Moreover, EAT is expensive and required lots of resources that are rarely available. Considering these issues, one should perhaps ask whether EAT is sufficiently better than other therapeutic options to justify the cost.

There are many fans of so-called alternative medicine (SCAM) who think that vitamin C is the answer to COVID (and many other ailments). Here, for instance, is a press release from Damien Downing (we already encountered him in my last post):

Vitamin C and COVID-19 Coronavirus

by Damien Downing, MBBS, MRSB and Gert Schuitemaker, PhD

FOR IMMEDIATE RELEASE

Orthomolecular Medicine News Service, Feb 28, 2020

There is only one existing treatment for the new coronavirus: vitamin C.

Vitamin C supports your immune system. Vitamin C helps to kill the virus and reduces the symptoms of infection. It’s not a COVID “cure,” but nothing is. It might just save your life, though, and will definitely reduce the severity of the infection.

If someone tells you it’s not proven, consider two things:

    1. Nothing is proven to work against COVID-19, because it is a new virus.
    2. Vitamin C has worked against every single virus including influenzas, pneumonia, and even poliomyelitis.

What to do

If you do nothing else, start taking vitamin C right away; at least 3 grams a day, spread right across the day. That’s a 1,000 milligram capsule every 8 hours, or a level teaspoon of powder dissolved in a pint or so of water, drank all through the day.

If you’re smart and motivated, do all the other things recommended in our previous release Vitamin C Protects Against Coronavirus (http://orthomolecular.org/resources/omns/v16n04.shtml)

When and if you catch a bug that might be COVID-19, simply increase your vitamin C intake: a rounded teaspoon (that’s 4 to 5 grams) in water (which helps to keep you hydrated) every 3 or 4 hours. And keep on taking it.

Do you consult a doctor? Do you self-isolate? Yes and yes. Of course you do; that’s your duty to others.

Vitamin C and the other measures are what you do for yourself…

Damien Downing’s press release did not age all that well, I fear. The evidence to support his claims is not just flimsy, it is negative. Let me show you the most recent (October 2021) systematic review of the subject:

Background and aims: Vitamin C has been used as an anti-oxidant in various diseases including viral illnesses like coronavirus disease (COVID-19).

Methods: Meta-analysis of randomized controlled trials (RCT) investigating the role of vitamin C supplementation in COVID-19 was carried out.

Results: Total 6 RCTs including n = 572 patients were included. Vitamin C treatment didn’t reduce mortality (RR 0.73, 95% CI 0.42 to 1.27; I2 = 0%; P = 0.27), ICU length of stay [SMD 0.29, 95% CI -0.05 to 0.63; I2 = 0%; P = 0.09), hospital length of stay (SMD -0.23, 95% CI -1.04 to 0.58; I2 = 92%; P = 0.57) and need for invasive mechanical ventilation (Risk Ratio 0.93, 95% CI 0.61 to 1.44; I2 = 0%; P = 0.76). Further sub-group analysis based on severity of illness (severe vs. non-severe), route of administration (IV vs. oral) and dose (high vs. low) failed to show any observable benefits.

Conclusion: No significant benefit noted with vitamin C administration in COVID-19. Well-designed RCTs with standardized control group needed on this aspect.

What does that tell us?

I think it suggests three things:

  • Damien Downing might be suffering from proctophasia,
  • we would be ill-advised to follow the advice of such pseudo-experts,
  • vitamin C is not the solution to COVID-19 infections.

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

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.

The global market for dietary supplements has grown continuously during the past years. In 2019, it amounted to around US$ 353 billion. The pandemic led to a further significant boost in sales. Evidently, many consumers listened to the sly promotion by the supplement industry. Thus they began to be convinced that supplements might stimulate their immune system and thus protect them against COVID-19 infections.

During the pre-pandemic years, the US sales figures had typically increased by about 5% year on year. In 2020, the increase amounted to a staggering 44 % (US$435 million) during the six weeks preceding April 5th, 2020 relative to the same period in 2019. The demand for multivitamins in the US reached a peak in March 2020 when sales figures had risen by 51.2 %. Total sales of vitamins and other supplements amounted to almost 120 million units for that period alone. In the UK, vitamin sales increased by 63 % and, in France, sales grew by around 40–60 % in March 2020 compared to the same period of the previous year.

Vis a vis such impressive sales figures, one should ask whether dietary supplements really do produce the benefit that consumers hope for. More precisely, is there any sound evidence that these supplements protect us from getting infected by COVID-19? In an attempt to answer this question, I conducted several Medline searches. Here are the conclusions of the relevant clinical trials and systematic reviews that I thus found:

Confused?

Me too!

Does the evidence justify the boom in sales of dietary supplements?

More specifically, is there good evidence that the products the US supplement industry is selling protect us against COVID-19 infections?

No, I don’t think so.

So, what precisely is behind the recent sales boom?

It surely is the claim that supplements protect us from Covid-19 which is being promoted in many different ways by the industry. In other words, we are being taken for a (very expensive) ride.

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