causation
This randomised, double blind controlled trial compared the efficacy of curcumin versus omeprazole in improving patient reported outcomes in people with dyspepsia.
The interventions were:
- curcumin alone (C),
- omeprazole alone (O),
- curcumin plus omeprazole (C+O).
Patients in the combination group received two capsules of 250 mg curcumin, four times daily, and one capsule of 20 mg omeprazole once daily for 28 days.
Main outcome measure was unctional dyspepsia symptoms on days 28 and 56, assessed using the Severity of Dyspepsia Assessment (SODA) score. Secondary outcomes were the occurrence of adverse events and serious adverse events.
A total of 206 patients were enrolled in the study and randomly assigned to one of the three groups; 151 patients completed the study. Demographic data (age 49.7±11.9 years; women 73.4%), clinical characteristics and baseline dyspepsia scores were comparable between the three groups. Significant improvements were observed in SODA scores on day 28 in the pain (−4.83, –5.46 and −6.22), non-pain (−2.22, –2.32 and −2.31) and satisfaction (0.39, 0.79 and 0.60) categories for the C+O, C, and O groups, respectively. These improvements were enhanced on day 56 in the pain (−7.19, –8.07 and −8.85), non-pain (−4.09, –4.12 and −3.71) and satisfaction (0.78, 1.07, and 0.81) categories in the C+O, C, and O groups, respectively. No significant differences were observed among the three groups and no serious adverse events occurred.
The authors concluded that curcumin and omeprazole had comparable efficacy for functional dyspepsia with no obvious synergistic effect.
This study, which was funded by the Thai Traditional and Alternative Medicine Fund, has been picked up by the press and is being lauded as a solid proof of efficacy. Its authors too are not half proud of their splendid trial:
This multicentre randomised controlled trial provides highly reliable evidence for the treatment of functional dyspepsia. PPIs, widely used and approved for over-the-counter use, were compared with curcumin, a popular herbal remedy. The study design, including double blind randomisation, minimised biases. Participants met strict criteria, underwent endoscopy and were tested for H pylori infection. Furthermore, we implemented measures to minimise biases by ensuring that the individuals administering the drugs, participants receiving the drugs and individuals conducting the assessment remained blinded to the type of medications administered to the participants. The trial was carried out in hospitals, and certified individuals used standardised questionnaires for assessments. Statistical methods were appropriate and followed accepted principles.
Two follow-up appointments were scheduled, and blood tests showed no abnormal symptoms or liver function abnormalities. However, participants with high body mass index indicated a trend towards liver function impairment in the curcumin group, suggesting the need for larger studies. Some participants did not provide follow-up information, which is a study weakness. However, the number of participants who provided this information was sufficient for statistical analysis and the majority of the participants attended the follow-up visit. Therefore, it can be deduced from the results that even if the number of participants followed after drug administration increased, the study findings would not be significantly different. Another limitation of this study was the absence of long term follow-up data for all patients after treatment. This is a question that will require further investigation.
The strength of the study lies in its relevance to daily clinical practice, providing additional drug options in addition to PPIs alone, without added side effects. The study was unbiased, partially funded by government organisations and the first well designed trial comparing curcumin with PPI for functional dyspepsia, with confirmation through endoscopy and ruling out H pylori infection. Limitations of this study included the small number of patients who were lost to follow-up and the lack of long term follow-up data.
However, I am far less impressed.
Why?
Curcumin is bright yellow and has a very distinct taste/smell. Even though curumin was given in capsules, patients can easily tell what they are taking. I therefore doubt that they were adequately blinded. In fact, the authors seem to agree when they state the following:
We observed that despite improvements in pain and non-pain scores, there was no significant improvement in the SODA satisfaction scores in the O and C+O groups (table 3). A possible explanation for this observation could be related to the taste and/or smell of curcumin, which might have caused reduced pleasantness for the participants while ingesting it. This potential discomfort could offset the improvements in pain and non-pain symptoms, leading to the non-significant change in satisfaction score. Further studies may be needed to explore this hypothesis as well as to improve the palatability of curcumin.
Sadly, the success of blinding (which under such circumstances should always be tested) was not reported and probably not even quantified. If many patients were de-blinded, it seems inevitable that their expectation influenced the results. In other words, the much-lauded effect of curcumin might just be due to placebo and curcumin might be entirely useless. Or, to put it bluntly, the trial was not nearly as good as many made it out to be.
PS
Sad to see that the reviewers of a reputable journal failed to pick up on this significant flaw.
The aim of this systematic review was to update the current level of evidence for spinal manipulation in influencing various biochemical markers in healthy and/or symptomatic population.
Various databases were searched (inception till May 2023) and fifteen trials (737 participants) that met the inclusion criteria were included in the review. Two authors independently screened, extracted and assessed the risk of bias in included studies. Outcome measure data were synthesized using standard mean differences and meta-analysis for the primary outcome (biochemical markers). The Grading of Recommendations, Assessment, Development and Evaluation (GRADE) was used for assessing the quality of the body of evidence for each outcome of interest.
There was low-quality evidence that spinal manipulation influenced various biochemical markers (not pooled). There was low-quality evidence of significant difference that spinal manipulation is better (SMD -0.42, 95% CI – 0.74 to -0.1) than control in eliciting changes in cortisol levels immediately after intervention. Low-quality evidence further indicated (not pooled) that spinal manipulation can influence inflammatory markers such as interleukins levels post-intervention. There was also very low-quality evidence that spinal manipulation does not influence substance-P, neurotensin, oxytocin, orexin-A, testosterone and epinephrine/nor-epinephrine.
The authors concluded that spinal manipulation may influence inflammatory and cortisol post-intervention. However, the wider prediction intervals in most outcome measures point to the need for future research to clarify and establish the clinical relevance of these changes.
The majority of the studies were of low or very low quality. This means that the collective evidence is less than reliable. In turn, this means, I think, that the conclusions are misleading. A more honest conclusion would be this:
There is no reliable evidence that spinal manipulation influences inflammatory and cortisol levels.
As for the clinical relevance, I would like to point out that it would not be surprising if chiropractors could one day convincingly show that spinal manipulation do influence various biochemical markers. Many things do! If you fall down a staircase, for instance, plenty of biochemical markers will be affected. This, however, does not mean that throwing our patients down the stairs is of therapeutic value.
This study aimed to compare the effects of cognitive functional therapy (CFT) and movement system impairment (MSI)-based treatment on pain intensity, disability, Kinesiophobia, and gait kinetics in patients with chronic non-specific low back pain (CNSLBP).
In a single-blind randomized clinical trial, the researchers randomly assigned 91 patients with CNSLBP into CFT (n = 45) and MSI-based treatment (n = 46) groups. An 8-week training intervention was given to both groups. The researchers measured the primary outcome, which was pain intensity (Numeric rating scale), and the secondary outcomes, including disability (Oswestry disability index), Kinesiophobia (Tampa Kinesiophobia Scale), and vertical ground reaction force (VGRF) parameters at self-selected and faster speed (Force distributor treadmill). They evaluated patients at baseline, at the end of the 8-week intervention (post-treatment), and six months after the first treatment. Mixed-model ANOVA was used to evaluate the effects of the interaction between time (baseline vs. post-treatment vs. six-month follow-up) and group (CFT vs. MSI-based treatment) on each measure.
CFT showed superiority over MSI-based treatment in reducing pain intensity (P < 0.001, Effect size (ES) = 2.41), ODI (P < 0.001, ES = 2.15), and Kinesiophobia (P < 0.001, ES = 2.47) at eight weeks. The CFT also produced greater improvement in VGRF parameters, at both self-selected (FPF[P < 0.001, ES = 3], SPF[P < 0.001, ES = 0.5], MSF[P < 0.001, ES = 0.67], WAR[P < 0.001, ES = 1.53], POR[P < 0.001, ES = 0.8]), and faster speed, FPF(P < 0.001, ES = 1.33, MSF(P < 0.001, ES = 0.57), WAR(P < 0.001, ES = 0.67), POR(P < 0.001, ES = 2.91)] than the MSI, except SPF(P < 0.001, ES = 0.0) at eight weeks.
The authors concluded that this study suggests that the CFT is associated with better results in clinical and cognitive characteristics than the MSI-based treatment for CNSLBP, and the researchers maintained the treatment effects at six-month follow-up. Also, This study achieved better improvements in gait kinetics in CFT. CTF seems to be an appropriate and applicable treatment in clinical setting.
To understand this study, we need to know what CFT and MSI exactly entailed. Here is the information that the authors provide:
Movement system impairment-based treatment
The movement system impairment-based treatment group received 11 sessions of MSI-based treatment over the 8 weeks for 60 min per session with a supervision of a native speaker experienced (above 5 years) physical therapist with the knowledge of MSI-based treatment. The researchers designed the MSI-based treatment uniquely for each patient based on the interview, clinical examination, and questionnaires, just like they did with the CFT intervention. First, they administered standardized tests to characterize changes in the patient’s low back pain symptoms, and then they modified the treatment to make it more specific based on the participant’s individual symptoms. Depending on the participant’s direction-specific low back pain classification, they performed the intervention following one of the five MSI subgroups namely [1] rotation, [2] extension, [3] flexion, [4] rotation with extension, and [5] rotation with flexion. Finally, Patients treated using the standardized MSI protocol as follows: [1] education regarding normal postures and movements such as sitting, walking, bending, standing, and lying down; [2] education regarding exercises to perform trunk movements as painlessly as possible; and [3] prescription of functional exercises to improve trunk movement [32].
Cognitive functional therapy
Cognitive functional therapy was prescribed for each patient in CFT group based the CFT protocol conducted by O’Sullivan et al. (2015). Patients received supervised 12 sessions of training over the 8-week period with 60 min per session provided with another physical therapist who had been trained in CFT treatment. In this protocol, a physical therapist with more than 5 years of experience conducted an interview and physical examination of the patients to determine their own unique training programs, considering modifiable cognitive, biopsychosocial, functional, and lifestyle behavior factors. The intervention consists of the following 3 main stages: [1] making sense of pain that is completely reflective, where physical therapist could use the context of the patient’s own story to provide a new understanding of their condition and question their old beliefs [2] exposure with control which is designed to normalize maladaptive or provocative movement and posture related to activities of daily living that is integrated into each patient’s functional impairments, including teaching how to relax trunk muscles, how to have normal body posture while sitting, lying, bending, lifting, moving, and standing, and how to avoid pain behaviors, which aims to break poor postural habits; and [3] lifestyle change which is investigating the influence of unhealthy lifestyles in the patient’s pain context. Assessing the individual’s body mass, nutrition, quality of sleep, levels of physical activity or sedentary lifestyle, smoking, and other factors via video calls. Identifying such lifestyle factors helped us to individually advise and design exercise programs, rebuild self-confidence and self-efficacy, promote changes in lifestyle, and design coping strategies.
I must admit that I am not fully convinced.
Firstly, the study was not large and we need – as the authors state – more evidence. Secondly, I am not sure that the results show CFT to be more effective that MSI. They might merely indicate 1) that the bulk of the improvement is due to non-specific effects (e.g. reression towards the mean, natural history of the condition, placebo) and 2) that CFT is less harmful than MSI.
My conclusion:
we need not just more but better evidence.
This study aimed to compare the effectiveness of three distinct interventions – Yoga, Naturopathy, and Conventional medical management – in alleviating pain, reducing disability, enhancing spinal mobility, and improving the quality of life in individuals with low back pain. Ninety participants were recruited and randomly divided into three groups.
- The first group (group 1) received Yoga,
- the second group (group 2) received Naturopathy treatments,
- the third group served as the control and received conventional medications.
Visual Analogue Scale (VAS) scores, Oswestry Disability Index (ODI), Flexion Test-Finger to Floor Test (FTFT) results, and Quality of Life (QOL) were assessed at baseline and after a 10-day intervention period for all groups.
Overall comparisons between the groups, utilizing ANOVA, revealed marked differences in pain severity, disability index, daily functional capacity, and Quality of Life (QoL) improvements following respective interventions. Substantial improvements were also noted within the yoga and naturopathic medicine groups across multiple variables.
The authors concluded that the results of this comparative analysis emphasize the effectiveness of Yoga, Naturopathy, and Conventional Medical Treatment in managing low back pain. All three interventions demonstrated significant improvements in pain intensity, disability, spinal mobility, and quality of life. This study contributes valuable insights into the diverse therapeutic approaches for low back pain management, highlighting the potential of holistic and alternative treatments to enhance patients’ well-being.
__________________
This is a remarkably poor study. Its flaws are too numerous to account for them all here. Let me focus on just a three that stand out.
- All we learn about the 3 treatment regimen is this (and it clearly not enough to do an independent replication of this trial):
Yoga Group:
Participants in the Yoga Group underwent a specifically designed integrated approach of Yoga therapy (IAYT) for back pain, incorporating relaxation techniques, spinal movements, breathing exercises, pranayama, and deep relaxation techniques. The intervention was conducted by qualified yoga instructors at SDM College of Naturopathy and Yogic Sciences.
Naturopathy Group:
Participants in the Naturopathy Group received neutral spinal baths and partial massages. The spinal bath was administered at Government Yoga & Nature Cure Out Patient Center, Puttur, and massages were performed by trained naturopathy therapists.
Conventional Medicine Group:
Participants in the Conventional Medicine Group received standard medical treatments for low back pain as recommended by orthopedic physicians from S.D.M Medical College, Dharward
- As an equivalence trial, the sample size of this study is far too small. This means that its findings are most likely caused by coincidence and not by the interventions applied.
- There was no attempt of blinding the patients. Therefore, the results – if they were otherwise trustworthy – would be dominated by expectations and not by the effects of the treatments.
Altogether, this study is, I think, a good example for the fact that
poor research often is worse than no research at all.
The KFF provides reliable, accurate, and non-partisan information to help inform health policy in the US. The KFF has just released its ‘Health Misinformation Tracking Poll Pilot‘ examining the public’s media use and trust in sources of health information and measuring the reach of specific false and inaccurate claims surrounding three health-related topics: COVID-19 and vaccines, reproductive health, and gun violence. It makes grimm reading indeed. Here are but a few excerpts pertaining to health/vaccination:
Health misinformation is widespread in the US with 96% of adults saying they have heard at least one of the ten items of health-related misinformation asked about in the survey. The most widespread misinformation items included in the survey were related to COVID-19 and vaccines, including that the COVID-19 vaccines have caused thousands of deaths in otherwise healthy people (65% say they have heard or read this) and that the MMR vaccines have been proven to cause autism in children (65%).
Regardless of whether they have heard or read specific items of misinformation, the survey also asked people whether they think each claim is definitely true, probably true, probably false, or definitely false. For most of the misinformation items included in the survey, between one-fifth and one-third of the public say they are “definitely” or “probably true.” The most frequently heard claims are related to COVID-19 and vaccines.
Uncertainty is high when it comes to health misinformation. While fewer than one in five adults say each of the misinformation claims examined in the survey are “definitely true,” larger shares are open to believing them, saying they are “probably true.” Many lean towards the correct answer but also express uncertainty, saying each claim is “probably false.” Fewer tend to be certain that each claim is false, with the exception of the claim that more people have died from the COVID-19 vaccines than from the virus itself, which nearly half the public (47%) recognizes as definitely false.
Across the five COVID-19 and vaccine related misinformation items, adults without a college degree are more likely than college graduates to say these claims are definitely or probably true. Notably, Black adults are at least ten percentage points more likely than White adults to believe some items of vaccine misinformation, including that the COVID-19 vaccines have caused thousands of sudden deaths in otherwise healthy people, and that the MMR vaccines have been proven to cause autism in children. Black (29%) and Hispanic (24%) adults are both more likely than White adults (17%) to say that the false claim that “more people have died from the COVID-19 vaccine than have died from the COVID-19 virus” is definitely or probably true. Those who identify as Republicans or lean towards the Republican Party and pure independents stand out as being more likely than Democratic leaning adults to say each of these items is probably or definitely true. Across community types, rural residents are more likely than their urban and suburban counterparts to say that some false claims related to COVID vaccines are probably or definitely true, including that the vaccines have been proven to cause infertility and that more people have died from the vaccine than from the virus.
Educational attainment appears to play a particularly important role when it comes to susceptibility to COVID-19 and vaccine misinformation. Six in ten adults with college degrees say none of the five false COVID-19 and vaccine claims are probably or definitely true, compared to less than four in ten adults without a degree. Concerningly, about one in five rural residents (19%), adults with a high school education or less (18%), Black adults (18%), Republicans (20%), and independents (18%) say four or five of the false COVID-19 and vaccine misinformation items included in the survey are probably or definitely true.
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If you have followed some of the comments on this blog, you might find it hard to be surprised!
I do encourage you to read the full article.
The case of a 91-year old male patient developing acute neuropathic pain along the sciatic nerve distribution following spinal manipulation has been reported. Manipulative treatment with an Activator Adjusting Instrument (AAI) had been performed. During this treatment, three applications of the AAI were administered. The applications were bilateral (1) over the sacroiliac joint, (2) gluteal area, and (3) paraspinal region just above the iliac crest.
Within 24 hours, the patient developed severe 10/10 pain originating from the left gluteal area at the site of one of the activator deployments with radiation all the way down his left leg to the foot. He was able to maintain distal left leg strength and sensation. Subsequently, the patient developed insomnia, confusion, and adrenal gland dysfunction in response to changes in steroids, gabapentin, and other drugs, thus highlighting some nuances of managing elderly patients with back pain.
Relief was achieved with subsequent physical therapy techniques aimed at relaxing the patient’s deep gluteal muscles, raising the hypothesis of temporary injury to the deep gluteal muscles, with painful contractions resulting in gluteal region pain as well as sciatic nerve inflammation as the nerve passed through that region.
The authors concluded that this clinical case illustrates some of the perils and risks of spinal manipulation, particularly in the elderly, and the need for careful patient selection.
The authors of this (stranely incomplete) case report discuss whether any manipulation was truly necessary or indicated as part of his initial chiropractic treatment plan. They state that, given that complications associated with similar practices are not often reported in the literature, this case highlights important considerations to be made in the elderly given the potential impact of transient/permanent neuropathic pain in that population subset.
Somehow, I doubt that we can be certain that the patient improved due to the physical therapy and not due to the drugs he received. Moreover, I question the authors’ repeated assertions that such adverse effects of chiropractic spinal manipulation are truly rare. Here is a section from our own 2002 systematic review of the subject:
A systematic review of five prospective investigations of the risks of spinal manipulation concluded that mild-to moderate transient adverse reactions occur in approximately half of patients who undergo spinal manipulation. The largest of these studies involved 1058 patients who received a total of 4712 treatments from 102 chiropractors in Norway. At least one adverse reaction was reported by 55% (n 580) of patients. About one quarter (n 1174) of treatments resulted in at least one adverse reaction. The most common reaction reported was local discomfort. Eighty-five percent (n 824) of reactions were described as “mild or moderate” and 1% (n 14) as “unbearable.” Seventy-four percent (n 1052) of reactions disappeared within 24 hours. No serious, permanent complications of spinal manipulation were reported, but follow-up was not described. These results were confirmed by a similar study in Sweden with 625 patients and a smaller one (68 patients) from the United Kingdom …
Non-life-threatening adverse effects after spinal manipulations are not rare – they are merely rarely reported!
Women experience more problems in their sexual functioning after childbirth. Due to the high prevalence of sexual problems during the lactation period, the World Health Organization suggests that measures are needed to improve women’s sexual functioning during breastfeeding. This study investigated the effect of auricular acupressure on sexual functioning among lactating women.
A randomized, sham-controlled trial was conducted between October 2019 to March 2020 in urban comprehensive health centers of Qazvin, Iran. Seventy-six women who had been lactating between six months and one year postpartum were randomly assigned to auricular acupressure group (n=38) or sham control group (n=38) using a balanced block randomization method. The intervention group received ear acupressure in 10 sessions (at four-day intervals) and control group received the sham intervention at the same intervals. Sexual functioning was the primary outcome of the study (assessed using the Female Sexual Function Index) before and at three time points post-intervention (immediately after, one month after, and two months after). The secondary outcome was sexual quality of life assessed using Sexual Quality of Life-Female Version.
Auricular acupressure had a large effect on female sexual functioning at all three post-intervention time points:
- immediately after the intervention (adjusted mean difference [95% CI]: 8.37 [6.27; 10.46] with Cohen’s d [95% CI]: 1.81[1.28; 2.34]),
- one month after the intervention (adjusted mean difference [95% CI]: 8.44 [6.41; 10.48] with Cohen’s d [95% CI]: 2.01 [1.46; 2.56]),
- two months after the intervention (adjusted mean difference [95% CI]: 7.43 [5.12; 9.71] with Cohen’s d [95% CI]: 1.57 [1.06; 2.08]).
Acupressure significantly increased participants’ sexual quality of life on the Sexual Quality of Life-Female scale by 13.73 points in the intervention group compared to the control group (p<0.001). The effect size of intervention for female sexual quality was large (adjusted Cohen’s d [95% CI]: 1.09 [0.58; 1.59]). Weekly frequency of sexual intercourse in the intervention group significantly increased compared to sham control group (p<0.001). These changes were clinically significant for sexual functioning and sexual quality of life.
The authors concluded that auricular acupressure was effective in increasing quality of sexual life and sexual functioning among lactating women. Although further research is needed to confirm the efficacy of auricular acupressure, based on the present study’s findings, the use of auricular acupressure by women’s healthcare providers after childbirth is recommended.
One possible explanation for this result is that the study was de-blinded; the sham treatment might not have been distinguished from the verum, or the verbal and/or non-verbal communications between the therapist and the patients contributed to a de-blinding effect. As the sucess of blinding was not reported and probably not even tested, we cannot know. The authors explain that auricular acupressure might improve both endocrine function (increased sex hormones including androgens and estrogens) and its physiological consequences (e.g., vaginal dryness, and vaginal epithelial atrophy), as well as reducing fatigue and insomnia problems (which might increase sexual desire).
Personally, I find this VERY hard to believe. Auricular acupressure or auriculotherapy, as it is also called, was invented by Paul Nogier in the 1950s. Its assumptions are not in line with our knowledge of anatomy and physiology. The different maps used by proponents of auriculotherapy show embarrassing disagreements. The therapy is being promoted as a treatment for many conditions. However, the clinical evidence that it might be effective is weak, not least because many of the clinical trials are of low quality and thus unreliable. One of the first rigorous tests of auriculotherapy was published in 1984 by one of the most prominent researchers of pain, R. Melzack. Here is the abstract[2]:
Enthusiastic reports of the effectiveness of electrical stimulation of the outer ear for the relief of pain (“auriculotherapy”) have led to increasing use of the procedure. In the present study, auriculotherapy was evaluated in 36 patients suffering from chronic pain, using a controlled crossover design. The first experiment compared the effects of stimulation of designated auriculotherapy points, and of control points unrelated to the painful area. A second experiment compared stimulation of designated points with a no-stimulation placebo control. Pain-relief scores obtained with the McGill Pain Questionnaire failed to show any differences in either experiment. It is concluded that auriculotherapy is not an effective therapeutic procedure for chronic pain.
Today we have an abundance of clinical trials of this therapy. Their results are by no means uniform. It is therefore best not to rely on single studies but on systematic reviews that include the evidence from all reliable trials. Our review concluded that “because of the paucity and of the poor quality of the data, the evidence for the effectiveness of auricular therapy for the symptomatic treatment of insomnia is limited. Further, rigorously designed trials are warranted to confirm these results.”[3] Other, less rigorous reviews arrive at more positive conclusions; due to the often poor quality of the primary studies, they should, however, be interpreted with great caution.[4]
The most frequently reported adverse events of auriculotherapy include local skin irritation and discomfort, mild tenderness or pain, and dizziness. Most of these events were transient, mild, and tolerable, and no serious adverse events were identified.[5]
In view of all this, I think that we need much more and much better evidence for auricular acupressure to be recommended for ANY condition.
[1] Wirz-Ridolfi A. The History of Ear Acupuncture and Ear Cartography: Why Precise Mapping of Auricular Points Is Important. Med Acupunct. 2019 Jun 1;31(3):145-156. doi: 10.1089/acu.2019.1349.
[2] Melzack, R., & Katz, J. (1984). Auriculotherapy fails to relieve chronic pain. A controlled crossover study. JAMA, 251(8), 1041–1043.
[3] Lee MS, Shin BC, Suen LK, Park TY, Ernst E (2008) Auricular acupuncture for insomnia: a systematic review. Int J Clin Pract 62(11):1744–1752.
[4] Usichenko, T. I., Hua, K., Cummings, M., Nowak, A., Hahnenkamp, K., Brinkhaus, B., & Dietzel, J. (2022). Auricular stimulation for preoperative anxiety – A systematic review and meta-analysis of randomized controlled clinical trials. Journal of clinical anesthesia, 76, 110581.
[5] Tan JY, Molassiotis A, Wang T, Suen LK (2014) Adverse events of auricular therapy: a systematic review. Evid Based Complement Alternat Med 2014:506758
Vaccine hesitancy has become a threat to public health, especially as it is a phenomenon that has also been observed among healthcare professionals. In this study, an international team of researchers analyzed the relationship between endorsement of so-called alternative medicine (SCAM) and vaccination attitudes and behaviors among healthcare professionals, using a cross-sectional sample of physicians with vaccination responsibilities from four European countries: Germany, Finland, Portugal, and France (total N = 2,787).
The results suggest that, in all the participating countries, SCAM endorsement is associated with lower frequency of vaccine recommendation, lower self-vaccination rates, and being more open to patients delaying vaccination, with these relationships being mediated by distrust in vaccines. A latent profile analysis revealed that a profile characterized by higher-than-average SCAM endorsement and lower-than-average confidence and recommendation of vaccines occurs, to some degree, among 19% of the total sample, although these percentages varied from one country to another: 23.72% in Germany, 17.83% in France, 9.77% in Finland, and 5.86% in Portugal.
The authors concluded that these results constitute a call to consider health care professionals’ attitudes toward SCAM as a factor that could hinder the implementation of immunization campaigns.
In my view, this is a very important paper. It shows what we on this blog have discussed often before: there is an association between SCAM and vaccination hesitancy. The big question is: what is the nature of this association. There are several possibilities:
- It could be coincidental. I think this is most unlikely; too many entirely different investigations have shown a link.
- It could mean that people start endorsing SCAM because they are critical about vaccination.
- It could be that people are critical about vaccination because they are proponents of SCAM.
- Finally, it could be that some people have a mind-set that renders them simultaneously hesitant about vaccination and fans of SCAM.
This study, like most of the other investigationson this subject, was not desighned to find out which possibility is most likely. I suspect that the latter two explanations apply both to some extend. The authors of this study argue that that, “from a theoretical point of view, this situation may be explicable by reasons that are both implicit (i.e., CAM would fit better with certain worldviews and ideological standpoints that conflict with the epistemology and values that underlies scientific knowledge) and explicit (i.e., some CAM techniques are doctrinally opposed to the use of vaccines). Although we have outlined these potential explanations for the observed relationships, more research is needed to better understand the underlying mechanisms”.
A ‘pragmatic, superiority, open-label, randomised controlled trial’ of sleep restriction therapy versus sleep hygiene has just been published in THE LANCET. Adults with insomnia disorder were recruited from 35 general practices across England and randomly assigned (1:1) using a web-based randomisation programme to either four sessions of nurse-delivered sleep restriction therapy plus a sleep hygiene booklet or a sleep hygiene booklet only. There was no restriction on usual care for either group. Outcomes were assessed at 3 months, 6 months, and 12 months. The primary endpoint was self-reported insomnia severity at 6 months measured with the insomnia severity index (ISI). The primary analysis included participants according to their allocated group and who contributed at least one outcome measurement. Cost-effectiveness was evaluated from the UK National Health Service and personal social services perspective and expressed in terms of incremental cost per quality-adjusted life year (QALY) gained. The trial was prospectively registered (ISRCTN42499563).
Between Aug 29, 2018, and March 23, 2020 the researchers randomly assigned 642 participants to sleep restriction therapy (n=321) or sleep hygiene (n=321). Mean age was 55·4 years (range 19–88), with 489 (76·2%) participants being female and 153 (23·8%) being male. 580 (90·3%) participants provided data for at least one outcome measurement. At 6 months, mean ISI score was 10·9 (SD 5·5) for sleep restriction therapy and 13·9 (5·2) for sleep hygiene (adjusted mean difference –3·05, 95% CI –3·83 to –2·28; p<0·0001; Cohen’s d –0·74), indicating that participants in the sleep restriction therapy group reported lower insomnia severity than the sleep hygiene group. The incremental cost per QALY gained was £2076, giving a 95·3% probability that treatment was cost-effective at a cost-effectiveness threshold of £20 000. Eight participants in each group had serious adverse events, none of which were judged to be related to intervention.
The authors concluded that brief nurse-delivered sleep restriction therapy in primary care reduces insomnia symptoms, is likely to be cost-effective, and has the potential to be widely implemented as a first-line treatment for insomnia disorder.
I am frankly amazed that this paper was published in a top journal, like THE LANCET. Let me explain why:
The verum treatment was delivered over four consecutive weeks, involving one brief session per week (two in-person sessions and two sessions over the phone). Session 1 introduced the rationale for sleep restriction therapy alongside a review of sleep diaries, helped participants to select bed and rise times, advised on management of daytime sleepiness (including implications for driving), and discussed barriers to and facilitators of implementation. Session 2, session 3, and session 4 involved reviewing progress, discussion of difficulties with implementation, and titration of the sleep schedule according to a sleep efficiency algorithm.
This means that the verum group received fairly extensive attention, while the control group did not. In other words, a host of non-specific effects are likely to have significantly influenced or even entirely determined the outcome. Despite this rather obvious limitation, the authors fail to discuss any of it. On the contrary, that claim that “we did a definitive test of whether brief sleep restriction therapy delivered in primary care is clinically effective and cost-effective.” This is, in my view, highly misleading and unworthy of THE LANCET. I suggest the conclusions of this trial should be re-formulated as follows:
The brief nurse-delivered sleep restriction, or the additional attention provided exclusively to the patients in the verum group, or a placebo-effect or some other non-specific effect reduced insomnia symptoms.
Alternatively, one could just conclude from this study that poor science can make it even into the best medical journals – a problem only too well known in the realm of so-called alternative medicine (SCAM).
In an aging society, it is crucial to understand why some people live long and others do not. There has been a proliferation of studies in recent years that highlight the importance of psycho-behavioral factors in the ways of aging, one of those psychological components is intelligence. In this meta-analysis, the association between intelligence and life expectancy in late adulthood is analysed through the Hazard Ratio (HR). The objectives are:
- (i) to update a previous meta-analysis, especially the estimate of the association between survival and intelligence;
- (ii) to evaluate the role of some moderators, especially the age of the participants, to explore intelligence–mortality throughout adulthood and old age.
The results show a positive relationship between intelligence and survival (HR•: 0.79; 95% CI: 0.81–0.76). This association is significantly moderated by the years of follow-up, the effect size being smaller the more years elapse between the intelligence assessment and the recording of the outcome.
The authors concluded that intelligence is a protective factor to reach middle-high age, but from then on survival depends less and less on intelligence and more on other factors.
The consistency of the primary studies is remarkable. This suggests that the association is real. Yet, the question remains: what causes the relationship between intelligence and longevity? Factors such as childhood environment, family income, schooling, and healthy/unhealthy lifestyle habits (diet, exercise, tobacco use, alcohol, illnesses), have been studied. There seems to be a reciprocal dynamic association between intelligence and health throughout life, and although there are several constructs associated with health/ illness and death (e.g., parental social class, intelligence in youth, more education, higher health literacy, healthy behaviors, and more affluent social class) shared genetic differences are likely to account for only a small proportion of these associations.
Arden and colleagues analyzed three twin studies (from the U.S., Denmark, and Sweden) and found a small positive phenotypic correlation between intelligence and lifespan, furthermore, in the combined sample, the genetic contribution to covariance was 95%; in the US study, 84%; in the Swedish study, 86%, and in the Danish study, 85%. These authors pointed out that any genetic factors contributing to intelligence and mortality may operate indirectly via good health choices.
Following this line of argument, I might (with my tongue placed firmly in my cheek) postulate that intelligence leads people to opt for medical treatments that are effective and thus prolong life, while avoiding so-called alternative medicines (SCAMs).
