clinical trial
This study aimed to evaluate whether individualized homeopathic medicines have a greater adjunctive effect than adjunctive placebos in the treatment of moderate and severe cases of coronavirus disease 2019 (COVID-19). It was designed as a randomized, single-blind, placebo-controlled trial set in the clinical context of standard care. Patients admitted in a tertiary care hospital, suffering from moderate or severe COVID-19 and above 18 years of age were included. In total, 150 patients were randomly divided into two groups to receive either:
- individualized homeopathic medicines
- or placebos.
Both options were administered in addition to the standard treatment of COVID-19.
The primary outcome was time taken to achieve RT-PCR-confirmed virus clearance for COVID-19. Secondary outcomes were changes in the Clinical Ordinal Outcomes Scale (COOS) of the World Health Organization, the patient-reported MYMOP2 scale, and several biochemical parameters. Parametric data were analyzed using unpaired t-test. Non-parametric data were analyzed using the Wilcoxon signed rank test. Categorical data were analyzed using Chi-square test.
In total, 72 participants of the add-on homeopathy (AoH) group showed conversion of RT-PCR status to negative, in an average time of 7.53 ± 4.76 days (mean ± SD), as compared with 11.65 ± 9.54 days in the add-on placebo (AoP) group (p = 0.001). The mean COOS score decreased from 4.26 ± 0.44 to 3.64 ± 1.50 and from 4.3 ± 0.46 to 4.07 ± 1.8 in the AoH and AoP groups respectively (p = 0.130). The mortality rate for the AoH group was 9.7% compared with 17.3% in the AoP group. The MYMOP2 scores between the two groups differed significantly (p = 0.001), in favor of AoH. Inter-group differences in the pre- and post- mean values of C-reactive protein, fibrinogen, total leukocyte count, platelet count and alkaline phosphatase were each found to be statistically significant (p <0.05), favoring AoH; six other biochemical parameters showed no statistically significant differences.
The authors concluded that the study suggests homeopathy may be an effective adjunct to standard care for treating moderate and severe COVID-19 patients. More rigorous, including double-blinded, studies should be performed to confirm or refute these initial findings.
I do agree with the authors that more rigorous studies are needed before we can accept these findings. As it stands, this study seems to have multiple flaws:
- I fail to understand why they did not design their trial as a double-blind study. The reason given by the authors makes little sense to me.
- I also have my doubts that the study was even single-blind. If I understand it correctly, the placebo group was did not benefit from the detailed homeopathic history taking that is necessary to find the optimal homeopathic remedy. If that is so, unblinding of patients is inevitable.
- The authors themselves point out that the relevance of many outcome measures is questionable
Generally speaking, I find the results suspicious, implausible, and frankly too good to be true. I might also point out that the authors’ afilitation do not inspire much trust in their objectivity:
- 1Central Council for Research in Homoeopathy, New Delhi, India.
- 2Central Council for Research in Homoeopathy, Ministry of AYUSH, Govt. of India, New Delhi, India.
- 3Rejoice Health Foundation, New Delhi, India.
- 4Department of Onco-Anaesthesia and Palliative Medicine, Dr. B.R. Ambedkar Institute Rotary Cancer Hospital and National Cancer Institute, All India Institute of Medical Sciences, Ministry of Health and Family Welfare, New Delhi, India.
- 5Department of Onco-Anaesthesia and Palliative Medicine, All India Institute of Medical Sciences, Ministry of Health and Family Welfare, New Delhi, India.
Neither do these statements:
Funding
The study was funded by the Central Council for Research in Homoeopathy, Ministry of AYUSH, Government of India. The funder approved the study through its review committees, delegated/recruited staff for conducting the study, and facilitated all collaborative procedures.
Conflict of Interest
None declared.
Lastly, I do wonder why the authors published their study in the 3rd class journal ‘Homeopathy’. Surely, such findings – if true – deserve to be published in a journal of a decent reputation!
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.
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
Manual therapy is considered a safe and less painful method and has been increasingly used to alleviate chronic neck pain. However, there is controversy about the effectiveness of manipulation therapy on chronic neck pain. Therefore, this systematic review and meta-analysis of randomized controlled trials (RCTs) aimed to determine the effectiveness of manipulative therapy for chronic neck pain.
A search of the literature was conducted on seven databases (PubMed, Cochrane Center Register of Controlled Trials, Embase, Medline, CNKI, WanFang, and SinoMed) from the establishment of the databases to May 2022. The review included RCTs on chronic neck pain managed with manipulative therapy compared with sham, exercise, and other physical therapies. The retrieved records were independently reviewed by two researchers. Further, the methodological quality was evaluated using the PEDro scale. All statistical analyses were performed using RevMan V.5.3 software. The Grading of Recommendations, Assessment, Development and Evaluations (GRADE) assessment was used to evaluate the quality of the study results.
Seventeen RCTs, including 1190 participants, were included in this meta-analysis. Manipulative therapy showed better results regarding pain intensity and neck disability than the control group. Manipulative therapy was shown to relieve pain intensity (SMD = -0.83; 95% confidence interval [CI] = [-1.04 to -0.62]; p < 0.0001) and neck disability (MD = -3.65; 95% CI = [-5.67 to – 1.62]; p = 0.004). However, the studies had high heterogeneity, which could be explained by the type and control interventions. In addition, there were no significant differences in adverse events between the intervention and the control groups.
The authors concluded that manipulative therapy reduces the degree of chronic neck pain and neck disabilities.
Only a few days ago, we discussed another systematic review that drew quite a different conclusion: there was very low certainty evidence supporting cervical SMT as an intervention to reduce pain and improve disability in people with neck pain.
How can this be?
Systematic reviews are supposed to generate reliable evidence!
How can we explain the contradiction?
There are several differences between the two papers:
- One was published in a SCAM journal and the other one in a mainstream medical journal.
- One was authored by Chinese researchers, the other one by an international team.
- One included 17, the other one 23 RCTs.
- One assessed ‘manual/manipulative therapies’, the other one spinal manipulation/mobilization.
The most profound difference is that the review by the Chinese authors is mostly on Chimese massage [tuina], while the other paper is on chiropractic or osteopathic spinal manipulation/mobilization. A look at the Chinese authors’ affiliation is revealing:
- Department of Tuina and Spinal Diseases Research, The Third School of Clinical Medicine (School of Rehabilitation Medicine), Zhejiang Chinese Medical University, Hangzhou, China.
- Department of Tuina and Spinal Diseases Research, The Third School of Clinical Medicine (School of Rehabilitation Medicine), Zhejiang Chinese Medical University, Hangzhou, China; Department of Tuina, The Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, China. Electronic address: [email protected].
- Department of Tuina and Spinal Diseases Research, The Third School of Clinical Medicine (School of Rehabilitation Medicine), Zhejiang Chinese Medical University, Hangzhou, China; Department of Tuina, The Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, China. Electronic address: [email protected].
What lesson can we learn from this confusion?
Perhaps that Tuina is effective for neck pain?
No!
What the abstract does not tell us is that the Tuina studies are of such poor quality that the conclusions drawn by the Chinese authors are not justified.
What we do learn – yet again – is that
- Chinese papers need to be taken with a large pintch of salt. In the present case, the searches underpinning the review and the evaluations of the included primary studies were clearly poorly conducted.
- Rubbish journals publish rubbish papers. How could the reviewers and the editors have missed the many flaws of this paper? The answer seems to be that they did not care. SCAM journals tend to publish any nonsense as long as the conclusion is positive.
This systematic review and meta-analysis assessed the effectiveness of visceral osteopathy in improving pain intensity, disability and physical function in patients with low-back pain (LBP).
MEDLINE (Pubmed), PEDro, SCOPUS, Cochrane Library and Web of Science databases were searched from inception to February 2022. PICO search strategy was used to identify randomized clinical trials applying visceral techniques in patients with LBP. Eligible studies and data extraction were conducted independently by two reviewers. Quality of the studies was assessed with the Physiotherapy Evidence Database scale, and the risk of bias with Cochrane Collaboration tool. Meta-analyses were conducted using random effects models according to heterogeneity assessed with I2 coefficient. Data on outcomes of interest were extracted by a researcher using RevMan 5.4 software.
Five studies were included in the systematic review involving 268 patients with LBP. The methodological quality of the included ranged from high to low and the risk of bias was high. Visceral osteopathy techniques have shown no improvements in pain intensity (Standardized mean difference (SMD) = -0.53; 95% CI; -1.09, 0.03; I2: 78%), disability (SMD = -0.08; 95% CI; -0.44, 0.27; I2: 0%) and physical function (SMD = -0.26; 95% CI; -0.62, 0.10; I2: 0%) in patients with LBP.
The authors concluded that this systematic review and meta-analysis showed a lack of high-quality studies showing the effectiveness of visceral osteopathy in pain, disability, and physical function in patients with LBP.
Visceral osteopathy (or visceral manipulation) is an expansion of the general principles of osteopathy and involves the manual manipulation by a therapist of internal organs, blood vessels and nerves (the viscera) from outside the body.
Visceral osteopathy was developed by Jean-Piere Barral, a registered Osteopath and Physical Therapist who serves as Director (and faculty) of the Department of Osteopathic Manipulation in Paris, France. He stated that through his clinical work with thousands of patients, he created this modality based on organ-specific fascial mobilization. And through work in a dissection lab, he was able to experiment with visceral manipulation techniques and see the internal effects of the manipulations.[1] According to its proponents, visceral manipulation is based on the specific placement of soft manual forces looking to encourage the normal mobility, tone and motion of the viscera and their connective tissues. These gentle manipulations may potentially improve the functioning of individual organs, the systems the organs function within, and the structural integrity of the entire body.[2] Visceral osteopathy comprises of several different manual techniques firstly for diagnosing a health problem and secondly for treating it.
Several studies have assessed the diagnostic reliability of the techniques involved. The totality of this evidence fails to show that they are sufficiently reliable to be od practical use.[3] Other studies have tested whether the therapeutic techniques used in visceral osteopathy are effective in curing disease or alleviating symptoms. The totality of this evidence fails to show that visceral osteopathy works for any condition.[4]
The treatment itself seems to be safe, yet the risks of visceral osteopathy are nevertheless considerable: if a patient suffers from symptoms related to her inner organs, the therapist is likely to misdiagnose them and subsequently mistreat them. If the symptoms are due to a serious disease, this would amount to medical neglect and could, in extreme cases, cost the patient’s life.
My bottom line: if you see visceral osteopathy being employed anywhere, turn araound and seek proper healthcare whatever your illness might be.
References
[1] https://www.barralinstitute.com/about/jean-pierre-barral.php .
[2] http://www.barralinstitute.co.uk/ .
[3] Guillaud A, Darbois N, Monvoisin R, Pinsault N (2018) Reliability of diagnosis and clinical efficacy of visceral osteopathy: a systematic review. BMC Complement Altern Med 18:65
Massage is frequently used for recovery and increased performance. This review, aimed to search and systemize current literature findings relating to massages’ effects on sports and exercise performance concerning its effects on motor abilities and neurophysiological and psychological mechanisms.
One hundred and fourteen articles were included. The data revealed that massages, in general, do not affect motor abilities, except flexibility. However, several studies demonstrated that positive muscle force and strength changed 48 h after the massage was given. Concerning neurophysiological parameters, massage did not change blood lactate clearance, muscle blood flow, muscle temperature, or activation. However, many studies indicated a reduction of pain and delayed onset muscle soreness, which are probably correlated with the reduction of the level of creatine kinase enzyme and psychological mechanisms. In addition, massage treatment led to a decrease in depression, stress, anxiety, and the perception of fatigue and an increase in mood, relaxation, and the perception of recovery.
The authors concluded that the direct usage of massages just for gaining results in sport and exercise performance seems questionable. However, it is indirectly connected to performance as an important tool when an athlete should stay focused and relaxed during competition or training and recover after them.
The evidence about the value of massage therapy is limited through the mostly poor quality of the primary studies. Unfortunately, the review authors did not bother to address this issue. Another recent and in my opinion more rigorous review identified 29 eligible studies recruiting 1012 participants, representing the largest examination of the effects of massage. Its authors found no evidence that massage improves measures of strength, jump, sprint, endurance, or fatigue, but massage was associated with small but statistically significant improvements in flexibility and DOMS. Massage therapy has the additional advantage that it is agreeable and nearly free of adverse effects. So, on balance, I think massage therapy might be worth considering for athletes.
Charles has a well-documented weakness for so-called alternative medicine (SCAM) – not just any SCAM but predominantly the type of SCAM that is both implausible and ineffective. Therefore, nobody can be all that surprised to read in THE TIMES that he has decided to use SCAM for helping women who have difficulties getting pregnant.
If one really wanted to employ SCAM for this aim one is spoilt for choice. In fact, there are only few SCAMs that don’t claim to be useful for this purpose.
A recent review, for instance, suggested that some supplements might be helpful. Other authors advocate SCAMs such as acupuncture, moxibustion, Chinese herbal medicine, psychological intervention, biosimilar electrical stimulation, homeopathy, or hyperbaric oxygen therapy.
Yes, I know! The evidence for these treatments is lousy, and I would never issue a recommendation based on such flimsy evidence.
Yet, the SCAM project at Dumfries House, the Scottish stately home Charles restored in 2007, offers acupuncture, reflexology, massage, yoga, and hypnotherapy for infertile women.
REFLEXOLOGY for female infertility?
Reflexology, also called zone therapy, is a manual treatment where pressure is applied usually to the sole of the patient’s foot and sometimes also to other areas such as the hands or ears. According to its proponents, foot reflexology is more than a simple foot massage that makes no therapeutic claims beyond relaxation. It is based on the idea that the human body is divided into 10 zones each of which is represented on the sole of the foot. Reflexologists employ maps of the sole of the foot where the body’s organs are depicted. By massaging specific zones which are assumed to be connected to specific organs, reflexologists believe to positively influence the function of these organs. While reflexology is mostly used as a therapy, some therapists also claim they can diagnose health problems through feeling tender or gritty areas on the sole of the foot which, they claim, correspond to specific organs.
Reflexology is not merely implausible as a treatment for infertility, it also boasts of some fairly rigorous trial evidence. A clinical trial (perhaps even the most rigorous of all the trials of SCAM for female fertility problems) testing whether foot reflexology might have a positive effect on the induction of ovulation stated that “the results suggest that any effect on ovulation would not be clinically relevant”.
So, as so often before in the realm of SCAM, Charles has demonstrated that his lack of critical thinking leads him to the least promising options.
Well done, Your Majesty!
Diabetic peripheral neuropathy (DPN) is a common complication of diabetes mellitus (DM) that can cause annoying symptoms. To address this condition, several treatment approaches have been proposed, including static magnetic field (SMF) therapy, which has shown promise in treating neurological conditions. Therefore, this study aimed to investigate the effects of SMF therapy on symptomatic DPN and the quality of life (QoL) in patients with type 2 diabetes.
A double-blind, randomized, placebo-controlled trial was conducted from April to October 2021. Sixty-four DPN patients (20 males, 44 females) were recruited for the study via invitation. The participants were divided into two groups: the magnet group, which used magnetic ankle bracelets (155 mT) for 12 weeks, and the sham group, which used non-magnetic ankle bracelets for the same duration. Neuropathy Symptom Score (NSS), Neuropathic Disability Score (NDS), and Visual Analogue Scale (VAS) were used to assess neuropathy symptoms and pain. In addition, the Neuropathy Specific Quality of Life Questionnaire (Neuro-QoL) tool was used to measure the patients’ quality of life.
Before treatment, there were no significant differences between the magnet and sham groups in terms of the NSS scores (P = 0.50), NDS scores (P = 0.74), VAS scores (P = 0.17), and Neuro-QoL scores (P = 0.82). However, after 12 weeks of treatment, the SMF exposure group showed a significant reduction in NSS scores (P < 0.001), NDS scores (P < 0.001), VAS scores (P < 0.001), and Neuro-QoL scores (P < 0.001) compared to the baseline. The changes in the sham group, on the other hand, were not significant.
The authors concluded that according to obtained data, SMF therapy is recommended as an easy-to-use and drug-free method for reducing DPN symptoms and improving QoL in diabetic type-2 patients.
Our own study and systematic review of the effects of magnetic bracelets and similar devices suggested that the effects of such treatments are due to placebo responses. Therefore, I find the findings of this new study most surprising. Not only that, to be honest, I also find them suspect. Apart from the fact that the treatment has no biological plausibility, I have three main reasons for my skepticism.
- The authors stated that there was no distinguishable difference between the sham and SMF devices in terms of their appearance, weight, or texture, which helped to ensure that the study was double-blinded. This is nonsense, I am afraid! The verum device is magnetic and the sham device is not. It is hardly conceivable that patients who handle such devices for any length of time do not discover this simple fact and thus de-blind themselves. In turn, this means that a placebo effect can easily explain the outcomes.
- Authors who feel that their tiny study of a highly implausible therapy lends itself to concluding that their therapy ‘is recommended as an easy-to-use and drug-free method for reducing DPN symptoms and improving QoL’ can, in my view, not be taken seriously.
- Something that always makes me suspicious of clinical trials is a lack of a placebo response where one would normally expect one. In this study, the control group exhibits hardly any placebo response. Wearing a strap around your ankle that allegedly emits therapeutic radiation would result in quite a strong placebo effect, according to our own findings.
So, forgive me if I do not trust this study any further than I can throw it! And pardon me if I still think that our previous conclusion is correct: The evidence does not support the use of static magnets for pain relief, and therefore magnets cannot be recommended as an effective treatment.
In the UK – this post is mainly for UK readers – journalists and opinion leaders are currently falling over themselves reporting about a major breakthrough: an Alzheimer’s drug has been shown to slow the disease by around 36%. “After 20 years with no new Alzheimer’s disease drugs in the UK, we now have two potential new drugs in 12 just months,” wrote Dr Richard Oakley, associate director at the Alzheimer’s Society. And the Daily Mail headlined: “New drug which claims to slow mental decline caused by Alzheimer’s by 36% could spell ‘the beginning of the end’ for the degenerative brain disease”.
That’s excellent news!
Many people will have made a sigh of relief!
So, why does it make me angry?
Once we listen to the news more closely we learn that:
- the drug only works for patients who are diagnosed early;
- for an early diagnosis, we need a PET scan;
- the UK hardly has any PET scanners, in fact, we have the lowest number among developed countries;
- these scanners are very expensive;
- the costs for the new drug are as yet unknown but will also be high.
Collectively these facts mean that we have a major advance in healthcare that could help many patients. At the same time, we all know that this is mere theory and that the practice will be very different.
Why?
- Because the NHS has been run down and is on its knees.
- Because our government will again say that they have invested xy millions into this area.
- The statement might be true or not, but in any case, the funds will be far too little.
- The UK has become a country where some patients suffering from severe toothache currently resort to pulling out their own teeth at home with pairs of pliers.
- In the foreseeable future, the NHS will not be allocated the money to invest in sufficient numbers of PET scans (not to mention the funds to buy the new and expensive drug).
In other words, the UK celebrates yet another medical advance raising many people’s expectations, while everyone in the know is well aware of the fact that the UK public will not benefit from it.
Does that not make you angry too?
