The objectives of this randomized double-blind placebo-controlled clinical trial were to determine if there:
- (a) is an overall effect of homeopathic treatment (homeopathic medicines plus consultation) in the treatment of ADHD;
- (b) are any specific effects the homeopathic consultation alone in the treatment of ADHD;
- (c) are any specific effects of homeopathic medicines in the treatment of ADHD.
Children aged 6–16 years diagnosed with ADHD were randomized to one of three arms:
- Arm 1 (Remedy and Consultation);
- Arm 2 (Placebo and Consultation);
- Arm 3 (Usual Care).
The primary outcome measure was the change of the Conner 3 Global Index-Parent T-score (CGI-P T score) between baseline and 28 weeks.
The results showed an improvement in ADHD symptoms as measured by the CGI-P T score in the two groups (Arms 1 and 2) that received consultations with a homeopathic practitioner when compared with the usual care control group (Arm 3). Parents of the children in the study who received homeopathic consultations (Arms 1 and 2) also reported greater coping efficacy compared with those receiving usual care (Arm 3). There was no difference in adverse events among the three study arms.
The authors concluded that, in this study, homeopathic consultations provided over 8 months with the use of homeopathic remedy was associated with a decrease in ADHD symptoms in children aging 6–16 years when compared with usual treatment alone. Children treated with homeopathic consultations and placebo experienced a similar decrease in ADHD symptoms; however, this finding did not reach statistical significance when correcting for multiple comparisons. Homeopathic remedies in and of themselves were not associated with any change in ADHD symptoms.
In the discussion section, the authors make their findings a little clearer: “The findings are generally consistent with a recent meta-analysis that concluded that (i)ndividualized homeopathy showed a clinically relevant and statistically robust effect in the treatment of ADHD. Similar to the meta-analysis, the authors found individualized homeopathy (consultation plus remedy) resulted in improvement in ADHD symptoms. However, the data suggest that this effect is not due to the remedy component of the intervention.”
The authors do not cite the (to the best of my knowledge) only study that had a very similar aim, namely differentiating between the effects of the homeopathic remedy and the homeopathic consultation. It was conducted by the late George Lweith who certainly was not against homeopathy. The conclusions of this trial were as follows: Homeopathic consultations but not homeopathic remedies are associated with clinically relevant benefits for patients with active but relatively stable rheumatoid arthritis.
Both trials confirm what rational thinkers have been saying for many years: the effects that many people experience after homeopathic therapy are not due to the homeopathic remedy but to the usually long and empathetic therapeutic encounter, the placebo effect, and other non-specific effects. To put it bluntly homeopathy is a kind of amateur psychotherapy.
Before someone now claims that this means homeopathy is fine, let me tell you this: no, it is not fine! If someone needs psychotherapy, he/she should see not an amateur but a professional, i.e. a psychologist who is properly trained in what she can and cannot do.
The American Chiropractic Association Council on Chiropractic Pediatrics (CCP) announced a new diplomate education program focused on pediatric care. The program will include 300 hours of education covering topics such as pediatric development from birth to age 16, adjusting techniques, working diagnosis, clinical application, integrated care and more…
Development of the diplomate education program has been in the works for several years, with contributions from many members of the CCP, including council president Jennifer Brocker, DC, DICCP. At the helm of course development for this education program are Mary Beth Minser, DC, CACCP, and Kris Tohtz, DC, LAc, educational coordinators for CCP. They agreed that the goal of the new program is to provide education that furthers knowledge of chiropractic pediatrics in an evidence-based, integrative way. “We wanted to make sure that we had something that aligned with ACA’s core principles,” Dr. Tohtz said. “Chiropractic-forward, yes, but scientifically focused.”
Dr. Brocker added, “There was a need for more evidence-informed education [in pediatrics]. I felt like the Council was well positioned to take this on because we had the opportunity to build it from scratch, making it what students and practicing doctors need.” …
Drs. Minser and Tohtz are excited that the diplomate program will also include a research component. “There is some lacking information when it comes to pediatric chiropractic,” Dr. Minser explained. She recently participated in the COURSE Study, an international study seeking to fill knowledge gaps in research relating to pediatric chiropractic treatment. “It was a very easy project to do, and pretty exciting to be involved,” she said. “But you have to know how to treat pediatric patients in order to be involved in those research projects. We want doctors and students [in this program] to be able to go through a case study, to be able to extract information for their clinical application from that case study or from research, or, if they would like, to write up case studies so we can get more published.”
“We feel we could really push pediatric chiropractic to a whole new level having doctors that have this type of knowledge base,” Dr. Minser said. “We just want to be the best pediatric chiropractors that we can be, and this diplomate [education] program helps [us] do that.”
“There is some lacking information when it comes to pediatric chiropractic.”
I think the evidence is quite clear: chiropractic has nothing to offer for ill children that other, properly trained healthcare professionals would not do better.
“We feel we could really push pediatric chiropractic to a whole new level.”
“We just want to be the best pediatric chiropractors that we can be.”
In this case, please study the evidence and you will inevitably arrive at the following conclusion:
THE BEST A CHIROPRACTOR CAN DO FOR A SICK CHILD IS TO REFER IT TO A COMPETENT DOCTOR – A DOCTOR OF MEDICINE, NOT CHIROPRACTIC!
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:
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
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  rotation,  extension,  flexion,  rotation with extension, and  rotation with flexion. Finally, Patients treated using the standardized MSI protocol as follows:  education regarding normal postures and movements such as sitting, walking, bending, standing, and lying down;  education regarding exercises to perform trunk movements as painlessly as possible; and  prescription of functional exercises to improve trunk movement .
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:  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  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  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.
we need not just more but better evidence.
The ‘ALTERNATIVE MEDICINE HALL OF FAME’ is my creation amd is meant to honour reserchers who have dedicated much of their professional career to investigating a form of so-called alternative medicine (SCAM) without ever publishing negative conclusions about it. Obviously, if anyone studies any therapy, he/she will occasionally produce a negative finding. This would be the case, even if he/she tests an effective treatment. However, if the treatment in question comes from the realm of SCAM, one would expect negative results fairly regularly. No therapy works well under all conditions, and to the best of my knowledge, no SCAM is a panacea!
This is why researchers who defy this inevitability must be remarkable. If someone tests a treatment that is at best dubious and at worst bogus, we are bound to see some studies that are not positive. He/she would thus have a high or norma ‘TRUSTWORTHINESS INDEX‘ (another creation of mine which, I think, is fairly self-explanatory). Conversely, any researcher who does manage to publish nothing but positive results of a SCAM is bound to have a very low ‘TRUSTWORTHINESS INDEX‘. In other words, these people are special, so much so that I decided to honour such ‘geniuses’ by admitting them to my ALTERNATIVE MEDICINE OF FAME.
So far, this elite group of people comprises the following individuals:
- Tery Oleson (acupressure , US)
- Jorge Vas (acupuncture, Spain)
- Wane Jonas (homeopathy, US)
- Harald Walach (various SCAMs, Germany)
- Andreas Michalsen ( various SCAMs, Germany)
- Jennifer Jacobs (homeopath, US)
- Jenise Pellow (homeopath, South Africa)
- Adrian White (acupuncturist, UK)
- Michael Frass (homeopath, Austria)
- Jens Behnke (research officer, Germany)
- John Weeks (editor of JCAM, US)
- Deepak Chopra (entrepreneur, US)
- Cheryl Hawk (chiropractor, US)
- David Peters (osteopathy, homeopathy, UK)
- Nicola Robinson (TCM, UK)
- Peter Fisher (homeopathy, UK)
- Simon Mills (herbal medicine, UK)
- Gustav Dobos (various SCAMs, Germany)
- Claudia Witt (homeopathy, Germany/Switzerland)
- George Lewith (acupuncture, UK)
- John Licciardone (osteopathy, US)
Today, it is my great pleasure to admit another osteopath to the HALL OF FAME:
- Osteopathic manipulative treatment for nonspecific low back pain: a systematic review and meta-analysis. BMC Muskuloskeletal Disorders, 2014
- Effectiveness of osteopathc manipulative therapy for managing symptoms of irritable bowel syndrome: a systematic review. Journal of the American Osteopathic Association, 2014
- Why reservations remain: A critical reflection about the systematic review and meta-analysis “Osteopathic manipulative treatment for low back pain” by Licciardone et al. Journal of Bodywork & Movement Therapies, 2012, Elsevier
- Osteopathic Manipulative Treatment (OMT) for Lower Urinary Tract Symptoms (LUTS) in Women. A Systematic Review and Meta-analyses. Journal of Bodywork & Movement Therapies, 2012, Elsevier
- Comment: Is a postural-structural-biomechanical model, within manual therapy, viable? A JBMT debate. Journal of Bodywork & Movement Therapies (2011) 15, 259-261, Elsevier
- Die manuelle Behandlung des Kniegelenks – veraltetes Verfahren oder alternative Option? Naturheilpraxis mit Naturmedizin 9-2010, 1019-1026, Pflaum Verlag
- CRPS und Osteopathie – Grenzen und Möglichkeiten DO – Deutsche Zeitschrift für Osteopathie 3-2010, 6-8, Hippokrates Verlag
- Research and osteopathy: An interview with Dr Gary Fryer by Journal of Bodywork & Movement Therapies. 14, 304-308, Elsevier
- „…there is not much we can say without any doubt“ DO Life about Gary Fryer DO – Deutsche Zeitschrift für Osteopathie 1-2010, 4-5, Hippokrates Verlag
- Fred Mitchell und die Entwicklung der Muskel-Energie-Techniken DO – Deutsche Zeitschrift für Osteopathie 2-2009, 4-5, Hippokrates Verlag
- A randomized trial of arthroscopic surgery for osteoarthritis of the knee. Commentary Forschende Komplementärmedizin 2008 Dec 15(6), 354-5, Karger
- Evidence-informed management of chronic low back pain with spinal manipulation and mobilization. Commentary Forschende Komplementärmedizin 2008 Dec 15(6), 353-4, Karger
- Interview mit Prof. Eyal Lederman Teil 1 Osteopathische Medizin, 2/2007, S.15-21, Elsevier
- Interview mit Prof. Eyal Lederman Teil 2 Osteopathische Medizin, 3/2007, S.22-27, Elsevier
- Artikel über das 3. Internationale Symposium über die Fortschritte in der osteopathischen Forschung. Osteopathische Medizin, 1-2007, S.23-24, Elsevier
- Die richtige Haltung des Behandlers Osteopathische Medizin, 4-2006, S.8-10, Elsevier
- Interview mit Laurie Hartman Osteopathische Medizin, 4-2006, S. 11-16, Elsevier
- Herausgeber des Sonderheftes „Functional Technique” Osteopathische Medizin, 2-2006, Elsevier
- Harold Hoover, Charles Bowles, William Johnston und die Geschichte der Funktionellen Technik Osteopathische Medizin, 2-2006, S.4-12, Elsevier
- Interview mit Harry Friedman Osteopathische Medizin, 2-2006, S.25-30, Elsevier
- Funktionelle Technik – Praxis Osteopathische Medizin, 2-2006, S.17-23, Elsevier
- Osteopathische Diagnose und Behandlung des Hüftgelenks Naturheilpraxis mit Naturmedizin, 10-2006, S.1383-1393, Pflaum-Verlag
- Bericht über das 2-Tage Seminar von Prof. Laurie Hartman in München Naturheilpraxis mit Naturmedizin, 5-2006, S.754-755, Pflaum Verlag
- Bewusstsein für Bewegung. Die minimale Hebeltechnik und das Behandlungskonzept von Laurie Hartman Osteopathische Medizin, 4-2006, S.4-7, Elsevier
- ICAOR 6 / Interview mit Florian Schwerla Osteopathische Medizin, 3-2006, S.15-17, Elsevier
- Muscle Energy Technique – Geschichte, Modell und Wirksamkeit Teil 1 Geschichte Osteopathische Medizin 2-2005, S.4-10, Elsevier
- Muscle Energy Technique – Geschichte, Modell und Wirksamkeit Teil 2 Modell Osteopathische Medizin 3-2005, S.4-10, Elsevier
- Muscle Energy Technique – Geschichte, Modell und Wirksamkeit Teil 3 Wirksamkeit Osteopathische Medizin 4-2005, S.4-10, Elsevier
- Die Behandlung der Rippen mit Muskel-Energie-Techniken Naturheilpraxis mit Naturmedizin, 10-2005, S. 1353-1359, Pflaum Verlag
Yes, I agree! The list is confusing because it contains all sorts of papers, including even interviews. Let’s do a Medline search after all and find the actual studies published by Franke:
- Osteopathic manipulative treatment (OMT) for lower urinary tract symptoms (LUTS) in women. Franke H, Hoesele K.J Bodyw Mov Ther. 2013 Jan;17(1):11-8. doi: 10.1016/j.jbmt.2012.05.001. Epub 2012 Jun 17.
- Effectiveness of osteopathic manipulative treatment for pediatric conditions: A systematic review. Franke H, Franke JD, Fryer G.J Bodyw Mov Ther. 2022 Jul;31:113-133. doi: 10.1016/j.jbmt.2022.03.013. Epub 2022 Mar 24.
- Muscle energy technique for non-specific low-back pain. Franke H, Fryer G, Ostelo RW, Kamper SJ. Cochrane Database Syst Rev. 2015 Feb 27;(2):CD009852. doi: 10.1002/14651858.CD009852.pub2.
Osteopathic manipulative treatment for nonspecific low back pain: a systematic review and meta-analysis. Franke H, Franke JD, Fryer G.BMC Musculoskelet Disord. 2014 Aug 30;15:286. doi: 10.1186/1471-2474-15-286.Effectiveness of osteopathic manipulative therapy for managing symptoms of irritable bowel syndrome: a systematic review. Müller A, Franke H, Resch KL, Fryer G.J Am Osteopath Assoc. 2014 Jun;114(6):470-9. doi: 10.7556/jaoa.2014.098.
- Osteopathic manipulative treatment for low back and pelvic girdle pain during and after pregnancy: A systematic review and meta-analysis. Franke H, Franke JD, Belz S, Fryer G.J Bodyw Mov Ther. 2017 Oct;21(4):752-762. doi: 10.1016/j.jbmt.2017.05.014. Epub 2017 May 31.
- Evidence-informed management of chronic low back pain with spinal manipulation and mobilization Franke H.Forsch Komplementmed. 2008 Dec;15(6):353-4
- Osteopathic manipulative treatment for chronic nonspecific neck pain: A systematic review and meta-analysis Helge Franke, Jan-David Franke, Gary Fryer, 2015 Int J Osteop Med.
Not a huge list, I agree. Yet it is respectable, particularly if we consider that Franke managed to squeeze out a little positive message even from cases where the data are fairly clearly negative. Another thing that I find noteworthy is the fact that Franke, as far as I can see, never published a clinical trial. He seems to specialize in reviews – and perhaps that is understandable: if one is compelled to spinning the message from fairly negative evidence to a positive conclusion, reviews might be better suited.
Altogether, I think Helge Franke deserves his place in the ALTERNATIVE MEDICINE HALL OF FAME!
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):
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.
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 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!
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?
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 with meta-analysis of randomized clinical trials (RCTs) estimated the benefits and harms of cervical spinal manipulative therapy (SMT) for treating neck pain. The authors searched the MEDLINE, Cochrane CENTRAL, EMBASE, CINAHL, PEDro, Chiropractic Literature Index bibliographic databases, and grey literature sources, up to June 6, 2022.
RCTs evaluating SMT compared to guideline-recommended and non-recommended interventions, sham SMT, and no intervention for adults with neck pain were eligible. Pre-specified outcomes included pain, range of motion, disability, health-related quality of life.
A total of 28 RCTs could be included. There was very low to low certainty evidence that SMT was more effective than recommended interventions for improving pain at short-term (standardized mean difference [SMD] 0.66; confidence interval [CI] 0.35 to 0.97) and long-term (SMD 0.73; CI 0.31 to 1.16), and for reducing disability at short-term (SMD 0.95; CI 0.48 to 1.42) and long-term (SMD 0.65; CI 0.23 to 1.06). Only transient side effects were found (e.g., muscle soreness).
The authors concluded that there was very low certainty evidence supporting cervical SMT as an intervention to reduce pain and improve disability in people with neck pain.
Harms cannot be adequately investigated on the basis of RCT data. Firstly, because much larger sample sizes would be required for this purpose. Secondly, RCTs of spinal manipulation very often omit reporting adverse effects (as discussed repeatedly on this bolg). If we extend our searches beyond RCTs, we find many cases of serious harm caused by neck manipulations (also as discussed repeatedly on this bolg). Therefore, the conclusion of this review should be corrected:
Low certainty evidence exists supporting cervical SMT as an intervention to reduce pain and improve disability in people with neck pain. The evidence of harm is, however, substantial. It follows that the risk/benefit ratio is not positive. Cervical SMT should therefore be discouraged.
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).