methodology
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.
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:
Helge Franke
Helge is a German Heilpraktiker and Osteopath. On his website, he lists his publications (kindly saving me the effort of doing a Medline search):
- 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):
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.
My ‘ALTERNATIVE MEDICINE HALL OF FAME‘ (the group of people who have managed to publish nothing but positive findings about a dubious therapy) currently consists of 20 members (unless I have forgotten somone, which is possible, of course):
- 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 (US chiropractor)
- 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 time to add the 21st member. My last post was about a weird study co-authored by someone who struck me as truly remarkable. Terry Oleson is employed by the Department of Traditional Oriental Medicine, Emperor’s College of Traditional Oriental Medicine, Santa Monica, CA, USA. On ‘research gate‘, he describes his expertise as follows:
- Cognitive Psychology
- Clinical Psychology
- Biological Psychology
- Clinical Trials
- Addiction Medicine
- Allied Health Science
Oleson received his BA in Biology from the University of California, Santa Barbara, in 1967, his MA in Psychology from California State University at Long Beach in 1971, and his PhD from UC Irvine in 1973. He went on to conduct a postdoctoral scholarship at UCLA at that time, where he conducted pioneering research in auricular diagnosis and auriculotherapy. Since many years, Oleson has published on auricular acupuncture and acupressure, at least one book and the papers listed below. This is an oddly dubious and biologically implausible so-called alternative medicine (SCAM). Terry Oleson – whom I never knowingly met in person – and his research are all the more remarkable: in his hands auricular therapy seems to work of just about everything:
- Effect of auricular acupressure on postpartum blues: A randomized sham controlled trial. Complement Ther Clin Pract. 2023 Aug;52:101762. doi: 10.1016/j.ctcp.2023.101762. Epub 2023 Apr 10.PMID: 37060791
- Auriculotherapy stimulation for neuro-rehabilitation. NeuroRehabilitation. 2002;17(1):49-62.PMID: 12016347
- Acupuncture: the search for biologic evidence with functional magnetic resonance imaging and positron emission tomography techniques. J Altern Complement Med. 2002 Aug;8(4):399-401. doi: 10.1089/107555302760253577.PMID: 12230898
- Commentary on auricular acupuncture for cocaine abuse. J Altern Complement Med. 2002 Apr;8(2):123-5. doi: 10.1089/107555302317371406.PMID: 12013511
- Clinical Commentary on an Auricular Marker Associated with COVID-19. Med Acupunct. 2020 Aug 1;32(4):176-177. doi: 10.1089/acu.2020.29152.com. Epub 2020 Aug 13.PMID: 32913483
- Comparison of Auricular Therapy with Sham in Children with Attention Deficit/Hyperactivity Disorder: A Randomized Controlled Trial. J Altern Complement Med. 2020 Jun;26(6):515-520. doi: 10.1089/acm.2019.0477. Epub 2020 May 20.PMID: 32434376
- Application of Polyvagal Theory to Auricular Acupuncture.Oleson T.Med Acupunct. 2018 Jun 1;30(3):123-125. doi: 10.1089/acu.2018.29085.tol.PMID: 29937963
- The effect of ear acupressure (auriculotherapy) on sexual function of lactating women: protocol of a randomized sham controlled trial. Trials. 2020 Aug 20;21(1):729. doi: 10.1186/s13063-020-04663-x.PMID: 32819441
- Randomized controlled study of premenstrual symptoms treated with ear, hand, and foot reflexology. Obstet Gynecol. 1993 Dec;82(6):906-11.PMID: 8233263
-
Auricular electrical stimulation and dental pain threshold. Anesth Prog. 1993;40(1):14-9.PMID: 8185085
- Rapid narcotic detoxification in chronic pain patients treated with auricular electroacupuncture and naloxone. Int J Addict. 1985 Sep;20(9):1347-60. doi: 10.3109/10826088509047771.PMID: 2867052
- Investigation of the effects of naloxone upon acupuncture analgesia. Pain. 1984 Jun;19(2):201-4. doi: 10.1016/0304-3959(84)90872-8.PMID: 6462730
- Electroacupuncture & auricular electrial stimulation. IEEE Eng Med Biol Mag. 1983;2(4):22-6. doi: 10.1109/MEMB.1983.5005987.PMID: 19493718
- An experimental evaluation of auricular diagnosis: the somatotopic mapping or musculoskeletal pain at ear acupuncture points. Pain. 1980 Apr;8(2):217-229. doi: 10.1016/0304-3959(88)90009-7.PMID: 7402685
14 papers about a dodgy SCAM without the hint of a negative finding! I hope we can all agree that this achievement makes Terry a worthy member of my ‘HALL OF FAME’, a group of people who, like Terry, have been able to publish nothing but positive findings about the most dubious SCAMs.
Welcome Terry!
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 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).
We discussed the 2015 Australian NHMRC report on homeopathy many times before, e.g.:
- Homeopathy: the 2015 NHMRC report and its criticism re-analysed
- HOMEOPATHY: the NHMRC report revisited
- Ombudsman investigates ‘flawed’ homeopathic study
- The final verdict on homeopathy: it’s a placebo
In a nutshell, the report was an hugely influential analysis of the effectiveness of homeopathy which came to squarely negative conclusions. Thus it was celebrated as a thorough and conclusive piece evidence demonstrating the madness of homeopathy. Unsurprisingly, homeopaths did not like it at all and produced various criticisms claiming that it was neither thorough nor conclusive.
Now the final evaluation of what has been going on was finally published (ISSUED BY THE COMMONWEALTH OMBUDSMAN, IAIN ANDERSON, ON 4 AUGUST 2023):
The Office of the Commonwealth Ombudsman (the Office) has finalised an investigation relating to the National Health and Medical Research Council’s (NHMRC) review of the evidence for the effectiveness of homeopathy, conducted between 2010 and 2015. We commenced this investigation in September 2017 in response to concerns raised with us about how the NHMRC review had proceeded.
The Office conducts its investigations in private, and the Ombudsman generally does not make a public statement in the absence of a formal report. In the circumstances of this matter, including that the then-Ombudsman released a public statement on 4 June 2021 which acknowledged the Office was investigating, we believe it is important to share publicly the information we can, now that the investigation is complete.
Our investigation was finalised in July 2023. We acknowledge the length of time the investigation has taken. This is in part due to the extensive efforts the Office made to source independent scientific expertise to advise us on some detailed and specific questions of scientific methodology that were raised with our Office, including some that were only brought to our attention as our investigation progressed. Despite our best efforts, it was not possible to engage an expert (or experts) to provide independent advice to our Office on this subject. In the absence of independent, expert scientific expertise we have not been able to conclusively determine those matters of scientific methodology. This did not prevent our Office from forming a view on other aspects of the matter.
Our investigation did not result in any adverse findings about the review or the NHMRC. When finalising investigations, we may offer comments and suggestions to an agency about areas for future improvement. In this instance, we offered comments and suggestions to the NHMRC about how it records and publicly explains decisions about its activities. The NHMRC also independently made several improvements to its processes during the course of our investigation.
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In essence, this means that the conclusions of the report stand:
Homeopathy should not be used to treat health conditions that are chronic, serious, or could become serious. People who choose homeopathy may put their health at risk if they reject or delay treatments for which there is good evidence for safety and effectiveness. People who are considering whether to use homeopathy should first get advice from a registered health practitioner. Those who use homeopathy should tell their health practitioner and should keep taking any prescribed treatments.
Thus the matter is closed – that is closed for rational thinkers. For irrationalists, the matter will no doubt continue to be a stone of contention. No, homeopath will be able to accept these conclusions simply because a member of a cult ceases to be a cultist once he/she accepts the criticism agaist the cult.
