Sixty thousand people are diagnosed with Parkinson’s disease (PD) each year, making it the second most common neurodegenerative disorder. PD results in a variety of gait disturbances, including muscular rigidity and decreased range of motion (ROM), that increase the fall risk of those afflicted. Osteopathic manipulative treatment (OMT) might address the somatic dysfunction associated with neurodegeneration in PD. Moreover, osteopathic cranial manipulative medicine (OCMM) might improve gait performance by improving circulation to the affected nervous tissue. Are these ideas realistic hypotheses or merely wishful thinking?
This study aimed to determine whether a single session of OMT or OMT + OCMM can improve the gait of individuals with PD by addressing joint restrictions in the sagittal plane and by increasing ROM in the lower limb. It was designed as a two-group, randomized controlled trial in which individuals with PD (n=45) and age-matched healthy control participants (n=45) were recruited from the community. PD participants were included if they were otherwise healthy, able to stand and walk independently, had not received OMT or physical therapy (PT) within 30 days of data collection, and had idiopathic PD in Hoehn and Yahr stages 1.0-3.0.
PD participants were randomly assigned to one of three experimental treatment protocols:
- a ‘whole-body’ OMT protocol (OMT-WB), which included OMT and OCMM techniques;
- a ‘neck-down’ OMT protocol (OMT-ND), including only OMT techniques;
- and a sham treatment protocol.
Control participants were age-matched to a PD participant and were provided the same OMT experimental protocol.
An 18-camera motion analysis system was utilized to capture 3-dimensional (3D) position data in a treadmill walking trial before and after the assigned treatment protocol. Pretreatment and posttreatment hip, knee, and ankle ROM were compared with paired t-tests, and joint angle waveforms during the gait cycle were analyzed with statistical parametric mapping (SPM), which is a type of waveform analysis.
Individuals with PD had significantly reduced hip and knee extension in the stance phase compared to controls (32.9-71.2% and 32.4-56.0% of the gait cycle, respectively). Individuals with PD experienced a significant increase in total sagittal hip ROM (p=0.038) following a single session of the standardized OMT-WB treatment protocol. However, waveform analysis found no significant differences in sagittal hip, knee, or ankle angles at individual points of the gait cycle following OMT-WB, OMT-ND, or sham treatment protocols.
The authors concluded that the increase in hip ROM observed following a single session of OMT-WB suggests that OCMM in conjunction with OMT may be useful for improving gait kinematics in individuals with PD. Longitudinal studies over multiple visits are needed to determine the long-term effect of regular OMT and OMT+OCMM treatments on Parkinsonian gait characteristics.
The study has many significant limitations. For instance, the hypotheses tested lack plausibility and the outcome measures are of doubtful validity. Most importantly, the observed effects are only short term and their clinical relevance is highly questionable.
Osteopathic tradition in the cranial field (OCF) postulates that the primary respiratory mechanism (PRM) relies on the anatomical links between the occiput and sacrum. Few studies investigated this relationship with inconsistent results. No studies investigated the occiput-sacrum connection from a neurophysiological perspective.
This study aims to determine whether the sacral technique (ST), compared to the compression of the fourth ventricle (CV4) technique, can affect brain alpha-band power (AABP) as an indicator of a neurophysiological connection between the occiput and sacrum.
Healthy students, 22-30 years old for men and 20-30 years old for women, were enrolled in the study and randomized into eight intervention groups. Each group received a combination of active techniques (CV4 or ST) and the corresponding sham techniques (sham compression of the fourth ventricle [sCV4] or sham sacral technique [sST] ), organized in two experimental sessions divided by a 4 h washout period. AABP was continuously recorded by electroencephalogram (EEG) of the occipital area in the first 10 min of resting state, during each intervention (active technique time) and after 10 min (post-active technique time), for a total of approximately 50 min per session. Analysis was carried out utilizing a repeated-measure ANOVA within the linear general model framework, consisting of a within-subject factor of time and a within-subject factor of treatment (CV4/ST).
Forty healthy volunteers (mean age ± SD, 23.73±1.43 years; range, 21-26 years; 16 male and 24 female) were enrolled in the study and completed the study protocol. ANOVA revealed a time × treatment interaction effect statistically significant (F=791.4; p<0.001). A particularly high increase in mean AABP magnitude was recorded during the 10 min post-CV4, compared to both the CV4 and post-sCV4 application (p<0.001). During all the times analyzed for ST and sST application, no statistically significant differences were registered with respect to the resting state.
The authors concluded that the ST does not produce immediate changes on occipital AABP brain activity. CV4, as previous evidence supported, generates immediate effects, suggesting that a different biological basis for OCF therapy’s connection between the head and sacrum should be explored.
Why on earth should a different biological mechanism be explored? Why not conclude that OCF and its assumptions are pure nonsense?
The answer to these questions is not difficult to find: the authors are from the ‘Istituto Superiore di Osteopatia, Milan, Italy’! One can understand that, at this institution, people are unlikely to agree with my conclusion that OCF is based on absurd concepts and does not merit further research.
According to the authors of this study, research is lacking regarding osteopathic approaches in treating polycystic ovary syndrome (PCOS), one of the prevailing endocrine abnormalities in reproductive-aged women. Limited movement of pelvic organs can result in functional and structural deficits, which can be resolved by applying visceral manipulation (VM). Already with these two introductory sentences, I have problems. But for the moment, we can leave this aside and have a look at their trial.
The study was aimed at analyzing the effect of VM on dysmenorrhea, irregular, delayed, and/or absent menses, and premenstrual symptoms in PCOS patients.
Thirty Egyptian women with PCOS, with menstruation-related complaints and free from systematic diseases and/or adrenal gland abnormalities, prospectively participated in a single-blinded, randomized controlled trial. They were recruited from the women’s health outpatient clinic in the faculty of physical therapy at Cairo University, with an age of 20-34 years, and a body mass index (BMI) ≥25, <30 kg/m2. Patients were randomly allocated into two equal groups (15 patients); the control group received a low-calorie diet for 3 months, and the study group received the same hypocaloric diet plus VM to the pelvic organs and their related structures, according to assessment findings, for eight sessions over 3 months. Evaluations for body weight, BMI, and menstrual problems were done by weight-height scale, and menstruation-domain of Polycystic Ovary Syndrome Health-Related Quality of Life Questionnaire (PCOSQ), respectively, at baseline and after 3 months of treatments.
A total of 30 patients were included, with baseline mean age, weight, BMI, and menstruation domain score of 27.5 ± 2.2 years, 77.7 ± 4.3 kg, 28.6 ± 0.7 kg/m2, and 3.4 ± 1.0, respectively, for the control group, and 26.2 ± 4.7 years, 74.6 ± 3.5 kg, 28.2 ± 1.1 kg/m2, and 2.9 ± 1.0, respectively, for the study group. Of the 15 patients in the study group, uterine adhesions were found in 14 patients (93.3%), followed by restricted uterine mobility in 13 patients (86.7%), restricted ovarian/broad ligament mobility (9, 60%), and restricted motility (6, 40%). At baseline, there was no significant difference (p>0.05) in any of the demographics (age, height), or dependent variables (weight, BMI, menstruation domain score) among both groups. Post-study, there was a statistically significant reduction (p=0.000) in weight, and BMI mean values for the diet group (71.2 ± 4.2 kg, and 26.4 ± 0.8 kg/m2, respectively) and the diet + VM group (69.2 ± 3.7 kg; 26.1 ± 0.9 kg/m2, respectively). For the improvement in the menstrual complaints, a significant increase (p<0.05) in the menstruation domain mean score was shown in the diet group (3.9 ± 1.0), and the diet + VM group (4.6 ± 0.5). On comparing both groups post-study, there was a statistically significant improvement (p=0.024) in the severity of menstruation-related problems in favor of the diet + VM group.
The authors concluded that VM yielded greater improvement in menstrual pain, irregularities, and premenstrual symptoms in PCOS patients when added to caloric restriction than utilizing the low-calorie diet alone in treating that condition.
VM involves the manual manipulation by a therapist of internal organs, blood vessels and nerves (the viscera) mostly from outside the body, but sometimes, the therapist also puts his/her fingers into the patient’s vagina. It was developed by the osteopath Jean-Piere Barral. 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. 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. The idea is that 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.
I don’t see any reason to believe the concepts of VM are plausible. Thus I find the hypothesis of this trial extremely far-fetched. The results are equally unconvincing. As we have often discussed, the ‘A+B vs B’ design cannot prove a causal relationship between the intervention and the outcome.
The most likely explanation for the findings is that the patients receiving VM experienced or merely reported improvements because the extra attention of mildly invasive treatments produced a powerful placebo effect. To put it bluntly: this is a poor, arguably unethical study where over-enthusiastic researchers reach a conclusion that is not supported by the data.
Despite considerable doubts about its effectiveness, osteopathic manipulative treatment (OMT) continues to be used for a range of pediatric conditions. Here is just one example of many osteopaths advertising their services:
I qualified as an Osteopath in 2009 after 4 years of intensive training from the British College of Osteopathic medicine, where I received a distinction for my efforts. After having two children I decided to do a 2-year Postgraduate training in Pediatric Osteopathy from the Osteopathic Centre for Children in London. Whilst at the centre I was lucky enough to meet a wide variety of children from premature babies in a Neonate Hospital ward to children with developmental issues and disabilities, children on the Autistic spectrum, to kids doing exams or experiencing high levels of stress. We also saw lots of children with normal coughs, colds, lumps and bumps.
And the ‘Institute of Osteopathy states this:
Parents visit osteopaths for a range of reasons to support their child’s health. Children, like adults, can be affected by general joint and muscle issues, which is one of the reasons people visit an osteopath. Parents will also take their children to visit an osteopath for a variety of other health reasons that may benefit from osteopathic care.
As osteopathic care is based on the individual needs of the patient, it will vary depending on your child’s age and the diagnosis. Osteopaths generally use a wide range of gentle hands-on techniques that focus on releasing tension, improving mobility and optimising function. This is often used together with exercise and helpful advice. Some osteopaths have been trained in very gentle techniques which are particularly suitable to assess and treat very young children, including new-borns. You do not need to consult your GP before you visit an osteopath, although you may wish to do so.
So, how good or bad is osteopathy for kids? Our systematic review wanted to find out. Specifically, the aim of this paper is to update our previous systematic review (SR) initially published in 2013 by critically evaluating the evidence for or against this treatment.
Eleven databases were searched (January 2012 to November 2021). Only randomized clinical trials (RCTs) of OMT in pediatric patients compared with any type of controls were considered. The Cochrane risk-of-bias tool was used. In addition, the quality of the evidence was rated using Grading of Recommendations, Assessment, Development and Evaluation (GRADE) criteria, as recommended by the Cochrane Collaboration.
Thirteen trials met the eligibility criteria, of which four could be subjected to a meta-analysis. The findings show that, in preterm infants, OMT has little or no effect on reducing the length of hospital stay (standardized mean difference (SMD) -0.03; 95% confidence interval (CI) -0.44 to 0.39; very low certainty of the evidence) when compared with usual care alone. Only one study (8.3%) was judged to have a low risk of bias and showed no effects of OMT on improving exclusive breastfeeding at one month. The methodological quality of RCTs published since 2013 has improved. However, adverse effects remain poorly reported.
We concluded that the quality of the primary trials of OMT has improved during recent years. However, the quality of the totality of the evidence remains low or very low. Therefore, the effectiveness of OMT for selected pediatric populations remains unproven.
These days, it is not often that I am the co-author of a systematic review. So, allow me to discuss one of my own papers for a change by making a few very brief points:
- Considering how many osteopaths treat children, the fact that only 13 trials exist is shameful. To me, it suggests that the osteopathic profession has little interest in research.
- The finding that adverse effects are poorly reported is even more shameful, in my view. It suggests that the few osteopaths who do some research don’t mind violating research ethics.
- The fact that overall our review fails to yield good evidence that osteopathy is effective for any pediatric condition is the most shameful finding of them all. It means that osteopaths are either not informed about the evidence for their own approach, or that they are informed but don’t give a hoot and treat kids regardless. In both cases, they behave unethically.
Many systematic reviews have summarized the evidence on spinal manipulative therapy (SMT) for low back pain (LBP) in adults. Much less is known about the older population regarding the effects of SMT. This paper assessed the effects of SMT on pain and function in older adults with chronic LBP in an individual participant data (IPD) meta-analysis.
Electronic databases were searched from 2000 until June 2020; reference lists of eligible trials and related reviews were also searched. Randomized controlled trials (RCTs) were considered if they examined the effects of SMT in adults with chronic LBP compared to interventions recommended in international LBP guidelines. The authors of trials eligible for the IPD meta-analysis were contacted and invited to share data. Two review authors conducted a risk of bias assessment. Primary results were examined in a one-stage mixed model, and a two-stage analysis was conducted in order to confirm the findings. The main outcomes and measures were pain and functional status examined at 4, 13, 26, and 52 weeks.
A total of 10 studies were retrieved, including 786 individuals; 261 were between 65 and 91 years of age. There was moderate-quality evidence that SMT results in similar outcomes at 4 weeks (pain: mean difference [MD] – 2.56, 95% confidence interval [CI] – 5.78 to 0.66; functional status: standardized mean difference [SMD] – 0.18, 95% CI – 0.41 to 0.05). Second-stage and sensitivity analysis confirmed these findings.
The authors concluded that SMT provides similar outcomes to recommended interventions for pain and functional status in the older adult with chronic LBP. SMT should be considered a treatment for this patient population.
This is a fine analysis. Unfortunately, its results are less than fine. Its results confirm what I have been saying ad nauseam: we do not currently have a truly effective therapy for back pain, and most options are as good or as bad as the rest. This is most frustrating for everyone concerned, but it is certainly no reason to promote SMT as usually done by chiropractors or osteopaths.
The only logical solution, in my view, is to use those options that:
- are associated with the least risks,
- are the least expensive,
- are widely available.
However you twist and turn the existing evidence, the application of these criteria does not come up with chiropractic or osteopathy as an optimal solution. The best treatment is therapeutic exercise initially taught by a physiotherapist and subsequently performed as a long-term self-treatment by the patient at home.
When I first saw this, I was expecting something like If Homeopathy Beats Science (Mitchell and Webb) – YouTube : videos (reddit.com). But no, “Acute Care Homeopathy for Medical Professionals” is not a masterpiece by gifted satirists. It is much better; it is for real! In fact, it is a collaboration between the “Academy of Homeopathy Education” (AHE) and the American Institute of Homeopathy (AIH). Together, they published the following announcement:
AHE and AIH are pleased to present a customized educational program designed for busy medical professionals interested in enhancing their practice and expanding the treatment tools available with Homeopathy. Grounded in the original theory and philosophy of Homeopathy, AHE’s quality curriculum empowers practitioners and the material’s inspirational delivery encourages further study towards the mastery of Homeopathy for chronic care.
This course is open to all licensed healthcare providers— medical, osteopathic, naturopathic, dentists, chiropractors, veterinarians, nurse practitioners, nurses, physician assistants, pharmacologists and pharmacists.
Acute-care homeopathy addresses the challenges of 21st-century medical practice.
Among many things, you’ll learn safe and effective ways to manage pain and mitigate antibiotic overuse with FDA-regulated and approved Homeopathic remedies. AHE delivers an integrated learning experience that combines online real-time classroom experiences culminating in a telehealth based clinical internship allowing participants to study from anywhere in the world.
AHE’s team of Homeopathy experts have taught thousands of students around the globe and are known for unparalleled academic rigor, comprehensive clinical training, and robust research initiatives. AHE ensures that every graduate develops the necessary critical thinking skills in homeopathy case taking, analysis, and prescribing to succeed in practice with confidence and competence.
- Smart and savvy tech support team helps to on-board and train even the most reticent digital participants
- Academic support professionals provide an educational safety-net
- Stellar faculty to inspire confidence and encourage students to achieve their best work
- “Fireside Chats,” forums, and social gatherings build community
- Tried and true administrative systems keep things running smoothly so you can focus on learning Homeopathy.
All AHE students receive Radar Opus, the leading software package used by professional homeopaths worldwide.
Upon completion of the didactic program, practitioners begin an Acute Care Internship through AHE and the Homeopathy Help Network’s Acute Care Telehealth Clinic “Homeopathy Help Now” (HHN) which sees thousands of cases each year. Upon successful completion of the internship, practitioners will be invited to participate in ongoing supervised practice through HHN.
AHE is part of a larger vision to shape the future of Homeopathy: HOHM Foundation and the Homeopathy Help NetworkAll clinical services are delivered in an education and research-driven model. HOHM’s Office of Research has multiple peer-reviewed publications focused on education, practice, and clinical outcomes. HOHM is committed to funding Homeopathy study and research at every level.
The Academy of Homeopathy Education (AHE) operates in conjunction with HOHM Foundation, a 501c3 initiative committed to education, advocacy, and access. The Homeopathy Help Network is a telehealth clinic providing fee-for-service chronic care as well as donation-based acute care through Homeopathy Help Now.
I suspect you simply cannot wait to enroll. To learn more about “Acute Care Homeopathy for Medical Professionals” please fill out the form.
… and don’t forget to pay the fee of US$ 5 500.
No, it’s not expensive, if you think about it. After all, acute-care homeopathy addresses the challenges of 21st-century medical practice.
Naprapathy is an odd variation of chiropractic. To be precise, it has been defined as a system of specific examination, diagnostics, manual treatment, and rehabilitation of pain and dysfunction in the neuromusculoskeletal system. It is aimed at restoring the function of the connective tissue, muscle- and neural tissues within or surrounding the spine and other joints. The evidence that it works is wafer-thin. Therefore rigorous studies are of interest.
The aim of this study was to evaluate the cost-effectiveness of manual therapy compared with advice to stay active for working-age persons with nonspecific back and/or neck pain.
The two interventions were:
- a maximum of 6 manual therapy sessions within 6 weeks, including spinal manipulation/mobilization, massage, and stretching, performed by a naprapath (index group),
- information from a physician on the importance to stay active and on how to cope with pain, according to evidence-based advice, on 2 occasions within 3 weeks (control group).
A cost-effectiveness analysis with a societal perspective was performed alongside a randomized controlled trial including 409 persons followed for one year, in 2005. The outcomes were health-related Quality of Life (QoL) encoded from the SF-36 and pain intensity. Direct and indirect costs were calculated based on intervention and medication costs and sickness absence data. An incremental cost per health-related QoL was calculated, and sensitivity analyses were performed.
The difference in QoL gains was 0.007 (95% CI – 0.010 to 0.023) and the mean improvement in pain intensity was 0.6 (95% CI 0.068-1.065) in favor of manual therapy after one year. Concerning the QoL outcome, the differences in mean cost per person were estimated at – 437 EUR (95% CI – 1302 to 371) and for the pain outcome the difference was – 635 EUR (95% CI – 1587 to 246) in favor of manual therapy. The results indicate that manual therapy achieves better outcomes at lower costs compared with advice to stay active. The sensitivity analyses were consistent with the main results.
Cost-effectiveness plane using bootstrapped incremental cost-effectiveness ratios for QoL and pain intensity outcomes
The authors concluded that these results indicate that manual therapy for nonspecific back and/or neck pain is slightly less costly and more beneficial than advice to stay active for this sample of working age persons. Since manual therapy treatment is at least as cost-effective as evidence-based advice from a physician, it may be recommended for neck and low back pain. Further health economic studies that may confirm those findings are warranted.
This is an interesting and well-conducted study. The differences between the groups seem small and of doubtful relevance. The authors acknowledge this fact by stating: “together with the clinical results from previously published studies on the same population the results suggest that manual therapy may be as cost-effective a treatment as evidence-based advice from a physician, for back and neck pain”. Moreover, the data do not convince me that the treatment per se was effective; it might have been the non-specific effects of touch and attention.
I have said it before: there is currently no optimal treatment for neck and back pain. Therefore, the findings even of rigorous cost-effectiveness studies will only generate lukewarm results.
This study used a US nationally representative 11-year sample of office-based visits to physicians from the National Ambulatory Medical Care Survey (NAMCS), to examine a comprehensive list of factors believed to be associated with visits where complementary health approaches were recommended or provided.
NAMCS is a national health care survey designed to collect data on the provision and use of ambulatory medical care services provided by office-based physicians in the United States. Patient medical records were abstracted from a random sample of office-based physician visits. The investigators examined several visit characteristics, including patient demographics, physician specialty, documented health conditions, and reasons for a health visit. They ran chi-square analyses to test bivariate associations between visit factors and whether complementary health approaches were recommended or provided to guide the development of logistic regression models.
Of the 550,114 office visits abstracted, 4.43% contained a report that complementary health approaches were ordered, supplied, administered, or continued. Among complementary health visits, 87% of patient charts mentioned nonvitamin nonmineral dietary supplements. The prevalence of complementary health visits significantly increased from 2% in 2005 to almost 8% in 2015. Returning patient status, survey year, physician specialty and degree, menopause, cardiovascular, and musculoskeletal diagnoses were significantly associated with complementary health visits, as was seeking preventative care or care for a chronic problem.
The authors concluded that these data confirm the growing popularity of complementary health approaches in the United States, provide a baseline for further studies, and inform subsequent investigations of integrative health care.
The authors used the same dataset for a 2nd paper which examined the reasons why office-based physicians do or do not recommend four selected complementary health approaches to their patients in the context of the Andersen Behavioral Model. Descriptive estimates were employed of physician-level data from the 2012 National Ambulatory Medical Care Survey (NAMCS) Physician Induction Interview, a nationally representative survey of office-based physicians (N = 5622, weighted response rate = 59.7%). The endpoints were the reasons for the recommendation or lack thereof to patients for:
- other non-vitamin supplements,
- chiropractic/osteopathic manipulation,
- mind-body therapies (including meditation, guided imagery, and progressive relaxation).
Differences by physician sex and medical specialty were described.
For each of the four complementary health approaches, more than half of the physicians who made recommendations indicated that they were influenced by scientific evidence in peer-reviewed journals (ranging from 52.0% for chiropractic/osteopathic manipulation [95% confidence interval, CI = 47.6-56.3] to 71.3% for herbs and other non-vitamin supplements [95% CI = 66.9-75.4]). More than 60% of all physicians recommended each of the four complementary health approaches because of patient requests. A higher percentage of female physicians reported evidence in peer-reviewed journals as a rationale for recommending herbs and non-vitamin supplements or chiropractic/osteopathic manipulation when compared with male physicians (herbs and non-vitamin supplements: 78.8% [95% CI = 72.4-84.3] vs. 66.6% [95% CI = 60.8-72.2]; chiropractic/osteopathic manipulation: 62.3% [95% CI = 54.7-69.4] vs. 47.5% [95% CI = 42.3-52.7]).
For each of the four complementary health approaches, a lack of perceived benefit was the most frequently reported reason by both sexes for not recommending. Lack of information sources was reported more often by female versus male physicians as a reason to not recommend herbs and non-vitamin supplements (31.4% [95% CI = 26.8-36.3] vs. 23.4% [95% CI = 21.0-25.9]).
The authors concluded that there are limited nationally representative data on the reasons as to why office-based physicians decide to recommend complementary health approaches to patients. Developing a more nuanced understanding of influencing factors in physicians’ decision making regarding complementary health approaches may better inform researchers and educators, and aid physicians in making evidence-based recommendations for patients.
I am not sure what these papers really offer in terms of information that is not obvious or that makes a meaningful contribution to progress. It almost seems that, because the data of such surveys are available, such analyses get done and published. The far better reason for doing research is, of course, the desire to answer a burning and relevant research question.
A problem then arises when researchers, who perceive the use of so-called alternative medicine (SCAM) as a fundamentally good thing, write a paper that smells more of SCAM promotion than meaningful science. Having said that, I find it encouraging to read in the two papers that
- the prevalence of SCAM remains quite low,
- more than 60% of all physicians recommended SCAM not because they were convinced of its value but because of patient requests,
- the lack of perceived benefit was the most frequently reported reason for not recommending it.
Osteopathic visceral manipulation (VM) is a bizarre so-called alternative medicine (SCAM) that has been featured on this blog with some regularity, e.g.:
- Osteopathic visceral manipulation: a new study fails to convince anyone
- Visceral manipulation…you couldn’t make it up
- Intravaginal manipulations by (German) osteopaths: a new low point for clinical research into alternative medicine?
- Visceral osteopathy is implausible and does not work … SO, LET’S FORGET ABOUT IT ONCE AND FOR ALL
Rigorous trials fail to show that it works for anything. So, the obvious solution to this dilemma is to conduct dodgy trials!
This study tested the effects of VM on dysmenorrhea, irregular, delayed, and/or absent menses, and premenstrual symptoms in PCOS patients.
Thirty Egyptian women with polycystic ovary syndrome (PCOS), with menstruation-related complaints and free from systematic diseases and/or adrenal gland abnormalities, participated in a single-blinded, randomized controlled trial. They were recruited from the women’s health outpatient clinic in the faculty of physical therapy at Cairo University, with an age of 20-34 years, and a body mass index (BMI) ≥25, <30 kg/m2. Patients were randomly allocated into two equal groups (15 patients); the control group received a low-calorie diet for 3 months, and the study group that received the same hypocaloric diet added to VM to the pelvic organs and their related structures for eight sessions over 3 months. Evaluations for body weight, BMI, and menstrual problems were done by weight-height scale, and menstruation-domain of Polycystic Ovary Syndrome Health-Related Quality of Life Questionnaire (PCOSQ), respectively, at baseline and after 3 months from interventions. Data were described as mean, standard deviation, range, and percentage whenever applicable.
Of 60 Egyptian women with PCOS, 30 patients were included, with baseline mean age, weight, BMI, and a menstruation domain score of 27.5 ± 2.2 years, 77.7 ± 4.3 kg, 28.6 ± 0.7 kg/m2, and 3.4 ± 1.0, respectively, for the control group, and 26.2 ± 4.7 years, 74.6 ± 3.5 kg, 28.2 ± 1.1 kg/m2, and 2.9 ± 1.0, respectively, for the study group. Out of the 15 patients in the study group, uterine adhesions were found in 14 patients (93.3%), followed by restricted uterine mobility in 13 patients (86.7%), restricted ovarian/broad ligament mobility (9, 60%), and restricted motility (6, 40%). At baseline, there was no significant difference (p>0.05) in any of the demographics (age, height), or dependent variables (weight, BMI, menstruation domain score) among both groups. Post-study, there was a statistically significant reduction (p=0.000) in weight, and BMI mean values for the diet group (71.2 ± 4.2 kg, and 26.4 ± 0.8 kg/m2, respectively) and the diet + VM group (69.2 ± 3.7 kg; 26.1 ± 0.9 kg/m2, respectively). For the improvement in the menstrual complaints, a significant increase (p<0.05) in the menstruation domain mean score was shown in the diet group (3.9 ± 1.0), and the diet + VM group (4.6 ± 0.5). On comparing both groups post-study, there was a statistically significant improvement (p=0.024) in the severity of menstruation-related problems in favor of the diet + VM group.
The authors concluded that VM yielded greater improvement in menstrual pain, irregularities, and premenstrual symptoms in PCOS patients when added to caloric restriction than utilizing the low-calorie diet alone in treating that condition.
WHERE TO START?
- Tiny sample size.
- A trail design (A+B vs B) which will inevitably generate a positive result.
- Questionable ethics.
VM is a relatively invasive and potentially embarrassing intervention for any woman; I imagine that this is all the more true in Egypt. In such circumstances, it is mandatory to ask whether a planned study is ethically justifiable. I would answer this question related to an implausible treatment like VM with a straight NO!
I realize that there may be people who disagree with me. But even those guys should accept that, at the very minimum, such a study must be designed such that it leads to a clear answer – is VM effective or not? The present trial merely suggests that the placebo effect associated with VM is powerful (which is hardly surprising for a therapy like VM).
Spondyloptosis is a grade V spondylolisthesis – a vertebra having slipped so far with respect to the vertebra below that the two endplates are no longer congruent. It is usually seen in the lower lumbar spine but rarely can be seen in other spinal regions as well. Spondyloptosis is most commonly caused by trauma. It is defined as the dislocation of the spinal column in which the spondyloptotic vertebral body is either anteriorly or posteriorly displaced (>100%) on the adjacent vertebral body. Only a few cases of cervical spondyloptosis have been reported. The cervical cord injury in most patients is complete and irreversible. In most cases of cervical spondyloptosis, regardless of whether there is a neurologic deficit or not, reduction and stabilization of the fracture-dislocation is the management of choice
The case of a 16-year-old boy was reported who had been diagnosed with spondyloptosis of the cervical spine at the C5-6 level with a neurologic deficit following cervical manipulation by a traditional massage therapist. He could not move his upper and lower extremities, but the sensory and autonomic function was spared. The pre-operative American Spinal Cord Injury Association (ASIA) Score was B with SF-36 at 25%, and Karnofsky’s score was 40%. The patient was disabled and required special care and assistance.
The surgeons performed anterior decompression, cervical corpectomy at the level of C6 and lower part of C5, deformity correction, cage insertion, bone grafting, and stabilization with an anterior cervical plate. The patient’s objective functional score had increased after six months of follow-up and assessed objectively with the ASIA Impairment Scale (AIS) E or (excellent), an SF-36 score of 94%, and a Karnofsky score of 90%. The patient could carry on his regular activity with only minor signs or symptoms of the condition.
The authors concluded that this case report highlights severe complications following cervical manipulation, a summary of the clinical presentation, surgical treatment choices, and a review of the relevant literature. In addition, the sequential improvement of the patient’s functional outcome after surgical correction will be discussed.
This is a dramatic and interesting case. Looking at the above pre-operative CT scan, I am not sure how the patient could have survived. I am also not aware of previous similar cases. This does, however, not mean they don’t exist. Perhaps most affected patients simply died without being diagnosed. So, do we need to add spondyloptosis to the (hopefully) rare but severe complications of spinal manipulation?