clinical trial
This pragmatic, randomised controlled trial was conducted between September 2018 and February 2021 and compared the difference between primary homoeopathic and conventional paediatric care in treating acute illnesses in children in their first 24 months of life. It was conducted at the Central Council for Research in Homoeopathy (CCRH) Collaborative Outpatient Department of the Jeeyar Integrated Medical Services (JIMS) Hospital in Telangana, India, a tertiary-care hospital that provides integrated patient-centric care, using homoeopathy and Ayurveda alongside conventional medicine.
One hundred eight Indian singleton newborns delivered at 37 to 42 weeks gestation were randomised at birth (1:1) to receive either homoeopathic or conventional primary care for any acute illness over the study period. In the homoeopathic group, conventional medical treatment was added when medically indicated. Clinicians and parents were unblinded.
The study’s primary outcome was a comparison of the number of sick days due to an acute illness experienced during the first 24 months of life by children receiving homoeopathic vs. conventional treatment. Sick days were defined as days with any acute illness (febrile or afebrile) reported by the parent and confirmed by the physician. Febrile illness was recorded when body temperature, measured via the ear canal, exceeded 37.5 °C.
The secondary outcomes compared were as follows:
- The number of sickness episodes, defined as illness events (febrile or afebrile), reported by the parent and confirmed by the physician.
- Number of respiratory illness episodes and days during the 24 months. Respiratory illnesses included infections in any part of the respiratory tract (nose, middle ear, pharynx, larynx, trachea, bronchi, bronchioles, and lungs) .
- Number of diarrhoeal episodes and days during the 24 months. Diarrhoea was defined as three or more episodes of watery stool/day, with or without vomiting, with indications of dehydration, weight loss, or defective weight gain.
- Anthropometric data included weight (measured by electronic scales to the nearest 5 g), height (measured in triplicate to the nearest 0.2 cm using a rigid-length board), head circumference (HC), and mid-upper arm circumference (MUAC) (measured with a standard measuring tape to the nearest 0.2 cm every 3 months until the 24th month).
- Developmental status was evaluated according to the Developmental Assessment Scales for Indian Infants (DASII) every 6 months from the age of 6 to 24 months.
- Direct cost of treatment for illnesses during the 24 months, including cost of medications, inpatient admissions, investigations, supplements, and treatment outside the hospital facility or study site (consultation and/or medicines).
- Use of antibiotics during the 24 months, defined as the number of antibiotic episodes during the study.
- Mortality: death due to any acute illness episode.
The results show that children in the homoeopathic group experienced significantly fewer sick days than those in the conventional group (RR: 0.37, 95% CI: 0.24-0.58; p < 0.001), with correspondingly fewer sickness episodes (RR: 0.53, 95% CI: 0.32-0.87; p = .013), as well as fewer respiratory illnesses over the 24-month period. They were taller (F (1, 97) = 8.92, p = .004, partial eta squared = 0.84) but not heavier than their conventionally treated counterparts. They required fewer antibiotics, and their treatment cost was lower.
The authors concluded that homoeopathy, using conventional medicine as a safety backdrop, was more effective than conventional treatment in preventing sick days, sickness episodes, and respiratory illnesses in the first 24 months of life. It necessitated fewer antibiotics and its overall cost was lower. This study supports homoeopathy, using conventional medicine as a safety backdrop, as a safe and cost-effective primary care modality during the first 2 years of life.
Here we have another study designed in such a way that a positive result was inevitable. Both groups of children received the necessary conventional care and treatment. The verum group received homeopathy in addition. There were no placebo controls and everyone knew which child belonged to which group. Thus the verum group benefitted from a poweful placebo effect, while the control group experience disappointment over not receiving the extra attention and medication. One might argue that newborn babies cannot experience a placebo response nor disappointment. Yet, one would be wrong and in need of reading up about placebo effects by proxy.
A+B is always more than B alone
To boldy entitle the paper ‘Homoeopathy vs. conventional primary care in children during the first 24 months of life’ and state that the trial aimed to “compared the difference between primary homoeopathic and conventional paediatric care in treating acute illnesses in children in their first 24 months of life”, is as close to scientific misconduct as one can get, in my view!
Yet again, I might ask: what do we call a study that is designed in such a way that a positive result was inevitable?
- misleading?
- waste of resources?
- unethical?
- fraud?
And again, I let you decide.
PS
I feel disappointed that a decent journal published this paper without even a critical comment!
In China, acupuncture has been employed as an adjunctive therapy for coronavirus disease 2019 (COVID-19). Press needle acupuncture is a special type of acupuncture that provides prolonged stimulation to acupuncture points. This study assessed the effectiveness of integrating press needles alongside pharmacologic treatment in patients with mild-to-moderate COVID-19.
Patients hospitalized with mild-to-moderate COVID-19 symptoms between December 2022 and January 2023 were included in the study. The enrolled patients were randomly assigned to receive:
- pharmacologic treatment alone (control group),
- or both pharmacologic treatment and press needle acupuncture (intervention group).
Patients were evaluated for clinical outcomes, including symptom scores, deterioration rates, fever durations, and nucleic acid test results. The patients’ complete blood count and C-reactive protein levels were also analyzed using venous blood samples both before and after treatment.
Both groups exhibited a reduction in clinical symptom scores, but symptoms regressed faster in the intervention group. Nucleic acid test negativity was achieved faster in the intervention group than in the control group. The intervention group also had a lower deterioration rate. Furthermore, the increase in the lymphocyte count and decrease in C-reactive protein levels following treatment were more pronounced in the intervention group than in the control group.
The authors concluded that this study suggests that utilizing press needle acupuncture as an adjunct to pharmacologic treatment can be effective in patients with mild-to-moderate COVID-19 symptoms.
To understand this study better, we need to comprehend the nature of the therapeutic ritual. This is how the authors describe it:
For each session, press needles were inserted into acupoints and kept in place for approximately 24 hours. Only 1 side of the body (left or right) was treated in each session. The following day, press needles were removed from 1 side of the body, and new press needles were placed on acupoints on the other side of the body. Press needle acupuncture was performed by a qualified physician who had completed comprehensive acupuncture training. By contrast, patients in the control group solely received daily pharmacologic treatment, such as Lianhua Qingwen granules, with ibuprofen added as needed for fever management. Study participants were instructed to notify researchers of the appearance of clinical symptoms, and they were prohibited from participating in other studies during the trial period.
So, neither the patients nor the therapists were blinded. To call such a study “single-blind” is a bit odd! And are we really supposed to assume that the verum therapy did not generate placebo effects?
What we have here, I fear, is a classic example of a study designed such that it cannot possibly produce a negative result. It followed the A+B versus B design and employed a treatment that is bound to generate a sizable placebo response. What is even worse, the authors do discuss the limitations of their study but ignore the ‘elefant in the room’: ” this study had several limitations. The sample size was modest, and basic randomization was used without stratification based on comorbidities, which could have introduced bias.”
What do we call a study that cannot possibly produce a negative result?
- A waste of resources?
- Fraud?
- Misleading?
- Naive?
- Unethical?
I leave the answer to you.
The objective of the present double-blind, randomized, placebo-controlled, feasibility trial was to identify the effects of individualized homeopathic medicinal products (IHMPs) against placebos in post-COVID-19 conditions. Sixty participants with post-COVID-19 conditions were randomised into either:
- group verum (n = 30; IHMPs plus concomitant care),
- group control (n = 30; placebos plus concomitant care).
Feasibility issues; primary—post-COVID-19 symptoms checklist; secondary—Measure Yourself Medical Outcomes Profile version 2 (MYMOP-2); all of them were measured at baseline, and monthly intervals, up to 3 months. The intention-to-treat sample was analyzed; group differences were reported using descriptive statistics: means, 95% confidence intervals (CIs), and between group effect sizes (Cohen’s d).
Feasibility concerns showed promise; recruitment, retention, and attrition rates were 34.2%, 95%, and 5%, respectively. Group differences in both primary and secondary outcomes favored IHMPs against placebos: symptoms checklist score mean difference after 3 months: −4.2, 95% CI −4.9 to −3.4, d = 2.854 and MYMOP-2 mean difference after 3 months: −2.2, 95% CI −2.8 to −1.7, d = 2.082, respectively. Natrum muriaticum (11.7%), Pulsatilla nigricans (10%), Rhus toxicodendron (8.3%), and Calcarea carbonica (8.3%) were the most frequently prescribed remedies.
The authors concluded that IHMPs produced better results than placebos in reducing symptoms checklist scores and MYMOP-2 scores in the treatment of post-COVID-19 conditions. Definitive trials are warranted to confirm the findings.
A feasibility study (the authors employ this term repeatedly) has – as I have often pointed out – the purpose of testing whether a trial disign, set-up, etc. is FEASIBLE. It is not meant to report other outcome data.
Why?
Mainly because such studies are far too underpowered for generating reliable results!
This means that the present findings can be ignored. They are most likely caused by chance.
Why are they published anyway, and why could the authors find a journal that goes along with such nonsense?
Are they too stupid or are they biased or both?
The nature of the journal might provide a hint for answering these questions (J Integr Complement Med), and so does the list of authors and their affiliations:
- 1Department of Organon of Medicine and Homoeopathic Philosophy, D. N. De Homoeopathic Medical College and Hospital, Govt. of West Bengal, Kolkata, India.
- 2Department of Pathology and Microbiology, D. N. De Homoeopathic Medical College & Hospital, Govt. of West Bengal, Kolkata, India.
- 3Department of Practice of Medicine, D. N. De Homoeopathic Medical College and Hospital, Govt. of West Bengal, Kolkata, India.
- 4Department of Homeopathy, East Bishnupur State Homoeopathic Dispensary, Chandi Daulatabad Block Primary Health Centre, Department of Health & Family Welfare, Govt. of West, Kolkata, India.
- 5Department of Repertory, D. N. De Homoeopathic Medical College and Hospital, Govt. of West Bengal, Kolkata, India.
- 6Department of Community Medicine, D. N. De Homoeopathic Medical College and Hospital, Govt. of West Bengal, Kolkata, India.
I rest my case.
- mind-body medicine (32.0%),
- massage (16.1%),
- chiropractic (14.4%),
- acupuncture (3.4%),
- naturopathy (2.2%),
- art and/or music therapy (2.1%).
Reporting post-COVID-19 was associated with an increased likelihood of using any SCAM in the last 12 months (AOR = 1.18, 95% CI [1.03, 1.34], p = 0.014) and specifically to visit an art and/or music therapist (AOR = 2.56, 95% CI [1.58, 4.41], p < 0.001). The overall use of any SCAM was more likely among post-COVID-19 respondents under 65 years old, females, those with an ethnical background other than Hispanic, African-American, Asian or Non-Hispanic Whites, having a higher educational level, living in large metropolitan areas and having a private health insurance.
Approximately 30% of children diagnosed with attention-deficit/hyperactivity disorder (ADHD), the most prevalent mental health disorder in children worldwide, do not respond to conventional pharmaceutical treatments. Previous studies of homeopathic treatment for ADHD have been inconclusive. 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 was the change of CGI-P T score between baseline and 28 weeks.
There was an improvement in ADHD symptoms as measured by the Conner 3 Global Index-Parent 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.
This is an interesting study. It – yet again! – confirms that the effects observed after homeopathic treatments are not due to the remedie but are caused by the interaction with the homeopath. To put it more clearly:
HOMEOPATHIC REMEDIES HAVE NO SPECIFIC EFFECTS; ANY BENEFITS ARE DUE TO THE EFFECTS OF THE THERAPEUTIC ENCOUNTER AND OTHER NON-SPECIFIC EFFECTS.
This study analyzed the effect of a protocol based on the Mat Pilates method in an intervention group compared to a usual care control group, on quality of life, fatigue and body image of head and neck cancer survivors.
The study was designed as a randomized clinical trial with 30 survivors, allocated into an intervention group and a control group.
- The intervention group underwent a 12-week Mat Pilates, twice a week, one hour long.
- The control group attended two lectures and received weekly follow-up throughout the study period.
Data collection took place through individual face-to-face interviews, focusing on assessing the outcomes: quality of life (FACT-H&N); fatigue (FACT-F) and body image (BIS).
The Mat Pilates group showed significant improvements compared to the control group in both intra-group and inter-group analyses across the variables:
- quality of life (in total score (p = 0.007)/(p = 0.003),
- family well-being (p = 0.001)/(p = 0.008),
- functional well-being (p = 0.001)/(p = 0.001)),
- body image in the total score (p = 0.001)/(p = 0.001),
- subscales: body image (p = 0.046)/(p = 0.010),
- body care (p = 0.026)/(p = 0.010),
- body touch (p = 0.013)/(p = 0.022),
- fatigue (p = 0.006)/(p = 0.003).
The authors concluded that, based on these findings, future research could delve deeper into understanding the long-term effects of Mat Pilates interventions on quality of life, body image, and fatigue levels among survivors of head and neck cancer.
These conclusions are prudently cautious. The reason for this caution probably is the fact that the findings tell us far less than the results might imply.
The naive reader would think they show the effectiveness of pilates excercises. This, however, would be erroneous. The positive results are to be expected, if only due to the extra attention given to the verum patients or the disappointment of the control group for not receiveing it.
If we truly want to evaluate the specific effects of a treatment like pilates, we need to design a different type of study. Nobody doubts that group excercise can improve plenty of subjective parameters. The question, I think, is whether pilates is better in achieving this aim than other forms of excercise. Thus we might need an equivalence study comparing two or more forms of excercise. Such studies are more difficult to plan and conduct. Yet, without them, I fear that we will not be able to determine the value of specific forms of excercise.
This study aimed to determine the effects of Reiki on pain and biochemical parameters in patients undergoing bone marrow transplantation. This investigation was designed as a “single-blind, repeated measures, randomized prospective controlled study”. It was conducted between August 2022 and April 2023 with patients who underwent autologous bone marrow transplantation (BMT).
- In the Reiki group (n = 21), Reiki therapy was applied directly to the energy centers for 30 min on the 0th and 1st day of BMT, and from a distance for 30 min on the 2nd day.
- No intervention was performed on the control group (n = 21).
Data were collected using the Personal Information Form, Visual Analog Scale (VAS), and biochemical parameters. Pain and biochemical parameters were evaluated on days 0, 1, 2, and 10 before the Reiki application.
There were no statistically significant differences in pain scores between the groups before the intervention (p > .005). The Reiki group showed a significant improvement in the mean VAS score compared with the control group on days 1 and 2 (p = .002; p < .001, respectively). The measurement of procalcitonin showed a decrease in the Reiki group and an increase in the control group (p = .026, p = .001, p < .001, respectively). Although the Reiki group had better absolute neutrophil, thrombocyte, and C-reactive protein values than the control group, no significant difference was observed between the groups (p > .05).
The authors concluded that Reiki is effective for pain control and enhancing the immune system response.
For the following reasons, I beg to differ:
- The patients of the verum group were fully aware of receiving the therapy; thus they were expecting/hoping to benefit from it.
- The patients of the control group received no therapy; thus they were disappointed which may have influenced thie VAS ratings.
- The procalcitonin levels are of doubtful relevance; they changed only within the group which, in a controlled clinical trial that is supposed to compare groups is meaningless and most likely a chance finding.
- The only people who could have been blinded in this ‘single blind’ study were the evaluators of the results (even though the authors state that “patients were blinded to the group assignments”) which is meaningless if patients and therapists are not blinded.
Because of all this, I feel that the conclusions should be re-written:
Reiki is known to cause a placebo effect which most likely caused the observed outcomes.
This study aimed at examining the feasibility issues of comparing individualized homeopathic medicines (IHMs) with identical-looking placebos for treating knee osteoarthritis (OA).
Forty eligible patients participated in this double-blind, randomized (1:1), placebo-controlled feasibility trial in the outpatient clinics of a homeopathic hospital in West Bengal, India. Either IHMs or identical-looking placebos were administered, along with mutually agreed-upon concomitant care guidelines. The Knee Injury and Osteoarthritis Outcome Score (KOOS) was the primary outcome measure, along with derived Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores from KOOS. The EQ-5D-5L questionnaire and Visual Analog Scale (VAS) were the secondary outcomes. All were measured at baseline and after 2 months. Group differences and effect sizes (Cohen’s d) were estimated using an intention-to-treat approach. p-Values less than 0.05 (two-tailed) were considered statistically significant.
Enrolment/screening and trial retention rates were 43% and 85% respectively. Recruitment was difficult owing to the coronavirus disease 2019 (COVID-19) lockdown. Group differences were statistically significant, favoring IHMs against placebos in all the KOOS sub-scales: symptoms (p < 0.001), pain (p = 0.002), activities of daily living (p < 0.001), sports or recreation (p = 0.016), and quality of life (p = 0.002). Derived WOMAC scores from KOOS favored IHMs against placebos: stiffness (p < 0.001) and pain (p < 0.001). The EQ-5D-5L questionnaire score (p < 0.001) and EQ-5D-5L VAS scores (p < 0.001) also yielded significant results, favoring IHMs over placebos. All the effect sizes ranged from moderate to large. Sulphur was the most frequently prescribed homeopathic medication. Neither group reported any harm or serious adverse events.
The authors concluded that, although recruitment was sub-optimal due to prevailing COVID-19 conditions during the trial, the action of IHMs was found to be superior to that of placebos in the treatment of knee OA. Larger and more definitive studies, with independent replications, are warranted in order to substantiate the findings.
Sorry, but I don’t understand this: the authors stated multiple times that this was a feasibility study (which tests feasibility and not effectiveness), and then they promptly report effectiveness data for which the trial was grossly under-powered (i.e. too small). Why are they doing such nonsense? Perhaps their affiliations provide a hint?
- 1Department of Materia Medica, D. N. De Homoeopathic Medical College and Hospital, Kolkata; affiliated to The West Bengal University of Health Sciences, Kolkata, West Bengal, India.
- 2Department of Repertory, D.N. De Homoeopathic Medical College and Hospital, Kolkata, West Bengal, India.
- 3Department of Organon of Medicine and Homoeopathic Philosophy, D.N. De Homoeopathic Medical College and Hospital, Kolkata, West Bengal, India.
- 4Department of Practice of Medicine, D.N. De Homoeopathic Medical College and Hospital, Kolkata, West Bengal, India.
- 5Department of Surgery, D.N. De Homoeopathic Medical College and Hospital, Kolkata, West Bengal, India.
- 6Department of Homoeopathy, East Bishnupur State Homoeopathic Dispensary, Chandi Daulatabad Block Primary Health Centre, West Bengal, India.
- 7Department of Community Medicine, D.N. De Homoeopathic Medical College and Hospital, Kolkata, West Bengal, India.
I do symathise with the pressures of reporting positive findings, if your salary comes from homeopathic institutions. Yet, I cannot help but pointing out:
THESE FINDINGS ARE INVALID AND FALSE-POSITIVE!
The aim of this non-inferiority randomised controlled study was to assess the efficacy and safety of laughter exercise in patients with symptomatic dry eye disease.
Recruitment was from clinics and community and the trial took place at Zhongshan Ophthalmic Center, Sun Yat-sen University, the largest ophthalmic centre in China, between 18 June 2020 to 8 January 2021. Patients were admitted with symptomatic dry eye disease aged 18-45 years with ocular surface disease index scores ranging from 18 to 80 and tear film break-up time of eight seconds or less.
Participants were randomised 1:1 to receive laughter exercise or artificial tears (0.1% sodium hyaluronic acid eyedrop, control group) four times daily for eight weeks. The laughter exercise group viewed an instructional video and participants were requested to vocalise the phrases “Hee hee hee, hah hah hah, cheese cheese cheese, cheek cheek cheek, hah hah hah hah hah hah” 30 times per five minute session. Investigators assessing study outcomes were masked to group assignment but participants were unmasked for practical reasons.
The primary outcome was the mean change in the ocular surface disease index (0-100, higher scores indicating worse ocular surface discomfort) from baseline to eight weeks in the per protocol population. The non-inferiority margin was 6 points of this index score. Main secondary outcomes included the proportion of patients with a decrease from baseline in ocular surface disease index score of at least 10 points and changes in dry eye disease signs, for example, non-invasive tear break up time at eight weeks.
A total of 299 participants (mean age 28.9 years; 74% female) were randomly assigned to receive laughter exercise (n=149) or 0.1% sodium hyaluronic acid (n=150). 283 (95%) completed the trial. The mean change in ocular surface disease index score at eight weeks was −10.5 points (95% confidence interval (CI) −13.1 to −7.82) in the laughter exercise group and −8.83 (−11.7 to −6.02) in the control group. The upper boundary of the CI for difference in change between groups was lower than the non-inferiority margin (mean difference −1.45 points (95% CI −5.08 to 2.19); P=0.43), supporting non-inferiority. Among secondary outcomes, the laughter exercise was better in improving non-invasive tear break up time (mean difference 2.30 seconds (95% CI 1.30 to 3.30), P<0.001); other secondary outcomes showed no significant difference. No adverse events were noted in either study group.
The authors concluded that the laughter exercise was non-inferior to 0.1% sodium hyaluronic acid in relieving subjective symptoms in patients with dry eye disease with limited corneal staining over eight weeks intervention.
Laughter or humour therapy is the use of laughter for therapeutic purposes. Laughter therapy is mostly practised in groups. In some hospitals, clowns are also employed for laughter therapy of children. The contagious nature of laughter is used to make participants laugh. Consequently, they relax which can have positive effects on health. Laughter is said to decrease blood levels of cortisol, epinephrine, growth hormone, and 3,4-dihydrophenylacetic acid (a major dopamine catabolite), indicating a reversal of the stress response. Laughter therapy is claimed to provide physical benefits, such as helping to:
- Relax muscles throughout the body
- Trigger the release of endorphins (the body’s natural painkillers)
- Relieve pain
- Improve mental functions (i.e., alertness, memory, creativity)
- Improve overall attitude and well-being
- Reduce stress/tension
- Improve sleep
- Strengthen social bonds and relationships.
Many of these outcomes are, however, not as well-documented as claimed by proponents. A systematic review concluded that “trials with clown doctors in pediatric population have shown conflicting results in allaying anxiety amongst children undergoing either hospitalization or invasive procedures.” Another assessment was more positive: “the meta-analysis confirmed the effectiveness of pre-operative clown therapy on reducing psychological distress in children and parents.” Yet another review concluded that “there exists sufficient evidence to suggest that laughter has some positive, quantifiable effects on certain aspects of health.” Finally, the most recent recent review showed that laughter therapy “can have beneficial effects on a variety of health-related outcomes including mental health, physical health, and physiological parameters.”
[references are in my book]The above trial is a well designed study with an interesting result. Laughing can, of course, produce tears; thus the findings seem plausible. Yet, I am not convinced that vocalising the phrases “Hee hee hee, hah hah hah, cheese cheese cheese, cheek cheek cheek, hah hah hah hah hah hah” 30 times per five minute session is the best way to do laughter therapy. Perhaps chopping omions for five minutes would be even be more tear-inducing?
Osteoarthritis of the knee (OAK) is a chronic degenerative musculoskeletal disorder that strongly affects the elderly population and decreases their quality of life. Pain, stiffness, and restricted knee movements are the major characteristic features of OAK. There are no studies available on the effect of the liver 7 (LR 7) acupuncture point on pain and range of motion. This study therefore tested the effectiveness of the LR 7 acupuncture point on pain and range of motion in chronic OAK patients.
Thirty-five subjects aged between 40 and 65 years were recruited from Government Yoga and Naturopathy Medical College, Chennai. Participants were included in the study after they fulfilled the eligibility criteria. The duration of acupuncture was 20 minutes (5 days/week) for 2 weeks. Baseline and post-intervention assessments were performed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and the degree of knee flexion and extension was measured using a goniometer.
Pre- and post-trial outcomes were compared using paired t-tests. LR 7 acupuncture reduced the WOMAC score from 49 to 30 (p < 0.001), indicating that pain was alleviated. Treatment increased the range of knee flexion from 110 to 115 degrees and reduced knee extension (p < 0.01) from 16 to 9 degrees (p < 0.001). These findings indicate that acupuncture treatment improved the range of knee movement.
The authors concluded that the present study showed that 10 sessions of LR 7 acupuncture for people with OAK significantly reduced pain and increased range of motion. We conclude that LR 7 acupuncture is an adjuvant therapy for alleviating pain and managing OAK.
On several levels, this is a shocking paper:
- There already are many controlled clinical trials of acupuncture for OAK; thus there is no reason whatsoever to conduct and publish a trial that is methodolagically inferior to this body of evidence.
- The conclusions are incorrect; as the study had no control group, it is impossible to establish causaality between the treatment and the outcome. The pain reduction might have been caused by phenomena that are unrelated to acupuncture, e.g. placebo effect, regression towards the mean, social desirability.
- The authors state that they are “grateful to principal and faculities of government of yoga and naturopathy medical college and hospital for their support”. This means that they were misguided by a governmental medical college and hospital in planning and running a study that is a waste of resources and thus arguably unethical.
Research of this nature is dangerous:
- It undermines the trust people put in science.
- It makes a laughing stock of more serious attempts to test the value of acupuncture.
- It misuses the cooperation of patients who give their time and good will to advance our knowledge.
- It wasts precious resources.
- It is an incentive for others to do similarly nonsensical pseudo-science.
- It misleads patients and carers into believing in quackery.
The only valid conclusion that can be drawn from this paper is, I think, this:
The people involed in planning, conducting, supporting and publishing this study have little understanding of clinical research and should receive adequate education and training before they are allowed to continue.
