MD, PhD, MAE, FMedSci, FRSB, FRCP, FRCPEd.

study design

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The Academy of Homeopathy Education is a US-based accredited teaching institution offering homeopathy education services to professional and medically licensed homeopathy students. This study reports on clinical outcomes from the teaching clinic from 2020 to 2021.

Data were collected using the patient-generated outcome measure, the Measure Yourself Concerns and Wellbeing (MYCaW). Mean MYCaW values for initial and subsequent consultations were analyzed for the degree of change across the intervention period in 38 clients. Each client listed up to two complaints. MYCaW scores between initial and subsequent consultations were analyzed for the degree of change (delta) across the intervention period.

A total of 95 body system-related symptoms were analyzed for change in intensity following the homeopathic intervention. Statistically significant improvements in the intensity of main symptoms were observed between initial and subsequent follow-ups. The main symptom scores showed a mean change in intensity (delta MYCaW) of −0.79 points (95% confidence interval (CI), −1.29 to −0.29; p = 0.003) at first follow-up, a mean change of −1.67 points (95% CI, −2.34 to −0.99; p = 0.001) at second follow-up compared with the initial visit, and a mean change of −1.93 points (95% CI, −3.0 to −0.86; p = 0.008) at third follow-up compared with the initial visit. For clients with four or more follow-ups, the mean delta MYCaW was −1.57 points (95% CI, −2.86 to −0.28; p = 0.039).

The authors concluded that statistically significant improvements as well as some clinically meaningful changes in symptom intensity were found across a diverse group of individuals with a variety of long-term chronic conditions. The improvement was evident across different body systems and different levels of chronicity. There are limitations to the generalizability of the study due to the research design. Further research and investigation are warranted given the promising results of this work.

There are, of course, not just limits to the generalizability of this study! I’d say there are limits to the interpretation of any of its findings.

What was the cause of the improvements?

Here are just a few questions that I asked myself while reading this paper:

  • Are the guys from the Academy of Homeopathy Education not aware of the fact that even chronic conditions often get better by themselves?
  • Have they heard of the placebo effect?
  • Are they trying to tell us that the patients did not also use conventional treatments for their chronic conditions?
  • What about regression towards the mean?
  • What about social desirability?
  • Why do they think that further research is needed?
  • Are these really results that look ‘promising for homeopathy?

To answer just the last question: No, these findings are in perfect agreement with the fact that highly diluted homeopathic remedies are pure placebos (to be honest, they would even be in agreement with such remedies being mildly harmful).

 

Rheumatoid arthritis (RA) is a chronic, systemic, polyarticular autoimmune inflammatory disease that destroys the capsule and synovial lining of joints. Antirheumatic treatment reduces disease activity and inflammation, but not all patients respond to treatment. Naturopathy is claimed to be effective, but there is little data on the effect on inflammation and disease activity in RA. The objective of this study was therefore to explore the effect of 12 weeks of integrated naturopathy interventions on disease-specific inflammatory markers and quality of life in RA patients.

A total of 100 RA patients were randomized into two groups:

  • the naturopathy group (integrated naturopathy interventions with routine medical therapy),
  • the control group (only with routine medical therapy).

Blood samples were collected pre- and post-intervention for primary outcome measurements of systemic inflammatory markers (ESR, CRP, and IL-6). Disease activity score (DAS-28) and quality of life were used to assess disease activity and functional status using SF-36, respectively, at pre- and post-intervention time points.

The results show a notable decrease in disease activity after 12 weeks of naturopathy intervention. As such, a significant decrease was found in levels of systemic inflammatory markers such as ESR (p = 0.003) and IL-6 (p < 0.001), RA disease activity score (DAS-28) (p = 0.02), and most of the components of health-related quality of life (SF 36 scores) (p < 0.05) except in vitality (p = 0.06).

The authors conclused that the findings of the present study suggest that integrated naturopathy treatments may have the ability to control persistent inflammation, maintain immune homeostasis, and lower disease activity.

The naturopathic treatments included:

  • acupuncture,
  • hot and cold-water application to the painful joints,
  • sauna baths,
  • enemas,
  • fasting,
  • mud therapy,
  • massage therapy.

The study was designed as an A+B versus B trial. Therefore, it is hardly surprising that subjective endpoints improved. A little more baffling are the changes in objective parameters. These could easily be due to the fasing interventions – there is reasonably sound evidence for such effects. Take this review, for instance:

Fasting is an act of restricting, for a certain length of time, food intake or intake of particular foods, and has been part of religious rituals for centuries. Religions such as Christianity and Islam use this practice as a form of sacrifice, self-discipline, and gratitude. However, in the past decade, fasting has penetrated the mainstream as a diet trend. There are several ways of fasting; existing fast mimicking eating methods promise accelerated weight loss, and many more benefits: lower cholesterol, prevention of type 2 diabetes and a longer lifespan. Even more, it has been proposed that fasting can downregulate the inflammatory process and potentially be used as a treatment regimen for several diseases. Here, we review the effects of fasting on immune and inflammatory pathways. Also, we present current knowledge about the role of fasting in the activity of inflammatory arthritides with a focus on rheumatoid arthritis.

What I am trying to say is this: some modalities used in naturopathy might well be effective in treating certain conditions. In my view, this is, however, no reason for condoning or recommening naturopathy as a whole. Or – to put it bluntly – naturopathy is a weird mixture of pure nonsense and some possibly reasonable interventions.

This systematic review and meta-analysis aimed to evaluate the effectiveness of spiritually based interventions on blood pressure (BP) among adults. A systematic search was performed using the PubMed, Scopus, and Cochrane databases to identify studies evaluating spiritual interventions, including:

  • meditation,
  • transcendental meditation,
  • mindfulness meditation,
  • yoga,

for high BP among adults up to January 1, 2022.

The inclusion criteria were:

  • (a) randomized controlled trials (RCTs),
  • (b) studies in English or Persian,
  • (c) studies conducted among adults (≥ 18 years),
  • (d) studies reporting systolic or diastolic BP.

Given the high heterogeneity of these studies, a random effect model was used to calculate the effect sizes for the RCTs.

In total, the systematic review included 24 studies and the meta-analysis included 23 studies. As some of studies reported two or more outcome measurements, separate estimates of each outcome were extracted for that study (24 datasets). Fifteen trials reported the mean (SD) systolic blood pressure (SBP), and 13 trials reported the mean (SD) diastolic blood pressure (DBP). In addition, 13 studies reported means (SDs) and six trials reported mean changes in DBP. A significant decrease was found in systolic BP following intervention ((WMD (weighted mean difference) =  − 7.63 [− 9.61 to − 5.65; P < 0.001]). We observed significant heterogeneity among the studies (I2 = 96.9; P < 0.001). A significant decrease was observed in DBP following the interventions (WMD =  − 4.75 [− 6.45 to − 3.05; P < 0.001]).

The authors concluded that spiritually based interventions including meditation and yoga had beneficial effects in reducing both SBP and DBP. Reducing BP can be expected to reduce the risk of cardiovascular diseases.

Q: What do the RCTs of these interventions have in common?

A: They cannot normally be placebo-controlled because no adequate placebos exist for these therapies.

Q: What does that mean?

A: It means that patients could not be blinded and that patient expectations influenced the outcome.

In view of the fact that blood pressure is an endpoint that is extremely sensitive to expectation, I think, the conclusions of this paper might need to be re-formulated:

This analysis confirms that expectation can have beneficial effects in reducing both SBP and DBP. Reducing BP can be expected to reduce the risk of cardiovascular diseases.

Pre-diabetes is a significant public health problem worldwide. India has a very high rate of progression from pre-diabetes to diabetes, 75-78 per thousand persons per year.

The objective of this study was to test the efficacy of individualized homeopathic medicinal products (HMPs) against placebos in preventing the progression from pre-diabetes to diabetes. It was designed as a ix-month, double-blind, randomized (1:1), two parallel arms, placebo-controlled trial.

Sixty participants with pre-diabetes were treated either with:

  • HMPs plus yoga therapy (YT; n = 30)
  • or with identical-looking placebos plus YT (n = 30).

Pre-diabetes was defined as elevated fasting blood glucose (FBS) of 100-125 mg/dL, glycated hemoglobin (HbA1c) value of 5.7-6.4%, and/or an elevated blood glucose level 2 hrs. after an oral glucose tolerance test (OGTT) of 140-199 mg/dL (ICD-10-R73.03).

The primary efficacy endpoint was the proportion of participants progressing from pre-diabetes to diabetes, measured after three and six months. Secondary outcomes comprised of fasting blood glucose (FBS), oral glucose tolerance test (OGTT), glycated hemoglobin percentage (HbA1c%), lipid profile, liver enzymes (alanine transaminase, aspartate transaminase), urea and creatinine, and Measure Yourself Medical Outcome Profile version 2 (MYMOP-2); all measured after 3 and 6 months.

The proportion of participants converted from pre-diabetics to diabetics (n/N; n = diabetics, N = prediabetics) was significantly less in the verum group than control: HbA1C% (month 3: verum – 2/30 versus control – 11/30, p = 0.003; month 6: 3/30 vs. 2/30, p = 0.008), OGTT (month 3: 0/30 vs. 8/30, p = 0.015; month 6: 0/30 vs. 1/30, p = 0.008), but not according to FBS (month 3: 1/30 vs. 1/30, p = 0.779; month 6: 1/30 vs. 3/30, p = 0.469). Several secondary outcomes also revealed significant improvements in the verum group than in placebo: HbA1C% (p < 0.001), OGTT (p = 0.001), serum ALT (p = 0.031), creatinine (p = 0.012), and MYMOP-2 profile scores (p < 0.001). Sulphur, Bryonia alba, and Thuja occidentalis were the most frequently indicated medicines. Thus, HMPs outperformed placebos by successfully preventing the progression of pre-diabetes to diabetes.

The authors concluded that HMPs with YT produced significantly better effects than placebos plus YT with moderate to large effect sizes. Overall, HMPs outperformed placebos by successfully preventing the progression of pre-diabetes to diabetes.

This is an odd study with very odd results; it begs several questions and comments, e.g.:

  • If the aim was to test the efficacy of individualized homeopathic medicinal products (HMPs) against placebos in preventing the progression from pre-diabetes to diabetes, why add yoga as a treatment?
  • What were the influences of other factors such as diet and life-style, and were these the same in both groups?
  • The sample size seems far too small for such firm conclusions.
  • What might be the alleged mechanism of action?
  • Why not publish such a study that has allegedly important results in one of the many established journals dealing with diabetes?

I fear that this trial is merely one in the long list of poor quality, false-positive homeopathy studies that are currently emerging from India. I predict that the findings will not even be taken seriously enough to be submitted to a replication by established diabetes researchers.

Cervical spondylosis is a chronic degenerative process of the cervical spine characterized by pain in neck, degenerative changes in intervertebral disc and osteophyte formation. The present study was aimed at evaluating the effect of wet cupping (Ḥijāma Bish Sharṭ) in the pain management of cervical spondylosis.

This Open, randomized, clinical study was conducted on 44 patients.

  • Subjects in the test group (n = 22) received a series of three-staged wet cupping treatment, performed on 0, 7th and 14th day.
  • Subjects in the control group (n = 22) received 12 sittings of Transcutaneous Electrical Nerve Stimulation (TENS): 6 sittings per week for two weeks.

The outcomes were assessed with the help of VAS, Neck Disability Index (NDI) and Cervical range of motion.

Intra group comparison in test group from baseline to 21st day were found highly significant (p < 0.001) in terms of VAS, NDI, Flexion, Extension and Left rotation score. While in Right rotation, Left rotation and Left lateral flexion score were found moderately significant (p < 0.01). Statistically significant difference was observed between two groups at 21st day in VAS scale, NDI, and Cervical range of motion score (p < 0.001).

The authors concluded that Ḥijāma Bish Sharṭ was found better in the management of pain due to cervical spondylosis than TENS. It can be concluded that Ḥijāma Bish Sharṭ may a better option for the pain management of cervical spondylosis.

Wet cupping is the use of a vacuum cup applied to the skin which has previously been lacerated. It draws blood and can thus be seen as a form of blood letting. It has been used in various cultures for the treatment of joint pain and many other conditions since antiquity.

The authors point out that, in Unani medicine, it is believed to reduce pain and other symptoms by diverting and evacuating the causative pathological humours (akhlāṭ-e-fasida). Galen (Jalinoos) mentioned wet cupping as a very useful modality in evacuating the thick humours (akhlāṭ-e-Ghaleez) (Nafeesi, 1954; Qamri, 2008). Wet cupping works on the principle of diversion and evacuation of morbid matter (imala wa tanqiya-i-mawād-i-fasida). It opens the pores of the skin, enhances the blood circulation, nourishes the affected area with fresh blood, improves the eliminative function and facilitates the evacuation of morbid matter from the body.

There are several studies of wet cupping, most of which are as flawed as the one above. This new trial has several limitations, e.g.:

  • It makes no attempt to control for placebo effects which could well be more prominent for wet cupping than for TENS.
  • It did not inhibit the influence of verbal or non-verbal communications between therapists and patients which are likely to influence the results.
  • The sample size is far too small, particularly as the study was designed as an equivalence study.

But some might say that my arguments a petty and argue that, regardless of a flimsy study, wet cupping is still worth a try. I would disagree – not because of the flaws of this study, nor the implausibility of the long-obsolete assumptions that underpin the therapy, but because wet cupping is associaated with infections of the skin lacerations which occasionally can be serious.

 

Some abstracts of medical papers are so bizarre that they must not be tempered with, I find. This is one of them:

Rationale:

This case report aims to provide clinical evidence on the effectiveness of integrating chiropractic and moxibustion techniques for treating pseudomyopia accompanied by elevated intraocular pressure resulting from cervical spine issues because the application of complementary medicine modalities for managing such vision disorders currently lacks adequate investigations.

Patient concerns:

A 6-year-old patient presented with blurred vision, intermittent ocular discomfort, and upper cervical discomfort.

Diagnoses:

Spine-related increased intraocular pressure and pseudomyopia.

Interventions:

The patient received integrative treatment of chiropractic and walnut-shell moxibustion 3 times a week for a total of 10 treatment sessions.

Outcomes:

The patient exhibited progressive improvements in visual acuity and reductions in intraocular pressure over the treatment period, with unaided vision exceeding 2 lines of improvement in visual acuity charts and normalized intraocular pressure after 10 treatment sessions. These therapeutic effects were sustained at 3-month follow-up.

Lessons:

The integrative use of chiropractic and walnut-shell moxibustion demonstrates considerable potential in alleviating symptoms of pseudomyopia, reducing intraocular pressure, and restoring visual function in spine-related pseudomyopia cases.

Pseudomyopia is a spasm of the ciliary muscle that prevents the eye from focusing in the distance. It differs from myopia which is caused by the eye’s shape or other basic anatomy. Pseudomyopia may be either organic, through stimulation of the parasympathetic nervous system, or functional in origin, through eye strain or fatigue of ocular systems. It is common in young adults after a change in visual requirements, such as students preparing for an exam, or a change in occupation. The condition is often transitory and it is necessary to request psychiatric consultation in each case of pseudomyopia. Comorbidity of anxiety and depressive disorders is more common in pseudomyopia cases. In addition, as the severity of psychiatric symptoms increases, the amount of accommodation also appears to increase.

A few question, if I may:

  • Walnut-shell moxibustion? Yes, it exists! Moxibustion with walnut shell spectacles is a characteristic therapy of Guang’anmen Hospital, developed on the basis of walnut shell moxibustion, and mainly composed of an eye moxibustion frame, a walnut shell soaked with wolfberry and chrysanthemum liquid, and moxibustion strips. Moxibustion with a walnut shell was first recorded by Shicheng Gu for treating surgical ulcers in the Qing dynasty. Then, moxibustion with walnut shell spectacles was reformed by us, combining Shicheng Gu’s experience with our clinical practice, and is mainly used for the treatment of optic nerve atrophy and myopia.
  • The authors state that, “based on traditional Chinese medicine principles, moxibustion is known to warm meridians, dredge collaterals, relax tendons, and enhance blood circulation”. Is this true? Well, based on TCM, anything goes, but it does not make it true.
  • How can we know whether chiropractic or walnut-shell moxibustion or both caused the outcome? We can’t!
  • Can we be sure what caused the child’s problem? No!
  • Do we know whether the outcome was not a spontaneous recovery? No!
  • The authors claim that “cervical spine imbalance leads to visual impairment”. Is that correct? Not as far as I know.
  • The authors state that “the patient in this case, presenting with pseudomyopia, elevated intraocular pressure, and neck pain, likely had a cervical spine-derived condition. Currently, such spine-derived vision disorders lack sufficient clinical recognition.” Is this true? No, I’d say such spine-derived vision disorders might not even exist.
  • Why would anyone publish a paper about the case? Search me!

 

Lumbar stabilization exercises (LSEs) are said to be beneficial for chronic mechanical low back pain (CMLBP). However, further research focusing on intervention combinations is recommended. This study examined the effect of kinesio tape (KT) with LSEs on CMLBP adult patients.

A randomized blinded clinical trial was conducted. Fifty CMLBP patients of both genders were assigned into one of two groups and received 8 weeks of treatment:

  • group A (control): LSEs only,
  • group B (experimental): KT with LSEs.

The primary outcome was back disability, measured by the Oswestry disability index. Secondary outcomes included pain intensity, trunk extensor endurance, and sagittal spinal alignment, as indicated by the visual analog scale, Sorensen-test, and C7–S1 sagittal vertical axis, respectively. The reported data was analyzed by a two-way MANOVA using an intention-to-treat procedure.

Multivariate tests indicate statistically significant effects for group (F = 4.42, p = 0.005, partial η2 = 0.148), time (F = 219.55, p < 0.001, partial η2 = 0.904), and group-by-time interaction (F = 3.21, p = 0.01, partial η2 = 0.149). Univariate comparisons between groups revealed significant reductions in the experimental group regarding disability (p = 0.029, partial η2 = 0.049) and pain (p = 0.001, partial η2 = 0.102) without a significant difference in the Sorensen test (p = 0.281) or C7–S1 SVA (p = 0.491) results. All within-group comparisons were statistically significant (p < 0.001).

The authors concluded that the combination of KT and LSEs is an effective CMLBP treatment option. Although patients in both groups displayed significant changes in all outcomes, the combined interventions induced more significant reductions in back disability and pain intensity.

One of the main reason for conducting a controlled clinical trial is to determine whether the intervention, rather than some other factor, was the cause of the observed outcome. Yet, these trials can be designed in such a way that they mislead us on precisely this point. The present study is an example for such a case.

The authors leave us in no doubt that the KT was the cause of the positive outcome. However, they might be entirely wrong. Here are some other possibilities:

  • the extra attention might have done the trick;
  • the ritual of applying KT must have an effect;
  • the expectation of the patient could have influenced the outcome;
  • verbal or non-verbal communication between the patient and the therapist would have had an effect.

I know, it is often difficult to control for such influences in clinical trials. But, if it proves to be impossible [and in the case of KT it probably is possible], one should at the very least be cautious when drawing conclusions from the results. I suggest something like this:

The combination of KT and LSEs generated better outcomes than LSE alone. Whether this is due to specific effects of KT or non-specific context effects remains unclear.

Whenever a journalist wants to discuss the subject of acupuncture with me, he or she will inevitably ask one question:

DOES ACUPUNCTURE WORK?

It seems a legitimate, obvious and simple question, particularly during ‘Acupuncture Awareness Week‘, and I have heard it hundreds of times. Why then do I hesitate to answer it?

Journalists – like most of us – would like a straight answer, like YES or NO. But straight answers are in short supply, particularly when we are talking about acupuncture.

Let me explain.

Acupuncture is part of ‘Traditional Chinese Medicine’ (TCM). It is said to re-balance the life forces that determine our health. As such it is seen as a panacea, a treatment for all ills. Therefore, the question, does it work?, ought to be more specific: does it work for pain, obesity, fatigue, hair-loss, addiction, anxiety, ADHA, depression, asthma, old age, etc.etc. As we are dealing with virtually thousands of ills, the question, does it work?, quickly explodes into thousands of more specific questions.

But that’s not all!

The question, does acupuncture work?, assumes that we are talking about one therapy. Yet, there are dozens of different acupuncture traditions and sites:

  • body acupuncture,
  • ear acupuncture,
  • tongue acupuncture,
  • scalp acupuncture,
  • etc., etc.

Then there are dozens of different ways to stimulate acupuncture points:

  • needle acupuncture,
  • electroacupuncture,
  • acupressure,
  • moxibustion,
  • ultrasound acupuncture,
  • laser acupuncture,
  • etc., etc.

And then there are, of course, different acupuncture ‘philosophies’ or cultures:

  • TCM,
  • ‘Western’ acupuncture,
  • Korean acupuncture,
  • Japanese acupuncture,
  • etc., etc.

If we multiply these different options, we surely arrive at thousands of different variations of acupuncture being used for thousands of different conditions.

But this is still not all!

To answer the question, does it work?, we today have easily around 10 000 clinical trials. One might therefore think that, despite the mentioned complexity, we might find several conclusive answers for the more specific questions. But there are very significant obstacles that are in our way:

  • most acupuncture trials are of lousy quality;
  • most were conducted by lousy researchers who merely aim at showing that acupuncture works rather that testing whether it is effective;
  • most originate from China and are published in Chinese which means that most of us cannot access them;
  • they get nevertheless included in many of the systematic reviews that are currently being published without non-Chinese speakers ever being able to scrutinise them;
  • TCM is a hugely important export article for China which means that political influence is abundant;
  • several investigators have noted that virtually 100% of Chinese acupuncture trials report positive results regardless of the condition that is being targeted;
  • it has been reported that about 80% of studies emerging from China are fabricated.

Now, I think you understand why I hesitate every time a journalist asks me:

DOES ACUPUNCTURE WORK?

Most journalists do not have the patience to listen to all the complexity this question evokes. Many do not have the intellectual capacity to comprehend an exhaustive reply. But all want to hear a simple and conclusive answer.

So, what do I say in this situation?

Usually, I respond that the answer would depend on who one asks. An acupuncturist is likely to say: YES, OF COURSE, IT DOES! An less biased expert might reply:

IT’S COMPLEX, BUT THE MOST RELIABLE EVIDENCE IS FAR FROM CONVINCING. 

According to its authors, this study‘s objective was to demonstrate that acupuncture is beneficial for decreasing the risk of ischaemic stroke in patients with rheumatoid arthritis (RA).

The investigation was designed as a propensity score-matched cohort nationwide population-based study. Patients with RA diagnosed between 1 January 1997 and 31 December 2010, through the National Health Insurance Research Database in Taiwan. Patients who were administered acupuncture therapy from the initial date of RA diagnosis to 31 December 2010 were included in the acupuncture cohort. Patients who did not receive acupuncture treatment during the same time interval constituted the no-acupuncture cohort. A Cox regression model was used to adjust for age, sex, comorbidities, and types of drugs used. The researchers compared the subhazard ratios (SHRs) of ischaemic stroke between these two cohorts through competing-risks regression models.

After 1:1 propensity score matching, a total of 23 226 patients with newly diagnosed RA were equally subgrouped into acupuncture cohort or no-acupuncture cohort according to their use of acupuncture. The basic characteristics of these patients were similar. A lower cumulative incidence of ischaemic stroke was found in the acupuncture cohort (log-rank test, p<0.001; immortal time (period from initial diagnosis of RA to index date) 1065 days; mean number of acupuncture visits 9.83. In the end, 341 patients in the acupuncture cohort (5.95 per 1000 person-years) and 605 patients in the no-acupuncture cohort (12.4 per 1000 person-years) experienced ischaemic stroke (adjusted SHR 0.57, 95% CI 0.50 to 0.65). The advantage of lowering ischaemic stroke incidence through acupuncture therapy in RA patients was independent of sex, age, types of drugs used, and comorbidities.

The authors concluded that this study showed the beneficial effect of acupuncture in reducing the incidence of ischaemic stroke in patients with RA.

It seems obvious that the editors of ‘BMJ Open’, the peer reviewers of the study and the authors are unaware of the fact that the objective of such an investigeation is not to to demonstrate that acupuncture is beneficial but to test whether acupuncture is beneficial. Starting a study with the intention to to show that my pet therapy works is akin to saying: “I am intending to mislead you about the value of my intervention”.

One needs therefore not be surprised that the authors of the present study draw very definitive conclusions, such as “acupuncture therapy is beneficial for ischaemic stroke prevention”. But every 1st year medical or science student should know that correlation is not the same as causation. What the study does, in fact, show is an association between acupuncture and stroke. This association might be due to dozens of factors that the ‘propensity score matching’ could not control. To conclude that the results prove a cause effect relationship is naive bordering on scientific misconduct. I find it most disappointing that such a paper can pass all the hurdles to get published in what pretends to be a respectable journal.

Personally, I intend to use this study as a good example for drawing the wrong conclusions on seemingly rigorous research.

 

 

There are many variations of acupuncture. Electroacupuncture (EA) and Laseracupuncture (LA) are but two examples both of which are commonly used. However, it remains uncertain whether LA is as effective as EA. This study aimed to compare EA and LA head to head in dysmenorrhea.

A crossover, randomized clinical trial was conducted. EA or LA was applied to selected acupuncture points. Participants were randomized into two sequence treatment groups who received either EA or LA twice per week in luteal phase for 3 months followed by 2-month washout, then shifted to other groups (sequence 1: EA > LA; sequence 2: LA > EA). Outcome measures were heart rate variability (HRV), prostaglandins (PGs), pain, and quality-of-life (QoL) assessment (QoL-SF12). We also compared the effect of EA and LA in low and high LF/HF (low frequency/high frequency) status.

43 participants completed all treatments. Both EA and LA significantly improved HRV activity and were effective in reducing pain (Visual Analog Scale [VAS]; EA: p < 0.001 and LA: p = 0.010) and improving QoL (SF12: EA: p < 0.001, LA, p = 0.017); although without intergroup difference. EA reduced PGs significantly (p < 0.001; δ p = 0.068). In low LF/HF, EA had stronger effects than LA in increasing parasympathetic tone in respect of percentage of successive RR intervals that differ by more than 50 ms (pNN50; p = 0.053) and very low-frequency band (VLF; p = 0.035).

The authors concluded that there is no significant difference between EA and LA in improving autonomic nervous system dysfunction, pain, and QoL in dysmenorrhea. EA is prominent in PGs changing and preserving vagus tone in low LF/HF; yet LA is noninvasive for those who have needle phobia. Whether LA is equivalent with EA and the mechanism warrants further study.

Looking at the affiliations of the authors, one might expect that they should be able to design a meaningful study:

  • 1Division of Hemato-Oncology, Department of Internal Medicine, Branch of Zhong-Zhou, Taipei City Hospital, Taipei, Taiwan.
  • 2Institute of Traditional Medicine, National Yang-Ming Chiao Tung University, Taipei, Taiwan.
  • 3Department of Traditional Medicine, Branch of Yang-Ming, Taipei City Hospital, Taipei, Taiwan.
  • 4Department of Traditional Medicine, Branch of Kunming, Taipei City Hospital, Taipei, Taiwan.
  • 5Department of Gynecology and Obstetrics, Branch of Yang-Ming, Taipei City Hospital, Taipei, Taiwan.

Sadly, this assumption is evidently mistaken.

The trial certainly does not show what they claim and neither had it ever the chance to show anything relevent. A clinical trial is comparable to a mathematical equation. It can be solved, if it has one unkown; it cannot produce a result, if it has two unknowns.

The efficacy of EA and LA for dysmenorrhea are both unknown. A comparative study with two unknowns cannot produce a meaningful result. EA and LA did not both improve autonomic nervous system dysfunction, pain, and QoL in dysmenorrhea but most likely they both had no effect. What caused the improvement was not the treatment per se but the ritual, the placebo effect, the TLC or other non-specific factors. The maginal differences in other parameters are meaningless; they are due to the fact that – as an equivalence trial – the study was woefully underpowered and thus open to coincidental differences.

Clinical trials should be about contributing to our knowledge and not about contributing to confusion.

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