MD, PhD, FMedSci, FSB, FRCP, FRCPEd

One phenomenon that can be noted more frequently than any other in alternative medicine research is that studies arrive at wrong or misleading conclusions. This is more than a little disappointing, not least because it is the conclusion of a trial that is often picked up by health writers and others who in turn mislead the public. On this blog, we must have seen hundreds of examples of this irritating phenomenon. Here is yet another one. This study, a randomized, parallel, open-label exploratory trial, evaluated and compared the effects of systemic manual acupuncture, periauricular electroacupuncture and distal electroacupuncture for treating patients with tinnitus. It included patients who suffered from idiopathic tinnitus for more than two weeks were recruited. They were divided into three groups:

  1. systemic manual acupuncture group (MA),
  2. periauricular electroacupuncture group (PE),
  3. distal electroacupuncture group (DE).

Nine acupoints (TE 17, TE21, SI19, GB2, GB8, ST36, ST37, TE3 and TE9), two periauricular acupoints (TE17 and TE21), and four distal acupoints (TE3, TE9, ST36, and ST37) were selected. The treatment sessions were performed twice weekly for a total of 8 sessions over 4 weeks. Outcome measures were the tinnitus handicap inventory (THI) score and the loud and uncomfortable visual analogue scales (VAS). Demographic and clinical characteristics of all participants were compared between the groups upon admission using one-way analysis of variance (ANOVA). One-way ANOVA was used to evaluate the THI, VAS loud, and VAS uncomfortable scores. The least significant difference test was used as a post-hoc test. In total, 39 subjects were eligible for analysis. No differences in THI and VAS loudness scores were observed between groups. The VAS uncomfortable scores decreased significantly in MA and DE compared with those in PE. Within the group, all three treatments showed some effect on THI, VAS loudness scores and VAS uncomfortable scores after treatment except DE in THI. The authors concluded that there was no statistically significant difference between systemic manual acupuncture, periauricular electroacupuncture and distal electroacupuncture in tinnitus. However, all three treatments had some effect on tinnitus within the group before and after treatment. Systemic manual acupuncture and distal electroacupuncture have some effect on VAS. Neither of the three treatments tested in this study have been previously proven to work. Therefore, it is quite simply nonsensical to compare them. Comparative studies are indicated only with therapies that have a solid evidence-base. They are called ‘superiority trials’ and require a different statistical approach as well as much larger sample sizes. In other words, this study was an unethical waste of resources from the outset. With this in mind, there is only one conclusion that fits the data: there was no statistically significant difference between the three types of acupuncture. The data are therefore in keeping with the notion that all three are placebos. Alternatively one might conclude more clearly for those who are otherwise resistant to learning a lesson: POORLY DESIGNED CLINICAL TRIALS ARE UNETHICAL AND NEVER LEND THEMSELVES TO MEANINGFUL CONCLUSIONS.

46 Responses to POORLY DESIGNED TRIALS ARE UNETHICAL AND NEVER LEND THEMSELVES TO MEANINGFUL CONCLUSIONS

  • The USPSTF has stated that screening for OSA in asymptomatic adults lacks scientific creedence, yet continues to be performed; likely some in “modern medicine” wish to pad their pockets via the performance of unnecesary tests. Of course the stakeholders have objected to the claim.

    “The scope of the recommendations was limited to adults without symptoms of OSA, such as snoring, witnessed apnea, or fatigue.
    Multiple screening tools for OSA are available. However, these instruments have NOT been validated in screening for OSA in a primary care practice setting. (Imagine that!)
    Compared with polysomnography, types II and III portable monitors demonstrated moderate to high sensitivity and specificity in diagnosing OSA, but data on type IV portable monitors were inconsistent in this regard.
    There are NO (read this….ZERO) clinical trials evaluating the balance of efficacy and safety of an OSA screening program.” Yet the screenings continue to be done, apparently to filter patients from the PCP’s to the “downstream” neurologists, who are more than happy to send bills for thousands of dollars to health insurance companies for dubiously necessary procedures.

    Where are the ethical, well designed trials which support such screenings, as well as the inevitable expensive follow-up testing which would be billed by “sleep experts”? It seems that they currently are nowhere to be found.

    • Sorry, you’ve lost me.
      What are USPSTF and OSA?
      I don’t see them in the article which is the subject of this thread.

      • Impeccable, pristine, perfectly executed double-blind RCT’s with absolutely positive results seem to be absolutely required per the opinions of Edzard and this blog’s claque when discussions of the validity of paramedical procedures and practices are discussed. Sans such research, such paramedical procedures are alleged by said sycophants to represent quackery. Yet the US Preventive Services Task Force has determined there to be essentially abysmal evidence for the use of Obstructive Sleep Apnea studies in asymptomatic patients…and the tests have continued to be performed despite the lack of evidence. By the “standards” of this site’s skeptics, it would logically follow that the performance of OSA tests should also be deemed as quack procedures.

        • Logos, you are off topic, but what indications are you referring to when claiming sleep studies are ordered for asymptomatic patients? OSA is a serious condition that leads to serious complications and unfortunately is often missed due it’s occult presentation. Any test can be abused but that does not mean it should not be done for the appropriate situations. An obese male who snores “aggressively,” who may not mention he falls asleep easily during daytime or driving, and has apneic spells at night but is unaware of such episodes may be considered by some to be asymptomatic. Again, what indications?

          • @Cox

            Sorry that I did get off topic a bit. My point was not that OSA was not serious or that screenings might not be appropriate. Rather, it was that there is minimal evidence to support testing for it in asymptomatic patients. If one were to coarse-grain Edzard’s implied necessity(at least when discussing paramedical procedures) of requiring basically airtight studies to justify the performance of clinical procedures, it would follow that such OSA tests represent quackery; of course this assumes that Edzard requires the same standards of research countenance for “modern medicine” as he does for paramedical disciplines.

        • Impeccable, pristine, perfectly executed double-blind RCT’s with absolutely positive results seem to be absolutely required per the opinions of Edzard and this blog’s claque when discussions of the validity of paramedical procedures and practices are discussed.

          You prefer flawed, less-than perfect studies? If so, what is their advantage over good studies?

          • @Bart

            My point was to note the hypocrisy of turning a blind eye relative to performing some medical treatments sans pristine studies while dissing the use of virtually all paramedical treatments if they allegedly lack absolutely positive outcomes resultant to such pristine studies.

          • My point was to note the hypocrisy of turning a blind eye relative to performing some medical treatments sans pristine studies while dissing the use of virtually all paramedical treatments if they allegedly lack absolutely positive outcomes resultant to such pristine studies.

            It is the wrong point to make in the discussion at hand. Furthermore, it is also lying by omission. No one in her/his right mind will claim that there are no properly tested treatments left in modern medicine, even if that number is decreasing rapidly, because testing is ongoing. Evidence and science based medicine are still very young, and not all treatments were somehow suddenly miraculously fully tested when these were conceived. But, instead of preaching, let me quote a verse from my favourite book of fiction, namely Matthew 7:5 Thou hypocrite, first cast out the beam out of thine own eye; and then shalt thou see clearly to cast out the mote out of thy brother’s eye.. I think that expresses reality better than I can.

          • @Bart

            “Matthew 7:5 Thou hypocrite, first cast out the beam out of thine own eye; and then shalt thou see clearly to cast out the mote out of thy brother’s eye.. I think that expresses reality better than I can.”

            You finally nailed it, Bart! This excerpt from Matthew precisely describes the hypocrisy regarding the plurality of criticisms of paramedical disciplines exhibited by Edzard and many of his sycophants on this site….and you thought the Bible was a work of fiction! I’m glad to see you’re coming around……..

          • I’m glad to see you’re coming around……..

            And this is why Defenders of the Quack are evil incarnate. There wasn’t any need, but thank you for making it so abundantly clear.

          • Why thank me, Edzard? Your links to previous self-authored opinion articles generally refer to ad hominems. Already today I have been called a troll(I think by FrankO) and been accused of not being able to read(by you). Ironically, it was your and Frank’s inability to recognize sarcasm(and my obviously failed attempt to be humorous) regarding my comment about the “disease of lesbianism” which ignited the barrage of insults aimed at me. Had either of you been able to comprehend my statement, you perhaps would simply have laughed and moved on to another post.

    • Could you explain how your comment is relevant to the subject at hand?

  • I wonder. Was this trial really poorly designed, or was it adequately designed to fool people who know little or nothing about trials?

    After all, would the obvious quack conclusion not be that all three methods are “equally effective”, hence “effective”?

    • This is a disturbing if not distinguishing feature of CAM research. The vast majority of it is junk like this trial, which if not deliberately designed to fool the unwary and please true believers, is nonetheless perfectly suited to doing so.

      • if not deliberately designed to fool the unwary and please true believers, is nonetheless perfectly suited to doing so

        • “Defenders of the quack”? This obtuse, stand-alone statement did not refer to a particular comment regarding clinical trials or meaningful conclusions; at best it could be understood as a walk-back of your misuse of the Matthew quote. I therefore infer that you are ascribing the “modern medical” testing for OSA of asymptomatic adults to quackery. By Edzard’s and your past comments regarding conclusive research’s necessity prior to providing services related to same, I would agree that such an inference is most consistent with with quackery per your standards. Please correct me if I am misunderstanding your position.

  • Absolutely agree. Yet such trials manage to get ethical approval. Something is wrong with ethics committees when that happens.

  • if not deliberately designed to fool the unwary and please true believers, is nonetheless perfectly suited to doing so

    Which is precisely why I can’t shake the impression that this is intentional. As Prof. Ernst has suggested repeatedly, he thinks it is mainly because of ignorance – not intent – but how long can we keep up that assumption?

  • “Do Investigator Ties With Pharma Influence Trial Results?” This title of a paper released on 2/24/17 is quite informative. According to Charles Vega, M.D. and Marcia Frellick, trials with drug-industry funding or company-paid authors should be interpreted with caution, especially since most of the prescribing information for PCP’s comes from their industry-employed drug reps. It is true that poorly designed trials are not meaningful and possibly unethical, but it also is blatantly obvious that trials christened with dubious, meretricious conclusions are most definitely unethical and not meaningful.

    As has been pointed out myriad times on this blog, the amount of research published by “modern medicine” dwarfs that of the paramedical disciplines. It is logical to conclude that research bias within “modern medicine” leads to much more iatrogenic mortality and morbidity than that claimed to result from “poorly designed trials” allegedly performed by paramedical professions.

    • Silence from the irrationally persistent and hypocritical cynics of paramedical research and disciplines. See Bart’s comment on Matthew 7:5 regarding this as posted on Tues, 3/14 at 20:41: he obviously is beginning to see the light!

      • Logos-Bios, the crucial thing that the CAM skeptics on this site are unwilling to see is that they should be more concerned about defending ‘scientific’ medicine.

        Interesting clip from Fox news: a drug that can be purchased in a cafe, petrol station, supermarket, ‘could actually increase the risk of cardiac arrest by 31%’. ‘Take the LOWEST dose you possibly can’
        http://video.foxnews.com/v/5364509957001/?#sp=show-clips

        Many pharmaceutical medicines have unknown mechanism of action.

        Talk about quackery.

        • don’t you think you discredit yourself by citing Fox News as evidence?
          “Many pharmaceutical medicines have unknown mechanism of action.”
          do you care to name the ones you have in mind?

          • No, there are commenters on this blog that are medical experts – they can help us out here.

            I will stick to my subject(s) but I await more ‘fox news’ comments about homeopathy from the bloggers on this site.

          • in other words: your comment lacks any foundation at all.

          • No, there are commenters on this blog that are medical experts – they can help us out here.

            Edzard Ernst would be one of those, which is precisely why his comments are plausible and yours are laughable.

        • Many pharmaceutical medicines have unknown mechanism of action.

          Whereas quack remedies almost invariably have very well known mechanisms of action, namely none. Assuming, for the sake of argument, that your claim is true and given the choice between something that works, and something that does not, the decision does not seem to be a difficult one.

          • Shouldn’t you be sorting this out instead of using your time to sprout nonsense on this blog:

            http://houseofquack.com/cgi-sys/suspendedpage.cgi

            houseofquack.com; are you the brainchild of this site?

          • houseofquack.com; are you the brainchild of this site?

            No, the site is my brainchild instead. But you are right. Other activities have been keeping me from taking care of the site, and a few others. I should do something about them. I hope it is going to be this year.

          • I wonder if Bart believes testing for obstructive sleep apnea in asymptomatic adults belongs in the house of quack? There are zero clinical trials regarding the balance of safety and efficacy of such tests yet they are still delivering gobs of money to providers within “modern medicine.” What say you. Bart? Your quote from Matthew 7 will either guide your hopefully inteligent response or it will serve as a noose to point out YOUR hypocrisy. Time will tell if you have the mettle to address this question directly.

  • In other words, I am not going to explain something to you that is commonly known. It is clear from following your blogs, that you are adept at ‘avoid and deflect”. I will save your comment: ‘in other words: your comment lacks any foundation at all.’ because that is your credibility on the line

    Tell me, Edzard, how does the example I cited (paracetamol) actually work and why does it increase cardiovascular risk?

    • I am not a pharmacologist but on Medline you find plenty of papers on the question, for instance this one (https://www.ncbi.nlm.nih.gov/pubmed/15662292):
      Paracetamol (acetaminophen) is generally considered to be a weak inhibitor of the synthesis of prostaglandins (PGs). However, the in vivo effects of paracetamol are similar to those of the selective cyclooxygenase-2 (COX-2) inhibitors. Paracetamol also decreases PG concentrations in vivo, but, unlike the selective COX-2 inhibitors, paracetamol does not suppress the inflammation of rheumatoid arthritis. It does, however, decrease swelling after oral surgery in humans and suppresses inflammation in rats and mice. Paracetamol is a weak inhibitor of PG synthesis of COX-1 and COX-2 in broken cell systems, but, by contrast, therapeutic concentrations of paracetamol inhibit PG synthesis in intact cells in vitro when the levels of the substrate arachidonic acid are low (less than about 5 mumol/L). When the levels of arachidonic acid are low, PGs are synthesized largely by COX-2 in cells that contain both COX-1 and COX-2. Thus, the apparent selectivity of paracetamol may be due to inhibition of COX-2-dependent pathways that are proceeding at low rates. This hypothesis is consistent with the similar pharmacological effects of paracetamol and the selective COX-2 inhibitors. COX-3, a splice variant of COX-1, has been suggested to be the site of action of paracetamol, but genomic and kinetic analysis indicates that this selective interaction is unlikely to be clinically relevant. There is considerable evidence that the analgesic effect of paracetamol is central and is due to activation of descending serotonergic pathways, but its primary site of action may still be inhibition of PG synthesis. The action of paracetamol at a molecular level is unclear but could be related to the production of reactive metabolites by the peroxidase function of COX-2, which could deplete glutathione, a cofactor of enzymes such as PGE synthase.
      or this one (https://www.ncbi.nlm.nih.gov/pubmed/23719833):
      Paracetamol is used worldwide for its analgesic and antipyretic actions. It has a spectrum of action similar to that of NSAIDs and resembles particularly the COX-2 selective inhibitors. Paracetamol is, on average, a weaker analgesic than NSAIDs or COX-2 selective inhibitors but is often preferred because of its better tolerance. Despite the similarities to NSAIDs, the mode of action of paracetamol has been uncertain, but it is now generally accepted that it inhibits COX-1 and COX-2 through metabolism by the peroxidase function of these isoenzymes. This results in inhibition of phenoxyl radical formation from a critical tyrosine residue essential for the cyclooxygenase activity of COX-1 and COX-2 and prostaglandin (PG) synthesis. Paracetamol shows selectivity for inhibition of the synthesis of PGs and related factors when low levels of arachidonic acid and peroxides are available but conversely, it has little activity at substantial levels of arachidonic acid and peroxides. The result is that paracetamol does not suppress the severe inflammation of rheumatoid arthritis and acute gout but does inhibit the lesser inflammation resulting from extraction of teeth and is also active in a variety of inflammatory tests in experimental animals. Paracetamol often appears to have COX-2 selectivity. The apparent COX-2 selectivity of action of paracetamol is shown by its poor anti-platelet activity and good gastrointestinal tolerance. Unlike both non-selective NSAIDs and selective COX-2 inhibitors, paracetamol inhibits other peroxidase enzymes including myeloperoxidase. Inhibition of myeloperoxidase involves paracetamol oxidation and concomitant decreased formation of halogenating oxidants (e.g. hypochlorous acid, hypobromous acid) that may be associated with multiple inflammatory pathologies including atherosclerosis and rheumatic diseases. Paracetamol may, therefore, slow the development of these diseases. Paracetamol, NSAIDs and selective COX-2 inhibitors all have central and peripheral effects. As is the case with the NSAIDs, including the selective COX-2 inhibitors, the analgesic effects of paracetamol are reduced by inhibitors of many endogenous neurotransmitter systems including serotonergic, opioid and cannabinoid systems. There is considerable debate about the hepatotoxicity of therapeutic doses of paracetamol. Much of the toxicity may result from overuse of combinations of paracetamol with opioids which are widely used, particularly in USA.

  • I thought that we were having a discussion on this; are you busy Googling the topic?

  • I have got things to do for today so I will leave you to do some research and have a look at your comments tonight.

    Have a good day.

  • I have screenshot the comment that appeared prior to 09:01
    Greg on Sunday 19 March 2017 at 08:52
    Your comment is awaiting moderation.

    In other words, I am not going to explain something to you that is commonly known. It is clear from following your blogs, that you are adept at ‘avoid and deflect”. I will save your comment: ‘in other words: your comment lacks any foundation at all.’ because that is your credibility on the line

    Tell me, Edzard, how does the example I cited (paracetamol) actually work and why does it increase cardiovascular risk?

    lol

    • Greg said:

      I have screenshot the comment that appeared prior to 09:01
      Greg on Sunday 19 March 2017 at 08:52
      Your comment is awaiting moderation.

      Your 08:52 and 09:01 comments were both published – can you say what you think the problem is?

      • What egg on my face? I am trying to be nice to you but that does not seem to work. Why don’t you address the the areas of uncertainty as per the extracts from the paper on Paracetamol that you posted.

        And you have not addressed the questions regarding it uncertain mode of action and why it increases cardiovascular risk?

        Lol, please stick to CAM Edzard because otherwise you will embarrass yourself more.

      • Edzard or admin selects comments. the 08:52 comment was published after:

        Greg on Sunday 19 March 2017 at 09:01

        I thought that we were having a discussion on this; are you busy Googling the topic? but yet was posted BEFORE this comment.

        It is your site, you can publish what you like. Lol.

  • Thus, the apparent selectivity of paracetamol may be due
    this hypothesis is consistent
    has been suggested to be the site of action of paracetamol
    The action of paracetamol at a molecular level is unclear
    the mode of action of paracetamol has been uncertain

    Medical pharmacology is a brilliant science and this paper is extraordinary in its complexity. Yet it is precise in its honesty that there are things known and things unknown about the actions of medicines, and as I said earlier: this is the case for many drugs.

    Let us stay focused on CAM.

    Have a good day.

  • I get it know, Edzard posts papers that he has not read? Like he writes books about things he has not studied (Materia Medica Pura).

    You are right Edzard, I am wrong – you should not even write about CAM. It is hopeless with you.

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