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

big pharma

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It has been reported that a German consumer association, the ‘Verbraucherzentrale NRW’, has first cautioned the manufacturer MEDICE Arzneimittel Pütter GmbH & Co. and then sued them for misleading advertising statements. The advertisement in question gave the wrong impression that their homeopathic remedy MEDITONSIN would:

  1. for certain generate a health improvement,
  2. have no side effects,
  3. be superior to “chemical-synthetic drugs”.

The study used by the manufacturer in support of such claims was not convincing according to the Regional Court of Dortmund. The results of a “large-scale study with more than 1,000 patients” presented a pie chart indicating that 90% of the patients were satisfied or very satisfied with the effect of Meditonsin. However, this was only based on a “pharmacy-based observational study” with little scientific validity, as pointed out by the consumer association. Despite the lack of evidence, the manufacturer claimed that their study “once again impressively confirms the good efficacy and tolerability of Meditonsin® Drops”. The Regional Court of Dortmund disagreed with the manufacturer and agreed with the reasoning of the consumer association.

“It is not permitted to advertise with statements that give the false impression that a successful treatment can be expected with certainty, as suggested by the advertising for Meditonsin Drops,” emphasizes Gesa Schölgens, head of “Faktencheck Gesundheitswerbung,” a joint project of the consumer centers of North Rhine-Westphalia and Rhineland-Palatinate. According to German law, this is prohibited. In addition, the Regional Court of Dortmund considered consumers to be misled by the advertising because the false impression was created that no harmful side effects are to be expected when Meditonsin Drops are taken. The package insert of the drug lists several side effects, according to which there could even be an initial worsening of symptoms after taking the drug.

The claim of advantages of the “natural remedy” represented by the manufacturer in comparison with “chemical-synthetic medicaments, which merely suppress the symptoms”, was also deemed to be inadmissible. Such comparative advertising is inadmissible.

__________________________________

This ruling is, I think, interesting in several ways. The marketing claims of so-called alternative medicine (SCAM) products seem all too often not within the limits of the laws. One can therefore hope that this case might inspire many more legal cases against the inadmissible advertising of SCAMs.

 

The U.S. Food and Drug Administration issued warning letters to seven companies for illegally selling dietary supplements that claim to cure, treat, mitigate or prevent cardiovascular disease or related conditions, such as atherosclerosis, stroke or heart failure, in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA is urging consumers not to use these or similar products because they have not been evaluated by the FDA to be safe or effective for their intended use and may be harmful.

The warning letters were issued to:

“Given that cardiovascular disease is the leading cause of death in the U.S., it’s important that the FDA protect the public from products and companies that make unlawful claims to treat it. Dietary supplements that claim to cure, treat, mitigate or prevent cardiovascular disease and related conditions could potentially harm consumers who use these products instead of seeking safe and effective FDA-approved treatments from qualified health care providers,” said Cara Welch, Ph.D., director of the Office of Dietary Supplement Programs in the FDA’s Center for Food Safety and Applied Nutrition. “We encourage consumers to remain vigilant when shopping online or in stores to avoid purchasing products that could put their health at risk.”

Under the FD&C Act, products intended to diagnose, cure, treat, mitigate or prevent disease are drugs and are subject to the requirements that apply to drugs, even if they are labeled as dietary supplements. Unlike drugs approved by the FDA, the agency has not evaluated whether the unapproved products subject to the warning letters announced today are effective for their intended use, what the proper dosage might be, how they could interact with FDA-approved drugs or other substances, or whether they have dangerous side effects or other safety concerns.

The FDA advises consumers to talk to their doctor, pharmacist or other health care provider before deciding to purchase or use any dietary supplement or drug. Some supplements might interact with medicines or other supplements. Health care providers will work with patients to determine which treatment is the best option for their condition.

If a consumer thinks that a product might have caused a reaction or an illness, they should immediately stop using the product and contact their health care provider. The FDA encourages health care providers and consumers to report any adverse reactions associated with FDA-regulated products to the agency using MedWatch or the Safety Reporting Portal.

The FDA has requested responses from the companies within 15 working days stating how they will address the issues described in the warning letters or provide their reasoning and supporting information as to why they think the products are not in violation of the law. Failure to correct violations promptly may result in legal action, including product seizure and/or injunction.

It has been reported that the Regional Court of Dortmund has prohibited the manufacturer of the homeopathic cold remedy Meditonsin from advertising with false health claims. The court did not see sufficient evidence for the advertising claims.

The Consumer Advice Centre (VZ) of North Rhine-Westphalia issued a warning to the Meditonsin manufacturer (MEDICE Arzneimittel Pütter GmbH & Co.) for misleading advertising statements and sued them. The complaint was:

  • that the advertising gave the false impression that an improvement in health could be expected with certainty after taking the product,
  • that no side effects were to be expected,
  • that the product was superior to “chemical-synthetic medicines”.

The Dortmund Regional Court was not convinced by a study referred to by the manufacturer. On its website, the manufacturer of Meditonsin presents the results of a “current, large-scale user study with more than 1,000 patients” under the heading “Proven efficacy & tolerability”. According to a pie chart, 90% of the patients were satisfied or very satisfied with the effect of Meditonsin.

However, according to the VZ, the study was only a “pharmacy-based observational study” with little scientific validity. Despite the lack of evidence, the manufacturer claimed that “the good efficacy and tolerability of Meditonsin® Drops could once again be impressively confirmed”. The Dortmund Regional Court, however, followed the VZ’s statement of grounds for action. “It is not allowed to advertise with statements that give the false impression that a successful treatment can be expected with certainty, as the advertisement for Meditonsin drops suggests,” emphasized Gesa Schölgens, head of “Faktencheck Gesundheitswerbung”, a joint project of the consumer centres of North Rhine-Westphalia and Rhineland-Palatinate. According to the Therapeutic Products Advertising Act, this is prohibited.

The Dortmund Regional Court also found that consumers were misled by the advertising because it gave a false impression that no harmful side effects were to be expected when taking Meditonsin. The package leaflet of the drug listed several side effects. According to this, there could even be an initial worsening of the symptoms after taking the medicine.

According to the VZ, the alleged advantage of the “natural medicinal product” over “many chemical-synthetic medicinal products that only suppress the symptoms”, as presented by the manufacturer, is also inadmissible. This is because it is not permissible to advertise to consumers with claims that the effect is equivalent or superior to that of another medicinal product. This, too, was confirmed by the court.

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In case you like to know more about the remedy, this is from its English language site:

Meditonsin consists of Aconitum, Atropinum Sulfuricum, Mercurius Cyanatus. Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease.

It has been reported that America’s Frontline Doctors (a right-wing organization that is associated with the ‘Tea Party’) is suing one of its founders in a battle for control over the controversial group, which gained national notoriety for spreading misinformation about COVID-19 treatments and vaccines during the pandemic.

The organization and its current board chairman have sued Simone Gold, MD, alleging that she misused the nonprofit organization’s funds to buy a $3.6 million Florida mansion, purchase a Mercedes-Benz and other luxury vehicles, and take trips on private planes.

The lawsuit, filed November 4 in federal court, comes just months after Gold was released from prison for her role in the January 6 US Capitol insurrection. Gold pleaded guilty to trespassing in the Capitol and was sentenced to 60 days in federal prison.

The group and the board chairman, Joseph Gilbert, claim that after her release from prison, Gold attempted to reassert control of the group, take over its website, and fraudulently represent herself as its director, according to the complaint. The complaint referred to Gold as a “rogue founder,” alleging that she spent almost $50,000 monthly on personal expenses using the organization’s credit cards.

Gold resigned from the group’s board in February ― before she pled guilty ― so that she could pursue her goal of opening health and wellness centers nationwide, according to the complaint. At that time, the board voted Gilbert to be its chairman and agreed to have Gilbert negotiate an agreement for Gold to serve as a consultant. Gold sought a “signing bonus” of $1.5 million, along with $50,000 to be paid monthly as a consulting fee, according to the complaint.

Another report has more details on Gold’s alleged wrong-doing: The complaint claims that in November 2021, Gold used “AFLDS charitable funds to purchase a $3.6 million home in Naples, Florida for her personal rent-free use, and at least three vehicles and has otherwise used AFLDS funds to resource her personal lifestyle and expenses since she formed AFLDS.” Plaintiffs also allege that Gold “currently lives in this home with John Strand, rent free.” Strand is a former underwear model and boyfriend of Gold’s who was arrested with her in connection with the January 6, 2021 insurrection in the U.S. Capitol. She moved with Strand to Florida this year from Los Angeles, where she had been an emergency room physician. Strand allegedly was paid $10,000 per month as an AFLDS employee and allegedly spent $15,000 to $17,000 a month using those credit cards. He was terminated from AFLDS in summer 2022, according to the complaint. In addition to purchasing the house with AFLDS funds, the complaint said Gold purchased a Mercedes Benz Sprinter van, a Hyundai Genesis, and a GMC Denali. After taking possession of the Naples home, she used AFLDS funds to pay a personal security officer $12,000, a personal housekeeper $5,600 a month, and charged “nearly $50,000 per month” to AFLDS credit cards.

I tried to find some information on th health and wellness centers that Simone Gold wanted or did open. Alas I was unsuccessful in my endeavor. However, I found an interesting passage she once wrote:

The World Health Organization, the FDA, the NIH, and the CDC are proven liars who have lost all credibility and common-sense, while jeopardizing YOUR health and safety. What disgusts me most is how their failed prescriptions have exposed the most vulnerable: our elderly and our children. The New York Times, CNN, NPR, and hundreds of other news outlets have censored the truth in order to preserve their power. Twitter, Facebook, Google/YouTube, Apple, and dozens of other Tech companies are throttling down content, suppressing information, and de-platforming those with whom they disagree.

I find it hard to find words for a comment – except perhaps this: maybe it is not such a bad thing when anti-vaxxers fight each other; it means they have less time, energy, and money to confuse the public with their lies.

DIARALIA is a homeopathic remedy for the symptomatic treatment of acute transient diarrhea. It is produced by Boiron, the world’s largest manufacturer of homeopathic remedies. This is how it is currently advertised:

Instructions DIARALIA

Dosage DIARALIA

Adults and children from 6 years

Lozenge 1, 4 to 6 times a day, for a maximum of three days of treatment.
Discontinue treatment as soon as symptoms disappear.

Method and route of administration DIARALIA
Sublingual (tablet to dissolve under the tongue)
In children 18 months to 6 years: dissolve the tablet in a little water before use, because of the risk of aspiration. As soon as the permitted age, dissolve the tablets under the tongue.

Duration of treatment DIARALIA
The duration of treatment should not exceed one week.

In case of overdose DIARALIA

If you have taken more DIARALIA orodispersible tablets that you don” should have:

Consult your doctor or pharmacist immediately.
In case of failure of one or more doses of DIARALIA

If you miss a dose of DIARALIA orodispersible tablets:

Do not take a double dose to make up for the dose that you forgot to take

Pregnancy and lactation with DIARALIA
Ask your doctor or pharmacist before taking any medicine.

In the absence of experimental and clinical data, and as a precautionary measure, the use of this drug should be avoided during pregnancy and lactation.

Composition DIARALIA

Excipients with known effect: This medicinal product contains lactose,
Active substances:
For a 300 mg tablet
Arsenicum album 9CH 1mg
China rubra 5CH 1mg
Podophyllum peltatum 9 CH 1mg
Excipients: sucrose, lactose monohydrate, magnesium stearate

Cons-indication DIARALIA

N” Never use DIARALIA orodispersible tablets:
· In children under 18 months.
· If you are allergic (hypersensitive) to the active substances or to any of the ingredients in CORYZALIA orodispersible tablets.

Possible interactions with DIARALIA

If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.

This medication is to be taken between meals.

Adverse DIARALIA

Like all medicines, DIARALIA orodispersible tablets may cause side effects, although not everybody will not matter.
If you notice any side effects not listed in this leaflet, or if the side effects gets serious, please tell your doctor or pharmacist.

Storage conditions DIARALIA

Store at a temperature not exceeding 30 ° C

Precautions and warnings DIARALIA

This medication should not be used in case of vomiting, high fever, blood in the stool.
Any significant diarrhea exposed to the risk of dehydration requiring appropriate rehydration.
If diarrhea persists beyond 3 days, a medical consultation is necessary.
If your doctor has told you have an intolerance to some sugars, contact your doctor before taking this medicine
Use of this medicine is not recommended in patients with galactose intolerance, a Lapp lactase deficiency or malabsorption syndrome glucose or galactose (rare hereditary diseases).

But is there any evidence that DIARALIA works?

I’m glad you asked!

I looked far and wide but found none (if a reader knows of a clinical trial, please let me know).

Jenifer Jacobs (JJ) published a review of 3 studies – all her own! – and concluded that the results from these studies confirm that individualized homeopathic treatment decreases the duration of acute childhood diarrhea and suggest that larger sample sizes be used in future homeopathic research to ensure adequate statistical power. Homeopathy should be considered for use as an adjunct to oral rehydration for this illness. So, some homeopathy fans might claim there is good evidence. But I dispute that.

We all know, of course, that diarrhea can be a symptom of a range of serious conditions. Thus, one should not joke about it. On the contrary, one should diagnose the reason for the symptom and treat it adequately.  And one should certainly not advertise unproven treatments for it; one could even go one step further and claim that anyone who does that is fraudulently endangering the health of the often all too gullible consumer.

About a year ago, I reported last on the situation of homeopathy in France. Now it might be time for another update. The end of the reimbursement of homeopathy was, of course, a heavy blow for the laboratories concerned, especially Boiron and Weleda.

Are these firms now going bust?

Is the French public missing homeopathy?

The cessation of reimbursement took place in two steps: in 2020, the reimbursement rate was reduced to 15 % and expired completely in 2021. The new director of Weleda France, Ludovic Rassat, explains that, in 2020, when the reimbursement was reduced to 15 %, the impact on sales was just 20 %. The decrease was limited because of the supplementary health insurance which 80 % of French people have still supplemented the reimbursement up to 100 %. In 2021, this generosity stopped and the reimbursement fell from 100 to 0 %. This led to a 60 % drop in sales and to losses of 13 million Euros for Weleda France.

According to an Ipsos survey commissioned by Boiron Laboratories in October 2018, 70 % of all French used homeopathy to relieve their first symptoms, 74 % thought homeopathic remedies were effective and 71 % thought homeopathy was a good complement to conventional treatments. One might, therefore, have assumed that French consumers would continue using their beloved remedies despite the cessation of reimbursement. However, this was not the case. The most obvious explanation for this phenomenon, I think, is that the above-mentioned survey had generated false-positive results and that people correctly judged homeopathic remedies to be superfluous.

Faced with unsustainable losses, the French manufacturers of homeopathic products are now forced to react. A press release by Weleda France from 4 July 2022 stated that “This project would result in the discontinuation of pharmaceutical production and medical information in France and the closure of the Weleda division. This would result in the cessation of production activities at the Huningue site and an adjustment of the organisation of activities at headquarters. In total, 127 jobs could be cut at Weleda France.” If this step is taken as planned, Weleda France will have to earn its money purely on its cosmetic and anthroposophical products, according to the director.

In 2019, Laboratoires Boiron owned 4 production laboratories and 28 distribution facilities in France. In March 2020, the company announced that it had decided to cut 646 jobs in France and close 13 of its 31 sites, due to the poor economic results that followed the cessation of reimbursement of its products by the social security system. Following the decision by the Minister of Health, Agnès Buzyn, to stop the reimbursement of homeopathic preparations by the social security system, Boiron announced that the Montrichard site in the Loir-et-Cher region had not managed to find a buyer. As a result, the site, which employed around 80 people, closed on 31 December 2021.

And the French consumers?

Are they missing homeopathy?

Are they suffering from homeopathy withdrawal?

Are they more frequently ill without homeopathy?

Are they switching to more expensive conventional drugs?

I currently spend much of my time in France and cannot say that I have noticed any of this. On the contrary, most people I talk to are delighted that homeopathy is no longer reimbursed. But this is no evidence, of course. I am unable to find any reliable data to answer the above questions.

When the French health minister decided against homeopathy two years ago, she said: “It’s possible to leave the doctor’s office without a prescription! Let’s take advantage of this debate on homeopathy to reflect more broadly on our use of medicine. The ultimate goal is to consume less.” She was correct, it seems.

 

 

The US Food and Drug Administration (FDA) state that dietary supplements can help people improve or maintain their overall health. But they may also come with health risks. Whether you’re a consumer of dietary supplements or it’s your job to inform and educate, it’s important to know the facts before deciding to take any dietary supplement.

Therefore, they launched the initiative, “Supplement Your Knowledge”. It aims to help inform health care professionals, consumers, and educators about dietary supplements.

“Dietary supplements can be valuable to your health but taking some supplements can also involve health risks,” Douglas Stearn, JD, deputy director for regulatory affairs in the FDA’s Center for Food Safety and Applied Nutrition, said in a statement. “These Supplement Your Knowledge resources will help provide consumers and health care professionals with facts to make informed decisions when determining if they want to use or recommend dietary supplements.”

In collaboration with the American Medical Association, publisher of JAMA, the FDA has developed a free continuing medical education program for physicians and other health care professionals about the regulation of dietary supplements, informing patients about their use, and reporting adverse events to the agency. The program includes 3 videos and accompanying educational materials. It is available on the FDA website and the AMA Ed Hub.

________________________

The objectives of the program are:
1. Define dietary supplements
2. Describe how dietary supplements are regulated
3. Describe how dietary supplements are labelled and the types of claims permitted
4. Review potential interactions of dietary supplements with other supplements, medications, and laboratory tests
5. Identify adverse events and how to report them to FDA

Even though some parts of the program are quite specific to the US, I think that the initiative is most laudable and an excellent resource for physicians, SCAM practitioners, consumers, and decision-makers to learn more about this important subject.

In India, the homeopathic remedy, Arsenicum Album 30C (prepared from arsenic trioxide) is widely prescribed and publicly supplied to adults and children for preventing COVID infections. Inorganic arsenic, known as the “king of poisons” is a highly toxic substance with the potential to cause acute as well as chronic injury to multiple organ systems, mainly skin, lung, liver, and kidneys.

Indian researchers present three cases of acute liver injury, leading to the death of one patient with underlying non-alcoholic steatohepatitis (NASH) cirrhosis, after consumption of the homeopathic remedy AA30 for COVID-19 prevention.

Case one

A 70-year-old man with compensated non-alcoholic steatohepatitis (NASH)-related cirrhosis and diabetes mellitus consumed the homeopathic IB AA30 as prescribed for 12 weeks prior to the onset of symptoms. He presented with jaundice and abdominal distension within four weeks after the onset of loss of appetite and well-being. The patient was not on any other hepatotoxic agents, over-the-counter medications, or herbal and dietary supplements. Investigations revealed the presence of conjugated hyperbilirubinemia, ascites, and abnormal coagulation, suggestive of acute-on-chronic liver failure (ACLF). Further investigations to identify known causes of acute deterioration of underlying cirrhosis were performed, including a transjugular liver biopsy. All competing causes for acute liver injury were meticulously ruled out. These included infections-tests for immunoglobulin M (IgM) for viral hepatitis A and E; hepatitis B surface antigen and IgM antibody to hepatitis B core antigen; nucleic acid tests via polymerase chain reaction for hepatitis C; IgM for herpes zoster and herpes simplex, cytomegalovirus, parvovirus, Epstein-Barr virus. Complete auto-antibody testing for autoimmune hepatitis (AIH) was negative. The Roussel Uclaf Causality Assessment (RUCAM) demonstrated “probable” (score 7) drug-induced liver injury (DILI) and simplified AIH score was less than 5, revealing the cause of acute liver injury leading to ACLF as the homeopathic remedy, AA30. The liver biopsy revealed multiacinar hepatocyte necrosis, lymphocytic, neutrophilic, and eosinophilic inflammation in the absence of interface hepatitis, which were predominantly portal-based in the background of cirrhosis, suggestive of DILI. Analysis of drugs consumed could not be performed in view of inadequate sample availability. The patient and family consented to arsenic analysis in nail and hair samples which revealed extremely high levels of the heavy metal, supportive of arsenic toxicity and associated liver injury in the patient. Evaluation of hair and hair samples of two family members (below detection limits, method detection limit being 0.1 mg/kg), staying in the same household did not reveal levels signifying cluster arsenic poisoning from water or soil sources. The patient succumbed to complications related to ACLF, nine months after the initial diagnosis.

Case two

A 68-year-old male with systemic hypertension controlled on telmisartan who ingested AA30 as prescribed for four weeks prior to the onset of symptoms. There was no associated jaundice or cholestatic symptoms, but liver tests revealed acute hepatitis with an elevation of liver enzymes. The patient was not on any other hepatotoxic agents, over-the-counter medications, or herbal and dietary supplements. Further investigations did not reveal the presence of underlying chronic liver disease or portal hypertension. All competing causes for acute liver injury were meticulously ruled out similar to the extensive workup that was done in case one. The RUCAM demonstrated “probable” (score 8) DILI and simplified AIH score was less than 5, revealing the cause of acute non-icteric hepatitis as the homeopathic remedy, AA30. The liver biopsy revealed perivenular hepatocyte necrosis, with predominantly portal-based mixed cellular inflammation consisting of plasma cells, eosinophils, lymphocytes, and scattered neutrophils. Additionally, ballooning of hepatocytes was marked with scattered rosettes and moderate interphase hepatitis in the presence of mild portal and sinusoidal fibrosis suggestive of DILI. Acute hepatitis resolved after drug withdrawal and finite course of steroids within three months, without any recurrence on follow-up.

Case three

A 48-year-old overweight woman consumed homeopathic AA30 pills as COVID-19 preventive for one week prior to the onset of her symptoms of cholestatic jaundice. Prior to the development of jaundice, she had nonspecific gastrointestinal symptoms such as nausea and progressive loss of appetite. Liver tests revealed conjugated hyperbilirubinemia with highly raised liver enzymes. The patient was not on any other hepatotoxic prescription drugs, over-the-counter medications, or herbal and dietary supplements. Further investigations did not reveal the presence of underlying chronic liver disease or portal hypertension. All competing causes for acute liver injury were meticulously ruled out similar to the extensive workup that was done in case one. The RUCAM demonstrated “probable” (score 7) DILI and simplified AIH score was less than 5, revealing the cause of acute cholestatic hepatitis as the homeopathic remedy, AA30. The liver biopsy revealed spotty, focal hepatocyte necrosis, with predominantly portal-based neutrophilic and eosinophil-rich inflammation, moderate steatosis, and mild interface hepatitis with underlying mild perisinusoidal fibrosis, suggestive of DILI. The acute cholestatic hepatitis resolved after drug withdrawal and a finite course of steroids within six months, without any recurrence on follow-up.

The chemical analysis and toxicology (inductively coupled optical emission spectroscopy and triple-quadrupole gas chromatography with tandem mass spectroscopy method) on two sets of AA30 samples retrieved from case three revealed D-mannose, melezitose, and arsenic respectively, demonstrating batch-to-batch variation due to poor manufacturing practices.

The authors draw the following conclusions: Health regulatory authorities, physicians, general and patient population must be aware of the potential harms associated with the large-scale promotion of untested, alternative medical systems during a medical emergency so as to prevent an “epidemic” of avoidable DILI within the ongoing pandemic. Even though ultra-diluted homeopathic remedies, found ineffective as shown in large-scale meta-analysis, are considered safe for use due to the absence of any active compound beyond 12C dilution. Nonetheless, poor manufacturing practices, use of concentrated tincture formulations, and adulteration and contamination of homeopathic remedies can still pose considerable toxicity in predisposed persons. From a scientific and evidence-based standpoint, it is imperative that the general population and at-risk persons understand that vaccination, and not untested, misleading IBs, remains the best available armamentarium against COVID-19 which helps in fighting back the pandemic.

How often have I pointed out that “the highly diluted homeopathic remedy may be harmless, but the homeopath isn’t”? I think I should amend this message to:
The highly diluted homeopathic remedy may be harmless, but neither the homeopath nor the manufacturer of the remedies is necessarily harmless.

 

Practitioners of so-called alternative medicine (SCAM) often argue against treating back problems with drugs. They also frequently defend their own therapy by claiming it is backed by published guidelines. So, what should we think about guidelines for the management of back pain?

This systematic review was aimed at:

  1. systematically evaluating the literature for clinical practice guidelines (CPGs) that included the pharmaceutical management of non-specific LBP;
  2. appraising the methodological quality of the CPGs;
  3. qualitatively synthesizing the recommendations with the intent to inform non-prescribing providers who manage LBP.

The authors searched PubMed, Cochrane Database of Systematic Review, Index to Chiropractic Literature, AMED, CINAHL, and PEDro to identify CPGs that described the management of mechanical LBP in the prior five years. Two investigators independently screened titles and abstracts and potentially relevant full text were considered for eligibility. Four investigators independently applied the Appraisal of Guidelines for Research and Evaluation (AGREE) II instrument for critical appraisal. Data were extracted for pharmaceutical intervention, the strength of recommendation, and appropriateness for the duration of LBP.

Only nine guidelines with global representation met the eligibility criteria. These CPGs addressed pharmacological treatments with or without non-pharmacological treatments. All CPGs focused on the management of acute, chronic, or unspecified duration of LBP. The mean overall AGREE II score was 89.3% (SD 3.5%). The lowest domain mean score was for applicability, 80.4% (SD 5.2%), and the highest was Scope and Purpose, 94.0% (SD 2.4%). There were ten classifications of medications described in the included CPGs: acetaminophen, antibiotics, anticonvulsants, antidepressants, benzodiazepines, non-steroidal anti-inflammatory drugs (NSAIDs), opioids, oral corticosteroids, skeletal muscle relaxants (SMRs), and atypical opioids.

The authors concluded that nine CPGs, included ten medication classes for the management of LBP. NSAIDs were the most frequently recommended medication for the treatment of both acute and chronic LBP as a first line pharmacological therapy. Acetaminophen and SMRs were inconsistently recommended for acute LBP. Meanwhile, with less consensus among CPGs, acetaminophen and antidepressants were proposed as second-choice therapies for chronic LBP. There was significant heterogeneity of recommendations within many medication classes, although oral corticosteroids, benzodiazepines, anticonvulsants, and antibiotics were not recommended by any CPGs for acute or chronic LBP.

Oddly, this review was published by chiros in a chiro journal. The authors mention that nearly all guidelines the included CPGs recommended non-pharmacological treatments for non-specific LBP, however it was not always delineated as to precede or be used in conjunction with pharmacological intervention.

I find the review interesting because I think it suggests that:

  1. CPGs are not the most reliable form of evidence. Their guidance depends on how up-to-date they are and on the identity and purpose of the authors.
  2. Guidelines are therefore often contradictory.
  3. Back pain is a symptom for which currently no optimal treatment exists.
  4. The most reliable evidence will rarely come from CPGs but from rigorous, up-to-date, independent systematic reviews such as those from the Cochrane Collaboration.

So, the next time chiropractors osteopaths, acupuncturists, etc. tell you “BUT MY THERAPY IS RECOMMENDED IN THE GUIDELINES”, please take it with a pinch of salt.

Stress is associated with a multitude of physical and psychological health impairments. To tackle these health disorders, over-the-counter (OTC) products like Neurodoron® are popular since they are considered safe and tolerable. One tablet of this anthroposophic remedy contains the following active ingredients:

  • 83.3 mg Aurum metallicum praeparatum trituration (trit.) D10,
  • 83.3 mg Kalium phosphoricicum trit. D6,
  • 8.3 mg Ferrum-Quarz trit. D2.

Experience reports and first studies indicate that Neurodoron® is efficient in the treatment of stress-associated health symptoms. “To confirm this” (!!!), a non-interventional study (NIS) with pharmacies was conducted.

The NIS was planned to enroll female and male patients who suffered from nervous exhaustion with symptoms caused by acute and/or chronic stress. The main outcome measures were characteristic stress symptoms, stress burden, and perceived stress. Further outcome measures included perceived efficacy and tolerability of the product as assessed by the patients and collection of adverse drug reactions (ADRs). A study duration of about 21 days with a recommended daily dose of 3–4 tablets was set.

In total, 279 patients were enrolled at 74 German pharmacies. The analyzed set (AS) included 272 patients (mean age 44.8 ± 14.4 years, 73.9% female). 175 patients of the AS completed the NIS. During the study, all stress symptoms declined significantly (total score 18.1 vs. 12.1 (of max. 39 points),  < 0.0001). Furthermore, a reduction of stress burden (relative difference in stress burden, VAS = −29.1%,  < 0.0001) was observed. For most patients, perceived stress was reduced at the study end (PSQ total score decreased in 70.9% of the patients). 75.9% of the study population rated the product efficacy as “good” or “very good” and 96.6% rated its tolerability as “good” or “very good.” One uncritical ADR was reported.

The authors concluded that this study adds information on the beneficial effects of Neurodoron® in self-medication. The results from this NIS showed a marked reduction in stress burden and perceived stress, along with an excellent safety profile of the medicinal product (MP) Neurodoron®. Further trials are required to confirm these results.

I beg to differ!

The study had no control group and therefore one cannot possibly attribute any of the observed changes to the anthroposophic remedy. They are more likely to be due to:

  • the natural history of the condition,
  • regression towards the mean,
  • a placebo effects,
  • other treatments administered during the trial period.

Sadly, the authors discuss none of these possibilities in their paper.

In view of this, I am tempted to rephrase their conclusions as follows:

This study adds no valuable information on the effects of Neurodoron® in self-medication. The results from this NIS showed what utter nonsense the Weleda marketing team is capable of producing in an attempt to boost sales.

PS

These declarations of the 4 study authors and the sponsorship are revealing, I thought:

RH and CS are employees of Weleda AG, Germany. JH and KS work for daacro GmbH & Co. KG, a clinical research organization, Germany. The authors declare that there are no conflicts of interest.

This study was financed by the pharmaceutical company Weleda AG, Arlesheim, the employer of RH and CS. Weleda commissioned the CRO daacro for their contribution to the manuscript.

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