Homeopathic PANDAS Trial

The homeopath Alan Freestone is proposing a trial to develop a homeopathic treatment for PANDAS (Pediatric Autoimmune Neuropsychiatric Diagnosis Associated with Streptococcal Infections). Regular readers of this blog will be aware of my opinion of homeopathy but we might all learn something from a properly conducted trial. Properly conducted. Aye, there’s the rub.

He gives the signs and symptoms of PANDAS as:

“The hallmark trait for PANDAS is sudden acute and debilitating onset of intense anxiety and mood lability (‘something that is constantly changing) accompanied by Obsessive Compulsive-like issues and/or Tics in association with a streptococcal-A (GABHS) infection that has occurred immediately prior to the symptoms. In some instances, the onset will be 4 to 6 months after a strep infection because the antibiotics did not fully eradicate the bacteria. Many pediatricians do not know the latent variability of strep – Rheumatologists and Streptococcal Experts do.”

Symptom onset includes Primary ONSET of OCD* and/or Tics along with at least two other following symptoms:

•Tics or other abnormal movements
•Severe separation anxiety, Generalized anxiety
•Irritability, Emotional lability, Aggression, Personality Changes
•ADHD, Inability to concentrate
•Sensory sensitivities
•Deterioration in learning abilities and school performance
•Developmental and age regression (inc. Deterioration in handwriting)
•Sleep and night time difficulties
•Urinary Frequency or Daytime or night-time secondary enuresis

*OCD may present as severe anxiety

This appears to be describing a chronic condition. It is a common trait of chronic ailments that symptoms come and go with time so to take account for that, a trial of any proposed new treatment would need a large number of participants divided into a new treatment arm and a control arm receiving either current best practise or a placebo and the two compared. (Since it is thought that PANDAS symptoms are due to a strep infection not being properly eradicated some doctors treat with antibiotics.)

Unfortunately, this is not what Freestone proposes:

How the trial will be structured
•Recruitment Phase: I am aiming for at least 15 participants.
•Initial Questionnaire and Skype interview (lasting 20 – 30 minutes) – This is to establish a base line for the person’s symptoms and the most appropriate remedy(s) for the trial.
•Prescription Phase: Each participant will be given a prescription to order from a homeopathic pharmacy (full details on how to do this will be given).
•Protocol Phase: Each participant will take the remedies as prescribed for 2 months.
•Final Questionnaire: Each participant will be asked to fill in an online questionnaire to record their experiences of the trial.
•Publishing Phase: The results and (hopefully) the effective protocol will be published.

Where to start? A tiny trial is proposed. The results will be subject to confirmation bias. There is no control arm. Cargo cult science at its worst.

There is one further point. Medical trials are subject to the Medicines for Human Use (Clinical Trials) Regulations 2004. In particular, Regulation 12 requires ethical approval before a trial can commence. No reference to this is made so I decided to email Mr Freestone with my concerns:

Dear Mr Freestone

I read with interest about your proposed trial to find a treatment for PANDAS. A couple of points occur to me:

1. Since PANDAS is a chronic condition, symptoms will come and go. How will you establish that any changes in the symptoms reported by participants are due to the reatment as there appears to be no placebo arm? Similarly, there is no comparison with current practise, so how will you establish which is better?

2. Has this trial received licensing and ethical approval under Regulation 12 of the Medicines for Human Use (Clinical Trials) Regulations 2004? This regulation states in part:

“12.—(1) No person shall—
(a)start a clinical trial or cause a clinical trial to be started; or.
(b)conduct a clinical trial,.
unless the conditions specified in paragraph (3) are satisfied.
(2) No person shall—
(a)recruit an individual to be a subject in a trial;.
(b)issue an advertisement for the purpose of recruiting individuals to be subjects in a trial,.
unless the condition specified in paragraph (3)(a) has been satisfied.
(3) The conditions referred to in paragraphs (1) and (2) are—
(a)an ethics committee or an appeal panel appointed under Schedule 4 has given a favourable opinion in relation to the clinical trial; and.
(b)the clinical trial has been authorised by the licensing authority

From
http://www.legislation.gov.uk/uksi/2004/1031/regulation/12/made

Yours sincerely

John Hawcock

As of the time of writing, no reply has been received.

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6 Responses to “Homeopathic PANDAS Trial”

  1. Alan Henness Says:

    @Slipp_Digby asked the MHRA whether this was a clinical trial. They replied:

    based on info available it appears to be a clinical trial within the Scope of the Directive

    I understand they will be contacting Freestone.

  2. Alan Henness Says:

    I’ve also asked the MHRA about homeopathic ‘provings’…

  3. Slipp Digby Says:

    I submitted a complaint to the MHRA on precisely the above points last week. As far as I can see an offence has already been committed.

    Rather amusingly Alan Freestone has documented all of the above breaches very clearly on his own website!

    I doubt he will get prosecuted, but a hefty fine and star prize of three months bed and board getting intimately acquainted with bubba would make a failure to engage with the MHRA rather unwise.

    I think there is another slightly technical breach in that they must provide participants the medicinal product free of charge in a trail, whereas the marks he has recruited must buy their own after consultation.

    When I read the MHRA guidance I thought a proving ticked all the boxes and also needs a clinical trails authorisation so it’ll be interesting to see their response to Zeno’s question.

    I contacted Alan on twitter and wrote on his blog. No response either.

  4. alcaponejunior Says:

    “…they must provide participants the medicinal product free of charge in a trail, whereas the marks he has recruited must buy their own after consultation”

    isn’t getting people to buy their crap the entire point of alt-med?

  5. A Sixth Year of Steam | Letting Off Steam Says:

    […] Venting my anger at the woos « Homeopathic PANDAS Trial […]

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