Flaws in Canadian study on AP to induce labour?

[Guest guest]

Hi All, & Are

 

Are wrote:

 

> Dear all, I have a question regarding this article; in the description

> of the investigation it is called " double blind " , but later it is stated

> that the therapist knew if he was putting needles or not. How is it

> possible to call the investigation double blind? Are

 

Are, in a Double-Blind Randomised Trial (DBRT) NEITHER the ASSESSORS

nor the PATIENTS know which ( " Verum " or " Placebo " ) treatment was

used.

 

The technicians / therapists / nurses etc who give the treatment are

irrelevant, provided they do not tell the patient, and are NOT

involved in the assessment of the outcome.

 

Those criteria WERE satisfied in the Canadian trial, IMO. The text

says:

 

> ... the acupuncturists were informed of the outcome of randomization

> for the patient but were blinded to obstetrical parameters (e.g.,

> cervical assessment) and outcomes. ... Patients, their obstetrical

> care providers, and trial researchers were blinded to the patients´

> study group; the acupuncturists were blinded to all obstetrical

> parameters...

 

I am unhappy with the " Sham AP " group. Points were used close to the

Verum points, and I would strongly disagree that they might have no

beneficial effect if needles in the same way as the Verum points.

 

The Verum points used were:

 

> In the treatment group, the points used were always inserted in the

> same order: Sp6, then St43 and Bl60 with manual stimulation of Li4.

> Sites are named for the acupuncture meridian on which they fall,

> followed by a number that indicates a set point along the meridian: Sp

> represents spleen, St the stomach, Bl the bladder, Li the liver [TYPO

> - that should be the Large Intestibne, as Sean noted] and Gb the

> gallbladder. The sites were Sp6: above the medial malleolus, Li4: at

> the highest point of adductor pollicis with the thumb adducted, St43:

> in the depression distal to the base of the second and third

> metatarsal bones, and Bl60: at the midpoint between the lateral

> malleolus and the Achilles tendon. If one of these sites was

> unavailable for use (e.g., the patient was unable to tolerate

> insertion at a given site) an alternate site (Gb36 located on the

> anterior border of the fibula) was used.

 

From the anatomical description of Li4, it must be Hegu because its

matching " Sham " point was in the " snuffbox " - see below.

 

> The [ " Sham " ] sites used were Sp6+, Li4+, St43+, Bl60+ and Gb36+. The

> locations were Sp6+: above the anterior ankle joint line slightly

> lateral to the border of the tibia, Li4+: in the centre of the

> anatomical snuff box (located between the 1st and 2nd metacarpal

> bones), St43+: at the joint line of the ankle superior to the web space

> of the 3rd and 4th metatarsal bones, Bl60+: inferior and posterior to

> the fibula head, and Gb36+: also inferior and posterior to the fibula

> head. ... Sham sites were stimulated in the same order as the true

> acupuncture sites. Acu-stimulation was applied as in the treatment

> group. ?

 

We need a much larger trial that compares two groups of women,

randomised into 2 groups of similar obstetrical parameters:

 

Group A (Control): Receiving STANDARD maternity hospital care.

 

Group B (Treatment): Receiving STANDARD maternity hospital care PLUS

Verum AP.

 

A statistical comparison of both groups would allow a conclusion as

to wthther or not AP improved the outcome over that attained in the

standard care group.

 

I will be offline for a few days to have stents placed in my right

coronary arteries on Thursday.

 

Otherwise, I am fine and working as usual

 

Best regards,