Evaluating botulinum toxin products for clinical use requires accurate, complete, and unbiased data

نویسنده

  • Andy Pickett
چکیده

Modern clinical use of botulinum toxin (BoNT) by doctors requires evidence-based facts and data to support their work. In particular, these need to be unbiased and complete. Too often in the past, speculative statements have been used and repeated until injectors have come to believe they are solid facts. 1 Yet no supporting data exist. Consequently, doctors have often been reluctant to change to or even try other products because of what they have been told. This has not been a good situation for either clinicians or patients. We have published about these " urban legends " 1 and tried, on many occasions, to correct these inaccuracies (see, for example, 2,3). Therefore the recent paper by Park and colleagues, claiming to be a review of a relatively new BoNT product used in blepharospasm, was disappointing at best. 4 Many of the old and outdated claims about the properties of BoNT products have again been repeated. In 2011, this is an incorrect approach and borders on a marketing activity. For example, the product data contained in their Table 1 4 has no references cited as to the sources of information, is inaccurate, and does not even take into consideration previous publications which have highlighted errors in such tabular data. 1 We published last year a definitive work on the formulation composition of BoNT products in clinical use 5 specifically to stop these errors. We have previously suggested that authors contact manufacturers of BoNT products before they publish such data, to ensure complete accuracy; 1 all of this has apparently been ignored by Park and colleagues. Data in error in their Table 1 include the manufacturer of Myobloc ® /Neurobloc ® (this should be US WorldMeds, who acquired Solstice in August 2010), " stabilization " of Xeomin ® (also a freeze-dried product and not as cited), the vial size of Dysport ® (also available as 300 units per vial in many countries, including the United States), the vial sizes of Botox ® (also available as a 50 and 200 units per vial product in many countries), the so-called " complex sizes " for each product (none of which exist for the BoNT-A products in the actual vial) 6 and storage after reconstitution of Myobloc ® (this is already liquid product and not stable " for a few hours " after reconstitution – which simply does not happen!) More important clinically, Park and …

برای دانلود رایگان متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید

ثبت نام

اگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید

منابع مشابه

Double Sandwich ELISA Modified Method for the Detection of Clostridium Botulinum Type E

Background & Objective: A very small amount of botulinum toxin can cause death and on the other hand, there is no cure for its poison other than antitoxin. Therefore, a diagnostic method that can detect very small amounts of botulinum toxin in a short time is very important. In this study, rapid and accurate detection of botulinum toxin type E has been performed with the double sandwich ELISA m...

متن کامل

INJECTION OF BOTULINUM TOXIN IN THE TREATMENT OF ACHALASIA: A RANDOMIZED, DOUBLE BLIND, CONTROLLED CLINICAL TRIAL

Our aim was to evaluate the short and long term efficacy of botulinum toxin therapy in Iranian patients with achalasia. In a randomized, double blind trial, 20 patients with achalasia, referring to Imam Khomeini Hospital, received either 80 units of botulinum toxin (BT) or placebo (PL) from 1995 to 1998. Two weeks later, the response to treatment was assessed on the basis of changes in the...

متن کامل

Characterization of Clostridium botulinum spores and its toxin in honey

Botulism is a serious paralytic disease caused by Clostridium botulinum toxin in foods. There are seven recognized serotypes of botulinum neurotoxins among which the principal prevalent types in humans include A, B and E. Infant botulism results from intestinal colonization and toxin production by C. botulinum spores in babies less than 1 year old. Honey is the most important food discriminated...

متن کامل

Review Diffusion of Botulinum Toxins

Background: It is generally agreed that diffusion of botulinum toxin occurs, but the extent of the spread and its clinical importance are disputed. Many factors have been suggested to play a role but which have the most clinical relevance is a subject of much discussion. Methods: This review discusses the variables affecting diffusion, including protein composition and molecular size as well as...

متن کامل

Treatment of severe axillary Hyperhidrosis with Botulinum toxin A

Background: Severe axillary hyperhidrosis causes considerable emotional stress to individuals affected with this condition. Existing topical and surgical therapies are either ineffective or associated with unacceptable morbidity and sequelae. Objective: In this study we attempted to determine the effect of botulinum toxin A (Dysport) in the treatment of axillary hyperhidrosis. Patients and Meth...

متن کامل

ذخیره در منابع من


  با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید

عنوان ژورنال:

دوره 5  شماره 

صفحات  -

تاریخ انتشار 2011