E-DRUG: Re: Serrapeptase

["Peter Mansfield" <Peter.Mansfield@flinders.edu.au>]

E-drug: Re: Serrapeptase
----------------------------------------------------------

For Kenneth and others interested in Serrapeptase the text of our MaLAM
letter to Takeda re Danzen follows.

We never received a satisfactory reply.

Peter Mansfield
Peter.Mansfield@flinders.edu.au
									 September 1991
Mr Kunio Takeda
President, Pharmaceutical Group 
Takeda Chemical Industries Ltd
27 Doshomachi 2-chome
Higashi-ku
Osaka 541
Japan

Dear Mr Takeda,

	Dr. Alfredo Bengzon, Secretary of Health for the Philippines has asked
MaLAM to write to you again about the marketing of serrapeptase (Danzen).

	MaLAM first wrote to your company in August 1989, but we have not yet
received a reply.  Pharmaceutical companies usually answer doctor's
requests for information about their products.  We do not understand why
your staff have responded differently.  We are concerned that your staff's
decision not to reply may indicate a belief that marketing of serrapeptase
cannot be justified.

Recommended Indications.

 	The Philippine Index of Medical Specialities (February, 1991) lists the
recommended indications for serrapeptase as: "Difficulty of expectoration
in bronchitis, pulmonary tuberculosis, bronchial asthma, bronchiectasis and
after anaesthesia.  Inflammation after surgery and traumatic injury. 
Inflammation in otorhinolaryngology, O & G, urology, dentistry and oral
surgery.  Enhancement of antibiotic penetration".

	The scientific literature available to MaLAM, summarised below, does not
support those claims for serrapeptase.  However, you may have access to
information which leads to more positive conclusions.  The purpose of this
letter is to give you the opportunity to express your point of view so that
we can determine what place serrapeptase should have in clinical practice. 
We hope that you will either provide evidence to support your subsidiary's
claims or urgently review the marketing of serrapeptase. 

Scientific assessment.

	MaLAM was unable to locate any studies of serrapeptase for the following
indications:  Difficulty of expectoration in bronchitis, tuberculosis,
asthma, bronchiectasis and after anaesthesia.  Inflammation after traumatic
injury.  Inflammation in O & G, urology, dentistry and oral surgery. 
Enhancement of antibiotic penetration. 
	Tachibana et al (1984) claimed significantly less swelling after antrotomy
for chronic empyema in a placebo controlled trial of serrapeptase.(1)  If
serrapeptase affects the rate of swelling we would expect an increasing
difference between control and treatment groups in the hours after the
operation.  There was a difference between the groups immediately
post-operation.  However, there was no significant increase in that
difference with time.  The most likely explanation for the data is a
difference in operative trauma rather than an effect of serrapeptase.

 	Conticello et al (1979) claimed that serrapeptase was useful for
miscellaneous ENT conditions.(2)  Their trial was only partially placebo
controlled and lacked proper blinding and randomisation.

	Schulte-Sasse et al (1987) reviewed three clinical trials of
serrapeptase.(3)  They concluded that a study of post-operative swelling by
Raneri et al (1983) failed to show any objective improvements from
treatment.(4)  A study by Laura et al (1982) of operative correction of
hallux valgus also failed to show objective improvement.(5)  Mizukoshi et
al (1979) claimed a subjective improvement in sinusitis but there was no
confirmation by objective criteria such as X-rays.(6)

Questions.

1.	What are your official recommended indications for serrapeptase?

2.	What is your best evidence to support your recommended
	indications for serrapeptase?

3.	In what countries do you sell serrapeptase?

I would appreciate receiving a personal copy of your answers to all three
questions.

						Yours sincerely,


1.  Tachibana M, et al. Serrapeptase versus placebo in post-antrotomy
buccal swelling. Pharmatherap 1984;3:8:526-30
2.  Conticello S, et al. La serratio-peptidasi in ORL. La Nuova Clin ORL
1979;31:15-20  
3.  Schulte-Sasse H, et al. Aniflazym. Intern Praxis 1987;27:368  
4.  Raneri L, et al. Impiego della serratio-peptidasi in chirurgia
ortopedica. Gaz Med Italiana 1983;142:515  
5.  Laura G, et al. Esperienze chliniche sall uso della serratio-peptidasi
(Dansen) in ortopedia e traumatologia. Minerva Ortopedia 1982;33:111  
6.  Mizukoshi O et al. A double blind clinical study of Dansen tablets in
the treatment of chronic sinusitis. Igaku No Ayumi 1979;109:50




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