How can a non-hormonal, collection of herbs, none of which have been shown to have an effect upon the endocrine system, be so widely used?  Do the fools suppose that plants manufacture alkaloids in sufficient concentration as to be biologically useful (undoubted by god's design)?  The results of their Avlimil study looks impressive.  But the history of cocktail preparations is dismal. The reasonable conclusion concerning this double-blind study is that it is not truly double-blind.  This negative conclusion is made all the more likely given the numerous examples of in-house studies being contradicted by independent researchers.

 Why do seemingly valid double-blind studiies succeed when funded by a drug company and fail when done by truly independent researchers?  A few years ago I came across the obvious answer, participants are able to recognize the placebo.  The commentary was in criticism of Prozac studies paid for by the drug company.  If the drug being tested has a noticable effect, such as drousiness, vertigo, dry mouth, and the placebo has none, recognition will occur by most of the participants in the study.  Moreover, some would simply taste the medication; the placebo would be bland.  Since it is not in the interest of the company that has invested millions to fail a double blind study, having participants in the study recognize the placebo pays off.  And there are ways to manipulate the results. 

http://www.avlimil.com/AvlimilStudy.pdf

Product:

Proprietary formulation, taken orally, to help female sexual function

Prepared by:

Marshall-Blum, LLC

Herbal Research Clinic, LLC

James M. Blum, Ph.D., CEO

Adjunct Faculty: University of Maine,

Department of Food Sciences and Human Nutrition

Adjunct Faculty: Husson College, College of Arts and Sciences

Cardiac Quality Improvement Consultant, Eastern Maine Medical Center

Member Northern New England Cardiovascular Disease Research Group,

Dartmouth-Hitchcock Medical Center

Member Health Services Research Group, Case Western Reserve University,

Department of Epidemiology and Biostatistics, Cleveland, OH

Ronald I. Blum, M.D. (no relation)

November 12, 2002

Avlimil claims it can help in all types of sexual problems. The assertion is based on a company-sponsored, three-month trial of 49 women.

Clinical Site:

Bangor, Maine: Marshall-Blum: Clinical Outcomes Specialists (parent company)

Herbal Research Clinic, Independent Medical Research Center, Located in Bangor, Maine

James M. Blum, PhD, Study Coordinator, Epidemiologist and Biostatistician

Medical Director: Ronald I. Blum, MD

Medical Advisory Team: Felix Hernandez, MD, and Irwin Gross, MD

Protocol:

Design:

 Prospective, randomized, double-blind, placebo-based, parallel-group clinical trial

 This trial had IRB approval (Fox Commercial IRB, Candace Woods, Senior Manager,

Springfield, IL.)

 This design was chosen over a traditional cross over design because the herbal blend

may have a long-term effect in improving sexual function

 The duration for this trial was three months on product or placebo. The randomization

ratio of subjects on product to control was equal (1:1)

 All subject contact was with a study coordinator or research nurse who was blinded to

the randomization scheme

 Subjects were recruited from the general population of Bangor, Maine; the major exclu-sion

criteria were alcohol abuse and abnormalities or dysfunction to the sexual organs,

while the major confounders include age and menopausal status

Product Usage:

Two tablets were taken daily; twice a day; morning and evening (one pill each), with

water and food

Placebo Product:

The placebo was (nearly) identical to the active product with respect to size, color, and odor.

Inclusion Criteria:

 Women who wish to enhance their sexual experience

 Subjects who respond to our advertisements inviting women age 25 65, who express

an interest in taking the product for reasons of simply improving their sexual satisfaction

 Subjects who pass a compliance screening test

 Subjects able to tolerate the active product and placebo

 Subjects who sign a consent form

 Subjects do not need a partner to participate

 Subjects may be of any sexual orientation

Exclusion Criteria:

 Subjects who are non-compliant with testing and taking treatment regimens

 Subjects who express problems with the treatment herbs

 Subjects under 25 or over the age of 65

 Subjects with alcohol abuse as determined by liver enzyme, provider interviews, or

medical history Confounding Factors:

 Age

 Menopausal Status

2

Primary End-Points:

Female Sexual Function Index (FSFI) (See References at end of this document)

19 Question Self-Report Instrument with the following categories

Desire: 2 Questions

Arousal: 4 Questions

Lubrication: 4 Questions

Orgasm: 3 Questions

Satisfaction: 3 Questions

Pain: 3 Questions

John Wares Functional Survey (SF-12)

Physical Parameters:

 Vaginal wetness

 Ease of climax

 Level of arousal

 Overall sexual satisfaction

Emotional Parameters:

 Libido

 Overall well-being (Wares Functional Survey Tool)

Analytical Methods:

Methods:

 Subject answers from baseline and the three-month follow-up period were subtracted

creating a difference variable for each questions (FSFI and Quality-of-Life)

 Answers from survey tools were coded from 1 to 6

 Answers from the follow-up questionnaires were subtracted from each subjects base-line

data to create the outcome measures

Example

Question 1: How often did you feel sexual desire or interest?

1. Almost always or always

2. Most times (more than half the time)

3. Sometimes (about half the time)

4. A few times (less than half the time)

5. Almost never or never

For example, a subject answering the question about desire at baseline

and final give the following responses,

Time Response

Baseline 4

Final at 3-months 2

The subtraction of the responses yields a point improvement for this subject on

this question:

4 2 = 2 point improvement

 The responses for the two groups (placebo and treatment) for each symptom were

summed. This forms the basis of the results.

 There is more.  A total of 16 pages were publishedgo to above link.  The graphs are impressive, but as with studies tinted by profits and products lacking a realistic modus operandi, impressive and honest are different.