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| Date: 06-30-2016 | HC# 061661-547 |
Greven
KM, Case LD, Nycum LR, et al. Effect of ArginMax on sexual functioning and
quality of life among female cancer survivors: results of the WFU CCOP Research
Base Protocol 97106. J Community Support
Oncol. March 2015;13(3):87-94.
T
hose that have experienced breast or
gynecological cancer are often left with sexual dysfunction, such as limited
desire and satisfaction. Targeting blood flow and hemodynamics is a popular
approach to this problem. ArginMax® (The Daily Wellness Company;
Honolulu, Hawaii) is a mixture of L-arginine, Korean ginseng (Asian ginseng; Panax ginseng, Araliaceae) aerial parts
and root, ginkgo (Ginkgo biloba, Ginkgoaceae)
leaf, and damiana (Turnera diffusa var.
aphrodisiaca syn. T. aphrodisiaca, Passifloraceae) leaf,
along with vitamins and minerals. L-arginine supports vascular function, and
ginseng and ginkgo have been investigated for effects on various aspects of the
vascular system.1 This randomized, placebo-controlled trial
investigated the potential effects of ArginMax on sexual function in female cancer
survivors.
The study took place between May 10, 2007, and
March 24, 2010, and patients were recruited from Wake Forest University Community
Clinical Oncology Program (Winston-Salem, North Carolina) member sites. Female cancer
survivors who were 6 months post-treatment with no evidence of cancer, had not
been in another clinical trial within 30 days of the study's start, and had sexual
dysfunction not caused by other reasons were enrolled. Patients were allowed
hormonal therapy and trastuzumab (a chemotherapy drug). Those who were
pregnant, allergic to any component of ArginMax, on other medications such as
anticoagulants or antidepressants, or had other illness, planned surgery, or planned
pregnancy were excluded.
Prior to the study, patients were asked about
their sexual function. If they answered that they had dissatisfaction with
their sex life, had sexual problems, and a desire for improvement, they were
considered. Patients were categorized based on pelvic or non-pelvic cancer and
ovarian function and were randomly assigned to receive ArginMax or placebo. ArginMax
and matched placebo were supplied by The Daily Wellness Company. Neither the exact
dosage of L-arginine and botanicals per caplet of ArginMax nor contents of
placebo were described. Note: The Arginmax website lists the amount per serving
size as 6 caplets, which was the amount the patients received. The amounts for 6
caplets are as follows: L-arginine, 2500 mg; Korean ginseng, 100 mg; ginkgo, 50
mg; damiana, 50 mg.
http://www.arginmax.com/sexual-enhancement-for-women/ingredients.php. Patients took 3 caplets twice per day
for 12 weeks and took note of the total caplets consumed for compliance. At baseline
and at 4, 8, and 12 weeks, assessment was made of sexual function, quality of
life, and toxicity.
The primary outcome was the score of the Female
Sexual Function Index (FSFI). This assessment addresses sexual desire, arousal,
lubrication, orgasm, satisfaction, and pain, with higher scores meaning better
sexual function. The secondary outcome was health-related quality of life as
measured by the Functional Assessment of Cancer Therapy-General (FACT-G). This
assessment consists of physical, social, emotional, and functional well-being,
with higher scores meaning better quality of life.
Overall, 186 patients were randomly assigned,
with 92 in the placebo group and 94 in the ArginMax group. Of these patients,
163 (74%) completed the study, with reasons for dropout including refusal of
treatment, loss to follow up
