Sexologists clinical review

We asked Dr. Melanie van der Merwe, a Pretoria based medical doctor for 9 years with a special interest in women’s wellness and more specifically women’s sexual wellness, to assess the Zestra clinical data received from the USA.

Dr van der Merwe is a qualified clinical sexologist through Maimonides University (USA), is registered with the American Academy of Clinical Sexologists (AACS), the South African Sexual Health Association (SASHA) and HPCSA.

She has a sexology and general practice in Pretoria and is involved with women’s support groups. She also writes articles for several magazines and newspapers.

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ZESTRA®…is this the answer South African women have been waiting for?

When looking at a product like Zestra® on a retailer's shelf, it might be more appealing than some of the other products if you only look at packaging. On closer inspection it can actually be promising … but possibly not immediately so to the laymen.
 Unlike other similar products, one key point that is promising about Zestra® is actually the absence of, rather than the presence of various ingredients. Almost all other arousal gel, oil or cream contains L-arganine which, apart from re-activating genital herpes, can cause an intense irritation rather than increased sensation. Combining this ingredient with menthol of some sorts can have a disastrous effects. 

At least all Zestra®’s ingredients are on the America’s GRAS list (generally recognized as safe) and some of these ingredients are used in infant milk formulas and cosmetic products. It can therefore be concluded that it cannot be too harmful.


Zestra® ingredients

By taking a closer look at the actual ingredients and what benefit might be had may also shed some light on the future possibilities of this product.

Borage seed oil, Evening primrose oil, Vitamin C (Ascorbyl palmitate)
Vitamin E (Alpha-tocopherol), Coleus forskohli extract, Angelica extract

This product contains both borage seed oil and evening primrose oil. Borage seed oil contains an even higher level of GLA (Gamma linolenic acid), an essential fatty acid, than evening primrose oil. GLA has, among other things a beneficial effect on inflammation. GLA has been used for mood changes and cramping during PMS with some success. GLA has also shown improvement of nerve function in diabetics and can therefore be a good supplementation for diabetic women.

Vitamin E, a fat-soluble vitamin and vitamin C are both popular antioxidants.

Coleus may dilate blood vessels, which can be the reason for enhanced sexual sensation. It can also cause the slight burning sensation experienced when using Zestra® seeing that coleus is from the mint family. It has been used in the treatment of glaucoma and blood pressure .

Angelica extract is believed to stimulate blood flow in the pelvic region and to nourish thin and dry vaginal tissue .

Unfortunately not enough clinical work has been done on any of these ingredients to verify these statements. 


Studies performed on Zestra®

In medical circles you can sell cannibis with a double blind placebo controlled study. That is because medical students are brought up on evidence-based medicine and are bound by the Hypocrates oath of "causing no harm".

Keeping this in mind, Zestra® most definitely scored points on my scale of favourite treatments. Like all homeopathic or natural products making a claim for fame by promising to be the treatment for everything from ingrown toenails to sinusitis, physicians are bound to be skeptical. Studies take time and money and thus do not appear on most suppliers of natural products’ budgets. 

The manufacturers of Zestra® have proved to be more trusting and confident in their product’s benefits than most other natural product suppliers, by actually conducting and announcing the results of a product study. This is where they deserve the consideration of the medical professional. Most patients are not likely to have too much time for studies let alone understanding the terminology “double blind placebo controlled” but healthcare providers owe it to their patients to consider this information and evaluate it for a possibly safer more effective route.


Reviewing the Zestra® clinical study :

Methodology

• Twenty (20) women were chosen – well represented with similar demographics as far as age and medication use were concerned. They were divided into two groups of ten (10) per group - one group with FSAD (female sexual arousal disorder) and one without.
• The placebo was matched to Zestra® in viscosity, fragrance, colour, absorbency and lubricity. Each group received diaries and five 1ml doses to use and record at home. On return to the clinic they completed questionnaires again and received the five (placebo) crossover test articles with diaries
• The methodology applied was scientifically correct and well executed. 

Exclusion/inclusion criteria

• Screening was done through an interview conducted by a sex therapist. A physical examination was done and two questionnaires were completed, namely the female sexual function index and the female sexual distress scale (FSDS) to diagnose FSAD (Female sexual arousal disorder). Women who score high on the FSDS and those with unresolved sexual abuse or trauma were excluded. This contributed towards ensuring a more objective response from the chosen subjects
• Subjects with risk of conception were excluded. (Ingredients not safe in pregnancy)    · Subjects with active STD and dyspareunia not attributable to vaginal dryness were excluded.
• Subjects were limited to having only arousal difficulty (40<FSDS<60 score in female sexual distress scale) for six months (Primary anorgasmia, vaginismus, sexual pain disorder or sexual aversion disorder were excluded). They had to volunteer to attempt sexual activity at least three times per week.
• They were in their relationships long enough (one year) and used hormonal replacement and contraception long enough (six months) to know the effect on their libido and sexual functioning - again ensuring a more objective response.

End notes on the methodology applied

• Adverse events where monitored and reported
• Primary efficacy variable was determined by dividing number of successes by number of valid attempts
• Secondary efficacy parameters were the response to five questionnaires: 
  o FSFI (female sexual function index),
  o FSDS (female sexual distress scale), 
  o Two global assessment questions and 
  o The QualiLife consumer Testing Survey (QCTS)

Although subjective, it does determine the experience, response and satisfaction of twenty (20) female subjects with Zestra® versus a placebo product, which meet the objectives of this study


Results of the Zestra® study

Safety of Zestra®

• All subjects completed the study
• Only three subjects complained of slight genital burning, which subsided shortly after use of Zestra®. This can be contributed to the coleus and is limited in duration and severity with no reported lasting effect
• One subject was diagnosed with yeast infection after using the placebo and could not be contributed to the use of Zestra®.

Efficacy of Zestra®

• Question 3 of the female sexual encounter profile (FSEP) assessed satisfaction with level of arousal and satisfaction with arousal was greater in the FSAD (female sexual arousal disorder) group than in the normal group although they both had a significant improvement
• Secondary efficacy was determined on answers to questions:
   o Two - level of desire, 
   o Four - sufficient lubrication, 
   o Five - increased frequency of orgasm, and 
   o Six - level of arousal
• The overall results showed a significantly improved arousal in the normal subjects and a significantly improved arousal, orgasm and satisfaction in the FSAD group
• Lubrication was not significantly effected as should be expected with the use of an oil versus a gel

On comparing the SSRI-users versus non-SSRI users Zestra® showed to eliminate sexual side effects like arousal difficulties experienced by SSRI usage. Although Zestra®’s effect is limited to local application and the mind still needs to be included, it is promising in being the first product to proof its benefit in this regard.


Feedback from local patients

From questionnaires and interviews conducted among eight South African (Pretoria) women who used Zestra®, an increase in sensation after use of Zestra® was reported, which was described as warm and gentle. It had a greater effect on arousal than on orgasm or sexual experience. It also showed promising effects in patients with possible nerve and blood vessel damage, e.g. diabetic patients with enhanced sensation and arousal.

Further feedback received from the local market was regarding the price and the packaging. 

o It seems that it will serve the suppliers well if they can bring the bottles rather than the sachets to the local market. It will make this product less messy and easier to use. 
o The product is pricey but not more than similar products with less proven efficacy. Still, this may be a serious consideration for some women.

Market awareness especially among health care providers might make a difference to the reception this product will enjoy in the local market. Purely for enjoyment, few women may be interested in purchasing this product - but when given for the right indication (women with arousal difficulties and possibly diabetic women) the user might get hooked. 

Summary

After due consideration of available information and interviews conducted with patients locally Zestra® is a product, which proved to be efficient and well accepted by women. Zestra® is safe to prescribe in patients with arousal difficulties as well as those who just want to try something new and safe to spice up their sex life.