Monday September 10 2012
The 'botox pill' is simply a zinc supplement plus an enzyme
A new supplement "keeps wrinkles at bay for 30% longer", the Daily Mail has reported.
The news is based on the results of a small trial that found that dietary supplementation with "Zytaze" – a combination of zinc and the enzyme phytase – can increase the effectiveness and duration of botulinum toxin (botox) injections.
Botox is a neurotoxin, which means it can disrupt normal nerve function. Neurotoxins can be useful at tiny doses as they can lead to a temporary smoothing of skin, reducing wrinkles. In most cases this lasts for around three months.
There are also several medical conditions that botox can be used to treat, such as benign essential blepharospasm – a nerve condition that causes involuntary closure of one or both eyelids.
Zinc is thought to be required in order for botox to act as a neurotoxin. The phytase contained in this new pill is an enzyme that can reduce the time it takes for zinc to break down inside the body. Combining the two may “boost” the effects of botox.
The authors reported that this caused clinically important improvements for some patients, particularly in people with blepharospasm that had previously not responded well to treatment. However, several participants also experienced adverse effects caused by the botulinum toxin being too effective, such as being unable to close their eyes (lagophthalmos).
Further studies will be required to confirm the findings of this study and to determine the optimum dose. It is advisable to consult your GP before taking this supplement in combination with botox injections.
Where did the story come from?
The study was carried out by researchers from Baylor College of Medicine, MD Anderson Cancer Center, the Methodist Hospital and Weill Cornell University, USA. The source of funding for this trial was not disclosed.
However, the corresponding author has a patent pending for the use of zinc and phytase for enhancing the efficacy of botulinum toxin injections, which would suggest an obvious financial interest. The study was published in the peer-reviewed Journal of Drugs in Dermatology.
This story was covered by the Daily Mail and the overall results were reported reasonably accurately. However, the headline writers made a basic error by referring to zinc as a vitamin. In this context it is in fact a mineral. Also, no detail was given to the potential medical applications of this study, such as improving treatment for people with neurological conditions including benign essential blepharospasm or hemifacial spasm (a condition that causes muscle spasms on one side of the face).
What kind of research was this?
This was a double-blind, placebo controlled trial. It aimed to determine whether an oral tablet combining an enzyme called phytase and the mineral zinc could increase the efficacy of botulinum toxin treatments in patients given botulinum toxin to treat wrinkles or facial muscle spasms. The researchers stated that zinc is required for the activity of botulinum toxin. They thought that by increasing the levels of zinc they could improve the efficacy of injections. The researchers aimed to increase the level of zinc with a zinc tablet containing phytase, an enzyme that degrades phytates, which block zinc absorption.
Although this is the ideal study design to answer this question, the trial was small, with a total of 98 participants, with only 77 participants receiving the zinc and phytase supplement. The findings of this trial need to be repeated with more people to confirm the results, and to determine the optimal amount of zinc and phytase.
What did the research involve?
The researchers recruited 98 people who had been regularly treated with one of three brands of botulinum toxin (Botox, Myobloc and Dysport) for the treatment of:
- facial wrinkles
- benign essential blepharospasm
- hemifacial spasms
To be eligible for the trial, the participants’ last three treatment patterns had to be the same.
Participants were randomly assigned to one of three dietary supplements:
- 50mg zinc citrate in combination with 3,000PU phytase (commercially trademarked as Zytaze)
- 10mg zinc gluconate (a standard form of zinc supplement available from most health food stores)
- lactulose placebo (dummy treatment)
The patients were told to take the supplements for four days prior to their botulinum toxin treatment. After treatment, the patients kept diaries recording the treatment effect (scored on a scale from -3 to +3) and the duration of effect.
The trial was supposed to give each participant all three supplements in a random order. After completing the initial treatment, the patients received their normal treatment without any supplementation. This was done to try to ensure that no effect from the previous treatment contaminated the next treatment. They would then receive the next treatment.
However, some of the beneficial effects seen with people in the 50mg zinc citrate group were so dramatic that some participants refused to continue with the trial as they wanted to remain in the zinc citrate group.
The researchers cited an example of a woman who at first had such poorly controlled benign essential blepharospasm that relatives had to drive her to the study as she was unable to see out of one eye. After treatment with the combination of botox and 50mg zinc citrate, she was able to safely drive over 400 miles to the researchers in order to ask for further treatment.
Once such a dramatic beneficial effect is detected, it can be inappropriate to continue the study for two reasons:
- Any attempt to blind the study goes “out of the window” as it becomes obvious to both researchers and some of the people taking part in the trial who is receiving the active treatment.
- Medical ethics: in some cases it may be unethical to deny a treatment for someone who would clearly benefit from it.
When the trial was stopped, only 27 patients had received all three supplements. Seventy-seven participants had received the zinc and phytase supplement and at least one other supplement (either the zinc only or the placebo only, or both).
What were the basic results?
The researchers found that the 77 participants who had received the zinc and phytase supplement reported greater treatment effect and longer duration of effect with this supplement. Increased effect was reported by 84% of participants, and 92% of participants experienced an increase in effect duration. No significant change in efficacy or duration was reported after patients received either the zinc or placebo supplement.
The researchers looked to see if the effects were greater in specific subgroups. They found that people aged 65 or older were more likely to report an improvement in efficacy with the zinc and phytase supplement. The zinc and phytase supplement increased treatment efficacy in patients with hard-to-treat eyelid spasms (benign essential blepharospasm), and treatment duration in patients with spasms of the muscles on one side of the face (hemifacial spasm).
The researchers also collected data on safety of the supplement. Five patients had too much botulinum toxin effect when they were receiving the zinc and phytase supplement.
How did the researchers interpret the results?
The researchers concluded: “This study suggests a potentially meaningful role for zinc and/or phytase supplementation in increasing the degree and duration of botulinum toxin effect.”
This small randomised controlled trial has found that dietary supplementation with zinc and phytase can increase the efficacy and duration of botulinum toxin injections. The authors reported that this caused clinically important improvements for some patients, especially those treated for benign essential blepharospasm, where there is regular spasm or twitching of the eyelid. However, several participants also experienced adverse effects caused by the botulinum toxin being too effective.
The findings of this small study will need to be confirmed in more people. The results of this study also raise many questions. It is unclear whether the effects seen are due to the dose of zinc, the type of zinc used (zinc citrate), the presence of phytase or a combination of these effects.
Further studies will be required to determine the optimum combination and dose. Also, it is unclear whether the supplement causes its effect by directly acting on muscle and nerves, or whether it increases the activity of the botulinum toxin.
While this would need to be confirmed by further studies, it is possible that a similar effect could be achieved by increasing the levels of zinc in your diet before having botox therapy.
Supplements do not go through the same regulatory processes as conventional medicines, with monitoring of their safety and effects. It is therefore advisable to consult your doctor before taking this supplement in combination with botulinum toxin injections.
Analysis by Bazian. Edited by NHS Choices. Follow Behind the Headlines on twitter.