Glutathione Usage for Skin Depigmentation - Research Paper Example

?Table of Contents Page I. Background of the study 2 A. Introduction 2 of the problem 2 Importance of the problem and its consequences 3 B. Review of literature 5 Glutathione usage for skin depigmentation 5 Modes of administration 5 Potential confounders in the treatment process 6 Potential health risks 7 C. Study purpose/Research questions 7 Study purpose 7 Theoretical/conceptual framework 8 Research questions 9 II. Methods 10 Study design 10 Study participants 11 Methods 11 Some recruitment techniques 12 Procedures 12 Measures 14 Independent variables 14 Dependent variables 14 Possible confounders 15 Data Analysis 15 References 17 I. Background of the study A. Introduction Description of the problem As a secret ingredient in lotion, oral tablets and injectable for skin whitening, Glutathione finds its way in Asia as antioxidant that is especially formulated to achieve a healthy glowing white skin. In the Philippines for instance, many people consult their doctors and other health experts and practitioners related to skin in order to keep it lighter. Most of them are entertainers in the show business industry. These people are very influential in the society because they tend to give some relevant fashion trends and these include how they achieve a healthy glowing skin and an excellent complexion through the use of glutathione (Belo Medical Group, 2008). They invest in their skin as the ultimate Philippine standard for beauty. In the Philippines, white simply enhances what is called as beauty. In India, people believed that one should have a fair complexion in order to find a partner successfully. Therefore, there is a great value placed on being fair skinned. This is a specific market opportunity for whitening products. Melanin protects the skin from harmful damage that may cause by being exposed to the ultraviolet from the sun. An individual losing melanin therefore decreases its chance to be protected from sun’s harmful radiance and increases its chance to acquire skin damage such as cancer. A study from Synovate in 2004, 40 percent of women in Taiwan, Hong Kong, South Korea, Malaysia and Philippines used skin whitening and lightening products. In fact, an estimate of $18 billion a year goes to expenses on whitening products in Asia. Male in Asia wants women with fair complexion or appear to be pale. Furthermore, it is associated with success which predominantly flooded the media and ads. However, in the United States, glutathione finds its use apart from being a skin whitener. It can be used to help improve the memory (Perlmutter and Colman, 2004). It has also protective effect or as antidote of toxicity (Goldfrank and Flomenbaum, 2006). It helps in enhancing human nutrition and metabolism (Gropper, Smith and Groff, 2008). Furthermore, it was also found that glutathione is said to help fight problematic health conditions such as infertility, human immunodeficiency virus, cancers, cataracts, thyroid problems, liver problems, chronic fatigue, heart disease, multiple sclerosis, Alzheimer disease, Parkinson’s disease, arteriosclerosis and more (Skin-Whitening-Product.com, 2011). These are just among of the many medical uses of glutathione in the United States. Compared it in Asia particularly in the Philippines, the importance of glutathione in the US is not limited or confined to only as skin whitening agent. Importance of the problem and its consequences By understanding the remarkable health benefits of glutathione, there is a need to understand deeply some of its potential side effects when used as skin whitening ingredient. Study shows based on the findings of Food and Drug Administration that glutathione can potentially cause serious health problems like kidney failure and blood poisoning (Presse, 2011). Aside from these, glutathione is also found associated with simple skin rashes up to potentially fatal diseases like Steven Johnsons Syndrome and Toxic Epdiermal Necrolysis (Malaya, 2009). Furthermore, people with allergies in milk proteins should consult their doctors prior to intake of glutathione, an indication that it is not totally safe to be taken without proper medical prescription (eHow Health, 2011). These are just some reported negative cases which interlinked glutathione and human health concerns. In other words, there remains to be important some important findings about glutathione that need to be carefully elaborated in great detail. There is a need therefore to conduct more significant studies that particularly point out the negative impact of glutathione on health particularly when it is used as skin whitening agent. Even though it promises significant health benefits, one cannot just simply overlook its potential negative impacts on health as well. It does not mean that it promotes many advantages that it has to be considered in great detail as safe for human consumption. Various important factors need to be explored and cases to be critically considered in order to understand the extent of its potential health benefits and risks. For instance, unfortunately, not all Asians could afford a very expensive skin treatment because many of them are poor. Considering a higher market potential for them, illegal whitening products flooded in the market which puts the efficacy of glutathione as a very important concerns especially on its health consequences relevant to its long-term use. B. Review of literature Glutathione usage for skin depigmentation Glutathione has a specific role towards skin lightening and it is found to be associated with human pigmentation as it may change various outcomes of chromophores on the human skin (Halprin & Ohkawara, 1966; Villarama & Maibach, 2005). The discovery of Glutathione was primarily for the suppression of tyrosinase production which is found to be associated with the synthesis of melanin, which is responsible for human skin color (Mishima et al., 1993). There were 60 medical students in Thailand who were involved in the study of Arjinpathana and Asawanoda (2010) with a randomized double blinded clinical study. They found that glutathione may potentially cause skin whitening but in only small subjects. Furthermore, they pointed out that more extensive clinical trials are necessary in order to establish its safety of administration for long-term use. Modes of administration Since it is directly administered into the body’s blood streams, glutathione injection is found to have significant high level of speed in body detoxification (Robertson, 2010). Applying this in the context of skin whitening treatment, it is expected therefore that injecting glutathione directly into the body ensures fast achievement of outcomes or results. Oral glutathione intake may be more convenient to do. Through oral intake, an individual can easily boost his or her glutathione intake. However, an individual should be able to take note of the right dosage because of its potential risks if there is tendency of taking in over dosage (Graci, 2010). External use of glutathione through lotions and other applications may be more convenient. However, its effectiveness may be inhibited due to the fact that the sun’s radioactive radiance may inhibit the actual role of glutathione. Glutathione is sensitive to sun’s actual exposure (Cadenas & Packer, 2001). Potential confounders in the treatment process However, glutathione for skin whitening treatment may turn out not that effective due to some significant factors. One important antioxidant that is affected by alcohol intake is glutathione (Maher, 1997). Sun exposure is associated with the decrease of some antioxidants in the body including glutathione (Cadenas & Packer, 2001). Finally, tobacco smoke is found to reduce the protective effect of glutathione (Halliwell & Poulsen, 2006). Potential health risks Although the available studies are quite limited regarding these potentially important risk claims on glutathione, it does not mean that they might not be eventually true. This means that in order to find these claims, further scientific studies are necessary and required. While majority of available related literature on the web try to report no significant risks associated with glutathione use, it does not mean that it is totally reliable and with significantly high benefits. It is still important to find out if these benefits are actually above the potential health risks it may contribute. Even though some would say that glutathione is potentially risk-free because it is classified as antioxidant, natural detoxifier and immunity booster (Glutathione-GSH.org, 2010), there are some potential risks claims about it that need to be investigated further. Aside from thyroid function and kidney failure, and abdominal pain, glutathione is reported to potentially cause abnormalities that affect the skin from simple rashes up to potentially fatal diseases such as the Steven Johnsons Syndrome and Toxic Epidermal Necrolysis (Malaya, 2009). C. Study Purpose/Research Questions Study purpose The proponent aims to examine the effects of the off label use of glutathione as a skin whitener among Adult Filipino Women residing in the Jersey shore. Theoretical/conceptual framework Figure 1: Theoretical Framework Shown in Figure 1 above is the theoretical framework for this study. The use of glutathione is the independent variable. It is the first primary focus of this study prior to finding some adverse treatment and health effects as the dependent variables. The mode of administration as integral part of the use of glutathione is oral in a form of pills. After this, the proponent will take down some notable treatment effects that may be in a form of depigmentation in general with having other important results such as glowing skin and smooth skin that has to be notable from the participants. Aside from these positive impacts, adverse health effects in line with the skin will be recorded. However, the proponent will also take note of potential confounders such as alcohol intake, smoking and sun exposure because they tend to lower the level of glutathione in the human body. These could potentially inhibit the treatment effects of glutathione intake. Research questions Does the off label use of glutathione in Filipino Adult women cause skin depigmentation? What are some of the adverse events associated with the use of Glutathione as a skin whitener? II. Methods In this section, the proponent tries to show the exact plan that has to be undertaken in this study and the specific approach that has to be executed in the actual implementation process. Study design This study will incorporate true experimental using Random Clinical Trial (RCT), pre-post with monthly post assessments for one year. The proponent will form two groups, control and treatment for women who are interested in taking daily an oral glutathione whitening pills. Outcomes should be noted from this activity should include skin color variation and adverse events (related health effects) among participants. However, due to the limited availability of literature regarding this study and the information about its being timely, the proponent should use a strong research design so as to add credibility of the findings. Thus, a randomized clinical trial so far is the most rigorous way to use in order to determine if there exist a cause and effect relation between the treatment and outcomes as illustrated in the theoretical framework. Study participants The proponent will choose adult Filipino woman because of their widespread use of commercial glutathione treatment and its popularity as a skin whitener for them. The proponent will use the Filipino-American Club of Jersey Shore member roster. Filipino women interested in participating in the trial will be randomly assigned to treatment and control groups. Participants will include: Adult Filipino women (18-35) with a skin tone of 20 or above in the Von Luschen’s chromatic scale who are residents of the Jersey shore for more than 2 years. Those who have chronic diseases, or are on medication and do not speak English well will be excluded. Methods Since the population involved in the study is special and a minority with cosmetic motivations rather than health related or illness driven ones, the proponent will use a combination of a convenience and snowball non- probability sampling through referrals and considering whoever wants to join as long as they meet eligibility criteria. There will be minimum of 300 participants that will be targeted for inclusion in the study. There is a possibility of a high attrition rate especially among the control group so to control for this, each of the treatment and control group will have 100 participants and the remaining 100 will account for any drop outs for adjustments to avoid the loss of statistical power. Some Recruitment Techniques The proponent will contact the president of PR officer of the Filipino American club in Jersey shore propose the study and ask to utilize the club’s media channel. Furthermore, the proponent will place a call for participation and advertise the need for participants in the clubs website. The proponent will also provide a number or email to sign up and register. The proponent will attend club meetings and community functions or local celebrations to recruit subjects while socializing, then flyers will be distributed at club members assemblies. The proponent should be able to get prominent and key figures in the community such as society wives and business owners to display the flyers in their establishments. For this study, media influences and perceived beauty standards as well as word of mouth will be a powerful tool in the recruitment process. Procedures Control and treatment groups will be given pills to be orally taken twice a day. Pill intake by both groups will be measured as the number of pills/ frequency through self report. Participants will be asked to keep a daily log of their intake and email the results weekly. A person from the research team will be assigned to receive emails and record the weekly data. All subjects will be asked to come in once a month for skin color evaluation using existing scientific methods. A blood test will administered every 6 months on all participants. This study will employ quantitative design particularly an experimental design. The proponent will come up with two important groups in this study. These groups should be composed of healthy individuals with no claims or significant background regarding health-related problems. The first group should be the study group and this should be composed of individuals to use real glutathione for skin whitening treatment. On the other hand, the other group should be the control group with individuals who will be using fake glutathione with no potential health hazard or even positive result. In other words, the first group should be expected to have positive result while there should be none with the second group. The proponent will then record potential health-related concerns that occur between these two groups. There should be high expectation that the first group should report potential health diseases and poor personal health evaluation in order to prove the claim that glutathione is associated with potential health hazards. The above design will be selected because the proponent will try to achieve high chance to have control over the internal threats to validity. The proponent will also place a strong importance to find differences between the two groups. All of these considerations will be addressed by an experimental design (Imas & Rist, 2009). However, Imas & Rist (2009) pointed out that the experimental design is “difficult to conduct in public sector, and selection and attrition are significant threats too” (279). Measures Independent Variable: Glutathione usage: Pills of a concentration of 500mg of L-Glutathione to be taken twice a day and measured through self report records and logs of the number of pills taken. This is the only way that the proponent will be able to measure the amount of tablets taken by the respondents, except however, if someone should be assigned to give tablets to them regularly and record it. The potential limitation of this approach is when the respondents forget to take the medicine at a specified time of intake. Dependent Variables: Treatment Effects (Depigmentation): Color skin evaluation done using a scale of colors with numbers and measured against the skin. Existing methods include the Von Luschan’s Chromatic. This method is beneficial in this study because its main intention is to only measure the skin tone of an individual (Ruiz, 2009). Adverse Health Events: Skin rashes, allergies, eczema and depigmentation. Severe Adverse Health Events include: Cancer, Vetiligo and death. Measures include a complete blood test every 5 months. Other than this, it is important that the respondents will undergo routine screening for skin cancer and other skin related diseases (U.S. Preventive Services Task Force, 1989). The importance of blood test in this case is to perform the actual test which may be dangerous to be implemented with skin test especially among individuals with strong allergic reactions (Moragne, 2011). Possible Confounders: The following contribute largely to the depletion of glutathione in the body: Smoking, alcohol, caffeine, Tylenol and other drugs, vigorous exercise, ultraviolet radiation, air pollution, xenobiotics and other hormone-mimicking chemicals. Measures for confounders in the study: Arizona Smoking assessment Questionnaire (ASAQ), scale and a Reflectance Spectrometere for Sun Exposure. Data analysis Statistical analysis will be employed in this study. Thus, finding for certain relationship between variables will require the use of statistical tools. Thus, the conclusion will be based on statistical results that will be obtained. The threat to wrong statistical conclusion is in line with the wrong inferences made (Madeyski, 2010). The proponent will come up with inferences as statistical control in finding relevant information that could generate the actual conclusion for this study. One of the threats to validity is finding a relationship when there is none or finding no relationship when in fact there is one. The proponent will take note of this problem because at some point, it can be rooted down to statistical conclusion that will be obtained. In order to avoid this, the proponent will use the appropriate statistical tool for the analysis. Understand their major strengths and basic disadvantages and their specific area of applications where they can be best applied. The proponent will also evaluate the data, understand their nature and basic components and take note of some assumptions that may arise. References Arjinpathana, N., & Asawanonda, P. (2010). Glutathione as an oral whitening agent: A randomized, double-blind, placebo-controlled study. Retrieved October 23, 2011, from http://www.ncbi.nlm.nih.gov/pubmed/20524875 Belo Medical Group. (2008). Welcome to Belo beauty blog. Retrieved December 15, 2011, from http://blogs.belomed.com/summer-promos/ Cadenas, A., & Packer, L. (2001). Handbook of Antioxidants: Revised and Expanded (2nd ed.). Basel: CRC Press. eHow Health. (2011). What are risks of glutathione? Retrieved October 23, 2011, from http://www.ehow.com/facts_5992638_risks-glutathione_.html Glutathione-GSH.org. (2010). Are There Any Risks in Taking Glutathione? Retrieved October 23, 2011, from http://glutathione-gsh.org/health/are-there-any-risks-in-taking-glutathione/ Goldfrank, L. R., & Flomenbaum, N. (2006). Goldfrank’s toxicologic emergencies. New York, NY: McGraw-Hill Professional. Graci, S. (2010). The Food Connection: The Right Food at the Right Time. Belmont, CA: Wiley and Sons. Gropper, S. S., Smith, J. L., & Groff, J. L. (2008). Advanced nutrition and human metabolism. Mason, OH: Cengage Learning. Halliwell, B., Poulsen, H. E. (2006). Cigarette smoke and oxidative stress. Berlin: Springer. Halprin, K. M., Ohkawara, A. (1966). Glutathione and Human Pigmentation. Archives of Dermatology. 94, 355-357. [Link: http://archderm.ama-assn.org/cgi/content/abstract/94/3/355] Imas, L. G. M., & Rist, R. C. (2009). The road to results: designing and conducting effective development evaluations. NW, Washington DC: World Bank Publications. Madeyski, L. (2010). Test-Driven Development: An Empirical Evaluation of Agile Practice. Wroclaw: Springer. Maher, J. J. (1997). Exploring Alcohol Effects on Liver Function. Alcohol World: Health and Research. 21, 5-12. Malaya. (2009). FDA cites health risks of glutathione injections. Retrieved October 23, 2009, from http://www.malaya.com.ph/may13/news14.html Mishima, Y., Sowa-cho, L., Hyogo, K., Oyama, Y., Kurimoto, M., Okayama, Kobeshi. (1993). United States Patent. Retrieved October 23, 2011, from http://www.google.com/patents/download/5262153_Skin_whitening_agent.pdf?id=MkcbAAAAEBAJ&output=pdf&sig=ACfU3U1zNJdx9EOG28a5zy--w1kT30OPmA&source=gbs_overview_r&cad=0 Moragne, W. (2011). Allergies. Minneapolis, MN: Twenty-First Century Books. Perlmutter, D., & Colman, C. (2004). The better brain book: the best tools for improving memory, sharpness, and preventing aging of the brain. Pennsylvania: Riverhead Books. Presse, A. F. (2011). Glutathione injections could kill, FDA warns. Retrieved October 23, 2011, from http://www.abs-cbnnews.com/lifestyle/05/31/11/glutathione-injections-could-kill-fda-warns Robertson, R. (2010). Finding Mary: One Familys Journey on the Road to Autism Recovery. Bloomington, IN: Universe. Ruiz, E. (2009). Discriminate Or Diversify. Lothian, MD: PositivePsyche.Biz Corp. Skin-Whitening-Product.com. (2011). Glutathione Supplements. Retrieved October 23, 2011, from http://www.skin-whitening-product.com/skin-whitening-pill.html US Preventive Services Task Force. (1989). Guide to clinical preventive services: report of the US Preventive Services Task Force. Cambridge, MA: DIANE. Villarama, C. D. & Maibach, H. I. (2005). Glutathione as a depigmenting agent: an overview. International Journal of Cosmetic Science. 27, 147-153. [Link: http://onlinelibrary.wiley.com/doi/10.1111/j.1467-2494.2005.00235.x/abstract] Read More