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This study examined the frequency and characteristics of alli® use among patients in eating disorder treatment facilities.
Patients from five treatment centers completed the Survey of Eating and Related Behaviors. Diagnoses were determined from survey responses.
Of 417 survey respondents, 26 (6.2%) reported a history of alli® use. Of those, 15 (57.7%) met criteria for an eating disorder, including one of 29 patients (3.4%) with anorexia nervosa binge-purge subtype, six of 66 patients (9.1%) with full or subthreshold bulimia nervosa, four of 49 (8.2%) with binge eating disorder, one of six (16.7%) with purging disorder, and three of 80 (3.8%) with an eating disorder not otherwise specified.
The results of this survey suggest that patients with eating disorders use alli®, albeit relatively uncommonly. Therefore, it is worthwhile for clinicians to inquire about alli® use when evaluating or treating these patients in any clinical setting.
Orlistat (Xenical®) has been available by prescription as a weight loss aid in the United States since 1999. In 2007, orlistat was also approved by the U.S. Food and Drug Administration (FDA) for nonprescription sales under the brand name of alli®, at one-half the daily dose of the prescription product. Currently, alli® is the only FDA-approved weight loss medication available over-the-counter. The majority of U.S. adults are currently classified as overweight or obese.1 For these individuals, the ability to readily obtain orlistat without a prescription may be advantageous. A substantial percentage of patients with an eating disorder engage in over-the-counter medication and herbal product use to promote weight loss2 and often continue these agents despite experiencing side effects.3 Therefore, the nonprescription availability of alli® warrants investigation of the frequency of use of this product in patients with eating disorders.
alli® is FDA-approved for nonprescription use in the United States by overweight patients ages 18 and older who are also on a reduced calorie, low-fat diet.4 alli® is formulated in 60 mg capsules, which are to be taken within 1 hour of each fat-containing meal, up to three capsules per day.4 Orlistat’s pharmacological effect occurs through the inhibition of gastric and pancreatic lipases in the gastrointestinal tract, which prevents triglyceride hydrolysis and results in the decreased absorption of dietary fats, which are excreted through the feces.5 alli® reduces dietary fat absorption by approximately 25% at the recommended dosage.4 Efficacy increases in a dose-dependent manner up to approximately 300–400 mg per day, at which point a plateau is observed.5
Orlistat’s pharmacological actions occur locally in the gut6 and less than 2% of the drug is absorbed systemically.7 Therefore, the adverse effect profile associated with orlistat predominantly consists of a variety of gastrointestinal side effects such as soft stools, abdominal pain, steatorrhea, fecal urgency, flatulence, and other less common side effects, such as fecal incontinence.5 These adverse effects increase in response to the amount of fat consumed,5 although they typically diminish over time as patients gain experience using the medication.8 The alli® package label instructs patients to take a multiple vitamin on a daily basis at bedtime while using orlistat since absorption of fat-soluble vitamins may be reduced.4
Not uncommonly, patients with eating disorders misuse medications such as laxatives, diuretics, and diet pills to compensate for binge eating and/or to promote weight loss. Rates of laxative abuse among outpatients who have an eating disorder have been reported to be 26.4% in the month prior to assessment in one study.9 Similarly, a study of patients with bulimia nervosa found that 64% of the sample had used diet pills, with 18% of the sample having used them in the month prior to the study assessment.10 This study also found the frequency of diuretic use to be 31%, with 21% of the sample having used them in the month prior to the study assessment. Therefore, it is possible that the nonprescription availability of alli® could lead to inappropriate use by patients with eating disorders. Indeed, a few case reports of use of orlistat by individuals with eating disorders have appeared in the literature. The majority of these case reports were published before orlistat became available over-the-counter. Details of these cases are summarized in Table 1. This study was developed to quantify the frequency of alli® use among patients with eating disorder symptoms. Therefore, a treatment-seeking sample was examined and results are subsequently described.
This study consisted of a survey that was administered at five eating disorder treatment facilities across the United States, including inpatient and outpatient facilities, between June of 2008 and March of 2009. Participants ages 12 and older who presented for evaluation or who were in ongoing treatment programs were eligible to participate. Those who completed the survey were compensated with a 10-dollar gift card. This study was supported through a research grant provided by GlaxoSmithKline.
Participants filled out the Survey of Eating and Related Behaviors, which is a 38-item self-report questionnaire designed for this study to capture demographic and diagnostic information, binge eating frequency, and compensatory behavior methods and frequency. Participant’s self-reported height and weight were used to determine body mass index (BMI). Participants were not informed that the purpose of the study was to collect data on alli® use, and the questions concerning this were embedded among multiple other compensatory behavior questions (e.g. diuretics, Syrup of Ipecac). Probable current eating disorder diagnoses were determined based upon participants’ responses to survey items according to the criteria sets described in Table 2, which were used to assign each participant to one category.
The study was approved by the Institutional Review Boards for all five study sites and all participants provided written informed consent. In addition, participants ages 12 through 17 were also required to provide written informed consent from a parent or legal guardian prior to taking the survey. All data were de-identified and maintained in a central database at the Neuropsychiatric Research Institute in Fargo, ND. Data were examined using SPSS Version 17.
Data were examined descriptively. The small sample size of alli® users, and the discrepancy between the sample size of those who used alli® and those who had not prohibited performing valid statistical comparisons. Cases of nonresponse to items were treated as a negative response to the question to enhance manuscript readability and this is also indicated as appropriate in Tables.
A total of 428 participants completed the survey. Of those, 417 completed the question regarding a history of alli® use and were explored in greater detail. Participants who had prior bariatric surgery (N = 22) or who had an undeterminable BMI or bariatric surgery history (N = 44) were excluded from eating disorder diagnostic categorization and are presented separately. Survey numbers obtained from each of the study sites are as follows: Neuropsychiatric Research Institute, 99; University of Minnesota, 98; University of Chicago, 100; University of North Carolina, 48; Columbia University, 81.
Data were split on the basis of whether patients reported a history of alli® use or not, and are presented along with descriptive information for the complete sample in Table 3. The majority of the sample was female and Caucasian, with a mean age of 33.2 (±13.1) years and a mean BMI of 28.3 (±11.8) kg/m2. As expected in a treatment-seeking sample of patients with eating disorder symptoms, binge eating and compensatory methods such as laxatives, diuretics, and vomiting in the past month were relatively common, both in those who had used alli® and in those who had not. The group with a history of alli® use was found to have a higher percentage of patients who engaged in laxative, diuretic, diet pill, Syrup of Ipecac, and herbal fat burner use in the past month compared to the group who had not used alli®. Given the small sample size associated with the group who had used alli®, this observation cannot be confirmed statistically.
Of the 417 participants who responded to the question regarding a history of alli® use, 26 (6.2%) reported that they had taken alli®. Table 4 summarizes the distribution of these patients according to diagnostic category. None of the 26 participants who reported symptoms consistent with anorexia nervosa restricting subtype (AN-R), and one of 29 (3.4%) of those with anorexia nervosa binge-purge subtype (AN-BP) indicated a history of alli® use. The frequency of alli® use was higher in those who were categorized as having full or subthreshold bulimia nervosa (BN), where six of 66 (9.1%) reported that they had used the drug. Reported frequencies of alli® use for the other eating disorder diagnoses were four of 49 (8.2%) for full or subthreshold binge eating disorder (BED), one of six (16.7%) for purging disorder (PD), three of 80 (3.8%) for eating disorder not otherwise specified (EDNOS), one of 10 (10%) for overweight, four of 85 (4.7%) for obese, six of 44 (13.6%) of those with an unknown BMI or bariatric surgery history, and none of the 22 who had previously undergone bariatric surgery.
Six of the 26 (23.1%) participants who had used alli® reported that they had exceeded the maximum recommended dose of alli®. Data on the extent to which they exceeded the recommended dosage were not collected. The majority of these patients (N = 4) were in the BN diagnostic category. The mean duration of alli® use varied according to diagnostic category. These data are also presented in Table 4. Ten of the 26 patients who had used alli® (38.5%) reported that they had experienced side effects while using the drug. Summarized according to the descriptions provided by the participants, these included: diarrhea (N = 3), extreme diarrhea (N = 1), loose bowels (N = 1), stomach cramps and pain (N = 1), fat/oily diarrhea/stools (N = 2), gas (N = 2), racing/increased heart rate/palpitations (N = 2), panic (N = 1), dizziness/faintness (N = 1), and depression (N = 1).
Patients who reported a history of alli® use (N = 26) are further described in Table 5 according to mean (±SD) BMI and age. alli® is indicated for adult patients who are overweight. The sample consisted of a small number of participants below age 18 (N = 20). One of these patients reported a history of alli® use and was found to be in the EDNOS category. Of the 26 participants who had used alli®, 10 (38.5%) had a BMI below 25 kg/m2 at the time the survey was conducted. Given the retrospective nature of this survey, however, it is possible that the current BMI does not accurately represent the BMI at the time when alli® was used.
As shown in Table 4, of the 26 participants who reported that they had used alli®, 12 (46.2%) had done so in the past month, consisting of those with BN (N = 4), BED (N = 1), EDNOS (N = 1), overweight (N = 1), obese (N = 3), and unknown BMI or bariatric surgery history (N = 2). Characteristics of patients who met criteria for an eating disorder (or EDNOS), and reported use of alli® in the past month (N = 6) are described in a brief case series according to their survey responses in Table 6. Ages ranged from 24 to 58 years old, BMI ranged from 18.9 to 42.9 kg/m2, most of the patients had a history of using other medications for weight loss or to compensate for binge eating, and all patients shared an extreme fear of weight gain.
The population described in this study represents a treatment-seeking sample collected from five eating disorder treatment facilities across the United States. The study was comprised of patients who reported a variety of eating disorder symptoms and the sample represented a broad range of ages and BMIs. The results of this study suggest that a small subset of patients who are presenting for evaluation or are engaged in treatment in eating disorder care facilities have used alli®. The sample size associated with alli® use was too small in several of the diagnostic groups to draw definite conclusions. The rates of alli® use by patients with BN (9.1%) and BED (8.2%) suggest that clinicians should inquire about alli® use along with other compensatory behaviors when interviewing patients with eating disorders.
Patients with BN frequently use medications to compensate for binge eating through purging and/or to promote weight loss. Notably, several of the patients who indicated alli® use in this survey also engaged in the use of other weight loss methods. This is consistent with prior literature which suggests that a subset of patients with BN, as well as AN, use multiple purging methods. This practice has been associated with a higher lifetime prevalence of significant psychopathology, including mood, substance abuse, and cluster B personality disorders.15 The use of multiple purging methods has also been associated with a higher level of eating disorder severity,16 and a longitudinal investigation of a college sample showed that multiple purging methods at baseline predicted higher eating disorder severity at 10 year follow-up.17 Although data addressing this issue are not available, as suggested by Cumella and colleagues (2), the risk of fat-soluble vitamin deficiency with alli® in patients with an eating disorder should be considered.
Orlistat has been examined as a potential treatment for BED.18,19 Two controlled trials have shown the prescription dosage of orlistat (120 mg three times daily) to be efficacious for reducing body weight in patients who are obese with BED in combination with either cognitive behavioral therapy18 or a reduced calorie diet.19 However, prior case reports suggest that unmonitored use of this drug by patients who binge eat can be problematic. Given orlistat’s mechanism of action, gastrointestinal side effects are more pronounced following a high-fat meal. Therefore, using alli® as a strategy to compensate for a binge eating episode with high fat content could increase the adverse effect burden associated with the drug. To provide overweight or obese patients who have BED with the highest likelihood of effectiveness from orlistat, clinicians should consider prescribing it in the dosage used in the two extant controlled trials (120 mg three times daily) and providing careful monitoring in the context of a structured treatment program which should also include a diet and exercise component.
Ten of the 26 participants (38.5%) in this study who had used alli® reported that they had experienced side effects with the drug. The adverse effects listed by participants were generally consistent with what is expected with alli®, including a variety of gastrointestinal complaints. Cardiovascular complaints including palpitations and increased heart rate and psychiatric symptoms were each reported by two patients, which are not commonly attributed to orlistat use.5 From this survey, it is not possible to determine whether these symptoms were related to alli®, to an eating disorder, to concomitant medications, or to another etiology.
Along with the self-report nature of these data, other limitations of this study include the inability to determine the precise temporal sequence of alli® use in relationship to the use of other medications for weight loss and binge eating. Other than asking specifically for information on alli® use, this survey did not include questions designed to collect data regarding which specific types of laxatives, diuretics, and diet pills participants were using. Also, BMI at the time the survey was completed may not have represented the BMI at the time alli® was used since patients were asked if they had ever taken alli®. Therefore, alli® use in the past month may be of greatest relevance for this comparison. Nonpurging weight loss methods were not assessed, such as food restriction and excessive exercise. Data on diuretic use in the last month that were collected in this survey were assumed to be for weight loss purposes, although it is possible that patients were using them for hypertension or other medical purposes.
The results of this survey suggest that patients with eating disorders do use alli®, although in comparison to published prevalence rates of other inappropriate compensatory weight loss methods such as laxative misuse, the use of alli® appears relatively uncommon at this time. The cost to purchase alli®, in comparison to some of the other nonprescription medications, may be one factor that has led to the lower reported rates of misuse of this product relative to other medication classes. No serious adverse effects that could be clearly attributed to the drug were reported. Given the potential for the inappropriate use of this medication by patients with eating disorders, clinicians are encouraged to monitor for alli® use along with all other medications for weight loss in all clinical settings.
Supported by GlaxoSmithKline.
Portions of this manuscript have been presented in poster format at the Eating Disorders Research Society Meeting, Brooklyn New York, 2009.
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