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Keywords:

  • complementary and alternative medicine;
  • Crohn disease;
  • inflammatory bowel disease;
  • pediatrics;
  • ulcerative colitis

Abstract

  1. Top of page
  2. Abstract
  3. Patients and Methods
  4. Results
  5. Discussion
  6. Acknowledgements
  7. References

Complementary and alternative medicine use is prominent in the United States. The use of complementary and alternative therapies appears to be common in patients with inflammatory bowel disease, but few studies have been completed in children. We sought to examine the extent that children with inflammatory bowel disease in the Greater Philadelphia area (Philadelphia County and the surrounding counties in Delaware, New Jersey, and Pennsylvania) use alternative therapies. We paid particular attention to the specific types of therapies used and whether certain demographic and disease associated factors influence the degree of usage. In this study, we questioned the families of all children diagnosed with inflammatory bowel disease, aged 6 to 16 years and living within Philadelphia and its surrounding counties, who were followed at 1 of the 2 academic pediatric gastroenterology programs that served the area. More than 80% of surveys were returned. Fifty-one percent (95% C.I. 45% to 56%) of patients surveyed reported some form of alternative medicine use within the previous year. Univariate analysis revealed increased use among patients who had Crohn disease, who used the Internet for research on their disease, who reported poor quality of life and had increased school absences in the past year. Therapies associated with alternative medicine use included biological and immunomodulatory therapy. Regression analysis revealed positive associations between use of alternative therapies and expenditure on nonprescription treatments, poor quality of life, Internet research, and the need for calorie supplementation, whereas there was a negative association with history of prior surgery for inflammatory bowel disease.

Inflammatory bowel disease (IBD) is the collective term for Crohn disease (CD) and ulcerative colitis (UC), which are chronic conditions associated with relapsing and remitting inflammation in the gastrointestinal tract. There is growing evidence that the diseases we call IBD actually represent a multitude of abnormalities, multifactorial in etiology, that may involve any of a number of body systems and result in the final, common pathway of chronic intestinal inflammation. 1 The prevalence of IBD is approximately 0.1%, and the annual incidence rate is between 2 and 4 per 100,000 population. 2 IBD is recognized as one of the most significant chronic diseases to affect children and adolescents, with up to 30% of all patients diagnosed during childhood. 3

Complementary and alternative medicine (CAM) covers a broad range of healing philosophies, approaches, and therapies. Historically, it has been defined as those treatments and health care practices not taught widely in medical schools, not generally used in hospitals, and not usually reimbursed by medical insurance companies. 4 This definition may change in the future, as with increasing frequency, certain types of CAM are being taught in medical schools, used in hospitals, and reimbursed by insurance companies. 5,6

CAM use is prominent in the United States. In 1993, it was estimated that 34% of the general U.S. population used some form of CAM. 4 By 1997, CAM use had increased to 42%, with herbals, massage, and megavitamin therapy increasing the most. 7 A study of adult patients with IBD reported that more than one-half of the people surveyed had used CAM in the previous 2 years. 8 Recognizing that many of their patients likely use CAM, traditional “allopathic” physicians are making efforts to acquaint themselves with the various types of CAM available. 9

Despite recent trends, however, there is continued skepticism within the traditional medical community regarding CAM. 10 Furthermore, there are few data on the use of CAM in pediatrics. One study reported that CAM use is near 10% in the general pediatric population, but that certain subgroups of children were more likely to be users. 6 The use of CAM is thought to be between 50% and 70% of children with chronic diseases such as arthritis, cancer, and cystic fibrosis—especially among those who suffer relapses or setbacks. 11 In addition, pediatricians are most likely to refer patients with chronic diseases to alternative practitioners, 11 making pediatric patients with IBD a likely group to use CAM.

Though it appears likely that pediatric patients with IBD use CAM, the published studies to date continue to raise questions regarding the overall prevalence of CAM use. In 2 studies of CAM and pediatrics, the reported use of CAM varied widely (from 7% to 41%). 12,13 With that in mind, we sought to determine the prevalence of CAM use in the greater Philadelphia area, while also examining the specific types of CAM that are used. Furthermore, we sought to identify particular patient or family characteristics that were most associated with CAM use.

Patients and Methods

  1. Top of page
  2. Abstract
  3. Patients and Methods
  4. Results
  5. Discussion
  6. Acknowledgements
  7. References

Questionnaire

The prevalence of CAM use was assessed using a mailed questionnaire to be answered by the patients' primary caregivers (ie, parents or guardians). The questionnaire was modified from an instrument developed to assess CAM use among pediatric patients with IBD in Canada. 12 The questionnaire included information on patient demographics, disease history and severity, therapies used, and practitioners seen during the previous 12 months. There were also questions regarding the use of the Internet for research on IBD therapies, out of pocket expenditures on IBD treatments, education level, and socioeconomic status. Questionnaires were free of identifiers except an identification number, which enabled us to identify subjects that needed subsequent mailings.

Patient Population

We sought to include all pediatric patients with IBD between ages 6 and 16 from the Greater Philadelphia area. Very young children were excluded because it was felt that their pattern of use might not be reflective of the rest of the childhood and adolescent population. Older teenagers were excluded because there was a higher likelihood that they would be treated by adult gastroenterologists, leading to missed cases.

At the time of the study, there were two academic pediatric gastroenterology programs serving the greater Philadelphia area: The Children's Hospital of Philadelphia (CHOP) and Alfred I duPont Hospital for Children (AID). Each program maintains a database of patients with IBD, defined by standard criteria. Patients were identified through the IBD databases of the respective programs. County of residence was determined using postal ZIP codes. Patients residing in Philadelphia County or its surrounding counties in Pennsylvania (Bucks, Chester, Delaware, Montgomery), New Jersey (Burlington, Camden, Gloucester), and Delaware (New Castle) were identified. A population of IBD patients identified through the IBD databases at 1 of the 2 academic centers serving the area, meeting the aforementioned age criteria, and living within the selected counties were ultimately included for survey.

Survey Strategy

To maximize response rate, a series of mailings was used based on the method published by Dillman. 14 Briefly, a pre-letter was sent before the questionnaire to alert the subjects to the upcoming questionnaire, followed by the questionnaire itself 1 week later. A thank you postcard was sent the following week, reminding those who had not responded to return the questionnaire. For those who did not respond following the postcard, another copy of the questionnaire was mailed, and if no response was returned at that point, 1 more copy of the questionnaire was sent using special delivery. Those who had not responded after the special delivery contact were considered nonresponders and did not receive further communications.

Statistical Analysis

Once all the questionnaires were returned, data were entered into a computerized database, and the prevalence of CAM use was estimated as the total number of patients reporting CAM use divided by the total number of responders. A 95% confidence interval was calculated for the prevalence estimate. Categorical variables were presented as frequencies.

Multiple logistic regression analysis was undertaken in an attempt to determine the independent association between CAM use and the potential predictors. The process of selection and including variables in the logistic regression model was based on careful univariate analysis of each variable using the χ2 test, a P value less than or equal to 0.25, and the assumption that particular variables were potential confounders. The multivariate relationship between predictors and the dependent variable was then examined using backward stepwise regression. The probability for entry into and removal from the model was set to be 0.05 and 0.10, respectively. We used the backward procedure to sequentially examine variables that had been removed from the final model. After 11 iterations, a final model included 5 variables (out of 15 initially included in the model) that were significantly associated with CAM use. Statistical significance was defined as a P value of less than or equal to 0.05 for a two-tailed test. Statistical analysis was performed using the statistical software package SPSS for Windows, version 10 (SPSS, Chicago, IL).

Ethical Considerations

The institutional review boards of CHOP and AID approved the study.

Results

  1. Top of page
  2. Abstract
  3. Patients and Methods
  4. Results
  5. Discussion
  6. Acknowledgements
  7. References

Four hundred sixteen patients were identified who met the inclusion criteria (300 from CHOP, 116 from AID). Based on census data from the 2000 United States Census, 15 there were 775,848 children aged 6 to 16 living in the area we have defined, giving an overall IBD prevalence estimate between the 2 centers of 53.6 cases per 100,000 patients living in the area. Responses were received from 257 of the CHOP questionnaires (85.7%) and 78 of the AID questionnaires (67.2%), resulting in an overall response rate of 80%. Demographic characteristics of the responders are presented in Table 1. Patients from CHOP were approximately 1 year older than patients from AID (13.2 years vs 11.9 years, P < 0.001). There were no differences in the demographics between the sites. Therapies did not differ between the sites, with the exception of corticosteroid use, which was more common in patients at AID (57% vs 42%, P = 0.02).

Table 1. Demographic Characteristics of Patients Who Responded to the Questionnaire
 CHOP (n = 258)AID (n = 77)
  1. CHOP. Children's Hospital of Philadelphia; AID, Alfred I. duPont Hospital; CD, Crohn disease; UC, ulcerative colitis; IC, indeterminate colitis or unknown; CAM. complementary and alternative medicine.

Age in years (SD)13.2(2.7)11.9(3.0)
Sex (male)145 (56.4%)45 (58.4%)
Disease  
CD138(53.5%)46 (59.7%)
UC88(34.1%)24(31.1%)
IC32(12.4%)7(9.1%)
Race  
African-American20 (7.8%)4 (5.5%)
White234 (90.7%)68 (93.2%)
Other4(1.5%)1(1.3%)
CAM use132(51.2%)38 (49.4%)

CAM Use

The overall prevalence of CAM use in this population, defined as the use of at least 1 type of CAM in the previous 12 months, was 50.8% (95% confidence interval, 45% to 56%). CAM use was similar at both sites (51.2% at CHOP, 49.4% at AID, P = 0.78). The responders from both sites were therefore combined into a general population when analyzing potential determinants of CAM use.

CAM use was associated with several variables based on univariate analysis (Table 2). Patients with CD were more likely to use CAM than patients who had UC or IC. Patients with 6 or more school absences in the previous year were more likely to use CAM than those who had 0 to 5 school absences. Those who spent more than $50/month on prescription medications and on nonprescription treatments were also more likely to use CAM. Those who reported that their quality of life had been significantly affected by their IBD tended to use CAM more often than those who reported minimal or no change in their quality of life. The use of the Internet to research IBD was associated with increased CAM use.

Table 2. Univariate Associations of CAM Use with Independent Variables
OR95%ClP Value
  1. OR, odds ratio; Cl, confidence interval; CAM, complementary and alternative medicine; IBD, inflammatory bowel disease.

Variable   
Nonprescription expense ($50/month)7.03.8–13.4<0.01
Internet research on IBD3.41.6–7.5<0.01
Poor quality of life2.41.2–4.8<0.01
School absences (6 or more)2.21.3–3.5<0.01
Crohn disease1.91.2–3.1<0.01
Prescription expense   
($50/month)1.81.1–2.8<0.01
Multiple hospital admissions1.60.9–2.60.06
Household income >$50,000/year1.50.9–1.60.13
College degree (parent)1.40.8–2.40.21
duPont patient0.90.5–1.60.78
Male sex0.80.5–1.20.21
No medical insurance0.80.1–4.60.72
Age (10 years or more)0.70.4–1.40.31
IBD surgery0.60.3–1.40.23
White race0.60.3–1.40.2
IBD therapy   
Calorie supplementation3.01.8–5.0<0.01
Steroid use2.81.8–4.5<0.01
Antibiotic use2.81.7–4.6<0.01
Biological use2.51.1–6.20.02
Non-narcotic analgesic use2.11.1–3.4<0.01
Immunomodulator use2.11.3–3.3<0.01
Antidiarrheal use1.40.6–3.60.44
Mesalamine use1.20.6–2.50.65
Narcotic use1.00.3–3.00.95

There were also several IBD treatments that were associated with increased prevalence of CAM use. Use of corticosteroids, antibiotics, immunomodulators, and biological therapies within the previous year were all independently associated with increased use of CAM. The use of non-narcotic analgesics was associated with increased use of CAM therapies, whereas the use of narcotic analgesics was not. Calorie supplementation, either parenteral or enteral, was also associated with CAM use. The use of 5-aminosalicylate medications and antidiarrheals were not associated with CAM use. No treatments were identified to have a negative association with CAM use.

Fifteen independent variables were then included in a logistic regression model. Using backward stepwise regression, a final model was created after 11 iterations that contained 4 variables associated with increased likelihood of using CAM. These were expenditure of $50/month or more on non-prescription treatments, use of the Internet to research IBD, poor quality of life related to IBD, and the use of calorie supplementation in the previous year. One variable (history of surgery for IBD) was associated with a decreased likelihood of CAM use. The odds ratios with 95% confidence intervals for these variables are presented in Table 3.

Table 3. Odds Ratios (OR) and 95% Confidence Intervals (CI) for CAM Use Based on Multiple Logistic Regression Model
VariableOR95% CI
  1. CAM, complementary and alternative medicine; IBD, inflammatory bowel disease.

Nonprescription expense ($50/month)3.11.9–4.9
Internet research on IBD2.31.0–5.2
Poor quality of life2.11.4–3.2
Calorie supplementation2.01.1–3.6
IBD surgery0.30.1–0.8

Types of CAM

The different types of CAM were classified into 4 categories: special diets, herbal remedies, nutritional therapy, and the use of alternative systems or practitioners. Special diets were defined as those that were specifically geared for the treatment of IBD. Patients with IBD will frequently limit their intake of certain foods or ingredients (eg, lactose, nuts, seeds). These dietary changes were not included as CAM use in our study. Similarly, patients with IBD will often supplement their diet with vitamins and minerals (eg, iron, folic acid). This type of supplementation was not considered nutritional therapy for the purposes of our study, as opposed to megavitamin therapy (vitamins in supra-physiologic doses), which was.

The most commonly used type of CAM was nutritional supplements, which encompassed the use of megavitamins, probiotics, and fish oil. Thirty-six percent of CAM users took at least 1 nutritional supplement, with 47 of 121 (39%) choosing multiple supplements. The next most common type of CAM was special diet, representing 20% of CAM use. Multiple diets were used by 13 of 66 patients (20%). Fifty-four patients (16% of CAM users) used alternative systems/practitioners, with 17 using more than 1 kind. Herbal remedies were used by 17 patients (5%), 2 of whom reported using combinations of herbs. Seventy-two of the 170 patients reporting CAM use (42%) used CAM from different categories (eg, nutritional supplement and alternative practitioners). The most common types of CAM used are detailed in Table 4.

Table 4. Number of Patients Reporting Use of at Least 1 Type of CAM Therapy, Listed by Category and the Most Common Specific Therapies
TherapyNumber of Users
  1. CAM, complementary and alternative medicine.

Nutritional supplements121 (36.2%)
Probiotics75 (22.3%)
Fish oil55(16.4%)
Megavitamins41 (12.2%)
Special diets66(19.7%)
Milk/dairy-free55(16.4%)
Low carbohydrate15 (4.5%)
Gluten-free10(3%)
Alternative systems/practitioners54(16.1%)
Allergist17(5.1%)
Relaxation therapy13 (3.9%)
Chiropractic12 (3.6%)
Homeopathy10(3%)
Herbalist8 (2.4%)
Massage therapy6(1.8%)
Naturopathy4(1.2%)
Yoga4(1.2%)
Acupuncture3 (0.9%)
Reiki1 (0.3%)
Herbal remedies17(5.1%)
Aloe3 (0.9%)
Echinacea3 (0.9%)
Garlic3 (0.9%)
Other15 (4.5%)

Discussion

  1. Top of page
  2. Abstract
  3. Patients and Methods
  4. Results
  5. Discussion
  6. Acknowledgements
  7. References

This is the largest study to describe CAM use in patients with IBD. Consistent with previous studies, we have demonstrated that a large proportion of patients with IBD use CAM, and that pediatric patients use CAM to a similar or higher degree than adults. 8,13,16–19

Hilsden and colleagues have published a number of studies of CAM use in IBD. Using a mailed questionnaire format, they found that 34% of responders were currently using CAM, with 51% reporting use within the previous 2 years. 19 In their population, longer duration of disease, history of surgery, and history of intravenous corticosteroids were predictors of CAM use, whereas disease activity and use of oral corticosteroids or immunomodulators were not. A subsequent study using an Internet-based questionnaire revealed similar numbers of users (34% current, 46% in the previous 2 years) but a negative association between CAM use and prior surgery, intravenous steroids, and oral steroids, and a lack of association with disease duration and activity. 8

Heuschkel et al performed a survey of pediatric and young adult patients with IBD in 3 sites (Boston, Detroit, and London). 13 They found that 41% of patients reported using CAM, most commonly megavitamins and dietary supplements. However, the overall prevalence in strictly pediatric patients is unclear, as the surveyed patients were up to 23 years of age. In contrast, Otley et al reported very modest CAM use (6.7% current, 22.2% past) among pediatric patients with IBD from three Canadian Maritime provinces. 12 A summary of surveys on CAM in IBD are presented in Table 5.

Table 5. Previous Studies of CAM in Patients with IBD
AuthorYearPopulation StudiedResponses Received (%)FormatProportion Using CAM
  1. N/A, not available or unable to calculate; CAM, complementary and alternative medicine; 1BD, inflammatory bowel disease.

Hilsden et al191998Adults134(70%)Male33% current, 51% in previous 2 years
Moody et al161998Adults239 (63%)Mail20%
HMsden et al81999Adults263 (N/A)Internet34% current, 46% in previous 2 years
Rawsthorne et al171999Adults289(91%)Clinic51%
Otley et al122001Children, adolescents90(79%)Clinic7% current, 22% past
Heuschkel et al132002Children, young adults208 (N/A)Clinic/mail41%
Langmead et al182002Adults239 (98%)Clinic26%

We believe that this study complements the previous work from both the adult and pediatric populations in several ways. This is the first pediatric study to define CAM use for a well-defined IBD population. Specifically, we attempted to capture an entire segment of the pediatric IBD population living in the Greater Philadelphia area. To accomplish this, we limited our study population to ages that had a very high likelihood of being followed by pediatric gastroenterologists. We then contacted every patient known to have IBD who (1) was followed by 1 of the 2 dominant pediatric gastroenterology groups in that area and (2) lived in the area based on postal ZIP code. We believe this enabled us to derive an overall appropriate estimate of the prevalence of CAM use.

Overall, our study had a very high response rate of 80%. Response rate is of utmost importance in a study where a goal is to generalize the results to the entire population. Poor response rates raise the concern that differences between the responders and nonresponders would significantly change the results. In this case, the number of nonresponders was small enough that any differences would not change the overall prevalence estimate significantly.

Based on univariate analysis, several variables were identified to be associated with CAM use. Among these were markers of increased disease severity, such as increased number of school absences, poor self-reported quality of life, and the need for more out of pocket expenditures on prescription medications. Two or more hospital admissions for IBD in the previous year demonstrated a trend toward an increased likelihood of CAM use (P = 0.06). Additionally, the need for certain therapies associated with CAM use could also be related to increased disease severity, such as steroids, immunomodulators, biological therapy, calorie supplementation, and antibiotics. Of particular interest are immunomodulators and biological therapies, increasingly used in the younger IBD population and previously unreported in the context of being associated with CAM use. It is unclear how CAM therapies affect the absorption and metabolism of these medications, which are known to have dose-related toxicities.

The size of our study population enabled us to identify several variables associated with CAM use through logistic regression. Among the variables related to CAM use in our model were expenditure on non-prescription treatments, poor quality of life, and the need for calorie supplementation. Expenditure on nonprescription treatments likely encompassed expenditure on CAM, given that insurance companies do not reimburse for many types of CAM. This finding is therefore not surprising. Poor quality of life and the need for calorie supplementation likely reflect increased disease severity, which might prompt families to search for treatments outside of conventional medicine. It appears that this search commonly takes place by using the Internet, which was also associated with CAM use.

Intuitively, one might associate the need for surgery with more severe disease leading to increased use of CAM therapy. However, a negative association between CAM use and surgery was seen in this population. A possible explanation could be that patients who had surgery experienced significant resolution of their symptoms, resulting in decreased need for alternative treatments. However, univariate analysis of quality of life and history of prior surgery demonstrated an association between surgery and poor reported quality of life (P = 0.001). Another possibility is that commitment to surgery reflects a higher degree of investment in more traditional therapies. Both positive and negative associations between CAM and surgery have previously been described in the adult population. 8,19

Despite its strengths, this study has several limitations. It is likely that our method of contacting patients failed to identify a proportion of patients. At the time of the study, there were two private pediatric gastroenterologists in the area who we expect cared for patients with IBD meeting our age criteria. We believe this number to be small, as the array of services generally required by a patient with IBD often necessitates referral to a larger center such as the 2 in our study. Additionally, there are undoubtedly some adult gastroenterologists who care for pediatric patients with IBD in our area. However, the unique aspects of pediatric IBD, including nutritional and growth issues that are not a part of standard adult care, often lead to consultation with a pediatric specialist. Using the most recent census data, the patients we identified resulted in an estimated prevalence of 54 per 100,000 patients aged 6 to 16. Although prevalence data for IBD in this age group is especially sparse, our prevalence estimate is at least as high as one would expect based on previously published data. 3,20 This strengthens our belief that we have captured most IBD patients in our area.

Another potential limitation is the variable definition of CAM use. As mentioned above, our definition of CAM use varied somewhat from a previous study. The prevalence of CAM use that we found was higher than the prevalence reported in the previous studies of CAM use in children. 12,13 This difference may be due to differences in the definitions of CAM use. A specific example is that Heuschkel et al chose not to include dietary therapies of any kind as a ‘true CAM’ but did include lifestyle adjustments (such as exercise, prayer, and allergen reduction) that were not included in our study. This exemplifies the common variation in the definitions of CAM from person to person and site to site. It is unclear if differences in CAM definition account for the large difference between our reported CAM prevalence and that in the Canadian pediatric IBD population.

Furthermore, there are several therapies that we considered to be CAM (eg, probiotics, fish oil) that have gained acceptance by gastroenterologists and have been reported in the peer-reviewed conventional medical literature. 21–23 Discounting the use of these CAM therapies would significantly lower the overall prevalence estimate that we reported. For example, 22% of participants used probiotics and 16% used fish oil. This problem raises the question of when a therapy changes from “CAM” to “conventional.” As of now there is no official answer. Because therapies such as probiotics and fish oil continue to be available without prescription and without Food and Drug Administration (FDA) oversight, 24 we feel comfortable classifying them as CAM for the purposes of this report.

Assessment of patients' rationale for CAM use was not a goal of this study. In previous studies of both children and adults, common reasons for using CAM were failure of prescribed medications, side effects associated with prescribed medications, and the desire for increased control of disease. 13,19 Conversely, a combination of contentment with traditional medical therapy and concern over potential side effects were listed as factors dissuading CAM use in the Canadian study of pediatric patients. 12

CAM use in patients with IBD may be especially important. Conventional therapy for IBD may include several medications that can have serious effects on the immune system (as seen with corticosteroids, immunomodulators, and biological therapy) as well as dose-related effects (such as the hepatotoxicity seen in methotrexate and mercaptopurine). Negative events associated with CAM therapies are beginning to receive more attention, with a significant proportion of events in 1 study classified as greater than mild severity. 25 Negative effects from CAM may be more likely in children, especially given the potential for inconsistent dosing in non-FDA regulated products. Just as certain medications may have excellent safety profiles in adults but cause significant adverse effects on children, CAM therapies must be considered potentially toxic to children even when they have been shown to be safe in adults. 6 Furthermore, the therapeutic window for a given treatment may be narrower in children due to smaller patient size and volume of distribution. When a child with IBD undergoing treatment with traditional and CAM therapies experiences side effects, one must consider the possibility that CAM therapy is responsible, either directly or through altered metabolism of the other medications. The high prevalence of CAM use in our study strongly suggests that studies of CAM safety are needed in this population.

In summary, we have reported on the largest sample of patients with IBD to be assessed for CAM use and the highest prevalence of CAM use. This sample came entirely from one major metropolitan American city and its surrounding counties, capturing most patients in that area and offering a population-based assessment of CAM use for the region. More than 50% of this population had used at least 1 form of CAM in the previous 12 months, with nutritional supplements such as probiotics and fish oil representing the most commonly used therapies. Combination therapy, both within and between classes of CAM, was common. Further research into CAM use in children is not only justified but sorely needed, especially with regard to the interaction with traditional therapies.

Acknowledgements

  1. Top of page
  2. Abstract
  3. Patients and Methods
  4. Results
  5. Discussion
  6. Acknowledgements
  7. References

The authors would like to thank Dr. Robert Hilsden for his generosity in sharing the questionnaire that served as the starting point for our study.

References

  1. Top of page
  2. Abstract
  3. Patients and Methods
  4. Results
  5. Discussion
  6. Acknowledgements
  7. References
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