Complementary Therapies in Medicine (2014) 22, 87—93

Available online at www.sciencedirect.com

ScienceDirect journal homepage: www.elsevierhealth.com/journals/ctim

Predictive factors of complementary and alternative medicine use for patients with inflammatory bowel disease in Korea Dong Il Park a, Jae Myung Cha b,∗, Hyun Soo Kim c, Hong Jun Park c, Jung Eun Shin d, Sung No Hong a, Sung Soo Hong e, Wan Jung Kim f a

Department of Internal Medicine, Sungkyunkwan University School of Medicine, Seoul, South Korea Department of Internal Medicine, Kyung Hee University School of Medicine, Seoul, South Korea c Department of Internal Medicine, Yonsei University College of Medicine, Wonju, South Korea d Department of Internal Medicine, Dankook University College of Medicine, Chonan, South Korea e Department of Internal Medicine, Vievis Namuh Hospital, Seoul, South Korea f Department of Internal Medicine, Soonchunhyang University College of Medicine, Gumi, South Korea Available online 12 December 2013 b

KEYWORDS Complementary and alternative medicine; Inflammatory bowel disease; Crohn’s disease; Ulcerative colitis; Risk factors

Summary Objectives: The aim of this study was to assess characteristics and predictive factors of complementary and alternative medicine (CAM) use for patients with inflammatory bowel disease (IBD) in Korea. Design: Prospective, questionnaire based study for patients with IBD in Korea. Setting: Six university hospitals and one primary IBD clinic. Main outcome measure: Overall characteristics and predictors of CAM use were compared between CAM users and non-users. Results: During the study period, 366 patients with IBD (ulcerative colitis = 228, Crohn’s disease = 138) completed the full questionnaire; 29.5% (n = 108) reported CAM use and 70.5% (n = 258) reported no CAM use after diagnosis of IBD. In total, 64.0% were male, the mean patient age was 42.3 ± 15.5 years, and the mean duration of IBD was 5.5 ± 5.8 years. Using logistic regression analysis, university education (p = 0.040), higher income levels (p = 0.009), and longer duration of IBD (p = 0.003) were found to be independent predictors of CAM use. Among CAM users, 65% of CAM was attained within 2 years of IBD diagnosis and only 28.7% discussed CAM use with their physician. Furthermore, 13.9% of CAM users discontinued conventional IBD therapy while using CAM.

∗ Corresponding author at: Department of Internal Medicine, Kyung Hee University School of Medicine, Kyung Hee University Hospital at Gangdong, 149 Sangil-dong, Gangdong-gu, Seoul 134-727, South Korea. Tel.: +82 2 440 6113. E-mail address: [email protected] (J.M. Cha).

0965-2299/$ — see front matter © 2013 Elsevier Ltd. All rights reserved. http://dx.doi.org/10.1016/j.ctim.2013.12.001

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D.I. Park et al. Conclusions: The overall use of CAM in Korea was comparable with those in the West. Physicians should be aware of the high prevalence of CAM use by patients with IBD, especially among those with higher education levels, higher income levels, and longer IBD duration. Furthermore, physicians should ask about CAM use, and help their IBD patients make a more informed choice about CAM use. © 2013 Elsevier Ltd. All rights reserved.

Introduction The terms complementary and alternative medicine (CAM) involve a wide group of systems, theories, and practices of medicine not included in the conventional scientific approach. The use of CAM among patients with inflammatory bowel disease (IBD) is increasing.1,2 Currently, nearly half of IBD patients report having used CAM at some point during their illness.3—5 This observation has been fairly consistent throughout various populations across North America, Norway, Europe, New Zealand, and China.3—11 However, most studies were reported from the West,3—5,8—11 and two studies from China were limited because the one was focused only on traditional Chinese medicine6 and the other small study was not designed to investigate CAM use.7 Moreover, the characteristics of CAM use in Korea may be different from those of the West, as the prevalence of CAM use in a general population was very high (up to 75%) in Korea.12 Physicians need to make an effort to understand why patients with IBD use CAM and understand the benefits patients gain from such treatment. Reasons for the high prevalence of CAM use in IBD include lack of response to conventional therapy, perceived favorable safety profile, and a sense of greater control over their disease.1,2,4,13 Many patients who used CAM reported minimal discussion with their physicians regarding CAM use,14 which may erode trust and affect the therapeutic patient—physician relationship and lead to potentially dangerous drug interactions and toxicities. Culture, acceptance, and faith in the ability of Western medicine and perpetuation of misconceptions may influence the use of CAM in patients with IBD. Therefore, the prevalence and predictive factors of CAM use may be different in Korea, however, little is known about the use of CAM in IBD patients of Korea. In this multicenter study based in Korea, we evaluated the characteristics and predictive factors of CAM use in patients with IBD.

Methods Participants All adult IBD patients with a confirmed diagnosis of ulcerative colitis (UC) or Crohn’s disease (CD) who received care at one of six university hospitals and one primary IBD clinic between December 1, 2012 and February 28, 2013 were invited to participate in the study. Patients with IBD were approached by the study coordinators and administered a questionnaire. The questionnaire gathered information on the following variables: age, gender, smoking/alcohol habit, marital status, religion, employment status, educational attainment, income levels, IBD phenotype, prior medication history, adverse events with conventional therapy,

hospitalizations, prior surgery, disease duration, quality of life (QOL) score, and history of non-adherence to medication. Respondents were classified as CAM users or non-users and characteristics and predictive factors of CAM use were compared between groups. This study was approved by the Institutional Review Board of each hospital (KHNMC IRB-212-124), however, an informed consent for IBD patients was waived for this survey-based study.

Definition and assessment of CAM use CAM was defined as a therapy that falls beyond the domain of conventional medicine and is not based on rigorous scientific evidence for a particular indication.15—17 CAMs used by patients with IBD were diverse, often overlapping, so CAMs were classified simply as CAM techniques or CAM products, like in Manitoba IBD study.15 CAM techniques include naturopathic medicines (holistic approaches that focus on natural remedies), homeopathy (treatments with diluted remedies prescribed by a homeopath), massage, relaxation, reflexology, aromatherapy, hypnosis, acupuncture, Chinese traditional service (including moxibustion and cupping), and any services delivered by a spiritual healer, religious healer, or others. CAM products include Chinese medicine, herbal remedies, ginseng, deer antlers, chamomile, lavender, ginkgo biloba, probiotics, vitamins, and others. Respondents completed questions about their specific use of CAM techniques or products, and if the use was specifically for IBD or other reasons. CAM users were defined as those who reported use of any CAM techniques or products after diagnosis of IBD. The CAM non-users were those who did not use CAM techniques or products after diagnosis of IBD. Income levels were classified as one of 3 groups: less than 1818 US dollars/month (2,000,000 Korea won), 1818—4545 US dollars/month, and more than 4545 US dollars/month (5,000,000 Korea won). For evaluation of the QOL, patients were assessed for 4 parameters—– bowel symptoms, systemic symptoms, social function, and emotional function18,19 —–using an unscaled visual analog self-assessment (0 = excellent, 100 = very poor) that has been validated across a wide range of medical conditions and populations.20 Self-reported adherence was measured using the Morisky scale,21 a validated adherence tool used in several chronic diseases. According to prior studies using the Morisky scale in IBD patients,22,23 subjects were categorized into the non-adherence group if they reported ‘‘yes’’ to any of the four items (Morisky scale score ≥ 1).

Statistical analysis The primary endpoints were predictive factors of CAM use and secondary endpoints included the characteristics of

CAM use in IBD patients

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Table 1 Demographic and baseline clinical information of patients according to the use of complementary and alternative medicine (CAM). CAM users (n = 108) Age (years), mean ± SD Age at IBD diagnosis Current age of patients

CAM non-users (n = 258)

p value

33.8 ± 14.0 40.5 ± 14.8

38.2 ± 15.1 43.1 ± 15.8

0.010 0.136

Gender, female, n (%) Height (cm), mean ± SD Body weight (kg), mean ± SD Past/current smoker, n (%) Alcohol use, n (%) Marital status (married), n (%) Religion (yes), n (%) Employment, n (%) Full/part time Not working/student/homemaker

67 (62.0) 167.5 ± 8.2 62.4 ± 11.5 13 (12.0) 23 (21.3) 65 (60.2) 43 (39.8)

170 (65.9) 167.0 ± 8.3 63.1 ± 10.8 38 (14.7) 68 (26.4) 157 (60.9) 112 (43.4)

0.481 0.582 0.629 0.574 0.307 0.872 0.525 0.525

65 (60.2) 43 (39.8)

146 (56.6) 112 (43.4)

University education or above, n (%)

56 (51.9)

109 (42.2)

Income (dollar/month), n (%) 4545

25 (23.1) 51 (47.2) 32 (29.7)

93 (36.0) 112(43.4) 53 (20.6)

0.092 0.032

CAM, complementary and alternative medicine; SD, standard deviation; IBD, inflammatory bowel disease.

CAM users with IBD. Continuous variables are expressed as means ± standard deviations and categorical variables are expressed as number (percentage). For intergroup comparisons, continuous variables were analyzed using the Student’s t-test or Mann—Whitney test and categorical variables using the X2 test. We computed odds ratios (OR) and 95% confidence intervals (CIs) using logistic regression analysis. Statistical adjustments were made for potentially relevant variables with univariate differences between two groups with p < 0.1. For each analysis, p < 0.05 was used for statistical significance and p < 0.1 for a statistical trend. Statistical analysis was performed using the Statistical Package for the Social Sciences (SPSS) version 18.0 for Windows (SPSS, Chicago, IL, USA).

Results During the study period, 366 patients with IBD (UC = 228, CD = 138) completed the questionnaire; 29.5% (n = 108) reported CAM use and 70.5% (n = 258) reported no CAM use after diagnosis of IBD. In total, 64.0% were male and the mean patient age was 42.3 ± 15.5 years. Approximately 57.7% (n = 211) of participants were working full-time or part-time and 60.7% (n = 222) were married or living under common-law marriage. The mean duration of IBD was 5.5 ± 5.8 years.

Overall characteristics of CAM users and non-users Table 1 provides demographic and baseline clinical information on CAM users and non-users. Comparison of the groups showed CAM users to be significantly younger at diagnosis of IBD (p = 0.010) and a higher proportion had higher incomes

(p = 0.032). There were no significant differences in other demographic and baseline clinical characteristics between the two groups, including current age, gender, height, weight, smoking, alcohol, marital status, religion, employment, and education level. Table 2 shows disease-related characteristics of IBD patients according to CAM use. CAM users had a significantly more frequent history of steroid use (70.4% use vs. 58.5% non-use, p = 0.033), higher episodes of adverse events with conventional therapy (38.0% vs. 24.0%, p = 0.007), higher proportion of IBD-related hospitalizations (62.0% vs. 45.3%, p = 0.003), and higher proportions of nonadherence to IBD medications (77.8% vs. 61.6%, p = 0.002). Furthermore, CAM users had significantly longer IBD duration than non-users (6.9 vs. 5.0 years, p = 0.004). There were no significant differences in other disease-related characteristics between the groups including IBD classification, prior use of immunomodulators or biologics, prior IBD-related surgeries, hospital visits within 1 year, and QOL score.

Characteristics of CAM use Table 3 provides characteristics of CAM use in patients with IBD. CAM users were more likely to use CAM products than CAM techniques: 64.8% of patients used CAM products only, 29.6% used CAM products and techniques, while only 5.6% used CAM techniques alone. Approximately 65% of CAM usage began within 2 years of diagnosis of IBD and 53% of CAM usage began at a flare-up or aggravated IBD state. Only 28.7% of CAM users discussed their use of CAM with a physician and 14% of CAM users discontinued conventional IBD therapy while using CAM. The mean satisfaction score with CAM was 2.5 of 4 points and 12.0% of CAM users experienced adverse side effects related to CAM, most commonly diarrhea and

90 Table 2

D.I. Park et al. Disease-related characteristics of patients according to use of complementary and alternative medicine (CAM). CAM users (n = 108)

CAM non-users (n = 258)

p value

Disease type, Crohn’s disease, n (%) Ulcerative colitis, n (%) Prior medication history of, n (%) Steroids Immunomodulators Biologics

41 (38.0) 67 (62.0)

97 (37.6) 161 (62.4)

0.947

76 (70.4) 51 (47.2) 25 (23.1)

151 (58.5) 120 (46.5) 55 (21.3)

0.033 0.901 0.699

Adverse event with conventional Tx, n (%) Hospitalized for IBD, n (%) Prior surgery for IBD, n (%) Disease duration of IBD

41 (38.0) 67 (62.0) 19 (17.6) 6.9 ± 6.5

62 (24.0) 117 (45.3) 36 (14.0) 5.0 ± 5.4

0.007 0.003 0.355 0.004

6.1 ± 3.8 3.9 ± 11.4

5.7 ± 3.5 2.4 ± 6.6

0.370 0.210

QOL score: Bowel symptoms, mean ± SD Systemic symptoms Emotional function Social function

36.6 ± 26.8 33.8 ± 27.4 53.1 ± 29.2 43.6 ± 24.9

33.0 ± 27.2 30.1 ± 30.2 47.0 ± 31.0 40.1 ± 27.0

0.252 0.329 0.081 0.255

History of non-adherence to medication, n (%)

84 (77.8)

Hospital visit within 1 year, mean ± SD No. of gastroenterological visits Days of hospitalization

159 (61.6)

0.002

CAM, complementary and alternative medicine; Tx, therapy; IBD, inflammatory bowel disease.

abdominal pain. Compared with conventional therapy, only 3.7% of CAM users reported better outcomes with CAM and none reported increased confidence with CAM. Furthermore, 18.5% of CAM users suggested more frequent adverse events

with CAM and 43.5% reported higher costs with CAM than conventional IBD therapy after CAM use.

Table 3 Characteristics of complementary and alternative medicine (CAM) use in patients with IBD.

To determine independent predictors of CAM use, we performed logistic regression analysis adjusted for age at diagnosis, educational attainment, income level, prior use of steroids, adverse events with conventional therapy, prior hospitalizations for IBD, disease duration, and nonadherence to conventional therapy, which were potentially relevant variables to show univariate differences between the two groups with p < 0.1 (Table 4). The model of multivariate regression analysis was significant (p = 0.743) by Hosmer and Lemeshow test, and the model explained about 14.1% of the variance in the use of CAM (Nagelkerke R2 = 14.1%). In this analysis, higher income levels (OR = 2.219, 95% CI = 1.209—3.750, p = 0.009), university education (OR = 1.731, 95% CI = 1.026—2.921, p = 0.040), and longer disease duration (OR = 2.142, 95% CI = 1.305—3.518, p = 0.001) were found to be independent predictors of CAM use in patients with IBD.

Characteristics of CAM use

CAM users (n = 108)

Type of CAM use, n (%) CAM techniques only CAM products only Both CAM techniques and products

6 (5.6) 70 (64.8) 32 (29.6)

Attained time and state of IBD, n (%) Within 2 years, n (%) At flare-up or aggravation state, n (%)

70 (64.8) 57 (52.8)

CAM discussion with gastroenterologist (yes), n (%)31 (28.7) Discontinuation of conventional therapy 15 (13.9) Aim of CAM use: For cure of IBD 32 (29.6) For remission or symptom control 23 (21.3) For improvement of general health 53 (49.1) Outcome of CAM use Satisfaction with CAM use (1—4) 2.5 ± 0.7 Side effects with CAM use, n (%) 13 (12.0) Results of CAM use compared with conventional therapy Better outcomes with CAM 4 (3.7) More frequent adverse effects with CAM 20 (18.5) Higher cost with CAM 47 (43.5) Better confidence with CAM 0 (0.0) CAM, complementary and alternative medicine; IBD, inflammatory bowel disease.

Predictive factors of CAM use

Discussion While CAM use in patients with IBD has been previously studied in other centers worldwide, there are a number of unique aspects to this study that help to understand the characteristics and predictive factors of CAM use in IBD patients of Korea. In general, the overall use of CAM in our study was comparable with what has previously been reported by Hilsden et al.24 in IBD patients from the West. The high rate (29.5%) of CAM use found in the present study is in concordance with worldwide studies, which has ranged between

CAM use in IBD patients Table 4

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Multivariate logistic regression analysis of predictive factors for use of complementary and alternative medicine (CAM).

Parameter

Odds Ratio (95% CI)

p-value

Age at diagnosis (continuous) University education (No vs. Yes) Income (

Predictive factors of complementary and alternative medicine use for patients with inflammatory bowel disease in Korea.

The aim of this study was to assess characteristics and predictive factors of complementary and alternative medicine (CAM) use for patients with infla...
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