Use of complementary and alternative medicines: a

Research Paper JPHS 2017, : – ª 2017 Royal Pharmaceutical Society Received June 2, 2017 Accepted November 13, 2017 DOI 10.1111/jphs.12209 ISSN 1759-8885

Use of complementary and alternative medicines: a cross-sectional study among hypertensive patients in Iraq Inas Rifaat Ibrahima , Mohamed Azmi Hassalia, Fahad Saleemb, Haydar F. Al Tukmagic and Omar Thanoon Dawoodd a Social and Administrative Pharmacy, School of Pharmaceutical Sciences, Universiti Sains Malaysia, Penang, Malaysia, bFaculty of Pharmacy and Health Sciences, University of Baluchistan, Quetta, Pakistan, c Department of Clinical Pharmacy, College of Pharmacy, University of Baghdad, and dMinistry of Science and Technology, Baghdad, Iraq

Abstract Objectives The purpose of this study was to assess the use, predictors and patient’s seeking behaviour of complementary and alternative medicines (CAM) in hypertension and evaluate patient’s perception of CAM adverse effects. Methods A cross-sectional questionnaire-based study was conducted among hypertensive patients from May to December 2015. A convenience sample technique was adopted to recruit patients attending two major teaching hospitals in the capital city Baghdad, Iraq. A total of 400 valid responses were obtained recording a response rate of 93.02%. Key findings The overall prevalence of CAM usage was 65.5% (n = 262). Biologicalbased therapies were the most used type of CAM by 62.8% (n = 251) of patients. The use of CAM was associated with patient’s educational level, marital status and duration of hypertension. The main reasons of using CAM were to support the standard treatment, decrease the symptoms of hypertension and protect the health. Monthly expenditure on CAM varied from Income in Iraqi Dinar (IQD) 10 000 to IQD 150 000 (US $8.6 to US $128.7). Users of CAM reported some unwanted effects that were associated with a certain category of it. Conclusions The use of CAM, particularly biological-based therapies, was prevalent among hypertensive patients in Iraq. This practice was associated with patients’ educational level, marital status and duration of hypertension. Patient’s perception of adverse effects was noticed with different modalities of CAM. Therefore, CAM practice should be suggested only if its benefit is proven, and the side effect is controlled. Keywords Alhijama; complementary medicines; herbals; hypertension; Iraq

Introduction

Correspondence: Inas Rifaat Ibrahim, Social and Administrative Pharmacy, School of Pharmaceutical Sciences, Universiti Sains Malaysia, 11800 Penang, Malaysia. E-mail: [email protected]

Challenges associated with hypertension and the socio-economical background of many patients have increased reliance on nonconventional treatment. Despite the fact that patients usually seek professional standard treatment for their illness, some cope with the problem individually. It was noted that patients with hypertension try to utilize other way of healing resources away from the classical treatment.[1–3] This may occur through the use of traditional practices inherited from the ancestors, nowadays known as complementary and alternative medicines (CAM). The National Centre for Complementary and Integrative Health NCCIH has categorized them into four overlapping groups.[4] These encompassed the following products: (1) Biological-based therapies (the use of vitamins, minerals, natural products, unconventional diets and herbals); (2) alternative medical system (the use of cupping or ‘Alhijama’ in Muslim society and acupuncture); (3) manipulative body-based therapies (the use of massage, chiropractic and osteopathic medicines); and (4) mind–body therapies (the use of spiritual, meditative and relaxation techniques). Within the context of Iraq, CAM represent an old-time habit to promote the general health or to cure from specific illness. The term ‘traditional medicine’ is more familiar in the society and reflects the values and socio-religious structure of old Iraqis. Various practices gathered under this umbrella term such as herbals, Alhijama, acupuncture, reflexology and some religious practices. However, information about CAM preparation, distribution and regulation is yet limited. The exact statistics on the prevalence of CAM

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use in the country still not available. Researchers noted that treatment with traditional therapies, particularly herbals, has evolved through ages depending on religions, social beliefs and cultural structure of various societies around the world.[5–8] Some previous studies have shown an increased prevalence of using herbals and other CAM modalities among hypertensive patients in developing countries as a way of self-care.[9–11] These have identified the simultaneous use of CAM products alongside the standard treatment of hypertension. Further, they examined the influence of demographic features on patients’ use of CAM. It is worth mentioning here that scientific evidence supporting the safety and efficacy of different modalities of CAM is ambiguous. Proof of the required doses of CAM for a particular disease is not available. This could be dangerous for many patients specifically in chronic disease in which treatment outcomes are closely related to adherence to the standard treatment. CAM–drug interaction or adverse effect may be the result of the concomitant use of CAM with diverse cardiovascular standard treatment.[12] This may add unnecessary outcomes in the disease-management process. For this, it is necessary to understand the use of CAM in the management of hypertension. This study aimed to (1) assess the use of CAM among hypertensive patients in Iraq; (2) find the associated factors and predictors of this practice; (3) evaluate patient’s behaviour of seeking CAM; and (4) evaluate patient’s perception of CAM adverse effects.

Ethics approval This study was approved by Iraqi Ministry of Health (N0.74633). Monetary payment or other forms of compensation were not offered. Informed consent from the respondents was also obtained before conducting the study. Respondent’s information obtained was kept confidential.

Methods The study adopted NCCIH definition of CAM which states ‘Complementary and alternative medicine is a group of diverse medical and health care systems, practices, and products that are not presently considered to be part of conventional medicine’.[4]

Study design A cross-sectional study was conducted among hypertensive patients in Baghdad, Iraq, from May to December 2015. Baghdad, the capital city, is divided by the river Tigris into two main areas Karkh (on the west side of the river) and Rusafa (on the east side of the river). From both parts of Baghdad, two major teaching hospitals were selected due to the following reasons (1) to allow a fair representation of hypertensive patients and (2) to adhere to the instructions of Iraqi MOH that do not allow a researcher to conduct any type of research in more than two hospitals. Therefore, Ibn Al-Nafees Teaching hospital from Rusafa side and Al-Karama Teaching hospital from Karkh side were chosen for the purpose of patients’ recruitment. A convenience sampling technique was adopted to recruit participants. Convenience

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sample, also known as judgement sample, involves the active selection of the most productive sample to answer the research questions. Hypertensive patients who were able and willing to describe their CAM practice were consented to participate in the study. The study was undertaken in accordance with Helsinki Declaration.[13]

Sample size and patient selection The target sample size was calculated based on the following assumptions:[14] Prevalence of hypertension in Iraq is 40%, a confidence interval of 95%, an allowable margin of error 5%. Assuming dropout rate of 20%, the target enrolment number was 436 patients. A total of 436 patients (228 from each hospital) were invited to the study. All of whom were diagnosed with hypertension for at least 1 year, both genders, and not too ill to communicate with the researcher. Newly diagnosed patients were not included to avoid the confusion that might be understood as suggesting more therapeutic options and prevent creating additional stress that often accompanies a new diagnosis. Furthermore, patients with long-standing hypertension may be less adhered to the standardly prescribed medicines and opt for other treatment modalities. Eligibility of patients was assessed by the medical consultant at the selected hospital. A complete explanation of the study objectives and protocols was done prior to patients’ enrolment. Participants were assured that their answers would be kept confidential, and no information that could reflect their identity will be disclosed. Further, they are informed that they have the right to decline from the study at any time without any penalty. An oral assent and written consent form were also obtained before starting the interview. Study tool A pretested and validated questionnaire was used for data collection. Questions were adopted according to NCCIH researches and developed through extensive reading of previous literatures.[4,9–11] The tool covered four main domains: (1) The demographic information of respondents; (2) Patients’ use of CAM and the product used; (3) Patients’ behaviour in seeking CAM including reasons, recommendations and expenditure; and (4) Perceptions of adverse effects that may accompany the use of CAM. Only users of CAM were asked to answer the last two parts of the questionnaire. Questions with multiple responses were used when necessary. Face validity was assessed by asking the experts in this field for reasonableness, appropriateness and sequence of the items. Further, the questions were tested among a sample of 20 hypertensive patients to take their views about clarity of the items, fluency and understandability. Coding and analysis The information was coded and entered into the Statistical Package of Social Science SPSS sversion 17 (SPSS Inc, Chicago, IL, USA) to analyse the data. Descriptive responses to the questions were presented as frequencies and percentages. Chi-square test was used to evaluate the

Inas Rifaat Ibrahim et al.

The use of CAM in hypertension

significant association of the categorical variables. Binary logistic regression analysis was performed to assess predictors of using CAM. An alpha level of ≤0.05 was considered significant.

Results Patients’ characteristics Of 400 responses, slightly more than half of them were men (55.2%, n = 221). The greatest proportion (54.8%, n = 219) was ≥65 years old (age ranged from 35 to 84 years old). Their systolic blood pressure extended between 155 and 230 mmHg (mean = 187.5  15.87 mmHg), while their diastolic blood pressure ranged from 80 to 110 mmHg (mean = 93.38  5.61 mmHg). Details of demographic characteristics are described in Table 1.

Table 1 Patients’ demographic characteristics and complementary and alternative medicines (CAM) usage Characteristics

n (%) (N = 400)

Gender Female 179 Male 221 Age groups in years 5 226 Comorbidity Yes 290 No 110

CAM usage n (%)

P value

Users 262 (65.5%)

Nonusers 138 (34.5%)

(44.8) (55.2)

113 (63.1) 149 (67.4)

66 (36.9) 72 (32.6)

0.428

(45.3) (54.8)

113 (62.4) 149 (68.0)

68 (37.6) 70 (32.0)

0.285

(35.0) (41.8) (23.2)

116 (82.9) 96 (57.5) 50 (53.8)

24 (17.1) 71 (51.4) 43 (46.2)

0.000*

(32.0) (41.2)

82 (64.1) 107 (64.8)

46 (35.9) 58 (35.2)

0.779

(26.8)

73 (68.2)

34 (31.8)

(61.5) (38.5)

174 (70.7) 88 (57.1)

72 (29.3) 66 (42.9)

0.007*

(43.5) (56.5)

104 (59.8) 158 (69.9)

70 (40.2) 68 (30.1)

0.045*

(72.5) (27.5)

195 (67.2) 67 (60.9)

95 (32.8) 43 (39.1)

0.284

*Chi-square test, P < 0.05. † Educational level was divided into elementary education (primary); intermediate (high-school/institute education); and high (college/postgraduate). ‡ Income in Iraqi Dinar (IQD) (US $1 = IQD 1164). § Marital status included single (6.8%, n = 27), married (61.4%, n = 246), widow (27%, n = 108) and divorced (4.8%, n = 19). Bold value discriminate the significant value from the non significant.

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The use of CAM and associated factors In terms of CAM use, more than two-thirds (65.5%, n = 262) of respondents reported using CAM to control their elevated blood pressure as seen in Table 1. The highest proportion of CAM users was dominated by male patients (67.4%, n = 149) and of age ≥65 years old (68.0%, n = 149), had an elementary level of education (82.9%, n = 116); was within the highest monthly income (68.2%, n = 73); was married (70.7%, n = 174); had a duration of hypertension of more than 5 years (69.9%, n = 158); and was with comorbidity (67.2%, n = 195). The association of patients’ characteristics with the use of CAM was initially assessed through bivariate analysis. Patients’ educational level, marital status and the duration of hypertension were significantly associated with the use of CAM (P < 0.001, P = 0.007 and P = 0.045 respectively). Gender, age, income and comorbidity were not associated with the use of CAM. A variety of CAM products have been used by the respondents to control their blood pressure. Biological-based therapies were among the most reported CAM (62.8%, n = 251) which encompassed some natural products, herbals, vitamins and dietary supplements. Other CAM modalities were used to a less extent such as alternative medical system (27.8%, n = 111) which was characterized by ‘Alhijama’ practice, followed by manipulative body-based therapies (18.5%, n = 74) in which both practices reflexology and acupuncture were predominant and then mind–body therapies (13.5%, n = 54) that involved doing sports and

Table 2 Categories of complementary and alternative medicines (CAM) used by hypertensive patients Category of CAM

n (%) (N = 400)

Biological-based therapies Natural/Herbal products Garlic Flaxseeds Dried lime Yogurt Lemon Rosella tea Raisins Green tea Saffron Ginger Peppermint tea Chines herbs (unidentified herbs) Vitamins Dietary supplements Alternative medical system Cupping or ‘Alhijama’ in Muslim society Manipulative body-based therapies Reflexology Acupuncture Mind–body therapies Sports Hypnosis

251 (62.8) 124 124 96 78 77 52 49 32 28 22 20 16 33 55

(31.0) (31.0) (24.0) (19.5) (19.3) (13.0) (12.3) (8.0) (7.0) (5.5) (5.0) (4.0) (8.3) (13.8)

111 74 30 67 54 43 11

(27.8) (18.5) (7.5) (7.5) (13.5) (10.8) (2.8)

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Table 3

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Predictors of using CAM by hypertensive patients

Predictors

Category of CAM Biological-based therapies

Educational level Marital status Duration of hypertension

Alternative medical system

Manipulative body-based therapies

Mind–body therapies

OR (95% CI)

P value

OR (95% CI)

P value

OR (95% CI)

P value

OR (95% CI)

P value

0.75 (0.54–0.88) 1.75 (1.1–1.8) 1.74 (1.1–2.7)

0.008* 0.020* 0.012*

1.09 (0.6–1.9) 1.33 (0.8–2.2) 1.0 (0.6–1.5)

0.761 0.274 0.980

0.99 (0.5–2.0) 1.5 (0.8–2.7) 1.23 (0.7–2.0)

0.991 0.169 0.431

1.92 (0.8–4.1) 1.45 (0.7–2.8) 0.98 (0.5–1.8)

0.101 0.279 0.962

CI: confidence interval; CAM, complementary and alternative medicines; OR: odds ratio. *Logistic regression analysis, P < 0.05.

hypnosis. Details of CAM products and practices used in this study are described in Table 2. Binary logistic regression analysis with backward selection of variables that influence the use of CAM revealed that patient’s educational level, marital status and duration of hypertension were predictors of using biological-based therapies only as seen in Table 3. Notably, none of these variables made any significant contribution to the use of other CAM modalities. The strongest predictor of using biological-based therapies was patient’s marital status which recorded an odds ratio of 1.75 indicating that married patients were more likely to use this type of CAM by a factor of almost double than patients who are not in a relation, where other factors were controlled in the analysis, followed by the predictor duration of hypertension which recorded an odds ratio of 1.74. This indicated that patients with a duration of more than 5 years were more willing to use this category of CAM than patients with a duration less than that by a factor of almost double, where other factors were controlled. The odds ratio of 0.75 for education level was 50 000 *The expenditure in Iraqi Dinar (IQD) (US $1 = IQD 1162).

n (%) (N = 262)

161 146 99 45 15

(61.5) (55.7) (37.8) (17.2) (5.7)

101 96 89 76 48 32 16

(38.5) (36.6) (33.9) (29.0) (18.3) (12.2) (6.1)

82 (31.3) 104 (39.7) 76 (29.0)

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The use of CAM in hypertension Table 5

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Perceived adverse effects of complementary and alternative medicines (CAM) among hypertensive patients

Types of CAM

Biological-based therapies Alternative medical system Manipulative body-based therapies Mind–body therapies

Adverse effect n (%)

Types of adverse effects n (%) (N = 262) Headache

79 (30.2)

Skin rash 15 (5.7)

Abdominal pain 12 (4.6)

Diarrhoea

13 (4.9)

Sleep disturbance 12 (4.6)

51 (19.4)

14 (5.3)

2 (0.8)

4 (1.5)

22 (8.4)

–

9 (3.4)

6 (2.3)

1 (0.4)

–

–

P value Frequent urination 5 (1.9)

Flatulence

10 (3.8)

Skin deformity 8 (3.1)

12 (4.6)

10 (3.8)

–

5 (1.9)

4 (1.5)

0.001*

3 (1.2)

–

–

8 (3.1)

–

–

0.001*

2 (0.8)

5 (1.9)

–

–

–

–

–

0.001*

–

–

–

–

–

–

–

–

4 (1.5)

*Chi-square test, P < 0.005.

Biological-based therapies (5.3%, n = 14) (P < 0.001). Headache was more pronounced with the use of ‘Alhijama’ (3.4%, n = 9) (P < 0.005). Sleep disturbance perceived to happen more with the use of manipulative body-based therapies (1.9%, n = 5) (P < 0.001). However, there was no report of any adverse effect within the use of mind–body therapies.

Discussion This is the first study that identified the prevalence of CAM use (65.5%) among hypertensive patients in Iraq. Previous evidence throughout Middle East region reported a high rate of CAM use in hypertension ranged from 63.8% to 85.7%.[5,11,15] In parallel with studies of the developed countries, there has been a remarkable increase in the use of CAM among hypertensive patients.[16,17] In our study, CAM usage was associated with patient’s educational level, marital status and duration of hypertension. Notably, it was independent of gender, age of patient and the presence of comorbidity. A conflicting evidence about patient’s characteristics in using CAM continues to exist in the literatures. A study conducted in Turkey has shown that gender, marital status, education, occupation and income were significantly associated with the use of CAM.[15] In Palestine, a hospital-based study found a positive association between patient’s residence, comorbidity and family history with the use of CAM.[11] Another study conducted in South African hypertensive community has reported that age, marital status and employment were the significant factors in using CAM. Contradiction with that, other reports have stipulated that the use of CAM was independent of socio-demographic characteristics.[18,19] This variation could be attributed to the differences in the definition of CAM in these studies, cultural variation and differences in beliefs and values of the communities included in these studies. It is therefore clear that the effect of demographic characteristics on the use of CAM may vary according to the dominant culture in the country of study. A variety of CAM modalities were utilized for the purpose of lowering the elevated blood pressure. It was not

surprising that biological-based therapies, specifically the use of herbals, appeared to be the most commonly used CAM in the present study. This practice is supported by the same trend throughout the developed and developing countries.[1,11–19] Availability of herbal products in Iraqi market, low cost of herbs, cultural acceptability and the traditional use of herbals for different aliments boosted patient’s confidence to choose this type of therapy in the management of hypertension. A serious health complications may be resulted from the concomitant use of diverse medications of hypertension and herbal products. This may worsen the clinical condition and may lead to far greater interactions with the treatment prescribed by the authorized medical professionals. The use of ‘Alhijama’ (Cupping in Western society) was the second common practice of CAM among Iraqi hypertensive patients. However, the percentage obtained in our study was less than that obtained in Saudi Arabia (70.6%) and Jordan (20.4%).[20,21] This practice is age-long practice in Islamic traditions and recommended as a therapy for most health problems. ‘Alhijama’ is a special technique depends on drawing blood from various points in the body by the use of surgical or razor blade.[22] Commonly, a traditional healer without formal medical education performs this practice. Scientific evidence supporting the safety and health benefit of ‘Alhijama’ is still poor. Other CAM techniques such as manipulative body-based therapies and mind–body therapies recorded the lowest percentages of use. Perhaps, these Western practices of therapies are still unusual among Arab society. It should be noted that patient’s characteristics of low level of education, being married and duration of hypertension of more than 5 years were the significant predictors of using biological-based therapy only. This may be due to fact that the use of this category of CAM in this study is more than double compared with the other categories. However, it is not easy to have a general theory in this regard. Reasons why patients opt for CAM therapies still disparate across different cultures. Patients in this study used CAM mostly to support the standard treatment; decrease the symptoms of hypertension; protect the general health;

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follow Arabic tradition; and obtain good price treatment. These reasons were consistent with those of previous studies.[11–18] The use of CAM in this study was influenced mainly by other hypertensive patients, family and friends, personal will, herbalist; and to a lesser extent by the nurse, pharmacist and media. Similar findings have shown that CAM users do not seek medical advice but rather they rely on relatives, friends, media and herbalist.[22,23] Further, the mean annual expenditure on CAM by our respondents was 319 U.S. Dollar. Yet, global information concerning the total expenditure on CAM is scant. A high annual expenditure on CAM was reported in the United States (34 Billion U.S. Dollar), United Kingdom (1.9 Billion U.S. Dollar), Malaysia (500 Million U.S. Dollar) and Canada (2400 U.S. Dollar),[24–27] while a lower estimated annual expenditure was reported in Australia (173 U.S. Dollar).[28] The inclusion of patient-reported perception of adverse effects due to the use of CAM is a unique feature of this study. Skin rash, headache, sleep disturbance, abdominal pain, diarrhoea, skin deformity, frequent urination and flatulence were the most reported unwanted effects. Despite the few reports about the possible side effects of using CAM, it was found that the skin is one of the main target organs of adverse clinical reactions for traditional treatment.[29] The risk of CAM–drug interactions may increase particularly in patients with chronic disease who consume multiple drug therapy for comorbid conditions. Concomitant use of biological-based therapies with standard cardiovascular drugs could lead to unexpected serious consequences. Example on this, the use of garlic or ginger may increase the bleeding risk with warfarin, heparin and aspirin.[8] Herbs that have hydrocolloidal carbohydrate components such as flaxseeds are apt to bind with drugs and inhibit their absorption.[30] Ginger may increase international standardized ratio and alter bleeding times if taken with warfarin, low-molecular-weight heparin and aspirin.[30] Green tea was found to decrease calcium absorption and thus increase the likelihood of dysrhythmias in patients on cardiac glycosides treatment.[31] There are however many studies brought to light that CAM therapies are not free of unwanted effect. Infectious complications including hepatitis and local skin infections have been happened following alternative medical systems and manipulative body-based therapies.[29] Mechanical injuries have been recorded in some reports after the use of manipulative bodybased therapies.[32,33] Cardiac tamponade, direct injury of the spinal cord and bleeding are sever mechanical complications following acupuncture therapy.[34,35] While adverse effects resulting from mind–body therapies are uncommon, a previous report suggested that excessive muscle relaxation can cause the Valsalva response in patients with poorly controlled cardiovascular disease.[36] For this, health professionals should be aware of the most common CAM therapies and advice their patients about the unexpected adverse effects. It is important for patients to realize that CAM therapies and drugs can interact in the same way that drugs interact with each other. Lack of standardization of doses, CAM–drug interaction and adverse effects are the major concern of using CAM. Yet, the debate continues among medical professionals about the clinical effectiveness of this type of treatment. The only scientific proof available indicates that a diet that is low

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in saturated fat and salt, increased physical activity and regular practice of relaxation techniques such as message help to lower the blood pressure.

Conclusion The use of CAM, particularly biological-based therapies, is common among hypertensive population in Iraq and mirrors the use in other Middle East countries. Patient’s characteristics such as educational level, marital status and duration of hypertension were the most significant determinates in pursuing this practice. A perception of CAM adverse effects has been noted involving skin rash, headache, sleep disturbance, abdominal pain, diarrhoea, skin deformity, frequent urination and flatulence which were the most reported adverse effects of using CAM. It is therefore important for many patients to realize that CAM treatment is not risk-free. Information on CAM interaction with antihypertensive medication is not well documented; therefore, a more quantitative research in this area would be desirable. A comprehensive assessment requires the health professionals to identify not only the prescribed treatment but also complementary therapies used by their patients.

Limitation Although study respondents were recruited from two major teaching hospitals serving different health population in Baghdad and represent both sides of it, hypertensive patients are managed also in other health setting. Together with the adoption of convenience sample technique, nonrandom sampling, results of this study may not be generalized to reflect the whole hypertensive population in Iraq.

Declarations Conflict of interests All contributing authors declare no conflict of interest. Funding This research did not receive any specific grant from funding agencies in the public, commercial or not-for-author profit sectors. Acknowledgement The authors would like to thank all participants in Iraq for their time and responses to this study. Authors’ contributions IRI was involved with the research concept, data collection, data analysis, interpretation of results and writing the manuscript. MAH and FS were involved in the research concept, study design, questionnaire development and review of the manuscript. HFA and OTD contributed to the research concept and data collection. All authors reviewed and approved the final draft of the manuscript.

The use of CAM in hypertension

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