23
REVIEW Fasting, Diabetes, and Optimizing Health Outcomes for Ramadan Observers: A Literature Review Hadi A. Almansour . Betty Chaar . Bandana Saini Received: November 23, 2016 / Published online: February 8, 2017 Ó The Author(s) 2017. This article is published with open access at Springerlink.com ABSTRACT Introduction: Globally, and in Australia, dia- betes has become a common chronic health condition. Diabetes is also quite prevalent in culturally and linguistically diverse pockets of the Australian population, including Muslims. There are over 90 million Muslims with diabetes worldwide. Diabetes management and medica- tion use can be affected by religious practices such as fasting during Ramadan. During Rama- dan, Muslims refrain from oral or intravenous substances from sunrise to sunset. This may lead to many potential health or medication-related risks for patients with diabetes who observe this religious practice. This literature review aimed to explore (1) health care-related interventions and (2) intentions, perspectives, or needs of health care professionals (HCPs) to provide clinical services to patients with diabetes while fasting during Ramadan with a view to improve health outcomes for those patients. Methods: Using a scoping review approach, a comprehensive search was conducted. Data- bases searched systematically included PubMed, Medline, Embase, and International Pharma- ceutical Abstracts. Studies published in English that described interventions or intentions to provide interventions regarding diabetes and Ramadan fasting were included. Results: Fourteen published articles that met the inclusion criteria were retrieved and content analyzed. Of those, nine intervention studies regarded diabetes management education. Five studies described professional service intention, four of which were related to the role of phar- macists in diabetes management in Qatar, Aus- tralia, and Egypt, and one French study examined the general practitioners’ (GPs) experiences in diabetes management for Rama- dan observers. The intervention studies had promising outcomes for diabetes management during Ramadan. Effect sizes for improvement in HbA1c post intervention ranged widely from -1.14 to 1.7. Pharmacists appeared to be willing to participate in programs to help fasting patients with diabetes achieve a safe therapeutic outcome. Service intention studies highlighted pharmacists’ and GPs’ need for training prior to providing services from a clinical as well as cultural competence perspective. Conclusion: Interventions research in this area requires robustly designed and structured inter- ventions that can be tested in different contexts. This literature review revealed many gaps regard- ing diabetes management in Ramadan. Health professionals are willing to provide services for fasting diabetes patients, but need upskilling. Enhanced content To view enhanced content for this article go to http://www.medengine.com/Redeem/ 4887F06060CC1453. H. A. Almansour (&) Á B. Chaar Á B. Saini Faculty of Pharmacy, University of Sydney, Sydney, Australia e-mail: [email protected] Diabetes Ther (2017) 8:227–249 DOI 10.1007/s13300-017-0233-z

Fasting, Diabetes, and Optimizing Health Outcomes for ... · PDF fileREVIEW Fasting, Diabetes, and Optimizing Health Outcomes for Ramadan Observers: A Literature Review Hadi A. Almansour

Embed Size (px)

Citation preview

Page 1: Fasting, Diabetes, and Optimizing Health Outcomes for ... · PDF fileREVIEW Fasting, Diabetes, and Optimizing Health Outcomes for Ramadan Observers: A Literature Review Hadi A. Almansour

REVIEW

Fasting, Diabetes, and Optimizing Health Outcomesfor Ramadan Observers: A Literature Review

Hadi A. Almansour . Betty Chaar . Bandana Saini

Received: November 23, 2016 / Published online: February 8, 2017� The Author(s) 2017. This article is published with open access at Springerlink.com

ABSTRACT

Introduction: Globally, and in Australia, dia-betes has become a common chronic healthcondition. Diabetes is also quite prevalent inculturally and linguistically diverse pockets ofthe Australian population, including Muslims.There are over 90 million Muslims with diabetesworldwide. Diabetes management and medica-tion use can be affected by religious practicessuch as fasting during Ramadan. During Rama-dan, Muslims refrain from oral or intravenoussubstances from sunrise to sunset. This may leadto many potential health or medication-relatedrisks for patients with diabetes who observe thisreligious practice. This literature review aimedto explore (1) health care-related interventionsand (2) intentions, perspectives, or needs ofhealth care professionals (HCPs) to provideclinical services to patients with diabetes whilefasting during Ramadan with a view to improvehealth outcomes for those patients.Methods: Using a scoping review approach, acomprehensive search was conducted. Data-bases searched systematically included PubMed,

Medline, Embase, and International Pharma-ceutical Abstracts. Studies published in Englishthat described interventions or intentions toprovide interventions regarding diabetes andRamadan fasting were included.Results: Fourteen published articles that metthe inclusion criteria were retrieved and contentanalyzed. Of those, nine intervention studiesregarded diabetes management education. Fivestudies described professional service intention,four of which were related to the role of phar-macists in diabetes management in Qatar, Aus-tralia, and Egypt, and one French studyexamined the general practitioners’ (GPs)experiences in diabetes management for Rama-dan observers. The intervention studies hadpromising outcomes for diabetes managementduring Ramadan. Effect sizes for improvementin HbA1c post intervention ranged widely from-1.14 to 1.7. Pharmacists appeared to be willingto participate in programs to help fastingpatients with diabetes achieve a safe therapeuticoutcome. Service intention studies highlightedpharmacists’ and GPs’ need for training prior toproviding services from a clinical as well ascultural competence perspective.Conclusion: Interventions research in this arearequires robustly designed and structured inter-ventions that can be tested in different contexts.This literature review revealed many gaps regard-ing diabetes management in Ramadan. Healthprofessionals are willing to provide services forfasting diabetes patients, but need upskilling.

Enhanced content To view enhanced content for thisarticle go to http://www.medengine.com/Redeem/4887F06060CC1453.

H. A. Almansour (&) � B. Chaar � B. SainiFaculty of Pharmacy, University of Sydney, Sydney,Australiae-mail: [email protected]

Diabetes Ther (2017) 8:227–249

DOI 10.1007/s13300-017-0233-z

Page 2: Fasting, Diabetes, and Optimizing Health Outcomes for ... · PDF fileREVIEW Fasting, Diabetes, and Optimizing Health Outcomes for Ramadan Observers: A Literature Review Hadi A. Almansour

Keywords: Fasting; HbA1c; Hypoglycemia;Pharmacist; Ramadan; Type 1 diabetes; Type 2diabetes

INTRODUCTION

Internationally, the prevalence of diabetes isapproximately 8.3%; 382 million people livewith diabetes [1]. Of these, nearly 90 million areMuslims [2]. Diabetes is also increasinglybecoming a common disease among the Aus-tralian adult population. In 2011–12, forexample, 4.7% of the Australian populationwere reported to have type 2 diabetes (T2D) [3].Diabetes is particularly prevalent in culturallyand linguistically diverse (CALD) Australians.Many of these CALD populations follow differ-ent religious beliefs. Islam is one of the keyreligions followed by CALD populations. Forexample many of those who have migrated toAustralia from the Indian subcontinent, centraland far east Asian countries (Indonesia/Malay-sia), Europe, and from the middle-eastern andNorth African regions are Muslims [4]. Therehas been an estimated 69% increase in theAustralian Muslim population from 2001 to2011, with the total current number of Muslimsbelieved to be approximately 476,300 [5].Although the prevalence of diabetes in Aus-tralian Muslims is not known directly, indirectmarkers point to the fact that diabetes may befairly common in this population. Studiesindicating, for example, that Australian womenand men born in the Middle East or NorthAfrica were 2.4 and 3.6 times more likely tohave diabetes than those who were born inAustralia [6]. Given that about 42% of Aus-tralian Muslims are of North African or MiddleEastern origin, these data suggest the possibilitythat diabetes may be quite prevalent in Aus-tralian Muslims [4]. This population group isalso likely to have socio-religious practices thatmay impact on their beliefs about health andhealth management practices [6]. Religiousfasts, such as Ramadan, are a key example ofthis issue.

Fasts may influence the body’s homeostaticrhythms and in those taking chronic medica-tions, fasts may upset established

pharmacokinetic and pharmacodynamics dis-position patterns of medications [5–7]. Fastinghas the potential to affect glucose control ofpatients who have diabetes mellitus and it candisrupt the actions of antidiabetic medications[7]. Ramadan is a well-known fast observed byMuslims. Ramadan occurs in the ninth monthof the lunar calendar in Islam and lasts 29–-30 days [8, 9]. Fasting in Ramadan is one of theprincipal pillars of Islam; it requires Muslims tofast during daylight hours, abstaining from allfood and drink, as well as substances, such asmedicines, taken orally or intravenously[10, 11]. Fasting people usually have a post-fastmeal (Iftar) after sunset and a pre-fast mealbefore sunrise (spelt varying in English asSohour, Suhoor, Suhur, or Sehri) [8, 10]. Theabsolute refraining from food and drinkbetween sunrise and sunset can lead to disrup-tion of homoeostasis [10]. It is worthwhile toconsider the impact of fasting on the health ofRamadan observers, as these observers havebeen reported to have higher prevalence ofdiabetes. There are, for example, more than50 million Muslims worldwide who observeRamadan although they live with diabetes [12].For instance, an epidemiological study mappingdiabetes patients observing the Ramadan fast(n = 12,914) in 13 Muslim countries indicatedthat almost 79% of patients with T2D observedthe fast of Ramadan [12].

Diabetes is actually the most common illnessstudied with regard to Ramadan [13–18]. Fast-ing has the obvious potential to disrupt diabetesmanagement as a result of the reduced food,drink, and medication intake during certainhours [17]. The practice of observing themonth-long fast can affect glucose control [19].This could lead to avoidable health problems.One of the potential adverse effect risks of tak-ing antidiabetic medications and fasting can behypoglycemia. Other issues that may occurinclude hyperglycemia, hyperglycemic-hyper-osmolar state, and diabetic ketoacidosis [13, 20].Several studies have attempted to document theeffect of fasting on diabetes. A prospectiveclinical trial was conducted in Iran to examinethe impact of Ramadan fasting on glycemiccontrol in T2D patients (n = 88). The trialreported that glycemic control deteriorated

228 Diabetes Ther (2017) 8:227–249

Page 3: Fasting, Diabetes, and Optimizing Health Outcomes for ... · PDF fileREVIEW Fasting, Diabetes, and Optimizing Health Outcomes for Ramadan Observers: A Literature Review Hadi A. Almansour

significantly among T2D patients who opted tofast during Ramadan. Nonetheless, hemoglobinA1c (HbA1c) reduced significantly a monthafter Ramadan from 9.4 ± 2% to 8.4 ± 2.5%(p\0.001) [21]. On the other hand, a recentreview highlighted that in insulin-dependentpatients with diabetes, severe hyperglycemiaand ketoacidosis were insignificant concerns,and only minor hypoglycemic episodes wereevident in this population, when they reportedobserving Ramadan [22].

Several studies have illustrated the impor-tance and positive effects of regular glucosemonitoring, dietary counselling, drug dosageand timing alteration, and patient educationduring Ramadan [23, 24]. The InternationalGroup for Diabetes and Ramadan (IGDR) con-sensus diabetes management recommendationsduring Ramadan (2015 update) reported byIbrahim et al. suggest several recommendationsfor adverse event prevention strategies duringRamadan as shown in Table 1 [24]. Also guide-lines for medication management duringRamadan have been suggested by a few groups,and key points are summarized in Table 2.

Ahmedani et al. demonstrated in a multi-center prospective study (n = 682 patients withdiabetes) that most participating patients fastedwithout any serious acute adverse events duringRamadan when the recommendations men-tioned above were provided [25]. In this study,

for example, 91% of fasting patients had theirdrug dose/timing altered, and physical activitypatterns were downgraded from moderate/heavy to lighter levels of exercise; changes wereoverseen by medical practitioners [25].

One of the health professionals that couldplay a key role in optimizing the health of thosewith T2D observing Ramadan may be commu-nity pharmacists. Pharmacists are usually con-sulted far more often than physicians. They arealso usually available for consultation withoutappointments, and in most cases health con-sults are provided without a fee for service.Robust data from multisite trials suggest thatpharmacists’ intervention for patients withdiabetes can improve clinical and humanisticoutcomes for patients [26–31]. However, therehas not been much research conducted in Aus-tralia on fasting patients with diabetes, nor arethere specific medical/allied health professionalguidelines for the management of T2D inpatients observing Ramadan in Australia. Thefirst exploratory study into pharmacists’ per-spectives about their role in care of patientswith diabetes observing Ramadan was con-ducted in 2015 [32]. Findings of this qualitativework indicated that pharmacists do not proac-tively provide care for T2D Ramadan observers,but are keen to do so if supported by trainingand practice frameworks [32]. To developguidelines and interventions to optimize

Table 1 Recommendations to prevent diabetes-related adverse events risks during Ramadan (adapted from Ibrahim et al.[24])

Recommendations to prevent adverse events risks

Blood glucose monitoring several times a day depending on treatment regimen for a month prior to Ramadan

Consultation with HCPs for changing medications based at least 1 month before Ramadan begins

Avoiding large pre-dawn (Sohour) meals

Avoiding vigorous physical activities during fasting time

Recording blood glucose readings regularly during Ramadan to determine the occurrence of hypoglycemia

Breaking the fast and eating snacks immediately if hypoglycemic symptoms appear. Further recommendations for

hypoglycemia treatment involve consuming 15 g of carbohydrates such as half a cup of orange, apple juice or regular

soda, three or four glucose tablets, a table spoon of honey or sugar, five or six hard candies, a cup of milk, or a serving of

glucose gel

HCP health care professional

Diabetes Ther (2017) 8:227–249 229

Page 4: Fasting, Diabetes, and Optimizing Health Outcomes for ... · PDF fileREVIEW Fasting, Diabetes, and Optimizing Health Outcomes for Ramadan Observers: A Literature Review Hadi A. Almansour

Table2

Medicationadjustmentsuggestionsduring

Ram

adan

(adapted

from

Karam

atet

al.[49]andAliet

al.[2])

Typeof

antidiabetic

medication

Dosebefore

Ram

adan

Medicationadjustmentsuggestion

sNote:

Soho

urim

pliesa.m.do

seandIftarim

pliesp.m.do

se

Metform

in500mgtds

Thisneedsto

bechangedto

1000

mgtakenat

sunset

meal(Iftar)and500mgat

predaw

nmeal(Sohour)

Short-acting

sulfo

nylurea

Forexam

ple,gliclazide

80mgbd

Changeto

gliclazide

80mgat

Iftar,40

mgat

Sohour

Forexam

ple,gliclazide

80mga.m.?

40mgp.m.

Changeto

gliclazide

80mgat

Iftar,40

mgat

Sohour

Long-acting

sulfo

nylurea

Forexam

ple,glim

epiride4mgod

Switch

torepaglinideor

short-acting

sulfo

nylurea,ifpossible,otherwisedoseshould

betakenwithIftar

DPP

-4inhibitors

Forexam

ple,vildagliptin50

mgbd,sitagliptin

100mgod,saxagliptin5mgod,and

linagliptin

5mgod

Nochange

indose

isrequired

butcautionaround

dehydrationandsyncopein

warm

coun

triesisadvised.

Patientsarealso

requestedto

paycloseattentionfor

anysignsof

ketoacidosisandbe

provided

withketone

testingkits

Glucagon-likepeptide

1agonist

Forexam

ple,liraglutide

1.2mgod,exenatide

10lg

bd,lixisenatide20

mgod,exenatide

qw

Withexenatideitshould

beensuredthat

theduration

betweenthedaily

dosesis

[6h.

Thismay

beaffected

whenduration

offastis[18

h

Sodium

–glucose

co-transporter

2

inhibitors

Forexam

ple,dapagliflozin,canagliflozin

Nochange

needsto

bemadeforthedosesof

thistype.H

owever,p

atientsshould

payattentionto

anysign

ofketoacidosisandthey

canbe

givenketone

kits.A

lso,

cautionisrequired

regardingsyncopeanddehydrationin

warm

coun

tries

Insulin

Long-acting

(basal)insulin

,e.g.,glargine

Long-acting

insulin

doseshould

bereducedby

20%andtakenatIftar,e.g.,glargine

dose

canbe

reducedfrom

20to

16U

andtakenwitheveningIftarmeal

Rapid-acting(m

eal-tim

e)insulin

,e.g.,Novorapid/

Hum

alog

10U

tdswithmeals

Lun

chtimedosecanbe

omittedandinsulin

canbe

takentwicedaily

withmealsat

Sohour

andIftar,e.g.,N

ovorapid/H

umalog

10U

withSohour

andIftar

Mixed

insulin

,e.g.,Novom

ix30–3

0U

a.m.and

20U

p.m.

Considerreversingdosesso

thattheusualm

orning

doseistakenatIftarandhalfof

theusualevening

doseistakenatSohour,e.g.,Novom

ix30–1

0U

atSohour

and

30U

atIftar

Mixed

insulin

,e.g.,Hum

alog

Mix

25–2

0U

a.m.

and20

Up.m.

Forexam

ple,Hum

alog

Mix25–1

0U

a.m.and

20U

p.m.

Mixed

insulin

,e.g.,Hum

ulin

M3–

32U

a.m.and

24U

p.m.

Forexam

ple,Hum

ulin

M3–

12U

a.m.and

32U

p.m.

tds3times

aday,bd

twiceaday,od

once

aday,qw

once

aweek

230 Diabetes Ther (2017) 8:227–249

Page 5: Fasting, Diabetes, and Optimizing Health Outcomes for ... · PDF fileREVIEW Fasting, Diabetes, and Optimizing Health Outcomes for Ramadan Observers: A Literature Review Hadi A. Almansour

diabetes management during Ramadan in Aus-tralia, an important step would be to utilizeresearch from international settings. Interna-tional reviews have been conducted to investi-gate pharmaceutical interventions (e.g.,medicine related trials) for patients observingRamadan, but none have looked at educationalor supportive interventions provided by healthprofessionals [1]. This literature review aimed toexplore (1) health care-related interventionsand (2) intentions, perspectives, or needs ofhealth care professionals (HCPs) to provideclinical services to patients with diabetes whilefasting during Ramadan with a view toimproving health outcomes for those patients.

METHODS

Description of Search Strategyfor Literature Review

Given the diverse nature of interventionsexpected, a scoping review method was appliedfor the conduct of this review. A scoping reviewgenerally maps out the literature to address abroader research question and clarifies the keyconcepts of a research area. It helps identifygaps in the research topic based on the availableliterature [33]. Studies exploring the effects offasting on patients with diabetes were searchedin various online libraries and databases such asPubMed, Medline, CINAHL, EMBASE Interna-tional Pharmaceutical Abstracts, andCOCHRANE. The search initially used MeSHterms and keywords in combination, such as‘‘[fasting OR Ramadan], [diabetic patients ORdiabetes], [fasting in Australia OR Ramadan inAustralia], [diabetes AND Ramadan], [diabetesAND Fasting], [diabetic patients AND Rama-dan], [diabetic patients AND Fasting], [diabeticpatients AND Fasting AND health care profes-sionals (HCPs)],’’ which yielded 1469 articles.Filtration was then applied by using keywordsand Boolean operands, e.g., ‘‘Fasting duringRamadan AND Diabetic patients,’’ which resul-ted in 592 articles. The search was furtherrefined by using key terms in combination‘‘Fasting AND diabetic patients.’’ The referencelists of articles at this stage were scoured for

further relevant articles. Duplicate removal wasfollowed by application of inclusion/exclusioncriteria to all identified abstracts by the researchteam. Selected articles were read by the first andlast author and data extracted using a tabularframework.

Exclusion and Inclusion Criteria

Inclusion CriteriaOnly articles published in the English languagefrom 1986 to August 2016 were selected for thereview. The period spanned 30 years as thereappeared to be limited research published onthe topic, so a broader period was selected toencompass as much research as possible in thescope of our review. The articles selected werereviewed to ensure that they were originalstudies, and that they were published inpeer-reviewed journals. Interventions deliveredby all health professionals were included in thereview, with a specific focus on those deliveredby pharmacists. Intervention research isinformed by needs analysis conducted pre-in-tervention. A key component of needs analysesincludes the willingness of providers to engagein intervention delivery. Therefore, researchconforming to this description was also inclu-ded in the review, in addition to interventiontrials.

Exclusion CriteriaSeveral exclusion criteria were applied. Forexample, research pertaining to other healthconditions or fasts other than Ramadan wasexcluded from selection. Literature reviews,consensus guidelines, and case or meetingreports were also excluded.

RESULTS

A total of 596 articles were extracted from theoriginal search. Upon further refining, as shownin Fig. 1, 14 relevant articles were obtained andincluded within this literature review. The studyauthor, year, country, research methods, samplesize, response rate, and the outcomes of thestudy were tabulated (Tables 3, 4). These 14

Diabetes Ther (2017) 8:227–249 231

Page 6: Fasting, Diabetes, and Optimizing Health Outcomes for ... · PDF fileREVIEW Fasting, Diabetes, and Optimizing Health Outcomes for Ramadan Observers: A Literature Review Hadi A. Almansour

studies had utilized heterogeneous researchmethods including cross-sectional observa-tional surveys or qualitative data gathering. Inmost studies data were collected via self-ad-ministered survey instruments, focus groupssessions, and face-to-face or telephoneinterviews.

Of the 14 articles, nine involved interven-tion studies regarding diabetes managementeducation, and a further four studies were rela-ted to the role of pharmacists in providing orbeing willing to provide diabetes managementinterventions in Qatar, Australia, and Egypt.A French study that examined the GPs’

experiences in diabetes management for Rama-dan observers was also included in the review.

Intervention-Based Studies

These studies led to safer fasting during Rama-dan, weight loss, and improved glycemic con-trol among the intervention group. The careprovided in some of the interventions, however,was not standardized; and some studies did notattempt to quantify the effect of interventions.

None of these studies had a robust designand response rates were either low or not pro-vided. Power calculations were not reported in

Records iden�fied through database searching

(n = 562)

Screen

ing

Includ

edEligibility

Iden

�fica�o

n

Addi�onal records iden�fied through other sources

(n = 34)

Records a�er duplicates removed (n = 385)

Records screened (n = 385)

Records excluded (n = 318)

i.e. 242 were excluded from the title and 76 were excluded after reading the

abstracts

Full-text ar�cles assessed for eligibility

(n = 67)

Full-text ar�cles excluded, (n = 53)

Reasons include: • Did not assess fas�ng

pa�ents’ interven�ons in Ramadan (n=34)

• Expert opinion (n=11)• Literature review (n=7)

Studies included in scoping review

(n = 14)

Fig. 1 Flow chart of the search strategy

232 Diabetes Ther (2017) 8:227–249

Page 7: Fasting, Diabetes, and Optimizing Health Outcomes for ... · PDF fileREVIEW Fasting, Diabetes, and Optimizing Health Outcomes for Ramadan Observers: A Literature Review Hadi A. Almansour

Table3

Characteristics

ofincluded

intervention

s

References

Cou

ntry

Metho

dsSampling

Participants

Respo

nse

rate

Results/outcomes

Bravisetal.

[39]

London,

UK

Parallelcontrolgrouptrial

testingtheeffectsof

the

READ

educationprogram

ondiabetesoutcom

es(i.e.,weight

andhypoglycem

icepisodes

during

Ram

adan),which

was

delivered

afortnightto

amonth

before

Ram

adan

bydoctors,specialistnu

rses,

dieticians,and

linkworkers

Patientswithdiabetes

who

wereobservingRam

adan,

self-selected

(i.e.,responded

topostersor

advertisem

ents)

orreferred

byGPs

tothe

study.The

intervention

was

a2-heducationprogram

that

included

educationon

mealplanning,p

hysical

activity,glucose

monitoring,

hypoglycem

ia,d

osage,and

thetimingof

medications

111patientswithT2D

,planning

tofastduring

Ram

adan—57

patients

receivingtheintervention

and54

ascontrols.

They

wererecruitedfrom

public

venu

esincludinglocal

mosques

orreferred

bytheir

GPs

NM

HbA

1creductionwas

sustainedin

theintervention

group(-

0.13%,p

=0.07),

whileitincreasedby

0.33%

(p=

0.03)in

thecontrol

groupat

12months(effect

size,d

=0.44).There

was

ameanweightlossof

0.7kg

afterRam

adan

inthe

intervention

group

(p\

0.001)

vs.0

.6kg

mean

weightgain

inthecontrol

group(p\

0.001).

Significant

decrease

intotal

hypoglycem

icepisodes

was

observed

intheintervention

group,

whereas

therewas

4-fold

increasesin

controls

(p\

0.001)

during

Ram

adan

Fatim

etal.

[38]

India

Prospectiveobservationalstudy

testingtheeffect

ofa

coun

selling

andeducation

program

ondiabetes.

Outcomes

measuredusinga

questionnaire.Focussed

onkeyRam

adan-related

health

behaviorsandevents

Purposivesampleinvolving

patientswho

visiteda

hospital’soutpatient

clinic

before

Ram

adan

in2009.

Theywereprovided

astructured

education

program

2–4weeks

priorto

Ram

adan,and

know

ledge

outcom

esandadverseevent

diarieswerecollected

post-Ram

adan

96patientswithT2D

intend

ingto

fastduring

Ram

adan

NM

Awarenessscores

increased

significantlyfrom

6.81

±1.63

pre-Ram

adan

to9.15

±0.95

post-Ram

adan

(effectsize,d

=1.7).L

ess

adverseeffectsandmorefasts

werekept

than

lastyear.T

hemaxim

alincrease

ofaw

arenessof

26%

from

baselin

ewas

seen

inthe

patientsaged

between40

and60

years

Diabetes Ther (2017) 8:227–249 233

Page 8: Fasting, Diabetes, and Optimizing Health Outcomes for ... · PDF fileREVIEW Fasting, Diabetes, and Optimizing Health Outcomes for Ramadan Observers: A Literature Review Hadi A. Almansour

Table3

continued

References

Cou

ntry

Metho

dsSampling

Participants

Respo

nse

rate

Results/outcomes

Siaw

etal.

[35]

Singapore

Prospectivestudythat

focussed

oncoun

selling

byHCPs,and

medicationdose

adjustment.

Studyquestionnaireand

HbA

1ccompleted

bypatients

before,d

uring,andafter

Ram

adan;patientsrecruited

from

anoutpatient

endocrine

clinic

AllMuslim

patientsattend

ing

thisoutpatient

endocrine

clinicwho

wereover21

years

ofagewithT2D

andwho

fasted

forat

least10

days

during

Ram

adan

153patientswho

completed

thestudy

61%

Significant

reductionin

HbA

1cfrom

8.9±

2.0%

before

Ram

adan

to8.6±

1.8%

during

Ram

adan

(p\

0.05)(H

bA1c

effect

size,d

=0.16).Significant

improvem

entsin

HbA

1calso

observed

insubgroups

where

thedose

ofantidiabeticwas

adjusted

during

Ram

adan

(p\

0.001)

McEwen

etal.

[36]

Egypt,Iran,

Jordan,and

SaudiArabia

Prospectivestudyof

patients

withT2D

attend

ingclinics

(n=

12)who

received

individualized

educationfrom

clinicstaff.Toexplore

whether

individualized

educationbefore

Ram

adan

canlead

toasaferfastfor

T2D

patients.E

ach

participantreceivedan

average

twosessions

of0.5–

1h

individualized

face-to-face

educationsessions

cond

ucted

bydiabetes

specialistnu

rses,

dieticians,o

rtrainedlin

kworkers.T

heeducation

sessions

delivered

before

and

during

Ram

adan

covered

issues

includingphysical

activity,m

ealplanning,b

lood

glucosemonitoring,andacute

metaboliccomplications

Purposivesamplingof

T2D

patientsrecruitedfrom

12clinics

774patients—515represent

theintervention

groupwho

received

individualized

educationthat

was

delivered

one-to-one

orin

agroupin

thepatient’s

preferred

language.2

59(control

group)

received

usualcare

andthey

weregivenandan

Englishor

Arabiccopy

ofthe2010

American

Diabetes

Association

(ADA)

guidelines

diabetes

managem

entwhileobserving

theRam

adan

fast

NM

The

intervention

groupwere

morelikelyto

adjusttheir

diabetes

treatm

entplan

during

Ram

adan

(97%

vs.

88%,p

\0.0001)andwere

ableto

self-monitor

their

bloodglucoseat

leasttwice

daily

during

Ram

adan

(70%

vs51%,p

\0.0001).They

also

have

enhanced

their

know

ledgeabout

hypoglycem

icsignsand

symptom

s(p

=0.0007).It

resultedin

reducedbody

massindex(BMIeffect

size,

d=

0.43)andglycated

hemoglobinof

the

intervention

groupduring

Ram

adan

comparedto

controlgroup

(HbA

1ceffect

size,d

=0.66)

234 Diabetes Ther (2017) 8:227–249

Page 9: Fasting, Diabetes, and Optimizing Health Outcomes for ... · PDF fileREVIEW Fasting, Diabetes, and Optimizing Health Outcomes for Ramadan Observers: A Literature Review Hadi A. Almansour

Table3

continued

References

Cou

ntry

Metho

dsSampling

Participants

Respo

nse

rate

Results/outcomes

Susilparat

etal.

[34]

Thailand

Prospectivestudyto

investigate

theeffectivenessof

contextual

educationfor

self-managem

entin

patients

withT2D

during

Ram

adan.

The

outcom

esweremeasured

afterRam

adan

using

interviewswithpatients,

weightandwaist

measurements,blood

pressure,

andbloodtests

Purposivesamplingof

T2D

patientsaged

35–6

5years

old,

withno

diabetes-related

complications

such

askidn

eyandheartdiseases,and

capableof

readingand

writing

inThai

90T2D

patients—62

patients

wereeducated

priorto

Ram

adan

indiabetes

managem

entandhowto

adjusttheirantidiabetics

accordingly.28

patients

received

usualcare

NM

Nosevere

hypoglycem

iaevents

werereported

bythe

experimentalor

control

group.

There

was

adecrease

inthenu

mberandportion

ofpatientswith

hypoglycem

icsymptom

sin

theexperimentalgroup

comparedto

thecontrol

group(p

=0.013)

(HbA

1ceffect

size,d

=0.14

and

basicknow

ledgeabout

diabetes

effect

size,

d=

0.34).Sw

eetenedfood

consum

ptionwas

reducedin

theexperimentalgroupafter

Ram

adan

(p=

0.002)

Ahm

edani

etal.

[23]

Karachi,P

akistan

Prospectivestudyto

findoutthe

effectsof

glucosemonitoring,

drug

dosage

andtiming

adjustments,p

atients’

coun

selling

andeducation

regardingdiet

and

complications

that

might

occurwhilefastingduring

Ram

adan.T

woeducational

sessions

werecond

ucted

separatelywitheach

patient

onaone-to-one

basis,onewas

cond

uctedby

adoctor

(lasted

for20–2

5min)andtheother

byadietician(lastedfor

20–2

5min)

Purposivesamplingfrom

the

outpatient

departmentof

the

BaqaiInstituteof

Diabetology

and

End

ocrinology

110patientswithdiabetes—

107T2D

patientsand3

T1D

patients

NM

Glucose

monitoring,drug

dosage

andtiming

adjustment,andpatient

educationledto

decrease

intheoccurrence

ofserious

acutecomplications

ofdiabetes

during

Ram

adan

amongmostof

the

participants.Ingeneral,a

significant

improvem

entwas

foun

din

themeanblood

glucoseduring

Ram

adan

(8.67±

1.92

mmol/l)

comparedto

theestimated

averageglucose

(12.47

±3.94

mmol/l)

before

Ram

adan

(p\

0.000)

(effectsize,d

=1.23)

Diabetes Ther (2017) 8:227–249 235

Page 10: Fasting, Diabetes, and Optimizing Health Outcomes for ... · PDF fileREVIEW Fasting, Diabetes, and Optimizing Health Outcomes for Ramadan Observers: A Literature Review Hadi A. Almansour

Table3

continued

References

Cou

ntry

Metho

dsSampling

Participants

Respo

nse

rate

Results/outcomes

Ahm

edani

etal.

[25]

Pakistan

Prospectivestudyto

exam

inethe

implem

entation

outcom

esof

Ram

adan-specific

diabetes

managem

ent

recommendationsby

HCPs

inpatientswithdiabetes.Itwas

cond

uctedin

twostages;first

was

pre-Ram

adan

recruitm

ent

interview(visitA)in

which

individualized

coun

selling

and

educationalmaterialwere

provided

toeach

patient.

Second

stageisa

post-Ram

adan

follow-up

interview(visitB)of

thesame

patients.P

re-Ram

adan

Purposivesamplingfrom

nine

diabetes

specialistcentersin

four

provincesof

Pakistan

682patientswithdiabetes—

655T2D

patientsand27

T1D

patients

NM

Alterationsof

drug

dosage

and

timingwereun

dertaken

byabout91%

patientswith

T2D

and80%

patientswith

T1D

during

Ram

adan.N

ohospitalizations

were

required

becauseof

symptom

atichypoglycem

iaor

hyperglycemiaandno

diabeticketoacidosis,

hyperglycemic,and

hyperosm

olar

states

were

experiencedduring

Ram

adan.T

hestudy

highlighted

theacceptability

ofHCPs’recom

mendations

bypatientswithT2D

fasting

during

Ram

adan/aswellas

thebenefitsof

advice

provided

topatients

236 Diabetes Ther (2017) 8:227–249

Page 11: Fasting, Diabetes, and Optimizing Health Outcomes for ... · PDF fileREVIEW Fasting, Diabetes, and Optimizing Health Outcomes for Ramadan Observers: A Literature Review Hadi A. Almansour

Table3

continued

References

Cou

ntry

Metho

dsSampling

Participants

Respo

nse

rate

Results/outcomes

Ahm

edani

andAlvi

[40]

SevenCountries

(i.e.,Pakistan,

Bangladesh,

Afghanistan,

SaudiArabia,

Oman,E

gypt,

andSriLanka)

Observationalstudyof

the

characteristicsof

fasting

patients,trend

sof

Ram

adan-specific

diabetes

education,

and

implem

entation

ofdiabetes

managem

ent

recommendationsin

patients

withdiabetes

during

Ram

adan.T

hisstudywas

undertaken

mainlyby

general

practitioners,diabetologists,

andinternistsusing

standardized

questionnaire-based,

face-to-face

interviews

cond

uctedon

one-to-one

basis

Convenience

samplingafter

theendof

Ram

adan

2014

(August–Decem

ber).T

heincluded

participantswere

patientswithdiabetes

who

fasted

forat

least10

days

during

Ram

adan

of2014

6610

patientswithdiabetes—

6350

T2D

patientsand260

T1D

patients

NM

BeforeRam

adan,

approxim

ately48%

ofparticipantsreceived

Ram

adan-specific

diabetes

educationandnearly66%

patientswererecommended

toaltertheirmedications

timinganddosage,w

hile

about70%

received

dietary

advice.R

eceiving

Ram

adan-specific

diabetes

educationhelped

participantsto

follow

Ram

adan-specific

diabetes

managem

ent

recommendationsduring

Ram

adan

better

than

those

who

didnotreceivesuch

education

Diabetes Ther (2017) 8:227–249 237

Page 12: Fasting, Diabetes, and Optimizing Health Outcomes for ... · PDF fileREVIEW Fasting, Diabetes, and Optimizing Health Outcomes for Ramadan Observers: A Literature Review Hadi A. Almansour

Table3

continued

References

Cou

ntry

Metho

dsSampling

Participants

Respo

nse

rate

Results/outcomes

Lee

etal.

[37]

Malaysia

Apilotrand

omized

controlled

studyto

evaluate

the

short-term

benefitsof

atelemonitoring-supplemented

focuseddiabeticeducation

comparedwitheducation

alonein

participantswith

T2D

who

werefastingduring

Ram

adan

Random

selectionfrom

five

prim

aryhealth

care

provider

practicesto

telemonitoring

group(TG)or

ausualcare

group(U

C)

37T2D

patients:in

the

tele-m

onitoringgroup

(n=

18)who

received

goal-setting

andpersonalized

feedback

and19

T2D

patientsreceiving

Ram

adan-focused

pre-educationonly,i.e.,usual

care

NM

The

TG

experiencedfewer

hypoglycem

iasymptom

scomparedto

theUC

during

thestudyperiod

(88vs.1

57episodes),(O

R0.1273;95%

CI0.0267–0

.6059,

p[0.01)(effect

size

=-1.14*).H

owever,

therewas

nosignificant

difference

observed

inglycem

iccontrolat

theend

ofstudybetweenthetwo

groups.T

elem

onitoring

might

beaconvenient

addition

toim

proveglucose

monitoringandreinforce

Ram

adan-focussed

education.

Educational

initiativesandmonitoring

areessentialfor

patientswith

diabetes

willingto

observe

Ram

adan

READ

Ram

adan

educationandaw

arenessin

diabetes,C

Scross-sectionalstudy,OSobservationalstudy,NM

notmentioned,O

Rodds

ratio,

CIconfi

denceinterval

Effectssizeswerebasedon

Cohen’sdvaluesandsomeeffectsizescalculations

arefordifferencesbetweenpre-andpost-m

easuresrather

forbetweencontroland

intervention

groups

*Thiseffect

size

valuewas

calculated

onthebasisof

Chinn

’sexplanation[50]

238 Diabetes Ther (2017) 8:227–249

Page 13: Fasting, Diabetes, and Optimizing Health Outcomes for ... · PDF fileREVIEW Fasting, Diabetes, and Optimizing Health Outcomes for Ramadan Observers: A Literature Review Hadi A. Almansour

Table4

Characteristics

ofincluded

needsanalysis(pre-in

tervention

)of

research

studies

Autho

rCou

ntry

Metho

dsSampling

Participants

Respo

nse

rate

Results/outcomes

Amin

and

Chewning

[13]

Alexand

ria,

Egypt

CS;

self-administeredcustom

developedsurvey.T

hissurvey

hadaknow

ledgesection

comprising3item

stesting

awarenessaround

clinical

managem

entof

diabetes

in

fastingpatientsandabehavior

sectionwithitem

sconstructed

usingthetheory

ofplanned

behavior

Random

samplingoutof

alistof

3309

commun

itypharmacies

inAlexand

ria

277 pharmacists

93%

16%

ofparticipatingpharmacists

couldnotanswer

anyquestion

correctly

intheknow

ledge

sectionandonly8.5%

answered

allthequestions

correctly.M

ostreported

being

willingto

attend

aworkshopto

learnabouttheadjustmentof

medicationregimensduring

Ram

adan

Amin

and

Chewning

[20]

Alexand

ria,

Egypt

CS;

analyzed

theresponsesfrom

theabovestudyto

explorethe

utility

oftheplannedbehavior

theory

modelin

predicting

the

behavior

ofpharmacists

towards

adjustingmedication

regimensforpatientsduring

Ram

adan

Random

samplingoutof

alistof

3309

commun

itypharmacies

inAlexand

ria

277 pharmacists

93%

Samplepharmacistsweremore

likelyto

change

simpler

aspects

ofpatientmedications

(e.g.,

dose

regimen

changes,rather

than

recommending

adifferent

classof

medications).In

this

sample,currentpractice

was

limited

tominim

al

intervention

delivery,which

is

perhapsreflectiveof

provider

confi

dence

Diabetes Ther (2017) 8:227–249 239

Page 14: Fasting, Diabetes, and Optimizing Health Outcomes for ... · PDF fileREVIEW Fasting, Diabetes, and Optimizing Health Outcomes for Ramadan Observers: A Literature Review Hadi A. Almansour

Table4

continued

Autho

rCou

ntry

Metho

dsSampling

Participants

Respo

nse

rate

Results/outcomes

Wilbur

etal.

[45]

Qatar

CSdescriptivestudyusinga

Web-based

custom

developed

questionnairethat

contains

item

sfocussed

onpharmacist

attitudestowards

appropriate

patientcare

andknow

ledge

aboutmedicationadjustments

forpatientswithdiabetes

who

wereun

dertakingtheRam

adan

fast.T

hiswas

completed

by

participants3monthspriorto

Ram

adan

2012

Convenience

sampleobtained

from

Qatar

UniversityCollege

ofPh

armacy—

internal

pharmacistdatabase

178 pharmacists

31%

Pharmacistsreported

frequent

encoun

terswithpatientswho

have

diabetesduring

Ram

adan.

Only7%

ofpharmacists

achieved

agood

scoreon

know

ledgequestions.In

a

specificcase

question

pertaining

toantidiabetic

medicationadjustment,only

43%

ofsamplepharmacists

provided

thecorrectresponse.

Severalbarrierswereidentified

buttherewas

anoveralldesire

toassumegreaterrolesin

assistingpatientswithdiabetes

fastingduring

Ram

adan

240 Diabetes Ther (2017) 8:227–249

Page 15: Fasting, Diabetes, and Optimizing Health Outcomes for ... · PDF fileREVIEW Fasting, Diabetes, and Optimizing Health Outcomes for Ramadan Observers: A Literature Review Hadi A. Almansour

Table4

continued

Autho

rCou

ntry

Metho

dsSampling

Participants

Respo

nse

rate

Results/outcomes

Almansour

etal.[32]

Australia,

Sydn

ey

CS;

analyzed

pharmacists’

perspectives

regardingtheir

rolein

care

ofpatientswith

T2D

who

choose

tofast

during

Ram

adan

Convenience

sampleobtained

from

areasof

ethn

icdiversity

inSydn

ey

21

pharmacists

75%

Mostparticipantsencoun

tered

fastingpatientsandwere

willingto

engage

indiabetes

care

services.H

owever,

them

aticanalyses

indicated

reactive

coun

selling,lackof

perceivedneed

forcoun

selling

patientsor

delegation

of

patientcare(tophysicians)in

a

fewinstancesas

wellas

organizationalissues

asa

practice

barrier.Authors

concludedthat

professional

awareness/training

ofthe

impact

ofreligious

practices

such

asRam

adan

fastingis

essentialandhealth

care

servicesshould

bedevelopedto

help

thesepatientsto

practice

theirreligious

practices

includingRam

adan

fast

without

affectingtheirhealth

Diabetes Ther (2017) 8:227–249 241

Page 16: Fasting, Diabetes, and Optimizing Health Outcomes for ... · PDF fileREVIEW Fasting, Diabetes, and Optimizing Health Outcomes for Ramadan Observers: A Literature Review Hadi A. Almansour

Table4

continued

Autho

rCou

ntry

Metho

dsSampling

Participants

Respo

nse

rate

Results/outcomes

Gaboritet

al.

[42]

Marseilles,

France

CSwascond

ucted3month

prior

toRam

adan;study1with

patientswas

cond

uctedvia

face-to-face

interviewswiththe

aim

ofexploringattitudesof

patientsandstudy2exam

ined

physicians’attitudesregarding

Ram

adan

fastinganddiabetes

control.In

study2,

the

physicians

filledoutthe

questionnaires

ontheirow

n

foramax.tim

eof

30min

each

Purposivesamplingof

patients

withdiabetes

andGPs

recruitedduring

four

rand

omlyselected

medical

training

sessions

thatwerepart

ofacontinuing

medical

educationprogramme

101 patients—

81T2D

patients

and20

T1D

patients.

101GPs

NM

77%

ofGPs

stated

they

hadnot

read

aboutdiabetes

control

during

Ram

adan

andonly15%

hadmanaged

someacute

diabeticissues

during

Ram

adan.A

lmost52%

of

patientscontinuedto

fast

during

Ram

adan

andonly

about64%

ofpatientshad

discussedfastinganddiabetes

managem

entduring

Ram

adan

withtheirGPs.G

Psadvised36

patientsto

notfast,b

ut19

of

thosepatientsfasted

inspiteof

theirGPs’recom

mendations.

Consequently,six

fasting

patientsexperienced

hypoglycem

iaas

they

persisted

taking

oralhypoglycem

ic

medications

orinsulin

at

middayeach

day.The

study

demonstratedthat

formore

cultu

rally

sensitivecare

for

thesepatientsandmore

medicaltraining

forphysicians

areneeded

CScross-sectionalstudy

242 Diabetes Ther (2017) 8:227–249

Page 17: Fasting, Diabetes, and Optimizing Health Outcomes for ... · PDF fileREVIEW Fasting, Diabetes, and Optimizing Health Outcomes for Ramadan Observers: A Literature Review Hadi A. Almansour

many instances. None of the included inter-ventions were large robust randomized controltrials (RCTs), some were pre–post studies andothers were parallel group quasi-experimentalstudies [23, 25, 34–40].

Intervention Specifics

Most interventions targeted patients with dia-betes who intended to or have the intention tofast during Ramadan. Interventions were mostlydelivered by HCPs such as GPs, dieticians, andlink workers and a few involved spiritual leadersto recruit or motivate patients to participate insuch interventions. Most intervention studiesstated focussing on patients’ education on mealplanning, physical activity, glucose monitoring,hypoglycemia, dosage, and the timing of med-ications. However, in most instances, the detailsof the educational intervention, e.g., the formatof delivery, props used to support the educa-tion, or the clinical guidelines which informedthe educational interventions, were notdetailed. A few studies reported the languageand the duration of the education sessions[34, 36, 39]. In multicenter studies, no qualityaudits were considered [36, 40]. Hence in theseinstances protocol fidelity is not known.

Key Outcomes Measured

Intervention assessment is best served by mea-suring a balanced set of outcomes that includeclinical measures, economic benefits as well asfunctional health status and well-being [41].Key clinical outcomes measured in the reviewedstudies included weight or BMI, HbA1c, andadverse events occurrence. However, humanis-tic outcomes (e.g., adherence, quality of life,satisfaction, health beliefs, awareness, behav-iors, and attitudes) were not considered to assessthe effects of the interventions. Therefore, thesestudies did not look into details of whetherparticipating patients learnt/benefited fromthese studies outside the bounds of clinicalimprovement. In most instances, the follow-upperiod was short and only one study looked intothe sustainability of the outcomes 12 monthsafter patients attended the education [39]. In

this study, i.e., the Ramadan Education andAwareness in Diabetes (READ) program, HbA1creduction was sustained in the interventiongroup (-0.13%, p = 0.07), while the meanHbA1c in the control group increased by 0.33%(p = 0.03) [39].

Effect sizes of the educational interventionson key outcomes, where calculable, rangedbetween -1.14 and 1.7.

Needs Analysis (Pre-intervention) Studies

Needs analysis research studies were conductedboth with GPs and pharmacists, and patients.None of these included active interventionstudies. Non-validated instruments, self-report-ing methods, sampling in one area, and limitedscope of questions on diabetes knowledge wereissues that restricted the generalizability of theresults. While most HCPs were willing to pro-vide health care services, clearly their knowl-edge of how such services will be provided wassuboptimal, and most were open to moretraining about their role in managing diabetesduring Ramadan. There was a wide variation inthe knowledge of participating HCPs (GPs andpharmacists) about managing diabetes forpatients with diabetes intending to fast duringRamadan. For example, the majority of theFrench GPs interviewed by Gaborit et al. lackedthe clinical awareness about medical manage-ment in T2D patients observing Ramadan andcultural awareness about the relevance of thefast [42].

DISCUSSION

This is the first literature review to focusspecifically on the health educational inter-ventions, and intentions of HCPs such as gen-eral practitioners (GPs) and pharmacists, toprovide clinical services to patients with dia-betes while fasting during Ramadan. The reviewrevealed a paucity of research in this area. Therewere only a few intervention studies locatedthrough the search, and the generalizability ofthese studies was limited. Power calculationswere not undertaken for most interventionstudies, making it difficult to extrapolate the

Diabetes Ther (2017) 8:227–249 243

Page 18: Fasting, Diabetes, and Optimizing Health Outcomes for ... · PDF fileREVIEW Fasting, Diabetes, and Optimizing Health Outcomes for Ramadan Observers: A Literature Review Hadi A. Almansour

significance of findings. Outcome measurescollected varied and humanistic outcomes wereoften not collected. A detailed description ofactual intervention or education was lacking,and protocol fidelity (e.g., checks to see ifintervention providers followed research pro-tocols) and assessment of patient adherence(checks to see if patients adhered to recom-mended interventions) to recommendationswere not measured in any of the reviewedstudies. The overall trend, however, indicatedthat education, counselling by HCPs, anddosage adjustment for oral hypoglycemics inthe pre-Ramadan period help decrease adverseevents and can thus improve the experience ofpatients choosing to fast for religious/spiritualreasons. Clearly, robust studies with attentionto trial design need to be conducted.

None of the included studies had a robustdesign, some were pre–post studies and otherswere parallel group quasi-experimental studies[23, 25, 34–40]. In studies where randomizedsampling was undertaken, the randomizationmethod, allocation concealment, or blindedoutcome collection are not mentioned. In termsof outcomes, the full gamut of clinical andhumanistic outcomes was not covered and cer-tainly economic analyses, e.g., the cost-effec-tiveness of the educational interventions, werealso not conducted. One reason for this ofcourse may have been the lack of validatedquestionnaires/tools to measure humanisticoutcomes such as participants’ knowledge, sat-isfaction, and quality of life with these inter-ventions. These studies used self-developedquestionnaires. Future intervention studies inthis area should consider adequately poweredrandomized controlled designs, with blindingof outcome measurements at least as well as asuite of outcomes (clinical, humanistic, andeconomic) measured using validated instru-ments or techniques.

In most of the intervention studies, HbA1cor blood glucose level and diabetes-relatedadverse events were improved in the interven-tion group. These are promising outcomes, eventhough study designs were not very robust, asmentioned earlier. The positive trends in thedata observed suggested that well-designedhealth care education models for Ramadan

observers with diabetes should be developed.However, a preceding step that may needresearch investment is the development andvalidation of measurement tools that can beused in this population, particularly for mea-suring humanistic outcomes.

As highlighted in the ‘‘Results’’ section,intervention/education details were not clearlydescribed, which prevents other researchersfrom using effective materials and having toreinvent the intervention. These details includethe period of how long the education took,method of delivery (e.g., power point slides,face to face), and whether clinical guidelineswere followed in constructing the educationalintervention. Key clinical details of interven-tions were missing. For example, smokingaffects enzymes inducers, and smokers who fastduring Ramadan may stop smoking suddenlyduring the fasting time, which might affect thedoses of some medications. However, none ofthe intervention studies discussed whether doseadjustment in relation to smoking cessationhad been advised to patients. This is an issueobserved by authors of other systematic reviews,e.g., Okumura et al. reported the same issue in areview of intervention trials focusing on coun-selling [43]. Future research needs to considerthese details to enable other researchers toimplement such research in other countries formore global benefits and universalstandardization.

Most of the interventions were delivered byphysicians and allied health professionals inclinics. In most communities around the world,pharmacists are knowledgeable HCPs, veryeasily accessible and commonly visited by manypeople every day. Therefore, pharmacists’ valu-able contribution to patient care can be betterutilized. Research has shown that communitypharmacists can help with diabetes manage-ment generally [29, 44]. Therefore, it is logicalthat community pharmacists can help peoplewith diabetes who are observing the fast ofRamadan by providing information and helpingto adjust medications. Pharmacists’ awarenessof and willingness to do so was evident to someextent in the needs analysis studies included inthis review [13, 20, 32, 42]. There were nostudies describing the effect of well-designed

244 Diabetes Ther (2017) 8:227–249

Page 19: Fasting, Diabetes, and Optimizing Health Outcomes for ... · PDF fileREVIEW Fasting, Diabetes, and Optimizing Health Outcomes for Ramadan Observers: A Literature Review Hadi A. Almansour

structured clinical interventions delivered bypharmacists to patients with diabetes fastingduring Ramadan.

The studies that were located in the literaturehad several limitations; however, put together,these needs analysis (pre-intervention), in thecase of those conducted with pharmacists’,highlighted that pharmacists have the ability toenact specific roles in adjustments of medica-tion regimens for patients observing fasts withconcomitant diabetes [13, 20, 32, 45]. Hence, itwould be ideal to upskill pharmacists so theycan adjust medication regimens for patients toensure that they take their medications safelyand appropriately before, during, and afterRamadan.

Patient education research often highlightsthe chasm between patient behaviors and pro-fessionals’ recommendations. Several culturalfactors may affect communication and coun-selling by health professionals and similar fac-tors may also influence patients’ knowledgeabout their condition/medications as well astheir help-seeking behaviors. Thus, several typesof interventions may be useful: enhancing cul-tural understanding of professionals about theimportance of the fast to patients in developedcountries, as well as clinical training aboutadjustment of medication regimens for patientswith diabetes opting to fast during Ramadan inboth developed and developing countries.Ultimately, patients themselves can be upskilledto self-manage medications through effectivepatient education and medication adjustmentskills. Very few studies in this review directlyaddressed both provider and patient attitudes.The work reported by Gaborit and colleagues[42] was the only study in the review whichevaluated attitudes of both patients and physi-cians regarding Ramadan fasting and diabetescontrol in Marseilles, France. As highlighted inTable 3, the authors reported that many GPslacked the cultural competency and medicalknowledge that are needed to appropriatelycounsel their patients with diabetes in regardsto medication management during Ramadan.This resulted in medically unjustified recom-mendations against fasting. Culturally insensi-tive recommendations were ineffective, in that,directing patients peremptorily not to fast did

not appear to deflect vulnerable patients fromstill undertaking the fast [42]. Generally,patients may choose to ignore HCP advice,especially if they feel the HCP is not culturallyattuned to their decisions [42, 46, 47]. In thecase of Ramadan fasting, where religious beliefsstrongly motivate patients to fast, HCPs(physicians and pharmacists) and religioussources, such as imams (Muslim religiouspriests), may need to collaborate as importantsources of knowledge about fasting and medi-cation use for patients. This is a research areawith clear gaps, and further research on bothpatient-focussed or health professional-focussedresearch is needed.

A few studies have been carried out in Aus-tralia regarding diabetes management in CALDpopulations (i.e., Maltese immigrants to Aus-tralia), but not specifically during fasting. Oneof these studies reported on interview data fromMaltese immigrants in Sydney, Australia. Thiswas a qualitative exploratory study and high-lighted how patients in this group have limiteddiabetes knowledge. Interestingly, this group ofpatients were interested to receive more dia-betes care and counselling from communitypharmacists as they are easily accessible [44]. Itwas concluded that CALD populations havedistinctive barriers to health care that might beunknown to HCPs or unrecognized clearly bypatients themselves. Some of these barrierscould be due to low health literacy or lack ofaccess to educational programs [44]. The effectof a community pharmacy diabetes servicemodel on the outcomes of general patients withT2D in Australia has been assessed. As a result ofthese significant outcomes, the Australian gov-ernment provided a clinical intervention fee forpharmacists to provide an abbreviated versionof this service in the Fifth Community Phar-macy Agreement [48]. Such programs could alsobe developed for niche population groups aswell, i.e., specifically for Muslim patients withdiabetes intending to fast in Ramadan. Also,future research may consider electronic onlineformats of resources for patient education andawareness such as smartphone apps (for iOS,iPhone, and Android) as digital tools are usedcommonly worldwide. Contextualized explora-tory research seeking patients’ perspectives of

Diabetes Ther (2017) 8:227–249 245

Page 20: Fasting, Diabetes, and Optimizing Health Outcomes for ... · PDF fileREVIEW Fasting, Diabetes, and Optimizing Health Outcomes for Ramadan Observers: A Literature Review Hadi A. Almansour

problems or cultural issues regarding diabetesself-control would need to be conducted priorto designing such pharmacy-based interventionprograms. Pharmacists’ perspectives aboutdealing with cultural concerns that could affectpatients’ health or clinical confidence in pro-viding specific interventions was investigated inAustralia for this group and the findings of suchwork could be beneficial in the planning phaseof such intervention programs [32].

There are a few limitations of this scopingreview. Meta-analysis could not be conductedbecause the reviewed studies had mixed meth-ods/protocols of the interventions. Similarly, asystematic review was not conducted as most ofthe included studies were not robustly designedclinical trials. Another limitation is that dia-betes was considered mostly to be studied withrelation to Ramadan fast, because of the possi-bility of hypoglycemia occurring while fasting.However, other health conditions such as ang-ina, ulcers, asthma, and chronic obstructivepulmonary disease (COPD) should be consid-ered in future studies as fasting may affecthealth and medication use in relation to otherconditions.

CONCLUSION

The results of this literature review revealednumerous gaps in the existing literature. ManyHCPs and patients lack the knowledge for themanagement and modification of medicationregimens for patients with diabetes who fastduring Ramadan. Addressing the knowledgedeficits and enhancing cultural competency arecritical for clinicians treating Muslim patientsliving with chronic illness and observing thefasting practices of their faith. Very few studies,however, have addressed health providers’ atti-tudes, knowledge, and advice with regards tofasting. In Australia, where thousands of Mus-lims observe the fast of Ramadan each year, thisresearch area is becoming increasinglyimportant.

Pharmacists have been the focus of researchin this area in other countries and have been

shown to be willing to provide specialized carefor fasting patients with diabetes and willing toupskill themselves in order to provide suchspecialized care. Hence, there is a need forresearch that helps to describe the extent towhich Australian pharmacists counsel theirpatients about fasting during Ramadan, theirwillingness to provide specialized care, andtheir level of current cultural and clinical skills.Similarly, research with Muslim Australianpatients observing Ramadan will help establishtheir Ramadan-based diabetes self-managementbehaviors, and their perceptions about, andwillingness for receiving specialized help fromclinicians, including pharmacists. This researchmight assist in the development of such pro-grams in Australia.

ACKNOWLEDGEMENTS

No funding or sponsorship was received for thisstudy or publication of this article. All namedauthors meet the International Committee ofMedical Journal Editors (ICMJE) criteria forauthorship for this manuscript, take responsi-bility for the integrity of the work as a whole,and have given final approval for the version tobe published.

Disclosures. H. A. Almansour, B. Chaar, andB. Saini have nothing to disclose.

Compliance with Ethics Guidelines. Thisarticle is based on published studies, and doesnot involve any new studies of human or ani-mal subjects performed by any of the authors.

Open Access. This article is distributedunder the terms of the Creative CommonsAttribution-NonCommercial 4.0 InternationalLicense (http://creativecommons.org/licenses/by-nc/4.0/), which permits any noncommercialuse, distribution, and reproduction in anymedium, provided you give appropriate creditto the original author(s) and the source, providea link to the Creative Commons license, andindicate if changes were made.

246 Diabetes Ther (2017) 8:227–249

Page 21: Fasting, Diabetes, and Optimizing Health Outcomes for ... · PDF fileREVIEW Fasting, Diabetes, and Optimizing Health Outcomes for Ramadan Observers: A Literature Review Hadi A. Almansour

REFERENCES

1. Lee SW, Lee JY, Tan CS, Wong CP. Strategies tomake Ramadan fasting safer in type 2 diabetics: asystematic review and network meta-analysis ofrandomized controlled trials and observationalstudies. Med (Baltimore). 2016;95(2):e2457.

2. Ali S, Davies MJ, Brady EM, et al. Guidelines formanaging diabetes in Ramadan. Diabet Med.2016;33(10):1315-29.

3. Australian Institute of Health and Welfare (AIHW).How common is diabetes? 2013. http://www.aihw.gov.au/how-common-is-diabetes/. Accessed 3 May2015.

4. University of South Australia. Australian Muslims: ademographic, social and economic profile ofMuslims in Australia. 2015. https://www.unisa.edu.au/Global/EASS/MnM/Publications/Australian_Muslims_Report_2015.pdf. Accessed 15 Aug 2016.

5. Australian Bureau of Statistics (ABS). Reflecting anation: stories from the 2011 census, 2012–2013.http://www.abs.gov.au/ausstats/[email protected]/Lookup/2071.0main?features902012-2013. Accessed 2May 2015.

6. Thow AM, Waters AM. Diabetes in culturally andlinguistically diverse Australians: identification ofcommunities at high risk. 2005. http://www.aihw.gov.au/WorkArea/DownloadAsset.aspx?id=6442454961. Accessed 5 May 2015.

7. Trepanowski JF, Bloomer RJ. The impact of religiousfasting on human health. Nutr J. 2010;9:57.

8. Aadil N, Houti IE, Moussamih S. Drug intake duringRamadan. BMJ. 2004;329(7469):778–82.

9. Al-Arouj M, Assaad-Khalil S, Buse J, et al. Recom-mendations for management of diabetes duringRamadan: update 2010. Diabetes Care.2010;33(8):1895–902.

10. Hui E, Bravis V, Hassanein M, et al. Management ofpeople with diabetes wanting to fast during Rama-dan. BMJ. 2010;340:c3053.

11. Pathy R, Mills KE, Gazeley S, Ridgley A, Kiran T.Health is a spiritual thing: perspectives of healthcare professionals and female Somali and Bangla-deshi women on the health impacts of fastingduring Ramadan. Ethn Health. 2011;16(1):43–56.

12. Salti I, Benard E, Detournay B, et al. A popula-tion-based study of diabetes and its characteristicsduring the fasting month of Ramadan in 13 coun-tries. Diabetes Care. 2004;27(10):2306–11.

13. Amin ME, Chewning B. Community pharmacists’knowledge of diabetes management during Rama-dan in Egypt. Int J Clin Pharm. 2014;36(6):1213–21.

14. Alberti H, Boudriga N, Nabli M. Lower attendancerates and higher fasting glucose levels in the monthof Ramadan in patients with diabetes in a Muslimcountry. Diabet Med. 2008;25(5):637–8.

15. Al-Mendalawi MD. Effects of Ramadan fasting onglucose levels and serum lipid profile among type 2diabetic patients. Saudi Med J. 2011;32(6):647.

16. Chan F, Slater C, Syed AA. Diabetes and Rama-dan. Fasts after bariatric surgery. BMJ. 2010;341:c3706.

17. Khaled BM, Belbraouet S. Effect of Ramadan fastingon anthropometric parameters and food consump-tion in 276 type 2 diabetic obese women. Int JDiabetes Dev Ctries. 2009;29(2):62–8.

18. Salman H, Abdallah MA, Abanamy MA, Howasi M.Ramadan fasting in diabetic children in Riyadh.Diabet Med. 1992;9(6):583–4.

19. Karatoprak C, Yolbas S, Cakirca M, et al. The effectsof long term fasting in Ramadan on glucose regu-lation in type 2 diabetes mellitus. Eur Rev MedPharmacol Sci. 2013;17(18):2512–6.

20. Amin ME, Chewning B. Predicting pharmacists’adjustment of medication regimens in Ramadanusing the theory of planned behavior. Res SocialAdm Pharm. 2015;11(1):e1–15.

21. Norouzy A, Mohajeri SM, Shakeri S, et al. Effect ofRamadan fasting on glycemic control in patientswith type 2 diabetes. J Endocrinol Invest.2012;35(8):766–71.

22. Alabbood MH, Ho KW, Simons MR. The effect ofRamadan fasting on glycaemic control in insulindependent diabetic patients: a literature review.Diabetes Metab Syndr. 2016. doi:10.1016/j.dsx.2016.06.028

23. Ahmedani MY, Haque MS, Basit A, Fawwad A, AlviSF. Ramadan prospective diabetes study: the role ofdrug dosage and timing alteration, active glucosemonitoring and patient education. Diabet Med.2012;29(6):709–15.

24. Ibrahim M, Abu Al Magd M, Annabi FA, et al. Rec-ommendations for management of diabetes duringRamadan: update 2015. BMJ Open Diabet Res Care.2015;3(1):e000108.

25. Ahmedani MY, Alvi SF, Haque MS, Fawwad A, BasitA. Implementation of Ramadan-specific diabetesmanagement recommendations: a multi-centered

Diabetes Ther (2017) 8:227–249 247

Page 22: Fasting, Diabetes, and Optimizing Health Outcomes for ... · PDF fileREVIEW Fasting, Diabetes, and Optimizing Health Outcomes for Ramadan Observers: A Literature Review Hadi A. Almansour

prospective study from Pakistan. J Diabetes MetabDisord. 2014;13(1):37.

26. Ali M, Schifano F, Robinson P, et al. Impact ofcommunity pharmacy diabetes monitoring andeducation programme on diabetes management: arandomized controlled study. Diabet Med.2012;29(9):e326–33.

27. Jacobs M, Sherry PS, Taylor LM, Amato M, TataronisGR, Cushing G. Pharmacist assisted medicationprogram enhancing the regulation of diabetes(PAMPERED) study. J Am Pharm Assoc.2012;52(5):613–21.

28. Krass I, Armour CL, Mitchell B, et al. The pharmacydiabetes care program: assessment of a communitypharmacy diabetes service model in Australia. Dia-bet Med. 2007;24(6):677–83.

29. Mitchell B, Armour C, Lee M, et al. Diabetes medi-cation assistance service: the pharmacist’s role insupporting patient self-management of type 2 dia-betes (T2DM) in Australia. Patient Educ Couns.2011;83(3):288–94.

30. Wang Y, Yeo QQ, Ko Y. Economic evaluations ofpharmacist-managed services in people with dia-betes mellitus: a systematic review. Diabet Med.2016;33(4):421–7.

31. Watson LL, Bluml BM. Integrating pharmacists intodiverse diabetes care teams: implementation tacticsfrom project IMPACT. Diabetes J Am Pharm Assoc.2014;54(5):538–41.

32. Almansour HA, Chaar B, Saini B. Pharmacists’ per-spectives about their role in care of patients withdiabetes observing Ramadan. Res Social AdmPharm. 2017;13(1):109–22.

33. Peters MD, Godfrey CM, Khalil H, McInerney P,Parker D, Soares CB. Guidance for conducting sys-tematic scoping reviews. Int J Evid Based Healthc.2015;13(3):141–6.

34. Susilparat P, Pattaraarchachai J, SongchitsomboonS, Ongroongruang S. Effectiveness of contextualeducation for self-management in Thai Muslimswith type 2 diabetes mellitus during Ramadan.J Med Assoc Thai. 2014;97(Suppl 8):S41–9.

35. Siaw MY, Chew DE, Dalan R, et al. Evaluating theeffect of Ramadan fasting on muslim patients withdiabetes in relation to use of medication and life-style patterns: a prospective study. Int J Endocrinol.2014;2014:308546.

36. McEwen LN, Ibrahim M, Ali NM, et al. Impact of anindividualized type 2 diabetes education programon clinical outcomes during Ramadan. BMJ OpenDiabet Res Care. 2015;3(1):e000111.

37. Lee JY, Lee SW, Nasir NH, How S, Tan CS, Wong CP.Diabetes telemonitoring reduces the risk of hypo-glycaemia during Ramadan: a pilot randomizedcontrolled study. Diabet Med.2015;32(12):1658–61.

38. Fatim J, Karoli R, Chandra A, Naqvi N. Attitudinaldeterminants of fasting in type 2 diabetes mellituspatients during Ramadan. J Assoc Phys India.2011;59:630–4.

39. Bravis V, Hui E, Salih S, Mehar S, Hassanein M,Devendra D. Ramadan Education and Awareness inDiabetes (READ) programme for Muslims with type2 diabetes who fast during Ramadan. Diabet Med.2010;27(3):327–31.

40. Ahmedani MY, Alvi SF. Characteristics andRamadan-specific diabetes education trends ofpatients with diabetes (CARE): a multinationalsurvey (2014). Int J Clin Pract. 2016;70(8):668–75.

41. Kozma CM, Reeder CE, Schulz RM. Economic,clinical, and humanistic outcomes: a planningmodel for pharmacoeconomic research. Clin Ther.1993;15(6):1121–32.

42. Gaborit B, Dutour O, Ronsin O, et al. Ramadanfasting with diabetes: an interview study of inpa-tients’ and general practitioners’ attitudes in theSouth of France. Diabetes Metab.2011;37(5):395–402.

43. Okumura LM, Rotta I, Correr CJ. Assessment ofpharmacist-led patient counseling in randomizedcontrolled trials: a systematic review. Int J ClinPharm. 2014;36(5):882–91.

44. Barbara S, Krass I. Self management of type 2 dia-betes by Maltese immigrants in Australia: cancommunity pharmacies play a supporting role? IntJ Pharm Pract. 2013;21(5):305–13.

45. Wilbur K, Al Tawengi K, Remoden E. Diabetespatient management by pharmacists during Rama-dan. BMC Health Serv Res. 2014;14:117.

46. Mir G, Sheikh A. ‘Fasting and prayer don’t concernthe doctors—they don’t even know what it is’:communication, decision-making and perceivedsocial relations of Pakistani Muslim patients withlong-term illnesses. Ethn Health.2010;15(4):327–42.

47. Mygind A, Kristiansen M, Wittrup I, Norgaard LS.Patient perspectives on type 2 diabetes and medi-cine use during Ramadan among Pakistanis inDenmark. Int J Clin Pharm. 2013;35(2):281–8.

48. The Pharmacy Guild of Australia. Fifth CommunityPharmacy Agreement (2010–2015). 2010. http://guild.

248 Diabetes Ther (2017) 8:227–249

Page 23: Fasting, Diabetes, and Optimizing Health Outcomes for ... · PDF fileREVIEW Fasting, Diabetes, and Optimizing Health Outcomes for Ramadan Observers: A Literature Review Hadi A. Almansour

org.au/the-guild/community-pharmacy-agreement.Accessed 15 May 2015.

49. Karamat MA, Syed A, Hanif W. Review of diabetesmanagement and guidelines during Ramadan. J RSoc Med. 2010;103(4):139–47.

50. Chinn S. A simple method for converting an oddsratio to effect size for use in meta-analysis. StatMed. 2000;19(22):3127–31.

Diabetes Ther (2017) 8:227–249 249