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Baldwin 2012
Baldwin 2012
CLINICAL NUTRITION
Dietary counselling with or without oral nutritional
supplements in the management of malnourished patients:
a systematic review and meta-analysis of randomised
controlled trials
C. Baldwin* & C. E. Weekes
*Diabetes and Nutritional Sciences Division, King’s College London, London, UK
Department of Nutrition and Dietetics, Guys and St Thomas’ NHS Foundation Trust, St Thomas’ Hospital, London, UK
Keywords Abstract
dietitian, food, malnutrition, oral nutritional
support, systematic review. Dietary counselling and oral nutritional supplements (ONS) are recommended
for managing malnutrition. A recent systematic review demonstrated (in sepa-
Correspondence rate analyses) that dietary counselling and dietary counselling with ONS
C. Baldwin, Diabetes and Nutritional Sciences improved energy intake, weight and some indices of body composition,
Division, King’s College London, Franklin
although there was considerable heterogeneity. The present analysis aimed to
Wilkins Building, 150 Stamford Street, London
SE1 9NH, UK.
examine the effects on mortality and nutritional indices of dietary counselling
Tel.: +44 (0)207 848 4318 given with or without ONS and to explore the heterogeneity in the meta-analy-
Fax: +44 (0)207 848 4500 ses aiming to characterise the groups most likely to benefit from these inter-
E-mail: christine.baldwin@kcl.ac.uk ventions. A systematic review and meta-analysis was performed using Cochrane
methodology. Twenty-six studies were included in the analysis: 12 comparing
How to cite this article dietary counselling with usual care and 14 comparing dietary counselling and
Baldwin C. & Weekes C.E. (2012) Dietary ONS if required with usual care (2123 participants). Quality of studies varied.
counselling with or without oral nutritional
Dietary counselling given with or without ONS had no effect on mortality
supplements in the management of malnour-
ished patients: a systematic review and
[relative risk (fixed) = 1.12; 95% confidence interval = 0.86–1.46] but was
meta-analysis of randomised controlled trials. associated with significant but heterogeneous benefits to weight [mean differ-
J Hum Nutr Diet. 25, 411–426 ence (random) = 1.7 kg; 95% confidence interval = 0.86–2.55], energy intake
doi:10.1111/j.1365-277X.2012.01264.x and some aspects of body composition. Subgroup analyses taking into account
clinical background, age, nutritional status, type and length of intervention
failed to reveal any differences in mortality, weight change and energy intake
between groups. There were insufficient data on functional outcomes to
explore these findings. Dietary counselling given with or without ONS is effec-
tive at increasing nutritional intake and weight but adequately-powered studies
in similar patient populations and standardised for factors that might account
for variations in response are required.
complications and weight gain, and these analyses have and the magnitude of the effects to be expected. An addi-
been used to derive general recommendations about the tional aim was to examine whether there were any bene-
use of oral nutritional support (NCC-AC, 2006). Interest- fits to mortality in specific patient groups that were
ingly, meta-analyses of the effects of ONS that are con- masked by grouping studies from different backgrounds
fined to specific clinical conditions (Arends et al., 2006; together.
Ockenga et al., 2006; Plauth et al., 2006; Volkert et al.,
2006; Koretz et al., 2007) have mostly failed to replicate
Materials and methods
the beneficial effects seen in analyses where several clinical
conditions are combined (Stratton et al., 2003; NCC-AC, A systematic review was conducted, according to the
2006). This observation may not only result from the lim- methods outlined by the Cochrane Collaboration
ited number of studies in some patient groups, but also (Higgins & Green, 2009). A summary of our methodol-
may suggest that some patient groups benefit from ONS ogy is outlined below; further details have been given pre-
more than others. Constraints on staff numbers and time viously (Baldwin & Weekes, 2011).
mean that it is important to be able to identify the
patients who are most likely to benefit from nutritional
Identification of studies
interventions to allow effective allocation of resources.
ONS are associated with considerable costs to health- The searches undertaken to identify the studies for the
care providers and compliance can be poor (Lawson present analysis have been derived from a series of
et al., 2000; Bruce et al., 2003; Hobday et al., 2010). Die- searches conducted from 1998 to 2010 (Fig. 1). Publica-
tary counselling has potential advantages in that it can tions describing randomised controlled trials of dietary
offer greater variety, can be tailored to the needs of an counselling given with or without ONS in patients with
individual and may be associated with lower healthcare malnutrition or at risk of malnutrition were retrieved by
costs. The use of dietary counselling and dietary counsel- searching electronic databases. The strategies for the
ling together with ONS is widely recommended (Thomas, searches from 2002 to 2005 and from 2005 to 2010 are
2001) in the management of malnutrition, although the provided in the Supporting information (Appendix S1).
evidence base for these interventions is unclear. All languages were included and publications not in Eng-
A systematic review, originally conducted in 2001 and lish, but considered to meet the inclusion criteria from
last updated in 2011, demonstrated that the use of dietary the abstract, were translated.
counselling alone or when given with ONS was associated The search strategy used to identify studies has evolved
with significant improvements in weight and some indices according to changes in information technology and devel-
of body composition, although there was significant het- opment of the search strategy and selection of appropriate
erogeneity in many of the analyses, suggesting that the databases has been undertaken with counselling from an
benefits may be confined to only some groups of patients expert librarian.
(Baldwin & Weekes, 2011). A frequent question is Reports of additional trials that may have been missed
whether the heterogeneity arises from the combination of were sought by assessing the bibliographic references of
groups that vary according to a range of characteristics all retrieved studies and the reference lists of key reviews
and specifically clinical background. The evidence base to (Stratton & Elia, 1999; Stratton et al., 2003; NCC-AC,
answer this question has not been explored. 2006), and the authors of all included studies were con-
The provision of dietary counselling with or without tacted. No hand-searching has been undertaken. In 2002,
ONS is frequently the first-line method used to manage experts in clinical nutrition, manufacturers of oral nutri-
malnourished patients. The review published in the Coch- tional supplements and all members of the British Die-
rane Library examines these two nutritional interventions tetic Association were contacted to identify any other
as separate entities, although they are closely-related strat- studies that might be in progress.
egies, predominately based on improving intake from
food. Dietetic practice usually utilises both food and sup-
Selection of studies
plements as appropriate; therefore, combining these two
methods increases the power to estimate the effect of the Studies were included if they were in adults in any care
type of care provided in the real life context of dietetic setting who were malnourished or judged to be at nutri-
practice. The aims of this analysis were to undertake a tional risk (their clinical condition and/or treatment may
combined analysis of dietary counselling alone and die- mean that food intake would be reduced for a number of
tary counselling with ONS if required and to explore the days) (NCC-AC, 2006) and included one of the following
heterogeneity in the analyses to characterise the patient comparisons: (i) dietary counselling compared with rou-
groups most likely to benefit from these interventions tine care or (ii) dietary counselling and ONS if required
Figure 1 Search strategy, study selection and process of identification of suitable trials. CI, confidence interval; DC, dietary counselling; ONS, oral
nutritional supplements.
compared with routine care. Outcomes considered for unclear, the authors were contacted for additional infor-
this review were mortality, weight, body composition mation.
assessed by mid-arm muscle circumference or triceps For data to be entered into a meta-analysis, it is neces-
skinfold thickness, and energy intake. sary to have sufficient information for both the interven-
Dietary counselling was defined as instruction to mod- tion and comparison groups to derive a mean (SD)
ify food intake, with the aim of improving nutritional change for continuous variables (weight, energy intake,
intake. In the second category, trials were included only if etc.) or the numbers experiencing the event of interest
ONS was a secondary measure to dietary counselling. and the total number in the group for dichotomous vari-
ables (deaths). These data have either been available from
the paper or the review authors have obtained these from
Data extraction and outcome measures
the study investigators where possible. Unfortunately, for
Titles and abstracts were reviewed on the screen by one a number of outcomes, it was not possible to obtain data
reviewer (CB). Potentially relevant studies were assessed in a format that can be entered into a meta-analysis.
for inclusion independently by two reviewers, who also Where data on mean change for the intervention group
extracted data from all included studies independently. and control group were presented with a P-value of the
The details extracted from each trial comprised: year change, this was used to derive the SD of the mean
and journal of publication, details of patient population, change. Where mean change data were presented without
including clinical condition, intended treatment, nutri- a P-value, the SDs were imputed according to the Coch-
tional status at study inclusion (malnourished/at nutri- rane Handbook (Higgins & Green, 2009).
tional risk) and demographic information, details of the
intervention and the comparison, number of patients
Methodological quality
randomised to each group and attrition, outcome data on
mortality, weight, body composition and energy intake. The methodological quality of each study was assessed
Where information on study design, quality or data were according to criteria described by Schulz et al. (1995) and
Journal of Human Nutrition and Dietetics ª 2012 The British Dietetic Association Ltd.
eating (100%) Group 3 RC
Imes 137 Crohn’s disease Not specified Group 1 DC to achieve Canadian Mortality*, hospital admissions, 6 months (6 months)
(outpatients) RDAs energy intake
Group 2 RC
Macia 92 Cancer Not specified Group 1 DC Weight Unclear (unclear)
H&N, breast, abdo-pelvic Group 2 RC
(not possible to tell)
Manguso 90 Liver cirrhosis (recruited Not specified Group 1 DC consisting of specific Weight*, MAMC*, TSF*, energy 3 months (6 months)
as inpatients) prescription for macronutrients intake* (Child’s score, First 3 months used in
and calcium biochemistry profile) this analysis
Group 2 RC
Ollenschlager 31 Acute leukaemia Recent weight loss >5% or Group 1 DC Mortality*, weight, energy intake Up to 25 weeks
(inpatients receiving >90% of ideal body weight Group 2 RC (25.5 weeks)
treatment) (100%)
Ravasco 66 Cancer PG-SGA (38% malnourished) Group 1 DC to achieve Mortality*, weight*, BMI, energy 42 days (3 months)
C/R receiving RT calculated energy and protein intake*, protein intake
(outpatients) requirements (symptom-induced morbidity,
Group 2 2 · 200 mL ONS QOL)
Group 3 RC
Groups 1 and 3 used in this
review
Dietetic interventions in malnourished patients
415
Table 1 (Continued)
416
Methods used to determine
Total Co-morbidity (healthcare nutritional status Outcomes included in review Duration of intervention
Trial (n) setting) (% malnourished) Comparison details (other outcomes reported) (length of follow-up)
Ravasco 50 Cancer PG-SGA (60%) Group 1 DC to achieve Mortality*, weight*, energy 42 days (3 months)
H&N receiving RT calculated energy and protein intake* [nutritional status
(outpatients) requirements (PG-SGA), symptom-induced
Group 2 2 · 200 mL ONS morbidity, QOL]
Group 3 RC
Groups 1 and 3 used in this
review
Rydwik 48 Frail elderly (outpatients) Unintentional weight loss Group 1 DC to › energy intake Weight*, BMI, TSF*, energy 3 months (3 months)
>5% and/or BMI <20 kg/m2 Group 2 DC + exercise training intake* (muscle strength,
Dietetic interventions in malnourished patients
Journal of Human Nutrition and Dietetics ª 2012 The British Dietetic Association Ltd.
ª 2012 The Authors
Table 1 (Continued)
Methods used to determine
Total Co-morbidity (healthcare nutritional status Outcomes included in review Duration of intervention
Ganzoni 30 COPD (outpatients) Not specified (implies Group 1 DC + ONS if required Mortality*, weight* 12 months (12 months)
patients <90% ideal body Group 2 RC
weight)
C. Baldwin and C. E. Weekes
Hampson 71 Women with BMI <21 kg/m2 (100%) Group 1 DC + 2 · 200 mL Mortality*, weight, energy 12 months (12 months)
osteoporosis ONS + 1 g calcium and intake* (bone mineral density,
(outpatients) 800 units cholecalciferol fat mass, lean mass)
Group 2 RC + 1 g calcium and
800 units cholecalciferol
Isenring 60 Cancer Patient-generated-SGA Group 1 DC + ONS Mortality*, weight*, energy 12 weeks (12 weeks)
H&N & abdomen (35%) Group 2 RC (standard nutrition intake*, HGS [fat free mass
receiving RT booklet; participants could (BIA), QOL, change in PG-SGA
(outpatients) request referral to a dietitian) score]
Jensen 87 Post-surgical (inpatient Not specified Group 1 DC + ONS if required Weight, energy intake 110 days (110 days)
fi home) to achieve protein intake of
1.5 g kg)1 body weight
Group 2 RC
Journal of Human Nutrition and Dietetics ª 2012 The British Dietetic Association Ltd.
Lovik 61 Cancer Not specified Group 1 DC + ONS Mortality*, weight*, energy 6 weeks (6 weeks)
H&N Group 2 RC (standard intake
(mixture of inpatients and information sheet providing
outpatients) information on all aspects of
treatment including advice to
eat a nutritious diet)
Moloney 84 Cancer receiving RT Not specified Group 1 DC + ONS Mortality*, energy intake* 3–5 weeks (unclear)
(mixture of inpatients Group 2 RC (macro and micronutrient
and outpatients) intake)
Ovesen 137 Cancer Patients stratified for amount Group 1 DC + ONS if Mortality*, weight*, energy 5 months (5 months)
Lung, breast and ovary of prior weight loss >5% or required to intake*, TSF*
(outpatients) <5% in previous 3 months exceed Nordic RDAs
Group 2 RC
Persson 142 Cancer Weight loss >5% (25% no Group 1 DC + ONS if Mortality*, weight* energy Unclear (2 years)
et al. (2002) C/R and gastric weight loss, 75% weight required to intake
(outpatients) loss >5%) meet Nordic RDAs
Group 2 RC
Persson 108 Elderly acute admissions MNA score <10 (100%) Group 1 DC + ONS + Weight*, BMI, HGS*, energy Unclear (3.6–6.9
et al. (2007) (hospital fi multivitamin intake* (activities of daily living, months)
community) Group 2 RC (brief written dietary cognitive function, peak
advice) expiratory flow, QOL)
Dietetic interventions in malnourished patients
417
Dietetic interventions in malnourished patients C. Baldwin and C. E. Weekes
Duration of intervention
Mortality
HGS, handgrip strength; MAMC, mid-arm muscle circumference; MNA, Mini Nutritional Assessment; MUAC, mid-upper arm circumference; ONS, oral nutritional supplements; PG-SGA, patient-
4 months (4 months)
(length of follow-up)
BIA, bioelectrical impedance analysis; BMI, body mass index; COPD, chronic obstructive pulmonary disease; C/R, colorectal; DC, dietary counselling; GI, gastrointestinal; H&N, head and neck;
Data were available on mortality from 18 of 26 studies
and were combined to evaluate the effect of dietary coun-
selling with or without ONS on mortality (Imes et al.,
1988; Ollenschlager et al., 1992; Ovesen et al., 1993;
Ganzoni et al., 1994; Lovik et al., 1996; Forli et al., 2001;
Persson et al., 2002, 2007; Hampson et al., 2003; Isenring
et al., 2004; Wong et al., 2004; Manguso et al., 2005;
generated subjective global assessment; QOL, quality of life; RC, routine care; RT, radiotherapy; TSF, triceps skinfold thickness; RDA, recommended daily allowance. Ravasco et al., 2005a,b; Campbell et al., 2008; Rydwik
Outcomes included in review
(other outcomes reported)
Weight
Data were available on weight change from 18 of 26 stud-
*Outcomes with usable data.
28
Table 1 (Continued)
C/R, colorectal; H&N, head and neck; ONS, oral nutritional supplements.
*Some characteristics not similar at baseline.
in one arm (Ravasco et al., 2005a). Participants who and supplements gained more weight than those who
received dietary counselling and dietary counselling plus received usual care [MD (random effects) = 2.98 kg;
ONS if required gained more weight than those who P = 0.01; 95% CI = 0.64–5.31], although the effect was
received usual care [mean difference (MD) (random very heterogeneous (I2 = 89%; P < 0.00001).
effects) = 1.7 kg; P = 0.0001; 95% CI = 0.86–2.55]. High Subgroup analyses on type of intervention age, propor-
heterogeneity between studies was observed in this analy- tion of patients malnourished or at nutritional risk, study
sis (I2 = 89%; P < 0.00001) (Fig. 2). quality and length of intervention had little or no effect
The specified subgroup analyses were conducted on on reducing heterogeneity. It is of note that patients
this data set. Heterogeneity was moderate to high in all receiving dietary counselling plus nutritional supplements
subgroup analyses (39–92%), suggesting that the studies if required gained more weight than patients receiving
were not sufficiently similar to allow conclusions to be dietary counselling alone (MD = 1.47 kg; 95% CI = 0.32–
drawn (Table 3). In the subgroup analyses according to 2.16; MD = 2.20 kg; 95% CI = 1.16–3.25).
clinical background, apart from cancer, there were few
studies in each clinical grouping, limiting any meaningful
Body composition
interpretation. In the seven studies of patients with cancer
(Ovesen et al., 1993; Lovik et al., 1996; Persson et al., Five studies comparing dietary counselling with or with-
2002; Isenring et al., 2004; Ravasco et al., 2005a,b; Bald- out ONS with usual care contributed data on indices of
win et al., 2011), those who received dietary counselling body composition, mid-arm muscle circumference
Mortality
Combined analysis
Dietary counselling or dietary counselling plus ONS if 18 1491 RR (fixed) 1.11 (0.81, 1.51) 0%
required versus routine care
Dietary counselling versus routine care 10 887 RR (fixed) 1.54 (0.75, 3.18) 0%
Dietary counselling plus ONS if required versus routine 9 604 RR (fixed) 1.01 (0.72, 1.43) 0%
care
Subgroup analyses
Clinical condition
Cancer 8 695 RR (fixed) 1.20 (0.83, 1.72) 0%
Gastrointestinal disease 2 227 Not estimable (no events in
either study)
Elderly 2 156 RR (fixed) 0.66 (0.28, 1.53) 0%
Respiratory 3 130 RR (fixed) 0.95 (0.31, 2.92) 0%
Osteoporosis 2 221 RR (fixed) 0.32 (0.01, 7.7) NA (events in one
study only)
Renal 1 62 RR (fixed) 8.45 (0.47, 150.66) NA (only one study
in analysis)
Age
Under 65 years 7 484 RR (fixed) 1.34 (0.37, 4.83) 0%
Over 65 years 11 1008 RR (fixed) 1.09 (0.79, 1.51) 0%
Nutritional status
>50% malnourished 10 837 RR (fixed) 0.98 (0.71, 1.37) 0%
At risk population 8 654 RR (fixed) 2.52 (0.93, 6.85) 0%
Study quality
Adequate 12 975 RR (fixed) 1.20 (0.85, 1.69) 0%
Duration of intervention
1–3 months 9 741 RR (fixed) 1.58 (0.75, 3.33) 7%
4–6 months 6 590 RR (fixed) 1.31 (0.63, 2.00) 38%
>6 months 3 237 RR (fixed) 0.93 (0.60, 1.43) 0%
Weight change
Combined analysis
Dietary counselling or dietary counselling plus ONS if 18 1187 MD (random) 1.79 kg (1.02, 2.56)* 86%
required versus routine care
Dietary counselling versus routine care 9 733 MD (random) 1.47 kg (0.32, 2.16)* 90%
Dietary counselling plus ONS if required versus 9 454 MD (random) 2.20 kg (1.16, 3.25)* 63%
routine care
Subgroup analyses
Clinical condition
Cancer 8 618 MD (random) 2.63 kg (0.63, 4.63)* 87%
Gastrointestinal disease 1 90 MD (random) )0.58 kg ()1.47, NA (only one study
0.31) n analysis)
Elderly 2 131 MD (random) 2.07 kg ()1.75, 5.88) 92%
Respiratory 3 133 MD (random) 2.25 kg (0.79, 3.70)* 63%
Osteoporosis 1 150 MD (random) 0.41 kg (0.36, 0.46) NA (only one study
in analysis)
Renal 1 50 MD (random) )0.16 kg ()1.34, NA (only one study
1.02) in analysis)
HIV infection 1 15 MD (random) 1.80 kg ()3.13, 6.73) NA (only one study
in analysis)
Age
<65 years 7 347 MD (random) 2.69 kg (0.58, 4.80)* 93%
>65 years 11 840 MD (random) 1.25 kg (0.48, 2.02)* 70%
Nutritional status
>50% malnourished 10 599 MD (random) 1.57 kg (0.71, 2.43)* 62%
Table 3 (Continued)
Number of Number of I2 result for
Comparison studies participants Analysis result heterogeneity
MD, mean difference; NA, not available; ONS, oral nutritional supplements; RR, relative risk.
*Result statistically significant.
(MAMC) and triceps skinfold thickness (TSF) (Macia ing nutritional intervention had significantly greater
et al., 1991; Rogers et al., 1992; Ovesen et al., 1993; improvements in MAMC and TSF than groups receiving
Manguso et al., 2005; Weekes et al., 2009). Groups receiv- usual care. In the analysis of MAMC, there was high
Table 4 Summary of additional clinical and functional outcome measures and quality of life assessments reported in included studies
Dietary counselling versus routine care Dietary counselling + ONS if required versus routine care
Clinical Disease activity/severity (Imes et al., 1988; Manguso et al., 2005) Immune function (Berneis et al., 2000)
outcomes Need for surgery (Imes et al., 1988) CD4 count and markers of HIV infection (Berneis et al., 2000)
Disease remissions (Ollenschlager et al., 1992) Tumour response to treatment (Evans et al., 1987; Ovesen
Change in medication (Imes et al., 1988; Weekes et al., 2009) et al., 1993)
Reduction in temperature (Ollenschlager et al., 1992) Respiratory function (Rogers et al., 1992; Ganzoni et al., 1994;
Days of work lost (Imes et al., 1988) Jensen & Hessov, 1997; Persson et al., 2007)
Hospital admissions (Imes et al., 1988; Weekes et al., 2009) Perceived dyspnoea (Rogers et al., 1992)
Change in symptoms (Macia et al., 1991; Ollenschlager et al.,
1992; Ravasco et al., 2005a,b)
Patient mobility assessments (Rydwik et al., 2008)
Respiratory function (Weekes et al., 2009)
Perceived dysnopea (Weekes et al., 2009)
Cost (Weekes et al., 2009)
Functional Handgrip strength (Baldwin et al., 2008; Weekes et al., 2009) Handgrip strength (Rogers et al., 1992; Jensen & Hessov,
outcomes Performance status (Karnofsky) (Dixon, 1984) 1997; Persson et al., 2007)
Functional independence Measure (Rydwik et al., 2008) Physical function (walking distance) (Rogers et al., 1992;
Instrumental activities measure (Rydwik et al., 2008) Ganzoni et al., 1994)
Health belief model (Rydwik et al., 2008) Ordinal fatigue scale (Jensen & Hessov, 1997)
Activities of daily living (Weekes et al., 2009) Lambert disability screening questionnaire (Jensen & Hessov,
Respiratory muscle function (Weekes et al., 2009) 1997)
Cognitive function (Persson et al., 2007)
Activities of daily living (Persson et al., 2007)
Quality of life EORTC-QLQ-C30 (Ravasco et al., 2005a,b; Baldwin et al., 2008) EORTC-QLQ-C30 (Persson et al., 2002; Isenring et al., 2004)
FAACT (Baldwin et al., 2008) Medical outcomes study instrument (Berneis et al., 2000)
Linear Analogue Scale (Ollenschlager et al., 1992) Quality of life index (Ovesen et al., 1993; Jensen & Hessov,
SF-36 (Weekes et al., 2009) 1997)
SGRQ (Weekes et al., 2009) SF-36 (Persson et al., 2007)
ONS, oral nutritional supplements; EORTC, European Organisation for Research and Treatment of Cancer; FAACT, Functional Assessment of
Anorexia/Cachexia Therapy; SF36, Short Form Health Survey; SGRQ, St George’s Respiratory Questionnaire.
Figure 2 Meta-analysis of the effects of oral nutritional intervention compared with no intervention on weight.
heterogeneity (I2 = 87%; P < 0.00001). In the analysis of as handgrip strength and activities of daily living and oth-
TSF, heterogeneity was low (I2 = 31%; P = 0.21). ers reporting disease specific outcomes (Table 4). There
were insufficient data on any one outcome to enable
meaningful analysis.
Nutritional intake
Seven studies comparing dietary counselling with routine
Quality of life
care (Wong et al., 2004; Manguso et al., 2005; Ravasco
et al., 2005a,b; Campbell et al., 2008; Rydwik et al., 2008) Quality of life was assessed in eleven of the included stud-
and six studies comparing dietary counselling plus ONS ies; however, seven different quality of life questionnaires
with routine care (Moloney et al., 1983; Ovesen et al., were used and there was variation in the number of
1993; Berneis et al., 2000; Forli et al., 2001; Hampson domains reported for any one questionnaire; therefore,
et al., 2003; Isenring et al., 2007) reported changes in no analyses were undertaken for this outcome.
energy intake from the start to the end of intervention The
combined analysis and analysis of dietary counselling alone
Discussion
suggested that nutritional intervention was associated with
significant improvements in energy intake. Heterogeneity It has been demonstrated that dietary counselling given
between studies, however, was high (I2 = 97%; with or without ONS is associated with significant bene-
P < 0.00001 and I2 = 98%; P < 0.00001, respectively). fits to weight and energy intake but is not associated with
There was no significant difference between groups in the clinical benefits (Baldwin & Weekes, 2011). Examining
analysis of dietary counselling plus ONS if required versus each of these closely-related intervention strategies sepa-
usual care [MD 661 kJ (158 kcal; 95% CI = )66 to 382, rately reduces the power of meta-analysis to detect any
P = 0.17], although again heterogeneity was high in this effect that might be apparent by combining similar stud-
analysis (I2 = 84%; P < 0.0001). ies together and does not represent real life dietetic prac-
The amount of weight gain achieved in groups receiv- tice. In addition, the high levels of heterogeneity in the
ing counselling and ONS was higher than that in groups analyses mean that it is impossible to identify which
receiving dietary counselling alone, although the energy patient groups are most likely to benefit from dietary
intake data suggest that improvements in intake were counselling and ONS-based interventions. The aim of the
greater in the groups receiving counselling alone. The lack present review was to examine the effects on mortality
of correspondence between improvements in energy and nutritional indices of dietary counselling given with
intake and weight gain suggests that there may be signifi- or without ONS and also to examine the heterogeneity in
cant errors in the reporting and analysis of food intake the meta-analyses aiming to characterise the groups of
data. patients that derived the greatest benefits from these
interventions. The main findings were that dietary coun-
selling alone or combined with ONS had significant but
Functional status
heterogeneous effects on weight, energy intake and body
Assessment of functional outcomes varied between stud- composition. Subgroup analyses taking into account clini-
ies, with some studies reporting universal outcomes such cal background of the patient, age, nutritional status at
recruitment, type of intervention and length of interven- (Milne et al., 2009). Subgroup size varied from 22 partici-
tion failed to reveal any differences between groups in pants to >8000 participants and benefits to mortality were
analyses of both mortality, weight change and energy found for supplementation of malnourished compared to
intake, and heterogeneity within each subgroup remained normally nourished patients (25 studies, 2466 partici-
high. Overall, there was no evidence of an effect of die- pants). The studies represented a wide range of clinical
tary counselling given with or without ONS in malnour- conditions, although the numbers of participants with
ished patients on mortality. In the absence of an effect on any one condition were small with the exception of can-
mortality, the effect of these interventions on other out- cer. Even amongst studies conducted in cancer patients,
comes has continued to receive surprisingly little atten- there was wide variation in site, stage and treatment. In
tion. Apart from a small number of studies assessing most of the included studies, the mean age of patients
changes in body composition, there were insufficient data was >65 years, although a wide age range was represented
to determine whether dietary counselling given with or overall. The majority of studies were conducted in outpa-
without ONS has an effect on clinical, nutritional and tients, with only seven studies including patients who
functional outcomes or quality of life. It remains to be spent some time in hospital. Although it was possible to
clarified whether the improvements in weight associated obtain information on the duration of intervention in
with dietary counselling translate to improvements in most of the studies, there was almost no information on
other outcomes. the nature, intensity and content of the dietary counsel-
Policy in the UK on the management of disease-related ling. In addition, details of the experience and training of
malnutrition suggests that improvements in mortality, the dietitian giving the counselling were not reported.
weight and complication rates can be achieved with the Decisions on the nutritional management of patients by
use of ONS (NCC-AC, 2006). The present review shows healthcare staff are frequently based on experience
that dietary counselling with or without ONS can result and judgement (Elia, 2011). The restrictive conditions
in similar improvements in weight gain. However, both imposed by clinical trials often do not mirror the more
the review by the National Institute for Health and Clini- flexible conditions of clinical practice and therefore ques-
cal Excellence (NICE) and the present review exhibit con- tions about day-to-day practice are difficult to answer.
siderable heterogeneity and so the effect size for either Capra et al. (2002) has suggested that failure to imple-
ONS or dietary counselling cannot be determined. ment the nutrition prescription and to monitor compli-
By contrast to the review by NICE, the present review ance with the prescription could be responsible for the
showed no effect of dietary counselling with or without ‘negative’ findings of studies. However, in all studies,
ONS on mortality. The review by NICE based their con- there was a consistent aim of improving nutritional intake
clusion on 25 studies with almost 3000 randomised par- with the goal of minimising weight loss or promoting
ticipants (NCC-AC, 2006). The present review included weight gain. The present review suggests that it is possible
2123 patients in 26 studies of which five studies reported to achieve an increase in energy intake and weight gain
no deaths. This finding suggests that dietary counselling with dietary counselling with or without ONS. Dietitians
given with or without ONS may have no effect on mor- provide nutritional support to patients from a variety of
tality rather than there being insufficient evidence. This clinical backgrounds and different healthcare settings.
raises the question of whether dietary counselling is com- From the findings of the present review, it is not possible
parable with ONS and whether the combinations of to be specific about the effects that can be achieved in
nutrients in ONS can be replicated in foods. Studies of any one patient group and, indeed, it is likely that it will
dietary counselling rarely report the details of specific vary according to all of the above variables. In addition,
foods and combinations of foods used to increase nutri- the optimal length of intervention has yet to be deter-
ent intake. mined. Although the included studies have measured a
The identified studies were heterogeneous for a number range of other clinical, nutritional and functional out-
of factors and it is likely that these factors contributed to comes and quality of life, has not been possible to deter-
the observed heterogeneity in the results. If we accept that mine whether the improvements in energy intake and
the effects of ONS (which derive mainly from analyses weight were translated into other improvements because
that combine heterogeneous groups of patients and have of a lack of similar data between studies.
not been universally replicated in individual clinical con- The quality of evidence in the present review is at best
ditions) may be the result of the small number of studies low to moderate. The main issue is that, although
in some patient groups, then the same may be true for sequence generation and allocation concealment were
interventions based on dietary counselling. In a meta- often adequate, very few studies were adequately blinded
analysis of protein-energy supplementation in elderly and most were small and inadequately powered. It is
patients, subgroup analysis was used to explore the results important to note that it is difficult to design an adequate
Library, of nutritional supplementation trials in patients Hampson, G., Martin, F.C., Moffat, K., Vaja, S., Sankaralin-
after hip fracture. Am. J. Clin. Nutr. 73, 505–510. gam, S., Cheung, J., Blake, G.M. & Fogelman, I. (2003)
Baldwin, C. & Weekes, C.E. (2011) Dietary advice with or Effects of dietary improvement on bone metabolism in
without oral nutritional supplements for disease-related elderly underweight women with osteoporosis: a randomised
malnutrition in adults. Cochrane Database Syst. Rev. 9, controlled trial. Osteoporos. Int. 14, 750–756.
CD002008. Higgins, J.P.T. & Green, S. (2009) Cochrane Handbook for Sys-
Baldwin, C., Weekes, C.E. & Campbell, K.L. (2008) Measuring tematic Reviews of Interventions. Chichester: John Wiley &
the effectiveness of dietetic interventions in nutritional sup- Sons Ltd.
port. J. Hum. Nutr. Diet. 21, 303–305. Higgins, J.P., Thompson, S.G., Deeks, J.J. & Altman, D.G. (2003)
Baldwin, C., Spiro, A., McGough, C., Norman, A.R., Gillbanks, Measuring inconsistency in meta-analyses. BMJ 327, 557–560.
A., Thomas, K., O’Brien, M., Cunningham, D.C. & Andr- Hobday, R., Sharott, P. & Aubrey, P. (2010) Clinical Oral
eyev, H.J.N. (2011) Simple nutritional intervention in Nutrition Support Project (Adults). London: NHS London
patients with advanced cancers of the gastrointestinal tract, Procurement Programme. Available at: http://www.lpp.nhs.
non-small cell lung cancers or mesothelioma and weight loss uk/page.asp?fldArea=2&fldMenu=6&fldSubMenu=6&fldKey=
receiving chemotherapy: a randomised controlled trial. 101 (accessed on 31 May 2012).
J. Hum. Nutr. Diet. 24, 431–440. Imes, S., Pinchbeck, B. & Thomson, A.B. (1988) Diet counsel-
Berneis, K., Battegay, M., Bassetti, S., Nuesch, R., Leisibach, A., ling improves the clinical course of patients with Crohn’s
Bilz, S. & Keller, U. (2000) Nutritional supplements com- disease. Digestion 39, 7–19.
bined with dietary counselling diminish whole body protein Isenring, E.A., Capra, S. & Bauer, J.D. (2004) Nutrition inter-
catabolism in HIV-infected patients. Eur. J. Clin. Invest. vention is beneficial in oncology outpatients receiving radio-
30, 87–94. therapy to the gastrointestinal or head and neck area.
Bruce, D., Laurance, I., McGuiness, M., Ridley, M. & Gold- Br. J. Cancer 91, 447–452.
swain, P. (2003) Nutritional supplements after hip fracture: Isenring, E.A., Bauer, J.D. & Capra, S. (2007) Nutrition sup-
poor compliance limits effectiveness. Clin. Nutr. 22, 497–500. port using the American Dietetic Association medical nutri-
Campbell, K.L., Ash, S., Davies, P.S. & Bauer, J.D. (2008) Ran- tion therapy protocol for radiation oncology patients
domized controlled trial of nutritional counseling on body improves dietary intake compared with standard practice.
composition and dietary intake in severe CKD. Am. J. J. Am. Diet. Assoc. 107, 404–412.
Kidney Dis. 51, 748–758. Jensen, M.B. & Hessov, I. (1997) Dietary supplementation at
Capra, S., Bauer, J., Davidson, W. & Ash, S. (2002) Nutritional home improves the regain of lean body mass after surgery.
therapy for cancer-induced weight loss. Nutr. Clin. Pract. Nutrition 13, 422–430.
17, 210–213. Koretz, R.L., Avenell, A., Lipman, T.O., Braunschweig, C.L. &
Chandra, R.K. & Puri, S. (1985) Nutritional support improves Milne, A.C. (2007) Does enteral nutrition affect clinical out-
antibody response to influenza virus vaccine in the elderly. come? A systematic review of the randomized trials. Am. J.
Br. Med. J. (Clin. Res. Ed) 291, 705–706. Gastroenterol. 102, 412–429; quiz 468.
Dixon, J. (1984) Effect of nursing interventions on nutritional Lawson, R.M., Doshi, M.K., Ingoe, L.E. & Collingan, J.M.
and performance status in cancer patients. Nurs. Res. 33, (2000) Compliance of orthopedic patients with postopera-
330–335. tive oral nutritional supplementation. Clin. Nutr. 19,
Elia, M. (2011) Oral nutritional support in patients with can- 171–175.
cer of the gastrointestinal tract. J. Hum. Nutr. Diet. 24, Lovik, A., Almendingen, K., Dotterud, M., Forli, L., Boysen,
417–419. M., Omarhus, M., Jacobsen, A.B. & Ose, T. (1996) Dietary
Evans, W.K., Nixon, D.W., Daly, J.M., Ellenberg, S.S., Gardner, information after radiotherapy of head and neck cancer.
L., Wolfe, E., Shepherd, F.A., Feld, R., Gralla, R., Fine, S., Tidsskr. Nor. Laegeforen. 116, 2303–2306.
Kemeny, N., Jeejeebhoy, K.N., Heymsfield, S. & Hoffman, Macia, E., Moran, J., Santos, J., Blanco, M., Mahedero, G. &
F.A. (1987) A randomized study of oral nutritional support Salas, J. (1991) Nutritional evaluation and dietetic care in
versus ad lib nutritional intake during chemotherapy for cancer patients treated with radiotherapy: prospective study.
advanced colorectal and non-small-cell lung cancer. J. Clin. Nutrition 7, 205–209.
Oncol. 5, 113–124. Manguso, F., D’Ambra, G., Menchise, A., Sollazzo, R. & D’Ag-
Forli, L., Bjortuft, O., Vatn, M., Kofstad, J. & Boe, J. (2001) A ostino, L. (2005) Effects of an appropriate oral diet on the
study of intensified dietary support in underweight candi- nutritional status of patients with HCV-related liver cirrho-
dates for lung transplantation. Ann. Nutr. Metab. 45, sis: a prospective study. Clin. Nutr. 24, 751–759.
159–168. Milne, A.C., Potter, J., Vivanti, A. & Avenell, A. (2009) Protein
Ganzoni, A., Heilig, P., Schonenberger, K., Hugli, O., Fitting, and energy supplementation in elderly people at risk from
J.W. & Brandli, O. (1994) High-caloric nutrition in chronic malnutrition. Cochrane Database Syst. Rev. 2, CD003288.
obstructive lung disease. Schweiz. Rundsch. Med. Prax. 83, Moloney, M., Moriarty, M. & Daly, L. (1983) Controlled
13–16. studies of nutritional intake in patients with malignant
disease undergoing treatment. Hum. Nutr. Appl. Nutr. 37, Rydwik, E., Lammes, E., Frandin, K. & Akner, G. (2008)
30–35. Effects of a physical and nutritional intervention program
NCC-AC. (2006) Nutrition Support in Adults: Oral Nutrition for frail elderly people over age 75. A randomized controlled
Support, Enteral Tube Feeding and Parenteral Nutrition. pilot treatment trial. Aging Clin. Exp. Res. 20, 159–170.
London: Royal College of Surgeons England. Schulz, K.F., Chalmers, I., Hayes, R.J. & Altman, D.G. (1995)
Norman, K., Pichard, C., Lochs, H. & Pirlich, M. (2008) Prog- Empirical evidence of bias. Dimensions of methodological
nostic impact of disease-related malnutrition. Clin. Nutr. 27, quality associated with estimates of treatment effects in con-
5–15. trolled trials. JAMA 273, 408–412.
Ockenga, J., Grimble, R., Jonkers-Schuitema, C., Macallan, D., Stratton, R.J. & Elia, M. (1999) A critical systematic analysis of
Melchior, J.C., Sauerwein, H.P., Schwenk, A. & Suttmann, U. the use of oral nutritional supplements in the community.
(2006) ESPEN guidelines on enteral nutrition: wasting in Clin. Nutr. 18(Suppl. 2), 29–84.
HIV and other chronic infectious diseases. Clin. Nutr. 25, Stratton, R.J. & Elia, M. (2007) A review of reviews: a new
319–329. look at the evidence for oral nutritional supplements in clin-
Ollenschlager, G., Thomas, W., Konkol, K., Diehl, V. & Roth, ical practice. Clin. Nutr. (Suppl.) 2, 5–23.
E. (1992) Nutritional behaviour and quality of life during Stratton, R.J., Green, C.J. & Elia, M. (2003) Disease Related
oncological polychemotherapy: results of a prospective study Malnutrition: An Evidence-Based Approach to Treatment.
on the efficacy of oral nutrition therapy in patients with Wallingford: CABI Publishing.
acute leukaemia. Eur. J. Clin. Invest. 22, 546–553. Thomas, B. (2001) Manual of Dietetic Practice. London:
Ovesen, L., Allingstrup, L., Hannibal, J., Mortensen, E.L. & Blackwell Science.
Hansen, O.P. (1993) Effect of dietary counseling on food Volkert, D., Berner, Y.N., Berry, E., Cederholm, T., Coti Ber-
intake, body weight, response rate, survival, and quality of trand, P., Milne, A., Palmblad, J., Schneider, S., Sobotka, L.,
life in cancer patients undergoing chemotherapy: a prospec- Stanga, Z., Lenzen-Grossimlinghaus, R., Krys, U., Pirlich,
tive, randomized study. J. Clin. Oncol. 11, 2043–2049. M., Herbst, B., Schutz, T., Schroer, W., Weinrebe, W., Ock-
Persson, C.R., Johansson, B.B., Sjoden, P.O. & Glimelius, B.L. enga, J. & Lochs, H. (2006) ESPEN guidelines on enteral
(2002) A randomized study of nutritional support in nutrition: geriatrics. Clin. Nutr. 25, 330–360.
patients with colorectal and gastric cancer. Nutr. Cancer 42, Weekes, C.E., Emery, P.W. & Elia, M. (2009) Dietary counsel-
48–58. ling and food fortification in stable COPD: a randomised
Persson, M., Hytter-Landahl, A., Brismar, K. & Cederholm, T. trial. Thorax 64, 326–331.
(2007) Nutritional supplementation and dietary advice in Wong, S.Y., Lau, E.M., Lau, W.W. & Lynn, H.S. (2004) Is die-
geriatric patients at risk of malnutrition. Clin. Nutr. 26, tary counselling effective in increasing dietary calcium, pro-
216–224. tein and energy intake in patients with osteoporotic
Plauth, M., Cabre, E., Riggio, O., Assis-Camilo, M., Pirlich, fractures? A randomized controlled clinical trial. J. Hum.
M., Kondrup, J., Ferenci, P., Holm, E., Vom Dahl, S., Mul- Nutr. Diet. 17, 359–364.
ler, M.J. & Nolte, W. (2006) ESPEN guidelines on enteral
nutrition: liver disease. Clin. Nutr. 25, 285–294.
Ravasco, P., Monteiro-Grillo, I., Marques Vidal, P. &
Supporting information
Camilo, M.E. (2005a) Impact of nutrition on outcome: a Additional Supporting information may be found in the
prospective randomized controlled trial in patients with online version of this article.
head and neck cancer undergoing radiotherapy. Head Neck Appendix S1. Search strategy used from 2002 to 2005
27, 659–668. on MEDLINE, EMBASE, CINAHL, CancerLit and AMED,
Ravasco, P., Monteiro-Grillo, I., Vidal, P.M. & Camilo, M.E. using OVID notation with slight variations.
(2005b) Dietary counseling improves patient outcomes: a
Please note: Wiley-Blackwell are not responsible for the
prospective, randomized, controlled trial in colorectal cancer
content or functionality of any supporting materials sup-
patients undergoing radiotherapy. J. Clin. Oncol. 23, 1431–
plied by the authors. Any queries (other than missing
1438.
material) should be directed to the corresponding author
Rogers, R.M., Donahoe, M. & Costantino, J. (1992) Physiologic
for the article.
effects of oral supplemental feeding in malnourished patients
with chronic obstructive pulmonary disease. A randomized
control study. Am. Rev. Respir. Dis. 146, 1511–1517.