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. Author manuscript; available in PMC: 2012 Mar 1.
Published in final edited form as: J Am Geriatr Soc. 2011 Mar;59(3):463–472. doi: 10.1111/j.1532-5415.2011.03320.x

Oral Feeding Options for Patients with Dementia: A Systematic Review

Laura C Hanson 1,2, Mary Ersek 3, Robin Gilliam 2, Timothy S Carey 2,4
PMCID: PMC3164780  NIHMSID: NIHMS290673  PMID: 21391936

Abstract

Background

Most patients with dementia develop feeding problems, leading physicians and families to consider tube feeding or oral feeding options. Tube feeding offers limited benefit, but current decision-making includes limited information on other options.

Objectives

To review the evidence for oral feeding options in dementia.

Design

Systematic review.

Setting

PubMed/MEDLINE, EMBASE, the Cochrane Library, CINAHL and PsychINFO literature indices between January 1990 and October 2009.

Participants

Clinical trials with random or non-random control groups were included if they reported on clinical outcomes of oral feeding interventions for patients with dementia.

Measurements

Systematic literature search with review of potentially eligible studies by two independent investigators. Investigators abstracted data from included studies using a structured instrument. Studies were graded on quality and potential bias, and overall strength of evidence summarized.

Results

Thirteen controlled trials provide data on use of supplements for patients with dementia, and twelve controlled trials test assisted feeding or other interventions. Studies provide moderate strength evidence for high calorie supplements, and low strength evidence for appetite stimulants, assisted feeding and modified foods to promote weight gain in dementia. The few studies measuring function or survival showed no difference.

Conclusion

High calorie supplements and other oral feeding options can help dementia patients with feeding problems to gain weight; they are unlikely to improve other outcomes. These treatments can be offered alone or in combination as an alternative to tube feeding.

Keywords: dementia, oral feeding

INTRODUCTION

Dementia is a syndrome of decline in cognitive domains causing functional impairment. In early dementia taste and smell dysfunction, medications or depression may reduce intake. 1 In advanced dementia apraxia and attention deficits interfere with self-feeding, and dysphagia causes choking or food avoidance.2 Feeding problems cause important health effects such as weight loss, dehydration, poor wound healing, and pneumonia. In the CASCADE Study 86% of persons with advanced dementia developed a feeding problem, and onset was associated with 39% mortality at 6 months.3

Treatments include medical feeding through a feeding tube, or modifications of oral feeding including high calorie supplements, appetite stimulants, modified foods, enhanced dining environments or personal assistance. The use of feeding tubes has increased for patients with serious illness, particularly dementia and other neurologic diseases.4,5,6,7 Controlled observational studies of persons with dementia provide evidence tube feeding does not prolong life or promote wound healing.8,9,10,11

Physicians and families make choices about feeding in dementia. Interview studies suggest they expect benefits from tube feeding that exceed actual outcomes.12,13 Consent for feeding tubes usually focuses on procedural risks, with limited information on outcomes and alternatives.14,15 If the choice is framed as opting for or against tube feeding, families may fear starvation without understanding other options.

To enhance evidence-based decision-making, we conducted a systematic review of oral feeding options in dementia. We aimed to answer two key questions for dementia care: 1) does the addition of high calorie supplements improve clinical outcomes including weight gain, function or survival; and 2) do other oral feeding interventions such as appetite stimulants, assisted feeding or modified diets improve outcomes?

METHODS

Data Sources

Assisted by an experienced health services librarian, investigators searched PubMed/MEDLINE, EMBASE, the Cochrane Library, CINAHL and PsychINFO literature indices between January 1990 and October 2009. Searches used a combination of medical subheadings, keywords and text words. We used search terms for dementia and long-term care in combination with terms to identify interventions for nutrition or feeding problems. (Table 1) We added evaluation terms to ensure we did not miss smaller studies. Reference lists of selected studies were hand searched for additional clinical trials.

Table 1.

Search Terms Used for All Databases

Dementia – dementia OR Alzheimer disease, OR dementia, multi- infarct
Long-term care populations – nursing homes OR long-term care OR institutionalized elders OR institutionalized seniors
Feeding – malnutrition OR weight loss OR inhalation OR dehydration OR eating problems OR decreased intake OR nutrition OR eating OR deglutition disorders, OR weight gain, OR anorexia, OR airway obstruction OR choking OR energy intake, OR feeding behavior, OR failure to thrive OR aspiration OR dysphagia OR dietary supplements
Feeding methods – feeding methods OR hand feeding OR feeding programs OR assisted feeding OR dining program OR restorative dining OR feeding aide OR nutritional support OR supplementation
Clinical trial or intervention study or systematic review – randomized controlled trials OR single-blind method OR double-blind method OR random allocation OR systematic reviews OR evaluation studies OR program evaluation
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Eligibility and Study Selection

Investigators defined eligibility prior to searches using the PICOT framework.16 This framework designates 1) population, 2) intervention, 3) comparison groups, 4) outcomes, and 5) time frame for outcomes. (Table 2) Eligible studies were in English. Study participants were aged 50 or older, with dementia of any stage or etiology, and evidence of a feeding problem. Initially, we planned to include only studies of dementia. Because some study populations varied in cognitive status, we accepted those that combined frail older persons with and without dementia. Participants could be in any setting – community, long-term care or hospital. Eligible interventions included 1) prescribed use of high calorie or protein supplements, or 2) other interventions such as appetite stimulants, modified diets, assistance in feeding, or modified dining environments. Supplements without caloric value, such as vitamins, were excluded. We required a comparator group, but accepted randomized or non-randomized controls including pre-post design. Studies had to address at least one major clinical outcome, including survival, hospitalization, pneumonia, aspiration, function, quality of life, weight change, or wound healing, with follow-up of at least 1 month. Intermediate outcomes such as serum proteins or amount of intake were excluded. Two investigators (RG, LCH) reviewed all titles and abstracts, and excluded duplicates, studies that were not clinical trials, studies with ineligible interventions, and studies excluding dementia.

Table 2.

PICOT Criteria and Search Strategy

Population of interest Inclusions: Adults (age 50 years and older) with any type or stage of dementia who have evidence of a feeding problem as defined by weight loss, dysphagia, or decreased intake or other evidence of risk of nutritional decline
Intervention of Interest Inclusions: high calorie and/or high protein supplements, assisted feeding, feeding aide programs, enhanced dining programs, modified diets, appetite stimulants
Exclusion: supplements without caloric value, e.g., vitamin supplements
Comparison Any comparison group, including randomized control group; historical control; matched, nonrandom comparison; pre-post design with subject as own control
Comparison group may have received: 1) no intervention, or “usual care,” or 2) alternative feeding intervention including tube feeding
Outcomes Inclusions: One or more of the following outcomes: survival, hospitalization, pneumonia, aspiration, function, quality of life, weight change, or wound healing, measured over follow-up of at least 1 month
Exclusion: Study reports only intermediate outcomes such as serum protein levels or amount of intake
Time Frame Follow-up of one month or longer
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Data abstraction and quality assessment

Three investigators reviewed all full text articles (RG, LCH, ME). Two investigators reached consensus on abstracted data on methods, results, study quality and potential sources of bias. A third investigator settled cases of disagreement. The structured abstraction tool recorded study size, dementia diagnosis and severity, type of feeding problems, intervention and control conditions, type of controls, outcome definitions and results, time to follow-up, study setting, as well as methods indicative of study quality.

Two investigators graded each included study on: 1) the strength of evidence and 2) risk of bias using the Cochrane rating approach.17 Strength of evidence was graded A if randomized, placebo-controlled, with concealed allocation; B if randomized without clearly defined concealment; and C if not randomized and concealment inadequate. Risk of bias was rated on type of controls, methods of double or single blinding, well-specified outcomes, well-specified inclusion criteria, >75% complete outcome assessment, risk of confounding bias, and intention to treat analysis. Studies meeting 5–7 of these criteria were judged to have low risk, those meeting 3–4 had medium risk, and those meeting 0–2 had high risk of bias. Data tables were created for summative assessment of evidence for each key question. Investigators used the PRISMA Statement to guide reporting of evidence, and AHRQ comparative effectiveness review guidelines and GRADE criteria for overall strength of evidence.18,19,20

RESULTS

Databases identified 1147 potential studies, and hand searches 65, representing 912 unduplicated publications. Abstract and title review excluded 802, leaving 110 articles for full-text review. Eighty-five studies failed to meet PICOT criteria (n=69) or did not test an intervention (n=16), leaving 25 studies for review. (Figure)

Figure.

Figure

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Flow of information for systematic review of feeding interventions

Studies of High Calorie Supplements for Dementia

We identified 13 original studies that examined the effect of high calorie supplements on clinical outcomes for feeding problems in dementia. 21,22,23,24,25,26,27,28,29,30,31,32,33 Studies examined a variety of outcomes meeting our criteria – change in weight or body mass index, mortality, morbidity, wound healing, physical or cognitive function. (Table 3) Follow-up varied from 1 month to 1 year. Ten studies found evidence for benefit using at least one outcome. Nine of twelve studies examining weight or body mass index found improvement. One study found improved pressure ulcer healing with supplementation.23 Four studies measuring function, three measuring cognition, and one measuring mortality found no differences with supplementation. One study reported reduced infections at 1 year (47% vs 66%, p=0.05).25

Table 3.

Summary of Evidence for Feeding interventions and Major Outcomes

Studies Population Intervention Type Major Outcomes Difference
High calorie supplement
Beck 2002 n=66 Liquid supplement Weight No
Carver 1995 n=46 Liquid supplement Weight Yes
Cereda 2009 n=28 Liquid supplement Pressure ulcer healing Yes
Gazzotti 2003 n= 80 Liquid supplement & soup Weight Yes
Gil Gregorio 2003 n=99 Liquid supplement BMI Yes
Morbidity Yes
Mortality No
Kwok 2001 n=47 Milk powder Weight No
Cognition No
Physical Function No
Lauque 2000 n=78 Liquid supplement, soup, fruit & dessert Weight Yes
BMI No
Grip strength No
Lauque 2004 n=91 Liquid supplement, soup & dessert Weight Yes
BMI Yes
Cognition No
Physical Function No
Parrott 2006 n=30 Liquid supplement & high calorie bar BMI Yes
Planas 2004 n=44 Liquid supplement BMI No
Cognition No
Wouters-Wessling 2002 n=35 Micronutrient-enriched liquid supplement Weight Yes
Wouters-Wessling 2006 n=34 Liquid supplement Weight Yes
Physical Function No
Young 2004 n=34 Liquid supplement & high calorie bar Weight Yes
Other Feeding Interventions
Beck 2008 n=121 Chocolate, hot chocolate, homemade supplement, exercise Weight Yes
BMI Yes
Crogan 2006 n=61 Individualized nutrition therapy process and care plans BMI No
Physical Function No
Goddaer 1994 n=29 Relaxing music played at lunchtime Behaviors Yes
Keller 2003 n=82 Enhanced dietician time and menu Weight Yes
Remsburg 2001 n=40 Buffet style dining program Weight No
Robbins 2008 n=515 Chin down posture vs thickened liquids Pneumonia No
Mortality No
Salas-Salvado 2005 n=56 Lyophilized foods Weight Yes
Simmons 2005 n=17 Megestrol acetate and assistance Weight No
Simmons 2008 n=69 Feeding assistance Weight Yes
BMI Yes
Volicer 1997 n=12 Dronabinol Weight Yes
Negative affect Yes
Disruptive behavior No
Yeh 2000 n=68 Megestrol acetate Weight Yes
Young 2005 n=34 Meals high in carbohydrates Weight No
Cognition No
Behavior No
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BMI=Body mass index

Quality of Studies of High Calorie Supplements for Dementia

Between 1990 and 2009, two high quality randomized clinical trials have addressed the effectiveness of high calorie supplements for dementia patients. (Table 4) Wouters-Wessling randomized 35 nursing home residents with moderate to severe dementia and low body mass index to a micronutrient-enriched supplement compared to placebo.31 Controls lost an average of 0.8 kg over 12 weeks, while intervention subjects gained 1.4 kg. Cereda enrolled 28 nursing home residents with Stage II–IV pressure ulcers to receive a high calorie, high protein supplement with micronutrients compared to usual diets.23 Although this study met inclusion criteria, two-thirds of participants used tube feeding and only one-third used oral nutrition for prescribed supplements. Wound healing was more rapid in the intervention group over 12 weeks, with mean reduction of wound size of 75% vs 45% (p<0.005).

Table 4.

Methodological Characteristics and Quality of Included Studies

 Supplementation
Source Population Intervention Methods Outcomes, Intervention vs. Control Quality/Bias
Beck 2002 66 undernourished nursing home residents in Denmark, mean age 84, mild to moderate cognitive impairment Home-made oral supplement, 384 Kcal RCT, 1–2 months follow-up Weight change: 1.3 (−1.0–3.0) vs 1.5 (−2.3–9.0), NSD Grade B/High
Carver 1995 46 elderly dementia residents with pressure ulcers, mean age for men 68 ± 9 in intervention, 68 ± 7 in control, for women, 80± 10 in intervention, and 79 ± 10 in control, no indication of dementia severity 200 ml oral supplement twice daily, 600 Kcal RCT, 12 weeks follow-up Weight change: +3.5 ± 1.8 kg vs 0.6±1.7, p<0.001 for within intervention group weight change, control group NSD Grade B/Low
Cereda 2009 28 nursing home residents in Italy, mean age 82 ± 10 in intervention and 81 ± 10 in control, 50% with vascular dementia or Alzheimer’s 30 kcal/kg per day nutritional supplement and two 400-ml, 500 Kcal enriched supplement RCT, 12 weeks follow-up Pressure ulcer healing by Pressure Ulcer Scale for Healing (PUSH) score: −6.1±2.7 vs. −3.3±2.4 Grade A/Low
Gazzotti 2003 80 geriatric ward patients in Belgium, mean age 80 ± 7, mean MMSE 21 ± 7 indicating mild cognitive impairment 200 ml supplement, received either soup or a nutritional supplement, 500 Kcal RCT, 2 months follow-up Weight change: +.28 ± 3.8 kg vs −1.23 ± 2.5 kg; p=0.05 between group comparison Grade B/Low
Gil Gegorio 2003 99 malnourished nursing home residents in Spain, mean age 86.5 ± 6.1, mean MMSE, 12.7 ± 5.3, indicating moderate to severe dementia 125 Kcal enriched oral supplement RCT, one year follow-up Weight change: +1.6 vs. −0.3, p=0.05
Infection: 47% vs. 66%, p=0.05
Days in bed: 7.5 vs 17.3, p=0.05
Mortality: NSD		 Grade B/Medium
Kwok 2001 47 nursing home residents with poor intake in China, mean age 81 ± 10 in intervention group and 80 ±10 in control group, 32% dementia in supplement group and 9% in control; dementia severity is moderate to severe Milk powder twice daily RCT, 7 weeks follow-up, controls received same foods as the intervention Weight change: intervention group increased from 42.94 to 44.39, controls decreased from 46.73 to 46.39, NSD
Grip strength, mental function, disability measures, NSD		 Grade B/Medium
Lauque 2000 78 malnourished nursing home residents in France, mean age range from 84 ± 8 to 88 ± 4, dementia percentage ranges from 47–91% in each group Nutritional supplements, 300–500 Kcal, four different supplements offered: soup, fruit, dessert, or a liquid supplement Concurrent controls, 60 days follow-up Malnourished group, weight gain of 1.5 ± 0.4 kg, p<0.05
At risk group, weight gain of +1.4 ±0.5 kg, NSD
Control group, no change in weight
BMI, grip strength, NSD		 Grade C/Medium
Lauque 2004 91 patients from geriatric wards and day centers in France with Alzheimer’s disease and risk of malnutrition, mean age 79, mean MMSE, 15 ± 8, indicating moderate impairment Oral supplements, 150–300 Kcal: soup, dessert, or a liquid supplement. Dietician made home visits and provided education RCT, intervention time 3 months, 6 months follow-up Weight change: +1.57 ±3.35 vs 0.67±3.55 kg, p=.001
BMI change: +0.66 ± 1.39 vs 0.29±1.38 kg/m2, p=.001
Cognition: NSD
Physical function: NSD		 Grade B/Low
Parrott 2006 30 geriatric care facility patients in Canada, mean age 88 ± 4 with probable moderate to severe Alzheimer’s Mid morning supplement (supplement bars or liquids) containing 250–258 Kcal Pre-post study design, 10 weeks follow-up BMI change: 23.7 ± 3.8 to 24.3 ±4.1 kg/m2, p<.001 and sustained one week after stopping intervention Grade C/Medium
Planas 2004 44 Alzheimer’s day center participants in Spain, mean age 73± 11 in study group and 77 ± 6 in control group, mild dementia and feeding problems Oral liquid supplements 500 kcal/day with or without micro nutrient enhancement RCT, 6 months follow-up BMI change: 25.4 ±4.4 kg/m to 26.5 ± 4.5 kg/m2 vs. 24.4 ±2.6 kg/m to 26.0 ±3.5 kg/m2, NSD
Cognition: NSD		 Grade B/Low
Wouters-Wesseling 2002 35 nursing home residents in the Netherlands, mean age 85± 8 in intervention group, 79 ±9 in control group, with moderate to severe dementia and low BMI Micronutrient-enriched liquid nutrient of 125 ml twice a day between main daytime meals RCT, placebo controlled, 12 weeks follow-up Weight change: 1.4 ±2.4 kg vs. −.08 ±3.0 kg, p=0.02 Grade A/Low
Wouters-Wesseling 2006 34 randomized nursing home residents with recent infection from a psychogeriatric unit in the Netherlands, mean age 83± 7 200 ml liquid nutrition enriched supplement after RX of antibiotics and a diagnosis of an acute infection RCT, 5 weeks follow-up after onset of infection Weight change: 0.8 kg vs. −0.4 kg, p=0.040
Physical function: NSD		 Grade B/Low
Young 2004 34 geriatric care center Alzheimer’s unit residents in Canada, mean age 88 ± 4, probable moderate to severe dementia, most with low BMI ¾ of a nutrition supplement bar and juice provided between breakfast and lunch RCT, crossover with washout periods, 4 phases lasting 21 days Weight change from baseline during intervention phases: 0.97 ±0.97 kg, p<.001 Grade B/Low
 Assisted Feeding and Other Interventions
Source Population Intervention Methods Outcomes Intervention vs Control Quality/Bias
Beck 2008 121 nursing home residents in Denmark, mean age 87, moderate cognitive impairment 25 grams of chocolate and 150 ml of hot chocolate, or 150 ml of homemade milk-based supplement, group exercise and oral care twice a week RCT, 11 weeks follow-up Weight change: 1.3% (0.6 to 3.2) vs 0.6% (−1.6 to 0.6), p=.005.
BMI change: 0.4% (0–1.0) vs −0.2%, p=.003		 Grade B/Low
Crogan 2006 61 nursing home residents in the US, mean age 85 intervention, 79 in comparison group, normal to moderately impaired cognition, at risk for malnutrition 6 month Individual Nutrition Rx (INRX) process with assessments, care planning, and interventions Concurrent controls, 6 months follow-up BMI change: 25.11 to 25.64 kg/m2 in treatment and 26.38 to 26.81 kg/m2 in controls, NSD
Function: no difference		 Grade C/Medium
Goddaer 1994 29 nursing home residents in Belgium, mean age 81, severe dementia Relaxing music played at lunchtime Pre-post study ABAB repeated measures design, A=no music, B=music, one week intervals Reduction in cumulative incidence of total agitated behaviors (63%), physically nonaggressive behaviors (56%), and verbally agitated behaviors(75%). Grade C/Medium
Keller 2003 82 nursing home residents with dementia, mean age 80, moderate cognitive impairment, moderate to severe nutritional risk Enhanced dietician time and care planning, enhanced menu with increased snack foods, high energy and high protein foods Concurrent controls, 30 months follow-up Weight change: 4.8% ± 0.7% vs. −4.5% ± 0.9%, p<0.001
27% intervention subjects gained weight vs. 7% controls		 Grade C/Medium
Remsburg 2001 40 nursing home residents, mean age 80, 50% had dementia, moderate cognitive impairment and at risk for malnutrition Buffet style dining program (supper only), implemented daily RCT, 3 months follow-up Weight change: −.11±0.7 vs .32±0.5, NSD Grade B/Medium
Robbins 2008 515 residents from subacute residential facilities, median age 81, 70% had dementia and evidence for aspiration Drinking liquids in chin down posture vs. drinking thickened liquids (nectar thick and honey thick) in a head neutral position RCT, parallel design trial, 3 months follow-up Incidence of pneumonia, HR 0.84(0.49–1.45), NSD
Mortality, NSD		 Grade B/Medium
Salas-Salvado 2005 56 patients with Alzheimer’s dementia, moderate to severe cognitive impairment, with weight loss and requiring a liquid or semi-solid diet Lyophilized food diet reconstituted to liquid or semi-solid consistency with nutritional advice RCT, controls received nutritional advice only, 3 months follow-up Weight change: 2.06 ± 1.9 vs 0.32 ± 3.04 kg
Depression scores: NSD		 Grade B/Medium
Simmons 2005 17 nursing home residents low BMI or poor intake of food, mean age 92, 41% with mild to moderate dementia Megestrol acetate 400 mg daily with vs without feeding assistance Pre-post study design, 63 days follow-up Weight change: −2.13 ±9.32lb from baseline
Intake improved only when combined with optimal feeding assistance		 Grade C/Medium
Simmons 2008 69 nursing home residents, mean age 82 intervention and 84 control, 41–43% subjects with dementia of moderate severity, at risk for weight loss Feeding assistance RCT, cluster design, 24 weeks follow-up for intervention and 24 weeks for control Weight change difference: 4 lbs, p=0.009
BMI change: 0.72 kg/m2, p=0.009		 Grade B/Medium
Volicer 1997 12 patients from a VA hospital dementia study unit, mean age 73± 5, moderate to severe dementia, mean MMSE 4.0 ±7.4 and exhibiting food refusal Dronabinol 2.5 mg capsule bid RCT, placebo controlled crossover design, 12 weeks follow-up Weight change: intervention group gained 7.0 ±1.5lb and 2.3 ±1.7lb, while controls gained 4.6 ±1.3lb and 1.7 ±2.3lb, p<0.017
Behavior: Negative affect was reduced during intervention (p=0.045), agitated behavior was unchanged		 Grade A/Low
Yeh 2000 68 nursing home residents with > 5% weight loss or low body weight, 30% incapable of consent Megestrol acetate 800 mg daily RCT, 25 weeks follow-up Weight change: 43% vs 18% gained 1.82 kg or more; 38% of intervention patients did not gain weight and advanced dementia was associated with lack of gain Grade A/Low
Young 2005 34 nursing home residents in Canada, mean age 88.2 ± 3.9, probable moderate to severe Alzheimer’s dementia, most with low BMI High carbohydrates meals, received supplements in non intervention phase RCT, crossover design with four phases, 84 days follow-up Weight increase of 0.36 ±1.12 kg in intervention group, p=.076, NSD
Measures of cognition and behavior did not change		 Grade B/Medium
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Quality Rating: Grade A=randomization, placebo-controlled, concealed allocation, Grade B=randomization, concealment not clearly defined, Grade C=not randomized, concealment inadequate; RCT=randomized, controlled trial; NSD=non-significant difference; BMI=body mass index

Nine additional randomized trials provided Grade B evidence for supplement use in dementia, and six demonstrated benefit. One additional trial with concerns for inadequate randomization and one study using pre-post design provided lower quality evidence. Lower and higher quality studies had similar outcomes. Study populations varied in the severity of cognitive impairment and nutritional problems, yet weight gains were consistently 0.5–2.0 kg. Studies rarely reported potential harms from supplements. In one study, 5 of 31 (16%) subjects, particularly those with lower baseline weight, reduced their lunch intake after the supplement.33

Studies of Assisted Feeding and Other Interventions

We identified 12 studies of diverse nutritional and environmental interventions to improve clinical outcomes for dementia patients.34,35,36,37,38,39,40,41,42, 43,44,45 Interventions included appetite stimulants (3); changes in environment with buffet-style dining (1) or music (1); thickened liquid or semi-solid food (2); or individualized nutritional care plans (4) including exercise (1). Ten studies used weight or body mass index as outcomes; six found positive effects. (Table 3) Follow-up ranged from 3–12 months. Function and mortality were rarely studied; two trials using these outcomes found no benefit.35,39 Three studies tested effects of feeding interventions on behaviors, with mixed results.36,43,45

Three studies tested appetite stimulants for dementia patients. Volicer found dronabinol improved weight and reduced negative affect with a trend toward improving disruptive behaviors.43, 43 Yeh randomized nursing home residents to megestrol acetate 800 mg or placebo. Analyzing subjects with complete data, 43% of the intervention vs. 18% of the placebo group gained > 1.82 kg over 12 weeks, but those with advanced dementia were less likely to respond.44 A pilot study of megestrol demonstrated no change in weight, but secondary analyses suggested benefit when combined with optimal assisted feeding.41

Four non-medication interventions showed positive effects on weight, including chocolate and exercise, enhanced dietician time, lyophilized foods with modified texture, and feeding assistance.34,37,40,42 One other study of enhanced dietician care had no effect, but enrolled less cognitively and nutritionally impaired patients.35 Buffet style dining at one meal a day had no effect on weight.38 A randomized trial of chin down posture compared to thickened liquids found no differential effect for aspiration; investigators commented a “usual care” control could not be used due to ethical concerns.39

Quality of Studies of Assisted Feeding and Other Interventions

The two high quality randomized trials in this group tested appetite stimulants and found beneficial effects on weight. (Table 4) Six additional randomized trials of non-medication interventions provided Grade B evidence with low to medium risk of bias. Four additional studies used non-random controls to test enhanced nutritional assessment, use of calming music, and megestrol. We detected no correlation between study quality and likelihood of positive results.

Four studies explicitly collected and reported data on harms. One randomized trial comparing chin down posture to thickened liquids as interventions to prevent aspiration pneumonia found that 23% of participants experienced an adverse event. Adverse events were equal between groups, but the combined outcome of fever or urinary infection or dehydration tended to be more common for the thickened liquid group (9% vs. 5%, p=0.055).39 In a randomized trial of lyophilized food compared to nutritional advice, nearly all deaths or hospitalizations involved patients with more advanced dementia, but rates did not differ between groups.40 In Simmons’ study of megestrol, nearly half of 17 participants reported new fatigue or loss of strength; 5 reported leg swelling but information on thrombotic disease was not provided.41 Finally, in a placebo-controlled study of dronabinol, one patient on treatment had a seizure, and the active treatment phase was marked by increases in somnolence and euphoria.43

Overall Strength of Evidence for Oral Feeding Interventions in Dementia

The evidence base for oral feeding options in dementia includes an encouraging number of randomized trials with low to medium risk of bias. Examining both the quantity and quality of research, there is moderate evidence to support the use of high calorie supplements to improve weight for patients with dementia and feeding problems, and low evidence these supplements promote wound healing and reduce infection risk. For the outcome of weight gain, current research offers low evidence for appetite stimulants, assisted feeding and modified foods. Findings regarding weight gain are consistent among trials, nearly uniformly positive, and effect size for supplements can be estimated at 0.5–2.0 kg of weight gain over 1–6 months. Evidence is sparse but consistent in showing no effect of oral feeding options on function, cognition or mortality for patients with moderate to severe dementia.

DISCUSSION

This systematic review summarizes research on oral feeding in dementia. High calorie supplements are an evidence-based option to promote weight gain for patients with dementia and feeding problems. Assisted feeding, appetite stimulants, and modified foods may also improve weight, and treatments can be used individually or in combination. Based on current evidence, specialized oral feeding interventions are unlikely to change how patients with dementia function or how long they live.

Our results are consistent with a meta-analysis which found protein energy supplementation improved nutrition and reduced morbidity and mortality for undernourished older hospitalized patients.46 Another systematic review found moderate evidence to support use of supplements for healing of pressure ulcers.47 The single study in this review demonstrating wound healing included patients who were both tube fed and orally fed, limiting clear conclusions about oral supplements and pressure ulcer healing. To be effective, prescribed supplements must be ingested. Incomplete administration of supplements occurs in practice, and is associated with weight loss among nursing home residents with dementia.48

This systematic review combines studies that are heterogeneous in the dementia status and feeding problems of enrolled participants, interventions, and outcome measures, precluding meta-analysis. Variation in baseline dementia severity and nutritional status of study subjects raises questions about optimal timing for nutritional interventions in the progression of dementia. Many studies target moderate to severe dementia, but are too small to stratify findings by stage. Some studies enrolled patients at risk for nutritional decline, while others enrolled patients with clear indications of nutritional insufficiency. Findings from individual studies suggest that interventions may be ineffective when initiated before nutrition is a major issue, or for very advanced dementia or very low body mass index, when interventions may be too late. This review focused on dementia, and results may not extend to other populations with nutritional problems.

Our review did identify several areas for improvement in this body of research. Future studies will be strengthened by careful definition of dementia stage and feeding problems of the enrolled subjects. Study of more complex, programmatic interventions make double blinding difficult; single-blinding of outcome assessment and concealment of randomization allocation can avoid important sources of bias. Several studies that demonstrated positive results were supported by manufacturers of nutritional supplements; it is unclear whether or not reporting bias (i.e., failure to publish studies with negative findings) affected the available published literature. Current evidence relies on numerous single-site small studies (average sample size n=73). Future interventions, and combinations of promising interventions in comprehensive nutritional programs, could be tested in multi-site randomized trials. Investigators should be encouraged to design trials that view intake and weight gain as intermediate outcomes, so as to provide stronger evidence about the effects on function, behavior, infection risk and wound healing. Ethical concerns about withholding feeding treatments may limit the range of possible control conditions, including a randomized comparison of oral assisted feeding to tube feeding.

Feeding treatments choices may cause great legal, ethical and clinical controversy, and remain emotionally difficult for family caregivers.49 State laws reflect this controversy, and many set stricter legal requirements, such as health status or explicit evidence of patient wishes, in order to withhold or withdraw medical forms of nutrition and hydration. Patients, and families of patients with dementia, may rely heavily on medical advice to understand other treatment options. No randomized trials of tube feeding compared to oral feeding exist, but observational studies of dementia patients indicate tube feeding is not superior for promoting survival, function or wound healing. In these observational studies, patients without tube feeding served as controls and many may have received oral feeding treatments included in this review.

Nearly all patients with advanced dementia develop feeding problems. Health care providers may confidently advise families that high calorie supplements, perhaps in combination with assisted feeding, foods modified in taste or texture, and appetite stimulants can promote weight gain for several months. Given the progressive nature of dementia, families should be counseled not to expect improvements in function or survival with any available form of feeding. In end-stage dementia, oral feeding may no longer be possible, and tastes and sips of food combined with mouth care may be used to promote comfort.50 Families and health care providers may improve the quality of informed decision-making using current evidence for oral feeding options in dementia.

Acknowledgments

This research was funded by the National Institute for Nursing Research, R01 NR009826

Sponsor’s Role: The sponsor had no role in the design, methods, subject recruitment, data collection, analysis or writing of this manuscript.

Footnotes

Conflict of Interest: The editor in chief has reviewed the conflict of interest checklist provided by the authors and has determined that the authors have no financial or any other kind of personal conflicts with this paper.

Author Contributions: Study concept, design, data analysis and interpretation, preparation of manuscript: Hanson, Ersek, Gilliam, Carey

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