Safety and Efficacy of Milk and Molasses Enemas Compared With Sodium Phosphate Enemas for the Treatment of Constipation in a Pediatric Emergency Department

Design

N= 96

Retrospective, comparative, chart review

Objective

To determine the safety and efficacy of routine milk and molasses enemas (MME) compared with sodium phosphate enemas for the treatment of constipation in the pediatric emergency department (ED)

Study Groups

Sodium Phosphate Enema (n= 47)

MME (n= 49)

Inclusion Criteria

Patients presented to the pediatric ED between November 1, 2007, and November 1, 2008, and were treated for constipation with either MME or sodium phosphate enema

Exclusion Criteria

Patients with medical records that lacked adequate documentation of improvement or worsening of constipation symptoms

Methods

Medical records of patients who presented to the ED and received either MME or sodium phosphate enema for constipation were identified and reviewed for data collection. The following data were collected to determine safety and efficacy: baseline demographics, chief complaint, medical history, radiographic imaging, enema type, treatment dose, adverse effects, symptom improvement, time until defecation, failure of initial therapy requiring additional intervention, and time from treatment until disposition.

Duration

November 1, 2007, to November 1, 2008

Outcome Measures

Treatment success, defined as having a bowel movement after administration of the enema; adverse events

Baseline Characteristics

Sodium Phosphate Enema (n= 47)

MME (n= 49)

Age, years

Female

White

Medical history

Constipation*

Sickle cell disease

Diabetes mellitus

Developmental delay

Hirschsprung 

Cardiac

Gastrointestinal

Renal

6.3%

2.1%

1%

7.3%

1%

1%

8.3%

1%

4.2%

17.7% 

5.2%

1%

5.2%

0

4.2%

18.5%

1%

3.1%

p< 0.05, patients who presented with a medical history of constipation were more likely to be given MMEs. 

Results

Endpoint

Sodium Phosphate Enema (n= 47)

MME (n= 49)

p-value

Treatment success

Treatment failure

Time to defecation, min

Time from treatment to disposition, min

Requirement of additional treatment

MME

Additional sodium phosphate enema

oral polyethylene glycol 3350

oral docusate sodium with senna

8

5

2

1

--

Individual Adverse Events   

Sodium Phosphate Enema (n= 47)

5

2

5

1

0

14 (64%)

In general, patients younger than 2 years old were more likely to receive a sodium phosphate enema, whereas patients older than 11 years were generally more likely to receive MME.

Adverse Events

See results

Study Author Conclusions

No statistically significant differences were found between MME and sodium phosphate enemas. Based on the results, the 2 treatment options were found to be equally safe and effective.

InpharmD Researcher Critique

Due to the retrospective nature of this study, there were significant inconsistencies in ED documentation that could create a potential for bias. Information regarding pain score, post-treatment assessment, and improvement in symptoms was generally not well documented. The primary reviewer was not blinded to the treatment method, which could create another source of bias.  

Safety and Efficacy of Milk and Molasses Enemas in the Emergency Department

Structured retrospective cohort study

N= 261

To evaluate the success and complication rates of administering milk and molasses (M&M) enemas in the emergency department (ED)

M&M enema only (n= 214)

M&M after other treatments (n= 34)

M&M before other treatments (n= 13)

Adult patients aged 18 years or older who received an enema in the ED

Patients with a history of lactose intolerance

Retrospective chart review of adult patients receiving milk and molasses (M&M) enemas in two emergency departments (EDs). M&M enemas were prepared by mixing 16 oz of warm milk and 16 oz of warm molasses and administered with the patient in the prone position. Patients were categorized into three groups: those receiving an M&M enema alone, those receiving an M&M enema after another constipation treatment (e.g., another enema or oral agent), and those receiving another enema after an M&M enema.

July 15, 2002 to July 15, 2010

Primary: Bowel movement

Secondary: Improved pain score by 2 or more points, lowering of heart rate by 20 or more beats/min

M&M only (n= 214)

188/214 (87.9%)

Five additional patients met a secondary efficacy outcome through a ≥2-point reduction in pain score.

Complications occurred in 8 patients (3.1%) and included increased heart rate (n= 4), hypotension (n= 2), fever (n= 1), and worsening abdominal pain requiring hospital admission (n= 1). No complications were reported among patients receiving M&M enemas after Fleet, soap suds, magnesium citrate, lactulose, or mineral oil.

The study provides valuable data on the use of M&M enemas in adults, showing high efficacy and low complication rates. However, the retrospective design and reliance on medical records may limit the accuracy of complication reporting. The study's findings are limited by the lack of a control group and the potential for selection bias.

The study consisted of two parts: an anonymous online survey of nurses and a retrospective chart review

N= 500

Primary: Enema success rate based on stool output and minimal side effects

Secondary: Patient tolerance, side effects, and adverse events

Are Milk and Molasses Enemas Safe for Hospitalized Adults? A Retrospective Electronic Health Record Review

Retrospective electronic health record review

N= 196

To evaluate the safety of milk and molasses enemas for hospitalized adults with constipation that remained unresolved after standard treatment options were exhausted

All patients (N= 196)

Adult patients who received a milk and molasses enema between July 2009 and July 2013 at a large midwestern academic medical center

Patients under the age of 18 years

Data were extracted from the EHRs of 615 adult patients. A random subset of 200 patients was selected for data analysis. Variables included age, sex, admitting diagnosis, diet orders, medications, laxatives and enemas administered before the milk and molasses enema, and laboratory values. Milk and molasses enemas were administered according to institutional practice; although formulations may have varied during the study period, the current institutional formulation consists of a 1:1 mixture of 240 mL whole milk and 240 mL molasses.

July 2009 to July 2013

All patients (N= 196)

Age, years

Female

Emergency admission

Yes

No

104 (53.1%)

92 (46.9%)

Primary admission diagnosis

Abdominal pain, unspecified site

Constipation, unspecified

Anorexia nervosa

Nausea with vomiting

Intestinal obstruction, unspecified

19 (9.7%)

14 (7.1%)

13 (6.6%)

13 (6.6%)

8 (4.1%)

Discharge disposition

Home or self-care

Skilled care facility

Home with home health care

Inpatient rehabilitation facility

Deceased

99 (50.5%)

26 (13.3%)

19 (9.7%)

19 (9.7%)

9 (4.6%)

Among 196 adults who received a milk and molasses enema, 97.4% had a laxative order and 86.2% had a stool softener order.

No milk and molasses enema-associated allergic reactions, bacteremia, bowel perforation, electrolyte abnormalities, abdominal compartment syndrome, cardiac arrhythmia, dehydration, or death were documented in the electronic health record.

In the subset of patients with serum sodium (n= 35) and potassium (n= 42) measured within 48 hours before and after enema administration, no significant changes in electrolyte concentrations were observed.

See above.

No safety concerns were identified from this retrospective EHR review of hospitalized adults who received a milk and molasses enema for constipation relief. The findings indicate that this treatment is safe, although further study examining its efficacy in this population is needed.

The study provides valuable insights into the safety of milk and molasses enemas in hospitalized adults, but its retrospective design and single-center setting may limit generalizability. The lack of detailed enema formulation data and the focus solely on safety without efficacy assessment are additional limitations. Further research is needed to evaluate efficacy and safety in more diverse populations.

A Randomized Trial of Enema Versus Polyethylene Glycol 3350 for Fecal Disimpaction in Children Presenting to an Emergency Department

Prospective, randomized comparison

N= 79

To compare efficacy of enema versus polyethylene glycol (PEG) 3350 for pediatric fecal impaction treatment

PEG arm (n= 39)

Enema arm (n= 40)

Children aged 1 to 17 years with fecal impaction, functional fecal retention, or excessive colonic stool as diagnosed by emergency department (ED) physician

Milk or molasses allergy, ill-appearing, received analgesia for abdominal pain (except acetaminophen or ibuprofen), prior abdominal or rectal surgery, non-English speaking, pregnant, long-term medical conditions associated with constipation, admitted to inpatient service

A convenience sample was recruited from the emergency department of a free-standing academic children’s hospital. Computer-generated block randomization was performed within 3 age groups (1–4, 5–10, and 11–17 years), with assignments concealed until immediately before treatment; blinding was not possible because the interventions were administered by different routes. Group A received a single milk and molasses enema in the emergency department, mixed 1:1 and administered at 10 mL/kg to a maximum of 500 mL. Group B received outpatient oral PEG 3350 at 1.5 g/kg/day, to a maximum of 100 g/day, for 3 days.

Both groups subsequently received PEG 3350 maintenance therapy at 0.8 g/kg/day for 3 days. Enema recipients began maintenance therapy within 24 hours after emergency department discharge, whereas oral PEG recipients began maintenance therapy within 24 hours after the third cleanout dose. Caregivers completed structured telephone follow-up on days 1, 3, and 5 regarding symptom improvement, stool frequency and consistency, straining, and bowel-movement regularity. Treatment failure was defined as receiving an enema at home, returning to the emergency department, or being admitted for fecal-impaction treatment. Subjects without follow-up data or with “don’t know” responses were omitted from the applicable analyses. The planned enrollment was 140 subjects, but the investigators analyzed the accumulated data early because of concern that outcomes were inferior in the oral cleanout group.

December 2006 to May 2009

Primary: Improvement in main symptom

Secondary: Stool frequency, consistency, ease of stool passage, treatment failures

PEG Arm (n= 39)

6.9 .7

Age group

1-4 years

5-9 years

11-17 years

15 (38%)

15 (38%)

9 (23%)

15 (37%)

16 (40%)

9 (23%)

20 (51%)

Race

African American

White

Hispanic/Latino

Other/missing

14 (36%)

18 (46%)

5 (13%)

2 (5%)

17 (43%)

12 (31%)

6 (15%)

5 (12%)

21 (54%)

12 (31%)

Main symptom

Abdominal pain

Constipation

18 (46%)

13 (33%)

13 (33%)

21 (53%)

At day 1, improvement in the main presenting symptom was reported more frequently with the milk and molasses enema than with oral PEG 3350 (82% vs 55%; odds ratio [OR] for PEG vs enema, 0.3; 95% confidence interval [CI] 0.1 to 0.8), although the PEG group had a greater mean number of stools (2.2 vs 1.0; p< 0.05).

At day 3, main-symptom improvement was similar between groups (91% vs 89%), whereas ideal stool consistency was more frequent with the enema (74% vs 38%; p< 0.05) and mean stool frequency remained higher with PEG 3350 (4.2 vs 2.7; p< 0.05).

No between-group differences in symptom improvement, straining, stool frequency, or stool consistency were observed at day 5.

Treatment failure occurred in 1 enema recipient and 5 PEG recipients (2.5% vs 12.8%; p= 0.08), while treatment-related distress was reported in 54% of enema recipients and no PEG recipients (p< 0.05); other adverse events were not systematically reported.

54% of children in the enema arm were reported as upset by the therapy, whereas no children in the PEG arm were upset.

This pilot study suggests that disimpaction by enema may be superior to PEG for more immediate relief of symptoms in the acute care setting. Symptoms and signs of treatment effect did not differ beyond 24 hours. When considering treatment, this initial benefit needs to be balanced with the potential distress that may be associated with enemas. Larger trials will be needed to assess any advantage.

Randomization, clearly defined treatment regimens, serial follow-up, and direct comparison with an active oral treatment support the finding of faster initial symptom improvement with a milk and molasses enema. However, the small, prematurely analyzed, unblinded pediatric trial had substantial refusal and follow-up loss, relied primarily on caregiver-reported outcomes, and did not systematically assess adverse events; therefore, it provides limited safety information and demonstrates an efficacy difference only during the first 24 hours.

Cardiopulmonary Compromise Associated With Milk and Molasses Enema Use in Children

Design

Case 1

A 3-year-old male with chromosome 2p duplication, panhypopituitarism, bronchopulmonary dysplasia, Tetralogy of Fallot, seizures, and constipation received two milk and molasses enemas (2 oz whole milk mixed with 2 oz molasses) during hospitalization for increased seizure activity.

Shortly after enema administration, he developed hypoxemia, abdominal distention, hypotension, bradycardia, and progressed to asystolic cardiac arrest requiring cardiopulmonary resuscitation and vasoactive support. Following return of spontaneous circulation, he remained anuric, with worsening acidosis and hypoxemia. An abdominal radiograph demonstrated anasarca and ascites, and abdominal compartment syndrome was diagnosed. Surgical decompression was declined by the family, life-sustaining treatment was withdrawn, and the patient died.

Case 2

A 20-month-old female with vesicoureteral reflux, imperforate anus, vesicostomy, ventricular septal defect, failure to thrive, and constipation presented with an Enterococcus urinary tract infection that had failed outpatient treatment.

After receiving a milk and molasses enema (3 oz whole milk mixed with 3 oz molasses) for severe constipation, she developed mottling, pallor, tachycardia, abdominal distention, altered mental status, and weak peripheral pulses within 10 minutes.

She was transferred to the pediatric intensive care unit, where she required endotracheal intubation, mechanical ventilation, fluid resuscitation, vasopressor support, blood products, broad-spectrum antibiotics, and manual stool disimpaction. Blood and urine cultures remained negative during hospitalization, and she recovered without significant morbidity and was discharged home 10 days after admission.

Case 3

A 7-month-old male with a history of repaired anterior meningomyelocele, rectal stenosis, and chronic constipation presented with decreased stool output and suspected fecal impaction.

After receiving a milk and molasses enema (1 oz whole milk mixed with 1 oz molasses) at home, he developed profuse diarrhea, repeated emesis, and subsequently became unresponsive.

On presentation to the emergency department, he was poorly perfused with unobtainable blood pressure and required intravenous fluid resuscitation, antibiotics, and pediatric intensive care unit admission. Blood, urine, and stool cultures were negative, his clinical status gradually improved with supportive care, and he was discharged home after 3 days.

Case 4

A 4-year-old female with metatrophic dwarfism, seizures, hydrocephalus with ventriculoperitoneal shunt, gastroesophageal reflux, gastrostomy tube, and constipation presented for routine immunizations, during which a fecal mass was identified on examination.

Following administration of a milk and molasses enema (35 mL whole milk mixed with 35 mL molasses), she immediately developed pallor and hypotension and was transferred to the emergency department, where she received intravenous fluid resuscitation and manual fecal disimpaction.

She was admitted to the pediatric intensive care unit, where additional intravenous fluids were administered without the need for inotropic support. Her fecal impaction resolved with manual disimpaction, polyethylene glycol electrolyte solution (GoLYTELY), and bisacodyl suppositories, and she was discharged in stable condition.

Case 5

A 6-year-old male with a chromosome 22 abnormality, asthma, recurrent pneumonia, and constipation presented with decreased responsiveness, perioral cyanosis, and cool extremities approximately 1 hour after receiving a milk and molasses enema (1 oz whole milk mixed with 1 oz molasses).

He had a large bowel movement and three episodes of emesis following enema administration. Evaluation demonstrated abdominal tenderness and metabolic acidosis, while abdominal imaging showed stool and gas throughout the bowel without free air. He received intravenous fluids and ceftriaxone for possible sepsis, with negative blood, urine, and cerebrospinal fluid cultures, and was discharged home after returning to his baseline clinical status.

Study Author Conclusions

The cases presented in this article indicate that enema administration has risk, even using seemingly benign preparations such as milk and molasses. Children with chronic illnesses are at a higher risk for constipation and may also be more likely to suffer adverse outcomes with the use of enemas. When enema therapy is unavoidable, low-volume enemas with short retention times may reduce the risk of complications. Intravascular volume status should be evaluated before using enemas involving hypertonic solutions of any kind and cardiac health should be considered. Enemas should be administered by individuals who are well trained to manage potential complications associated with this therapy.

Use of Milk and Molasses Enema in Colonic Obstruction in An Octogenarian

Design

Case presentation

An 86-year-old male with chronic constipation, severe mixed dementia, immobility, malnutrition, and very severe frailty presented with 7 days of constipation unresponsive to sennosides and polyethylene glycol, followed by abdominal pain, fever, nausea, and vomiting.

Imaging demonstrated colonic obstruction involving the descending and sigmoid colon, with dilation up to 10 cm. After nasogastric decompression produced no drainage and the patient and his family declined surgery, he received levofloxacin, intravenous fluids, electrolyte replacement, and a milk and molasses (“Mayo”) enema consisting of 300 mL of milk and 50 mL of molasses heated to 35 °C and administered every 24 hours for 3 days.

The enemas produced abundant evacuation and symptomatic relief without bleeding; the authors reported no electrolyte abnormalities 24 hours after administration. Following 3 days of treatment, abdominal radiography demonstrated improvement of the obstruction, and the patient was discharged home with polyethylene glycol added to his regimen.

Study Author Conclusions

This case demonstrates that Mayo enema may be an option in geriatric patients who are unable to undergo surgery or decompressive endoscopy for intestinal obstruction due to medical, environmental, or personal reasons.

The patient’s comorbidities prevented the surgeon from performing the surgery, so the enemas were a rapid and efficient option in a grim situation where the patient’s life was in danger. The caretakers appreciated the conservative management.