Infectious Diarrhea

Effect of Enercel® on Acute Documented or

Presumed Infectious Diarrhea

in Children Less Than 5 Years of Age

at the Emergency Ward of B. Bloom Hospital in San Salvador

Izaguirre RR, Guzmán, MR, Fuentes, RC, Mena CE, Peñate E.,

Christner D MD(MA), PhD, Laurent D MD.

Running Head: Enercel® for Acute Infectious Diarrhea in Children


AIMS: The homeopathic medicine Enercel® was tested in acute cases of presumed or documented infectious diarrhea in children less than 5 years of age. A total of 123 cases were evaluated– 59 in the control (observation) group and 64 in the test (Enercel®) group. Test subjects received 3 ml IM doses at baseline and 12 hours. Patients with parasitic and non-infectious causes of diarrhea were excluded. A clinical score to determine improvement or deterioration was created and applied to both groups. Statistical analysis was worked through EPI-INFO and SPSS programs. Clinical changes were measured every 6 hours for the first 24 hours, then again at 72 post-enrollment.

RESULTS: Both groups were comparable statistically in terms of clinical presentation, demographics and laboratory findings on enrollment. Differences in clinical status score became become significant at 18 and 24 hours (p < 0.05) and more so at 72 hours after enrollment (p < 0.01). The Enercel-treated group had significant improvement in fecal output at 12 – 18 hours and 18 – 24 hours (p < .01 for both). Seventeen subjects in the control and 15 in the test group had rotavirus infection. There was a borderline significant difference in clinical status at 18 hours (p = 0.08) and 24 hours (p = 0.06) after enrollment. At 72 hours, however, the difference was significant (p < 0.01).

CONCLUSIONS: Enercel® was effective in limiting clinical manifestations of infectious diarrhea in children < 5 years old. Such infections result in considerable morbidity and mortality in underdeveloped countries. The rotavirus infection subgroup responded more slowly, but the difference between control and test groups was significant at 72 hours. Enercel® may be a candidate as an inexpensive, completely safe alternative to antibiotic or symptom-only treatment of acute documented or presumed infectious diarrhea in children from developing nations.


Infectious acute diarrhea is a problem that persists as an important public health problem, especially in developing countries, where it is one of the major causes of morbidity and mortality affecting children under 5 years of age (1). When social conditions associate diarrhea with pre-existing malnutrition, the problem worsens (2-9).

In El Salvador, this has been one of the major causes in children for consultation, hospitalization and mortality since epidemiological tracking was first instituted in 1950. Since malnutrition, poverty, deficient education and limited health resources are still prevalent factors (10-12), the situation is most concerning. At the Benjamin Bloom National Children’s Hospital (HNNBB), the main governmental pediatric hospital in El Salvador, there have been at least 10,000 consultations per epidemic outbreak of acute diarrhea in the last 4 years. Over 5% of these children have been hospitalized because of the severity of the case (13). This is more than double expected for this group of patients in developing countries, but is also in part determined by severe cases being transferred from the provincial hospitals (13). Nine hundred seventy-seven cases of death from acute infectious diarrhea have been recorded between 1998 and 2002 (4.2 % of admissions for acute diarrhea) at HNNBB (13). The cost of care provided by this hospital represents for the state a cost of $120 to $ 550 per day, depending of the degree of complexity or technological requirements of each case (13).

Enercel® is a combination of homeopathics as per the Homeopathic Pharmacopoeia of the United States (HPUS). Enercel® has been proven to be completely non-toxic and without negative side effects in patients both in clinical trials and general use (Table 1). Enercel has imunomodulatory properties that, according to other researchers, act at the Natural Killer (NK) cell and T-lymphocyte level and (14) through pathways of energy generation and intracellular restoration (15).

Enercel® has shown clinical efficacy in cases of acute infections, presumably through immune-mediation. Two studies demonstrated improvement in acute respiratory diseases (16,17). A series of 17 cases of acute diarrhea in a private practice setting—including 14 children and 3 adults—recorded significant improvement compared to controls with the administration of IM Enercel given at baseline and 12 hours later (18).

T-Lymphocytes and NK cells are crucial elements (19-23) in gut-associated lymphoid tissue (GALT; 2). Support of this immunologically-vital system is associated with amelioration and control of infectious diarrhea (22,23). Children whose immune response is compromised through concomitant infections and/or malnutrition are particularly susceptible to severe or life-threatening infectious diarrhea (24). In developing countries like El Salvador, even diarrheal diseases that are normally self-limited in more developed countries can be fatal due to malnutrition and limited public health resources.
Acute infectious diarrhea is associated with significant morbidity and cost-of-care (2,4,21,22,25). Enercel® was studied for its potential to decrease the symptoms and shorten the course of acute infectious diarrhea. As a consequence of a successful intervention such as the use of Enercel® in this study, costs of treating cases in children can be decreased (2,10,26-28). Two IM administrations of Enercel® can be accomplished at less than $2. Hospitalizations can be shortened or eliminated; symptomatic medicine use decreased and complications such as dehydration reduced (29). The hospital may save vital human and material resources when caring for over 1200 children per week during epidemics (13)

We report that two IM injections of Enercel® was effective in decreasing the severity and duration of symptoms associated with acute infectious diarrhea in children. The potential of this intervention in developing countries may be substantial in lowering the mortality and morbidity of such cases, reducing cost-of-care and limiting the burden on public health services. Larger studies and those targeted at specific infectious diarrheal diseases such as rotavirus and cholera may be indicated.


General Description

One hundred seventy-seven (177) children were enrolled in this study. Fifty-four subjects were dropped from the study due to various reasons, leaving an evaluable study population of 123. Children were sequentially enrolled that presented with a diagnosis of presumed acute infectious diarrhea to the outpatient clinic of the emergency ward at B. Bloom Hospital in San Salvador. The children were admitted for 24 hours, during which time they received clinical observation, diagnostic procedures and oral or parenteral rehydratation, as determined by their medical team. Antibiotics, antipyretics, antiparasitics, antidiarreals and antispasmodics were not allowed. They were then discharged and instructed to return in 48 hours for a final evaluation (72 hours post admission).

Children were randomized to one of two study groups. Of the 123 evaluable subjects, 64 received Enercel®, 3 ml IM at enrollment and again 12 hours later. The control group was made of 59 children and received supportive care only. The investigators, house staff, nurses and parents were alerted to observe the children closely for any adverse or side-effects and to record them if present.

Inclusion criteria

1. Children between 6 months and 5 years of age at the time of screening

2. Three or more loose or watery stools during the 24 hours prior to consultation.

3. Clinical syndrome consistent with acute infectious diarrhea in the opinion of the investigator

4. Viral, bacterial or undetermined cause of diarrhea

5. Consultation with the staff of the emergency ward at B Bloom hospital

6. Consent form signed by a parent

Exclusion criteria

1. Symptoms > 24 hours duration

2. One or more bloody stools

3. Having received any of the following medications within 24 hours of enrollment: antibiotics, antiparasitics, antipyretics, antispasmodics, antidiarreals or laxatives

4. Any significant chronic disease such as diabetes, renal insufficiency, cancer or liver disease

5. Sepsis

6. Concurrent infections such as urinary tract infections or amoebiasis

7. Lack of parental informed, signed consent

Recorded Parameters

Information such as name, date, time of enrollment and demographic data pertinent was obtained and recorded. Enrolled, parental-consented subjects were assigned a study number that was randomized 1:1 to the control (group A) or test (group B) groups. A group of 21 local pediatricians were polled to create a list of signs and symptoms that could be scored as study parameters of clinical status. Seven clinical parameters were chosen and scored from 0 to 10 in terms of severity (0 not present and 10 very severe). These parameters were documented and recorded: refusal to ingest food and/or water, vomiting; abdominal pain; temperature; peristalsis; hydration status; and number of bowel movements.
Using these parameters, a retrospective assessment of the patient’s average condition during the 24-hour period prior to admission was performed; after admission this scoring was implemented at 6, 12, 18 and 24 hours after enrollment. A final evaluation was performed 72 hours after admission (48 hours post discharge from the hospital).

The Yale Observation Scale (YOS; 30) was used as an instrument to assess the severity of each child’s clinical presentation. Six criteria were scored from 1 to 5 in terms of severity (with 5 the worst and 1 the best) for a total score of 6 to 30. Scores were compiled at each time period and a comparison was made between the two groups.

Fecal volume over each time interval was recorded during the first 24 hours (0 – 6, 6 – 12, 12 – 18, and 18 – 24 hours) and expressed as cc/kg of body weight. Volumes were compared between groups A and B.

A subgroup analysis of overall clinical status score between groups A and B for confirmed rotavirus cases was performed.

Laboratory Examination

The laboratory studies included in the study were:

1. Complete Blood Count (CBC; Hematological counter SF 300, Sysmex)

2. Standard urinalysis according to established protocol

3. Conventional stool exam including a Wright stain.

4. Stool amoeba antigen test (E. histolytica II; TechLab)

5. Stool Rotavirus examination (Virotect-rota; Omega Diagnostic).

6. Stool culture for Salmonella, Shigella and E. Coli O157 (Vitek)

Work plan and distribution of responsibilities

A full time medical supervisor was available at all times for patient work-up, clinical evaluation and study enrollment. Four full time positions were created in order to have a Maternal & Child Health Professional on hand to assist the mother, child and house staff. While on duty, they participated in clinical evaluations, study coordination, collection of information, updating case reports, and collection and transportation of samples to the lab. Each one of these physicians was available in-house on 24-hour shifts.

The medical residents were fully instructed as to the goals and methodology of the study. In conjunction with the in-house Maternal and Child Health Professional, they actively enrolled new patients, performed clinical evaluations, obtained the written consent of the parents, signed admission, medication and laboratory test orders, assisted in study documentation and updated case report forms.

Ethical requisites

The consent form was prepared based on internationally accepted ethical requirements (30), and given to or read to the person in charge of the child. This document was signed by a parent or guardian and a witness in additional to the investigator, whether the medical resident or Maternal and Child Health Professional.

Creation of a measurement instrument for the observed parameters

A scale of 0 to 10 was assigned to each of the seven study parameters, where 0 was defined as not present and 10 very severe. The investigators assigned a value for each factor at time points 0, 6, 12, 18, 24 and 72 hours based upon their history and examination of the subject. A numerical average was created at each time point as an overall representation of clinical status specific for an acute diarrheal illness. In addition, the YOS was scored using standard methods at each time period (scored from 6 to 30).


Study data was entered using the program Epi-Info 2000 for preliminary analysis and the SPSS for the definitive analysis. Bivariate association tests with time sequences were done, using the student’s t-test or chi-square, according to each case. The processing of this information and its evaluation were the responsibility of statistical consultants.

Information from the patient charts and case report forms were cross-checked with information entered in the computer, confirming a projected correlation of > 99.7 % between them.


Thirty five out of the 177 children screened to participate in the study (19.7 %) were not enrolled in the study in the study because of a co-existing infection, most commonly a urinary tract infection; a non-infectious or parasitic cause of diarrhea; failure of the parents to sign the consent form; or a chronic medical condition. An additional 19 (10.7%) were lost to follow-up between discharge from the hospital after 24 hours and the 72 hour final evaluation. When all screening failures or children lost to 72 hour follow-up were considered, 54 (30%) of the screened cases could not be evaluated.

One hundred thirty-four subjects were evaluable, 64 in the test group and 59 in the control group, randomly assigned to either group A (control) or group B (test).

There were no recorded side- or adverse effects suspected or attributed to Enercel® administration. In particular, there were no infections, bleeding episodes or excessive pain at the IM injection sites.

The study analysis strategy was two-fold: (1) to confirm that both groups were comparable and (2) to statistically determine significant differences of clinical status between the two groups.

Group comparison

In order to confirm that both groups were comparable, variables that could produce intra-group error were compared. Demographic and clinical variables were: age and sex; time since onset of symptoms; nutritional status, and clinical condition at admission. Laboratory characteristics were: fresh stool examination, rotavirus testing, stool culture for enteric bacteria and peripheral WBC. No significant difference between the two groups was recorded.

Demographics and Clinical:

a- Age and sex: In both groups the males predominated (76% in group A and 74% in group B). Median age was similar in both groups (13 months versus 12 months).

b- Time from symptom onset to screening: The mean in hours was 13 hours in group A and 15 hours in group B.

c- Nutritional Status: The Z points median for anthropometrical indicators of height-age, weight-age and height-weight failed to reveal any statistical difference between the two groups.
d- Signs and symptoms in the 24 hours prior to screening (Table 2): More than 5 bowel movements were present in 82% of cases for group A and 88% in group B; recorded body temperature > 38.5° C was present in 76% (group A) and 83% (group B); frequent vomiting was found in 69% (group A) and 69% (group B); refusal of oral water and/or food was recorded in 59% (group A) and 57% (Group B); and frequent abdominal cramps were reported in 50% (Group A) and 55% (Group B).

Laboratory testing:

a- Fresh stool examination: The fresh stool examination and cultures yielded viral, bacterial and non-specific characteristics at the beginning in both study groups without significant statistical differences: bacterial 22% vs. 34%, p = NS; viral 12% vs. 17%, p = NS and non-specific 19% vs. 16%, p = NS.

b- Rotavirus testing: In the control (A) group, rotavirus was identified in 29% (17) of the cases, while rotavirus was isolated in 23% (15) of the cases in the test (B) group.

c- Stool culture for Salmonella, Shigella and E. Coli O157: positive cultures were recorded in 10% of group A vs. 8% of group B cases, primarily Shigella

d- Blood WBC: White blood cell count was similar in both groups (group A = 12.3 +/-3.1k; group B = 13.6 +/- 3.9k); neutrophil count was not statistically different between the groups (61% vs. 59% for groups A and B, respectively)

Differences in clinical status between groups

Mean clinical status score:

Means for the seven clinical signs and symptoms (refusal to ingest food and/or water, vomiting; abdominal pain; temperature; peristalsis; hydration status; and number of bowel movements) at each time point were determined by averaging the seven scores from 0 to 10. A clinical status score from 0 to 10 was determined at each time point and compared using the SPSS program.

Mean clinical scores at baseline were 7.9 +/- 1.9 and 8.3 +/- 2.2 for groups A and B, respectively. These high values reflected the severity of the illness at enrollment. There was no significant difference between the two groups (p > 0.1) No significant difference between the groups in scores at 6 or 12 hours after enrollment were recorded (Figure 1). However, there was a significant difference between groups A and B at 18 hours (group A 5.7 +/- 1.2 and group B 3.7 +/- 0.8; p < .05); 24 hours (group A 4.1 +/- 1.0 and group B 2.2 +/- 0.5; p < .05) and 72 hours (group A 2.8 +/- 0.7 and group B 0.9 +/- 0.3; p < .01).

Yale Observation Score:

YOS scores at baseline were 15.8 +/- 3.3 and 15.3 +/- 3.7 for groups A and B, respectively. The scores improved over time, but more rapidly in the Enercel® treatment group (Figure 2). Significant differences in YOS between the groups was observed at 18 hours (control group: 10.1 +/- 2.7 and test group 7.2 +/- 1.6; p < 0.5), 24 hours (control group 9.8 +/- 2.6 and test group 6.9 +/- 1.6; p < .01) and 72 hours (control group 8.1 +/- 2.3 and test group 6.4 +/- 1.7; p < .05).

Fecal volume:

The volume of fecal output was very high during the initial 6 hour period and similar between the two groups (mean 24.1 +/- 7.3 cc/kg body weight group A and 22.9 +/- 7.5 cc/kg body weight group B, p = NS). The total fecal output dropped over time in both groups, but more quickly in the Enercel® treatment group (Figure 3). No difference in output was noted during the time 6 – 12 hours, but there was a significant difference in fecal output between the two groups at time periods 12 – 18 hours (group A, 10.6 +/- 2.9 cc/kg and group B, 4.9 +/- 2.0); p < .01 and 18 – 24 hours (group A, 5.8 +/- 2.3 and group B, 2.2 +/- 1.2; p < .01).

Rotavirus subgroup:

A total of 32 cases of rotaviruses infection (as documented by a positive latex agglutination test for rotavirus antigens) were identified. Seventeen were distributed among group A and 15 in group B.
There was no significant difference between mean clinical score in the rotavirus subgroup at baseline and the entire population. For group A, mean score for the entire group was 7.9 +/- 1.9 versus 8.2 +/- 2.2 for the rotavirus subgroup. For group B, mean scores were 8.3 +/- 1.9 versus 8.0 +/- 2.1 for the entire population or rotavirus subgroup, respectively. Using the clinical status scale described earlier, it was found that the mean values descended through the study time intervals in a similar way that the group as a whole. The Enercel® treatment group tended to have better outcome scores than the controls (Figure 4). Statistical significance was marginal (p = 0.08 and p = 0.06) at 18 and 24 hours, respectively, but became significant (p < 0.01) at 72 hours.


Since acute diarrhea in children under five years of age is a complex clinical entity with multiple etiologies, the therapeutic approach has explored many options that range from antibiotics either presumptively or based on specific cultures (27); probiotics (3, 32-33); lactobacilli (34); immunoglobulins of different origins (35); intestinal secretion inhibiters (36); vaccines (37), and symptomatic measures only like rehydration and anti-diarrheal agents.
The current research study focuses on a non-conventional approach used early (within 24 hours) in the diarrheal illness. Enercel® is a complex homeopathic mixture with documented imunomodulatory (12) and energy-inducing (13) properties. Which of these mechanisms, if any, is responsible for the positive response in this study is currently unknown. Other investigators (38-39) have also published their favorable experiences with other homeopathic compounds in the treatment of acute infectious diarrhea in children.

The two IM Enercel® doses at 12 hour intervals were used based upon preliminary results by one of the investigators (18). Such a regimen is low-cost and two total doses may be manageable given the reduced capacity of individuals in developing countries to access medical care. IM use also obligates the need for oral medications, which may be poorly tolerated and have undependable absorption. Further studies may be indicated to assess the capacity of Enercel® to have clinical utility using a single IM injection.

The results are based on the comparison of two groups of children that were well-matched at baseline in terms of age, sex, nutritional status, length of illness and clinical presentation. Both groups received the same supportive care during their initial 24 hour hospitalization. Therefore, it is felt that the significant differences in clinical response, general health (as assessed by the Yale Observation Score) and volume of fecal output were not biased by differences in the two study groups. The only detectable variable was Enercel® use.

The study was not controlled by use of a placebo. Furthermore, investigators were not blinded as to which patients received Enercel® and which did not. However, it is felt that the placebo effect, if any, in this study would be minimal given that the study population was small children. Furthermore, statistically significant improvements in the Enercel® treatment group compared to the controls were consistently recorded for all parameters. Of note, fecal output improved significantly better in the Enercel® group; this outcome measure is unlikely to be influenced by a placebo effect. Potential investigator bias is limited by the fact that neither the medical residents, the Maternal & Child Health Professionals, the hospital staff nor the hospital itself benefitted from a positive outcome in any way, including financially. Enercel® is not used as a therapy in that hospital.
The study involved children that were ill enough to seek help at an emergency center. A set of 7 symptoms and signs were selected by a panel of 21 local pediatricians to generate a scale which scored the severity of the clinical syndrome at baseline and time points throughout the study. A mean score of approximately 8.0 (maximal score 10.0) at time of screening exemplified a rather sick initial population. Although there were no deaths and all of the children improved over the 72 hours study period, the Enercel®-treated group improved faster. This rapid and dependable clinical recovery could translate in the population into fewer deaths, lower the cost of medical care, obligate the need for antibiotics and result in fewer complications such as severe dehydration. These considerations would be more compelling in developing countries.

Rotavirus infections typically cause a more prolonged and severe acute diarrheal syndrome compared to most other causes of infectious diarrhea, so analysis of the confirmed rotavirus infections was performed in the current study. The severity of the clinical syndrome was similar at baseline between the entire population and the rotavirus subgroup. Clinical recovery from the acute illness was somewhat slower in the rotavirus subgroup compared to the entire population. Clinical response to Enercel® was slightly less in this subgroup compared to the groups as a whole, but there was significantly greater improvement at 72 hours in the Enercel® group compared to controls. Based on these results, further study of the use of Enercel® in rotavirus outbreaks may be indicated.


This study reports the clinical utility of intramuscular Enercel® administration in cases of acute, presumed or documented infectious diarrhea in children from 6 months to 5 years of age. Larger studies are indicated to assess whether Enercel® is similarly effective in the community and whether it can impact endpoints not evaluable in the current study like mortality and cost-savings.


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Table 1: Ingredients and dilutions of Enercel® Plus IM:

Name of Ingredient Dilution Volume
Cacti Grandiflora 4X 2.5 ml
Aloe Socotrina 4X 3.75 ml
Abis Nigra 6X 4.8 ml
Arnica 6X 6.4 ml
Lachesis 11X 4.8 ml
Calcium Carbonate 6X 3.6 ml
Licopodium 4X 6.0 ml
Water for injection 68.15 ml


Table 2: Comparison of clinical signs and symptoms between the control (group A) and the test group (B) at baseline:

Clinical parameter

Study Group

Control (A)

Test (B)

p value


Dehydration present 74% 79% NS* 76%
YOS points 15.8 15.3 NS 12.7
Frequent vomiting 69% 69% NS 69%
Refused oral food/water 59% 57% NS 58%
More than 5 stools/24 hrs 82% 88% NS 85%
More than 7 stools/24 hrs 68% 61% NS 64%
Abdominal cramps 50% 55% NS 53%
Temperature > 38.5 deg C 76% 83% NS 79%
Peristalsis > 15/15 seconds 40% 45% NS 43%

* NS = non-significant


Diarrhea Newspaper writeup

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