Ranit Mishori, MD, MHS

More than 5 million Americans are living with paralysis, and for nearly one in 4 of them the cause is spinal cord injury or disease (SCI/D).¹ More common than multiple sclerosis (17%) as a cause for the loss of movement, SCI/D is second only to stroke (29%).¹

The percentage of people living with paralysis due to SCI/D is increasing, partly because the population is aging and partly because management of infections has improved. Prior to the 1970s, life expectancy for people with SCI/D was significantly shortened, largely because of urologic and respiratory infections. But improved bladder management, in particular, has increased life expectancy—especially for the least severely injured.² Respiratory diseases and septicemia remain the leading causes of death, but with increased longevity, other causes, such as endocrine, metabolic and nutritional diseases, accidents, nervous system diseases, and musculoskeletal disorders, are becoming increasingly common.^2,3

Primary care’s pivotal role. Given the size of the population affected by SCI/D and the increase in life expectancy, family physicians (FPs) are more likely than ever before to care for these patients, most of whom have highly specific needs. However, little information about the primary care of patients with SCI/D exists. This patient population tends to consume a relatively large share of practices’ resources because of high case complexity.⁴

A recent Canadian report confirms our clinical experience that FPs report knowledge gaps in the area of SCI/D care, yet the same report found that 90% of people with SCI/D identify FPs as their “regular doctors.”⁵ Although a large number of patients with SCI/D identify their physiatrist as their primary care physician (PCP), one study reported that fewer than half of physiatrists are willing to assume that role.⁶ And while more than half of all patients with SCI/D have both specialists and PCPs involved in their care,⁵ communication breakdowns are a concern for patients receiving medical and rehabilitative direction from multiple health care professionals.

Below we take a closer look at the distinct patient populations affected by SCI/D, summarize several clinical conditions that contribute to hospitalization, and provide clinical management recommendations (TABLE^7-26).

2 patient populations, one diagnosis

Paralysis due to spinal trauma occurs predominantly in non-Hispanic white and black males because of vehicular accidents, falls, violence, and sports.² The mean age of injury has increased from 29 years during the 1970s to 42 years since 2010.² However, this calculated average is misleading because there is an emerging bimodal distribution of people injured during early adulthood and a new increase in older adults injured primarily because of falls.²⁷ In addition to those injured traumatically, a broader cohort of approximately 1 million patients represents a largely undefined group of people with paralysis due to diseases such as spinal stenosis, cancer, infection, multiple sclerosis, or other non-traumatic causes.

Rehospitalization, an outcome often quoted as a proxy for inadequate primary care, remains unacceptably high—up to 50%—for people with spinal cord injury/disease.

As a result, the population with SCI/D is comprised primarily of young adult males who have relatively few chronic medical conditions at the time of their injury and age with SCI/D, and older patients who are more likely to have already developed chronic medical conditions by the time of their SCI/D. Approximately 60% of SCI/Ds result in tetraplegia (ie, 4 limbs affected), although approximately two-thirds are incomplete, meaning that patients have some residual motor or sensory function below the level of injury.² Not surprisingly, the level and severity of SCI/D impact life expectancy inversely and lifetime financial costs directly.

High health care utilization. Morbidity data largely parallel mortality data, often resulting in high health care utilization and cost among SCI/D patients.²⁸ In a recent prospective observational study of nearly 1000 people with new traumatic SCI, 36.2% were rehospitalized at least once and 12.5% were rehospitalized at least twice during the 12-month period after discharge following injury.²⁹

Rehospitalization, an outcome often quoted as a proxy for inadequate primary care, remains unacceptably high (36%-50%) for people with SCI/D.^29,30 The leading causes of rehospitalization—pneumonia, urinary tract infection (UTI), and pressure ulcers²⁹—have not changed over the years and persist over the lifetime of individuals with SCI/D.³⁰

Take steps to prevent pneumonia, other respiratory complications

Many people with SCI/D are at high risk for respiratory complications because of their weakened respiratory muscles. This is particularly true for individuals who have injuries occurring above T10; those with injuries that are high on the spinal cord have the highest complication risk.^7,8 In fact, pneumonia, atelectasis, and other respiratory complications are the leading causes of mortality in patients with tetraplegia, occurring in 40% to 70% of these patients.⁷

The diaphragm, innervated by the phrenic nerve (C3-C5), is the primary muscle of inspiration. Accessory muscles of inspiration include the scalenes (C5-C8), sternocleidomastoid and trapezius (C1-C4), and intercostals (T1-T11); whereas forced exhalation (cough) occurs with contraction of the abdominals (T5-T12).⁹ Diminished inspiration in individuals with higher level lesions can lead to microatelectasis, dyspnea with exertion, and even respiratory insufficiency.

In SCI/D above T8, weakened expiration can severely decrease cough effectiveness and secretion clearance, increasing susceptibility to lower respiratory tract infections. In addition, experts have described asthma-like disorders of airway function, particularly in those with higher lesions, due to unopposed parasympathetic innervation of respiratory smooth muscle.¹⁰

Use general population guidelines to target antibiotic therapy, as guidelines validated for use in the spinal cord injury/disease population don't exist.

Management of this neurogenic pulmonary dysfunction after SCI/D relies on extensive preventive measures, including positioning and postural changes, breathing techniques, coughing (assisted for patients with tetraplegia), postural drainage, chest compression and percussion, and suctioning to avoid atelectasis, aspiration, and pneumonia. Ensure that patients receive influenza and pneumococcal vaccinations, and encourage smoking cessation. Obtain a chest x-ray if the patient demonstrates a decrease in respiratory function, deteriorating vital signs, reduced vital capacity, an increase in subjective dyspnea, or a change in sputum quantity. Treat respiratory infections early and aggressively,^7-10 and strongly consider inpatient management because of the high risk of respiratory failure.

Pneumococcus is the most common cause of respiratory infections, although up to 21% of cases of community-acquired pneumonia in patients with SCI/D are caused by Pseudomonas.^11-13 Avoid the use of antibiotics in patients who do not have signs or symptoms of a respiratory infection to minimize the development of resistant organisms. Target antibiotic therapy as per general population guidelines, as guidelines validated for use in the population with SCI/D do not currently exist.^7,11

Be alert for UTIs—typical signs, symptoms don’t apply

The bladder receives innervation from S2 to S4 via the hypogastric, pudendal, and pelvic nerves. As such, the vast majority—70% to 84%—of patients with SCI/D report some degree of bladder dysfunction.¹⁴ Generally, SCI/D contributes to a combination of a failure to empty the bladder and a failure to store urine. The former is more frequent and the latter occurs more often in people with bladder outlet flaccidity, which usually occurs with low injury, such as that of the lumbar spine.¹⁴

The majority of people with SCI/D who are unable to empty their bladder require the use of some type of bladder catheter, either intermittent, indwelling (urethral or suprapubic), or condom. The choice of bladder management technique depends on gender, hand function, body habitus, caregiver assistance, and medical comorbidities. People with SCI/D are at greater risk for bladder and renal stones, UTI, vesicoureteral reflux, and bladder cancer.^15,16 That said, the risk of bladder and renal stones declines somewhat after the first 6 months following an injury due to an immobility-induced loss of calcium.

One can't rely on the typical UTI symptoms of dysuria and increased urinary frequency in this patient population.

Patients with SCI/D are often found to have bacteruria and even pyuria, and although they are at high risk for recurrent UTIs, these can be difficult to diagnose because signs and symptoms may differ from those seen in people with neurologically intact bladders. Symptomatic UTIs may present with fever, hematuria, abdominal discomfort, and/or increased spasticity, among other symptoms. They may cause increased bouts of autonomic dysreflexia, malaise, or a change in functional status. One cannot rely on the typical symptoms of dysuria and increased urinary frequency in this patient population. Further, the Infectious Diseases Society of America (IDSA) states that cloudy or foul-smelling urine in adults with catheters is not a symptom or sign mandating treatment.¹⁷

Because there is a lack of consensus as to what constitutes UTI symptoms in patients with SCI/D, PCPs need to be aware of changes from baseline in patients; these, combined with urine dip and culture results, should guide initiation of treatment.¹⁶

Prophylactic antibiotics have no role in the prevention of UTIs in patients with SCI/D. The minimal benefits associated with prophylaxis are outweighed by the risks of increased bacterial resistance to antibiotics. Research shows no significant benefit associated with the use of non-antibiotic prophylaxis, including the use of cranberry products and mannose, but further studies are needed in this patient population.¹⁸

Focus on bowel function; it correlates with quality of life

Bowel dysfunction is nearly universal in patients with SCI/D. The enteric nervous system is modulated via the sympathetic, parasympathetic, and somatic systems, and intrinsic control occurs via the myenteric and submucosal plexi. The loss of volitional control of defecation can result in prolonged transit time, reduced colonic motility, fecal incontinence, and difficulty with evacuation.

Because bowel care and function are highly correlated with quality of life,¹⁹ recommend bowel emptying every day or every other day, as well as adequate fiber in the diet, intake of fluids, stool softeners, bulk forming agents, contact irritants (eg, bisacodyl), and prokinetic agents to achieve optimal bowel care.

Prevent and treat pressure ulcers whenever possible

Fertility is often unaffected in women with spinal cord injury/disease, so routine discussions about contraception in those who are sexually active are imperative.

Accompanying the paralysis associated with SCI/D is often some degree of sensory loss of pain, light touch, temperature, and/or proprioception. The combination of insensate skin, immobility, and sarcopenia with resultant body composition changes places individuals with SCI/D at high risk for skin breakdown.^21,22 Blood flow and oxygen tension at the skin surface are also decreased in patients with SCI/D compared to those without, further contributing to the problem.^21,23 Increased latency from the time of injury correlates with increased likelihood of pressure ulcer development.^21,22,24

External risk factors for pressure ulcers include prolonged pressure exposure, or intense pressure over a short period, shear forces, poor nutrition, smoking, moisture, and immobility. The incidence of pressure ulcers in patients with SCI/D is 25% to 66%, compared with 0.38% in the general population.^21,22 Research indicates that US hospitals spend $11 billion annually on the treatment of the condition.²²

To minimize pressure ulcers in this population, perform a risk assessment, using, for example, the Spinal Cord Injury Pressure Ulcer Scale-Acute (SCIPUS-A) available at https://www.scireproject.com/outcome-measures-new/spinal-cord-injury-pressure-ulcer-scale-acute-scipus. In addition, recommend that patients use pressure redistribution surfaces for beds and wheelchairs, turn while in bed, perform frequent (approximately every 15-30 minutes) pressure reliefs, exercise or move regularly, and that they or a caregiver inspect the skin daily. If pressure ulcers do occur, start treatment immediately and document the stage of the ulcer.

Ensure that screening efforts go beyond what’s standard

Preventive care for patients with SCI/D is similar in many ways to that recommended for the general population. Screening for colorectal cancer,³¹ cervical cancer, and breast cancer³² should follow the same evidence-based intervals and age ranges suggested by groups such as the US Preventive Services Task Force (USPSTF). The only difference is to give special consideration to patients’ physical limitations and the set-up of exam rooms when scheduling and conducting procedures, such as Pap smears, colonoscopies, and mammograms.^33,34

Bladder cancer. Because of the high risk for bladder cancer (ie, squamous cell carcinoma, as opposed to the more common transitional cell carcinoma) in this population, experts recommend annual cystoscopy for bladder cancer surveillance in patients who have had indwelling catheters for more than 5 to 10 years.³⁵

Osteoporosis. Screening for osteoporosis is another preventive health area in which recommendations differ from those addressing the general population. Paralysis contributes to a decrease in mechanical stress on bone and to accelerated bone loss, and, thus, to osteoporosis.³⁶

In patients with SCI/D, osteoporosis affects primarily weight-bearing areas below the injured lesion, such as the distal femur and proximal tibia. Fractures in patients with SCI/D may occur during minor trauma (eg, during transfers from wheelchair to bed). Although screening and treatment guidelines for osteoporosis in patients with SCI/D are not established, most experts recommend early screening and early and aggressive treatment.³⁶

Male fertility is usually profoundly affected by spinal cord injury/disease; patients and their partners who are interested in having children will require specialized interventions.

Depression reportedly occurs more frequently in individuals with SCI/D than in the general population,^37,38 affecting adjustment, quality of life, and social, behavioral, and physical functioning. In light of this, it’s advisable to use screening tools, such as The Patient Health Questionnaire (PHQ)-9, routinely.³⁹

Sexuality and sexual function are often adversely affected in both men and women with SCI/D. Loss of sensation in the sexual organs, combined with difficulty with positioning and mobility and bowel and bladder dysfunction, contribute not only to sexual dysfunction, but to lower self-esteem and altered body image.⁴⁰

It is important to remember that fertility is often unaffected in women, so routine discussions about contraception with women who have SCI/D and who are sexually active are imperative. At the same time, male fertility is usually profoundly affected by SCI/D; patients and their partners who are interested in having children will require specialized interventions. Address sexuality and fertility during primary care visits and refer patients to counseling or specialists as necessary.^41-43

SCI/D requires a whole-person approach

The care of individuals with SCI/D requires a holistic approach that takes into consideration physical, psychological, environmental, and interpersonal factors^44,45 and involves ongoing support from a variety of specialists. FPs, with their whole-person orientation, can be instrumental in ensuring the successful rehabilitation of patients affected by SCI/D, and in helping individuals attain, preserve, and enhance their health and well-being.

CORRESPONDENCE
Ranit Mishori, MD, MHS, FAAFP, Georgetown University School of Medicine, 3900 Reservoir Road, NW, Pre-clinical Building GB-01D, Washington, DC 20007; [email protected].

More than 5 million Americans are living with paralysis, and for nearly one in 4 of them the cause is spinal cord injury or disease (SCI/D).¹ More common than multiple sclerosis (17%) as a cause for the loss of movement, SCI/D is second only to stroke (29%).¹

The percentage of people living with paralysis due to SCI/D is increasing, partly because the population is aging and partly because management of infections has improved. Prior to the 1970s, life expectancy for people with SCI/D was significantly shortened, largely because of urologic and respiratory infections. But improved bladder management, in particular, has increased life expectancy—especially for the least severely injured.² Respiratory diseases and septicemia remain the leading causes of death, but with increased longevity, other causes, such as endocrine, metabolic and nutritional diseases, accidents, nervous system diseases, and musculoskeletal disorders, are becoming increasingly common.^2,3

Primary care’s pivotal role. Given the size of the population affected by SCI/D and the increase in life expectancy, family physicians (FPs) are more likely than ever before to care for these patients, most of whom have highly specific needs. However, little information about the primary care of patients with SCI/D exists. This patient population tends to consume a relatively large share of practices’ resources because of high case complexity.⁴

A recent Canadian report confirms our clinical experience that FPs report knowledge gaps in the area of SCI/D care, yet the same report found that 90% of people with SCI/D identify FPs as their “regular doctors.”⁵ Although a large number of patients with SCI/D identify their physiatrist as their primary care physician (PCP), one study reported that fewer than half of physiatrists are willing to assume that role.⁶ And while more than half of all patients with SCI/D have both specialists and PCPs involved in their care,⁵ communication breakdowns are a concern for patients receiving medical and rehabilitative direction from multiple health care professionals.

Below we take a closer look at the distinct patient populations affected by SCI/D, summarize several clinical conditions that contribute to hospitalization, and provide clinical management recommendations (TABLE^7-26).

2 patient populations, one diagnosis

Paralysis due to spinal trauma occurs predominantly in non-Hispanic white and black males because of vehicular accidents, falls, violence, and sports.² The mean age of injury has increased from 29 years during the 1970s to 42 years since 2010.² However, this calculated average is misleading because there is an emerging bimodal distribution of people injured during early adulthood and a new increase in older adults injured primarily because of falls.²⁷ In addition to those injured traumatically, a broader cohort of approximately 1 million patients represents a largely undefined group of people with paralysis due to diseases such as spinal stenosis, cancer, infection, multiple sclerosis, or other non-traumatic causes.

Rehospitalization, an outcome often quoted as a proxy for inadequate primary care, remains unacceptably high—up to 50%—for people with spinal cord injury/disease.

As a result, the population with SCI/D is comprised primarily of young adult males who have relatively few chronic medical conditions at the time of their injury and age with SCI/D, and older patients who are more likely to have already developed chronic medical conditions by the time of their SCI/D. Approximately 60% of SCI/Ds result in tetraplegia (ie, 4 limbs affected), although approximately two-thirds are incomplete, meaning that patients have some residual motor or sensory function below the level of injury.² Not surprisingly, the level and severity of SCI/D impact life expectancy inversely and lifetime financial costs directly.

High health care utilization. Morbidity data largely parallel mortality data, often resulting in high health care utilization and cost among SCI/D patients.²⁸ In a recent prospective observational study of nearly 1000 people with new traumatic SCI, 36.2% were rehospitalized at least once and 12.5% were rehospitalized at least twice during the 12-month period after discharge following injury.²⁹

Rehospitalization, an outcome often quoted as a proxy for inadequate primary care, remains unacceptably high (36%-50%) for people with SCI/D.^29,30 The leading causes of rehospitalization—pneumonia, urinary tract infection (UTI), and pressure ulcers²⁹—have not changed over the years and persist over the lifetime of individuals with SCI/D.³⁰

Take steps to prevent pneumonia, other respiratory complications

Many people with SCI/D are at high risk for respiratory complications because of their weakened respiratory muscles. This is particularly true for individuals who have injuries occurring above T10; those with injuries that are high on the spinal cord have the highest complication risk.^7,8 In fact, pneumonia, atelectasis, and other respiratory complications are the leading causes of mortality in patients with tetraplegia, occurring in 40% to 70% of these patients.⁷

The diaphragm, innervated by the phrenic nerve (C3-C5), is the primary muscle of inspiration. Accessory muscles of inspiration include the scalenes (C5-C8), sternocleidomastoid and trapezius (C1-C4), and intercostals (T1-T11); whereas forced exhalation (cough) occurs with contraction of the abdominals (T5-T12).⁹ Diminished inspiration in individuals with higher level lesions can lead to microatelectasis, dyspnea with exertion, and even respiratory insufficiency.

In SCI/D above T8, weakened expiration can severely decrease cough effectiveness and secretion clearance, increasing susceptibility to lower respiratory tract infections. In addition, experts have described asthma-like disorders of airway function, particularly in those with higher lesions, due to unopposed parasympathetic innervation of respiratory smooth muscle.¹⁰

Use general population guidelines to target antibiotic therapy, as guidelines validated for use in the spinal cord injury/disease population don't exist.

Management of this neurogenic pulmonary dysfunction after SCI/D relies on extensive preventive measures, including positioning and postural changes, breathing techniques, coughing (assisted for patients with tetraplegia), postural drainage, chest compression and percussion, and suctioning to avoid atelectasis, aspiration, and pneumonia. Ensure that patients receive influenza and pneumococcal vaccinations, and encourage smoking cessation. Obtain a chest x-ray if the patient demonstrates a decrease in respiratory function, deteriorating vital signs, reduced vital capacity, an increase in subjective dyspnea, or a change in sputum quantity. Treat respiratory infections early and aggressively,^7-10 and strongly consider inpatient management because of the high risk of respiratory failure.

Pneumococcus is the most common cause of respiratory infections, although up to 21% of cases of community-acquired pneumonia in patients with SCI/D are caused by Pseudomonas.^11-13 Avoid the use of antibiotics in patients who do not have signs or symptoms of a respiratory infection to minimize the development of resistant organisms. Target antibiotic therapy as per general population guidelines, as guidelines validated for use in the population with SCI/D do not currently exist.^7,11

Be alert for UTIs—typical signs, symptoms don’t apply

The bladder receives innervation from S2 to S4 via the hypogastric, pudendal, and pelvic nerves. As such, the vast majority—70% to 84%—of patients with SCI/D report some degree of bladder dysfunction.¹⁴ Generally, SCI/D contributes to a combination of a failure to empty the bladder and a failure to store urine. The former is more frequent and the latter occurs more often in people with bladder outlet flaccidity, which usually occurs with low injury, such as that of the lumbar spine.¹⁴

The majority of people with SCI/D who are unable to empty their bladder require the use of some type of bladder catheter, either intermittent, indwelling (urethral or suprapubic), or condom. The choice of bladder management technique depends on gender, hand function, body habitus, caregiver assistance, and medical comorbidities. People with SCI/D are at greater risk for bladder and renal stones, UTI, vesicoureteral reflux, and bladder cancer.^15,16 That said, the risk of bladder and renal stones declines somewhat after the first 6 months following an injury due to an immobility-induced loss of calcium.

One can't rely on the typical UTI symptoms of dysuria and increased urinary frequency in this patient population.

Patients with SCI/D are often found to have bacteruria and even pyuria, and although they are at high risk for recurrent UTIs, these can be difficult to diagnose because signs and symptoms may differ from those seen in people with neurologically intact bladders. Symptomatic UTIs may present with fever, hematuria, abdominal discomfort, and/or increased spasticity, among other symptoms. They may cause increased bouts of autonomic dysreflexia, malaise, or a change in functional status. One cannot rely on the typical symptoms of dysuria and increased urinary frequency in this patient population. Further, the Infectious Diseases Society of America (IDSA) states that cloudy or foul-smelling urine in adults with catheters is not a symptom or sign mandating treatment.¹⁷

Because there is a lack of consensus as to what constitutes UTI symptoms in patients with SCI/D, PCPs need to be aware of changes from baseline in patients; these, combined with urine dip and culture results, should guide initiation of treatment.¹⁶

Prophylactic antibiotics have no role in the prevention of UTIs in patients with SCI/D. The minimal benefits associated with prophylaxis are outweighed by the risks of increased bacterial resistance to antibiotics. Research shows no significant benefit associated with the use of non-antibiotic prophylaxis, including the use of cranberry products and mannose, but further studies are needed in this patient population.¹⁸

Focus on bowel function; it correlates with quality of life

Bowel dysfunction is nearly universal in patients with SCI/D. The enteric nervous system is modulated via the sympathetic, parasympathetic, and somatic systems, and intrinsic control occurs via the myenteric and submucosal plexi. The loss of volitional control of defecation can result in prolonged transit time, reduced colonic motility, fecal incontinence, and difficulty with evacuation.

Because bowel care and function are highly correlated with quality of life,¹⁹ recommend bowel emptying every day or every other day, as well as adequate fiber in the diet, intake of fluids, stool softeners, bulk forming agents, contact irritants (eg, bisacodyl), and prokinetic agents to achieve optimal bowel care.

Prevent and treat pressure ulcers whenever possible

Fertility is often unaffected in women with spinal cord injury/disease, so routine discussions about contraception in those who are sexually active are imperative.

Accompanying the paralysis associated with SCI/D is often some degree of sensory loss of pain, light touch, temperature, and/or proprioception. The combination of insensate skin, immobility, and sarcopenia with resultant body composition changes places individuals with SCI/D at high risk for skin breakdown.^21,22 Blood flow and oxygen tension at the skin surface are also decreased in patients with SCI/D compared to those without, further contributing to the problem.^21,23 Increased latency from the time of injury correlates with increased likelihood of pressure ulcer development.^21,22,24

External risk factors for pressure ulcers include prolonged pressure exposure, or intense pressure over a short period, shear forces, poor nutrition, smoking, moisture, and immobility. The incidence of pressure ulcers in patients with SCI/D is 25% to 66%, compared with 0.38% in the general population.^21,22 Research indicates that US hospitals spend $11 billion annually on the treatment of the condition.²²

To minimize pressure ulcers in this population, perform a risk assessment, using, for example, the Spinal Cord Injury Pressure Ulcer Scale-Acute (SCIPUS-A) available at https://www.scireproject.com/outcome-measures-new/spinal-cord-injury-pressure-ulcer-scale-acute-scipus. In addition, recommend that patients use pressure redistribution surfaces for beds and wheelchairs, turn while in bed, perform frequent (approximately every 15-30 minutes) pressure reliefs, exercise or move regularly, and that they or a caregiver inspect the skin daily. If pressure ulcers do occur, start treatment immediately and document the stage of the ulcer.

Ensure that screening efforts go beyond what’s standard

Preventive care for patients with SCI/D is similar in many ways to that recommended for the general population. Screening for colorectal cancer,³¹ cervical cancer, and breast cancer³² should follow the same evidence-based intervals and age ranges suggested by groups such as the US Preventive Services Task Force (USPSTF). The only difference is to give special consideration to patients’ physical limitations and the set-up of exam rooms when scheduling and conducting procedures, such as Pap smears, colonoscopies, and mammograms.^33,34

Bladder cancer. Because of the high risk for bladder cancer (ie, squamous cell carcinoma, as opposed to the more common transitional cell carcinoma) in this population, experts recommend annual cystoscopy for bladder cancer surveillance in patients who have had indwelling catheters for more than 5 to 10 years.³⁵

Osteoporosis. Screening for osteoporosis is another preventive health area in which recommendations differ from those addressing the general population. Paralysis contributes to a decrease in mechanical stress on bone and to accelerated bone loss, and, thus, to osteoporosis.³⁶

In patients with SCI/D, osteoporosis affects primarily weight-bearing areas below the injured lesion, such as the distal femur and proximal tibia. Fractures in patients with SCI/D may occur during minor trauma (eg, during transfers from wheelchair to bed). Although screening and treatment guidelines for osteoporosis in patients with SCI/D are not established, most experts recommend early screening and early and aggressive treatment.³⁶

Male fertility is usually profoundly affected by spinal cord injury/disease; patients and their partners who are interested in having children will require specialized interventions.

Depression reportedly occurs more frequently in individuals with SCI/D than in the general population,^37,38 affecting adjustment, quality of life, and social, behavioral, and physical functioning. In light of this, it’s advisable to use screening tools, such as The Patient Health Questionnaire (PHQ)-9, routinely.³⁹

Sexuality and sexual function are often adversely affected in both men and women with SCI/D. Loss of sensation in the sexual organs, combined with difficulty with positioning and mobility and bowel and bladder dysfunction, contribute not only to sexual dysfunction, but to lower self-esteem and altered body image.⁴⁰

It is important to remember that fertility is often unaffected in women, so routine discussions about contraception with women who have SCI/D and who are sexually active are imperative. At the same time, male fertility is usually profoundly affected by SCI/D; patients and their partners who are interested in having children will require specialized interventions. Address sexuality and fertility during primary care visits and refer patients to counseling or specialists as necessary.^41-43

SCI/D requires a whole-person approach

The care of individuals with SCI/D requires a holistic approach that takes into consideration physical, psychological, environmental, and interpersonal factors^44,45 and involves ongoing support from a variety of specialists. FPs, with their whole-person orientation, can be instrumental in ensuring the successful rehabilitation of patients affected by SCI/D, and in helping individuals attain, preserve, and enhance their health and well-being.

CORRESPONDENCE
Ranit Mishori, MD, MHS, FAAFP, Georgetown University School of Medicine, 3900 Reservoir Road, NW, Pre-clinical Building GB-01D, Washington, DC 20007; [email protected].

More than 5 million Americans are living with paralysis, and for nearly one in 4 of them the cause is spinal cord injury or disease (SCI/D).¹ More common than multiple sclerosis (17%) as a cause for the loss of movement, SCI/D is second only to stroke (29%).¹

The percentage of people living with paralysis due to SCI/D is increasing, partly because the population is aging and partly because management of infections has improved. Prior to the 1970s, life expectancy for people with SCI/D was significantly shortened, largely because of urologic and respiratory infections. But improved bladder management, in particular, has increased life expectancy—especially for the least severely injured.² Respiratory diseases and septicemia remain the leading causes of death, but with increased longevity, other causes, such as endocrine, metabolic and nutritional diseases, accidents, nervous system diseases, and musculoskeletal disorders, are becoming increasingly common.^2,3

Primary care’s pivotal role. Given the size of the population affected by SCI/D and the increase in life expectancy, family physicians (FPs) are more likely than ever before to care for these patients, most of whom have highly specific needs. However, little information about the primary care of patients with SCI/D exists. This patient population tends to consume a relatively large share of practices’ resources because of high case complexity.⁴

A recent Canadian report confirms our clinical experience that FPs report knowledge gaps in the area of SCI/D care, yet the same report found that 90% of people with SCI/D identify FPs as their “regular doctors.”⁵ Although a large number of patients with SCI/D identify their physiatrist as their primary care physician (PCP), one study reported that fewer than half of physiatrists are willing to assume that role.⁶ And while more than half of all patients with SCI/D have both specialists and PCPs involved in their care,⁵ communication breakdowns are a concern for patients receiving medical and rehabilitative direction from multiple health care professionals.

Below we take a closer look at the distinct patient populations affected by SCI/D, summarize several clinical conditions that contribute to hospitalization, and provide clinical management recommendations (TABLE^7-26).

2 patient populations, one diagnosis

Paralysis due to spinal trauma occurs predominantly in non-Hispanic white and black males because of vehicular accidents, falls, violence, and sports.² The mean age of injury has increased from 29 years during the 1970s to 42 years since 2010.² However, this calculated average is misleading because there is an emerging bimodal distribution of people injured during early adulthood and a new increase in older adults injured primarily because of falls.²⁷ In addition to those injured traumatically, a broader cohort of approximately 1 million patients represents a largely undefined group of people with paralysis due to diseases such as spinal stenosis, cancer, infection, multiple sclerosis, or other non-traumatic causes.

Rehospitalization, an outcome often quoted as a proxy for inadequate primary care, remains unacceptably high—up to 50%—for people with spinal cord injury/disease.

As a result, the population with SCI/D is comprised primarily of young adult males who have relatively few chronic medical conditions at the time of their injury and age with SCI/D, and older patients who are more likely to have already developed chronic medical conditions by the time of their SCI/D. Approximately 60% of SCI/Ds result in tetraplegia (ie, 4 limbs affected), although approximately two-thirds are incomplete, meaning that patients have some residual motor or sensory function below the level of injury.² Not surprisingly, the level and severity of SCI/D impact life expectancy inversely and lifetime financial costs directly.

High health care utilization. Morbidity data largely parallel mortality data, often resulting in high health care utilization and cost among SCI/D patients.²⁸ In a recent prospective observational study of nearly 1000 people with new traumatic SCI, 36.2% were rehospitalized at least once and 12.5% were rehospitalized at least twice during the 12-month period after discharge following injury.²⁹

Rehospitalization, an outcome often quoted as a proxy for inadequate primary care, remains unacceptably high (36%-50%) for people with SCI/D.^29,30 The leading causes of rehospitalization—pneumonia, urinary tract infection (UTI), and pressure ulcers²⁹—have not changed over the years and persist over the lifetime of individuals with SCI/D.³⁰

Take steps to prevent pneumonia, other respiratory complications

Many people with SCI/D are at high risk for respiratory complications because of their weakened respiratory muscles. This is particularly true for individuals who have injuries occurring above T10; those with injuries that are high on the spinal cord have the highest complication risk.^7,8 In fact, pneumonia, atelectasis, and other respiratory complications are the leading causes of mortality in patients with tetraplegia, occurring in 40% to 70% of these patients.⁷

The diaphragm, innervated by the phrenic nerve (C3-C5), is the primary muscle of inspiration. Accessory muscles of inspiration include the scalenes (C5-C8), sternocleidomastoid and trapezius (C1-C4), and intercostals (T1-T11); whereas forced exhalation (cough) occurs with contraction of the abdominals (T5-T12).⁹ Diminished inspiration in individuals with higher level lesions can lead to microatelectasis, dyspnea with exertion, and even respiratory insufficiency.

In SCI/D above T8, weakened expiration can severely decrease cough effectiveness and secretion clearance, increasing susceptibility to lower respiratory tract infections. In addition, experts have described asthma-like disorders of airway function, particularly in those with higher lesions, due to unopposed parasympathetic innervation of respiratory smooth muscle.¹⁰

Use general population guidelines to target antibiotic therapy, as guidelines validated for use in the spinal cord injury/disease population don't exist.

Management of this neurogenic pulmonary dysfunction after SCI/D relies on extensive preventive measures, including positioning and postural changes, breathing techniques, coughing (assisted for patients with tetraplegia), postural drainage, chest compression and percussion, and suctioning to avoid atelectasis, aspiration, and pneumonia. Ensure that patients receive influenza and pneumococcal vaccinations, and encourage smoking cessation. Obtain a chest x-ray if the patient demonstrates a decrease in respiratory function, deteriorating vital signs, reduced vital capacity, an increase in subjective dyspnea, or a change in sputum quantity. Treat respiratory infections early and aggressively,^7-10 and strongly consider inpatient management because of the high risk of respiratory failure.

Pneumococcus is the most common cause of respiratory infections, although up to 21% of cases of community-acquired pneumonia in patients with SCI/D are caused by Pseudomonas.^11-13 Avoid the use of antibiotics in patients who do not have signs or symptoms of a respiratory infection to minimize the development of resistant organisms. Target antibiotic therapy as per general population guidelines, as guidelines validated for use in the population with SCI/D do not currently exist.^7,11

Be alert for UTIs—typical signs, symptoms don’t apply

The bladder receives innervation from S2 to S4 via the hypogastric, pudendal, and pelvic nerves. As such, the vast majority—70% to 84%—of patients with SCI/D report some degree of bladder dysfunction.¹⁴ Generally, SCI/D contributes to a combination of a failure to empty the bladder and a failure to store urine. The former is more frequent and the latter occurs more often in people with bladder outlet flaccidity, which usually occurs with low injury, such as that of the lumbar spine.¹⁴

The majority of people with SCI/D who are unable to empty their bladder require the use of some type of bladder catheter, either intermittent, indwelling (urethral or suprapubic), or condom. The choice of bladder management technique depends on gender, hand function, body habitus, caregiver assistance, and medical comorbidities. People with SCI/D are at greater risk for bladder and renal stones, UTI, vesicoureteral reflux, and bladder cancer.^15,16 That said, the risk of bladder and renal stones declines somewhat after the first 6 months following an injury due to an immobility-induced loss of calcium.

One can't rely on the typical UTI symptoms of dysuria and increased urinary frequency in this patient population.

Patients with SCI/D are often found to have bacteruria and even pyuria, and although they are at high risk for recurrent UTIs, these can be difficult to diagnose because signs and symptoms may differ from those seen in people with neurologically intact bladders. Symptomatic UTIs may present with fever, hematuria, abdominal discomfort, and/or increased spasticity, among other symptoms. They may cause increased bouts of autonomic dysreflexia, malaise, or a change in functional status. One cannot rely on the typical symptoms of dysuria and increased urinary frequency in this patient population. Further, the Infectious Diseases Society of America (IDSA) states that cloudy or foul-smelling urine in adults with catheters is not a symptom or sign mandating treatment.¹⁷

Because there is a lack of consensus as to what constitutes UTI symptoms in patients with SCI/D, PCPs need to be aware of changes from baseline in patients; these, combined with urine dip and culture results, should guide initiation of treatment.¹⁶

Prophylactic antibiotics have no role in the prevention of UTIs in patients with SCI/D. The minimal benefits associated with prophylaxis are outweighed by the risks of increased bacterial resistance to antibiotics. Research shows no significant benefit associated with the use of non-antibiotic prophylaxis, including the use of cranberry products and mannose, but further studies are needed in this patient population.¹⁸

Focus on bowel function; it correlates with quality of life

Bowel dysfunction is nearly universal in patients with SCI/D. The enteric nervous system is modulated via the sympathetic, parasympathetic, and somatic systems, and intrinsic control occurs via the myenteric and submucosal plexi. The loss of volitional control of defecation can result in prolonged transit time, reduced colonic motility, fecal incontinence, and difficulty with evacuation.

Because bowel care and function are highly correlated with quality of life,¹⁹ recommend bowel emptying every day or every other day, as well as adequate fiber in the diet, intake of fluids, stool softeners, bulk forming agents, contact irritants (eg, bisacodyl), and prokinetic agents to achieve optimal bowel care.

Prevent and treat pressure ulcers whenever possible

Fertility is often unaffected in women with spinal cord injury/disease, so routine discussions about contraception in those who are sexually active are imperative.

Accompanying the paralysis associated with SCI/D is often some degree of sensory loss of pain, light touch, temperature, and/or proprioception. The combination of insensate skin, immobility, and sarcopenia with resultant body composition changes places individuals with SCI/D at high risk for skin breakdown.^21,22 Blood flow and oxygen tension at the skin surface are also decreased in patients with SCI/D compared to those without, further contributing to the problem.^21,23 Increased latency from the time of injury correlates with increased likelihood of pressure ulcer development.^21,22,24

External risk factors for pressure ulcers include prolonged pressure exposure, or intense pressure over a short period, shear forces, poor nutrition, smoking, moisture, and immobility. The incidence of pressure ulcers in patients with SCI/D is 25% to 66%, compared with 0.38% in the general population.^21,22 Research indicates that US hospitals spend $11 billion annually on the treatment of the condition.²²

To minimize pressure ulcers in this population, perform a risk assessment, using, for example, the Spinal Cord Injury Pressure Ulcer Scale-Acute (SCIPUS-A) available at https://www.scireproject.com/outcome-measures-new/spinal-cord-injury-pressure-ulcer-scale-acute-scipus. In addition, recommend that patients use pressure redistribution surfaces for beds and wheelchairs, turn while in bed, perform frequent (approximately every 15-30 minutes) pressure reliefs, exercise or move regularly, and that they or a caregiver inspect the skin daily. If pressure ulcers do occur, start treatment immediately and document the stage of the ulcer.

Ensure that screening efforts go beyond what’s standard

Preventive care for patients with SCI/D is similar in many ways to that recommended for the general population. Screening for colorectal cancer,³¹ cervical cancer, and breast cancer³² should follow the same evidence-based intervals and age ranges suggested by groups such as the US Preventive Services Task Force (USPSTF). The only difference is to give special consideration to patients’ physical limitations and the set-up of exam rooms when scheduling and conducting procedures, such as Pap smears, colonoscopies, and mammograms.^33,34

Bladder cancer. Because of the high risk for bladder cancer (ie, squamous cell carcinoma, as opposed to the more common transitional cell carcinoma) in this population, experts recommend annual cystoscopy for bladder cancer surveillance in patients who have had indwelling catheters for more than 5 to 10 years.³⁵

Osteoporosis. Screening for osteoporosis is another preventive health area in which recommendations differ from those addressing the general population. Paralysis contributes to a decrease in mechanical stress on bone and to accelerated bone loss, and, thus, to osteoporosis.³⁶

In patients with SCI/D, osteoporosis affects primarily weight-bearing areas below the injured lesion, such as the distal femur and proximal tibia. Fractures in patients with SCI/D may occur during minor trauma (eg, during transfers from wheelchair to bed). Although screening and treatment guidelines for osteoporosis in patients with SCI/D are not established, most experts recommend early screening and early and aggressive treatment.³⁶

Male fertility is usually profoundly affected by spinal cord injury/disease; patients and their partners who are interested in having children will require specialized interventions.

Depression reportedly occurs more frequently in individuals with SCI/D than in the general population,^37,38 affecting adjustment, quality of life, and social, behavioral, and physical functioning. In light of this, it’s advisable to use screening tools, such as The Patient Health Questionnaire (PHQ)-9, routinely.³⁹

Sexuality and sexual function are often adversely affected in both men and women with SCI/D. Loss of sensation in the sexual organs, combined with difficulty with positioning and mobility and bowel and bladder dysfunction, contribute not only to sexual dysfunction, but to lower self-esteem and altered body image.⁴⁰

It is important to remember that fertility is often unaffected in women, so routine discussions about contraception with women who have SCI/D and who are sexually active are imperative. At the same time, male fertility is usually profoundly affected by SCI/D; patients and their partners who are interested in having children will require specialized interventions. Address sexuality and fertility during primary care visits and refer patients to counseling or specialists as necessary.^41-43

SCI/D requires a whole-person approach

The care of individuals with SCI/D requires a holistic approach that takes into consideration physical, psychological, environmental, and interpersonal factors^44,45 and involves ongoing support from a variety of specialists. FPs, with their whole-person orientation, can be instrumental in ensuring the successful rehabilitation of patients affected by SCI/D, and in helping individuals attain, preserve, and enhance their health and well-being.

CORRESPONDENCE
Ranit Mishori, MD, MHS, FAAFP, Georgetown University School of Medicine, 3900 Reservoir Road, NW, Pre-clinical Building GB-01D, Washington, DC 20007; [email protected].

CASE 1 A 31-year-old African American woman sought treatment at her local emergency department (ED) for nausea, vomiting, and diarrhea. She reported passing more than 6 yellowish-brown, watery, nonbloody stools during the previous 2 days. She felt weak, feverish, and light-headed and showed signs of dehydration.

The patient had Crohn’s disease and had undergone a partial colectomy 5 years earlier. She told the ED physician that 2 days before visiting the ED she had gone to a “cleansing center” for a colonic cleansing, but was unable to complete the process because she developed cramps 15 minutes into the procedure. Less than an hour later, she developed diarrhea, nausea, and vomiting.

In the ED, her serum potassium was 2.9 mEq/L, blood urea nitrogen was 26 mg/dL, and creatinine was 1.9 mg/dL. She was afebrile, with a blood pressure of 135/75 mm Hg and a heart rate of 113 beats per minute. After receiving 2 liters of normal saline and 90 mEq of potassium chloride replacement, the patient felt better and was later discharged from the ED.

Three days later, the patient came to our residency clinic. She described her stools as being loose, but not watery or bloody, and passed in small amounts, about 4 times daily. She still had some abdominal cramping just before passing stool, but bowel movements relieved that. Her vital signs were within normal limits, and her physical exam was benign. The patient was instructed to follow her normal diet, as tolerated, and drink plenty of fluids to maintain good hydration. Her symptoms resolved by the following week.

CASE 2 A 49-year-old African American man came to our community hospital because of vomiting, diarrhea, and abdominal pain he had been experiencing for 4 days. He linked the symptoms to eating a large fast-food breakfast, followed by a big lunch the day before. He described having multiple episodes of nonbloody, nonbilious vomiting, nonbloody watery diarrhea, and “twisting” abdominal pain that was constant but temporarily relieved with a warm compress or positional maneuvers. He had never had a similar episode and had not taken any antibiotics recently.

Upon further questioning, the patient revealed that he had used a colon cleanser a few days earlier. A review showed that he had lost 24 pounds in 10 days. Vitals were within normal limits. Serum potassium was 2.9 mEq/L, and creatinine was 2.1 mg/dL. A computed tomography scan of the abdomen revealed moderate to moderately severe dilatation of multiple small bowel loops with multiple air fluid levels, suggesting an early or partial small bowel obstruction. We obtained a surgical consultation, but surgery was not required. He was discharged after 2 days.

The patient returned to the hospital 3 days later with similar symptoms and severe weakness associated with dizziness. At that time his serum potassium was 2.4 mEq/L and creatinine was 4.0 mg/dL. Aspartate aminotransferase was 29 U/L, alanine aminotransferase was 80 U/L, lipase was 418 U/L, and amylase was 94 U/L.

The patient was readmitted for dehydration, hypokalemia, and pancreatitis and, following a colonoscopy and biopsy that revealed chronic and acute inflammation, a gastroenterologist made a diagnosis of “herbal intoxication.” The patient was hydrated, his electrolytes were replaced, and his diet was slowly returned to normal. He was discharged after 5 days.

An old practice rediscovered

Colon cleansing has been around since ancient times, when its purported benefits were based on the belief that intestinal waste can poison the body (“autointoxication”).¹ The procedure became popular in the early 1900s, but in a 1919 paper, the American Medical Association discounted the autointoxication theory and condemned the practice.¹ The procedure then fell out of favor, albeit temporarily.² Colon cleansing has staged a comeback in recent years.

Colon cleansing basics
Colon cleansing, also called colonic irrigation or colonic hydrotherapy, is performed by colonic hygienists or colon therapists, or can be self-administered. The procedure works like an enema. The patient generally lies on a table and water (with or without additional herbs or compounds) is pumped through the rectum via a tube.

Unlike enemas, for which a small amount of fluid is used, however, colon cleansing calls for a large volume of fluid—up to 60 liters—to be introduced into the rectum.^3,4 Fluids and waste are expelled through another tube. The procedure may be repeated several times.

Products go by many names
Most colon cleansing products come in the forms of laxatives, teas, powders, and capsules. They can be taken by mouth or inserted into the rectum. They often contain sodium phosphate, coffee, probiotics, enzymes, or any of a variety of herbs.⁵ Some products contain fiber preparations, including psyllium, flaxseed, and laxatives such as cascara, magnesium oxide, cat’s claw, artichoke leaves, burdock root, licorice, and milk thistle.²

With names such as Nature’s Bounty Colon Cleanser Natural Detox Formula, Health Plus Inc. Colon Cleanse, and 7-Day Miracle Cleanse, as well as endorsements by movie stars, these colon cleansing products are actively promoted as a natural way to enhance one’s well-being. Advertisements promising that colon cleansing will alleviate fatigue, headache, weight gain, and low energy are ubiquitous on the Internet and in newspapers and magazines. The ads tout the safety of “herbal” and “natural” preparations. These materials also provide anecdotal support for claims that colon cleansing improves the immune and circulatory systems, enhances cognitive abilities, and aids weight loss through “detoxification.”⁶

Individuals who want to cleanse their own colons can choose among home kits, some of which include disposable tubing, while others have components that can be reused if they are sterilized after each use.^5,7 But many people turn to a “hydrotherapist” for colon irrigation. The services are also increasingly being offered by practitioners who describe themselves as “colon hygienists.”

These individuals sometimes belong to organizations such as the National Board for Colon Hydrotherapy (NBCH) or the International Association for Colon Hydrotherapy (I-ACT).^8,9 These practitioners are not licensed, but they are required to have a high school or equivalent degree plus 3 semesters of postsecondary education and to be certified in cardiopulmonary resuscitation. They also take various seminars and continuing education courses from the NBCH and I-ACT.

How many individuals have used colon cleansing is unclear, although one study suggested that in the United Kingdom, registered practitioners carry out an estimated 5600 procedures every month.¹⁰

Where’s the evidence?

Despite colon cleansing’s long history and current popularity, the literature does not support its purported benefits. Historically, colon cleansing was thought to prevent autointoxication from toxins originating in the colon, but the evidence for this claim is limited.¹¹ A search of the literature using the terms “colon cleansing,” “herbal colon cleanse,” “colon detoxification,” and “colon irrigation,” yielded no scientifically robust studies in support of this practice. One study suggested that lymphocytes might migrate from the gut into the circulation after the procedure, which may “improve colon and immune system function.”¹²

Even though colon cleansing is touted as a commonly used form of holistic, complementary and alternative medicine, the Natural Standard Professional Database concluded in a monograph that there is “limited clinical evidence validating colon therapy as a health promotion practice” and noted a “lack of sufficient evidence” for most of its prescribed uses.¹³

Adverse effects: From cramping to renal failure
Most reports in the literature note a variety of adverse effects of colon cleansing that range from mild (eg, cramping, abdominal pain, fullness, bloating, nausea, vomiting, perianal irritation, and soreness) to severe (eg, electrolyte imbalance and renal failure).^11,14-17 Some herbal preparations have also been associated with aplastic anemia and liver toxicity.¹⁸

Case reports also have noted back and pelvic abscesses after colonic hydrotherapy, fatal aeroportia (gas accumulation in the mesenteric veins) with air emboli, rectal perforations, perineal gangrene, acute water intoxication, coffee enema-associated colitis and septicemia, and deaths due to amebiasis.^2,3,19-21

The FDA has issued many warning letters
The preparations used for colon cleansing are considered dietary supplements, and the US Food and Drug Administration (FDA) requires that they be labeled as such; the FDA does not preapprove these substances, however. The FDA also requires that colonic hydrotherapy and irrigation system devices meet certain requirements, but the agency has never approved any system for general nonmedical purposes, such as colon cleansing.

The devices have an FDA Class III designation, indicating that if a device is used for purposes beyond what is medically indicated (preparation for radiologic and endoscopic procedures), the manufacturer must obtain premarket approval from the FDA, which is based on evaluation of the safety and effectiveness of the device as shown by available scientific evidence and current regulations.²² During the past decade the FDA has issued numerous warning letters to manufacturers for unapproved use of the devices for colon cleansing.^23-26

Raise the issue with patients
Given the current popularity of colon cleansing, it’s important to recognize that some of your patients may engage in, or be thinking about, the practice. (See “4 things to tell patients about colon cleansing”.) Be sure to tell patients about the potential consequences of colon cleansing and to emphasize that there is a lack of evidence to back up supporters’ claims.

CORRESPONDENCE
Ranit Mishori, MD, MHS, Georgetown University School of Medicine, 3900 Reservoir Road, NW, Washington, DC 20007; [email protected]

CASE 1 A 31-year-old African American woman sought treatment at her local emergency department (ED) for nausea, vomiting, and diarrhea. She reported passing more than 6 yellowish-brown, watery, nonbloody stools during the previous 2 days. She felt weak, feverish, and light-headed and showed signs of dehydration.

The patient had Crohn’s disease and had undergone a partial colectomy 5 years earlier. She told the ED physician that 2 days before visiting the ED she had gone to a “cleansing center” for a colonic cleansing, but was unable to complete the process because she developed cramps 15 minutes into the procedure. Less than an hour later, she developed diarrhea, nausea, and vomiting.

In the ED, her serum potassium was 2.9 mEq/L, blood urea nitrogen was 26 mg/dL, and creatinine was 1.9 mg/dL. She was afebrile, with a blood pressure of 135/75 mm Hg and a heart rate of 113 beats per minute. After receiving 2 liters of normal saline and 90 mEq of potassium chloride replacement, the patient felt better and was later discharged from the ED.

Three days later, the patient came to our residency clinic. She described her stools as being loose, but not watery or bloody, and passed in small amounts, about 4 times daily. She still had some abdominal cramping just before passing stool, but bowel movements relieved that. Her vital signs were within normal limits, and her physical exam was benign. The patient was instructed to follow her normal diet, as tolerated, and drink plenty of fluids to maintain good hydration. Her symptoms resolved by the following week.

CASE 2 A 49-year-old African American man came to our community hospital because of vomiting, diarrhea, and abdominal pain he had been experiencing for 4 days. He linked the symptoms to eating a large fast-food breakfast, followed by a big lunch the day before. He described having multiple episodes of nonbloody, nonbilious vomiting, nonbloody watery diarrhea, and “twisting” abdominal pain that was constant but temporarily relieved with a warm compress or positional maneuvers. He had never had a similar episode and had not taken any antibiotics recently.

Upon further questioning, the patient revealed that he had used a colon cleanser a few days earlier. A review showed that he had lost 24 pounds in 10 days. Vitals were within normal limits. Serum potassium was 2.9 mEq/L, and creatinine was 2.1 mg/dL. A computed tomography scan of the abdomen revealed moderate to moderately severe dilatation of multiple small bowel loops with multiple air fluid levels, suggesting an early or partial small bowel obstruction. We obtained a surgical consultation, but surgery was not required. He was discharged after 2 days.

The patient returned to the hospital 3 days later with similar symptoms and severe weakness associated with dizziness. At that time his serum potassium was 2.4 mEq/L and creatinine was 4.0 mg/dL. Aspartate aminotransferase was 29 U/L, alanine aminotransferase was 80 U/L, lipase was 418 U/L, and amylase was 94 U/L.

The patient was readmitted for dehydration, hypokalemia, and pancreatitis and, following a colonoscopy and biopsy that revealed chronic and acute inflammation, a gastroenterologist made a diagnosis of “herbal intoxication.” The patient was hydrated, his electrolytes were replaced, and his diet was slowly returned to normal. He was discharged after 5 days.

An old practice rediscovered

Colon cleansing has been around since ancient times, when its purported benefits were based on the belief that intestinal waste can poison the body (“autointoxication”).¹ The procedure became popular in the early 1900s, but in a 1919 paper, the American Medical Association discounted the autointoxication theory and condemned the practice.¹ The procedure then fell out of favor, albeit temporarily.² Colon cleansing has staged a comeback in recent years.

Colon cleansing basics
Colon cleansing, also called colonic irrigation or colonic hydrotherapy, is performed by colonic hygienists or colon therapists, or can be self-administered. The procedure works like an enema. The patient generally lies on a table and water (with or without additional herbs or compounds) is pumped through the rectum via a tube.

Unlike enemas, for which a small amount of fluid is used, however, colon cleansing calls for a large volume of fluid—up to 60 liters—to be introduced into the rectum.^3,4 Fluids and waste are expelled through another tube. The procedure may be repeated several times.

Products go by many names
Most colon cleansing products come in the forms of laxatives, teas, powders, and capsules. They can be taken by mouth or inserted into the rectum. They often contain sodium phosphate, coffee, probiotics, enzymes, or any of a variety of herbs.⁵ Some products contain fiber preparations, including psyllium, flaxseed, and laxatives such as cascara, magnesium oxide, cat’s claw, artichoke leaves, burdock root, licorice, and milk thistle.²

With names such as Nature’s Bounty Colon Cleanser Natural Detox Formula, Health Plus Inc. Colon Cleanse, and 7-Day Miracle Cleanse, as well as endorsements by movie stars, these colon cleansing products are actively promoted as a natural way to enhance one’s well-being. Advertisements promising that colon cleansing will alleviate fatigue, headache, weight gain, and low energy are ubiquitous on the Internet and in newspapers and magazines. The ads tout the safety of “herbal” and “natural” preparations. These materials also provide anecdotal support for claims that colon cleansing improves the immune and circulatory systems, enhances cognitive abilities, and aids weight loss through “detoxification.”⁶

Individuals who want to cleanse their own colons can choose among home kits, some of which include disposable tubing, while others have components that can be reused if they are sterilized after each use.^5,7 But many people turn to a “hydrotherapist” for colon irrigation. The services are also increasingly being offered by practitioners who describe themselves as “colon hygienists.”

These individuals sometimes belong to organizations such as the National Board for Colon Hydrotherapy (NBCH) or the International Association for Colon Hydrotherapy (I-ACT).^8,9 These practitioners are not licensed, but they are required to have a high school or equivalent degree plus 3 semesters of postsecondary education and to be certified in cardiopulmonary resuscitation. They also take various seminars and continuing education courses from the NBCH and I-ACT.

How many individuals have used colon cleansing is unclear, although one study suggested that in the United Kingdom, registered practitioners carry out an estimated 5600 procedures every month.¹⁰

Where’s the evidence?

Despite colon cleansing’s long history and current popularity, the literature does not support its purported benefits. Historically, colon cleansing was thought to prevent autointoxication from toxins originating in the colon, but the evidence for this claim is limited.¹¹ A search of the literature using the terms “colon cleansing,” “herbal colon cleanse,” “colon detoxification,” and “colon irrigation,” yielded no scientifically robust studies in support of this practice. One study suggested that lymphocytes might migrate from the gut into the circulation after the procedure, which may “improve colon and immune system function.”¹²

Even though colon cleansing is touted as a commonly used form of holistic, complementary and alternative medicine, the Natural Standard Professional Database concluded in a monograph that there is “limited clinical evidence validating colon therapy as a health promotion practice” and noted a “lack of sufficient evidence” for most of its prescribed uses.¹³

Adverse effects: From cramping to renal failure
Most reports in the literature note a variety of adverse effects of colon cleansing that range from mild (eg, cramping, abdominal pain, fullness, bloating, nausea, vomiting, perianal irritation, and soreness) to severe (eg, electrolyte imbalance and renal failure).^11,14-17 Some herbal preparations have also been associated with aplastic anemia and liver toxicity.¹⁸

Case reports also have noted back and pelvic abscesses after colonic hydrotherapy, fatal aeroportia (gas accumulation in the mesenteric veins) with air emboli, rectal perforations, perineal gangrene, acute water intoxication, coffee enema-associated colitis and septicemia, and deaths due to amebiasis.^2,3,19-21

The FDA has issued many warning letters
The preparations used for colon cleansing are considered dietary supplements, and the US Food and Drug Administration (FDA) requires that they be labeled as such; the FDA does not preapprove these substances, however. The FDA also requires that colonic hydrotherapy and irrigation system devices meet certain requirements, but the agency has never approved any system for general nonmedical purposes, such as colon cleansing.

The devices have an FDA Class III designation, indicating that if a device is used for purposes beyond what is medically indicated (preparation for radiologic and endoscopic procedures), the manufacturer must obtain premarket approval from the FDA, which is based on evaluation of the safety and effectiveness of the device as shown by available scientific evidence and current regulations.²² During the past decade the FDA has issued numerous warning letters to manufacturers for unapproved use of the devices for colon cleansing.^23-26

Raise the issue with patients
Given the current popularity of colon cleansing, it’s important to recognize that some of your patients may engage in, or be thinking about, the practice. (See “4 things to tell patients about colon cleansing”.) Be sure to tell patients about the potential consequences of colon cleansing and to emphasize that there is a lack of evidence to back up supporters’ claims.

CORRESPONDENCE
Ranit Mishori, MD, MHS, Georgetown University School of Medicine, 3900 Reservoir Road, NW, Washington, DC 20007; [email protected]

CASE 1 A 31-year-old African American woman sought treatment at her local emergency department (ED) for nausea, vomiting, and diarrhea. She reported passing more than 6 yellowish-brown, watery, nonbloody stools during the previous 2 days. She felt weak, feverish, and light-headed and showed signs of dehydration.

The patient had Crohn’s disease and had undergone a partial colectomy 5 years earlier. She told the ED physician that 2 days before visiting the ED she had gone to a “cleansing center” for a colonic cleansing, but was unable to complete the process because she developed cramps 15 minutes into the procedure. Less than an hour later, she developed diarrhea, nausea, and vomiting.

In the ED, her serum potassium was 2.9 mEq/L, blood urea nitrogen was 26 mg/dL, and creatinine was 1.9 mg/dL. She was afebrile, with a blood pressure of 135/75 mm Hg and a heart rate of 113 beats per minute. After receiving 2 liters of normal saline and 90 mEq of potassium chloride replacement, the patient felt better and was later discharged from the ED.

Three days later, the patient came to our residency clinic. She described her stools as being loose, but not watery or bloody, and passed in small amounts, about 4 times daily. She still had some abdominal cramping just before passing stool, but bowel movements relieved that. Her vital signs were within normal limits, and her physical exam was benign. The patient was instructed to follow her normal diet, as tolerated, and drink plenty of fluids to maintain good hydration. Her symptoms resolved by the following week.

CASE 2 A 49-year-old African American man came to our community hospital because of vomiting, diarrhea, and abdominal pain he had been experiencing for 4 days. He linked the symptoms to eating a large fast-food breakfast, followed by a big lunch the day before. He described having multiple episodes of nonbloody, nonbilious vomiting, nonbloody watery diarrhea, and “twisting” abdominal pain that was constant but temporarily relieved with a warm compress or positional maneuvers. He had never had a similar episode and had not taken any antibiotics recently.

Upon further questioning, the patient revealed that he had used a colon cleanser a few days earlier. A review showed that he had lost 24 pounds in 10 days. Vitals were within normal limits. Serum potassium was 2.9 mEq/L, and creatinine was 2.1 mg/dL. A computed tomography scan of the abdomen revealed moderate to moderately severe dilatation of multiple small bowel loops with multiple air fluid levels, suggesting an early or partial small bowel obstruction. We obtained a surgical consultation, but surgery was not required. He was discharged after 2 days.

The patient returned to the hospital 3 days later with similar symptoms and severe weakness associated with dizziness. At that time his serum potassium was 2.4 mEq/L and creatinine was 4.0 mg/dL. Aspartate aminotransferase was 29 U/L, alanine aminotransferase was 80 U/L, lipase was 418 U/L, and amylase was 94 U/L.

The patient was readmitted for dehydration, hypokalemia, and pancreatitis and, following a colonoscopy and biopsy that revealed chronic and acute inflammation, a gastroenterologist made a diagnosis of “herbal intoxication.” The patient was hydrated, his electrolytes were replaced, and his diet was slowly returned to normal. He was discharged after 5 days.

An old practice rediscovered

Colon cleansing has been around since ancient times, when its purported benefits were based on the belief that intestinal waste can poison the body (“autointoxication”).¹ The procedure became popular in the early 1900s, but in a 1919 paper, the American Medical Association discounted the autointoxication theory and condemned the practice.¹ The procedure then fell out of favor, albeit temporarily.² Colon cleansing has staged a comeback in recent years.

Colon cleansing basics
Colon cleansing, also called colonic irrigation or colonic hydrotherapy, is performed by colonic hygienists or colon therapists, or can be self-administered. The procedure works like an enema. The patient generally lies on a table and water (with or without additional herbs or compounds) is pumped through the rectum via a tube.

Unlike enemas, for which a small amount of fluid is used, however, colon cleansing calls for a large volume of fluid—up to 60 liters—to be introduced into the rectum.^3,4 Fluids and waste are expelled through another tube. The procedure may be repeated several times.

Products go by many names
Most colon cleansing products come in the forms of laxatives, teas, powders, and capsules. They can be taken by mouth or inserted into the rectum. They often contain sodium phosphate, coffee, probiotics, enzymes, or any of a variety of herbs.⁵ Some products contain fiber preparations, including psyllium, flaxseed, and laxatives such as cascara, magnesium oxide, cat’s claw, artichoke leaves, burdock root, licorice, and milk thistle.²

With names such as Nature’s Bounty Colon Cleanser Natural Detox Formula, Health Plus Inc. Colon Cleanse, and 7-Day Miracle Cleanse, as well as endorsements by movie stars, these colon cleansing products are actively promoted as a natural way to enhance one’s well-being. Advertisements promising that colon cleansing will alleviate fatigue, headache, weight gain, and low energy are ubiquitous on the Internet and in newspapers and magazines. The ads tout the safety of “herbal” and “natural” preparations. These materials also provide anecdotal support for claims that colon cleansing improves the immune and circulatory systems, enhances cognitive abilities, and aids weight loss through “detoxification.”⁶

Individuals who want to cleanse their own colons can choose among home kits, some of which include disposable tubing, while others have components that can be reused if they are sterilized after each use.^5,7 But many people turn to a “hydrotherapist” for colon irrigation. The services are also increasingly being offered by practitioners who describe themselves as “colon hygienists.”

These individuals sometimes belong to organizations such as the National Board for Colon Hydrotherapy (NBCH) or the International Association for Colon Hydrotherapy (I-ACT).^8,9 These practitioners are not licensed, but they are required to have a high school or equivalent degree plus 3 semesters of postsecondary education and to be certified in cardiopulmonary resuscitation. They also take various seminars and continuing education courses from the NBCH and I-ACT.

How many individuals have used colon cleansing is unclear, although one study suggested that in the United Kingdom, registered practitioners carry out an estimated 5600 procedures every month.¹⁰

Where’s the evidence?

Despite colon cleansing’s long history and current popularity, the literature does not support its purported benefits. Historically, colon cleansing was thought to prevent autointoxication from toxins originating in the colon, but the evidence for this claim is limited.¹¹ A search of the literature using the terms “colon cleansing,” “herbal colon cleanse,” “colon detoxification,” and “colon irrigation,” yielded no scientifically robust studies in support of this practice. One study suggested that lymphocytes might migrate from the gut into the circulation after the procedure, which may “improve colon and immune system function.”¹²

Even though colon cleansing is touted as a commonly used form of holistic, complementary and alternative medicine, the Natural Standard Professional Database concluded in a monograph that there is “limited clinical evidence validating colon therapy as a health promotion practice” and noted a “lack of sufficient evidence” for most of its prescribed uses.¹³

Adverse effects: From cramping to renal failure
Most reports in the literature note a variety of adverse effects of colon cleansing that range from mild (eg, cramping, abdominal pain, fullness, bloating, nausea, vomiting, perianal irritation, and soreness) to severe (eg, electrolyte imbalance and renal failure).^11,14-17 Some herbal preparations have also been associated with aplastic anemia and liver toxicity.¹⁸

Case reports also have noted back and pelvic abscesses after colonic hydrotherapy, fatal aeroportia (gas accumulation in the mesenteric veins) with air emboli, rectal perforations, perineal gangrene, acute water intoxication, coffee enema-associated colitis and septicemia, and deaths due to amebiasis.^2,3,19-21

The FDA has issued many warning letters
The preparations used for colon cleansing are considered dietary supplements, and the US Food and Drug Administration (FDA) requires that they be labeled as such; the FDA does not preapprove these substances, however. The FDA also requires that colonic hydrotherapy and irrigation system devices meet certain requirements, but the agency has never approved any system for general nonmedical purposes, such as colon cleansing.

The devices have an FDA Class III designation, indicating that if a device is used for purposes beyond what is medically indicated (preparation for radiologic and endoscopic procedures), the manufacturer must obtain premarket approval from the FDA, which is based on evaluation of the safety and effectiveness of the device as shown by available scientific evidence and current regulations.²² During the past decade the FDA has issued numerous warning letters to manufacturers for unapproved use of the devices for colon cleansing.^23-26

Raise the issue with patients
Given the current popularity of colon cleansing, it’s important to recognize that some of your patients may engage in, or be thinking about, the practice. (See “4 things to tell patients about colon cleansing”.) Be sure to tell patients about the potential consequences of colon cleansing and to emphasize that there is a lack of evidence to back up supporters’ claims.

CORRESPONDENCE
Ranit Mishori, MD, MHS, Georgetown University School of Medicine, 3900 Reservoir Road, NW, Washington, DC 20007; [email protected]