Amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease, is a relatively rare, adult-onset, rapidly progressive, and fatal disease that involves degeneration of upper and lower motor neurons [
Data were collected by interview from 231 patients with ALS treated in 12 hospitals, including 7 Western medicine hospitals and 5 integrative medicine hospitals, in Shanghai over a 6-month period (between December 1, 2012, to May 31, 2013). Patients with definite or probable sporadic ALS, according to the revised El Escorial criteria [
The patients were asked to fill out a structured questionnaire (original questionnaire printed in Chinese) that included demographic information, previous and current use of Western medicine, use of IT such as Chinese herbal decoctions, Chinese herbal compounds, acupuncture or acupressure and moxibustion, massage therapy, wild Jinsheng and Chinese caterpillar fungus (these 6 therapies are also defined as traditional Chinese medicine, TCM), Ginkgo biloba, vitamins, nutritional supplements, art therapy, magnets, music therapy, energy healing, homeopathy, chiropractic techniques, reflexology, relaxation techniques, spiritual healing, imagery, biofeedback, hypnosis supplements, psychotherapy, melatonin, fatty acids from fish oil concentrate, lipoic acid, Qi Gong exercise, Tai Chi quan, and antidepressant or other additional therapies. If a subject did not understand an item on the list, a standardized explanation of the therapy was provided. When a patient or caregiver/relative responded affirmatively to the use of one or more therapies, they were further asked about the frequency and duration of its use. We also asked how they learned about such therapy and whether the physician treating their ALS was consulted before initiating its use. We considered the use of vitamin E to be an IT because it has been proven not to be of use in the treatment of ALS.
ALS-related symptoms that have been treated were also evaluated, and the rationale for using IT was calculated for evaluation. The questionnaire forms were filled out by the patients or a caregiver (spouse or family member) in the presence of the physician and interviewers. Twelve specially trained investigators performed all assessments as interviewers. One investigator (P.R.R.) conducted all interviews, which ranged from 7 minutes to 1 hour depending on the extent of IT use.
In addition to the use of IT, the patients were also asked about their marital status, household income, and education level. Additional data on each patient included the age at onset of ALS, its duration, and any surgical procedures for ALS. The ALS functional rating scale revised (ALSFRS-R) total score [
EpiData software (version 3.2) was used for data entry and data documentation. The original data were converted to the SAS system (version 9.2) for statistical analysis [
Initially, 258 subjects (patients or their spouse or relative) were invited to fill out the questionnaires with their physicians and the interviewers in the 12 hospitals. Of these 258 patients, 231 (89.5% overall response rate, age
Characteristics of the study population (
Characteristic | Value |
---|---|
Mean age, |
63.2 (29–76) |
Sex, |
|
Male | 148 (64%) |
Female | 83 (36%) |
Average age at onset, |
59.3 (28–75) |
Mean duration of ALS, |
2.1 (0.9–4.2) |
Mean duration of diagnosis, |
1.3 (0.3–3.6) |
Mean ALSFRS-R score (range) | 40.2 (28.3–44.8) |
Marital status, |
|
Married | 179 (77.5) |
Single, divorced, or widowed | 52 (22.5) |
Education level, |
|
Less than high school | 23 (10) |
High school | 96 (41.6) |
Some college | 58 (25.1) |
College graduate | 42 (18.2) |
Graduate school | 12 (5.2) |
Household income, |
|
<$1,500 | 19 (8.2) |
$1,500–3,000 | 23 (10) |
$3,000–4,500 | 78 (33.8) |
$4,500–6,000 | 45 (19.5) |
$6,000–7,500 | 32 (13.8) |
>$7,5000 | 34 (14.7) |
ALS: amyotrophic lateral sclerosis; ALSFRS-R: amyotrophic lateral sclerosis functional rating scale revised.
A total of 229 (99%) patients reported the use of at least one IT for the treatment of ALS; 96% reported using two therapies and 87% reported using more than two. Specifically, 47% used 5 or more therapies. Vitamins and Chinese herbal decoctions, Chinese herbal compounds, massage therapy, and acupuncture were the 5 most commonly used therapies. Both vitamins and Chinese herbal decoctions and/or Chinese herbal compounds were used by 209 patients (90.5%). The most common were vitamin E (95%) at an average daily dosage of
Integrative therapy (IT) usage rates and the reasons for using IT. Demonstrates the usage rates (a) of integrative medicine (IT) and the reasons (b) of using IT in treating for patients with amyotrophic lateral sclerosis (ALS) in Shanghai, China.
The most common reason for using IT was to treat weakness and fatigue (68.72% of male IT users) in males and muscle atrophy (66.35% of female IT users) in females (Figure
Various TCM compounds were used to treat patients with ALS. The most frequently used compounds were
Acupuncture therapy was often used to treat patients with ALS. The most frequently used acupoints were
Approximately two-thirds (63.23%) of the patients reported no obvious effects from the IT therapies, while 24.69% indicated the IT was working for the symptoms but they did not feel the additional treatments resulted in any significant improvement. Only a few subjects (9.37%) reported they could obtain additional effects from IT therapies; the others were not able to evaluate the effects of IT therapies. Most of the effects of the IT therapies were improvements in subjective symptoms, such as feeling more comfortable, slightly happier, more energetic, experiencing better relaxful sleep or deeper sleep, better appetite, and even delayed development of ALS; however, no evidence-based study has been conducted.
The mean cost of IT for all IT users was 1669 RMB ($270) per month. The most expensive was 6000 RMB ($595) per month, while the cheapest was 200 RMB ($33) per month. As of the time of this study, the mean total cost was 20,677 RMB ($3,434) for all IT treatments. The most spent was 53,275 RMB ($8,850) over 29 months, and the least spent was 8,360 RMB ($1,389) over 5 months.
Identifying effective treatments for ALS is an important task for neurologists. IT might be one choice for treating various symptoms of ALS due to the benefits that have been reported in clinical studies [
One reason for using IT might be due to the insufficiency of ALS therapies. There is currently no effective therapy for treating the symptoms and development of ALS. There is one drug, Riluzole; however, its efficacy is poor. Patients and their caregivers are desperately hoping for the development of an effective therapy, no matter what the method is. In the present study, we found that starting IT may not have been recommended by their physicians. Family members, friends, and even patients themselves often try to find effective methods to improve symptoms or delay the development of ALS. We found a strong correlation between IT use and higher levels of education and income. Patients or family members with high education level might gain more personal insight into the IT market easily, and they might have more payment capacity to pay the extra charges because the higher income reflects the fact that most IT are out-of-pocket expenditures. Married subjects used IT more often than singles because of their higher levels of education and income, and family members might have been more able to obtain information about treatment methods more easily than single subjects.
The IT used most often were vitamin E and TCM decoction or compounds (about 90.5% of IT users). The reasons for this may be as follows. First, vitamin E is often introduced as a complementary therapy for neurodegenerative disease [
The most debilitating symptoms of ALS are weakness and fatigue, and with the development of ALS, atrophy becomes more grievous for the patient. However, no therapy is effective at treating these symptoms. Interestingly, the fourth most common reason for using IT was to treat the side effects of Riluzole, suggesting that Riluzole has more side effects than IT. Even though no evidence-based research has definitively identified the effects of IT in the treatment of ALS, family members, friends, and some physicians still want to try IT for serious problems with the hope it will be effective for treating the symptoms. We found no correlation between the use of IT and disease severity, as measured by the ALSFRS-R scores. This suggests that patients with ALS are not turning to IT in desperation. This finding may be disease-specific because the most common reasons cited by patients with brain tumors for the use of IT were the limited effectiveness of conventional therapies [
TCM decoctions and compounds seem to be chosen by most patients. The most cited TCM decoctions and compounds are
The present results indicate that a high proportion of the ALS patients responding to this questionnaire did or would use IT without informing their physician, indicating that patients and physicians are not communicating effectively concerning the use of IT and that most patients are motivated to use IT by family, friends, and the media. In addition to improving communication between physicians and patients about IT, this survey, although limited, has provided an insight into IT utilization and referral patterns in ALS patients in Shanghai. Further investigation is needed to identify and quantify IT offered to ALS patients and the decision-making criteria used. The extensive and expanding use of IT requires further examination of their safety, efficacy, and drug interactions, as well as the factors that lead patients to use it. Physicians might include IT in their clinical practice when treating ALS patients.
The authors declare that there is no conflict of interests regarding the publication of this paper.
This study was sponsored and supported by National Natural Science Foundation of China (81373138), The National High Technology Research and Development Programme of China (863 Programme: Hua Zhou, 2010AA0221396001), the Special Fund of National Traditional Chinese Medicine (The promotion of base for standard research of traditional Chinese medicine: Hua Zhou, ZYYS-2010) and the Three-Year Developmental Plan Project for Traditional Chinese Medicine (major research) of the Shanghai Municipal Health Bureau (ZYSNXD-CC-ZDYJ028), and the Shanghai Pujiang Programme of the Science and Technology Commission of Shanghai Municipality (Weidong Pan, 09PJ1409300).