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Effects of acupuncture and homeopathy: prospective documentation. Interim results
British Homeopathic Journal (2000) 89, Suppl 1, S31±S34 ß 2000 Macmillan Publishers Ltd All rights reserved 0007±0785/00 $15.00 www.nature.com/bhj
Effects of acupuncture and homeopathy: prospective documentation. Interim results H Walach1* and C GuÈthlin1 1 Department of Environmental Medicine, University Hospital Freiburg, Hugstetterstrasse 55, D-79106 Freiburg I.BR, Germany
Objective: To evaluate the overall effectiveness in general practice of homeopathy and acupuncture, and to estimate costs. Method: Prospective documentation of all patients insured with an insurance company who are provided with free treatment of acupuncture and homeopathy. 4000 patients treated by acupuncture and 1000 patients by homeopathy will be enrolled. All patients will be followed up from the beginning of treatment for another 4 years. Doctors will provide data on each visit (diagnosis, treatment, change of symptoms, etc.), patients will ®ll in questionnaires at the beginning and at the end of treatment, as well as each year after the end of treatment (complaints, current treatment, general health status as measured by the MOS-SF 36). Insurance data on workdays lost will be provided by the insurance company. Results: Data acquisition and entry is continuing. Up to now data from the ®rst questionnaire of 1453 patients have been entered and 951 patients have returned the follow-up questionnaire. Doctors' ratings of the change of the main diagnosis shows improvement of around 80% with only 2% deteriorated. This impression is vindicated by the patients' follow-up questionnaire. 36% patients rated the therapy as ef®cacious, 47% as partially ef®cacious. Quality of life as measured by the SF 36 questionnaire improved signi®cantly in all dimensions. Data on workdays off will be presented. Conclusion: Homeopathy and acupuncture are clinically effective in a variety of medical problems. British Homeopathic Journal (2000) 89, Suppl 1, S31±S34 Keywords: prospective documentation; health insurance; Germany; homeopathy
Introduction In Germany the law provides the possibility to health insurance companies to make available unconventional medicine in the course of a so-called `trial phase' to their customers for 5 years, provided that this trial phase is evaluated scienti®cally. The scienti®c evaluation should, at the end of this trial period, make possible decisions about the ef®ciency of the alternative therapeutic approaches. The federate health insurance corporation Innungskrankenkassen (IKK) decided to evaluate homeopathy and acupuncture in such a trial phase. This company traditionally is the health insurance company of self-employed
artisans or small companies and their family members. It covers about 6% of the insured population of Germany. In a representative survey the IKK showed that about 75% of IKK insured subjects were interested in consulting with an acupuncturist, a homeopathic doctor or other provider of unorthodox medicine. Therefore, from the beginning of 1995 or 1996 all members of the IKK health insurance company in the states of Baden-WuÈrttemberg, Sachsen Anhalt and Sachsen are potentially able to consult a medically quali®ed practitioner of acupuncture or homeopathy.
Objectives *Correspondence: Dr H Walach, Department of Environmental Medicine, University Hospital Freiburg, Hugstetterstrasse 55, D-79106 Freiburg I.BR, Germany.
The evaluation of the trial phase aims to answer the following questions.
Effects of acupuncture and homeopathy H Walach and C GuÈthlin
S32
What are the effects of treatment by diagnosis, patients, and on the whole? What are the average costs of this treatment over the whole period of observation per patient, and is there a potential economic bene®t? What kind of diseases do homeopathic doctors and acupuncturists treat? Is there a difference in the effectiveness of the treatment by doctors, methods, diagnosis, and other criteria of illness? How does the general health status of the treated population change?
Method The design is prospective documentation. This means that all new patients, insured by the IKK, who visit one of the eligible doctors within the period of one year are included in the documentation. Every visit with the doctor and the effects of the treatment will be documented. The documentation will be continued over the whole period of the trial phase (5 years). Patients who do not re-attend will be questioned by telephone interviews and by mail questionnaires about the effects of the therapy and about their health status. The documentation will use three sources of data:
Documentation sheet for doctors. Questionnaires for patients. Data from the health insurance company ®les.
We developed a documentation sheet for each consultation. The data sheet is short, enabling the doctor to ®ll it out within two minutes. The questionnaires for the patients are handed out to all patients at the end of the treatment. The health insurance company will provide the data from the health insurance company's data ®les.
Doctors' documentation sheet
The documentation sheet for the doctor will consist of a general and a speci®c part. The general part is the same for all doctors (acupuncture, homeopathy). The speci®c part will contain information about homeopathy and acupuncture and has been formulated after consultation with the respective specialists and professional organisations. General
patient ID-number date ®rst, follow-up, telephone consultation up to 3 diagnoses (ICD) with each diagnosis: duration and severity of illness (4 point rating) acute or chronic disease
British Homeopathic Journal
prescription allopathic prescrption homeopathic prescription other time spent with patient patient referral to specialist=clinic=cure=physio-= or psychotherapy side effect mentioned. Speci®c-homeopathy four key symptoms or modalities leading to prescription four main complaints change of these complaints at follow-up visits (®ve point, bipolar rating) aggravation indication of antidotation. At follow-up visits additionally to be answered in the general part of the documentation: for main ICD-diagnosis estimated effects as compared with last visit (very much aggravated to very much improved), 9 point rating side effects follow-up visit ®xed. Patient questionnaire
At the beginning of the treatment all patients are informed about the scienti®c evaluation and the purpose of the documentation. They are asked to consent to give their address and personal data such as telephone number for possible telephone interviews and mailed questionnaires, to allow the use of their IKKinsurance number as ID, and to give their written consent to this. Patients who give their written informed consent are asked to complete a questionnaire at the beginning and at the end of the treatment. Follow-up questionnaires are sent automatically every year for patients who have ®nished treatment or every 6 months for patients with ongoing treatment. The patient questionnaire collects data on the following items. First questionnaire:
complaints (structured free text) number and types of therapeutic approaches used current treatment current medication reasons for consulting the alternative practitioner health status: MOS SF 36.
Follow-up questionnaire:
satisfaction with treatment (®ve point rating) subjectively experienced effectiveness of treatment side effects of treatment other concurrent illnesses during the treatment
Effects of acupuncture and homeopathy H Walach and C GuÈthlin
use of other therapeutic approaches with other doctors=therapists or providers during the treatment health status MOS SF 36. In case of failure of therapy or disruption of therapy: reasons for failure or disruption Health insurance company data
As a third source of data we will use the number of workdays lost, hospitalisation days and additional therapy costs which are monitored in the health insurance company's ®les. We will compare the average number of workdays lost over the ®ve years before commencement of the trial phase with the ®ve years of the trial phase, and additionally compare these trends to the trends observable in all other patients. Doctors
Potentially all doctors having acquired the additional quali®cation `homeopathic doctor' according to the standards of the Germany Homoeopathic Doctors' Association (Deutscher Zentralverein homoÈoÈ rzte) and are registered with the medical pathischer A corporation regulating reimbursement (KassenaÈrztliche Vereiningung) can apply to take part. For acupuncturists special regulations apply.
Interim results So far, 4000 patients treated with acupuncture and 685 patients treated with homeopathy have been enrolled in the study. These patients are treated by more than 1100 doctors, 101 of them practising homeopathy, 1029 practising acupuncture. Data from 1453 ®rst-visit patient questionnaires have been entered and from 951 follow-up questionnaires. Altogether 8187 doctor's documentation sheets have been entered. While data-acquisition and dataentering is ongoing and updated numbers will be reported, results have been remarkably stable over several intermediate analyses. First-visit questionnaires
There is little difference between patients treated with homeopathy and acupuncture in terms of effectiveness parameters and other variables. Therefore combined data are reported. Patients seeking acupuncture or homeopathy mostly consult with chronic complaints of a median duration of 7 years. 79% have already tried conventional therapies, 50% between one and three different doctors. They have been treated previously by drugs (60%) or physiotherapy (19%). At the beginning of the complementary treatment 19% are still taking medication, and 14% are using physiotherapy. Patients present with many different diag-
noses. Typical diagnoses for the patients insured with the IKK are pain syndromes (low back pain, neck ± shoulder pain, and other pain syndromes Ð 45%), asthma and chronic cough (15%), headaches and migraines (12%). But also skin problems in homeopathy patients and tinnitus, mainly with acupuncture, are reported. Reasons for seeking complementary medicine are the lack of effectiveness of previous treatments (74%), side effects (43%), possibility of reimbursement (69%) and speci®c desire to use complementary therapies (45%). 73% of the patients have never had a similar treatment before. 58% are convinced that homeopathy or acupuncture can help, 34% are uncertain about that.
S33
Follow-up questionnaires
29% of the 951 patients in our data ®le who have ®nished treatment indicated the treatment was a success, 41% rated it as partially successful. Altogether 70% of the patients seemed to pro®t from the treatment. 5% of the patients reported aggravations or had missing data, 4% reported side effects, mainly with acupuncture, 7% said that during the treatment they had contracted other diseases. Altogether 90% of the patients were in some sense satis®ed. Health-related quality of life (SF 36)
We have so far data from 856 patients with corresponding ®rst visit and follow-up data on healthrelated quality of life. We see signi®cant and clear improvements in all eight scales of the SF 36 questionnaire. Mostly physical functioning, but also vitally, pain, and social functioning is improved markedly by 10 to 20 points on the t-normed (ie 100%) scale. Change of main complaint Ð doctor's assessment
These subjective patient reports are vindicated by the doctors' assessment of the change of the main diagnosis. While the exact scaling is still ongoing, we can see that doctors indicate an improvement in 80% of their documentation sheets. Workdays off
These parameters are being processed.
Discussion and tentative conclusion Acupuncture and homeopathy seem to be effective in a broad range of complaints and in a variety of patients. Since the patients of the IKK insurance company are representative of lower to middle class patients, our results are fairly robust as to population selection effects. We have not yet evaluated long-term follow-up data nor performed sensitivity analyses. At present we only have historic controls for our qualityof-life-data. But since the SF 36 questionnaire is British Homeopathic Journal
Effects of acupuncture and homeopathy H Walach and C GuÈthlin
S34
widely used nationally and internationally, we can rely on a host of comparable health-status data from different well described populations. While the initial data of our patients are comparable to data from university outpatient departments and rehabilitation centres, thereby con®rming the severity of their initial status, the improvement is of clinical signi®cance according to accepted standards.1 Therefore it seems safe to conclude that homeopathy and acupuncture are effective in improving health-related quality of life, at least in the short run. These data corroborate the change ratings given by the doctors, which can be assumed to be positively biased. It remains to be seen whether these results are stable over a longer time period and whether the change is also re¯ected in
British Homeopathic Journal
workdays off and hospital days as important cost parameters. Our tentative conclusion thus is that homeopathy and acupuncture are clinically effective in improving health-related quality of life in patients who have sought medical treatment before without lasting success.
References 1 Lydick E, Yawn BP. Clinical interpretation of health-related quality of life data. In: Staquet MJ, Hays RD and Fayers PM (eds) Quality of Life Assessment in Clinical Trials. Methods and Practice. Oxford: Oxford University Press, 1998, pp 299 ± 314.
Effects of acupuncture and homeopathy: prospective documentation. Interim results H Walach1* and C GuÈthlin1 1 Department of Environmental Medicine, University Hospital Freiburg, Hugstetterstrasse 55, D-79106 Freiburg I.BR, Germany
Objective: To evaluate the overall effectiveness in general practice of homeopathy and acupuncture, and to estimate costs. Method: Prospective documentation of all patients insured with an insurance company who are provided with free treatment of acupuncture and homeopathy. 4000 patients treated by acupuncture and 1000 patients by homeopathy will be enrolled. All patients will be followed up from the beginning of treatment for another 4 years. Doctors will provide data on each visit (diagnosis, treatment, change of symptoms, etc.), patients will ®ll in questionnaires at the beginning and at the end of treatment, as well as each year after the end of treatment (complaints, current treatment, general health status as measured by the MOS-SF 36). Insurance data on workdays lost will be provided by the insurance company. Results: Data acquisition and entry is continuing. Up to now data from the ®rst questionnaire of 1453 patients have been entered and 951 patients have returned the follow-up questionnaire. Doctors' ratings of the change of the main diagnosis shows improvement of around 80% with only 2% deteriorated. This impression is vindicated by the patients' follow-up questionnaire. 36% patients rated the therapy as ef®cacious, 47% as partially ef®cacious. Quality of life as measured by the SF 36 questionnaire improved signi®cantly in all dimensions. Data on workdays off will be presented. Conclusion: Homeopathy and acupuncture are clinically effective in a variety of medical problems. British Homeopathic Journal (2000) 89, Suppl 1, S31±S34 Keywords: prospective documentation; health insurance; Germany; homeopathy
Introduction In Germany the law provides the possibility to health insurance companies to make available unconventional medicine in the course of a so-called `trial phase' to their customers for 5 years, provided that this trial phase is evaluated scienti®cally. The scienti®c evaluation should, at the end of this trial period, make possible decisions about the ef®ciency of the alternative therapeutic approaches. The federate health insurance corporation Innungskrankenkassen (IKK) decided to evaluate homeopathy and acupuncture in such a trial phase. This company traditionally is the health insurance company of self-employed
artisans or small companies and their family members. It covers about 6% of the insured population of Germany. In a representative survey the IKK showed that about 75% of IKK insured subjects were interested in consulting with an acupuncturist, a homeopathic doctor or other provider of unorthodox medicine. Therefore, from the beginning of 1995 or 1996 all members of the IKK health insurance company in the states of Baden-WuÈrttemberg, Sachsen Anhalt and Sachsen are potentially able to consult a medically quali®ed practitioner of acupuncture or homeopathy.
Objectives *Correspondence: Dr H Walach, Department of Environmental Medicine, University Hospital Freiburg, Hugstetterstrasse 55, D-79106 Freiburg I.BR, Germany.
The evaluation of the trial phase aims to answer the following questions.
Effects of acupuncture and homeopathy H Walach and C GuÈthlin
S32
What are the effects of treatment by diagnosis, patients, and on the whole? What are the average costs of this treatment over the whole period of observation per patient, and is there a potential economic bene®t? What kind of diseases do homeopathic doctors and acupuncturists treat? Is there a difference in the effectiveness of the treatment by doctors, methods, diagnosis, and other criteria of illness? How does the general health status of the treated population change?
Method The design is prospective documentation. This means that all new patients, insured by the IKK, who visit one of the eligible doctors within the period of one year are included in the documentation. Every visit with the doctor and the effects of the treatment will be documented. The documentation will be continued over the whole period of the trial phase (5 years). Patients who do not re-attend will be questioned by telephone interviews and by mail questionnaires about the effects of the therapy and about their health status. The documentation will use three sources of data:
Documentation sheet for doctors. Questionnaires for patients. Data from the health insurance company ®les.
We developed a documentation sheet for each consultation. The data sheet is short, enabling the doctor to ®ll it out within two minutes. The questionnaires for the patients are handed out to all patients at the end of the treatment. The health insurance company will provide the data from the health insurance company's data ®les.
Doctors' documentation sheet
The documentation sheet for the doctor will consist of a general and a speci®c part. The general part is the same for all doctors (acupuncture, homeopathy). The speci®c part will contain information about homeopathy and acupuncture and has been formulated after consultation with the respective specialists and professional organisations. General
patient ID-number date ®rst, follow-up, telephone consultation up to 3 diagnoses (ICD) with each diagnosis: duration and severity of illness (4 point rating) acute or chronic disease
British Homeopathic Journal
prescription allopathic prescrption homeopathic prescription other time spent with patient patient referral to specialist=clinic=cure=physio-= or psychotherapy side effect mentioned. Speci®c-homeopathy four key symptoms or modalities leading to prescription four main complaints change of these complaints at follow-up visits (®ve point, bipolar rating) aggravation indication of antidotation. At follow-up visits additionally to be answered in the general part of the documentation: for main ICD-diagnosis estimated effects as compared with last visit (very much aggravated to very much improved), 9 point rating side effects follow-up visit ®xed. Patient questionnaire
At the beginning of the treatment all patients are informed about the scienti®c evaluation and the purpose of the documentation. They are asked to consent to give their address and personal data such as telephone number for possible telephone interviews and mailed questionnaires, to allow the use of their IKKinsurance number as ID, and to give their written consent to this. Patients who give their written informed consent are asked to complete a questionnaire at the beginning and at the end of the treatment. Follow-up questionnaires are sent automatically every year for patients who have ®nished treatment or every 6 months for patients with ongoing treatment. The patient questionnaire collects data on the following items. First questionnaire:
complaints (structured free text) number and types of therapeutic approaches used current treatment current medication reasons for consulting the alternative practitioner health status: MOS SF 36.
Follow-up questionnaire:
satisfaction with treatment (®ve point rating) subjectively experienced effectiveness of treatment side effects of treatment other concurrent illnesses during the treatment
Effects of acupuncture and homeopathy H Walach and C GuÈthlin
use of other therapeutic approaches with other doctors=therapists or providers during the treatment health status MOS SF 36. In case of failure of therapy or disruption of therapy: reasons for failure or disruption Health insurance company data
As a third source of data we will use the number of workdays lost, hospitalisation days and additional therapy costs which are monitored in the health insurance company's ®les. We will compare the average number of workdays lost over the ®ve years before commencement of the trial phase with the ®ve years of the trial phase, and additionally compare these trends to the trends observable in all other patients. Doctors
Potentially all doctors having acquired the additional quali®cation `homeopathic doctor' according to the standards of the Germany Homoeopathic Doctors' Association (Deutscher Zentralverein homoÈoÈ rzte) and are registered with the medical pathischer A corporation regulating reimbursement (KassenaÈrztliche Vereiningung) can apply to take part. For acupuncturists special regulations apply.
Interim results So far, 4000 patients treated with acupuncture and 685 patients treated with homeopathy have been enrolled in the study. These patients are treated by more than 1100 doctors, 101 of them practising homeopathy, 1029 practising acupuncture. Data from 1453 ®rst-visit patient questionnaires have been entered and from 951 follow-up questionnaires. Altogether 8187 doctor's documentation sheets have been entered. While data-acquisition and dataentering is ongoing and updated numbers will be reported, results have been remarkably stable over several intermediate analyses. First-visit questionnaires
There is little difference between patients treated with homeopathy and acupuncture in terms of effectiveness parameters and other variables. Therefore combined data are reported. Patients seeking acupuncture or homeopathy mostly consult with chronic complaints of a median duration of 7 years. 79% have already tried conventional therapies, 50% between one and three different doctors. They have been treated previously by drugs (60%) or physiotherapy (19%). At the beginning of the complementary treatment 19% are still taking medication, and 14% are using physiotherapy. Patients present with many different diag-
noses. Typical diagnoses for the patients insured with the IKK are pain syndromes (low back pain, neck ± shoulder pain, and other pain syndromes Ð 45%), asthma and chronic cough (15%), headaches and migraines (12%). But also skin problems in homeopathy patients and tinnitus, mainly with acupuncture, are reported. Reasons for seeking complementary medicine are the lack of effectiveness of previous treatments (74%), side effects (43%), possibility of reimbursement (69%) and speci®c desire to use complementary therapies (45%). 73% of the patients have never had a similar treatment before. 58% are convinced that homeopathy or acupuncture can help, 34% are uncertain about that.
S33
Follow-up questionnaires
29% of the 951 patients in our data ®le who have ®nished treatment indicated the treatment was a success, 41% rated it as partially successful. Altogether 70% of the patients seemed to pro®t from the treatment. 5% of the patients reported aggravations or had missing data, 4% reported side effects, mainly with acupuncture, 7% said that during the treatment they had contracted other diseases. Altogether 90% of the patients were in some sense satis®ed. Health-related quality of life (SF 36)
We have so far data from 856 patients with corresponding ®rst visit and follow-up data on healthrelated quality of life. We see signi®cant and clear improvements in all eight scales of the SF 36 questionnaire. Mostly physical functioning, but also vitally, pain, and social functioning is improved markedly by 10 to 20 points on the t-normed (ie 100%) scale. Change of main complaint Ð doctor's assessment
These subjective patient reports are vindicated by the doctors' assessment of the change of the main diagnosis. While the exact scaling is still ongoing, we can see that doctors indicate an improvement in 80% of their documentation sheets. Workdays off
These parameters are being processed.
Discussion and tentative conclusion Acupuncture and homeopathy seem to be effective in a broad range of complaints and in a variety of patients. Since the patients of the IKK insurance company are representative of lower to middle class patients, our results are fairly robust as to population selection effects. We have not yet evaluated long-term follow-up data nor performed sensitivity analyses. At present we only have historic controls for our qualityof-life-data. But since the SF 36 questionnaire is British Homeopathic Journal
Effects of acupuncture and homeopathy H Walach and C GuÈthlin
S34
widely used nationally and internationally, we can rely on a host of comparable health-status data from different well described populations. While the initial data of our patients are comparable to data from university outpatient departments and rehabilitation centres, thereby con®rming the severity of their initial status, the improvement is of clinical signi®cance according to accepted standards.1 Therefore it seems safe to conclude that homeopathy and acupuncture are effective in improving health-related quality of life, at least in the short run. These data corroborate the change ratings given by the doctors, which can be assumed to be positively biased. It remains to be seen whether these results are stable over a longer time period and whether the change is also re¯ected in
British Homeopathic Journal
workdays off and hospital days as important cost parameters. Our tentative conclusion thus is that homeopathy and acupuncture are clinically effective in improving health-related quality of life in patients who have sought medical treatment before without lasting success.
References 1 Lydick E, Yawn BP. Clinical interpretation of health-related quality of life data. In: Staquet MJ, Hays RD and Fayers PM (eds) Quality of Life Assessment in Clinical Trials. Methods and Practice. Oxford: Oxford University Press, 1998, pp 299 ± 314.