Herpes Zoster, Virus Diseases
Conditions
Keywords
Herpes, Shingles, virus disease, vitamin C, ascorbic acid, antioxidant, oxidative stress
Brief summary
Chronic viral infections induce oxidative stress that can cause a number of concomitant diseases, e.g. cardio-vascular diseases or metabolic disorders. Therefore, a sufficient treatment of oxidative stress may be of benefit for the patient to prevent further diseases. Shingles (herpes zoster infection) have been successfully treated with antioxidative substances like high-dose vitamin C for ages. Not only the acute symptoms can be diminished by high-dose vitamin C. Even long-term sequelae, like painful post-herpetic neuropathy, may be mitigated or even fully avoided.
Interventions
None listed
Sponsors
Dr. Loges & Co. GmbH
Pascoe Pharmazeutische Praeparate GmbH
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Due to the design of an Observational Cohort Study, no inclusion or
Exclusion criteria
are named. The included patient group is described under Cohort / Group. Observational Criteria: * adult patients * acute viral infection (especially herpes zoster) * Primary Care patient * eligible for add-on therapy with vitamin C * willingness to provide pseudonymized data to the Sponsor
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Pain Measured by VAS | visit 1 - 3 | VAS (minimum = 0 = no pain, maximum = 10 = extrem pain, change of pain measured by VAS |
Countries
Germany
Participant flow
Recruitment details
The patients were recruited from general practioners between April 2009 and December 2010.
Pre-assignment details
Between April 2009 and December 2010 16 general practitioners recorded data of 68 participants with symptomatic herpes zoster (one patient with viral infection) who received vitamin C intravenously (Pascorbin® 7.5 g/50 ml) for approximately 2 weeks in addition to standard treatment.
Participants by arm
| Arm | Count |
|---|---|
| Vitamin C Adult patients suffering from acute viral infection, especially herpes zoster, presenting themselves in Primary Care Centers or hospitals all over Germany, and who are treated with standard therapy and add-on vitamin C. | 68 |
| Total | 68 |
Baseline characteristics
| Characteristic | Vitamin C |
|---|---|
| Age, Categorical <=18 years | NA Participants |
| Age, Categorical >=65 years | 24 Participants |
| Age, Categorical Between 18 and 65 years | 44 Participants |
| Age, Customized >=65 years | 67.7 years STANDARD_DEVIATION 8.2 |
| Age, Customized Between 18 and 65 years | 43.6 years STANDARD_DEVIATION 14.5 |
| Body mass index Female | 24.4 kg/m^2 STANDARD_DEVIATION 3.9 |
| Body mass index Male | 27.6 kg/m^2 STANDARD_DEVIATION 4.9 |
| Body mass index Total | 25.8 kg/m^2 STANDARD_DEVIATION 4.6 |
| Common symptoms at baseline gerneral fatigue Mild | 30 participants |
| Common symptoms at baseline gerneral fatigue Moderate | 20 participants |
| Common symptoms at baseline gerneral fatigue Not present | 13 participants |
| Common symptoms at baseline gerneral fatigue Strong | 5 participants |
| Common symptoms at baseline impaired concentration Mild | 24 participants |
| Common symptoms at baseline impaired concentration Moderate | 17 participants |
| Common symptoms at baseline impaired concentration Not present | 24 participants |
| Common symptoms at baseline impaired concentration Strong | 3 participants |
| Concomitant immunosuppressive disease no | 57 participants |
| Concomitant immunosuppressive disease yes | 11 participants |
| Duration of Herpes Zoster-specific complaints (separated into groups) 0 to 14 days | 31 participants |
| Duration of Herpes Zoster-specific complaints (separated into groups) 2 to 6 weeks | 30 participants |
| Duration of Herpes Zoster-specific complaints (separated into groups) > 6 weeks | 7 participants |
| Number of concomitant medications for the inclusion diagnosis 1 | 24 participants |
| Number of concomitant medications for the inclusion diagnosis 2 | 15 participants |
| Number of concomitant medications for the inclusion diagnosis 3 | 2 participants |
| Number of concomitant medications for the inclusion diagnosis 4 | 3 participants |
| Number of concomitant medications for the inclusion diagnosis None | 24 participants |
| Region of Enrollment Germany | 68 participants |
| Sex: Female, Male Female | 39 Participants |
| Sex: Female, Male Male | 29 Participants |
| Weihgt, kg Female | 65.6 kg STANDARD_DEVIATION 10.6 |
| Weihgt, kg Male | 83.3 kg STANDARD_DEVIATION 12.4 |
| Weihgt, kg Total | 73.1 kg STANDARD_DEVIATION 14.3 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 68 |
| serious Total, serious adverse events | 0 / 68 |
Outcome results
Primary
Change of Pain Measured by VAS
VAS (minimum = 0 = no pain, maximum = 10 = extrem pain, change of pain measured by VAS
Time frame: visit 1 - 3
Population: Three patients had no pain at baseline (score value = 0) and were thus excluded from the statistical analysis. The descriptive results per visit are presented in the data below. V1 (Baseline) N=64, V2 (week 2)N=64, V3 (week 12)N= 47, Last vsit (N=64).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vitamin C | Change of Pain Measured by VAS | V1 (Baseline) | 5.8 pain intensity | Standard Deviation 2.4 |
| Vitamin C | Change of Pain Measured by VAS | V2 (week 2) | 2.2 pain intensity | Standard Deviation 2.2 |
| Vitamin C | Change of Pain Measured by VAS | V3 (week 12) | 0.6 pain intensity | Standard Deviation 1.1 |
| Vitamin C | Change of Pain Measured by VAS | Last visit | 1.2 pain intensity | Standard Deviation 2 |