Openly prescribed placebos to reduce symptoms of allergic rhinitis
| ISRCTN | ISRCTN11274834 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11274834 |
- Submission date
- 06/11/2020
- Registration date
- 04/05/2021
- Last edited
- 23/08/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English Summary
Background and study aims
Placebo (a substance or treatment which is designed to have no therapeutic value) can reduce physical symptoms even when provided with full honesty and disclosure. Yet, the precise mechanisms underlying the effects of “open-label placebos” (OLPs) have remained subject of debate. Furthermore, it is unclear whether OLPs are similarly effective when provided remotely, as is sometimes required e.g. in the current COVID-19 pandemic.
Who can participate?
People (at least 18 years old) with allergic rhinitis (inflammation and swelling of the mucous membrane of the nose, characterized by a runny nose and stuffiness and usually caused by the common cold or a seasonal allergy)
What does the study involve?
In a randomized-controlled trial, we examined the effects of OLP plus treatment as usual (TAU) compared to TAU alone on symptom reduction in people with allergic rhinitis over the course of two weeks. Due to the COVID-19 pandemic, OLP was provided remotely (i.e. sent via postal service). To investigate the potential influence of the clinical encounter on the effects of OLP, we manipulated the perception of the virtual clinical encounter, both with respect to verbal and nonverbal factors (augmented vs. limited encounter).
What are the possible benefits and risks of participating?
A possible benefit was that the treatment received would reduce people's symptoms of allergic rhinitis. A possible risk was that the treatment would not help.
Where is the study run from?
University of Koblenz-Landau (Germany)
When is the study starting and how long is it expected to run for?
August 2019 to August 2020
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Tobias Kube, kube@uni-landau.de
Contact information
Scientific
Ostbahnstr. 10
Landau
76829
Germany
 ORCID ID |
0000-0002-5420-4506 |
|---|---|
| Phone | +49 634128035652 |
| kube@uni-landau.de |
Study information
| Study design | Single-site interventional randomized-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Providing open-label placebos remotely – a randomized controlled trial in allergic rhinitis |
| Study acronym | OLP_REMOTE |
| Study hypothesis | Open-Label Placebos (OLP) plus treatment as usual (TAU) will reduce symptoms of allergic rhinits more than TAU alone. Additionally, the influence of the clinical encounter and its potential interaction with OLP vs. TAU on symptom improvement will be examined in a 2 (treatment: OLP vs. TAU) x 2 (clinical encounter: augmented vs. limited) design. |
| Ethics approval(s) | Approved 01/04/2020, Local Ethics Committee of the Department of Psychology, University of Koblenz-Landau (Ostbahnstr. 10, 76829 Landau, Germany; +49 06341 280 31460; lek@uni-landau.de), ref: 2020_236 |
| Condition | Allergic rhinitis |
| Intervention | Participants received either open-label placebo plus treatment as usual (TAU) or TAU alone for their allergic rhinitis over the course of two weeks TAU+OLP If participants were randomized to TAU+OLP, participants were sent the placebo pills via postal service. The placebos were in a small glass container, which was sent to the participants in a padded envelope. Participants were asked to swallow the placebos, not to chew or suck them, twice a day (one tablet in the morning and another one in the evening). Participants took the placebos for 14 days. In addition to OLP, participants were allowed to continue to take their regular medication (if there was any), but were asked not to change their medication until the second study visit. TAU only Participants from the TAU group did not receive placebos after the first virtual study visit. With respect to their regular treatment, they received the same information as participants from the OLP group. Participants from the TAU group were offered the possibility of receiving the placebos after the second (virtual) study visit (“switch-over"). Randomization and Blinding Prior to the first virtual appointment, participants were randomly allocated to one of the two clinical encounter styles (augmented vs. limited) using a computer-generated randomization sequence. At the end of the first virtual encounter, the provider randomized participants to either OLP or the control group by opening a concealed container (visible to the participants). Thus, neither the provider nor the participant was blinded with respect to the participants’ treatment allocation. Participants were not aware, however, of their allocation in terms of the clinical encounter style, since the variation of this factor was disclosed only at the end of the study. |
| Intervention type | Mixed |
| Primary outcome measure | Allergic symptoms measured using the combined symptom medication score (CSMS) at baseline and two weeks |
| Secondary outcome measures | Impairment caused by allergic symptoms measured using the adapted version of the Pain Disability Index (PDI) at baseline and two weeks |
| Overall study start date | 15/08/2019 |
| Overall study end date | 13/08/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 52 |
| Total final enrolment | 54 |
| Participant inclusion criteria | 1. Diagnosed allergic rhinitis 2. At least 18 years old 3. Sufficient German language skills |
| Participant exclusion criteria | 1. Pregnancy 2. Diabetes 3. Any mental or neurological illness 4. Lactose intolerance |
| Recruitment start date | 20/04/2020 |
| Recruitment end date | 16/07/2020 |
Locations
Countries of recruitment
- Germany
Study participating centre
Landau
76829
Germany
Sponsor information
University/education
Ostbahnstr. 10
Landau
76829
Germany
| Phone | +49 6341 28035645 |
|---|---|
| klinpsych@uni-landau.de | |
| Website | http://www.uni-koblenz-landau.de/en |
"ROR" |
https://ror.org/01j9f6752 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 31/03/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in an open-access peer-reviewed journal. |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 11/03/2021 | 23/08/2022 | Yes | No |
Editorial Notes
23/08/2022: Publication reference added.
09/11/2020: Trial’s existence confirmed by University of Koblenz-Landau.
