TriangleNCT02589938 · OUTCOME
Xerostomia Questionnaire Scores
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- LEAST_SQUARES_MEAN
- Unit
- score on a scale 0-80
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Baseline to 4, 8, 12, 26 weeks post acupuncture
What was measured
Self reported Xerostomia questionnaire consists of eight items (scored on an 11-point scale; 0-10), has been validated in several cohorts, and is regarded as the gold-standard measure for xerostomia.The questions are equally divided into 4 items about oral dryness while eating or chewing and 4 items about dryness while not eating or chewing. Item scores are summed and transformed linearly to produce a final summary score between 0 and 80. Higher scores represent more xerostomia. Questionnaire is completed prior to randomization and at each time point week 4, week 8, week 12, and end of study.
Analysis population: Intent to treat analysis. Considered and utilized all data available at each timepoint.
Groups in this outcome
Standard Oral Hygiene
All patients will receive standard oral hygiene patient teaching information that includes instructions regarding mouth rinses, use of lip balms, use of mild fluoride toothpaste, the importance of adequate oral hydration, and other standard advice. Each participating site determines the standard oral hygiene recommendations used at their site. Standard Oral Hygiene: Oral hygiene care provided per individual institutions standard of care.
Standard Oral Hygiene + True Acupuncture
All patients will receive standard oral hygiene patient teaching information that includes instructions regarding mouth rinses, use of lip balms, use of mild fluoride toothpaste, the importance of adequate oral hydration, and other standard advice. Each participating site determines the standard oral hygiene recommendations used at their site. The True acupuncture points will be at 3 sites on each ear, a site on the chin, on each forearm, a site on each hand, a site on each leg, and one placebo needle for a total of 14 sites. All sites will be applied for 20 minutes. Standard Oral Hygiene + True Acupuncture: Oral hygiene care provided per individual institutions standard of care. 14 true acupoint sites will be selected and applied to each participant for 20 minutes at each session. There will be 2 sessions a week for 8 weeks.
Standard Oral Hygiene + Sham Acupuncture
All patients will receive standard oral hygiene patient teaching information that includes instructions regarding mouth rinses, use of lip balms, use of mild fluoride toothpaste, the importance of adequate oral hydration, and other standard advice. Each participating site determines the standard oral hygiene recommendations used at their site. The Sham acupuncture points will be given according to the same schedule as the active acupuncture points, except the Sham needles will be placed below, above or between true active points. Standard Oral Hygiene + Sham Acupuncture: Oral hygiene care provided per individual institutions standard of care. 14 sham acupoint sites will be selected and applied to each participant for 20 minutes at each session. There will be 2 sessions a week for 8 weeks.
| Group | Source count |
|---|---|
| Standard Oral Hygiene | 86 |
| Standard Oral Hygiene + True Acupuncture | 86 |
| Standard Oral Hygiene + Sham Acupuncture | 86 |
Reported measurements
Week 4
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Standard Oral Hygiene | 57.3 | Not reported | 54.0 | 60.6 | Not reported |
| Standard Oral Hygiene + True Acupuncture | 50.6 | Not reported | 47.7 | 53.5 | Not reported |
| Standard Oral Hygiene + Sham Acupuncture | 55.0 | Not reported | 52.0 | 58.0 | Not reported |
Week 8
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Standard Oral Hygiene | 55.2 | Not reported | 51.3 | 59.1 | Not reported |
| Standard Oral Hygiene + True Acupuncture | 48.3 | Not reported | 45.3 | 52.3 | Not reported |
| Standard Oral Hygiene + Sham Acupuncture | 51.2 | Not reported | 47.6 | 54.8 | Not reported |
Week 12
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Standard Oral Hygiene | 54.8 | Not reported | 50.9 | 58.8 | Not reported |
| Standard Oral Hygiene + True Acupuncture | 48.9 | Not reported | 45.3 | 52.6 | Not reported |
| Standard Oral Hygiene + Sham Acupuncture | 49.9 | Not reported | 46.2 | 53.7 | Not reported |
Week 26
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Standard Oral Hygiene | 54.4 | Not reported | 50.4 | 58.4 | Not reported |
| Standard Oral Hygiene + True Acupuncture | 49.2 | Not reported | 45.5 | 52.9 | Not reported |
| Standard Oral Hygiene + Sham Acupuncture | 47.4 | Not reported | 43.6 | 51.2 | Not reported |
Source statistical analyses
- group Description
- The primary endpoint was to determine whether true acupuncture (TA) was more effective than sham acupuncture (SA) or standard oral hygiene (SOH) at treating xerostomia as assessed by the xerostomia questionnaire (XQ) at Week 4. The study was powered to detect a difference of 10 points with an assumed standard deviation (SD)=16 between each pair of groups on XQ.This assumed a t-test with a two-sided significance level of 0·0133 and 84% power with 20% dropout.
- group Ids
- OG000
- OG001
- OG002
- non Inferiority Comment
- Repeated measures analysis of covariance (RMANCOVA) models were constructed to assess differences in each outcome adjusting for baseline outcome value, group, time, and group by time interaction assuming an unstructured covariance. The primary objective was assessed using a linear contrast of group effect at 4 weeks
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0167
- statistical Method
- ANCOVA
Complete source fields
- analyses
- group Description
- The primary endpoint was to determine whether true acupuncture (TA) was more effective than sham acupuncture (SA) or standard oral hygiene (SOH) at treating xerostomia as assessed by the xerostomia questionnaire (XQ) at Week 4. The study was powered to detect a difference of 10 points with an assumed standard deviation (SD)=16 between each pair of groups on XQ.This assumed a t-test with a two-sided significance level of 0·0133 and 84% power with 20% dropout.
- group Ids
- OG000
- OG001
- OG002
- non Inferiority Comment
- Repeated measures analysis of covariance (RMANCOVA) models were constructed to assess differences in each outcome adjusting for baseline outcome value, group, time, and group by time interaction assuming an unstructured covariance. The primary objective was assessed using a linear contrast of group effect at 4 weeks
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0167
- statistical Method
- ANCOVA
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 54.0
- upper Limit
- 60.6
- value
- 57.3
- group Id
- OG001
- lower Limit
- 47.7
- upper Limit
- 53.5
- value
- 50.6
- group Id
- OG002
- lower Limit
- 52.0
- upper Limit
- 58.0
- value
- 55.0
- title
- Week 4
- categories
- measurements
- group Id
- OG000
- lower Limit
- 51.3
- upper Limit
- 59.1
- value
- 55.2
- group Id
- OG001
- lower Limit
- 45.3
- upper Limit
- 52.3
- value
- 48.3
- group Id
- OG002
- lower Limit
- 47.6
- upper Limit
- 54.8
- value
- 51.2
- title
- Week 8
- categories
- measurements
- group Id
- OG000
- lower Limit
- 50.9
- upper Limit
- 58.8
- value
- 54.8
- group Id
- OG001
- lower Limit
- 45.3
- upper Limit
- 52.6
- value
- 48.9
- group Id
- OG002
- lower Limit
- 46.2
- upper Limit
- 53.7
- value
- 49.9
- title
- Week 12
- categories
- measurements
- group Id
- OG000
- lower Limit
- 50.4
- upper Limit
- 58.4
- value
- 54.4
- group Id
- OG001
- lower Limit
- 45.5
- upper Limit
- 52.9
- value
- 49.2
- group Id
- OG002
- lower Limit
- 43.6
- upper Limit
- 51.2
- value
- 47.4
- title
- Week 26
- denoms
- counts
- group Id
- OG000
- value
- 86
- group Id
- OG001
- value
- 86
- group Id
- OG002
- value
- 86
- units
- Participants
- description
- Self reported Xerostomia questionnaire consists of eight items (scored on an 11-point scale; 0-10), has been validated in several cohorts, and is regarded as the gold-standard measure for xerostomia.The questions are equally divided into 4 items about oral dryness while eating or chewing and 4 items about dryness while not eating or chewing. Item scores are summed and transformed linearly to produce a final summary score between 0 and 80. Higher scores represent more xerostomia. Questionnaire is completed prior to randomization and at each time point week 4, week 8, week 12, and end of study.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- All patients will receive standard oral hygiene patient teaching information that includes instructions regarding mouth rinses, use of lip balms, use of mild fluoride toothpaste, the importance of adequate oral hydration, and other standard advice. Each participating site determines the standard oral hygiene recommendations used at their site. Standard Oral Hygiene: Oral hygiene care provided per individual institutions standard of care.
- id
- OG000
- title
- Standard Oral Hygiene
- description
- All patients will receive standard oral hygiene patient teaching information that includes instructions regarding mouth rinses, use of lip balms, use of mild fluoride toothpaste, the importance of adequate oral hydration, and other standard advice. Each participating site determines the standard oral hygiene recommendations used at their site. The True acupuncture points will be at 3 sites on each ear, a site on the chin, on each forearm, a site on each hand, a site on each leg, and one placebo needle for a total of 14 sites. All sites will be applied for 20 minutes. Standard Oral Hygiene + True Acupuncture: Oral hygiene care provided per individual institutions standard of care. 14 true acupoint sites will be selected and applied to each participant for 20 minutes at each session. There will be 2 sessions a week for 8 weeks.
- id
- OG001
- title
- Standard Oral Hygiene + True Acupuncture
- description
- All patients will receive standard oral hygiene patient teaching information that includes instructions regarding mouth rinses, use of lip balms, use of mild fluoride toothpaste, the importance of adequate oral hydration, and other standard advice. Each participating site determines the standard oral hygiene recommendations used at their site. The Sham acupuncture points will be given according to the same schedule as the active acupuncture points, except the Sham needles will be placed below, above or between true active points. Standard Oral Hygiene + Sham Acupuncture: Oral hygiene care provided per individual institutions standard of care. 14 sham acupoint sites will be selected and applied to each participant for 20 minutes at each session. There will be 2 sessions a week for 8 weeks.
- id
- OG002
- title
- Standard Oral Hygiene + Sham Acupuncture
- param Type
- LEAST_SQUARES_MEAN
- population Description
- Intent to treat analysis. Considered and utilized all data available at each timepoint.
- reporting Status
- POSTED
- time Frame
- Baseline to 4, 8, 12, 26 weeks post acupuncture
- title
- Xerostomia Questionnaire Scores
- type
- PRIMARY
- unit Of Measure
- score on a scale 0-80
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Preserved source evidence · Not medical advice