Trial Outcomes & Findings for Pilot Study Comparing Hypnotherapy and Gabapentin for Hot Flashes. (NCT NCT00711529)
NCT ID: NCT00711529
Last Updated: 2013-06-24
Results Overview
Patients kept daily diaries of their hot flashes. The absolute number of hot flashes in a 24 hour period is "number of daily hot flashes." The median number was calculated for each week of data. The median number of daily hot flashes for the first week (7 days) of participation is used as baseline. The median number of daily hot flashes for the fourth week (over 7 day interval) is reported for the week four time point. The median number of daily hot flashes for the eighth week (over 7 day interval) is reported for the week eight time point (study completion). Of the 13 women randomized to the hypnotherapy arm, 2 women were ineligible and therefore not included in analysis. Two women were unable to initiate treatment and did not submit diaries. An additional two women completed treatment but lost their diaries, leaving 7 diaries for analysis at baseline. Of the 14 randomized to receive gabapentin, 6 dropped out of the study and did not submit diaries.
COMPLETED
PHASE3
27 participants
Baseline
2013-06-24
Participant Flow
Between September 2008 and September 2010, 73 women were screened for this study. Fourteen women were deemed ineligible and 32 decided not to participate. A total of 27 women were randomized to receive treatment, 14 to gabapentin and 13 to hypnotherapy.
Participant milestones
| Measure |
Hypnotherapy
Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.
|
Gabapentin
Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
14
|
|
Overall Study
COMPLETED
|
9
|
8
|
|
Overall Study
NOT COMPLETED
|
4
|
6
|
Reasons for withdrawal
| Measure |
Hypnotherapy
Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.
|
Gabapentin
Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
|
|---|---|---|
|
Overall Study
Protocol Violation
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
6
|
Baseline Characteristics
Pilot Study Comparing Hypnotherapy and Gabapentin for Hot Flashes.
Baseline characteristics by cohort
| Measure |
Hypnotherapy
n=11 Participants
Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.
|
Gabapentin
n=14 Participants
Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
25 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
25 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: BaselinePatients kept daily diaries of their hot flashes. The absolute number of hot flashes in a 24 hour period is "number of daily hot flashes." The median number was calculated for each week of data. The median number of daily hot flashes for the first week (7 days) of participation is used as baseline. The median number of daily hot flashes for the fourth week (over 7 day interval) is reported for the week four time point. The median number of daily hot flashes for the eighth week (over 7 day interval) is reported for the week eight time point (study completion). Of the 13 women randomized to the hypnotherapy arm, 2 women were ineligible and therefore not included in analysis. Two women were unable to initiate treatment and did not submit diaries. An additional two women completed treatment but lost their diaries, leaving 7 diaries for analysis at baseline. Of the 14 randomized to receive gabapentin, 6 dropped out of the study and did not submit diaries.
Outcome measures
| Measure |
Hypnotherapy
n=7 Participants
Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.
|
Gabapentin
n=8 Participants
Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
|
|---|---|---|
|
Number of Daily Hot Flashes
|
5 daily hot flashes
Interval 2.0 to 11.0
|
4.5 daily hot flashes
Interval 2.0 to 9.0
|
PRIMARY outcome
Timeframe: Week 4Patients kept daily diaries of their hot flashes. The absolute number of hot flashes in a 24 hour period is "number of daily hot flashes." The median number was calculated for each week of data. The median number of daily hot flashes for the first week (7 days) of participation is used as baseline. The median number of daily hot flashes for the fourth week (over 7 day interval) is reported for the week four time point. The median number of daily hot flashes for the eighth week (over 7 day interval) is reported for the week eight time point (study completion). A total of 15 diaries were submitted (7 hypnotherapy, 8 gabapentin). One person in each arm stopped recording in her diary before the 4 week mark.
Outcome measures
| Measure |
Hypnotherapy
n=6 Participants
Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.
|
Gabapentin
n=7 Participants
Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
|
|---|---|---|
|
Number of Daily Hot Flashes
|
4 daily hot flashes
Interval 1.0 to 7.0
|
4 daily hot flashes
Interval 2.0 to 9.0
|
PRIMARY outcome
Timeframe: Week 8Patients kept daily diaries of their hot flashes. The absolute number of hot flashes in a 24 hour period is "number of daily hot flashes." The median number was calculated for each week of data. The median number of daily hot flashes for the first week (7 days) of participation is used as baseline. The median number of daily hot flashes for the fourth week (over 7 day interval) is reported for the week four time point. The median number of daily hot flashes for the eighth week (over 7 day interval) is reported for the week eight time point (study completion). One woman in the hypnotherapy arm and 3 women in the gabapentin arm stopped keeping their diary before the 8 week mark.
Outcome measures
| Measure |
Hypnotherapy
n=6 Participants
Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.
|
Gabapentin
n=5 Participants
Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
|
|---|---|---|
|
Number of Daily Hot Flashes
|
1 daily hot flashes
Interval 0.0 to 7.0
|
3 daily hot flashes
Interval 3.0 to 5.5
|
PRIMARY outcome
Timeframe: BaselineThe patients kept daily hot flash diaries, including the total number of hot flashes they characterized as mild, moderate,severe and very severe. Hot flash severity scores were calculated by assigning one point to each mild hot flash, two points for each moderate hot flash, three points for each severe hot flash and four points for each very severe hot flash. The hot flash severity score for a 24 hour period was the sum of these scores. The score was calculated for each day in the diary. For each subject, median scores were calculated for each week (7 day period) of participation. The median hot flash severity score for the first week was considered the baseline. The median hot flash severity score for the fourth week is considered the week 4 time point. The median hot flash severity score for the eighth week is considered the week 8 time point. The median result for the group was then calculated at each of the timepoints.
Outcome measures
| Measure |
Hypnotherapy
n=7 Participants
Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.
|
Gabapentin
n=8 Participants
Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
|
|---|---|---|
|
Hot Flash Severity Score
|
10 units on a scale (severity score)
Interval 2.0 to 14.0
|
7.5 units on a scale (severity score)
Interval 2.0 to 17.5
|
PRIMARY outcome
Timeframe: Week 4The patients kept daily hot flash diaries, including the total number of hot flashes they characterized as mild, moderate,severe and very severe. Hot flash severity scores were calculated by assigning one point to each mild hot flash, two points for each moderate hot flash, three points for each severe hot flash and four points for each very severe hot flash. The hot flash severity score for a 24 hour period was the sum of these scores. The score was calculated for each day in the diary. For each subject, median scores were calculated for each week (7 day period) of participation. The median hot flash severity score for the first week was considered the baseline. The median hot flash severity score for the fourth week is considered the week 4 time point. The median hot flash severity score for the eighth week is considered the week 8 time point. The median result for the group was then calculated at each of the timepoints.
Outcome measures
| Measure |
Hypnotherapy
n=6 Participants
Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.
|
Gabapentin
n=7 Participants
Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
|
|---|---|---|
|
Hot Flash Severity Score
|
6.5 units on a scale (severity score)
Interval 1.0 to 11.0
|
4 units on a scale (severity score)
Interval 2.0 to 17.5
|
PRIMARY outcome
Timeframe: Week 8The patients kept daily hot flash diaries, including the total number of hot flashes they characterized as mild, moderate,severe and very severe. Hot flash severity scores were calculated by assigning one point to each mild hot flash, two points for each moderate hot flash, three points for each severe hot flash and four points for each very severe hot flash. The hot flash severity score for a 24 hour period was the sum of these scores. The score was calculated for each day in the diary. For each subject, median scores were calculated for each week (7 day period) of participation. The median hot flash severity score for the first week was considered the baseline. The median hot flash severity score for the fourth week is considered the week 4 time point. The median hot flash severity score for the eighth week is considered the week 8 time point. The median result for the group was then calculated at each of the timepoints.
Outcome measures
| Measure |
Hypnotherapy
n=6 Participants
Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.
|
Gabapentin
n=5 Participants
Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
|
|---|---|---|
|
Hot Flash Severity Score
|
1.5 units on a scale (severity score)
Interval 0.0 to 12.0
|
5 units on a scale (severity score)
Interval 3.0 to 11.5
|
SECONDARY outcome
Timeframe: BaselineThe HFRDIS is a validated survey of 10 questions asking patients to rate ten symptoms on a scale of 0-10. The HFRDIS is a sum of the scores in each category, so that total score can range from 0 (no symptoms) to 100 (10 severe symptoms). These surveys were conducted at the time of enrollment (baseline), after four weeks of treatment, and at the conclusion of the study (8 weeks). All women who were randomized were included in the baseline analysis (with the exception of 2 women excluded from the hypnotherapy arm who were deemed ineligible after randomization).
Outcome measures
| Measure |
Hypnotherapy
n=11 Participants
Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.
|
Gabapentin
n=14 Participants
Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
|
|---|---|---|
|
Hot Flash Related Daily Interference Score (HFRDIS)
|
58 units on a scale (HFRDIS)
Interval 16.0 to 64.0
|
45.5 units on a scale (HFRDIS)
Interval 11.0 to 82.0
|
SECONDARY outcome
Timeframe: Week 4The HFRDIS is a validated survey of 10 questions asking patients to rate ten hot flash-related symptoms on a scale of 0-10. The HFRDIS is a sum of the scores in each category, so that total score can range from 0 (no symptoms) to 100 (10 severe symptoms). These surveys were conducted at the time of enrollment (baseline), after four weeks of treatment, and at the conclusion of the study (8 weeks). Of 11 eligible women in the hypnotherapy arm, 2 never initiated treatment, and 3 did not complete the survey at this time point. Of the 14 eligible women in the gabapentin arm, 3 never initiated treatment, and 3 dropped out of the study before the 4 week time point.
Outcome measures
| Measure |
Hypnotherapy
n=6 Participants
Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.
|
Gabapentin
n=8 Participants
Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
|
|---|---|---|
|
Hot Flash Related Daily Interference Score (HFRDIS)
|
25.5 units on a scale (HFRDIS)
Interval 1.0 to 57.0
|
21.5 units on a scale (HFRDIS)
Interval 0.0 to 57.0
|
SECONDARY outcome
Timeframe: Week 8The HFRDIS is a validated survey of 10 questions asking patients to rate ten hot flash-related symptoms on a scale of 0-10. The HFRDIS is a sum of the scores in each category, so that total score can range from 0 (no symptoms) to 100 (10 severe symptoms). These surveys were conducted at the time of enrollment (baseline), after four weeks of treatment, and at the conclusion of the study (8 weeks). All nine women who initiated hypnotherapy treatment completed the survey at the end of 8 weeks. One woman in the gabapentin arm did not submit a survey at 8 weeks.
Outcome measures
| Measure |
Hypnotherapy
n=9 Participants
Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.
|
Gabapentin
n=7 Participants
Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
|
|---|---|---|
|
Hot Flash Related Daily Interference Score (HFRDIS)
|
26 units on a scale (HFRDIS)
Interval 0.0 to 68.0
|
22 units on a scale (HFRDIS)
Interval 7.0 to 41.0
|
Adverse Events
Hypnotherapy
Gabapentin
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place