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Gabapentin, estrogen, and placebo for treating hot flushes: a randomized controlled trial.
Obstet Gynecol. 2006 Jul; 108(1):41-8.OG

Abstract

OBJECTIVE

To compare the efficacy of gabapentin, estrogen, and placebo in the treatment of hot flushes.

METHODS

We performed a randomized, double-blind, placebo-controlled trial of 60 postmenopausal women to assess the efficacy of estrogen and gabapentin in the treatment of moderate-to-severe hot flushes. Participants were randomly assigned to receive either 0.625 mg/d of conjugated estrogens (n = 20), placebo (n = 20), or gabapentin titrated to 2,400 mg/d (n = 20) for 12 weeks. Participants recorded frequency and severity of baseline hot flushes on a hot flush diary for 2 weeks before randomization and for 12 weeks after randomization. The primary outcome measure was the weekly hot flush composite score, which takes into account both severity and frequency of hot flushes. Secondary outcome measures were differences in pre- and posttreatment scores pertaining to depression (Zung Depression Scale) and other climacteric symptoms (Greene Climacteric Scale).

RESULTS

Intention-to-treat analysis showed that the reduction in the hot flush composite score for both estrogen (72%, P = .016) and gabapentin (71%, P = .004) was greater than the reduction associated with placebo (54%) at the conclusion of the 12th week. The extent of reduction in hot flush composite score, however, was not significantly different between estrogen and gabapentin (P = .63). No differences were seen between groups in the Zung Depression Scale, or in any of the Greene Climacteric subscales except for the Somatic Symptom cluster, which was significantly greater in the gabapentin arm than in the placebo arm. Despite a lack of group differences in adverse events, the Headache, Dizziness, and Disorientation cluster appeared with greater frequency in the gabapentin group. Estimation of the number needed to harm in this cluster suggests that these symptoms may occur with every fourth patient treated with gabapentin.

CONCLUSION

Despite the small scale of this study, gabapentin appears to be as effective as estrogen in the treatment of postmenopausal hot flushes.

CLINICAL TRIAL REGISTRATION

Clinicaltrials.gov, NCT 00276081.

LEVEL OF EVIDENCE

I.

Authors+Show Affiliations

Department of Obstetrics and Gynecology, University of Rochester School of Medicine and Dentistry, Rochester, New York 14642, USA. Sireesha_Reddy@urmc.rochester.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16816054

Citation

Reddy, Sireesha Y., et al. "Gabapentin, Estrogen, and Placebo for Treating Hot Flushes: a Randomized Controlled Trial." Obstetrics and Gynecology, vol. 108, no. 1, 2006, pp. 41-8.
Reddy SY, Warner H, Guttuso T, et al. Gabapentin, estrogen, and placebo for treating hot flushes: a randomized controlled trial. Obstet Gynecol. 2006;108(1):41-8.
Reddy, S. Y., Warner, H., Guttuso, T., Messing, S., DiGrazio, W., Thornburg, L., & Guzick, D. S. (2006). Gabapentin, estrogen, and placebo for treating hot flushes: a randomized controlled trial. Obstetrics and Gynecology, 108(1), 41-8.
Reddy SY, et al. Gabapentin, Estrogen, and Placebo for Treating Hot Flushes: a Randomized Controlled Trial. Obstet Gynecol. 2006;108(1):41-8. PubMed PMID: 16816054.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Gabapentin, estrogen, and placebo for treating hot flushes: a randomized controlled trial. AU - Reddy,Sireesha Y, AU - Warner,Hiral, AU - Guttuso,Thomas,Jr AU - Messing,Susan, AU - DiGrazio,William, AU - Thornburg,Loralei, AU - Guzick,David S, PY - 2006/7/4/pubmed PY - 2006/8/11/medline PY - 2006/7/4/entrez SP - 41 EP - 8 JF - Obstetrics and gynecology JO - Obstet Gynecol VL - 108 IS - 1 N2 - OBJECTIVE: To compare the efficacy of gabapentin, estrogen, and placebo in the treatment of hot flushes. METHODS: We performed a randomized, double-blind, placebo-controlled trial of 60 postmenopausal women to assess the efficacy of estrogen and gabapentin in the treatment of moderate-to-severe hot flushes. Participants were randomly assigned to receive either 0.625 mg/d of conjugated estrogens (n = 20), placebo (n = 20), or gabapentin titrated to 2,400 mg/d (n = 20) for 12 weeks. Participants recorded frequency and severity of baseline hot flushes on a hot flush diary for 2 weeks before randomization and for 12 weeks after randomization. The primary outcome measure was the weekly hot flush composite score, which takes into account both severity and frequency of hot flushes. Secondary outcome measures were differences in pre- and posttreatment scores pertaining to depression (Zung Depression Scale) and other climacteric symptoms (Greene Climacteric Scale). RESULTS: Intention-to-treat analysis showed that the reduction in the hot flush composite score for both estrogen (72%, P = .016) and gabapentin (71%, P = .004) was greater than the reduction associated with placebo (54%) at the conclusion of the 12th week. The extent of reduction in hot flush composite score, however, was not significantly different between estrogen and gabapentin (P = .63). No differences were seen between groups in the Zung Depression Scale, or in any of the Greene Climacteric subscales except for the Somatic Symptom cluster, which was significantly greater in the gabapentin arm than in the placebo arm. Despite a lack of group differences in adverse events, the Headache, Dizziness, and Disorientation cluster appeared with greater frequency in the gabapentin group. Estimation of the number needed to harm in this cluster suggests that these symptoms may occur with every fourth patient treated with gabapentin. CONCLUSION: Despite the small scale of this study, gabapentin appears to be as effective as estrogen in the treatment of postmenopausal hot flushes. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov, NCT 00276081. LEVEL OF EVIDENCE: I. SN - 0029-7844 UR - https://www.unboundmedicine.com/medline/citation/16816054/Gabapentin_estrogen_and_placebo_for_treating_hot_flushes:_a_randomized_controlled_trial_ L2 - http://ovidsp.ovid.com/ovidweb.cgi?T=JS&PAGE=linkout&SEARCH=16816054.ui DB - PRIME DP - Unbound Medicine ER -