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Are progesterone or progestogens effective in managing premenstrual syndrome (PMS) symptoms?
ABSTRACT
BACKGROUND: Progestational therapy has been claimed effective in patients with PMS for many years. In the United States, progesterone or progestogen products account for 60% to 70% of prescriptions for PMS symptoms.
POPULATION STUDIED: The authors searched for clinical trials of progesterone or progestogens in the management of PMS. A systematic search of multiple databases in all languages yielded the reports of clinical trials included in this review. A search of references cited and contact with pharmaceutical companies completed the list of trials for evaluation. The report does not indicate whether searches were performed by more than one person. Trials were included if patients had a pretreatment diagnosis of PMS. Ten trials of progesterone therapy, evaluating 531 patients, remained for analysis. For progestogen therapy, analysis included 4 trials comprising a total of 378 patients. Although the authors do not describe the patients from the included trials in detail, they probably represent patients seen in family practice settings.
STUDY DESIGN AND VALIDITY: The authors of this meta-analysis evaluated all trials for quality using 2 separate rating scales. The quality of available studies was low. The authors independently extracted data in duplicate from the trials selected for analysis.
OUTCOMES MEASURED: The authors defined their primary outcome as the reduction in overall symptoms of PMS. The authors summarized outcomes by intention to treat, where possible. They calculated a standardized mean difference in effect of treatment and converted this statistic to an odds ratio (OR).
RESULTS: Trials of progesterone suppositories or pessaries showed a marginal effect in favor of placebo (OR = 0.93; 95% CI, 0.91-0.95). Oral micronized progesterone had marginal benefit (OR = 1.30; 95% CI, 1.25-1.36). When all trials of progesterone were combined, there was a small, but clinically insignificant, effect (OR = 1.05; 95% CI, 1.03-1.08). Trials of progestogen therapy showed a clinically insignificant effect in favor of the drug (OR = 1.07; 95% CI, 1.03-1.11). Patients given active treatment had a nonsignificant increase in dropout rate because of side effects (OR = 1.65; 95% CI, 0.86-3.21).
Progesterone and progestogen therapy should no longer be prescribed for PMS. This systematic review shows that published evidence does not support use of such therapy. Evidence of effectiveness in reducing overall symptoms of PMS is better for other therapies. Similar systematic reviews by the same group of authors show benefit from the use of selective serotonin-reuptake inhibitors (SSRIs)1 and vitamin B6.2 For women with PMS symptoms that require pharmacologic management, SSRIs provide effective first-line therapy. Vitamin B6is also likely to be of benefit, although the quality of the evidence is poor. Nonmedication measures may help, but they have not been systematically studied. Calcium therapy and chasteberry fruit extract have been reviewed in previous POEMs and have been found effective.
ABSTRACT
BACKGROUND: Progestational therapy has been claimed effective in patients with PMS for many years. In the United States, progesterone or progestogen products account for 60% to 70% of prescriptions for PMS symptoms.
POPULATION STUDIED: The authors searched for clinical trials of progesterone or progestogens in the management of PMS. A systematic search of multiple databases in all languages yielded the reports of clinical trials included in this review. A search of references cited and contact with pharmaceutical companies completed the list of trials for evaluation. The report does not indicate whether searches were performed by more than one person. Trials were included if patients had a pretreatment diagnosis of PMS. Ten trials of progesterone therapy, evaluating 531 patients, remained for analysis. For progestogen therapy, analysis included 4 trials comprising a total of 378 patients. Although the authors do not describe the patients from the included trials in detail, they probably represent patients seen in family practice settings.
STUDY DESIGN AND VALIDITY: The authors of this meta-analysis evaluated all trials for quality using 2 separate rating scales. The quality of available studies was low. The authors independently extracted data in duplicate from the trials selected for analysis.
OUTCOMES MEASURED: The authors defined their primary outcome as the reduction in overall symptoms of PMS. The authors summarized outcomes by intention to treat, where possible. They calculated a standardized mean difference in effect of treatment and converted this statistic to an odds ratio (OR).
RESULTS: Trials of progesterone suppositories or pessaries showed a marginal effect in favor of placebo (OR = 0.93; 95% CI, 0.91-0.95). Oral micronized progesterone had marginal benefit (OR = 1.30; 95% CI, 1.25-1.36). When all trials of progesterone were combined, there was a small, but clinically insignificant, effect (OR = 1.05; 95% CI, 1.03-1.08). Trials of progestogen therapy showed a clinically insignificant effect in favor of the drug (OR = 1.07; 95% CI, 1.03-1.11). Patients given active treatment had a nonsignificant increase in dropout rate because of side effects (OR = 1.65; 95% CI, 0.86-3.21).
Progesterone and progestogen therapy should no longer be prescribed for PMS. This systematic review shows that published evidence does not support use of such therapy. Evidence of effectiveness in reducing overall symptoms of PMS is better for other therapies. Similar systematic reviews by the same group of authors show benefit from the use of selective serotonin-reuptake inhibitors (SSRIs)1 and vitamin B6.2 For women with PMS symptoms that require pharmacologic management, SSRIs provide effective first-line therapy. Vitamin B6is also likely to be of benefit, although the quality of the evidence is poor. Nonmedication measures may help, but they have not been systematically studied. Calcium therapy and chasteberry fruit extract have been reviewed in previous POEMs and have been found effective.
ABSTRACT
BACKGROUND: Progestational therapy has been claimed effective in patients with PMS for many years. In the United States, progesterone or progestogen products account for 60% to 70% of prescriptions for PMS symptoms.
POPULATION STUDIED: The authors searched for clinical trials of progesterone or progestogens in the management of PMS. A systematic search of multiple databases in all languages yielded the reports of clinical trials included in this review. A search of references cited and contact with pharmaceutical companies completed the list of trials for evaluation. The report does not indicate whether searches were performed by more than one person. Trials were included if patients had a pretreatment diagnosis of PMS. Ten trials of progesterone therapy, evaluating 531 patients, remained for analysis. For progestogen therapy, analysis included 4 trials comprising a total of 378 patients. Although the authors do not describe the patients from the included trials in detail, they probably represent patients seen in family practice settings.
STUDY DESIGN AND VALIDITY: The authors of this meta-analysis evaluated all trials for quality using 2 separate rating scales. The quality of available studies was low. The authors independently extracted data in duplicate from the trials selected for analysis.
OUTCOMES MEASURED: The authors defined their primary outcome as the reduction in overall symptoms of PMS. The authors summarized outcomes by intention to treat, where possible. They calculated a standardized mean difference in effect of treatment and converted this statistic to an odds ratio (OR).
RESULTS: Trials of progesterone suppositories or pessaries showed a marginal effect in favor of placebo (OR = 0.93; 95% CI, 0.91-0.95). Oral micronized progesterone had marginal benefit (OR = 1.30; 95% CI, 1.25-1.36). When all trials of progesterone were combined, there was a small, but clinically insignificant, effect (OR = 1.05; 95% CI, 1.03-1.08). Trials of progestogen therapy showed a clinically insignificant effect in favor of the drug (OR = 1.07; 95% CI, 1.03-1.11). Patients given active treatment had a nonsignificant increase in dropout rate because of side effects (OR = 1.65; 95% CI, 0.86-3.21).
Progesterone and progestogen therapy should no longer be prescribed for PMS. This systematic review shows that published evidence does not support use of such therapy. Evidence of effectiveness in reducing overall symptoms of PMS is better for other therapies. Similar systematic reviews by the same group of authors show benefit from the use of selective serotonin-reuptake inhibitors (SSRIs)1 and vitamin B6.2 For women with PMS symptoms that require pharmacologic management, SSRIs provide effective first-line therapy. Vitamin B6is also likely to be of benefit, although the quality of the evidence is poor. Nonmedication measures may help, but they have not been systematically studied. Calcium therapy and chasteberry fruit extract have been reviewed in previous POEMs and have been found effective.
Can regular intake of either cranberry juice or a drink containing Lactobacillus bacteria prevent urinary tract infection (UTI) recurrence in women after an initial episode?
BACKGROUND: UTIs are common in adult women, and many will have recurrences of UTI. The effectiveness of cranberry juice or Lactobacillus in preventing such recurrences is not known.
POPULATION STUDIED: The authors recruited women with culture-confirmed Escherichia coli UTI from university students and staff of a university hospital in Finland (n=149). Participants had an average age of 30 years and averaged 6 previous UTIs. Only 5 patients were older than 55 years. The study groups were similar; however, the cranberry juice group had a slightly higher previous use of antibiotics. The population studied would likely fit the practices of many family physicians. Eighty-five percent of the women had taken antimicrobials for a UTI in the year before enrollment. All were treated for their index episode of UTI with 5 days of standard drug therapy (communication with authors). Most (78%) used birth control during the study; none used a diaphragm or spermicides. Five women became pregnant during the 1-year follow-up.
STUDY DESIGN AND VALIDITY: Patients were randomized to 1 of 3 groups, with study personnel unaware of patients’ treatment assignments until after they were enrolled (concealed allocation; communication with authors). Fifty patients received daily oral concentrate (50 mL) of cranberry-lingonberry juice for 6 months. They were to dilute the concentrate with 200 mL of water. This product is no longer commercially available, even in Finland. In the second group, 49 patients took a Lactobacillus drink 5 days a week for 12 months. The 100-mL drink contained 4 × 1010 cfu of Lactobacillus. There were 50 untreated control patients. Treating physicians and patients were not blinded to the treatment assignment. Each recurrence was treated with nitrofurantoin for 5 days (communication with authors).
OUTCOMES MEASURED: The primary outcome measured was recurrence of UTI within 1 year. Patient symptoms were confirmed with culture to diagnose each recurrence.
RESULTS: Daily cranberry juice significantly decreased the incidence of UTI. Lactobacillus ingestion did not change the recurrence rate. Eight patients in the cranberry group had at least one recurrent UTI, compared with 19 in the Lactobacillus group and 18 in the control group (P=.023; number needed to treat [NNT]=5; 95% confidence interval [CI], 3-34). At 12 months, 12 patients in the cranberry group had a recurrent UTI, compared with 21 in the Lactobacillus group and 19 in the control group (P=.048; NNT=7). Most (80%) of the recurrences were due to E coli.
Daily ingestion of cranberry juice is effective in decreasing the number of UTIs experienced by women. This study used a product no longer available, but if the cranberry juice your patients can obtain has the same effect as the study product, a daily glass of juice can decrease the risk of a recurrent UTI. The absolute risk reduction is 20% (from 36% to 16% recurrence rate) in 6 months, giving an NNT of 5. The relative risk reduction is 56%. A larger study is needed before we can know that Lactobacillus-laced drinks are not effective.
BACKGROUND: UTIs are common in adult women, and many will have recurrences of UTI. The effectiveness of cranberry juice or Lactobacillus in preventing such recurrences is not known.
POPULATION STUDIED: The authors recruited women with culture-confirmed Escherichia coli UTI from university students and staff of a university hospital in Finland (n=149). Participants had an average age of 30 years and averaged 6 previous UTIs. Only 5 patients were older than 55 years. The study groups were similar; however, the cranberry juice group had a slightly higher previous use of antibiotics. The population studied would likely fit the practices of many family physicians. Eighty-five percent of the women had taken antimicrobials for a UTI in the year before enrollment. All were treated for their index episode of UTI with 5 days of standard drug therapy (communication with authors). Most (78%) used birth control during the study; none used a diaphragm or spermicides. Five women became pregnant during the 1-year follow-up.
STUDY DESIGN AND VALIDITY: Patients were randomized to 1 of 3 groups, with study personnel unaware of patients’ treatment assignments until after they were enrolled (concealed allocation; communication with authors). Fifty patients received daily oral concentrate (50 mL) of cranberry-lingonberry juice for 6 months. They were to dilute the concentrate with 200 mL of water. This product is no longer commercially available, even in Finland. In the second group, 49 patients took a Lactobacillus drink 5 days a week for 12 months. The 100-mL drink contained 4 × 1010 cfu of Lactobacillus. There were 50 untreated control patients. Treating physicians and patients were not blinded to the treatment assignment. Each recurrence was treated with nitrofurantoin for 5 days (communication with authors).
OUTCOMES MEASURED: The primary outcome measured was recurrence of UTI within 1 year. Patient symptoms were confirmed with culture to diagnose each recurrence.
RESULTS: Daily cranberry juice significantly decreased the incidence of UTI. Lactobacillus ingestion did not change the recurrence rate. Eight patients in the cranberry group had at least one recurrent UTI, compared with 19 in the Lactobacillus group and 18 in the control group (P=.023; number needed to treat [NNT]=5; 95% confidence interval [CI], 3-34). At 12 months, 12 patients in the cranberry group had a recurrent UTI, compared with 21 in the Lactobacillus group and 19 in the control group (P=.048; NNT=7). Most (80%) of the recurrences were due to E coli.
Daily ingestion of cranberry juice is effective in decreasing the number of UTIs experienced by women. This study used a product no longer available, but if the cranberry juice your patients can obtain has the same effect as the study product, a daily glass of juice can decrease the risk of a recurrent UTI. The absolute risk reduction is 20% (from 36% to 16% recurrence rate) in 6 months, giving an NNT of 5. The relative risk reduction is 56%. A larger study is needed before we can know that Lactobacillus-laced drinks are not effective.
BACKGROUND: UTIs are common in adult women, and many will have recurrences of UTI. The effectiveness of cranberry juice or Lactobacillus in preventing such recurrences is not known.
POPULATION STUDIED: The authors recruited women with culture-confirmed Escherichia coli UTI from university students and staff of a university hospital in Finland (n=149). Participants had an average age of 30 years and averaged 6 previous UTIs. Only 5 patients were older than 55 years. The study groups were similar; however, the cranberry juice group had a slightly higher previous use of antibiotics. The population studied would likely fit the practices of many family physicians. Eighty-five percent of the women had taken antimicrobials for a UTI in the year before enrollment. All were treated for their index episode of UTI with 5 days of standard drug therapy (communication with authors). Most (78%) used birth control during the study; none used a diaphragm or spermicides. Five women became pregnant during the 1-year follow-up.
STUDY DESIGN AND VALIDITY: Patients were randomized to 1 of 3 groups, with study personnel unaware of patients’ treatment assignments until after they were enrolled (concealed allocation; communication with authors). Fifty patients received daily oral concentrate (50 mL) of cranberry-lingonberry juice for 6 months. They were to dilute the concentrate with 200 mL of water. This product is no longer commercially available, even in Finland. In the second group, 49 patients took a Lactobacillus drink 5 days a week for 12 months. The 100-mL drink contained 4 × 1010 cfu of Lactobacillus. There were 50 untreated control patients. Treating physicians and patients were not blinded to the treatment assignment. Each recurrence was treated with nitrofurantoin for 5 days (communication with authors).
OUTCOMES MEASURED: The primary outcome measured was recurrence of UTI within 1 year. Patient symptoms were confirmed with culture to diagnose each recurrence.
RESULTS: Daily cranberry juice significantly decreased the incidence of UTI. Lactobacillus ingestion did not change the recurrence rate. Eight patients in the cranberry group had at least one recurrent UTI, compared with 19 in the Lactobacillus group and 18 in the control group (P=.023; number needed to treat [NNT]=5; 95% confidence interval [CI], 3-34). At 12 months, 12 patients in the cranberry group had a recurrent UTI, compared with 21 in the Lactobacillus group and 19 in the control group (P=.048; NNT=7). Most (80%) of the recurrences were due to E coli.
Daily ingestion of cranberry juice is effective in decreasing the number of UTIs experienced by women. This study used a product no longer available, but if the cranberry juice your patients can obtain has the same effect as the study product, a daily glass of juice can decrease the risk of a recurrent UTI. The absolute risk reduction is 20% (from 36% to 16% recurrence rate) in 6 months, giving an NNT of 5. The relative risk reduction is 56%. A larger study is needed before we can know that Lactobacillus-laced drinks are not effective.