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What is the most effective regimen for eradication of Helicobacter pylori in patients who have failed a first eradication attempt?
ABSTRACT
BACKGROUND: Based on randomized clinical trials (RCTs), the most effective first-line eradication therapy for Helicobacter pylori is a combination of proton pump inhibitor (PPI) and 2 antimicrobial agents.1 Yet there remains a significant treatment failure rate of 5% to 25%. Antibiotic resistance is the major impediment of cure.2 Using a pooled analysis approach, the authors determined the second-line treatment strategy resulting in the greatest percentage of H pylorieradication.
POPULATION STUDIED: Studies of H pylori re-eradication in adults were retrieved from MEDLINE database, reference lists of retrieved research papers, and major congress abstract lists. All studies were performed between 1994 and 1999, were conducted prospectively (or without information on study design), contained detailed information on eradication agents, and included subjects with only one treatment failure. Eighteen articles and 47 abstracts were identified; 16 articles and 24 abstracts met the inclusion criteria.
STUDY DESIGN AND VALIDITY: The authors performed a pooled efficacy analysis of re-treatment regimens for H pylori eradication in adults. They included all prospective studies—randomized and nonrandomized—that reported eradication rates in patients previously treated with antibiotic therapy. The inclusion criteria were appropriate, and the search for relevant articles was complete in that the authors included abstracts from international gastroenterology meetings. An analysis strategy of simple pooling was used (total number of patients successfully treated divided by all those enrolled in given treatment category), which is appropriate since the primary outcome was the eradication rate.
OUTCOMES MEASURED: The authors calculated a pooled eradication rate with 95% confidence intervals for each of the 6 general treatment categories. They also determined the eradication rate of each second treatment, accounting for differences in initial treatment therapy regimen. Finally, they ascertained if the effectiveness of second-line therapy regimens improved when distinct antimicrobials not used in the first attempt at treatment were used.
RESULTS: The most effective second-line therapies for eradication of H pylori were quadruple therapy, either ranitidine-bismuth-based triple therapy (ranitidine-bismuth product plus 2 antimicrobials) at 80.2% (95% confidence interval [CI], 75%-85%) or H2-blocker or PPI, bismuth compound, and 2 antimicrobials) at 75.8% (95% CI, 73%-79%). The second-line treatment eradication rate was lower when the initial therapy was a PPI with 2 antimicrobials versus a PPI with one antimicrobial. Re-treatment was more difficult with an increased number of antimicrobials used in initial therapy. The re-treatment eradication rate was greater when 2 new antimicrobials were included in the regimen than when a single new antimicrobial was added (P=.0064).
If initial attempts fail at eradication of H pylori then quadruple therapy (an antisecretory agent, a bismuth compound, and 2 antimicrobials) or ranitidine-bismuth (Tritec) plus 2 antimicrobials is the most effective follow-up treatment. The latter approach is fairly expensive ($150). For patients whose first course included only one antimicrobial, using 2 new antimicrobials is just as effective as quadruple or ranitidine bismuth-based therapy. These approaches will achieve eradication in 75% to 80% of resistant cases.
ABSTRACT
BACKGROUND: Based on randomized clinical trials (RCTs), the most effective first-line eradication therapy for Helicobacter pylori is a combination of proton pump inhibitor (PPI) and 2 antimicrobial agents.1 Yet there remains a significant treatment failure rate of 5% to 25%. Antibiotic resistance is the major impediment of cure.2 Using a pooled analysis approach, the authors determined the second-line treatment strategy resulting in the greatest percentage of H pylorieradication.
POPULATION STUDIED: Studies of H pylori re-eradication in adults were retrieved from MEDLINE database, reference lists of retrieved research papers, and major congress abstract lists. All studies were performed between 1994 and 1999, were conducted prospectively (or without information on study design), contained detailed information on eradication agents, and included subjects with only one treatment failure. Eighteen articles and 47 abstracts were identified; 16 articles and 24 abstracts met the inclusion criteria.
STUDY DESIGN AND VALIDITY: The authors performed a pooled efficacy analysis of re-treatment regimens for H pylori eradication in adults. They included all prospective studies—randomized and nonrandomized—that reported eradication rates in patients previously treated with antibiotic therapy. The inclusion criteria were appropriate, and the search for relevant articles was complete in that the authors included abstracts from international gastroenterology meetings. An analysis strategy of simple pooling was used (total number of patients successfully treated divided by all those enrolled in given treatment category), which is appropriate since the primary outcome was the eradication rate.
OUTCOMES MEASURED: The authors calculated a pooled eradication rate with 95% confidence intervals for each of the 6 general treatment categories. They also determined the eradication rate of each second treatment, accounting for differences in initial treatment therapy regimen. Finally, they ascertained if the effectiveness of second-line therapy regimens improved when distinct antimicrobials not used in the first attempt at treatment were used.
RESULTS: The most effective second-line therapies for eradication of H pylori were quadruple therapy, either ranitidine-bismuth-based triple therapy (ranitidine-bismuth product plus 2 antimicrobials) at 80.2% (95% confidence interval [CI], 75%-85%) or H2-blocker or PPI, bismuth compound, and 2 antimicrobials) at 75.8% (95% CI, 73%-79%). The second-line treatment eradication rate was lower when the initial therapy was a PPI with 2 antimicrobials versus a PPI with one antimicrobial. Re-treatment was more difficult with an increased number of antimicrobials used in initial therapy. The re-treatment eradication rate was greater when 2 new antimicrobials were included in the regimen than when a single new antimicrobial was added (P=.0064).
If initial attempts fail at eradication of H pylori then quadruple therapy (an antisecretory agent, a bismuth compound, and 2 antimicrobials) or ranitidine-bismuth (Tritec) plus 2 antimicrobials is the most effective follow-up treatment. The latter approach is fairly expensive ($150). For patients whose first course included only one antimicrobial, using 2 new antimicrobials is just as effective as quadruple or ranitidine bismuth-based therapy. These approaches will achieve eradication in 75% to 80% of resistant cases.
ABSTRACT
BACKGROUND: Based on randomized clinical trials (RCTs), the most effective first-line eradication therapy for Helicobacter pylori is a combination of proton pump inhibitor (PPI) and 2 antimicrobial agents.1 Yet there remains a significant treatment failure rate of 5% to 25%. Antibiotic resistance is the major impediment of cure.2 Using a pooled analysis approach, the authors determined the second-line treatment strategy resulting in the greatest percentage of H pylorieradication.
POPULATION STUDIED: Studies of H pylori re-eradication in adults were retrieved from MEDLINE database, reference lists of retrieved research papers, and major congress abstract lists. All studies were performed between 1994 and 1999, were conducted prospectively (or without information on study design), contained detailed information on eradication agents, and included subjects with only one treatment failure. Eighteen articles and 47 abstracts were identified; 16 articles and 24 abstracts met the inclusion criteria.
STUDY DESIGN AND VALIDITY: The authors performed a pooled efficacy analysis of re-treatment regimens for H pylori eradication in adults. They included all prospective studies—randomized and nonrandomized—that reported eradication rates in patients previously treated with antibiotic therapy. The inclusion criteria were appropriate, and the search for relevant articles was complete in that the authors included abstracts from international gastroenterology meetings. An analysis strategy of simple pooling was used (total number of patients successfully treated divided by all those enrolled in given treatment category), which is appropriate since the primary outcome was the eradication rate.
OUTCOMES MEASURED: The authors calculated a pooled eradication rate with 95% confidence intervals for each of the 6 general treatment categories. They also determined the eradication rate of each second treatment, accounting for differences in initial treatment therapy regimen. Finally, they ascertained if the effectiveness of second-line therapy regimens improved when distinct antimicrobials not used in the first attempt at treatment were used.
RESULTS: The most effective second-line therapies for eradication of H pylori were quadruple therapy, either ranitidine-bismuth-based triple therapy (ranitidine-bismuth product plus 2 antimicrobials) at 80.2% (95% confidence interval [CI], 75%-85%) or H2-blocker or PPI, bismuth compound, and 2 antimicrobials) at 75.8% (95% CI, 73%-79%). The second-line treatment eradication rate was lower when the initial therapy was a PPI with 2 antimicrobials versus a PPI with one antimicrobial. Re-treatment was more difficult with an increased number of antimicrobials used in initial therapy. The re-treatment eradication rate was greater when 2 new antimicrobials were included in the regimen than when a single new antimicrobial was added (P=.0064).
If initial attempts fail at eradication of H pylori then quadruple therapy (an antisecretory agent, a bismuth compound, and 2 antimicrobials) or ranitidine-bismuth (Tritec) plus 2 antimicrobials is the most effective follow-up treatment. The latter approach is fairly expensive ($150). For patients whose first course included only one antimicrobial, using 2 new antimicrobials is just as effective as quadruple or ranitidine bismuth-based therapy. These approaches will achieve eradication in 75% to 80% of resistant cases.
What is the most effective treatment for tinea pedis (athlete’s foot)?
Topical therapy is effective for tinea pedis. Topical terbinafine has a 70% cure rate, is available over the counter (OTC), and requires only 1 to 2 weeks of therapy. Two other OTC topicals, tolnaftate and miconazole, require 2 to 4 weeks to achieve slightly lower cure rates, but are considerably less expensive. (Grade of recommendation: A)
The most effective treatment for tinea pedis is oral terbinafine 250 mg twice a day for 2 weeks (94% clinical cure rate). However, oral terbinafine is expensive and not approved for this indication. Oral therapy may be required for patients with hyperkerototic soles, severe disease, topical therapy failure, chronic infection or immunosuppression. (Grade of recommendation: B, based on small randomized controlled trials [RCTs] with limited head-to head comparisons of drugs)
Evidence summary
The Cochrane Database of Systemic Reviews1,2 reported 72 placebo-controlled trials of topical agents that yielded the following cure rates: undecenoic acid, 72%; allylamines (terbinafine, naftifine, butenafine), 70%; tolnaftate, 64%; azoles (miconazole, clotrimazole, ketoconazole, econazole, oxiconazole), 47%. A meta-analysis of 11 RCTs suggests that allylamines are slightly more effective than azoles.
Orally administered antifungal agents are expensive and can have systemic side effects. Griseofulvin and ketoconazole are approved for oral therapy, but product labels clearly state that they should be used only after topical agents have failed. Griseofulvin has been used for more than 30 years, is well tolerated, and efficacious in treating dermatomycoses in the range of 60%.3 Ketoconazole’s cure rate is similar, but its use in cutaneous infections is limited by multiple drug interactions and serious side effects. Three placebo-controlled RCTs of itraconazole of varying doses and duration of treatment suggested favorable clinical cure of moccasin-type tinea pedis (51%-85%) . The most effective itraconazole regimen was 200 mg twice daily for 1 week. In a large double-blind multicenter study of all forms of tinea pedis, De Keyser et al4 compared 2 weeks of terbinafine at 250 mg/day to 2 weeks of itraconazole at 100 mg/day. After 8 weeks they found terbinafine superior to itraconazole for clinical cure (94.1% vs 72.4%). In a single multicenter open study the cure rate for fluconazole 150 mg was 77% when used once weekly for 3 weeks. See Table 1 for summary.
TABLE
RECOMMENDED TOPICAL TREATMENTS FOR TINEA PEDIS
| Drug | Cure Rates, % | Form | Frequency and duration of treatment* | Comments |
|---|---|---|---|---|
| Miconazole (Micatin) | 47 | 2% lotion, spray, cream, powder | BID for 2-4 weeks | Inexpensive, OTC |
| Terbinafine (Lamisil) | 70 | 1% cream, solution, spray | BID for 1-2 weeks | Shorter length of treatment, OTC |
| Naftifine (Naftin) | 70 | 1% gel, cream | QD for 2-4 weeks | Once a day, Rx |
| Butenafine (Mentax) | 70 | 1% cream | QD for 4 weeks | Once a day, Rx |
| Tolnaftate (Tinactin, Altate) | 64 | 1% powder, spray, cream | BID for 2-4 weeks | Inexpensive, OTC |
| Rx denotes prescription; OTC, over the counter; BID, twice a day; QD, every day. | ||||
| *Frequency and duration of treatment varies according to the type of tinea pedis. | ||||
Recommendations from others
American Academy of Dermatology Guidelines5 recommend topical therapy for initial treatment of tinea pedis. Oral therapy may be required to treat patients with hyperkeratotic soles, disabling or extensive disease, topical therapy failure, chronic infection, or immunosuppression. Surgical therapy is not indicated.
1. Crawford F, Hart R, Bel-Syer S, Togerson D, Young P, Russell I. Cochrane Review. In: The Cochrane Library, Issue 3, 2001. Oxford: Update Software.
2. Hart R, Sally E, Bell-Syer S, Crawford F, Togerson D, Young P, Russell I. BMJ 1999;319:79-82.
3. Pierard G, Arrese J, Pierrard-Franchimont C. Drugs 1996;52:209.-
4. De Keyser P, De Backer M, Massart DL, Westelnick KJ. Br J Dermatol 1994;130:22-5.
5. Drake LA, Dinehart SM, Farmer ER, et al. J Am Acad Dermatol 1996;34:282-6.
Topical therapy is effective for tinea pedis. Topical terbinafine has a 70% cure rate, is available over the counter (OTC), and requires only 1 to 2 weeks of therapy. Two other OTC topicals, tolnaftate and miconazole, require 2 to 4 weeks to achieve slightly lower cure rates, but are considerably less expensive. (Grade of recommendation: A)
The most effective treatment for tinea pedis is oral terbinafine 250 mg twice a day for 2 weeks (94% clinical cure rate). However, oral terbinafine is expensive and not approved for this indication. Oral therapy may be required for patients with hyperkerototic soles, severe disease, topical therapy failure, chronic infection or immunosuppression. (Grade of recommendation: B, based on small randomized controlled trials [RCTs] with limited head-to head comparisons of drugs)
Evidence summary
The Cochrane Database of Systemic Reviews1,2 reported 72 placebo-controlled trials of topical agents that yielded the following cure rates: undecenoic acid, 72%; allylamines (terbinafine, naftifine, butenafine), 70%; tolnaftate, 64%; azoles (miconazole, clotrimazole, ketoconazole, econazole, oxiconazole), 47%. A meta-analysis of 11 RCTs suggests that allylamines are slightly more effective than azoles.
Orally administered antifungal agents are expensive and can have systemic side effects. Griseofulvin and ketoconazole are approved for oral therapy, but product labels clearly state that they should be used only after topical agents have failed. Griseofulvin has been used for more than 30 years, is well tolerated, and efficacious in treating dermatomycoses in the range of 60%.3 Ketoconazole’s cure rate is similar, but its use in cutaneous infections is limited by multiple drug interactions and serious side effects. Three placebo-controlled RCTs of itraconazole of varying doses and duration of treatment suggested favorable clinical cure of moccasin-type tinea pedis (51%-85%) . The most effective itraconazole regimen was 200 mg twice daily for 1 week. In a large double-blind multicenter study of all forms of tinea pedis, De Keyser et al4 compared 2 weeks of terbinafine at 250 mg/day to 2 weeks of itraconazole at 100 mg/day. After 8 weeks they found terbinafine superior to itraconazole for clinical cure (94.1% vs 72.4%). In a single multicenter open study the cure rate for fluconazole 150 mg was 77% when used once weekly for 3 weeks. See Table 1 for summary.
TABLE
RECOMMENDED TOPICAL TREATMENTS FOR TINEA PEDIS
| Drug | Cure Rates, % | Form | Frequency and duration of treatment* | Comments |
|---|---|---|---|---|
| Miconazole (Micatin) | 47 | 2% lotion, spray, cream, powder | BID for 2-4 weeks | Inexpensive, OTC |
| Terbinafine (Lamisil) | 70 | 1% cream, solution, spray | BID for 1-2 weeks | Shorter length of treatment, OTC |
| Naftifine (Naftin) | 70 | 1% gel, cream | QD for 2-4 weeks | Once a day, Rx |
| Butenafine (Mentax) | 70 | 1% cream | QD for 4 weeks | Once a day, Rx |
| Tolnaftate (Tinactin, Altate) | 64 | 1% powder, spray, cream | BID for 2-4 weeks | Inexpensive, OTC |
| Rx denotes prescription; OTC, over the counter; BID, twice a day; QD, every day. | ||||
| *Frequency and duration of treatment varies according to the type of tinea pedis. | ||||
Recommendations from others
American Academy of Dermatology Guidelines5 recommend topical therapy for initial treatment of tinea pedis. Oral therapy may be required to treat patients with hyperkeratotic soles, disabling or extensive disease, topical therapy failure, chronic infection, or immunosuppression. Surgical therapy is not indicated.
Topical therapy is effective for tinea pedis. Topical terbinafine has a 70% cure rate, is available over the counter (OTC), and requires only 1 to 2 weeks of therapy. Two other OTC topicals, tolnaftate and miconazole, require 2 to 4 weeks to achieve slightly lower cure rates, but are considerably less expensive. (Grade of recommendation: A)
The most effective treatment for tinea pedis is oral terbinafine 250 mg twice a day for 2 weeks (94% clinical cure rate). However, oral terbinafine is expensive and not approved for this indication. Oral therapy may be required for patients with hyperkerototic soles, severe disease, topical therapy failure, chronic infection or immunosuppression. (Grade of recommendation: B, based on small randomized controlled trials [RCTs] with limited head-to head comparisons of drugs)
Evidence summary
The Cochrane Database of Systemic Reviews1,2 reported 72 placebo-controlled trials of topical agents that yielded the following cure rates: undecenoic acid, 72%; allylamines (terbinafine, naftifine, butenafine), 70%; tolnaftate, 64%; azoles (miconazole, clotrimazole, ketoconazole, econazole, oxiconazole), 47%. A meta-analysis of 11 RCTs suggests that allylamines are slightly more effective than azoles.
Orally administered antifungal agents are expensive and can have systemic side effects. Griseofulvin and ketoconazole are approved for oral therapy, but product labels clearly state that they should be used only after topical agents have failed. Griseofulvin has been used for more than 30 years, is well tolerated, and efficacious in treating dermatomycoses in the range of 60%.3 Ketoconazole’s cure rate is similar, but its use in cutaneous infections is limited by multiple drug interactions and serious side effects. Three placebo-controlled RCTs of itraconazole of varying doses and duration of treatment suggested favorable clinical cure of moccasin-type tinea pedis (51%-85%) . The most effective itraconazole regimen was 200 mg twice daily for 1 week. In a large double-blind multicenter study of all forms of tinea pedis, De Keyser et al4 compared 2 weeks of terbinafine at 250 mg/day to 2 weeks of itraconazole at 100 mg/day. After 8 weeks they found terbinafine superior to itraconazole for clinical cure (94.1% vs 72.4%). In a single multicenter open study the cure rate for fluconazole 150 mg was 77% when used once weekly for 3 weeks. See Table 1 for summary.
TABLE
RECOMMENDED TOPICAL TREATMENTS FOR TINEA PEDIS
| Drug | Cure Rates, % | Form | Frequency and duration of treatment* | Comments |
|---|---|---|---|---|
| Miconazole (Micatin) | 47 | 2% lotion, spray, cream, powder | BID for 2-4 weeks | Inexpensive, OTC |
| Terbinafine (Lamisil) | 70 | 1% cream, solution, spray | BID for 1-2 weeks | Shorter length of treatment, OTC |
| Naftifine (Naftin) | 70 | 1% gel, cream | QD for 2-4 weeks | Once a day, Rx |
| Butenafine (Mentax) | 70 | 1% cream | QD for 4 weeks | Once a day, Rx |
| Tolnaftate (Tinactin, Altate) | 64 | 1% powder, spray, cream | BID for 2-4 weeks | Inexpensive, OTC |
| Rx denotes prescription; OTC, over the counter; BID, twice a day; QD, every day. | ||||
| *Frequency and duration of treatment varies according to the type of tinea pedis. | ||||
Recommendations from others
American Academy of Dermatology Guidelines5 recommend topical therapy for initial treatment of tinea pedis. Oral therapy may be required to treat patients with hyperkeratotic soles, disabling or extensive disease, topical therapy failure, chronic infection, or immunosuppression. Surgical therapy is not indicated.
1. Crawford F, Hart R, Bel-Syer S, Togerson D, Young P, Russell I. Cochrane Review. In: The Cochrane Library, Issue 3, 2001. Oxford: Update Software.
2. Hart R, Sally E, Bell-Syer S, Crawford F, Togerson D, Young P, Russell I. BMJ 1999;319:79-82.
3. Pierard G, Arrese J, Pierrard-Franchimont C. Drugs 1996;52:209.-
4. De Keyser P, De Backer M, Massart DL, Westelnick KJ. Br J Dermatol 1994;130:22-5.
5. Drake LA, Dinehart SM, Farmer ER, et al. J Am Acad Dermatol 1996;34:282-6.
1. Crawford F, Hart R, Bel-Syer S, Togerson D, Young P, Russell I. Cochrane Review. In: The Cochrane Library, Issue 3, 2001. Oxford: Update Software.
2. Hart R, Sally E, Bell-Syer S, Crawford F, Togerson D, Young P, Russell I. BMJ 1999;319:79-82.
3. Pierard G, Arrese J, Pierrard-Franchimont C. Drugs 1996;52:209.-
4. De Keyser P, De Backer M, Massart DL, Westelnick KJ. Br J Dermatol 1994;130:22-5.
5. Drake LA, Dinehart SM, Farmer ER, et al. J Am Acad Dermatol 1996;34:282-6.
Evidence-based answers from the Family Physicians Inquiries Network
Does a hip protector reduce the risk of hip fracture in frail elderly patients?
BACKGROUND: Various interventions to prevent hip fractures have been tested with mediocre success. Most have treated underlying risk factors, such as osteoporosis and fall propensity. This study evaluated the effectiveness of an external hip protector to prevent hip fractures.
POPULATION STUDIED: The trial involved 1801 ambulatory but frail elderly adults (1409 women and 392 men, mean age=82 years) from 22 community-based health care centers in Finland. All patients were aged at least 70 years, were ambulatory (assisted or unassisted), and had at least one identifiable risk factor for hip fracture.
STUDY DESIGN AND VALIDITY: Patients were randomized using adequate concealment of allocation, in an unblinded manner, to receive a hip protector or to not receive one. The hip protector (KPH Hip Protector, Respecta, Helsinki, Finland) covered the greater trochanter, was 19 cm × 9 cm with a convex shape. It was designed to shunt the energy of an impact away from the greater trochanter, the most common site of hip fracture. The 2 padded protectors were worn inside pockets of a stretchy undergarment and did not limit walking or sitting. The subjects in the hip protector group were asked to wear the protector whenever they were on their feet and especially when they were at risk for falling. Many patients randomized to receive the hip protector (204 of 650) refused to participate. The dropout rate during the 18-month study period was high (657 out of 1427), mostly because of death, inability to walk, or refusal to continue in the study. The subjects from a waiting list replaced the dropouts. The sample size was sufficient to identify a 50% reduction in hip fractures over 1 year. As a group, hip protector subjects had significantly more risk factors for falls. However, statistical adjustment for baseline differences did not alter the results. The authors compensated for the high dropout rate by using an intention-to-treat analysis and including the subjects in the analysis for the time period of participation. Information on other factors associated with hip fractures (race, presence of osteoporosis, and use of osteoporosis medications) would have been helpful for generalizing the results to US patients.
OUTCOMES MEASURED: The primary outcome was hip fracture. Secondary outcome variables were the number and rate of falls in the hip protector group and the number of days the subjects wore the protector.
RESULTS: During follow-up, 13 subjects in the hip protector group had a hip fracture compared with 67 controls. Hip fracture risk was significantly lower in the treatment group (21.3 vs 46.0 per 1000 person-years; relative hazard 0.4; 95% confidence interval [CI], 0.2-0.8; P=.008). The risk of other fractures was similar in the 2 groups, which supports the effectiveness of the hip protector (ie, these patients were not at risk for fractures in general). Subjects in the hip protector group wore them during 48% of all days and during 74% of all falls, suggesting that they were being worn during higher risk times. In the hip protector group, 4 subjects had a hip fracture while wearing the device; 9 subjects had a hip fracture while not wearing it (P=.002). A total of 41 people would have to wear a hip protector for 1 year to prevent one hip fracture (95% CI, 25-115).
Elderly frail adults at risk for falls should be encouraged to use these simple cost-effective devices. The price is less than $100, much cheaper than the cost associated with a fracture.1 The hip protector is approved by the US Food and Drug Administration, manufactured by several companies in the United States, and can be ordered on the Internet (search word “hip protector”).
BACKGROUND: Various interventions to prevent hip fractures have been tested with mediocre success. Most have treated underlying risk factors, such as osteoporosis and fall propensity. This study evaluated the effectiveness of an external hip protector to prevent hip fractures.
POPULATION STUDIED: The trial involved 1801 ambulatory but frail elderly adults (1409 women and 392 men, mean age=82 years) from 22 community-based health care centers in Finland. All patients were aged at least 70 years, were ambulatory (assisted or unassisted), and had at least one identifiable risk factor for hip fracture.
STUDY DESIGN AND VALIDITY: Patients were randomized using adequate concealment of allocation, in an unblinded manner, to receive a hip protector or to not receive one. The hip protector (KPH Hip Protector, Respecta, Helsinki, Finland) covered the greater trochanter, was 19 cm × 9 cm with a convex shape. It was designed to shunt the energy of an impact away from the greater trochanter, the most common site of hip fracture. The 2 padded protectors were worn inside pockets of a stretchy undergarment and did not limit walking or sitting. The subjects in the hip protector group were asked to wear the protector whenever they were on their feet and especially when they were at risk for falling. Many patients randomized to receive the hip protector (204 of 650) refused to participate. The dropout rate during the 18-month study period was high (657 out of 1427), mostly because of death, inability to walk, or refusal to continue in the study. The subjects from a waiting list replaced the dropouts. The sample size was sufficient to identify a 50% reduction in hip fractures over 1 year. As a group, hip protector subjects had significantly more risk factors for falls. However, statistical adjustment for baseline differences did not alter the results. The authors compensated for the high dropout rate by using an intention-to-treat analysis and including the subjects in the analysis for the time period of participation. Information on other factors associated with hip fractures (race, presence of osteoporosis, and use of osteoporosis medications) would have been helpful for generalizing the results to US patients.
OUTCOMES MEASURED: The primary outcome was hip fracture. Secondary outcome variables were the number and rate of falls in the hip protector group and the number of days the subjects wore the protector.
RESULTS: During follow-up, 13 subjects in the hip protector group had a hip fracture compared with 67 controls. Hip fracture risk was significantly lower in the treatment group (21.3 vs 46.0 per 1000 person-years; relative hazard 0.4; 95% confidence interval [CI], 0.2-0.8; P=.008). The risk of other fractures was similar in the 2 groups, which supports the effectiveness of the hip protector (ie, these patients were not at risk for fractures in general). Subjects in the hip protector group wore them during 48% of all days and during 74% of all falls, suggesting that they were being worn during higher risk times. In the hip protector group, 4 subjects had a hip fracture while wearing the device; 9 subjects had a hip fracture while not wearing it (P=.002). A total of 41 people would have to wear a hip protector for 1 year to prevent one hip fracture (95% CI, 25-115).
Elderly frail adults at risk for falls should be encouraged to use these simple cost-effective devices. The price is less than $100, much cheaper than the cost associated with a fracture.1 The hip protector is approved by the US Food and Drug Administration, manufactured by several companies in the United States, and can be ordered on the Internet (search word “hip protector”).
BACKGROUND: Various interventions to prevent hip fractures have been tested with mediocre success. Most have treated underlying risk factors, such as osteoporosis and fall propensity. This study evaluated the effectiveness of an external hip protector to prevent hip fractures.
POPULATION STUDIED: The trial involved 1801 ambulatory but frail elderly adults (1409 women and 392 men, mean age=82 years) from 22 community-based health care centers in Finland. All patients were aged at least 70 years, were ambulatory (assisted or unassisted), and had at least one identifiable risk factor for hip fracture.
STUDY DESIGN AND VALIDITY: Patients were randomized using adequate concealment of allocation, in an unblinded manner, to receive a hip protector or to not receive one. The hip protector (KPH Hip Protector, Respecta, Helsinki, Finland) covered the greater trochanter, was 19 cm × 9 cm with a convex shape. It was designed to shunt the energy of an impact away from the greater trochanter, the most common site of hip fracture. The 2 padded protectors were worn inside pockets of a stretchy undergarment and did not limit walking or sitting. The subjects in the hip protector group were asked to wear the protector whenever they were on their feet and especially when they were at risk for falling. Many patients randomized to receive the hip protector (204 of 650) refused to participate. The dropout rate during the 18-month study period was high (657 out of 1427), mostly because of death, inability to walk, or refusal to continue in the study. The subjects from a waiting list replaced the dropouts. The sample size was sufficient to identify a 50% reduction in hip fractures over 1 year. As a group, hip protector subjects had significantly more risk factors for falls. However, statistical adjustment for baseline differences did not alter the results. The authors compensated for the high dropout rate by using an intention-to-treat analysis and including the subjects in the analysis for the time period of participation. Information on other factors associated with hip fractures (race, presence of osteoporosis, and use of osteoporosis medications) would have been helpful for generalizing the results to US patients.
OUTCOMES MEASURED: The primary outcome was hip fracture. Secondary outcome variables were the number and rate of falls in the hip protector group and the number of days the subjects wore the protector.
RESULTS: During follow-up, 13 subjects in the hip protector group had a hip fracture compared with 67 controls. Hip fracture risk was significantly lower in the treatment group (21.3 vs 46.0 per 1000 person-years; relative hazard 0.4; 95% confidence interval [CI], 0.2-0.8; P=.008). The risk of other fractures was similar in the 2 groups, which supports the effectiveness of the hip protector (ie, these patients were not at risk for fractures in general). Subjects in the hip protector group wore them during 48% of all days and during 74% of all falls, suggesting that they were being worn during higher risk times. In the hip protector group, 4 subjects had a hip fracture while wearing the device; 9 subjects had a hip fracture while not wearing it (P=.002). A total of 41 people would have to wear a hip protector for 1 year to prevent one hip fracture (95% CI, 25-115).
Elderly frail adults at risk for falls should be encouraged to use these simple cost-effective devices. The price is less than $100, much cheaper than the cost associated with a fracture.1 The hip protector is approved by the US Food and Drug Administration, manufactured by several companies in the United States, and can be ordered on the Internet (search word “hip protector”).