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Do complementary agents lower HbA1c when used with standard type 2 diabetes therapy?
No, there is no high-quality evidence that supports using complementary or alternative agents to lower hemoglobin A1c (HbA1c) in patients with noninsulin-dependent type 2 diabetes. Oral chromium in widely varying doses reduces HbA1c a small amount (strength of recommendation [SOR]: C, meta-analysis of low-quality randomized, controlled trials [RCTs] of disease-oriented outcomes, with inconsistent results).
Oral cinnamon 1 to 3 g/d causes a small (<0.1%) drop in HbA1c (SOR: C, meta-analysis of low-quality RCTs of disease-oriented outcomes).
Fenugreek, milk thistle, safflower oil, and sweet potato extract may also reduce HbA1c (SOR: C, small, low-quality RCTs of disease-oriented outcomes).
EVIDENCE SUMMARY
Almost all complementary and alternative agents reviewed here were tested against placebo, and most were used in combination with standard therapy, usually identified as diet with or without oral hypoglycemic agents (TABLE).1-8
Meta-analyses evaluate effects of chromium and cinnamon
A meta-analysis of 13 RCTs evaluating the effect of oral chromium in patients with type 2 diabetes (age range not given) found a small improvement in HbA1c.1 Limitations of the meta-analysis included a wide range of chromium dosages and preparations. Ten studies showed no benefit, and of the 3 showing improvement, the researchers rated 2 as poor-quality.
A meta-analysis of 5 RCTs assessing the effect of oral cinnamon in patients with type 2 diabetes, 42 to 71 years of age, found that cinnamon produced a clinically irrelevant but statistically significant decrease in mean HbA1c.2 After analyzing the 2 RCTs with the largest effects, the researchers concluded that cinnamon might have a greater effect in patients with poorly controlled diabetes (baseline HbA1c>8.2%).
When they evaluated these RCTs for study homogeneity, they found significant differences among the studies in subject age, gender, ethnicity, body mass index, disease duration, concurrent medications, and baseline HbA1c levels, as well as variations in cinnamon dose, preparation, and therapy duration. Furthermore, only one of the studies reported randomization methods and whether allocation was concealed.
What about caiapo, fenugreek, milk thistle, and safflower oil?
Two small, moderate-quality RCTs of caiapo (sweet potato skin extract) in diet-controlled patients with diabetes demonstrated small but possibly clinically significant reductions in HbA1c between the intervention and control groups.3,4
TABLE
Effect of complementary or alternative agents on HbA1c in type 2 diabetes
CAA* | Dose/day | Concurrent diabetes therapy | Study type | Study size | Study duration | Difference in HbA1c (in HbA1c units) | 95% CI or P value |
Chromium1 | 1.28-1000 mcg | Not given | Meta-analysis of 13 RCTs | 381 | 3 wk-8 mo | -0.6† | -0.9 to -0.2 |
Cinnamon2 | 1-3 g | Various oral hypoglycemic agents‡ | Meta-analysis of 5 RCTs | 315 | 1.5-4 mo | -0.09 (WMD)† | -0.14 to -0.04 |
Caiapo3 | 4 g | Diet only | RCT | 61 | 5 mo | -0.21 (caiapo)§ +0.25 (placebo)§ | P=.08
P=.0001 |
Caiapo4 | 4 g | Diet only | RCT | 61 | 3 mo | -0.53 (caiapo)§ +0.06 (placebo)§ | P<.001
P=.23 |
Trigonella foenum-graecum (fenugreek)5 | 6.84 g | Sulfonylurea | RCT | 69 | 3 mo | -1.46 (fenugreek)§ -0.41 (placebo)§ | P<.05
P<.05 |
Silybum marianum (milk thistle)6 | 200 mg | Metformin and sulfonylurea | RCT | 51 | 4 mo | -1.0 (milk thistle)§ +1.2 (placebo)§ | P<.001
P<.0001 |
Silybum marianum (milk thistle)7 | 200 mg | Sulfonylurea | RCT | 38 | 4 mo | -1.5 (milk thistle)§ -0.5 (placebo)§ | P<.05
P=NS |
Safflower oil vs conjugated linoleic acid8 | 8 g | Various oral hypoglycemic agents‡ | DBRCD | 35 | 4 mo | -0.6 (safflower oil)§ +0.1 (conjugated linoleic acid)§ | P=.0007
P=NS |
CAA, complementary or alternative agents; CI, confidence interval; DBRCD, double-blind, randomized, crossover design; HbA1c, glycosylated hemoglobin A1c; NS, not significant; RCT, randomized controlled trial; WMD, weighted mean difference.
*All CAAs were compared against placebo, with the exception of safflower oil, which was compared against conjugated linoleic acid supplementation.
† Change in HbA1c means at study endpoint; the difference in HbA1c in intervention vs placebo groups.
‡ Oral hypoglycemic agents included a-glucosidase inhibitors, biguanides, glinides, glitazones, sulfonylureas, and thiazolidinediones.
§ Change in HbA1c means at study endpoint; the change in HbA1c from baseline.
Four small, placebo-controlled RCTs of fenugreek, milk thistle, and safflower oil found statistically and clinically significant reductions in HbA1c, but all these studies were of poor quality with unclear methods of randomization, threats to blinding, and a lack of baseline demographics.5-8
RECOMMENDATIONS
Both the American Diabetes Association (ADA) and the Diabetes UK Nutrition Working Group state that, “there is no clear evidence of benefit from vitamin or mineral supplementation in people with diabetes (compared with the general population), who do not have underlying deficiencies.”9,10 The ADA specifically states that chromium cannot be recommended because it lacks any clear benefit.9
1. Balk ME, Tatsioni A, Lichtenstein AH, et al. Effect of chromium supplementation on glucose metabolism and lipids: a systematic review of randomized controlled trials. Diabetes Care. 2007;30:2154-2163.
2. Akilen R, Tsiami A, Devendra D, et al. Cinnamon in glycaemic control: Systematic review and meta analysis. Clin Nutr. 2012;31:609-615.
3. Ludvik B, Hanefeld M, Pacini G. Improved metabolic control by Ipomoea batatas (Caiapo) is associated with increased adiponectin and decreased fibrinogen levels in type 2 diabetic subjects. Diabetes Obes Metab. 2008;10:586-592.
4. Ludvik, B, Neuffer, B, Pacini G. Efficacy of Ipomoea batatas (Caiapo) on diabetes control in type 2 diabetic subjects treated with diet. Diabetes Care. 2004;27:436-440.
5. Lu FR, Shen L, Qin Y, et al. Clinical observation on trigonella foenum-graecum L. total saponins in combination with sulfonylureas in the treatment of type 2 diabetes mellitus. Chin J Integr Med. 2008;14:56-60.
6. Huseini HF, Larijani B, Heshmat R, et al. The efficacy of Silybummarianum (L.) Gaertn. (silymarin) in the treatment of type II diabetes: a randomized, double-blind, placebo-controlled clinical trial. Phytother Res. 2006;20:1036-1039.
7. Hussain SA. Silymarin as an adjunct to glibenclamide therapy improves long-term and postprandial glycemic control and body mass index in type 2 diabetes. J Med Food. 2007;10:543-547.
8. Asp ML, Collene AL, Norris LE, et al. Time-dependent effects of safflower oil to improve glycemia, inflammation and blood lipids in obese, post-menopausal women with type 2 diabetes: a randomized,double-masked, crossover study. Clin Nutr. 2011;30:443-449.
9. American Diabetes Association; Bantle JP, Wylie-Rosett J, Albright AL, et al. Nutrition recommendations and interventions for diabetes: a position statement of the American Diabetes Association. Diabetes Care. 2008;31 suppl 1:S61-S78.
10. Diabetes UK Nutrition Working Group, Dyson PA, Kelly T, Deakin T, et al. Evidence-Based Nutrition Guidelines for the Prevention and Management of Diabetes. Diabetes UK Web site. Available at: www.diabetes.org.uk/Documents/Reports/nutritional-guidelines-2013-amendment-0413.pdf. Accessed October 2, 2013.
No, there is no high-quality evidence that supports using complementary or alternative agents to lower hemoglobin A1c (HbA1c) in patients with noninsulin-dependent type 2 diabetes. Oral chromium in widely varying doses reduces HbA1c a small amount (strength of recommendation [SOR]: C, meta-analysis of low-quality randomized, controlled trials [RCTs] of disease-oriented outcomes, with inconsistent results).
Oral cinnamon 1 to 3 g/d causes a small (<0.1%) drop in HbA1c (SOR: C, meta-analysis of low-quality RCTs of disease-oriented outcomes).
Fenugreek, milk thistle, safflower oil, and sweet potato extract may also reduce HbA1c (SOR: C, small, low-quality RCTs of disease-oriented outcomes).
EVIDENCE SUMMARY
Almost all complementary and alternative agents reviewed here were tested against placebo, and most were used in combination with standard therapy, usually identified as diet with or without oral hypoglycemic agents (TABLE).1-8
Meta-analyses evaluate effects of chromium and cinnamon
A meta-analysis of 13 RCTs evaluating the effect of oral chromium in patients with type 2 diabetes (age range not given) found a small improvement in HbA1c.1 Limitations of the meta-analysis included a wide range of chromium dosages and preparations. Ten studies showed no benefit, and of the 3 showing improvement, the researchers rated 2 as poor-quality.
A meta-analysis of 5 RCTs assessing the effect of oral cinnamon in patients with type 2 diabetes, 42 to 71 years of age, found that cinnamon produced a clinically irrelevant but statistically significant decrease in mean HbA1c.2 After analyzing the 2 RCTs with the largest effects, the researchers concluded that cinnamon might have a greater effect in patients with poorly controlled diabetes (baseline HbA1c>8.2%).
When they evaluated these RCTs for study homogeneity, they found significant differences among the studies in subject age, gender, ethnicity, body mass index, disease duration, concurrent medications, and baseline HbA1c levels, as well as variations in cinnamon dose, preparation, and therapy duration. Furthermore, only one of the studies reported randomization methods and whether allocation was concealed.
What about caiapo, fenugreek, milk thistle, and safflower oil?
Two small, moderate-quality RCTs of caiapo (sweet potato skin extract) in diet-controlled patients with diabetes demonstrated small but possibly clinically significant reductions in HbA1c between the intervention and control groups.3,4
TABLE
Effect of complementary or alternative agents on HbA1c in type 2 diabetes
CAA* | Dose/day | Concurrent diabetes therapy | Study type | Study size | Study duration | Difference in HbA1c (in HbA1c units) | 95% CI or P value |
Chromium1 | 1.28-1000 mcg | Not given | Meta-analysis of 13 RCTs | 381 | 3 wk-8 mo | -0.6† | -0.9 to -0.2 |
Cinnamon2 | 1-3 g | Various oral hypoglycemic agents‡ | Meta-analysis of 5 RCTs | 315 | 1.5-4 mo | -0.09 (WMD)† | -0.14 to -0.04 |
Caiapo3 | 4 g | Diet only | RCT | 61 | 5 mo | -0.21 (caiapo)§ +0.25 (placebo)§ | P=.08
P=.0001 |
Caiapo4 | 4 g | Diet only | RCT | 61 | 3 mo | -0.53 (caiapo)§ +0.06 (placebo)§ | P<.001
P=.23 |
Trigonella foenum-graecum (fenugreek)5 | 6.84 g | Sulfonylurea | RCT | 69 | 3 mo | -1.46 (fenugreek)§ -0.41 (placebo)§ | P<.05
P<.05 |
Silybum marianum (milk thistle)6 | 200 mg | Metformin and sulfonylurea | RCT | 51 | 4 mo | -1.0 (milk thistle)§ +1.2 (placebo)§ | P<.001
P<.0001 |
Silybum marianum (milk thistle)7 | 200 mg | Sulfonylurea | RCT | 38 | 4 mo | -1.5 (milk thistle)§ -0.5 (placebo)§ | P<.05
P=NS |
Safflower oil vs conjugated linoleic acid8 | 8 g | Various oral hypoglycemic agents‡ | DBRCD | 35 | 4 mo | -0.6 (safflower oil)§ +0.1 (conjugated linoleic acid)§ | P=.0007
P=NS |
CAA, complementary or alternative agents; CI, confidence interval; DBRCD, double-blind, randomized, crossover design; HbA1c, glycosylated hemoglobin A1c; NS, not significant; RCT, randomized controlled trial; WMD, weighted mean difference.
*All CAAs were compared against placebo, with the exception of safflower oil, which was compared against conjugated linoleic acid supplementation.
† Change in HbA1c means at study endpoint; the difference in HbA1c in intervention vs placebo groups.
‡ Oral hypoglycemic agents included a-glucosidase inhibitors, biguanides, glinides, glitazones, sulfonylureas, and thiazolidinediones.
§ Change in HbA1c means at study endpoint; the change in HbA1c from baseline.
Four small, placebo-controlled RCTs of fenugreek, milk thistle, and safflower oil found statistically and clinically significant reductions in HbA1c, but all these studies were of poor quality with unclear methods of randomization, threats to blinding, and a lack of baseline demographics.5-8
RECOMMENDATIONS
Both the American Diabetes Association (ADA) and the Diabetes UK Nutrition Working Group state that, “there is no clear evidence of benefit from vitamin or mineral supplementation in people with diabetes (compared with the general population), who do not have underlying deficiencies.”9,10 The ADA specifically states that chromium cannot be recommended because it lacks any clear benefit.9
No, there is no high-quality evidence that supports using complementary or alternative agents to lower hemoglobin A1c (HbA1c) in patients with noninsulin-dependent type 2 diabetes. Oral chromium in widely varying doses reduces HbA1c a small amount (strength of recommendation [SOR]: C, meta-analysis of low-quality randomized, controlled trials [RCTs] of disease-oriented outcomes, with inconsistent results).
Oral cinnamon 1 to 3 g/d causes a small (<0.1%) drop in HbA1c (SOR: C, meta-analysis of low-quality RCTs of disease-oriented outcomes).
Fenugreek, milk thistle, safflower oil, and sweet potato extract may also reduce HbA1c (SOR: C, small, low-quality RCTs of disease-oriented outcomes).
EVIDENCE SUMMARY
Almost all complementary and alternative agents reviewed here were tested against placebo, and most were used in combination with standard therapy, usually identified as diet with or without oral hypoglycemic agents (TABLE).1-8
Meta-analyses evaluate effects of chromium and cinnamon
A meta-analysis of 13 RCTs evaluating the effect of oral chromium in patients with type 2 diabetes (age range not given) found a small improvement in HbA1c.1 Limitations of the meta-analysis included a wide range of chromium dosages and preparations. Ten studies showed no benefit, and of the 3 showing improvement, the researchers rated 2 as poor-quality.
A meta-analysis of 5 RCTs assessing the effect of oral cinnamon in patients with type 2 diabetes, 42 to 71 years of age, found that cinnamon produced a clinically irrelevant but statistically significant decrease in mean HbA1c.2 After analyzing the 2 RCTs with the largest effects, the researchers concluded that cinnamon might have a greater effect in patients with poorly controlled diabetes (baseline HbA1c>8.2%).
When they evaluated these RCTs for study homogeneity, they found significant differences among the studies in subject age, gender, ethnicity, body mass index, disease duration, concurrent medications, and baseline HbA1c levels, as well as variations in cinnamon dose, preparation, and therapy duration. Furthermore, only one of the studies reported randomization methods and whether allocation was concealed.
What about caiapo, fenugreek, milk thistle, and safflower oil?
Two small, moderate-quality RCTs of caiapo (sweet potato skin extract) in diet-controlled patients with diabetes demonstrated small but possibly clinically significant reductions in HbA1c between the intervention and control groups.3,4
TABLE
Effect of complementary or alternative agents on HbA1c in type 2 diabetes
CAA* | Dose/day | Concurrent diabetes therapy | Study type | Study size | Study duration | Difference in HbA1c (in HbA1c units) | 95% CI or P value |
Chromium1 | 1.28-1000 mcg | Not given | Meta-analysis of 13 RCTs | 381 | 3 wk-8 mo | -0.6† | -0.9 to -0.2 |
Cinnamon2 | 1-3 g | Various oral hypoglycemic agents‡ | Meta-analysis of 5 RCTs | 315 | 1.5-4 mo | -0.09 (WMD)† | -0.14 to -0.04 |
Caiapo3 | 4 g | Diet only | RCT | 61 | 5 mo | -0.21 (caiapo)§ +0.25 (placebo)§ | P=.08
P=.0001 |
Caiapo4 | 4 g | Diet only | RCT | 61 | 3 mo | -0.53 (caiapo)§ +0.06 (placebo)§ | P<.001
P=.23 |
Trigonella foenum-graecum (fenugreek)5 | 6.84 g | Sulfonylurea | RCT | 69 | 3 mo | -1.46 (fenugreek)§ -0.41 (placebo)§ | P<.05
P<.05 |
Silybum marianum (milk thistle)6 | 200 mg | Metformin and sulfonylurea | RCT | 51 | 4 mo | -1.0 (milk thistle)§ +1.2 (placebo)§ | P<.001
P<.0001 |
Silybum marianum (milk thistle)7 | 200 mg | Sulfonylurea | RCT | 38 | 4 mo | -1.5 (milk thistle)§ -0.5 (placebo)§ | P<.05
P=NS |
Safflower oil vs conjugated linoleic acid8 | 8 g | Various oral hypoglycemic agents‡ | DBRCD | 35 | 4 mo | -0.6 (safflower oil)§ +0.1 (conjugated linoleic acid)§ | P=.0007
P=NS |
CAA, complementary or alternative agents; CI, confidence interval; DBRCD, double-blind, randomized, crossover design; HbA1c, glycosylated hemoglobin A1c; NS, not significant; RCT, randomized controlled trial; WMD, weighted mean difference.
*All CAAs were compared against placebo, with the exception of safflower oil, which was compared against conjugated linoleic acid supplementation.
† Change in HbA1c means at study endpoint; the difference in HbA1c in intervention vs placebo groups.
‡ Oral hypoglycemic agents included a-glucosidase inhibitors, biguanides, glinides, glitazones, sulfonylureas, and thiazolidinediones.
§ Change in HbA1c means at study endpoint; the change in HbA1c from baseline.
Four small, placebo-controlled RCTs of fenugreek, milk thistle, and safflower oil found statistically and clinically significant reductions in HbA1c, but all these studies were of poor quality with unclear methods of randomization, threats to blinding, and a lack of baseline demographics.5-8
RECOMMENDATIONS
Both the American Diabetes Association (ADA) and the Diabetes UK Nutrition Working Group state that, “there is no clear evidence of benefit from vitamin or mineral supplementation in people with diabetes (compared with the general population), who do not have underlying deficiencies.”9,10 The ADA specifically states that chromium cannot be recommended because it lacks any clear benefit.9
1. Balk ME, Tatsioni A, Lichtenstein AH, et al. Effect of chromium supplementation on glucose metabolism and lipids: a systematic review of randomized controlled trials. Diabetes Care. 2007;30:2154-2163.
2. Akilen R, Tsiami A, Devendra D, et al. Cinnamon in glycaemic control: Systematic review and meta analysis. Clin Nutr. 2012;31:609-615.
3. Ludvik B, Hanefeld M, Pacini G. Improved metabolic control by Ipomoea batatas (Caiapo) is associated with increased adiponectin and decreased fibrinogen levels in type 2 diabetic subjects. Diabetes Obes Metab. 2008;10:586-592.
4. Ludvik, B, Neuffer, B, Pacini G. Efficacy of Ipomoea batatas (Caiapo) on diabetes control in type 2 diabetic subjects treated with diet. Diabetes Care. 2004;27:436-440.
5. Lu FR, Shen L, Qin Y, et al. Clinical observation on trigonella foenum-graecum L. total saponins in combination with sulfonylureas in the treatment of type 2 diabetes mellitus. Chin J Integr Med. 2008;14:56-60.
6. Huseini HF, Larijani B, Heshmat R, et al. The efficacy of Silybummarianum (L.) Gaertn. (silymarin) in the treatment of type II diabetes: a randomized, double-blind, placebo-controlled clinical trial. Phytother Res. 2006;20:1036-1039.
7. Hussain SA. Silymarin as an adjunct to glibenclamide therapy improves long-term and postprandial glycemic control and body mass index in type 2 diabetes. J Med Food. 2007;10:543-547.
8. Asp ML, Collene AL, Norris LE, et al. Time-dependent effects of safflower oil to improve glycemia, inflammation and blood lipids in obese, post-menopausal women with type 2 diabetes: a randomized,double-masked, crossover study. Clin Nutr. 2011;30:443-449.
9. American Diabetes Association; Bantle JP, Wylie-Rosett J, Albright AL, et al. Nutrition recommendations and interventions for diabetes: a position statement of the American Diabetes Association. Diabetes Care. 2008;31 suppl 1:S61-S78.
10. Diabetes UK Nutrition Working Group, Dyson PA, Kelly T, Deakin T, et al. Evidence-Based Nutrition Guidelines for the Prevention and Management of Diabetes. Diabetes UK Web site. Available at: www.diabetes.org.uk/Documents/Reports/nutritional-guidelines-2013-amendment-0413.pdf. Accessed October 2, 2013.
1. Balk ME, Tatsioni A, Lichtenstein AH, et al. Effect of chromium supplementation on glucose metabolism and lipids: a systematic review of randomized controlled trials. Diabetes Care. 2007;30:2154-2163.
2. Akilen R, Tsiami A, Devendra D, et al. Cinnamon in glycaemic control: Systematic review and meta analysis. Clin Nutr. 2012;31:609-615.
3. Ludvik B, Hanefeld M, Pacini G. Improved metabolic control by Ipomoea batatas (Caiapo) is associated with increased adiponectin and decreased fibrinogen levels in type 2 diabetic subjects. Diabetes Obes Metab. 2008;10:586-592.
4. Ludvik, B, Neuffer, B, Pacini G. Efficacy of Ipomoea batatas (Caiapo) on diabetes control in type 2 diabetic subjects treated with diet. Diabetes Care. 2004;27:436-440.
5. Lu FR, Shen L, Qin Y, et al. Clinical observation on trigonella foenum-graecum L. total saponins in combination with sulfonylureas in the treatment of type 2 diabetes mellitus. Chin J Integr Med. 2008;14:56-60.
6. Huseini HF, Larijani B, Heshmat R, et al. The efficacy of Silybummarianum (L.) Gaertn. (silymarin) in the treatment of type II diabetes: a randomized, double-blind, placebo-controlled clinical trial. Phytother Res. 2006;20:1036-1039.
7. Hussain SA. Silymarin as an adjunct to glibenclamide therapy improves long-term and postprandial glycemic control and body mass index in type 2 diabetes. J Med Food. 2007;10:543-547.
8. Asp ML, Collene AL, Norris LE, et al. Time-dependent effects of safflower oil to improve glycemia, inflammation and blood lipids in obese, post-menopausal women with type 2 diabetes: a randomized,double-masked, crossover study. Clin Nutr. 2011;30:443-449.
9. American Diabetes Association; Bantle JP, Wylie-Rosett J, Albright AL, et al. Nutrition recommendations and interventions for diabetes: a position statement of the American Diabetes Association. Diabetes Care. 2008;31 suppl 1:S61-S78.
10. Diabetes UK Nutrition Working Group, Dyson PA, Kelly T, Deakin T, et al. Evidence-Based Nutrition Guidelines for the Prevention and Management of Diabetes. Diabetes UK Web site. Available at: www.diabetes.org.uk/Documents/Reports/nutritional-guidelines-2013-amendment-0413.pdf. Accessed October 2, 2013.
Evidence-based answers from the Family Physicians Inquiries Network
Is it safe to vaccinate children against varicella while they’re in close contact with a pregnant woman?
YES. All healthy children without evidence of immunity to varicella who are living in a household with a susceptible pregnant woman should be vaccinated (strength of recommendation [SOR]: C, expert opinion).
The risk of transmission of vaccine virus to household contacts is very low (SOR: B, observational studies). Transmission is higher, but still rare, among contacts of immunocompromised vaccinees (SOR: B, observational studies).
Varicella infection has not been reported in unborn babies of women who had contact with a recently vaccinated person.
Evidence summary
Pregnant women without immunity to varicella are at risk of developing chickenpox, which can cause congenital varicella syndrome. An estimated 44 cases of congenital varicella occurred each year in the prevaccine era.1
Varicella vaccine contains live attenuated virus. Approximately 2% to 3% of vaccinees develop either a localized rash around the injection site or a generalized rash.1 The vaccine virus can, theoretically, spread from vaccinees who develop a rash to other people. Nevertheless, the probability of contracting varicella after contact with a healthy vaccinee is very low.
Minimal transmission, no infection from contact with healthy vaccinees
A prospective vaccine efficacy study found that 3 of 446 (0.67%) contacts of healthy vaccinees seroconverted, but had no clinical evidence of varicella.2 In a smaller study, 30 immunocompromised siblings of 37 healthy children who received varicella vaccine showed no clinical or serological evidence of the virus.3
Five case reports document varicella infection in people who had contact with healthy vaccinees.1 One of these was a pregnant woman who chose to terminate the pregnancy, but subsequent tests showed no virus in the fetus.4 We couldn’t find any reports of congenital varicella attributable to infection of the mother from a recent vaccinee.
Transmission by immunocompromised vaccinees is slightly higher
The risk of contracting vaccine-associated varicella from contact with an immunocompromised vaccinee is slightly higher than for a healthy vaccinee. The National Institute of Allergy and Infectious Diseases Varicella Vaccine Collaborative Study evaluated transmission and infectivity of the varicella vaccine virus in the close contacts of 482 vaccinated children with leukemia.5 One hundred fifty-six vaccinees developed a rash approximately one month after vaccination. Among 88 healthy susceptible siblings in close contact with the 156 vaccinees, 15 (17%) showed evidence of virus transmission. Of the 15, 4 had subclinical infection and the other 11 had a mild rash.
Recommendations
The American Academy of Pediatrics, Advisory Committee on Immunization Practices, and Centers for Disease Control and Prevention say that no precautions are necessary after varicella vaccination of family members in households with pregnant women. If a vaccinee develops a rash, precautions such as separating the vaccinee and the pregnant woman until the rash resolves are advisable. Giving Varicella zoster immune globulin to pregnant women without immunity who are exposed to varicella should be considered. Varicella vaccines are contraindicated in people with malignancies, immunodeficiencies (congenital or acquired), and immunosuppression caused by medications.1,3,6,7
1. Centers for Disease Control and Prevention. Prevention of varicella: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2007;56(RR-4):1-40.
2. Weibel R, Neff B, Kuter B, et al. Live attenuated varicella virus vaccine: efficacy trial in healthy children. N Engl J Med. 1984;310:1409-1415.
3. Diaz PS, Au D, Smith S, et al. Lack of transmission of the live attenuated varicella vaccine virus to immunocompromised children after immunization of their siblings. Pediatrics. 1991;87:166-170.
4. Salzman MB, Sharrar RG, Steinberg S, et al. Transmission of varicella-vaccine virus from a healthy 12-month-old child to his pregnant mother. J Pediatr. 1997;131:151-154.
5. Tsolia M, Gershon AA, Steinberg SP, et al. Live attenuated varicella vaccine: evidence that the virus is attenuated and the importance of skin lesions in transmission of varicella-zoster virus. National Institute of Allergy and Infectious Diseases Varicella Vaccine Collaborative Study Group. J Pediatr. 1990;116:184-189.
6. American Academy of Pediatrics Committee on Infectious Diseases. Prevention of varicella: recommendations for use of varicella vaccines in children, including a recommendation for a routine 2-dose varicella immunization schedule. Pediatrics. 2007;120:221-231.
7. Centers for Disease Control and Prevention. Varicella vaccine—Q&As about pregnancy. Available at: http://cdc.gov/vaccines/VPD-VAC/varicella/vac-faqs-clinic-preg.htm. Accessed October 11, 2010.
YES. All healthy children without evidence of immunity to varicella who are living in a household with a susceptible pregnant woman should be vaccinated (strength of recommendation [SOR]: C, expert opinion).
The risk of transmission of vaccine virus to household contacts is very low (SOR: B, observational studies). Transmission is higher, but still rare, among contacts of immunocompromised vaccinees (SOR: B, observational studies).
Varicella infection has not been reported in unborn babies of women who had contact with a recently vaccinated person.
Evidence summary
Pregnant women without immunity to varicella are at risk of developing chickenpox, which can cause congenital varicella syndrome. An estimated 44 cases of congenital varicella occurred each year in the prevaccine era.1
Varicella vaccine contains live attenuated virus. Approximately 2% to 3% of vaccinees develop either a localized rash around the injection site or a generalized rash.1 The vaccine virus can, theoretically, spread from vaccinees who develop a rash to other people. Nevertheless, the probability of contracting varicella after contact with a healthy vaccinee is very low.
Minimal transmission, no infection from contact with healthy vaccinees
A prospective vaccine efficacy study found that 3 of 446 (0.67%) contacts of healthy vaccinees seroconverted, but had no clinical evidence of varicella.2 In a smaller study, 30 immunocompromised siblings of 37 healthy children who received varicella vaccine showed no clinical or serological evidence of the virus.3
Five case reports document varicella infection in people who had contact with healthy vaccinees.1 One of these was a pregnant woman who chose to terminate the pregnancy, but subsequent tests showed no virus in the fetus.4 We couldn’t find any reports of congenital varicella attributable to infection of the mother from a recent vaccinee.
Transmission by immunocompromised vaccinees is slightly higher
The risk of contracting vaccine-associated varicella from contact with an immunocompromised vaccinee is slightly higher than for a healthy vaccinee. The National Institute of Allergy and Infectious Diseases Varicella Vaccine Collaborative Study evaluated transmission and infectivity of the varicella vaccine virus in the close contacts of 482 vaccinated children with leukemia.5 One hundred fifty-six vaccinees developed a rash approximately one month after vaccination. Among 88 healthy susceptible siblings in close contact with the 156 vaccinees, 15 (17%) showed evidence of virus transmission. Of the 15, 4 had subclinical infection and the other 11 had a mild rash.
Recommendations
The American Academy of Pediatrics, Advisory Committee on Immunization Practices, and Centers for Disease Control and Prevention say that no precautions are necessary after varicella vaccination of family members in households with pregnant women. If a vaccinee develops a rash, precautions such as separating the vaccinee and the pregnant woman until the rash resolves are advisable. Giving Varicella zoster immune globulin to pregnant women without immunity who are exposed to varicella should be considered. Varicella vaccines are contraindicated in people with malignancies, immunodeficiencies (congenital or acquired), and immunosuppression caused by medications.1,3,6,7
YES. All healthy children without evidence of immunity to varicella who are living in a household with a susceptible pregnant woman should be vaccinated (strength of recommendation [SOR]: C, expert opinion).
The risk of transmission of vaccine virus to household contacts is very low (SOR: B, observational studies). Transmission is higher, but still rare, among contacts of immunocompromised vaccinees (SOR: B, observational studies).
Varicella infection has not been reported in unborn babies of women who had contact with a recently vaccinated person.
Evidence summary
Pregnant women without immunity to varicella are at risk of developing chickenpox, which can cause congenital varicella syndrome. An estimated 44 cases of congenital varicella occurred each year in the prevaccine era.1
Varicella vaccine contains live attenuated virus. Approximately 2% to 3% of vaccinees develop either a localized rash around the injection site or a generalized rash.1 The vaccine virus can, theoretically, spread from vaccinees who develop a rash to other people. Nevertheless, the probability of contracting varicella after contact with a healthy vaccinee is very low.
Minimal transmission, no infection from contact with healthy vaccinees
A prospective vaccine efficacy study found that 3 of 446 (0.67%) contacts of healthy vaccinees seroconverted, but had no clinical evidence of varicella.2 In a smaller study, 30 immunocompromised siblings of 37 healthy children who received varicella vaccine showed no clinical or serological evidence of the virus.3
Five case reports document varicella infection in people who had contact with healthy vaccinees.1 One of these was a pregnant woman who chose to terminate the pregnancy, but subsequent tests showed no virus in the fetus.4 We couldn’t find any reports of congenital varicella attributable to infection of the mother from a recent vaccinee.
Transmission by immunocompromised vaccinees is slightly higher
The risk of contracting vaccine-associated varicella from contact with an immunocompromised vaccinee is slightly higher than for a healthy vaccinee. The National Institute of Allergy and Infectious Diseases Varicella Vaccine Collaborative Study evaluated transmission and infectivity of the varicella vaccine virus in the close contacts of 482 vaccinated children with leukemia.5 One hundred fifty-six vaccinees developed a rash approximately one month after vaccination. Among 88 healthy susceptible siblings in close contact with the 156 vaccinees, 15 (17%) showed evidence of virus transmission. Of the 15, 4 had subclinical infection and the other 11 had a mild rash.
Recommendations
The American Academy of Pediatrics, Advisory Committee on Immunization Practices, and Centers for Disease Control and Prevention say that no precautions are necessary after varicella vaccination of family members in households with pregnant women. If a vaccinee develops a rash, precautions such as separating the vaccinee and the pregnant woman until the rash resolves are advisable. Giving Varicella zoster immune globulin to pregnant women without immunity who are exposed to varicella should be considered. Varicella vaccines are contraindicated in people with malignancies, immunodeficiencies (congenital or acquired), and immunosuppression caused by medications.1,3,6,7
1. Centers for Disease Control and Prevention. Prevention of varicella: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2007;56(RR-4):1-40.
2. Weibel R, Neff B, Kuter B, et al. Live attenuated varicella virus vaccine: efficacy trial in healthy children. N Engl J Med. 1984;310:1409-1415.
3. Diaz PS, Au D, Smith S, et al. Lack of transmission of the live attenuated varicella vaccine virus to immunocompromised children after immunization of their siblings. Pediatrics. 1991;87:166-170.
4. Salzman MB, Sharrar RG, Steinberg S, et al. Transmission of varicella-vaccine virus from a healthy 12-month-old child to his pregnant mother. J Pediatr. 1997;131:151-154.
5. Tsolia M, Gershon AA, Steinberg SP, et al. Live attenuated varicella vaccine: evidence that the virus is attenuated and the importance of skin lesions in transmission of varicella-zoster virus. National Institute of Allergy and Infectious Diseases Varicella Vaccine Collaborative Study Group. J Pediatr. 1990;116:184-189.
6. American Academy of Pediatrics Committee on Infectious Diseases. Prevention of varicella: recommendations for use of varicella vaccines in children, including a recommendation for a routine 2-dose varicella immunization schedule. Pediatrics. 2007;120:221-231.
7. Centers for Disease Control and Prevention. Varicella vaccine—Q&As about pregnancy. Available at: http://cdc.gov/vaccines/VPD-VAC/varicella/vac-faqs-clinic-preg.htm. Accessed October 11, 2010.
1. Centers for Disease Control and Prevention. Prevention of varicella: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2007;56(RR-4):1-40.
2. Weibel R, Neff B, Kuter B, et al. Live attenuated varicella virus vaccine: efficacy trial in healthy children. N Engl J Med. 1984;310:1409-1415.
3. Diaz PS, Au D, Smith S, et al. Lack of transmission of the live attenuated varicella vaccine virus to immunocompromised children after immunization of their siblings. Pediatrics. 1991;87:166-170.
4. Salzman MB, Sharrar RG, Steinberg S, et al. Transmission of varicella-vaccine virus from a healthy 12-month-old child to his pregnant mother. J Pediatr. 1997;131:151-154.
5. Tsolia M, Gershon AA, Steinberg SP, et al. Live attenuated varicella vaccine: evidence that the virus is attenuated and the importance of skin lesions in transmission of varicella-zoster virus. National Institute of Allergy and Infectious Diseases Varicella Vaccine Collaborative Study Group. J Pediatr. 1990;116:184-189.
6. American Academy of Pediatrics Committee on Infectious Diseases. Prevention of varicella: recommendations for use of varicella vaccines in children, including a recommendation for a routine 2-dose varicella immunization schedule. Pediatrics. 2007;120:221-231.
7. Centers for Disease Control and Prevention. Varicella vaccine—Q&As about pregnancy. Available at: http://cdc.gov/vaccines/VPD-VAC/varicella/vac-faqs-clinic-preg.htm. Accessed October 11, 2010.
Evidence-based answers from the Family Physicians Inquiries Network