Blood pressure lowering efficacy of coenzyme Q10 for primary hypertension

Meghan J Ho; Anthony Bellusci; James M Wright

doi:10.1002/14651858.CD007435.pub2

Blood pressure lowering efficacy of coenzyme Q10 for primary hypertension

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References

References to studies included in this review

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excluded studies
additional references

Digiesi V, Cantini F, Brodbeck B. Effect of coenzyme Q10 on essential arterial hypertension. Current Therapeutic Research May 1990;47:841‐845.

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Singh RB, Niaz MA, Rastogi SS, Shukla PK, Thakur AS. Effect of hydrosoluble coenzyme Q10 on blood pressures and insulin resistance in hypertensive patients with coronary artery disease. Journal of Human Hypertension 1999;13:203‐208.

Yamagami T, Takagt M, Akagami H, Kubo H, Toyama S, Okamoto T, Kishi T, Folkers K. Effect of coenzyme Q10 on essential hypertension, a double blind controlled study. Biomedical and Clinical Aspects of Coenzyme Q 1986;5:337‐343.

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References to studies excluded from this review

Jump to:

included studies
additional references

Burke BE, Neuenschwander R, Olson RD. Randomized, Double‐Blind, Placebo‐Controlled Trial of Coenzyme Q10 in Isolated Systolic Hypertension. Southern Medical Journal 2001;94(11):1112‐1117.

Digiesi V, Cantini F, Oradei A, Bisi G, Guarino GC, Brocchi A, Bellandi F, Mancini M, Littarru GP. Coenzyme Q10 in essential hypertension. Mol Aspects Med 1994;15 Suppl:s257‐63.

Drzewoski J, Folkers K, Richardson PC, Shizukuishi S, Baker LE. Usefulness of coenzyme Q10 in the treatment of hypertension. Polski Tygodnik Lekarski 1981;36(27):997‐1001.

Folkers K, Drzewoski J, Richardson PC, Ellis J, Shizukuishi S, Baker L. Bioenergetics in clinical medicine. XVI. Reduction of hypertension in patients by therapy with coenzyme Q10. Res Comm Chem Pathol Pharmacol 1981;31(1):129‐40.

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Hata S, Kunida H, Oyama Y. Antihypertensive effects of coenzyme Q10 in essential hypertension ‐ in relation to the renin‐aldosterone system. Horumon to Rinsho ‐ Clinical Endocrinology 1977;25(9):1019‐23.

Hodgson JM, Watts GF, Playford DA, Burke V, Croft KD. Coenzyme Q10 improves blood pressure and glycaemic control: a controlled trial in subjects with type 2 diabetes. Eur J Clin Nutr 2002;56:1137‐1142.

Langsjoen P, Willis R, Folkers K. Treatment of essential hypertension with coenzyme Q10. Mol Aspects Med 1994;15 Suppl:S265‐72.

Shah SA, Sander S, Cios D, Lipeika J, Kluger J, White CM. Electrocardiographic and hemodynamic effects of coenzyme Q10 in healthy individuals: a double‐blind, randomized controlled trial. Ann Pharmacother. 2007;41(3):420‐5.

Additional references

Jump to:

included studies
excluded studies

Burke BE, Neuenschwander R, Olson RD. Randomized, Double‐Blind, Placebo‐Controlled Trial of Coenzyme QIO in Isolated Systolic Hypertension. Southern Medical Journal 2001;94(11):1112‐1117.

Burt VL, Whelton P, Roccella EJ, Brown C, Cutler JA, Higgins M, Horan MJ, Labarthe D. Prevalence of hypertension in the US adult population. Hypertension. 1995;25(3):303‐304.

Heran BS, Wong MMY, Heran IK, Wright JM. Blood pressure lowering efficacy of angiotensin converting enzyme (ACE) inhibitors for primary hypertension. Cochrane Database of Systematic Reviews 2008, Issue 4. [CD003823. DOI: 10.1002/14651858.CD003823.pub2]

Heran BS, Wong MMY, Heran IK, Wright JM. Blood pressure lowering efficacy of angiotensin receptor blockers for primary hypertension. Cochrane Database of Systematic Reviews 2008, Issue 4. [CD003822. DOI: 10.1002/14651858.CD003822.pub2]

Langsjoen PH, Vadhanavikit S, Folkers K. Response of patients in classes III and IV of cardiomyopathy to therapy in a blind and crossover trial with coenzyme Q10. Proc. Nati. Acad. Sci. USA June 1985;82:4240‐4244.

Mann J. The Indo‐Mediterranean diet revisited. Lancet 2005;366:353‐354.

McCarty MF. Coenzyme Q versus hypertension: does CoQ decrease endothelial superoxide generation?. Medical Hypotheses. 1999;53(4):300–304.

Musini VM, Fortin PM, Bassett K, Wright JM. Blood pressure lowering efficacy of renin inhibitors for primary hypertension. Cochrane Database of Systematic Reviews 2008, Issue 4. [CD007066. DOI: 10.1002/14651858.CD007066.pub2]

Musini VM, Wright JM. Factors affecting blood pressure variability: lessons learned from two systematic reviews of randomized controlled trials. PLoS One 2009;4(5):e5673. [PUBMED: 19479061]

Niklowitz P, Sonnenschein A, Janetzky B, Andler W, Menke T. Enrichment of coenzyme Q10 in plasma and blood cells: defense against oxidative damage. Int. J. Biol. Sci. 2007;3(4):257‐262.

Quinzii CM, DiMauro S, Hirano M. Human Coenzyme Q10 Deficiency. Neurochem Res. 2007;32:723–727.

Rosenfeldt F, Hilton D, Pepe S, Krum H. Systematic review of effect of coenzyme Q10 in physical exercise, hypertension and heart failure. BioFactors 2003;18:91‐100.

Rosenfeldt FL, Haas SJ, Krum H, Hadj A, Ng K, Leong J‐Y, Watts GF. Coenzyme Q10 in the treatment of hypertension: a meta‐analysis of the clinical trials. Journal of Human Hypertension 2007;21:297–306.

White, C. Suspected research fraud: difficulties of getting at the truth. BMJ 2005;331:281‐288.

Characteristics of studies

Characteristics of included studies [ordered by study ID]

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excluded studies

Digiesi 1990

Methods	Randomized, placebo‐controlled, crossover trial. 2 week washout period, 10 week treatment period, 2 week treatment suspension, 10 week crossover treatment.
Participants	18 patients (4 women, 14 men) with essential hypertension, WHO stages 1 and 2, average age 55.9 years (range 42‐66 years). Patients older than 70 years, renal failure or body weight > 90 kg excluded.
Interventions	Intervention: Monotherapy with 100 mg oral coenzyme Q10 daily for 10 weeks Control: Placebo
Outcomes	Resting supine SBP and DBP at 10 weeks
Notes	Sources of funding not stated. Small study size.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Unclear risk	Quote "...patients were randomly assigned... then each patient in group A crossed over to placebo treatment and each patient in group B crossed over to CoQ treatment..." Does not describe the sequence generation process.
Allocation concealment?	High risk	Insufficient information provided. Does not describe how allocation concealment was ensured.
Blinding? Blood Pressure	High risk	No information provided as to whether blinding was achieved.
Incomplete outcome data addressed? Blood Pressure	Low risk	No missing outcome data.
Free of selective reporting?	High risk	BP reported was stated as end of treatment. BPs at other times were not reported.
Free of other bias?	High risk	Patients could have been selected based on previous response to coenzyme Q10. BP standard deviations are lower and not as variable as would be expected.

Singh 1999

Methods	Randomized, placebo‐controlled, double‐blind trial.
Participants	59 patients (52 men) patients with known coronary heart disease and essential hypertension (receiving medications for more than 1 year)
Interventions	Intervention: Monotherapy with 60 mg CoQ twice daily (120 mg/day) Control: Placebo (Vitamin B complex)
Outcomes	Resting supine SBP and DBP and heart rate at 4 and 8 weeks
Notes	Sources of funding not stated. Q‐gel capsules provided free of cost by Tischon Corporation, USA.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	High risk	Quote: "Each was individually randomised by the pharmacist..." Does not describe the sequence generation process.
Allocation concealment?	High risk	Does not describe allocation concealment
Blinding? Blood Pressure	High risk	Quote: "The subjects in both groups remain blinded... and both the groups met separately." Meeting separately would lead to loss of blinding. Quote: "... to receive either coenzyme Q10 or vitamin capsules supplied in identical containers by the Heart Research Laboratory blinded to physicians and technicians examining the blood."
Incomplete outcome data addressed? Blood Pressure	High risk	Author reports placebo group n=32 with 3 patients lost to follow‐up (n=29), however, table of results during follow‐up displays n=28. Quote (from correspondence): "It is possible that data may have been available for only 28. I don't remember exactly."
Free of selective reporting?	High risk	Patients were seen weekly and BP data was only reported at 4 and 8 weeks.
Free of other bias?	High risk	BP standard deviations are lower and not as variable as would be expected.

Yamagami 1986

Methods	Randomized, placebo‐controlled, double‐blind trial. Washout period of 4 weeks or more with stable baseline BP. Measurement every 2 weeks for 12 weeks.
Participants	52 patients with essential hypertension (BP > 150/90 mmHg) were selected at random from the outpatient clinic of The Center for adult Diseases in Osaka, Japan. 20 patients (8 men and 12 women, mean age 60 years) with low coenzyme Q10 and low SDH‐Q reductase activity were accepted. Conventional hypertension therapies were continued without change.
Interventions	Intervention: Monotherapy with 33.3 mg CoQ 3x daily (100 mg/day) Control: Placebo
Outcomes	SBP and DBP at 2 week intervals: (no description of position of patient or method of BP measurement).
Notes	Sources of funding not stated. Limited to patients with low coenzyme Q10 levels, who could be particularly responsive to BP lowering effect of intervention.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Unclear risk	Quote: "A total of 20 patients was randomized..." Does not describe the sequence generation process.
Allocation concealment?	Unclear risk	"The capsules were numbered and the code was kept... until all trial had been over" Not clear whether numbers were random or in sequence.
Blinding? Blood Pressure	Unclear risk	Quote [direct quotation, note typographical errors]: "The capsules were numbered and the code was kept... until all trial had been over... After all data were fixed in each case, key code was opened and the change of blood pressure was compared between coQ group and placebo group." Comment: insufficient information about how key codes were assigned.
Incomplete outcome data addressed? Blood Pressure	Low risk	No missing outcome data.
Free of selective reporting?	Low risk	BP data at all time points was provided.
Free of other bias?	Low risk	SD data is as would be expected.

Characteristics of excluded studies [ordered by study ID]

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included studies

Study	Reason for exclusion
Burke 2001	Washout period was only 10 days.
Digiesi 1994	No placebo control.
Drzewoski 1981	No placebo control.
Folkers 1981	No placebo control.
Hata 1977	Trial is not randomized, no parallel placebo group. Washout period is only 1‐2 weeks.
Hodgson 2002	Included mostly patients with normal blood pressure, baseline BP ranged from 127/75 to 136/80 mmHg and therefore, did not meet hypertension criteria.
Langsjoen 1994	No placebo control.
Shah 2007	Treatment period was less than 3 weeks (longest post‐dose period was 8 hours).

Data and analyses

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Comparison 1. Coenzyme Q10 vs placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 SBP Show forest plot	3	96	Mean Difference (Fixed, 95% CI)	‐10.72 [‐13.77, ‐7.67]
Open in figure viewer Analysis 1.1 Comparison 1 Coenzyme Q10 vs placebo, Outcome 1 SBP.
2 DBP Show forest plot	3	96	Mean Difference (Fixed, 95% CI)	‐6.64 [‐8.10, ‐5.17]
Open in figure viewer Analysis 1.2 Comparison 1 Coenzyme Q10 vs placebo, Outcome 2 DBP.
3 Heart rate Show forest plot	1	58	Mean Difference (Fixed, 95% CI)	‐12.0 [‐15.19, ‐8.81]
Open in figure viewer Analysis 1.3 Comparison 1 Coenzyme Q10 vs placebo, Outcome 3 Heart rate.

Figure 1

Forest plot of comparison: 1 Coenzyme Q10 vs placebo, outcome: 1.1 SBP.

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Figure 2

Forest plot of comparison: 1 Coenzyme Q10 vs placebo, outcome: 1.2 DBP.

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Figure 3

Forest plot of comparison: 1 Coenzyme Q10 vs placebo, outcome: 1.3 Heart rate.

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Analysis 1.1

Comparison 1 Coenzyme Q10 vs placebo, Outcome 1 SBP.

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Analysis 1.2

Comparison 1 Coenzyme Q10 vs placebo, Outcome 2 DBP.

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Analysis 1.3

Comparison 1 Coenzyme Q10 vs placebo, Outcome 3 Heart rate.

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Summary of findings for the main comparison. Coenzyme Q10 versus placebo in patients with essential arterial hypertension

Patient population: patients with essential arterial hypertension (SBP > 140 mmHg or DBP > 90 mmHg) Settings: primary care in Japan, Italy and India Intervention: coenzyme Q10 Comparison: placebo
Outcomes	Relative effect (95% CI)	Number of participants (studies)	Quality of evidence (GRADE)	Comments
Systolic blood pressure (SBP)	‐10.72 [‐13.77, ‐7.67]	96 (3)	Low
Diastolic blood pressure (DBP)	‐6.64 [‐8.10, ‐5.17]	96 (3)	Low
Change in heart rate (HR)	‐12.00 [‐15.19, ‐8.81]	58 (1)	Low
Number of withdrawals due to adverse effects compared to placebo		unknown, reason for withdrawals not reported in Singh 1999

Summary of findings for the main comparison. Coenzyme Q10 versus placebo in patients with essential arterial hypertension

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Comparison 1. Coenzyme Q10 vs placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 SBP Show forest plot	3	96	Mean Difference (Fixed, 95% CI)	‐10.72 [‐13.77, ‐7.67]

2 DBP Show forest plot	3	96	Mean Difference (Fixed, 95% CI)	‐6.64 [‐8.10, ‐5.17]

3 Heart rate Show forest plot	1	58	Mean Difference (Fixed, 95% CI)	‐12.0 [‐15.19, ‐8.81]

Comparison 1. Coenzyme Q10 vs placebo

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References

References to studies included in this review

Digiesi 1990 {published data only}

Singh 1999 {published data only}

Yamagami 1986 {published data only}

References to studies excluded from this review

Burke 2001 {published data only}

Digiesi 1994 {published data only}

Drzewoski 1981 {published data only}

Folkers 1981 {published data only}

Hata 1977 {published data only}

Hodgson 2002 {published data only}

Langsjoen 1994 {published data only}

Shah 2007 {published data only}

Additional references

Burke 2001

Burt 1995

Heran 2008a

Heran 2008b

Langsjoen 1985

Mann 2005

McCarty 1999

Musini 2008

Musini 2009

Niklowitz 2007

Quinzii 2007

Rosendfeldt 2003

Rosenfeldt 2007

White 2005

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Characteristics of excluded studies [ordered by study ID]

Data and analyses

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