Evidence-based Medicine (EBM) Guidance in Current Therapies

Compiled by:
Constantine Kaniklidis, medical researcher    [ updated: 1/1/2016 ]


Obesity Paradox: Overweight, Live Longer
The Evidence: Flawed
(new)
Recently we have been treated yet again to the usual cacophony of poorly informed and misleading headlines, this time concerning the "obesity paradox" - that overweight and low-grade (grade 1) obesity are not associated with compromised mortality and that being overweight in fact is associated with lower mortality compared to normal weight people. The claim comes from a systematic review and meta-analysis (SR/MA) publsihed in JAMA (Jan 2013) conducted rby Katherine Flegal and colleagues  at the CDC.

The truth is that the balance of critically reviewed and appraised evidence fails to support the contention of the Flegal study that overweight is associated with significantly lower all-cause mortality relative to normal weight and that obesity at certain lower levels (grade 1) is not associated with higher mortality. Rather the cumulative weight of the data to date continue to support the negative impact on health, mortality, and morbidity of being overweight or obese.

Read the full EvidenceWatch critical appraisal at our Cancer Research Edge site, at:
The Obesity Paradox & the Flegal Study.  

Breast Cancer Watch Digest:
Breast Cancer Brain Metastasis Review of the State of the Art
Our new newsletter, Breast Cancer Watch Digest, presents a comprehensive review of the the latest, and emerging, treatments for brain metastasis from breast cancer, covering whole-brain radiotherapy (WBRT), stereotactic radiosurgery, new effective chemotherapies across the blood-brain barrier, TMZ (temozolomide), radiosensitizers, issues in the HER2 / trastuzumab (Herceptin) setting, and the potential benefit of a natural agent, boswellia.
[Learn more . . . ]

Evidencewatch Alert:
LIFT Tibolone Study Halted:
Increased Risk of Stroke

Evidencewatch
reports an early termination of the Organon LIFT study investigating tibolone efficacy on new vertebral fractures in elderly osteoporotic women under DSMB and Steering Committee rules. The interim findings reported an increased incidence of ischemic plus hemorrhagic events (strokes) in tibolone treatment group compared to the control group. But the precise and full clinical implications however are not wholly clear.
[Learn more . . . ]

Tibolone: HRT Alternative
Tibolone, already established for bone loss prevention, is a viable alternative to HRT, shown to be as effective as HRT for relief of hot flashe
s and vaginal dryness, while improving sexual response, with a favorable safety and side effect profile.
[Learn more . . . ]

Issues with Tibolone
Some studies have raised concern about tibolone's effects on endometrial and breast cell proliferation. Evidencewatch has conducted a systematic review of the literature and finds these concerns unwarranted.
[Learn more . . . ]

Vasomotor Symptom Relief
The North American Menopause Society (NAMS) has published an evidence-based review of the treatment of menopausal vasomotor symptoms, especially hot flashes. Evidencewatch here presents and refines the NAMS findings / recommendations.
[Learn more . . . ]

Vaginal Atrophy / Dryness
Post-menopausal diminished estrogen levels result in numerous physiologic vaginal tissue changes (reduced blood flow and mucosal thickness, increased pH level) manifesting primarily as vaginal dryness. Evidencewatch critically reviews the literature, presenting best practice guidelines for treatment of vaginal atrophy / dryness.
[Learn more . . . ]
 


Osteoporosis
Low-Dose Steroids and Bone Health

New findings suggest that even low doses of prednisone (5 mg per day) suppresses several bone formation indices in postmenopausal women and may reduce bone repair / renewal, with potentially adverse effects on bone mass and/or bone strength.

[Learn more . . . ]

No Surrender Forum Debuts
(new) The newly launched website
No Surrender Breast Cancer Support
, designed and run by two-time breast cancer survivor and author Gina Maisano, brings a professionally sophisticated, and uniquely evidence-based resource of exceptional value to all women with breast cancer. The main site is supplemented by an outstanding information-rich discussion forum, the No Surrender Message Board, moderated by Gina herself, as well as by an uncommonly inspiring personal blog (
No Nosurrender Blog).
Strongly recommended.
[Visit No Surrender. . . ]

Melatonin & Breast Cancer
(new) New findings show that melatonin (1) is a radioprotector agent, protecting against the organ-injury of radiation and radiotherpy; (2) protects against Adriamycin-induced cardiotoxicity as well as enhancing its antitumor activity; (3) shows positive anti-breast cancer activity by decreasing aromatase activity and expression in MCF-7 cells; (4) may reduce cancer-related mortality.
[Learn more . . . ]

OCs & Breast Cancer
(new) Recently there appeared a widely cited study on oral contraceptives (OCs) use and breast cancer risk. The principle author, Chris Kahlenborn, is a former US Congressman and self-acknowledged opponent of all forms of artificial contraception, and is on the advisory board of the anti-choice Christian organization Concerned Women for America which actively lobbies for legislation recognizing the claimed abortion-breast cancer link. However, the study, besides the author's predisposition, suffers from serious methodological flaws, and the charged issue needs to examined in a broader scientific perspective.
[Learn more . . . ]

Melatonin & Breast Cancer
(new) New findings show that melatonin (1) is a radioprotector agent, protecting against the organ-injury of radiation and radiotherpy; (2) protects against adriamycin-induced cardiotoxicity as well as enhancing its antitumor activity; (3) shows positive anti-breast cancer activity by decreasing aromatase activity and expression in MCF-7 cells; (4) may reduce cancer-related mortality.
[Learn more . . . ]


Inflammatory Breast Cancer

IBC Watch
(new) This new site provides an evidence-based research update on inflammatory breast cancer (IBC), focusing on new and emerging treatments.
[Learn more . . . ]


Flaxseed / Lignans
and Breast Cancer

(new) A new study found that dietary flaxseed (daily intake of 25g flaxseed-containing muffin) reduced two tumor biological markers used to measure cancer cell growth, and increased apoptosis, suggesting that dietary flaxseed has the potential to reduce tumor growth in patients with breast cancer.
[Learn more . . . ]

Depression
Adult Depression & Self Harm

By now, the association between suicidal ideation and risk of self-harm with SSRI antidepressants in children and adolescents is well known, but some studies have raised similar questions of safety and efficacy in adults.

[Learn more . . . ]

Optimal INR:
Several recent findings have critically clarified the optimal range of anticoagulation required to avoid excess mortality.

[Learn more . . . ]

Hawthorn for (CHF)
Chronic Heart Failure:

Several studies strongly suggest a significant cardioprotective effect of Hawthorn extract.
[Learn more . . . ]

Coenzyme Q10:
Evidencewatch notes that the antioxidant Coenzyme Q10 (CoQ10) has demonstrated efficacy and benefit in cardiovascular disease, especially hypertension, coronary artery disease, hyperlipidemia, and heart failure.
[Learn more . . . ]

Herbal/Warfarin Interaction:
Correcting the Record:
Despite anecdotal claims to the contrary, recent evidence has found that Coenzyme Q10 (CoQ10) and Ginkgo biloba do not influence the clinical effect of warfarin.

[Learn more . . . ]

 

Intimacy after Breast Cancer
The just published and invaluable Intimacy after Breast Cancer: Dealing with Your Body, Your Relationships, and Sex occupies a unique place in books for breast cancer survivors. As the author, two-time breast cancer survivor Gina Maisano points out,  cancer treatment often fails to address the patient's emotional and sexual psyche and concerns. This is finally remedied in this rare book where Ms. Maisano compassionately discusses these issues in a new and candid way, weaving together expert advice, scientific research, and firsthand experience.

Part One explores how to reclaim control of body and spirit, regain confidence and self-esteem, and deal with the often deep but neglected emotional and physical scars of breast cancer.  Part Two then explores how to rediscover your sexuality and reclaim your sexual self after breast cancer, instilling confidence and hope into this, the most intimate side of breast cancer.

Some Reviews:
Stacey Martello, founder the Fight Pink organization and herself a breast cancer survivor, recently reviewed the book, saying “Intimacy After Breast Cancer is a no holds barred, straight to the point guide for all of us women who have heard the words, “You have Breast Cancer.” It guides you back to your ‘before cancer’ you, helping you to reclaim your spirit, your sexuality and your relationship with yourself, and those around you.”.

The Library Journal review agreed: "Although health-care professionals prepare patients for treatments, they often fail to address the resulting emotional and sexual issues. Maisano—two-time breast cancer survivor and founder of the No Surrender Breast Cancer Foundation, which provides support for women coping with post-therapy issues—fills this void. . . . VERDICT An excellent book that fills a gap in breast cancer collections" [Library Journal, 06/01/2010].

Now, see the interview with Gina Maisano about the book on "Dr. Harvey Passes Presents ... " (click here to view).

Strongly recommended.

Other News


Smoke Watch:

Secondhand Smoke and Smoking Cessation

The Surgeon General issued (6/27/06) a comprehensive scientific report showing that there is no risk-free level of exposure to secondhand smoke: breathing even small amounts during short periods of exposure is hazardous to the health of nonsmokers: the risk of developing heart disease increases by 25 to 30% and of lung cancer by 20 to 30%. And nearly half of all nonsmoking Americans are still regularly exposed to secondhand smoke.

[Learn more . . . ]

Bisphosphonate Warning
Both Oral and IV Bone Agents
Associated with Jaw Osteonecrosis

There appears to be increased incidence of osteonecrosis of the jaw (ONJ) with prolonged bisphosphonate administration. Although it was thought that the association was restricted to IV-administered agents like zoledronic acid (Zometa) and pamidronate (Aredia), it now appears that oral bisphosphonates such as alendronate (Fosamax) and risedronate (Actonel) exhibit the same adverse potential.
To learn more:
For our technical coverage see Osteoporosis Watch and for implications with respect to breast cancer therapy, see Breast Cancer Watch. There is also consumer-oriented coverage at: Consumer Alert: Osteoporosis Drugs - A Pain in the Jaw?

 

Flawed Study Watch:
PPIs ( Proton pump Inhibitors) Increase Hip Fracture Risk
In a recent case-control study in JAMA1, University of Pennsylvania researcher Yu-Xiao Yang and colleagues examined the UK-based General Practice Research Database, concluding that long-term PPI therapy was associated with an increased hip fracture risk. But our critical appraisal found some potentially serious methodological compromises in the study and hence it may be insuffcient to support this claim:
(1)
The authors failed to control for use of calcium supplements; without calcium supplement use data, there may have been suboptimal, or little or no essential use of calcium supplements.
(2) Hip-fracture cases and controls exhibited potentially confounding between-group differences, with cases more likely to have used psychotropics like anxiolytics, antiepileptics, antidepressants, antipsychotics, and antiparkinsonian agents; yet psychtropics are independently associated with hip fracture risk2,3.
(3) In addition, corticosteriod use was higher in cases than controls, but there is a well-known increased fracture risk during oral corticosteroid therapy4.
(4) There were also additional potentially confounding between-group differences in health, with cases more likely to suffer from dementia, seizure disorders, and impaired mobility among others.

Given the above unresolved issues, further studies are required to be dispositive on the association between PPI use and the risk of osteoporosis and fracture.

1. Yang YX, Lewis JD, Epstein S, Metz DC. Long-term proton pump inhibitor therapy and risk of hip fracture. JAMA. Apr 4 2007;297(13):1429.
2. Takkouche B, Montes-Martinez A, Gill SS, Etminan M. Psychotropic Medications and the Risk of Fracture: A Meta-Analysis. Drug Saf. 2007 ;30 (2):171-84.
3. Genever RW, Downes TW, Medcalf P. Fracture rates in Parkinson's disease compared with age- and gender-matched controls: a retrospective cohort study. Age Ageing. Jan 2005;34(1):21-4.
4. Van Staa, TP, Leufkens HGM, Abenhaim L, and Cooper C. Use of oral corticosteroids and risk of fracture. J Bone Miner Res. 2000;15:993-1000.

 


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