Lepor H, Williford WO, Barry MJ, Brawer MK, Dixon CU.
The efficacy of terazosin, finasteride or both in benign prostate hyperplasia.
N Engl J Med 1996; 335:533-9.

Research question

There are two main types of medications for the treatment of benign prostate hyperplasia (BPH): the first are α-adrenergic-antagonist drugs (eg, terazosin) that relax the smooth muscle in the prostate and the second are 5-α-reductase inhibitors (eg, finasteride) that block formation of dihydrotestosterone and thereby shrink the prostate. Which works better? Does a combination of the two drugs work best?

Type of article and design

Randomized, controlled trial of therapy.

Relevance to family physicians

In the last few years you could hardly open a medical journal without being bombarded with information about finasteride (Proscar). Many of us were using terazosin (Hytrin) also to treat BPH patients who had symptoms or were tired of “watchful waiting.” Terazosin is cheaper, is covered on most provincial formularies, and works faster, but we often wondered which drug was more effective and whether a combination could be used for treatment-resistant cases to prevent surgery. In the United States in 1990, more than 329000 men had transurethral prostatectomies (TURPs). A TURP is very effective but patients are understandably concerned about the side effects of surgery. Benign prostatic hyperplasia is extremely common and becomes more common with age. It can have a deleterious effect on quality of life, especially in the context of such conditions as chronic disease and depression.

Overview of study and outcomes

This study recruited 1686 men, aged 45 to 80 years, who had symptomatic benign prostate hyperplasia and were seen at Veterans Affairs medical centres. During a 4-week lead-in time, the men received a placebo and were evaluated twice using the American Urological Association’s (AUA) symptom index; to be eligible, men had to score at least 8 points out of 35.

Uroflometry, residual volume after voiding, serum concentrations of prostate-specific antigen (PSA), urine culture and sensitivity, and transrectal ultrasound examinations were all performed. No threshold level of prostatic enlargement was required (which fits with current evidence that severity of BPH is not simply a function of size). Exclusion criteria were use of similar medications to those being tested, symptoms of severe coronary artery disease, orthostatic hypotension, prostate cancer, history of prostate surgery, and active urinary or kidney disease. This left 1229 men (73% of those recruited) who were mostly white, averaged approximately 65 years old, had prostatic volumes of 37 cm³, had PSAs of 2 to 3, and had AUA symptom scores of an average 16 out of 35.

Results

The men at each site, randomized to finasteride, terazosin, combination therapy, or placebo, were evaluated at 2, 4, and 8 weeks and then every 6 weeks for 1 year for AUA symptom scores and peak urinary flow rates. Symptom scores in each of the four groups had decreased at 1 year by 2.6 (placebo), 3.2 (finasteride), 6.1 (terazosin), and 6.2 (combination) points (P < 0.001). Peak urinary flow rates had increased by mean values of 1.4, 1.6, 2.7, and 3.2 mL/sec, respectively (P < 0.001). Adverse effects caused 1.9% of the placebo group, 6.2% of the finasteride group, 7% of the terazosin group, and 9.4% of the combination group to drop out. As expected, dizziness was significantly more frequent in the terazosin group. Impotence and decreased libido were significantly more frequent among finasteride subjects. Combination therapy had these side effects and significantly more ejaculatory abnormalities.

Analysis of methodology

This sophisticated, four-arm, randomized trial had good follow up and compliance. Groups were similar at the start of the trial and were treated equally with intention-to-treat analysis.

Application to clinical practice

This study is interesting in that it tells us that a drug that many physicians are prescribing is no better than placebo.

This conflicts with some previous data, and the editorial accompanying the study tells why: benign prostate hyperplasia is not a homogeneous process and size does not predict symptoms. This study had no threshold size of prostate whereas the previous two studies positive for finasteride were restricted to men with larger prostates (60 mL² and 47 mL², respectively). Given the mechanism of shrinking or debulking with finasteride, those with larger prostates might well do better than they did with placebo.

What is the clinical significance of a 3- to 4-point reduction out of 35 in an AUA symptom score? It might be worthwhile for patients with severe symptoms who are getting up at night repeatedly to urinate, but perhaps not for patients with milder symptoms who wish to avoid the adverse effects of terazosin. Including some patient-oriented outcomes might have been helpful to further assess the benefits of treatment against the adverse effects of medications. Quality-of-life measurements might have been helpful also to assess how lower scores and increased flow allowed better social functioning, especially for elderly or chronically ill men.

Bottom line

Terazosin is probably the first-line drug of choice for benign prostate hyperplasia given its effectiveness, low cost, and rapid action.

Finasteride did no better than placebo in this trial. Patients who are treatment resistant and have large prostates might choose finasteride as a final alternative if they wish to delay surgery. The mixed results of this trial indicate the heterogeneous nature of this disease process and dispel the myth that all symptoms of BPH are simply the result of an enlarging prostate.

Private Parts. An Owner's Guide to the Male Anatomy, 2nd Ed

Yosh Taguchi

McClelland & Stewart Inc, Suite 900, 481 University Ave, Toronto, ON M5G 2E9
1996/320 pp

Strengths

Easy to read, no-nonsense language, mostly accurate information

Weaknesses

Not always strongly evidence-based, sometimes too much emphasis on surgery, not patient-centred

This is Dr Taguchi’s second and updated edition of his “Canadian bestseller” first published in 1988. He is a well-known Montreal urologist who says he wrote this as “… the answer to all those questions I have ever been asked… in my office.” Further, as it says on the jacket, “Most men know more about their cars than about the workings of their own bodies.” Many family physicians would agree.

This book is a cleanly laid out, how-to manual for men who want to know more about their genitourinary system. The first chapter deals with basic anatomy and functions. The rest covers various problem areas, such as impotence (when will the medical establishment call this erectile dysfunction?), infertility, vasectomy, lumps, prostate problems, sexually transmitted diseases, and incontinence. The information is straightforward and accurate, and the last few pages contain commonly asked questions and answers.

The section on prostate problems is full of details on diagnosis and management. The author, however, gives too much information on surgical aspects, walking readers through every detail of how he performs the surgery. I also objected to the way routine prostate-specific antigen screenings and almost routine surgery (for prostate cancer) were encouraged. The evidence is still unclear about whether routine prostate-specific antigen screenings help, and no one will pass the College of Family Physicians of Canada’s (CFPC) examination if they push surgery for prostate cancer. I also believe the author makes too light of the quite high postoperative rates of erectile dysfunction. I have fewer points to criticize in the other sections. The details on STDs are good, and I liked the case reports in the section on lumps. This book might not pass the CFPC’s standard for patient-centred material; however, I recommend it as a practical book for patients and residents as long as their physicians read it first.

Finasteride reduced symptoms and need for surgery for benign prostatic hypertrophy. Commentator, Barry, M. Massachusetts General Hospital, Boston, MA, USA.
Evidence-based Medicine, 3(4): 107, July/Aug. 1998.

The following article is briefly presented

The effect of finasteride on the risk of acute urinary retention and the need for surgical treatment among men with benign prostatic hyperplasia. McConnel, J., Bruskewitz, R., Walsh, P. et al.
N Engl J Med, 338: 557-563, 26 Feb. 1998.

This was a 4-year randomized double-blind placebo-controlled trial involving around 3000 men who had BPH with moderate to severe lower urinary tract symptoms, decreased maximal urine flow rates and an enlarged prostate. They were randomized to receive either finasteride at 5 mg/day or placebo for 4 years.

The authors found the following:

• Those who had received finasteride had significantly greater decreases in symptom scores. Significantly fewer men in the finasteride group had surgery or acute urine retention.

•There was a significantly higher incidence of side effects in the finasteride group.

Commentary

The commentator suggests that patients should make an informed choice concerning treatment for BPH, as neither treatment option is particularly risky. The Veterans Affairs study (N Engl J Med, 1996) found terazosin to be superior to finasteride. A combination of ct-blocker and finasteride may work well for the long-term conservative management of BPH.

Editorial – Controversy in managing patients with prostate cancer. Mulley, A. and Barry, M. General Medical Division, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.
BMJ, 316(7149): 19219-19220, 27 June 1998.

and

Dilemmas in treating early prostate cancer: the evidence and a questionnaire survey of consultant urologists in the United Kingdom. Donovan, J., Frankel, S., Faulkner, A., Selley, S., Gillat, E. and Hamdy, F. Department of Social Medicine, University of Bristol, Bristol, UK.
BNU, 318(7179): 299-300, 30 Jan. 1999.

The effectiveness of radical treatments (prostatectomy and radiotherapy) for prostate cancer over conservative management (surveillance plus hormonal therapy if required) is debatable. Also, quality of life after radical treatment may be poor compared with conservative management. Because of this lack of evidence, controversy still remains over the best form of treatment. Two surveys of British urologists (Savage asked 274 urologists, Br J Urol, 1997; Donovan asked 244 urologists, BMJ, Jan. 1999), found that most favoured active treatment in men aged under 70 years. However, the Savage survey found that this view was contradictory to their views on screening. Most felt that early detection did not confer any survival advantage. Because of these dilemmas, the Prostate Cancer Clinical Guidelines Panel of the American Urological Association have advised that patients should be presented with all the possible treatment alternatives so that they can make informed choices for themselves.

Book: Urinary Incontinence in the Elderly. Pharmacotherapy Treatment

Urinary Incontinence in the Elderly. Pharmacotherapy Treatment

Editor: James W. Cooper

The Haworth Press, Inc, 10 Alice St, Binghamton, NY 13904-1580 USA

1997, 72 pp

Overall Rating

Good

Strengths

Comprehensive, current, useful information

Weakness

Information is difficult to access, is in table format, and is in small print

Audience

Family physicians, other health care providers, and caregivers

Urinary Incontinence in the Elderly is not so much a textbook as it is a collection of papers dealing with different aspects of urinary incontinence (UI). As such, the articles might be useful to different audiences.

For physicians whose practices primarily involve the elderly, either in the office or in long-term care settings, this book has many excellent features. There is a comprehensive overview of the risk factors, clinical evaluation, and treatment of urinary incontinence. This information is presented primarily in table format. Although the title suggests only pharmacologie treatment, other management options, such as behavioural interventions and surgical treatments, are described.

For physicians working in chronic care settings and learning about assessment, laboratory tests that include urodynamic studies and current pharmacologie treatment are invaluable. Physicians in the office recognize urinary incontinence in the aging population as a common and distressful condition. As such, any measures, pharmacologie or behavioural, to minimize the problem, will be appreciated.

Most of the information, useful as it is, is presented in tables and logarithms. One chapter, however, is a paper on caregiver guidelines that is written in text format. It is directed toward non-professional caregivers responsible for people at home or in institutions. This material is clear and well organized. It can be photocopied and given to patients and their families.

One drawback is the small size of the book and the minuscule print — a great disadvantage for many of us.

Overall, the information could be better organized and more visible. If readers are willing to accept these drawbacks, the text is current and helpful.

Book: Everyone's Guide еo Cancer Therapy

, 2nd Ed

Authors: Malin Dollinger, Ernest H. Rosenbaum, Greg Cable

Editor: Richard Hasselback

Somerville House Books limited, 3080 Yonge St, Suite 5000, Toronto, ON M4N 3N1

1995, 706 pp

Overall Rating

Good

Strengths

A good overview of cancer care for health professionals from a psychosocial, technical, and medical perspective. Forty-seven common cancers are concisely described in the last part of the book

Weaknesses

Content varies greatly in technical complexity, making it difficult reading for general readers. The book implies that it is accessible to everyone but remains a resource for health professionals

Audience

Health professionals, including family physicians, nurses, interns, residents, and medical students. Those very knowledgeable in health science could be a secondary audience

I anticipated the opportunity to read this book because of my clinical care of people living with cancer, and more recently, my contact with family members living with cancer.

The book is divided into five parts: diagnosis and treatment; supportive care; quality of life; new advances in research, risk assessment, diagnosis, and treatment; and treating common cancers. At the end, there is a glossary, a section on common anticancer drugs, a directory of resources, and a list of suggested readings.

The title is popular and eye-catching. An authoritative book that provides information on the diagnosis, treatment, and management of cancer for a wide audience is very appealing. After a thorough review and careful analysis, I faced the conundrum of determining who would be able to access and benefit from this book. After my review, it was clear that only parts of this book are accessible to everyone.

Authors and editors of medical review books face a difficult task when they seek to address technical, medical, psychological, social, and other components in the same book. The challenge is more daunting when the book targets a diverse audience, including patients and health professionals. These types of books must be concerned about being accessible and understandable. Overall, this book variés greatly in the quantity of complex technical and medical content contained in its chapters. Parts II, III, and the directory of resources will be valuable to patients living with cancer, their families, and their friends. However, the more technical and cancer-specific chapters in parts I, IV, and V are best suited to health professionals.

I wanted to validate this assessment by asking a family member with cancer to review chapters of the book. This woman has been living with cancer for more than 5 years and has been actively involved in her care and learning about cancer since her diagnosis. She concluded that chapters in parts II and III were mainly understandable, with some exceptions. The chapters in parts IV and V were not. The cancer-specific chapters in part V were the most difficult

She concluded that too much inaccessible information in this book made it unsuitable for either everyone or every patient. In her opinion, books targeted to include patients in their readership have an obligation to be comprehensible. A book that cannot be understood by patients lessens their confidence in learning and participating in their care and makes them more fearful of their disease.

I respect the good intentions of the authors who wrote this book and the Canadian editor who adapted it. However, the title is a disservice to most readers. If this book was intended to inform and educate patients living with cancer, their families and Mends, the authors would have benefited by integrating members of this audience into the development and review process.

As a physician, I enjoyed reading the chapters in the first four parts. They provided a quick overview of cancer diagnosis, treatment, and the issues related to the holistic care of patients living with cancer. Part V, treating common cancers, was a concise, well organized source of information on risk factors, screening, presenting signs and symptoms, diagnostic tests, disease classification and staging, and treatment. For health care professionals, there is sufficient psychosocial, technical, and medical information to make the book worthwhile. Further, part V can serve as a concise clinical reference. This information will help physicians coordinate the care of their patients living with cancer.

J. Curtis Nickel; Richard W. Norman
Grosvenor House Press Inc, King West Centre, 2 PardeeAve, Suite 203, Toronto, 0NM6K3H5. Available through the Canadian Medical Association, PO Box 8650, 1867 Alta Vista, Ottawa, ON K1G 0G8, 1993, 88 pp

This attractive softcover manual is part of the Canadian Medical Association’s Disease Management / Patient Counselling series. Written by two urologists, the chapters, though short, cover essential material in enough depth that readers do not feel shortchanged or patronized. References are sufficient and up-to-date, and the text is well written, well organized, well presented, and well illustrated.

Topics covered include the definition, pathology, pathophysiology, and natural history of benign prostatic hyperplasia. Symptoms and signs are lucidly explained. Investigative procedures that are sometimes necessary are explained, but needless investigations are discouraged. A variety of therapeutic options are described, including “watchful waiting”; medical therapy with α-adrenergic blockers, such as terazosin; 5-alpha reductase inhibitors, such as finasteride; luteinizing hormone-releasing hormone analogues and androgen antagonists; and many traditional and more innovative surgical procedures.

The book is well balanced, and there is no evidence of bias in favour of surgical treatment. Even the references to prostate-specific antigen (PSA) testing, while inevitably encouraging it (the authors are urologists), includes the statement: “Whether earlier detection (of prostate cancer) will be beneficial can only be determined by long-term (ie, 10-year) studies of screened populations.”

This is a fine monograph, which is both useful and easy to read. Drs Nickel and Norman are to be congratulated for doing a first-class job.