Sunday, November 06, 2005

Botox for Headaches

From Headache
The Journal of Head and Face Pain

Botulinum Toxin Type A for the Prophylaxis of Chronic Daily Headache: Subgroup Analysis of Patients Not Receiving Other Prophylactic Medications: A Randomized Double-Blind, Placebo-Controlled Study
David W. Dodick, MD; Alexander Mauskop, MD, FAAN; Arthur H. Elkind, MD; Ronald DeGryse, MA, MS; Mitchell F. Brin, MD; Stephen D. Silberstein, MD


Objective: To assess the efficacy and safety of botulinum toxin type A (BoNT-A; BOTOX®, Allergan, Inc., Irvine, CA) for the prophylaxis of headaches in patients with chronic daily headache (CDH) without the confounding factor of concurrent prophylactic medications.

Background: Several open-label studies and an 11-month, randomized, double-blind, placebo-controlled study suggest that BoNT-A may be an effective therapy for the prophylaxis of headaches in patients with CDH.

Design and Methods: This was a subgroup analysis of an 11-month, randomized double-blind, placebo-controlled study of BoNT-A for the treatment of adult patients with 16 or more headache days per 30-day periods conducted at 13 North American study centers. All patients had a history of migraine or probable migraine. This analysis involved data for patients who were not receiving concomitant prophylactic headache medication and who constituted 64% of the full study population. Following a 30-day screening period and a 30-day single-blind, placebo injection, eligible patients were injected with BoNT-A or placebo and assessed every 30 days for 9 months The following efficacy measures were analyzed per 30-day periods: change from baseline in number of headache-free days; change from baseline in headache frequency; proportion of patients with at least 30% or at least 50% decrease from baseline in headache frequency; and change from baseline in mean headache severity. Acute medication use was assessed, and adverse events were recorded at each study visit.

Results: Of the 355 patients randomized in the study, 228 (64%) were not taking prophylactic medication and were included in this analysis (117 received BoNT-A, 111 received placebo injections). Mean age was 42.4 ± 10.90 years; the mean frequency of headaches per 30 days at baseline was 14.1 for the BoNT-A group and 12.9 for the placebo group ( P = .205). After two injection sessions, the maximum change in the mean frequency of headaches per 30 days was -7.8 in the BoNT-A group compared with only -4.5 in the placebo group ( P = .032), a statistically significant between-group difference of 3.3 headaches. The between-group difference favoring BoNT-A treatment continued to improve to 4.2 headaches after a third injection session ( P = .023). In addition, BoNT-A treatment at least halved the frequency of baseline headaches in over 50% of patients after three injection sessions compared to baseline. Statistically significant differences between BoNT-A and placebo were evident for the change from baseline in headache frequency and headache severity for most time points from day 180 through day 270. Only 5 patients (4 patients receiving BoNT-A treatment; 1 patient receiving placebo) discontinued the study due to adverse events and most treatment-related events were transient and mild to moderate in severity.

Conclusions: BoNT-A is an effective and well-tolerated prophylactic treatment in migraine patients with CDH who are not using other prophylactic medications.

Thursday, November 03, 2005

Pregnancy and Back Pain


A woman's body undergoes significant hormonal and physical changes during the nine months of pregnancy. For most women, this can lead to back pain as an unavoidable side effect during this time.Early in pregnancy, certain hormonal changes result in increased joint laxity. As a result, the spine, abdominal and back muscles,and posture of the low back change and become more relaxed.Poor posture and poor muscle tone prior to pregnancy can affect how the back adjusts. The lumbar (lower back) curve begins to increase slightly as the pelvis tilts backward. This posture begins to influence the weakened and now fatigued lower back muscles. A woman may experience mildly painful spasms, which can be the first sign of a persistent backache in early pregnancy.

As the pregnancy progresses:

  • The abdomen protrudes.

  • Both gravity and hormonal changes continue to relax the

  • muscles of the low back and abdomen.

  • The increased lumbar curve places stress on the lower

  • back muscles and lumbar spine.

  • The chance of back pain rises significantly with activity.

Without treatment, the frequency of muscle spasms and pain may increase.

Back pain during pregnancy can usually be managed with:

  • Using better posture

  • Learning about body mechanics (proper sitting, bending,

  • lifting, etc.)

  • Using an external brace or support

  • Following a proper exercise plan

Sciatica during pregnancy can also develop from the increased size of the baby itself. The growing fetus can place pressure directly on the nerves of the lumbar area, causing direct pressure and pain. Sciatica almost always goes away after delivery.

Pregnancy & Back Pain

Oh my aching back!

From Robin Elise Weiss, LCCE,
Your Guide to Pregnancy / Birth.
FREE Newsletter. Sign Up Now!

Back pain and pregnancy just seem to go together! When you see a pregnant woman you see her rubbing her belly and holding her back. Why is it that the majority of pregnant women will have back ache as a nearly daily complaint? And, more importantly, what can you do about it?

Why Your Back Hurts

When you are pregnant your body produces a variety of hormones. One of these hormones is called Relaxin. Sounds like something really soothing and helpful, which it is, for birth. Relaxin causes the ligaments and the pelvis to soften to allow the baby out through the pelvis. This is also why pregnant women "waddle."

In addition the pelvis relaxing for the upcoming event of birth, your uterus is growing and this does two things:

  • Changes your center of gravity
  • Relaxing uterine ligaments cause additional strain to be placed on the spine and your surrounding muscles
  • Your overstretched abdominal muscles are also not equipped to handle the entire weight of the uterus so your spine and back muscles will bear this extra burden as well.

Posture is another culprit. As your mother would say, "Stand up straight, shoulders back..." I would add, "Uterus up and out, be proud!"

If this is not your first pregnancy you have two additional concerns regarding your back: your older children and the fact that second pregnancies tend to experience all symptoms of pregnancy a bit earlier on. Ensure that you lift you children using your legs and not your back, when bathing them kneel at the tub instead of bending at the waist (What waist?), or have someone else take on these chores. Children may need a bit of an explanation why you can't carry them around as much, but in the long run you will be grateful for protecting your back.


Prevention is the best management for this discomfort. Preventative measures include:

  • Exercises (Particularly Pelvic Tilts)
  • Paying attention to your posture
  • Lifting and bending appropriately

Pregnancy and Back Pain

From the Editors of health magazine

With a weight bulge challenging a woman's center of gravity, it's no wonder that half of pregnant women battle back pain. While most back pain goes away within six weeks of childbirth, about 15 percent of new moms still flinch with lingering aches, says Alan M. Levine, M.D., a Baltimore-based orthopedic spine surgeon and editor in chief of the Journal of the American Academy of Orthopaedic Surgeons. Protect your back with Levine's strain-saving strategies:

Tone your ab and back muscles. During pregnancy, exercise as far along in the process as your doctor allows. After giving birth, start crunches and back extensions as soon as possible (for most women this means one week -- C-section, six weeks -- but check with your doctor).

Keep moving. Regular aerobic activity and stretching (as simple as bending over and reaching for your toes) will loosen and warm up muscles, making them less vulnerable to getting twisted and pulled out of whack.

Lift correctly. Holding weight at arm's length will strain muscles more than carrying items close to your chest. Avoid reaching over obstacles: Lower the side of the crib; remove the high-chair tray. (Even non-moms can benefit from lifting the right way.)

Carry with care. Do not prop a child on your hip; this overloads the back muscles. Try a backpack or a Snugli.

Just like extra pounds, back pain should eventually be part of a new mom's past. If you're using these strategies and pain persists longer than six weeks or gets worse, see a doctor. Also, if the pain radiates from your back down into your legs, it could be a sign of something more serious, such as a disk herniation, which will need a doctor's attention.