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Biomedical subjects

M F Gallo

Publications and source records attributed to M F Gallo.

At least 37 records · Page 2Linked to original sources

Hormonal contraception during lactation. systematic review of randomized controlled trials.

Contraception choices may be limited for lactating women due to concerns about hormonal effects on quality and quantity of milk, passage of hormones to the infant and infant growth. We conducted a systematic review of randomized controlled trials to determine the effect of hormonal contraception on lactation. We sought all randomized controlled trials, reported in any language, that included any form of hormonal contraception compared with another form of hormonal contraception, nonhormonal contraception or placebo during lactation. Seven reports from five randomized controlled trials met the inclusion criteria. Most of the five trials did not specify their method used to generate a random sequence, method of allocation concealment, blinding of treatments or use of an intention-to-treat analysis. Additionally, high loss-to-follow-up rates invalidated at least two trials. The findings from two trials comparing oral contraceptives to placebo during lactation were conflicting. Another trial found no inhibitory effects on lactation from progestin-only contraceptives. Finally, the World Health Organization trial found a statistically significant decline in breast milk volume in women using combined oral contraceptives compared to women using progestin-only pills. However, infant growth for the two groups did not differ. The limited evidence from randomized controlled trials on the effect of hormonal contraceptives during lactation is of poor quality and insufficient to establish an effect of hormonal contraception, if any, on milk quality and quantity. At least one properly conducted randomized controlled trial of adequate size is urgently needed to make recommendations regarding hormonal contraceptive use for lactating women.

Contraceptives, Oral, Combined↗

Cervical cap versus diaphragm for contraception.

BACKGROUND: The cervical cap and the diaphragm are vaginal barrier contraceptive methods that prevent pregnancy by covering the cervix. The two devices also act as a reservoir for spermicide. The cervical cap is smaller and can remain in place longer than the diaphragm. Two types of cervical caps, the Prentif cap and the FemCap, have been compared to the diaphragm in randomized controlled trials. OBJECTIVES: The review seeks to evaluate the contraceptive efficacy, safety, discontinuation, and acceptability of the cervical cap with that of the diaphragm. SEARCH STRATEGY: We searched MEDLINE, Popline, Cochrane Controlled Trials Register, EMBASE, and LILACS for randomized controlled trials of cervical caps, and we reviewed the references of the included publications. Also, we wrote to the manufacturers and known investigators to request information about any other published or unpublished trials not found in our search. SELECTION CRITERIA: All randomized controlled trials in any language comparing a cervical cap with a diaphragm were eligible for inclusion. DATA COLLECTION AND ANALYSIS: All titles and abstracts located in the literature searches were assessed, and articles identified for inclusion were independently abstracted by two reviewers. Data were entered and analyzed with RevMan 4.1, and a second reviewer verified the data entered. Outcome measures include contraceptive efficacy, safety, discontinuation, and acceptability. Outcomes were calculated as Peto odds ratios with 95 percent confidence intervals using women as the denominators. Life-table and Kaplan-Meier cumulative rate ratios for selected measures were also presented in "Additional Tables." MAIN RESULTS: The Prentif cap was comparable to the diaphragm in preventing pregnancy, but the FemCap was not as effective in preventing pregnancy as its comparison diaphragm. The curves for the life-table cumulative pregnancy rates through 24 months for the Prentif cap and the diaphragm were not statistically significantly different (p-value of 0.39). However, the six-month Kaplan-Meier cumulative pregnancy rates for the FemCap and the diaphragm did not meet the a priori definition of clinical equivalence. The Prentif cap had a higher proportion of Class I to Class III cervical cytologic conversions at the three-month visit than the diaphragm; the odds ratio was 2.3 (95% CI, 1.0-5.1). The FemCap trial did not find differences in Papanicolaou smear results between the cap and diaphragm groups. Prentif cap users had a lower odds ratio of vaginal ulcerations or lacerations (0.3; 95% CI, 0.1-0.7) than diaphragm users. FemCap users had a higher odds ratio of blood in the device on removal (2.3; 95% CI, 1.3-4.1), but a lower odds ratio of urinary tract infections (0.6; 95% CI, 0.4-1.0) than those in the diaphragm group. In the FemCap trial, similar proportions of women reported liking their assigned device "somewhat" or "a lot" at the two-week interview. However, FemCap users were less likely than the diaphragm users to state that they were "probably" or "definitely" likely to use the device alone after completing the trial (odds ratio of 0.5; 95% CI, 0.3-0.7) or that they would recommend it to a friend (odds ratio of 0.5; 95% CI, 0.3-0.8). REVIEWER'S CONCLUSIONS: The Prentif cap was as effective as its comparison diaphragm in preventing pregnancy, but the FemCap was not. Both cervical caps appear to be medically safe.

Adult↗

Terbutaline pump maintenance therapy after threatened preterm labor for preventing preterm birth.

BACKGROUND: Women with preterm labor that is arrested with tocolytic therapy are at increased risk of recurrent preterm labor. Terbutaline pump maintenance therapy has been given to such women to decrease the risk of recurrent preterm labor, preterm birth, and its consequences. OBJECTIVES: To determine the effectiveness and safety of terbutaline pump maintenance therapy after threatened preterm labor in preventing preterm birth and its complications. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group trials register (searched May 2002) and the Cochrane Controlled Trials Register (Cochrane Library Issue 2, 2002). SELECTION CRITERIA: Randomized trials comparing terbutaline pump maintenance therapy with alternative therapy, placebo, or no therapy after threatened preterm labor. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed the studies for inclusion and then extracted data from eligible studies. MAIN RESULTS: We included two studies. Terbutaline pump maintenance therapy did not appear to offer any advantages over the saline placebo pump or oral terbutaline maintenance therapy in preventing preterm births by prolonging pregnancy or its complications among women with arrested preterm labor. The weighted mean difference (WMD) for gestational age at birth was -0.1 weeks (95% confidence interval (CI) -1.7 to 1.4) for terbutaline pump therapy compared with saline placebo pump for both trials combined and 1.4 weeks (95% CI -1.1 to 3.9) for terbutaline pump versus oral terbutaline therapy for the first trial. The second trial reported a relative risk (RR) of 1.17 (95% CI 0.79 to 1.73) of preterm birth (less than 37 completed weeks) and a RR of 0.97 (95% CI 0.51 to 1.84) of very preterm birth (less than 34 completed weeks) for terbutaline pump compared with saline placebo pump. Terbutaline pump therapy also did not result in a higher rate of therapy continuation or a lower rate of infant complications. No data were reported on long-term infant outcomes, costs, or maternal assessment of therapy. REVIEWER'S CONCLUSIONS: Terbutaline pump maintenance therapy has not been shown to decrease the risk of preterm birth by prolonging pregnancy. Furthermore, the lack of information on the safety of the therapy, as well as its substantial expense, argues against its role in the management of arrested preterm labor. Future use should only be in the context of well-conducted, adequately powered randomized controlled trials.

Drug Administration Schedule↗

Nimesulide in the treatment of menstrual migraine.

In a controlled double-blind clinical trial, 30 patients aged 18 to 45 years, with menstrual migraine, were randomly assigned to 2 parallel treatment groups of 15 patients each. One group received granular nimesulide 100mg 3 times daily and the other group received placebo. Each treatment was given for 10 days, starting from the onset of migraine symptoms, and was repeated for the 2 following menstrual cycles. The overall assessment of efficacy in the 2 groups was based on hourly self-evaluation of pain during each study day. In patients treated with nimesulide, pain intensity and duration were significantly reduced compared with placebo (p = 0.0001) during all the menstrual cycles in the study.

Adolescent↗

Genetic markers of cluster headache and the links with the lithium salts therapy.

The existing relationship between genetic markers of the cluster headache and the efficacy of lithium salts therapy was described in the present study. Thirty-five patients suffering from cluster headache, who were already typed for the HLA antigens, were studied. Typing was carried out with the microlymphocytotoxicity technique used by US National Institutes of Health. The patients were treated with lithium carbonate for a period of three months. Three parameters for evaluation of the efficacy of lithium therapy was used: the percentage of improvement, the wake-sleep rhythm and the pupil diameter measurement. The parameters were statistically (Student's t-test) evaluated and it was possible to separate two subgroups of patients: "responders" and "non-responders" to the lithium therapy. The phenotypical frequencies in the two subgroups was analysed using the chi 2 test, Data emerging showed a higher frequency of antigen HLA-B18 (23.8% versus 0%; p less than 0.005 pc less than 0.06) and of antigen HLA-A9 (42.9% versus 14.3%) in the "responders" subgroup. In the "non-responders" subgroup a higher frequency of antigen HLA-A1 (35.7% versus 14.3%) was found.

Adult↗

Telethermographic investigations in migraine patients before and after flunarizine treatment.

Fifty migraine patients were tested prior to and after a three-month period of flunarizine treatment (10 mg per day) by means of a new computerized telethermography apparatus. At completion of therapy a new computerized telethermography was carried out. The telethermographic data obtained showed an improvement in 70% of the cases; for the other patients telethermographic relevant modifications were not singled out.

Adult↗

[Verification of the validity of the Giacovazzo skin test with histamine at neutral pH].

In this study the different activities of histamine chloride and histamine phosphate have been tested in the cutaneous test as Giacovazzo in patients with Cluster Headache. The Authors executed the test in 20 C.H. patients and in 20 control subjects, using histamine chloride and phosphate. In order to evaluate the results, three parameters were taken into consideration: Latency Time, Hyperemia Diameter and Extinction Time. A statistical (non orthogonal) comparison of data obtained, showed no difference within the groups, while it showed the significant difference (p less than 0.001) between the groups. There was no difference between the activity of histamine chloride and phosphate in the "histamine skin test" as Giacovazzo.

Histamine↗

[New contributions on extinction tests of essential headache. I. The test with lysine acetylsalicylate].

We report some preliminary results of a study carried out in ten patients observed during headache attack and concerning particularly the plasma values of beta-ELI after acetylsalicylic acid (lysini acetylsalicylas: i.v. 1.8 g) administration. Blood samples for beta-ELI determination were drawn every ten minutes for 30 minutes beginning at time of drug administration. Plasma was immediately separated and stored at -20 degrees C until assayed. Lysini acetylsalicylas administration gave in our subjects a significant relief from pain, with a disappearance of headache in all cases. We showed, in comparison with basal conditions, increased-plasma beta-ELI values after drug administration. The levels of pain were evaluated by the analogic visual scale.

Adult↗

[New contributions on extinction tests of essential headache. II. The test with indoprofen].

The authors described the results about the action of indoprofen (i.v. 400 mg) in three subjects affected by premenstrual migraine. They showed decreased levels of PGF2 alpha in the cerebrospinal fluid evaluated by gas-chromatography and mass spectrometry. The samples were extracted at 0, 15, 30 and 45 minutes. The levels of pain, was also decreased, they were evaluated by the analogic visual scale (V.A.S.).

Adult↗

Low plasma testosterone levels in cluster headache.

Serum levels of various hormones have been estimated in cluster headache and non-cluster headache controls. Cluster headache patients were studied prior to, during, and after attack. During the cluster phase, plasma testosterone levels were low, whereas levels were within the reference limits. Normal values were also found in control patients with non-cluster headache. It is suggested that a decrease of plasma testosterone levels in episodic cluster headache should be viewed in context with disordered REM sleep in cluster headache.

Adolescent↗

Histamine skin test in cluster headache: effects of dihydroergotamine with timed release.

The histamine skin test, as modified by Giacovazzo, was carried out on 20 patients with cluster headache and on 20 control subjects, 10 of whom suffered from migraine and 10 who were healthy volunteers not presenting any form of headache. The test was carried out before and after 30 days treatment with timed-release dihydroergotamine methanesulphonate in a dose of 10 mg/day. Data recorded on a "headache time chart" before and after treatment were evaluated by statistical analysis. Block variance analysis was used to evaluate results of three parameters (latency time, hyperemia diameter, extinction time) emerging from the histamine skin test before and after treatment. A statistical comparison was also made of data obtained in basal conditions in the three groups of subjects, in order to confirm the usefulness of this simple test in the diagnosis of cluster headache.

Adult↗