Regulatory science forum--its background and goal

Regulatory science is, broadly speaking, the effort to insure that the products of our advanced technological civilization are developed in harmony with human needs. More specifically, regulatory science can be described as the science of evaluating the safety, efficacy and quality of these products. An unbiased assessment of these aspects is necessary for proper regulation of food, drugs, the environment, agricultural chemicals as well as the countless new materials available to the public every year. Evaluation does not interfere with product development; indeed, it often hastens the appearance of beneficial products in the public sector. Evaluation criteria should be established through consensus between industry, academia, and government and only after a thorough scientific discussion grounded in the basic principle of protecting the welfare of society's citizens. Even more important than broad-ranging knowledge is the need to develop new evaluation strategies and methodologies. Numerous problems confronting the world today can surely benefit from the evaluative techniques of regulatory science. Since research in the academic sphere often fails to address many of these issues, I want to reiterate the need for our National Institute to play a more prominent role in coordinating regulatory policy and pursuing these issues based on my firm belief that such activity is indispensable for human survival.     

Suffering for science: The effects of implicit social demands on response to experimentally induced pain.

144 undergraduates rated their pain during baseline trials of cold-pressor and finger-pressure pain in 2 experiments. After various instructional treatments, they were posttested with the same stimuli. Results show that coping suggestions significantly reduced reported pain. In Exp I (80 Ss), however, Ss often refrained from using available cognitive coping strategies to reduce pain unless they had been given explicit permission to do so. Exp II (64 Ss) replicated this finding and showed that explicit permission to "do whatever you can to reduce pain" was as effective as a coping suggestion in decreasing reported pain. Findings show that Ss' interpretation of what was appropriate responding in the test situation determined how they chose to cope with the painful stimulation. It is suggested that standard experimental procedures for assessing baseline levels of pain implicitly lead Ss to refrain from coping and thereby tend to underestimate their ability to control pain. It is further suggested that instructional techniques for coping with pain may produce much of their effect by giving Ss permission to use already available coping strategies. (39 ref) (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Response to cold pressor pain and to acupuncture analgesia in Oriental and Occidental subjects

On a no treatment trial, a group of 24 oriental subjects rated cold pressor pain as significantly more painful and distressing than did a group of 24 occidental subjects. For half of the Orientals and half of the Occidentals, a second trial was conducted after acupuncture analgesia had been induced. The remaining 12 Orientals and 12 Occidentals served as no treatment controls on trial 2. Regardless of racial group, there was no difference between the pain of those experimental subjects who received acupuncture and the pain of those controls who did not. As they had on trial 1, Orientals reported significantly more pain and distress in response to ice water on trial 2. It is concluded that: (1) if acupuncture does work better for the Chinese than for other racial groups, the likely cause is a more refined patient selection procedure rather than an inherent difference in response to acupuncture; (2) evidence does not support the stereotyped view of Orientals as stoical in the face of physical pain.     

Analgesic effects of acupuncture on the pain of ice water: A double-blind study.

Under double-blind conditions, 30 female college students were randomly assigned to either an acupuncture condition or 1 of 2 placebo conditions, and then tested on the same standardized pain task (immersion of hand in ice water). The pain ratings of the acupuncture group were significantly lower than the ratings of the placebo groups. Results support the position that acupuncture analgesia has a physiological basis, and is not simply due to suggestion. (French summary) (16 ref) (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Chronic neck pain: a comparison of acupuncture treatment and physiotherapy

OBJECTIVE: To evaluate the effectiveness of acupuncture, as compared with physiotherapy, in the management of chronic neck pain. DESIGN: Seventy adult patients with non-inflammatory neck pain of >6 weeks duration and with no abnormal neurology were randomly assigned to receive either of the treatments. Thirty-five patients were included in each group. OUTCOME MEASURES: Pain by visual analogue scale and neck pain questionnaire, improvement in range of movement of neck relative to baseline, and well-being (general health questionnaire). Measurements were recorded at the start of treatment, at 6 weeks and at 6 months. RESULTS: Both treatment groups improved in all criteria. Acupuncture was slightly more effective in patients who had higher baseline pain scores. CONCLUSIONS: Both acupuncture and physiotherapy are effective forms of treatment. Since an untreated control group was not part of the study design, the magnitude of this improvement cannot be quantified.     

Analgesia for experimentally induced pain: Multiple sessions of acupuncture compared to hypnosis in high- and low-susceptible subjects.

Repeated trials with cold-pressor pain were used to (a) determine whether the modest relation between hypnotic susceptibility and response to acupuncture analgesia obtained in previous experiments is enhanced over a series of treatments; (b) compare acupuncture and hypnotic analgesias; and (c) assess whether acupuncture analgesia increases with repeated treatments. 20 high and 20 low hypnotically susceptible undergraduates participated on 5 days. For half of each susceptibility group, Sessions 1–3 consisted of a baseline trial followed by an acupuncture analgesia trial. The remaining Ss had 2 no-treatment trials on each of these sessions. For all Ss Session 4 was a baseline followed by a hypnotic analgesia trial, and Session 5 was a repetition of the procedures followed in Sessions 1–3. Repeated exposures to acupuncture did not alter its analgesic effect in either susceptibility group; there were no instances of significant postacupuncture pain reduction. High, but not low, susceptibles reported marked pain reduction after hypnotic analgesia. The effect of acupuncture on experimentally induced pain is at best small and fragile. (32 ref) (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

The effectiveness of acupuncture in treating acute dental pain: a systematic review

OBJECTIVE: Acupuncture is frequently advocated as an effective treatment of dental pain. The question whether or not it is effective for this indication remains controversial. The aim of this systematic review therefore was to assess the effectiveness of acupuncture in dental pain. DATA SOURCES: Four electronic databases were searched: Medline, Embase, CISCOM, and the Cochrane Library. Only controlled trials were included in this review. DATA EXTRACTION: Information was extracted from included studies and entered on standard forms independently by both authors. Methodological quality was assessed using the Jadad score. MAIN RESULTS: 16 such studies were located. The majority of these trials imply that acupuncture is effective in dental analgesia. However, important questions remain unanswered. CONCLUSION: It is concluded that acupuncture can alleviate dental pain and that future investigations should define the optimal acupuncture technique and its relative efficacy compared with conventional methods of analgesia.     

Chronicle of functional pain: chronic pelvic pains

Chronic pelvic pains are one of the most frequent complaints in our daily gynecological practice, motivating at least a quarter of our consultants. As it usually puts the practitioner ill at ease in a difficult situation, we will try to understand the meaning of those particular pains, thus defined: a duration outlasting 6 months and the absence or the ineffective suppression of any organic--somatic--substratum. But every alleged pain is real and true, and we must work on that. To validate such suffering, to accept such repetitive complaints, can also be a therapeutic medical approach, even if it is less gratifying for the gynecologist, and certainly less customary.     

Reduction of cold-pressor pain with acupuncture analgesia in high- and low-hypnotic subjects.

Examined the effect of acupuncture on the cold-pressor pain of high and low hypnotically susceptible undergraduates. The 24 high-susceptible Ss and the 24 low-susceptible Ss verbally reported their course of pain over each 60-sec cold-pressor trial on a numerical rating scale. On Trial 1, in which no groups received treatment, pain ratings did not differ between groups. On Trial 2, Ss who received acupuncture reported significantly less pain than their no-treatment counterparts. The Treatment by Susceptibility interaction was significant, with high-susceptible Ss being more responsive to acupuncture. When an acupuncture effect occurred, it was invariably one of pain reduction; in no case was pain elimination reported. It is concluded that hypnotic susceptibility may be a relevant dimension of individual differences in responsivity to acupuncture. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Sickle cell disease pain in children and adolescents: change in pain frequency and coping strategies over time

Examined 9-month follow-up data obtained from children and adolescents with sickle cell disease (SCD) and their parents participating in a longitudinal study of pain coping strategies. Of 87 subjects completing the baseline assessment of pain coping strategies, 70 (80%) of their parents completed a structured pain interview assessing their child's health care use and activity reduction during painful episodes over the follow-up period. Regression analyses controlling for age and pain frequency revealed that baseline Coping Attempts were associated with higher levels of school, household, and social activity during painful episodes. Baseline Passive Adherence was associated with more frequent health care contacts during the subsequent 9 months. Increases in Negative Thinking over time were associated with further increases in health care contacts during the follow-up period. Comparing pain coping strategies assessed at baseline to pain coping strategies measured at follow-up revealed that pain coping strategies were relatively stable over time for younger children but changed more for adolescents.     

Sickle cell disease pain: Relation of coping strategies to adjustment.

This study examines pain coping strategies in a relatively neglected pain population, sickle cell disease (SCD) patients. Seventy-nine patients diagnosed with SCD were given a structured interview to assess pain, activity level, and health care use during painful episodes. Patients also completed the SCL-90—R as an index of psychological distress and the Coping Strategies Questionnaire. Regression analyses controlled for age, sex, and disease severity measures. Results indicated that the coping strategies factors were important predictors of pain and adjustment. Individuals high on Negative Thinking and Passive Adherence had more severe pain, were less active and more distressed, and used more health care services. Individuals high on Coping Attempts were more active during painful episodes. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

A review of basic science issues in low back pain

This review article is based on a workshop, "New Horizons in Low Back Pain" that was held in November 1995 in San Diego, California. The current article follows the 1995 workshop format of a series of three case study models. Three classical clinical profiles were presented for consideration: lumbar radiculopathy, idiopathic (degenerative disk) low back pain, and degenerative stenosis. This article summarizes the basic science perspectives that were presented and discussed on each topic.     

Exposure to physical movement in low back pain patients: Restricted effects of generalization.

Whether the effects of exposure to 1 movement generalize to another dissimilar movement was investigated in 37 patients with low back pain (15 men, 22 women). Two movements were executed twice: bending forward while standing and lifting 1 leg while lying down. During each trial, baseline pain, expected pain, and experienced pain were recorded. Similar ratings for perceived harm were obtained. Analyses revealed an initial overprediction of pain, but after exposure the overprediction was readily corrected. This exposure effect did not generalize toward another dissimilar movement. These results were only characteristic for patients with catastrophic thinking about pain. Low pain catastrophizers did not overpredict pain. There were no effects of exposure on perceived harm. Exposure may profitably be conceived of as the learning of exceptions to a general rule. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Fenfluramine and idiopathic pain: a serotonergic study in non-psychiatric patients with functional gastrointestinal disorder

BACKGROUND: We investigated prolactin and cortisol response to fenfluramine in non-psychiatric patients with chronic functional gastrointestinal disorder (FGD). METHODS: Sixty milligrams fenfluramine was given orally to 55 subjects without any DSM-III axis-1 psychopathology and 29 healthy control subjects matched for sex and age. Serum cortisol and prolactin levels were analysed at base line and after 120, 180, and 240 min. RESULTS: Fenfluramine challenge induced an increase in mean prolactin and cortisol serum values in both patients and controls. Female patients showed lower base-line values of prolactin and higher delta values of cortisol than controls. Male patients and controls showed very uniform values for all variables. Length of illness history influenced delta cortisol values in both sexes. CONCLUSIONS: The cortisol and prolactin responses to fenfluramine suggest a psychobiologic gender difference with a possible stress-induced central serotonergic dysfunction in female patients but not in male patients. The close relationship between length of illness and delta cortisol may also suggest an increased state of distress in females with chronic functional gastrointestinal disorder.     

The Chiropractic Outcome Study: pain, functional ability and satisfaction with care

BACKGROUND: Elevation of intraocular pressure in the supine position has been previously described in literature. Aim of this study is to investigate the elevation of intraocular pressure in normal tension glaucoma and its effect on the morphology of the optic disc, visual field function and capillary blood flow of the retina and optic disc. PATIENTS AND METHODS: 56 eyes of 28 preperimetric and advanced normal tension glaucoma patients were prospectively evaluated. Ten eyes of ten normal patients served as a control group for the measurements of the intraocular pressure. In the course of a 24-h pressure profile applanation tonometry was performed in the morning in a supine and three and ten minutes later in a sitting position with Draeger's and Goldmann's tonometers. Arterial blood pressure was measured at the same time. The optic disc's morphology was evaluated by stereo photographs and Laser Scanning Tomography. As a sensory test computer perimetry was used. Capillary blood flow was measured at defined areas of the retina and optic disc. An intraocular pressure above 21 mm Hg in the supine position was used as a criterium to define two groups of normal tension glaucoma patients. RESULTS: In the supine position a statistically significant elevation of intraocular pressure was observed in 24 normal tension glaucoma patients by 6.2 +/- 2.8 mm Hg up to 21.8 +/- 3 mm Hg. Diastolic blood pressure in the supine position (80 +/- 10.5 mm Hg) was significantly lower than in the sitting position (94 +/- 11 mm Hg, p = 0.021). 12 of 28 normal tension glaucoma patients showed an intraocular pressure lower than 22 mm Hg in the supine position. In these patients a tendency towards a higher incidence for the occurrence of optic disc haemorrhages and significantly higher values for blood flow (p < 0.0005) and volume (p < 0.005) in the retina and optic nerve head could be shown. In this group of normal pressure glaucoma patients a higher incidence of migraine and vasospastic complaints was reported in the patients' history. CONCLUSION: In this study some normal tension glaucoma patients showed intraocular pressures in the supine position higher than 21 mm Hg and a lower diastolic arterial pressure. The higher incidence of haemorrhages and higher values for flow and volume parameters of the optic disc in normal tension glaucoma patients with an intraocular pressure lower than 22 mm Hg implicate the existence of two entities: real and pseudo normal tension glaucomas.